130508_FANTIC%20M%2014070_01

Toelatingsnummer 14070 N
Fantic M
14070 14070 NN
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 VOORLOPIGE TOELATING
Gelet op de aanvraag d.d. 13 november 2008 (20080938 TGV) van
Makhteshim-Agan Holland B.V.
Arnhemseweg 87
3832 GK LEUSDEN
tot verkrijging van een voorlopige toelating als bedoeld in artikel 80, vijfde lid Verordening (EG)
1107/2009 juncto artikel 34, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor het
gewasbeschermingsmiddel, op basis van de werkzame stoffen benalaxyl-M en mancozeb,
Fantic M
gelet op artikel 80, vijfde lid Verordening (EG) 1107/2009 juncto artikel 34, eerste lid, Wet
gewasbeschermingsmiddelen en biociden,
IS HET COLLEGE VOORNEMENS OM TE BESLUITEN als volgt:
1.1 Toelating
Het middel Fantic M is toegelaten voor de in bijlage I genoemde toepassingen onder nummer
14070 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar
bijlage II bij dit besluit.
De toelating geldt tot 1 mei 2016.
1.2 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.3 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij
dit besluit is voorgeschreven.
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,
Fantic M
14070 N
1. De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer
en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding
milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld,
worden hierbij vastgesteld als volgt:
aard van het preparaat: Water dispergeerbaar granulaat
werkzame stof: gehalte:
mancozeb 650 g/kg
benalaxyl-M 40 g/kg
letterlijk en zonder enige aanvulling:
andere zeer giftige, giftige, bijtende of schadelijke stof(fen):
-
gevaarsymbool: aanduiding:
Xn Schadelijk
N Milieugevaarlijk
Waarschuwingszinnen:
R50/53 -Zeer vergiftig voor in het water levende organismen; kan in het
aquatisch milieu op lange termijn schadelijke effecten
veroorzaken.
R63 -Mogelijk gevaar voor beschadiging van het ongeboren kind.
Veiligheidsaanbevelingen:
S08 -Verpakking droog houden.
S36/37 -Draag geschikte handschoenen en beschermende kleding.
S60 -Deze stof en de verpakking als gevaarlijk afval afvoeren.
S61 -Voorkom lozing in het milieu. Vraag om speciale instructies /
veiligheidsgegevenskaart.
Specifieke vermeldingen:
DPD01 -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te
voorkomen.
2. Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en
Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten
voorgeschreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:
a. letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.
b. hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede
bestrijding mits deze niet met die tekst in strijd zijn.
2

2 DETAILS VAN DE AANVRAAG
2.1 Aanvraag
Het betreft een aanvraag tot voorlopige toelating van het middel Fantic M (14070 N), een
middel op basis van de werkzame stoffenbenalaxyl-M en mancozeb. Het middel wordt
aangevraagd als schimmelbestrijdingsmiddel in de teelt van
a. consumptie- en zetmeelaardappelen.
Aangezien Fantic M een voor Nederland nieuwe werkzame stof bevat (zie hieronder), is de
zienswijzenprocedure zoals bedoeld in artikel 2:3 Besluit bestuursreglement regeling toelating
gewasbeschermingsmiddelen en biociden Ctgb 2007 van toepassing.
2.2 Informatie met betrekking tot de stof
De werkzame stof benalaxyl-M betreft een nieuwe stof. Er zijn in Nederland nog geen andere
middelen op basis van deze stof toegelaten. De aanvraag tot plaatsing van benalaxyl-M op
Bijlage I van Richtlijn 91/414/EEG is gedaan door ISAGRO S.p.A.. De monografie voor de
benalaxyl-M wordt opgesteld door Portugal. Er is een concept-monografie beschikbaar.
De werkzame stof mancozeb is bij Richtlijn 2005/72/EG d.d.21 oktober 2005 van de Europese
Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn
91/414/EEG. Mancozeb is goedgekeurd krachtens Verordening (EG) No 1107/2009
(Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011) en geplaatst als stof 114 in de
bijlage.
2.3 Karakterisering van het middel
Fantic M is geformuleerd als een water-oplosbaar granulaat dat 4% benalaxyl-M en 65%
mancozeb bevat. Fantic M heeft zowel een preventieve als curatieve werking. Daarnaast zorgt
de combinatie van actieve stoffen voor een verbreding van de werking en versterkt het de
werking op de doelorganismen (m.n. Oomyceten) door het synergistisch effect van de
specifieke mono-site werking van benalaxyl-M en de preventief multi-site werking van
mancozeb. Daardoor past het in resistentie-management strategieën.
2.4 Voorgeschiedenis
De aanvraag is op 14 november 2008 ontvangen; op 12 november 2008 zijn de verschuldigde
aanvraagkosten ontvangen. Bij brief d.d. 23 juli 2009 is de aanvraag in behandeling genomen.
3 RISICOBEOORDELINGEN
De beoordeling is uitgevoerd conform RGB (Hoofdstuk 2) en de HTB 1.0.
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in toxicologisch en ecotoxicologisch
opzicht belangrijke onzuiverheden in de werkzame stoffen 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).
Fantic M
14070 N
3

De beoordeling van de evaluatie van de analysemethoden staat beschreven in Hoofdstuk 3,
Methods of Analysis, in Bijlage II bij dit besluit.
3.3 Risico voor de mens
Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale
omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik,
geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De
voorlopige vastgestelde maximum residugehalten op landbouwproducten zijn aanvaardbaar
(artikel 28, eerste lid, sub b, onderdeel 4 en sub f, Wet gewasbeschermingsmiddelen en
biociden).
Het profiel humane toxicologie inclusief de beoordeling van het risico voor de toepasser staat
beschreven in Hoofdstuk 4 Mammalian Toxicology, in Bijlage II bij dit besluit.
Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico
voor de volksgezondheid staan beschreven in Hoofdstuk 5, Residues in bijlage II behorende bij
dit besluit.
3.4 Risico voor het milieu
Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale
omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik,
geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt
gehouden met de volgende aspecten:
- de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat
betreft besmetting van het water, waaronder drinkwater en grondwater,
- de gevolgen voor niet-doelsoorten.
(artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden).
De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental
Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.
3.5 Werkzaamheid
Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale
omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik,
voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige
producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen
en biociden).
De beoordeling van het aspect werkzaamheid staat beschreven in Hoofdstuk 8, Efficacy, in
Bijlage II bij dit besluit.
3.6 Eindconclusie
Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Fantic M
op basis van de werkzame stoffen benalaxyl-M en mancozeb voldoende werkzaam en heeft het
geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 80, vijfde lid
Verordening (EG) 1107/2009 juncto artikel 34, Wet gewasbeschermingsmiddelen en biociden).
Fantic M
14070 N
4

Ingevolge artikel 2:3 Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen
en biociden Ctgb 2007 geldt dat dit ontwerpbesluit gedurende twee weken ter inzage wordt
gelegd op het Ctgb; hiervan wordt mededeling gedaan in de Staatscourant. Het ontwerpbesluit
wordt gedurende deze periode tevens op de website van het Ctgb geplaatst.
Belanghebbenden kunnen gedurende de ter inzagenlegging schriftelijk bij het Ctgb aangeven
dat zij een zienswijze zullen indienen; de zienswijze dient schriftelijk binnen twee weken na de
inzagenperiode te worden ingediend..
Wageningen, 10 mei 2013
Fantic M
14070 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN,
ir. J.F. de Leeuw
voorzitter
5

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
Dit middel is uitsluitend bestemd voor professioneel gebruik
BIJLAGE I bij het besluit d.d. 10 mei 2013 tot voorlopige toelating van het middel Fantic M,
toelatingnummer 14070 N
Fantic M
14070 N
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als schimmelbestrijdingsmiddel in de teelt van
a. consumptie- en zetmeelaardappelen;
Om het grondwater te beschermen mag dit product niet worden gebruikt in
grondwaterbeschermingsgebieden.
Om het oppervlaktewater te beschermen ten behoeve van de drinkwaterbereiding is de
toepassing in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik
gemaakt wordt van minimaal 75% driftreducerende doppen
Om de vogels te beschermen is toepassing in teelt van consumptie- en zetmeelaardappelen
uitsluitend toegestaan vanaf BBCH 40 (sluiting van het gewas).
Resistentiemanagement
Om resistentieopbouw te voorkomen dit product of andere producten die benalaxyl-m of
verwante stoffen bevatten, niet vaker gebruiken dan drie maal per seizoen.
Veiligheidstermijn
De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan:
14 dagen voor consumptie- en zetmeelaardappelen;
Het middel is uitsluitend bestemd voor professioneel gebruik.
B.
GEBRUIKSAANWIJZING
Algemeen
Fantic M is een systemisch fungicide met een preventieve en curatieve werking.
Resistentiemanagement
Fantic M bevat naast mancozeb het systemische fungicide benalaxyl-M. Hiertegen kan zich
resistentie ontwikkelen of reeds aanwezig zijn. Het gebruik van dit middel dient daarom beperkt
te blijven tot maximaal drie achtereenvolgende bespuitingen per seizoen. Daar er tussen
benalaxyl-M en verwante stoffen kruisresistentie bestaat, dienen bespuitingen met aan
benalaxyl-M verwante stoffen in hetzelfde seizoen te worden vermeden. Om verspreiding van
resistente schimmelstammen via het pootgoed te vermijden mag het middel niet in de teelt van
pootaardappelen worden toegepast.
Gereedmaken spuitvloeistof
Eerst de tank voor de helft vullen met water, vervolgens onder voortdurend roeren het middel
toevoegen en de tank verder met water vullen. Tijdens het opspuiten moet de spuitvloeistof in
beweging worden gehouden.
1

Toepassingen
Consumptie- en zetmeelaardappelen, ter voorkoming van aantasting door aardappelziekte
(Phytophthora infestans)
Het middel vroeg in het seizoen toepassen als het gewas nog in volle ontwikkeling is (voor de
bloei). Het verdient daarbij aanbeveling de eerste bespuiting uit te voeren met een ander
geschikt middel. Toepassen met een interval van 7 tot 10 dagen afhankelijk van de
infectiedruk. Maximaal drie opeenvolgende bespuitingen uitvoeren en binnen 7 dagen na de
laatste bespuiting met Fantic M de bestrijding voortzetten met een ander daarvoor toegelaten
middel. Niet toepassen op gewassen met stagnerende groei en op gewassen waar een
aantasting zichtbaar is (i.v.m. resistentie).
Dosering: 2,5 kg middel per ha
Fantic M
14070 N
2

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II bij het besluit d.d. 10 mei 2013 tot voorlopige toelating van het middel Fantic M,
toelatingnummer 14070 N
RISKMANAGEMENT
Contents Page
1. Identity of the plant protection product 3
2. Physical and chemical properties 4
3. Methods of analysis 12
4. Mammalian toxicology 20
5. Residues 32
6. Environmental fate and behaviour 40
7. Ecotoxicology 79
8. Efficacy 120
9. Conclusion 125
10. Classification and labelling 125
Appendix 1 Table of authorised uses
Appendix 2 Reference List
pag. 2

1. Identity of the plant protection product
1.1 Applicant
ISAGRO S.p.A.
Centro Uffici San Siro, Fabbricato D, ala 3
20153 Milano
Italy
1.2 Identity of the active substance
Common name Benalaxyl-M
Name in Dutch Benalaxyl-M
Chemical name methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate
CAS no 98243-83-5
EC no Not available
The new active substance benalaxyl-M is not decided upon for inclusion in Annex I of Directive
91/414/EEC and approval of Regulation (EG) 1107/2009. A draft assessment report (DAR) of
benalaxyl-M is available (RMS: Portugal).
Common name Mancozeb
Name in Dutch Mancozeb
Chemical name manganese ethylenebis (dithiocarbamate) (polymeric) complex with zinc
salt
CAS no 8018-01-7
EC no Not allocated
The active substance was included on July 1 st , 2006 in Annex I of Directive 91/414/EEC.
1.3 Identity of the plant protection product
Name Fantic M
Formulation type WG
Content active substance 40 g/kg pure benalaxyl-M
650 g/kg pure mancozeb
The formulation is not part of the assessment of either active substance for inclusion in Annex I
of Directive 91/414/EEC. Although the code for the formulation applied for is identical to that
included in the DAR of benalaxyl-M, the composition is not comparable.
1.4 Function
Fungicide.
1.5 Uses applied for
See GAP (appendix 1).
1.6 Background to the application
It concerns an application for provisional authorization.
As a consequence of the European assessment of the active substance in the light of the
decision whether it can be placed upon Annex I of Directive 91/414/EEG or not, a concept for a
monograph has been conceived. The CTGB has evaluated this concept-monograph and has
given comments upon its contents. With full consideration of these comments, the CTGB has
made the contents of the concept-monograph her own and applies them in the handling of the
present application. In the List of Endpoints underneath, the Dutch comments are typed in
italics.
pag. 3

1.7 Packaging details
1.7.1 Packaging description
Material: Polyester-aluminium-low density polyethylene
Capacity: 1.15kg
Type of closure and size Bag from welded tube. 12 bags are packed in secondary
of opening:
packaging (corrugated box) with glue and tape seal.
Other information Complies with UNI7970, compression resistance and water
soaking (COBB ISO 535-1976).
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: benalaxyl-M
Benalaxyl-M is a new active substance. The List of Endpoints presented below is taken from
the EFSA Scientific report (2007) 108; 1-86 (d.d. 27 July 2007). Where relevant, some
additional remarks/information are given in italics.
Identity
Active substance (ISO Common
Name)
Benalaxyl-M
Chemical name (IUPAC) methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate
Chemical name (CA) methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-Dalaninate
CIPAC No 766
CAS No 98243-83-5
EEC No (EINECS or ELINCS) Not available
FAO Specification (including year of
publication)
Minimum purity of the active
substance as manufactured (g/kg)
Identity of relevant impurities (of
toxicological, environmental and/or
other significance) in the active
substance as manufactured (g/kg)
Molecular formula
Molecular mass
Structural formula
Not available
950 g/kg 1)
No impurities of toxicological or environmental
significance
C20 H23 N O3
325.4 g/mol
pag. 4
C
H 3
O
N
CH 3
COOCH 3
1) In addendum 3 to volume 4, a batch analysis based on full-scale production was summarised. This information is
not yet peer-reviewed. Whether the specification will remain the same may still be open for discussion, but as the
CH 3

industrial plant produces a higher quality material than the pilot plant, the current specification is considered
sufficiently representative for the manufacturing process.
Physical-chemical properties
Melting point (state purity) 76 0.5 ºC (100%)
Boiling point (state purity) No boiling point determined, compound decomposed
(100%)
Temperature of decomposition 280 - 290 ºC
Appearance (state purity) White microcristalline solid (100%, 97.56%)
Relative density (state purity) 1.1731 0.0004 (100%)
Surface tension 59.82 0.07 mN/m (conc. 29.6 mg/L)
Vapour pressure (in Pa, state
temperature)
60.84 0.03 mN/m (conc. 28.5 mg/L) (20 ºC)
5.95 10 -5 Pa (25 ºC)
2.36 10 -5 Pa (20 ºC)
Henry’s law constant (in Pa·m 3 ·mol -1 ) 2.33 10 -4 Pa m 3 mol 1 (20 ºC)
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)
pH=4 33.07 1.32 mg/L (20 ºC)
pH=7 33.00 1.82 mg/L (20 ºC)
pH=9 37.05 1.72 mg/L (20 ºC)
Readily soluble in most organic solvents (20 ºC).
heptane 17074 mg/L
Xylene > 39 % w/w
Acetone > 49 % w/w
ethyl acetate > 49 % w/w
1,2-dichloroethane > 50% w/w
Methanol > 50% w/w
log Pow = 3.87 (calculated value)
Measured values:
pH=4 log Pow = 3.66 ± 0.05 (20 ºC)
pH=7 log Pow = 3.68 ± 0.19 (20 ºC)
pH=9 log Pow = 3.61 ± 0.06 (20 ºC)
pH 4: no significant degradation at 25 ºC
pH 7: no significant degradation at 25 ºC
pH 9 (25 ºC): DT50 = 301.3 days
Dissociation constant Dissociation in water does not occur (based on
theoretical justification)
UV/VIS absorption (max.) (if
absorption >290 nm state at
wavelength)
Photostability (DT50) (aqueous,
sunlight, state pH)
Quantum yield of direct phototransformation
in water at > 290 nm
Photochemical oxidative degradation
in air
Max. at wavelengths: 252.7, 258.6, 264.6 and 274.1nm
no absorption at 290nm
Not required ( < 10 L.mol -1 .cm -1 for 290nm)
Not required (no absorption 290nm)
Benalaxyl is rapidly degraded in air atmospheric:
DT50 = 4.2 – 12.5 hours.
Flammability Open (as the full scale production was not peer
reviewed)
pag. 5

Auto-flammability Not auto-flammable (EC A16, 97.56%)
Oxidising properties Not oxidising (EC A17, 97.46%)
Explosive properties Open (as the full scale production was not peer
reviewed)
2) Study provided. Conclusion: Not highly flammable (EC A10, 97.56%)
3) Study provided. Conclusion: Not explosive (EC A14, 97.56%)
2.2 Active substance: mancozeb
Data on the identity and the physical and chemical properties of mancozeb are taken from the
List of Endpoints included in the EFSA Review Report, SANCO/4058/2001 – rev 4.4 of July
2009, originally finalised in June 2005. Where relevant, some additional remarks/information
are depicted in italics.
Identity mancozeb
Active substance (ISO Common Mancozeb
Name)
Chemical name (IUPAC)
manganese ethylenebis (dithiocarbamate) (polymeric)
complex with zinc salt
Chemical name (CA)
[1,2-ethanediylbis[carbamodithioato](2-)] manganese
mixture with [1,2-ethanediylbis [carbamodithioato] (2-)]
zinc (9CI)[ethylenebis(dithiocarbamato)]manganese
mixture with [ethylenebis(dithiocarbamato)]zinc (8CI)
CIPAC No 34
CAS No 8018-01-7 (formerly 8065-67-5)
EEC No (EINECS or ELINCS) 006-076-00-1 (annex I of Directive 67/548/EEC entry)
FAO Specification (including year of
publication)
Minimum purity of the active
substance as manufactured (g/kg)
Identity of relevant impurities (of
toxicological, environmental and/or
other significance) in the active
substance as manufactured (g/kg)
Tentative, 1980
800 g/kg
Molecular formula (C 4 H 6 MnN 2 S 4 ) x (Zn) y
Molecular mass 271.3
Structural formula
Declared content of ETU is < 0.1% w/w day of
manufacture
S
S C
pag. 6
NH CH2 CH2 NH C S Mn
S
Mancozeb is a polymeric complex of the monomer
illustrated which contains 20% manganese and 2.5%
zinc
Physical-chemical properties
Melting point (state purity) Not measurable as the product decomposes without
melting.
Boiling point (state purity) Not applicable, decomposes before melting.
Temperature of decomposition see melting point
Appearance (state purity) Yellowish powder (80%)
Relative density (state purity) density: 1.9938 g/ml at 20°C (81.5%)
relative density: 1.976 g/ml at 22°C. (80%)
x
Zn y

Surface tension Not submitted *
Vapour pressure (in Pa, state 1.33 x 10
temperature)
-5 Pa
Henry’s law constant (in Pa·m 3 ·mol -1 ) (a) Henry's law constant is calculated from the vapour
pressure value and water solubility. KD < 5.9 x 10 -4 Pa
x m 3 x mol -1 (not volatile).
Solubility in water (in g/l or mg/l, state 20 mg/l
temperature)
Solubility in organic solvents (in g/l or Mancozeb is practically insoluble in organic solvents.
mg/l, state temperature)
Partition co-efficient (log Pow) (state Kow 1.8 (first partioning),
pH and temperature)
and 21.4 (second partitioning of octanol vs fresh
water)
Indicative Log Pow = 1.33
ETU: Kow (1 ppm ETU in octanol): 0.15.
Kow(10 ppm ETU in octanol): 0.14. (indicative
values)
Indicative Log Pow = -0.85
Hydrolytic stability (DT50) (state pH < 1 day
and temperature)
Dissociation constant At 25°C, the typical pKa value for Mancozeb is 10.3.
UV/VIS absorption (max.) (if
The EBDC ion from the soluble disodium salt absorbs
absorption >290 nm state at at 280.5 - 285 nm (227 nm shoulder) with molar
wavelength)
absorbance of 6 x 10 4 in water and at 296 nm with
molar absorbance of 2.9 x 10 4 +/- 0.8 x 10 4 in DMSO.
The test substance has the same spectrum in DMSO
as the soluble EBDC ion.
In UV B with a maximum at 310 nm (10% NaOH, pH
9.8).
Photostability (DT50) (aqueous, Mancozeb decomposes completely with 3 hours at pH
sunlight, state pH)
8.8. Irradiated and dark control samples showed
similar decomposition behaviour indicating that the
major routes were hydrolysis and oxidation not
photolysis. Four main decomposition products were
observed: EBIS, ETU, EDA and EU.
Quantum yield of direct photo- Quantum yield cannot be calculated for mancozeb
transformation in water at > 290 nm because the measured photodegradation rate was
negligible.
Photochemical oxidative degradation Half-Life = 0.050 Days (12-hr day; 1.5E6 OH/cm3)
in air
EPWIN 3.10 (Ctgb calculation).
Flammability Mancozeb technical is not flammable in the sense of
the method EEC A 10.
Auto-flammability > 209 o C
Oxidising properties Not oxidizing
Explosive properties The chemical structure, possible decomposition
reactions and energies, and the decomposition
products of the substance have been studied. No
potential explosive properties are expected.
Therefore, on the basis of this theoretical evaluation, it
is not necessary to perform the test for explosive
properties.
* Volume 3 of the DAR states the surface tension of the active substance is not relevant, due to the fact that
mancozeb is a solid. According to guidelines the surface tension is required for all substances with a solubility in
water of over 1 g/mL in order to determine the validity of the determination of the log Pow.
pag. 7

2.3 Plant protection product: Fantic M
The range of the application concentration of the plant protection product is 0.42 – 1.25%
Section
(Annex
point)
B.2.2.1
(IIIA 2.1)
Study Guidelines
and GLP
Appearance:
physical state
GLP
Visual
Findings Evaluation and
conclusion
Nearly spherical
microgranules in size range
Acceptable
2.36-0.250 mm.
Fantic M is a solid.
Yellowish Acceptable
B.2.2.2 Appearance: GLP
(IIIA 2.1) colour Visual
B.2.2.3 Appearance: GLP Faint aromatic odour Acceptable
(IIIA 2.1) odour Olfactory
B.2.2.4 Explosive GLP Not explosive, based on DSC Acceptable
(IIIA 2.2) properties EC A14,
OECD 113
analysis.
B.2.2.5 Oxidising GLP Not oxidising. Acceptable
(IIIA 2.2) properties EC A17
B.2.2.6 Flammability GLP Not highly flammable. Acceptable
(IIIA 2.3)
EC A10
B.2.2.7 Auto- GLP Relative self-ignition
(IIIA 2.3) flammability EC A16 temperature: 395 o Acceptable
C
B.2.2.8
(IIIA 2.3)
Flash point Not applicable
B.2.2.9 Acidity /
Not applicable
(IIIA 2.4) alkalinity
B.2.2.10 pH GLP 1%: 7.22 Acceptable
(IIIA 2.4)
CIPAC
MT75.3
B.2.2.11 Surface
Not applicable
(IIIA 2.5) tension
B.2.2.12
(IIIA 2.5)
Viscosity Not applicable
B.2.2.13 Relative
Not applicable
(IIIA 2.6) density
B.2.2.14 Bulk (tap) GLP Tap density: 0.67 g/mL Acceptable
(IIIA 2.6) density CIPAC
MT169
B.2.2.15 Storage GLP Stable for 2 weeks at 54
(IIIA 2.7) stability
o C in Acceptable
unstated packaging type.
Properties determined:
appearance, pH, a.i. content,
wettability, foam persistence,
suspensibility, spontaneity of
dispersion, wet sieve residue,
particle size, dust content,
attrition resistance.
pag. 8

Section
(Annex
point)
B.2.2.16
(IIIA 2.7)
B.2.2.17
(IIIA 2.8)
B.2.2.18
(IIIA 2.8)
Study Guidelines
and GLP
Findings Evaluation and
conclusion
Shelf life GLP Interim 12 month report:
Stable for 12 months in 1 kg
sacks made of
polyester/aluminium/LDPE.
Wettability GLP
CIPAC
Persistent
foaming
Properties determined before
and after storage:
appearance, pH (1%), water
content, tap density,
wettability, foam persistence,
suspensibility (0.17% and
2.5%), spontaneity of
dispersion, wet sieve residue,
particle size distribution, dust
content, attrition resistance,
flowability, a.i. content.
GLP Stable for 24 months in 1 kg
sacks made of
polyester/aluminium/LDPE.
MT53.3.1
GLP
CIPAC
MT47.2
pag. 9
Acceptable
Acceptable
Shelf-life is 2 years.
Properties determined before
and after storage:
appearance, pH (1%), water
content, tap density,
wettability, foam persistence,
suspensibility (0.17% and
2.5%), spontaneity of
dispersion, wet sieve residue,
particle size distribution, dust
content, attrition resistance,
flowability, a.i. content.
Immediate Acceptable
~1%w/v in CIPAC D: 3 mL
foam after 1 minute.
Acceptable
Although not
performed at the
intended maximum
concentration of
1.25%, it is
considered unlikely
the threshold of 60
mL foam after 1
minute will be
exceeded.

Section
(Annex
point)
B.2.2.19
(IIIA 2.8)
B.2.2.20
(IIIA 2.8)
Study Guidelines
and GLP
Suspensibility GLP
CIPAC
MT168
Spontaneity
of dispersion
GLP
CIPAC
MT174
B.2.2.21 Dilution
(IIIA 2.8) stability
B.2.2.22 Dry sieve test GLP
(IIIA 2.8)
CIPAC
MT170
B.2.2.23 Wet sieve test GLP
(IIIA 2.8)
CIPAC
MT167
B.2.2.24 Particle size
(IIIA 2.8) distribution
B.2.2.25 Content of GLP
(IIIA 2.8) dust/fines CIPAC
MT171
B.2.2.26 Attrition and GLP
(IIIA 2.8) friability CIPAC
MT178
Findings Evaluation and
conclusion
Assay:
0.17%:
Mancozeb 57.87%
Benalaxyl-M 79.79%
2.5%:
Mancozeb 74.70%
Benalaxyl-M 67.03%
pag. 10
Acceptable
Suspensibility is
slightly lower than
the minimum value
of 60% considered
acceptable for WG
formulations.
The applicant has
proposed to add the
following to the
label instructions
(continuous
agitation during
application):
“Eerst de tank voor
de helft vullen met
water, vervolgens
onder voortdurend
roeren het middel
toevoegen en de tank
verder met water
vullen. Tijdens het
opspuiten moet de
spuitvloeistof in
beweging worden
gehouden.”
83% (1% in CIPAC D) Acceptable
Not applicable
91.2% > 250 µm
0.5% < 75 µm
Trace of residue (0.018%) on
a 75 µm sieve.
See B.2.2.22
Acceptable
Acceptable
21.6 mg dust (30g sample).
Formulation is essentially dust
free.
96% Acceptable
Lowest value
reported was 93%
after 12 months
storage.

Section
(Annex
point)
B.2.2.27
(IIIA 2.8)
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)
Study Guidelines
and GLP
Emulsifiability,
reemulsifiability
and emulsion
stability
Stability of
dilute
emulsion
Findings Evaluation and
conclusion
Not applicable
Not applicable
Flowability GLP
CIPAC
MT172
Spontaneous Acceptable
Pourability
(rinsibility)
Not applicable
Dustability Not applicable
Adherence
and
distribution to
seeds
2.9.1 Physical
compatibility
with other
products
2.9.2 Chemical
compatibility
with other
products
Other GLP
CIPAC
MT30.2
Not applicable
Not applicable
Not applicable
Water content is 3.2% 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.
The applicant has proposed to add the following to the label instructions (continuous agitation
during application):
“Eerst de tank voor de helft vullen met water, vervolgens onder voortdurend roeren het middel toevoegen
en de tank verder met water vullen. Tijdens het opspuiten moet de spuitvloeistof in beweging worden
gehouden.”
Fantic M has a shelf-life of 2 years in the proposed packaging for the Dutch market.
2.3 Data requirements
None.
pag. 11

3 Methods of analysis
Benalaxyl-M is a new active substance. The List of Endpoints presented below is taken from
the EFSA Scientific report (2007) 108; 1-86 (d.d. 27 July 2007). Where relevant, some
additional remarks/information are given in italics.
Description and data concerning the analytical methods for mancozeb are taken from the List of
Endpoints (February 2003), included in the DAR. Where relevant, some additional
remarks/information are given in italics.
3.1. Analytical methods in technical material and plant protection product
3.1.1 Benalaxyl-M
Technical as (principle of method) HPLC-UV
Impurities in technical as (principle GLC-FID
of method)
Preparation (principle of method) HPLC-UV at 265 nm
3.1.2 Mancozeb
Technical as (principle of method) Sample digestion in sulfuric acid solution to produce
carbon disulfide which is aspirated through a lead
acetate solution absorber to remove hydrogen sulfide;
carbon disulfide is absorbed in methanolic potassium
hydroxide to form potassium xanthate which is
neutralized and titrated with iodine solution to the starch
end point. Sulfide is determined by removing the lead
acetate trap from the train, reanalyzing the sample and
calculating sulfide from the difference in the two results.
Presented methods are more or less following CIPAC
61/1/M/1.2
Study conducted demonstrates the precision of the
method: RSD = 0.34-0.63% (for sample containing mean
wt% concentration of 36.3% to 99.4%carbamate
complex)
Titration methods are absolute method, thus linearity
data not apply to this type of method
The minor changes to CIPAC method are acceptable.
pag. 12

Impurities in technical as (principle
of method)
Extraction with zinc chloride solution; reversed phase
HPLC with UV detection at 233 nm and
methanol/acetonitrile/water mobile phase and multilevel
linear external standard calibration with a working
standard.
ETU is extracted from the sample with methanol. After
centrifugation and dilution the amount of ETU is
determined by HPLC using UV-detection at 230 nm with
N,N,N'-trimethylthiourea as internal standard
Extraction: with 2.03 % ammonium hydroxide in acetone.
Clean-up: TLC on a 20 cm x 20 cm glass sheet covered
with a 25 µm layer of silica, developed in an
acetone/ammonium hydroxide 98 :2 solution.
Determination: measurement of UV absorption at 231
nm. The percent ETU is calculated from calibration data.
LOD=0.005%
For determination of ETU content, an in-house method
involves Zinc chloride extraction of samples instead of
methanol extraction procedure CIPAC MT 162 -
HPLC/UV-detection (233 nm) - LOD= 0.00009%
Method validated
Preparation (principle of method) Volumetric titration (CS2 determination) using sulphuric
acid, cadmium sulphate and methanolic potassium
hydroxide. A phenolphthalein and starch indicator were
used. Titration was performed using an iodine solution.
3.1.3 Conclusion
These analytical methods have been assessed in the DAR and are considered to be
acceptable. For the formulation, an acceptable method for determination of the active
substances was provided.
3.2 Residue analytical methods
3.2.1 Benalaxyl-M
Food/feed of plant origin (principle
of method and LOQ for methods
for monitoring purposes)
Food/feed of animal origin
(principle of method and LOQ for
methods for monitoring purposes)
Benalaxyl-M:
HPLC-MS with chiral column
LOQ - 0.02 mg/kg (grape bunches and wine)
Note: If the residue definition is set as benalaxyl for MRL
purposes then there is a method available in the benalaxyl
DAR.
- (Not required)
Soil (principle of method and LOQ) Benalaxyl-M:
HPLC-MS with chiral column
LOQ - 0.02 mg/kg
Metabolites M3 and M7:
HPLC-MS/MS with chiral column
LOQ - 0.05 mg/kg
pag. 13

Water (principle of method and
LOQ)
Benalaxyl-M:
HPLC-MS with chiral column
LOQ - 0.1 g/L (drinking water)
HPLC-MS/MS with chiral column
LOQ - 0.05 g/L (surface water)
Air (principle of method and LOQ) Benalaxyl-M:
HPLC-MS/MS with chiral column
LOQ - 9x10 -4 mg/m 3
Body fluids and tissues (principle of - (Not required)
method and LOQ)
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 (leek, potato).
Matrix
Definition of the residue and MRL’s for benalaxyl-M
Definition of the residue for monitoring MRL
Food/feed of plant Benalaxyl including other mixtures of 0.05 mg/kg
origin
constituent isomers including benalaxyl-M
(sum of isomers)
Food/feed of animal No residues are expected to occur in No MRL required.
origin
food/feed of animal origin.
Required LOQ
Soil Benalaxyl-M 0.05 mg/kg (default)
Drinking water Benalaxyl-M 0.1 µg/L (drinking water
guideline)
Surface water Benalaxyl-M 0.1 µg/L
Air Benalaxyl-M 18 µg/m 3 (derived from the
AOEL (0.06 mg/ kg bw/day)
according to
SANCO/825/00)
Body fluids and The active substance is not classified as (very) toxic thus no definition
tissues
of the residue is proposed.
The residue analytical methods, included in the abovementioned List of Endpoints, are suitable
for monitoring of the proposed MRL’s. The residue analytical method included in the List of
Endpoints for plant material was specifically validated to be able to distinguish between
benalaxyl isomers, benalaxyl-M specifically. A method for determination of benalaxyl is
available as well.
The residue analytical methods for water, soil and air, evaluated in the DAR, are acceptable
and suitable for monitoring of residues in the environment.
3.2.2 Mancozeb
Food/feed of plant origin (principle
of method and LOQ for methods
for monitoring purposes)
Mancozeb
The test system is a sealed, 160 ml reaction flask,
charged with 4.0 grams of ground test sample, 10%
EDTA solution (to make 10 ml total volume), and 15 ml
HCl/stannous chloride (8N/3%) reagent. The flask is
maintained at 100°C, and duplicate 1000 ul head space
aliquots are removed with an air-tight syringe for injection
into a gas chromatograph. EBDC's present in the sample
are converted to carbon disulfide (CS2) by reaction with
pag. 14

HCl/Stannous chloride reagent at 100°C in a sealed
reaction flask. An aliquot of the head space is injected
into a gas chromatograph chromatograph with a flame
photometric detector in the sulfur mode, where the
sample responses are compared to a similarly prepared
and injected EBDC standard.
LOD: 0.02-0.05 mg/kg.
Wheat (grains and straw), potatoes (tubers and leaves),
spinach, celery, celeriac, barley, lettuce and apples are
analysed by the method. For extraction the sample
material is boiled in hydrochloric acid, in presence of tin-
(II)-chloride, decomposing the 1,2ethylenebisdithiocarbamate
to its diamine salt and
carbondisulphide. The clean up/derivatisation is done by
carrieing carbondisulphide by a stream of nitrogen
through absorbers containing lead acetate solution to
remove hydrogen sulphide and then into an absorber
containing Cullens reagent, being a solution of copper-
(II)-acetate and diethanolamine in ethanol. Determined
as Copper-(II)-dithiocarbamate complex, by spectrometry
measuring the absorbance at 435 nm.
LOD=0.02 mg/kg
The method (S15) is used for samples coming from
apples, barley, carrots, celeriac (leaves and bulbs),
cereal straw, cherries, cucumbers, currants (black and
red), grapes, leeks, lettuce, peaches, pears, potatoes,
rape (green matter), red beet, small radishes,
strawberries, sugar beet (foliage and edible root), wheat.
Digestion: with a solution of stannous chloride and
hydrochloric acid followed by clean-up by sweeping
gases produced through a sodium hydroxide solution and
a lead acetate solution. Color reaction: CS2 produced is
trapped in an absorber containing an ethanolic solution of
cupric acetate and diethanolamine. Determination: is
done with spectrophotometric absorbance measurement
of the resulting solution at 435 nm
LOD = 0.1 mg/kg (c), 0.05mg/kg (d)
Apples, beans, carrots, cucumbers, lettuce, potatoes and
tomatoes. samples are measured (method S21). The
extraction: is done with an aqueous solution of
ethylenedinitrolo- tetraacetic acid (tetrasodium salt).
Clean-up made by column chromatography on Sephadex
LH-20 using an aqueous solution of ethylenedinitrolotetraacetic
acid as eluent. The determination is
performed with spectrophotometric measurement at 285
nm of the absorbance of the ethylene bisdithiocarbamate
anion in the resulting solution.
LOD = 0.05 mg/kg.
20 g sample is mixed and finely cut followed by addition
of 40 ml 1.5% stannous chloride. Thiophene is added to
the solution and it is incubated at 70°-80°C for 15 min.
100-1000 µl of the headspace is sampled. The
pag. 15

Food/feed of animal origin
(principle of method and LOQ for
methods for monitoring purposes)
determination is done with GC-FPD in the sulfur mode
LOD= 0.001 mg/kg
ETU
Crops are ground in a Hobart Grinder while frozen with
dry ice. The dry ice is sublimed in a freezer, and the
samples are kept frozen until analysis. ETU present in
the sample is extracted into water/ethanol. An aliquot of
the extract is passed through an alumina column for
cleanup. The sample is then submitted for HPLC
analysis.
LOD =0.001 -0.01 mg/kg
Apple, tomato, grape, beer, celeriac -turnip and -leave,
tomato juice, wine, spinach, potato and milk. Grain of
wheat, wheatenbread, straw, hay, hops. The samples are
blended with methanol or water in the presence of some
filter aids. The filtrate is partially evaporated and residual
water is removed by hydratation of di-sodium hydrogen
phosphate. Impurities are removed by extraction with nhexane
or carbon tetrachloride. Then ETU is extracted
from the crystalline mass with dichloromethane eluted
through a column packed with sodium sulphatealuminoxide-cellulose
and determined by GC-FPD. No
fully validated.
LOD =0.002 mg/kg
Mancozeb
A frozen, ground sample of meat is placed in a special
160 ml reaction flask. EDTA solution and HCl/Stannous
chloride reagent are added to the flask, which is then
immediately crimp sealed. The flask is then placed in a
boiling water bath for 2 hours, periodically being shaken
by hand. After the reaction, the sample is maintained at
100°C in the water bath during GLC analysis of the head
space gases.
Principally same method is used for milk.
No validation
ETU
(Milk). ETU present in the sample is extracted in
water/methanol. An aliquot of the extract is passed
through an alumina column for cleanup. The sample is
then submitted for HPLC analysis.
(Meat) Principally the same methods as the one used for
milk analysis.
ETU in milk EBDC’s in milk
HPLC/EC GC/FPD/S
LOQ=0.0010 ppm LOQ=0.01 ppm
ETU in meat EBDC’s in meat
HPLC/EC GC/FPD/S
LOQ=0.001 ppm LOQ=0.01 ppm
Soil (principle of method and LOQ) Mancozeb
In the method a sample of soil is weighed into a
headspace vial to which a solution of SnCl2/HCl/EDTA is
pag. 16

Water (principle of method and
LOQ)
added. The vial is capped, mixed and heated at 100ºC
for 4 hours. The headspace is sampled and analyzed via
GC/MS.
LOQ = 0.005 mg/kg
For grass, sand and Poecilus cupreus a sample is
digested with hot acid to release CS2 and then extracted
with heptane. The heptane is then analyzed using
GC/MS.
Grass LOQ = 0.51 mg/kg
Sand LOQ = 0.05 mg/kg
Poecilus cupreus LOQ = 0.98 mg/kg
ETU
In the method a sample of soil is extacted with
methanol/water After filtration the extract is azeotroped
with ethanol on a rotary evaporator and the volume
adjusted. The water is saturated with potassium
carbonate and portioned withacetonitrile in
dichloromethane. The dichloromethane is cancentrated,
exchanged into acetonitrile and analyzed by LC/MS/MS.
LOQ= 5 ppb
mancozeb
The test system is a ground water sample placed in a
Keppel digestion apparatus containing aqueous HCl and
stannous chloride. The CS 2 evolved by reflux is trapped
in a cold ethanol trap, from which an aliquot is analyzed
for CS 2 using a gas chromatograph equipped with a
flamephotometric detector in the sulfur mode.
LOD = 0.1 µg/l
Derivatization with iodomethane, determination as S , S'dimethyl
ethylene - 1 , 2 - bis - dithiocarbamate
(DMEBDC) by HPLC using a reverse phase and UV
detection at 272 nm..
LOD= 0.01 mg/kg
ETU
The method is based on a two column HPLC isolation of
ETU from a groundwater sample. A sample of
groundwater is directly injected onto the first separation
column in an RPLC column switching system. The eluent
fraction from this column, which contains the ETU, is
passed onto a second column for further separation. The
ETU is detected with a UV detector at 233 nm. Further
sensitivity can be obtained by concentration of the water
sample and subsequent extraction with dichloromethane
(indirect method). Further workup and transfer of the
concentrated sample to a water phase allows analysis by
LC/UV.
LOD = 0.03 µg/l.
Addition of thiourea and sodium L-ascorbate. Extraction
with dichloromethane or ethyl acetate, addition of
pag. 17

diethylene glycol before concentration of extract, and
determination with gas chromatography with a alkali
flame ionization (nitrogen-phosphorus) detector.
LOD =

Body fluids and
tissues
ETU 0.0012 g/m 3 (derived from
the AOEL [0.004 mg/kg
bw/day] according to
pag. 19
SANCO/825/00)
Mancozeb and ETU 0.05 mg/L (blood)
0.1 mg/kg (tissues; meat or
liver)
The residue analytical methods, included in the abovementioned List of Endpoints, are suitable
for monitoring of the proposed MRL’s.
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 MRL’s and for monitoring of
residues in the environment.
3.3 Data requirements
None.
3.4 Physical-chemical classification and labelling
Proposal for the classification and labelling of the formulation concerning physical
chemical properties
Professional use
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 S8 Keep container dry.
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: -
Supported shelf life of the formulation: 2 years
In the GAP/instructions for use the following has to be stated:
Instructions for continuous agitation of the spray fluid to be added to the product label:
“Eerst de tank voor de helft vullen met water, vervolgens onder voortdurend roeren het middel toevoegen
en de tank verder met water vullen. Tijdens het opspuiten moet de spuitvloeistof in beweging worden
gehouden.”

4 Mammalian toxicology
List of Endpoints
Benalaxyl-M
Benalaxyl-M is a new active substance, not decided upon for inclusion in Annex I of Directive
91/414/EEC. The substance has already been discussed in an expert meeting and the EFSA
conclusion is available. The List of Endpoints presented below is taken from the EFSA
Scientific Report on benalaxyl-M (2007) 108; 1-86 (d.d. 27 July 2007). Where relevant, some
additional remarks/information are given in italics.
The racemic mixture benalaxyl was included in Annex I of Council Directive 91/414/EEC on 23
April 2004 by Commission Directive 2004/58/EC. During the EU review of benalaxyl-M (pure
isomer), the pattern of effects and NOAELs in studies with benalaxyl and benalaxyl-M were
considered and it was concluded that the two compounds are of similar toxicity. Consequently,
some data from the racemic mixture benalaxyl were used to assess the toxicity of the
enantiomeric form benalaxyl-M.
Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)
Rate and extent of absorption Rapid and extensive absorption, > 80% within
8 h based on urinary (4–14%) and biliary (60–
70%) excretion, benalaxyl
Distribution Widely distributed, benalaxyl and benalaxyl-M
Potential for accumulation No evidence of accumulation, benalaxyl and
benalaxyl-M
Rate and extent of excretion > 95% within 72 hours mainly by faeces (about
86%) with both compounds. T1/2 = 18 h,
benalaxyl-M
Metabolism in animals Extensive metabolism mainly by oxidation and
hydroxylation. 12 metabolites found in both
urine and faeces; parent compound found only
in faeces. Same pathways with benalaxyl and
benalaxyl-M
Toxicologically significant compounds
(animals, plants and environment)
Acute toxicity (Annex IIA, point 5.2)
Benalaxyl-M
Groundwater metabolites R-isomers of F4, F7
and F8 have not been appropriately assessed
for their toxicological relevance.
Rat LD50 oral > 2000 mg/kg bw, benalaxyl-M
Rat LD50 dermal > 2000 mg/kg bw, benalaxyl-M
Rat LC50 inhalation Not technically feasible, benalaxyl-M 1
> 4.204 mg/L air (4h, nose only, highest
technically achievable concentration),
benalaxyl
Skin irritation Non irritant, benalaxyl-M
Eye irritation Non irritant, benalaxyl-M
pag. 20

Skin sensitization (test method used and
result)
Non sensitising (M&K test), benalaxyl-M
1 It was not possible to determine the LC50 by inhalation due to technical reasons, because of the
adhesive/melting properties of the active substance and because of its poor solubility in water. The LC50
of benalaxyl was found adequate to assess the inhalative toxicity of benalaxyl-M.
Short term toxicity (Annex IIA, point 5.3)
Target / critical effect Liver, benalaxyl and benalaxyl-M
Lowest relevant oral NOAEL / NOEL 6.2 mg/kg bw/d (90d rat), benalaxyl-M
Lowest relevant dermal NOAEL / NOEL No data - not required
Lowest relevant inhalation NOAEL / NOEL No data - not required
Genotoxicity (Annex IIA, point 5.4)
No genotoxic potential, benalaxyl and
benalaxyl-M 2
2 The potential genotoxicity of benalaxyl-M has been investigated in three in vitro tests (Ames test, gene
mutation test in mouse lymphoma L5178Y cells and chromosome aberration test in Chinese Hamster
Ovary cells) and one in vivo (mouse micronucleus test). Benalaxyl has been investigated in eight in vitro
and one in vivo tests. All tests were negative, so there is no evidence of genotoxicity associated with
either compounds.
Long term toxicity and carcinogenicity (Annex IIA, point 5.5)
Target/critical effect Heart weight and clinical chemistry, benalaxyl
Lowest relevant NOAEL / NOEL 4.42 mg/kg bw/d (2y rat), benalaxyl
Carcinogenicity No carcinogenic potential, benalaxyl
Reproductive toxicity (Annex IIA, point 5.6)
Reproduction target / critical effect No reproductive effects. Decreased pup body
weight gain and increased liver weight at
parental toxic dose levels, benalaxyl (rat).
Lowest relevant reproductive NOAEL /
NOEL
Parental and offspring: 5.33 mg/kg bw/d (rat),
benalaxyl
Reproductive toxicity: 275 mg/kg bw/day,
benalaxyl (rat, highest dose tested)
Developmental target / critical effect No developmental effects, benalaxyl-M (rat)
Delayed ossification (rat) and reduced
bodyweight, benalaxyl (rabbit).
Lowest relevant developmental NOAEL /
NOEL
Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)
Maternal and developmental: 50 mg/kg
bw/day, benalaxyl (rabbit)
Maternal: 50 mg/kg bw/day, benalaxyl-M (rat)
Developmental: 250 mg/kg bw/day, benalaxyl-
M (rat)
No data, no concern from other studies, not
pag. 21

equired
Other toxicological studies (Annex IIA, point 5.8) 3
Metabolite M7 (=A-M1) Oral LD50 > 2000 mg/kg bw (rat)
Ames test: negative
Cell mutation assay in mouse lymphoma cells:
negative
Chromosome aberration test in CHO cells:
positive (-S9)
Chromosome aberration test in human
lymphocytes: positive (-S9)
Micronucleus assay in vivo: negative
90-d oral study in rats: NOAEL = 922.8 mg/kg
bw/d
Metabolite M3 (=B-M2) oral LD50 > 2000 mg/kg bw (rat)
Ames test: negative
Cell mutation assay in mouse lymphoma cells:
negative
Chromosome aberration test in CHO cells:
negative
90-d oral study in rats: NOAEL = 819.2 mg/kg
bw/d
3 The metabolites M3 and M7 are the D-isomers of the racemic benalaxyl soil metabolites M2 and M1
respectively. Acute oral toxicity, 90-day oral toxicity and genotoxicity studies were submitted for M1 and
M2. They are of low oral acute toxicity and not genotoxic in vivo. The NOAELs in the 90-day oral studies
in rats are 922.8 mg/kg bw/d for M1 and 819.2 mg/kg bw/d for M2.
Benalaxyl-M has been discussed by the experts in EPCO 28, June/July 2005. Considering the available
data on M1 and M2, the experts took into account their conclusion that the parent compounds benalaxyl
(racemic mixture) and benalaxyl-M (pure isomer) had a similar toxicity and agreed that the same could
be applied for M1/M2 and M3/M7. Therefore, M3 and M7 were considered as non relevant groundwater
metabolites from a toxicological point of view.
Medical data (Annex IIA, point 5.9)
No clinical cases of poisoning were notified
since the beginning of the production of
benalaxyl (early 80’s)
Summary (Annex IIA, point 5.10) Value Study Safety factor
ADI 0.04 mg/kg
bw/d
AOEL 0.06 mg/kg
bw/d
pag. 22
rat, 2y study,
benalaxyl
rat, 90d study,
benalaxyl-M
ARfD (acute reference dose) not allocated, not necessary
Dermal absorption (Annex IIIA, point 7.3)
Formulation: IR-6141 M 4
100
100
In vivo, rat: 2.5 % (undiluted product); 29 %
(diluted), 6h. exposure, benalaxyl-M

4 IR6141 M is a wettable powder containing 40 g/kg of benalaxyl-M and 650 g/kg of mancozeb. The
tested area doses are 0.08 mg/cm 2 (since the formulation is a powder it was necessary to apply it as a
highly concentrated aqueous suspension) and 0.001 mg/cm 2 .
Mancozeb
Mancozeb is a member of the EBDC (ethylene bisdithiocarbamate) family of fungicides. The
other substances in this class of compounds are maneb, metiram and zineb. The most
important common metabolite formed by these four substances is ETU (ethylene thiourea). The
toxicological properties of the four substances have its main origin in the formation of ETU,
particularly for the effect on the thyroid in mammals.
Mancozeb is an existing 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 mancozeb
(SANCO/4058/2001 – rev. 4.4, July 2009 1 ). Where relevant, some additional
remarks/information are given in italics.
Subsequently, also the List of Endpoints for ETU is presented.
Absorption, distribution, excretion and metabolism in mammals
Rate and extent of absorption: Rapid, 50% based on urinary excretion.
Distribution: Widely distributed, the highest residues in thyroid.
Potential for accumulation: No potential for accumulation.
Rate and extent of excretion: Rapid, > 95% within 4 d.
Toxicologically significant compounds: Parent compound and metabolite (ETU).
Metabolism in animals: Extensively metabolised, reactions of hydrolysis,
conjugation and ring formation (ETU).
Acute toxicity
Rat LD50 oral: > 5000 mg/kg bw.
Rat LD50 dermal: > 2000 mg/kg bw.
Rat LC50 inhalation: > 5.14 mg/l, whole body exposure
Skin irritation: Non irritant.
Eye irritation: Slightly irritant, no classification needed.
Skin sensitization (test method used
and result):
Short term toxicity
Sensitiser (M & K).
Target / critical effect: Thyroid (inhibition of thyroid peroxidase,
hyperplasia/hypertrophy).
Lowest relevant oral NOAEL / NOEL: 7 mg/kg bw/d
(overall NOAEL, 90-d rat, 90-d & 1-year dog)
Lowest relevant dermal NOAEL /
NOEL:
>1000 mg/kg bw/day (28-d & 90-d, rat)
1 On July 2009, the Standing Committee on the Food Chain and Animal Health, took note of the present revision 4.4.
in which the results of the confirmatory study on developmental neurotoxicity have been included in Appendix II with
respect to the new endpoint and data of the study.
pag. 23

Lowest relevant inhalation NOAEL /
NOEL:
36 mg/m 3 (respirable concentration)
(90-d, rat)
Genotoxicity
The overall body of toxicological data coming from a
number of in vitro and in vivo assays indicates that
there is no concern. 1
1
The genotoxic potential of mancozeb was investigated in in vitro studies (3 Ames tests, 2 host
mediated assays in S. typhimurium, mammalian gene mutation assay in Chinese hamster ovary cells,
UDS test in rat hepatocytes, , and 2 cell transformation assays in C3H10T 1/2 cells) and in five in vivo
studies (2 chromosomal aberration assays, and 3 micronucleus assays).
Long term toxicity and carcinogenicity
Target / critical effect: Thyroid (inhibition of thyroid peroxidase,
hypertrophy/hyperplasia); retinopathy at high doses.
Lowest relevant NOAEL: 125 ppm (4.8 mg/kg bw/d) (2-years rat).
Carcinogenicity: Thyroid adenomas and carcinomas in rats at high
doses. 2
2 This tumourigenic effect is attributable to ETU which is a metabolite of mancozeb. Anti-thyroid activity
of ETU inhibits the synthesis of thyroid hormone thereby stimulating the release of high TSH levels by
the pituitary. Thyroid tumours occur in the rat when the threshold for pituitary-thyroid feedback is
exceeded on a chronic basis resulting in an over-stimulation of the thyroid and subsequent development
of proliferative lesions. Humans are considerably less sensitive to thyroid inhibitors than rodents.
Reproductive toxicity
Target / critical effect - Reproduction: Decreased pup weight at parentally toxic dose level.
Lowest relevant reproductive NOAEL /
NOEL:
Target / critical effect - Developmental
toxicity:
150 ppm (about 7 mg/kg bw/d) (two-generation study
in rat). 3
Malformations at high doses in rats; embryo-
/fetotoxicity (delayed ossification, abortions) at lower
maternally toxic doses in rats and rabbits.
Lowest relevant developmental Rat: 60 mg/kg bw/d.
NOAEL / NOEL:
4
3
Parental and offspring NOAEL. NOAEL reproduction >1100 ppm (highest dose tested).
4
Maternal and developmental NOAEL. Rabbit: NOAEL maternal is 55 mg/kg bw/day and NOAEL
developmental is >100 mg/kg bw/day.
Delayed neurotoxicity There is no evidence from toxicology studies for
delayed neurotoxicity.
Other toxicological studies Neurotoxicity study, 90-d, rat: clinical signs and
histopathology; NOAEL 125 ppm (8.2 mg/kg bw/d).
An oral developmental neurotoxicity study of
mancozeb
in rats has been submitted in 2008. No test related
effects on any of the F1 litter parameters investigated
in
this study. NOAEL 30 mg/Kg /day the highest dose
tested. 5
5 The SCFCAH took note of revision 4.4. of this review report in July 2009. The study as required by the
pag. 24

directive of inclusion has been submitted in 2008. Oral developmental neurotoxicity study of mancozeb
in rats; WIL research laboratories. Ashland OH 44805-8946.
After Annex I inclusion, the RMS Italy evaluated this new developmental neurotoxicity (DNT) study of
mancozeb in rats. It was concluded that mancozeb has been adequately tested for DNT and showed no
developmental neurotoxicity.
Medical data Human studies of manufacturing workers exposed to
mancozeb have detected the presence of mancozeb
in urine but, with the exception of sporadic reports of
sensitisation by skin contact; no evidence of thyroid
effects; evidence of increased chromosomal
aberrations in manufacturing workers in one report
Summary
Value Study Safety factor
ADI: 0.05 mg/kg bw/d 2-years, rat 100
AOEL systemic: 0.035 mg/kg
bw/d
pag. 25
overall shortterm
NOAEL in
rats and dogs;
correction for 50
% oral
absorption
ARfD (acute reference dose): Mancozeb: 0.6 mg/kg bw/d (based on teratogenicity
NOEL of 60 mg/kg bw/d in rat)
ETU 0.05 mg/kg bw/d.
Dermal absorption 0.11% by 8 hours (high level dose formulation)
0.24% by 8 hours (low level dose formulation)
based on the results of in vivo rat dermal absorption
study. 6
6 The dermal absorption of mancozeb, formulated as an 80 Wettable Powder, was investigated in rats
(see addendum on mammalian toxicology, d.d. February 2003). The compound was applied as a
concentrate (equivalent to the commercial powder dissolved in a minimum quantity of water; 12 mg/cm 2 ))
and spray dilution (850 times diluted; 0.014 mg/cm 2 ).
ETU (ethylene thiourea)
ETU is a metabolite of mancozeb, which is responsible for the major toxicological effects of
mancozeb and which can be formed on food crops. Since this application also concerns
application on food crops, the List of Endpoints for ETU (based on the DARs for maneb,
mancozeb, metiram and zineb, ECCO 118 (Febr. 2002) and the addendum for mammalian
toxicology for maneb (Sept. 2003)) is also presented.
Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)
Rate and extent of absorption: Rapid, ca. 90% in rats
Distribution: Widely distributed, highest residues in
thyroid
Potential for accumulation: Low potential (t1/2 42 h for the thyroid)
Rate and extent of excretion: Rapid, > 75% in urine within 48 h
Metabolism in animals: Limited; excreted mainly as unchanged ETU
Toxicologically significant compounds (animals,
plants and environment)
Parent compound and metabolites
100

Acute toxicity (Annex IIA, point 5.2)
Rat LD50 oral 545 – 2400 mg/kg bw
Rat LD50 dermal > 2000 mg/kg bw
Rat LC50 inhalation LC 50 > 10.4 mg/l air, 4 hour-exposure in rat.
Skin irritation Non-irritant
Eye irritation Non-irritant
Skin sensitisation (test method used and result) Inconclusive
Short-term toxicity (Annex IIA, point 5.3)
Target/critical effect Thyroid (inhibition of thyroid peroxidase,
hyperplasia/hypertrophy); liver
(hypertrophy); anaemia in dog
Lowest relevant oral NOAEL/NOEL 10 ppm = 0.39 mg/kg bw/day (90-day dog)
5 ppm = 0.18 mg/kg bw/day (1-yr dog)
Lowest relevant dermal NOAEL/NOAL No data available
Lowest relevant inhalation NOAEL/NOEL No data available
Genotoxicity (Annex IIA, point 5.4) Overall no genotoxic potential 1
1 ETU has been tested in a very large battery of genotoxicity tests. ETU is not mutagenic in most
bacterial, fungal and mammalian cell culture gene mutation assays. Although there is sporadic genotoxic
activity at high doses in some bacterial/fungal systems, the bulk of the evidence is negative. This
conclusion is further supported by the results of UDS and SCE assays in mammalian cells and by
negative results in the higher tier for germ cell gene mutation potential, the D. melanogaster sex-linked
recessive lethal mutation test. There is no evidence that ETU is an in vivo or heritable gene mutagen.
ETU is also non-mutagenic in assays of chromosomal damage in mammalian systems, including in vivo
assays (chromosomal aberration test, micronuclei test, dominant lethal study).
Long-term toxicity and carcinogenicity (Annex IIA, point 5.5)
Target/critical effect Thyroid (inhibition of thyroid peroxidase,
hyperplasia/hypertrophy); liver (hyperplasia),
pituitary (hypertrophy)
Lowest relevant NOAEL/NOEL 0.37 mg/kg bw/day (2-year rat)
Carcinogenicity Thyroid adenomas and carcinomas in rats
and mice; liver adenomas and carcinomas in
mice. 2
2 Mechanism is inhibition of iodoperoxidase and not genotoxicity. Therefore, a risk assessment based on
reference values can be performed.
Reproductive toxicity (Annex IIA, point 5.6)
Reproduction target/critical effect No reproductive effects at parentally toxic
dose levels
Lowest relevant reproductive NOAEL/NOEL Reproductive: >125 ppm (> 4 mg/kg bw/day)
3
Systemic: 2.5 ppm (0.2 mg/kg bw/day) 4
Developmental target/critical effect Malformations (brain and skull) below
maternally toxic dose levels in rats
Lowest relevant developmental NOAEL/NOEL Rat: 5 mg/kg bw/day 5
3 reproductive and offspring NOAEL
4 parental NOAEL
5 NOAEL maternal is 40 mg/kg bw/day
pag. 26

Neurotoxicity / Delayed neurotoxicity (Annex IIA, point 5.7)
Apparently neurotoxic (cats, clinical findings)
Other toxicological studies (Annex IIA, point 5.8)
Medical data (Annex IIA, point 5.9)
Summary (Annex IIA, point 5.10)
pag. 27
No evidence of thyroid effects
Value Study Safety factor
ADI 0.002 1-yr dog 100
AOEL 0.004 90-day dog 100
ARfD (Acute Reference Dose) 0.05 rat teratogenicity
study
100
Dermal absorption (Annex IIIA, point 7.3)
20%, rough estimate, 10 h exposure
Local effects
Benalaxyl-M: Benalaxyl-M does not produce local effects after a single exposure, and it is not
expected that local effects are produced after repeated exposure.
Mancozeb: Mancozeb produces skin effects in a sensitisation study, but these effects are
covered in the risk assessment/management by means of assignment of R- and S-phrases. No
local effects were observed in a 90-day inhalation study in rats. In a 28-d and 90-d dermal
toxicity study in rats, the NOAEL for dermal and systemic effects is >1000 mg/kg bw/day.
Data requirements active substance
Benalaxyl-M and mancozeb: No additional data requirements are identified.
4.1 Toxicity of the formulated product (IIIA 7.1)
The formulation Fantic M does not need to be classified on the basis of its acute oral (LD50 rat
>5000 mg/kg bw), dermal (LD50 rat >5000 mg/kg bw), and inhalation toxicology (no study
performed, not required).
The formulation Fantic M is considered not irritating to skin and eyes.
The formulation Fantic M does not have sensitising properties in a Maximisation test.
4.1.1 Data requirements formulated product
No additional data requirements are identified.
4.2 Dermal absorption (IIIA 7.3)
Benalaxyl-M
See list of endpoints. The formulation Fantic M contains the same amount of benalaxyl-M and
mancozeb as the tested formulation IR6141 M and it is not expected that the co-formulants
which are present in the formulations influence the dermal absorption of benalaxyl-M. Also the
tested area doses are representative for Fantic M. For the risk assessment, a dermal
absorption value of 2.5% will be used for the concentrate and 29% for the spray dilution.

Mancozeb
The values in the List of Endpoints are representative for the formulation Fantic M (a 65% WG
formulation), as the dermal absorption study was conducted with an 80% WP formulation and
the co-formulants in Fantic M are expected not to influence dermal absorption of mancozeb.
However, the values are the sum of the radioactivity found directly after 8 hours exposure in
urine, faeces, carcass and stripped skin. The dermal absorption is still increasing thereafter,
whereas the amount of radioactivity in the stratum corneum is decreasing, indicating transport
from the stratum corneum into the body after the end of the exposure. Therefore the dermal
absorption will be calculated from the total radioactivity in urine, faeces, carcass and stripped
skin at the end of the study, at 144 hours. For the risk assessment, a value for dermal
absorption of 0.6% will be used for the concentrate and the spray dilution.
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.
4.4 Exposure/risk assessments
An application has been submitted for the authorisation of the plant protection product Fantic
M, a fungicide based on the active substances benalaxyl-M and mancozeb.
Fantic M is a WG formulation and contains 40 g/kg benalaxyl-M and 650 g/kg mancozeb.
The intended uses are listed under Appendix 1 (GAP).
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
Benalaxyl-M
Tier 1
Calculation of the EU-AOEL / Tolerable Limit Value (TLV)
For benalaxyl-M no TLV has been set. The AOEL will be used for the risk assessment.
Considering the intended uses, the formulation can be applied during the period April – July or
July – November and taking into account that contract workers can also perform the application
in potatoes and leek, chronic exposure cannot be excluded for the operator.
Benalaxyl-M is not yet included in Annex I of 91/414/EEC, and therefore the AOEL in the list of
endpoints is provisional. The calculation of the systemic AOEL for semi-chronic exposure is
based on the NOAEL of 6.2 mg/kg bw/day in the 90-d study with the rat, and a safety factor of
100. This results in a systemic AOEL of 0.06 mg/kg bw/day (= 4.2 mg/day for a 70-kg
operator/worker). This AOEL can also be regarded as a chronic AOEL, since the NOAEL of the
long-term rat study (4.4 mg/kg bw/day) is comparable to the short-term NOAEL (6.2 mg/kg
bw/day), specifically when taking the dose spacing of the long-term study into account (LOAEL
is 44 mg/kg bw/day).
Exposure/risk
Exposure to benalaxyl-M during mixing and loading and application of Fantic M 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.
pag. 28

In the Table below the estimated internal exposure is compared with the systemic EU-AOEL.
Table T.1 Internal operator exposure to benalaxyl-M and risk assessment for the use of
Fantic M
Route Estimated internal
exposure a Systemic Risk-index
(mg /day) EU-AOEL
(mg/day)
b
Mechanical downward spraying on ware and starch potatoes and leek (uncovered)
Mixing/
Loading c
Application d
Respiratory 0.060 4.2 0.01
Dermal 0.200 4.2 0.05
Respiratory 0.008 4.2 1% and this has been taken into account).
d External exposure is estimated with EUROPOEM.
Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not
required.
Mancozeb
Tier 1
Calculation of the EU-AOEL / Tolerable Limit Value (TLV)
For mancozeb no TLV has been set. The AOEL will be used for the risk assessment.
Considering the intended uses, the formulation can be applied during the period April – July or
July – November and taking into account that contract workers can also perform the application
in potatoes and leek, chronic exposure cannot be excluded for the operator.
Since mancozeb is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.035
mg/kg bw/day (= 2.45 mg/day for a 70-kg operator), based on the overall short-term NOAEL in
rats and dogs and corrected for 50% oral absorption, is used for the risk assessment (see List
of Endpoints). The EU-AOEL can also be regarded as a chronic AOEL, since the AOEL is
among others based on a 1 year dog study and since the NOAEL of the long-term rat study
(4.8 mg/kg bw/day or 125 ppm) is comparable to the short-term overall NOAEL (7 mg/kg
bw/day), specifically when taking the dose spacing of the long-term study into account (LOAEL
is 750 ppm).
Exposure/risk
Exposure to mancozeb during mixing and loading and application of Fantic M 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.2 Internal operator exposure to mancozeb and risk assessment for the use of
Fantic M
Route Estimated internal
exposure a Systemic Risk-index
(mg /day) EU-AOEL
(mg/day)
b
pag. 29

Route Estimated internal
exposure a (mg /day)
pag. 30
Systemic
EU-AOEL
(mg/day)
Mechanical downward spraying on ware and starch potatoes and leek (uncovered)
Mixing/
Loading c
Application d
Risk-index b
Respiratory 0.975 2.45 0.40
Dermal 0.780 2.45 0.32
Respiratory 0.130 2.45 0.05
Dermal 0.293 2.45 0.12
Total 2.2 2.45 0.9
a Internal exposure was calculated with:
biological availability via the dermal route: 0.6% (concentrate and spray dilution) (see 4.2)
biological availability via the respiratory route: 100% (worst case)
b The risk-index is calculated by dividing the internal exposure by the systemic AOEL.
c External exposure is estimated with the NL-model (the exposure during mixing/loading is relatively high, because
the powder fraction of the granulate formulation Fantic M can be >1% and this has been taken into account).
d External exposure is estimated with EUROPOEM.
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
Benalaxyl-M and mancozeb
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.
4.4.3 Worker exposure/risk
Benalaxyl-M and mancozeb
Shortly after application it is not necessary to perform any re-entry activities during which
intensive contact with the treated crop will occur. Therefore no worker exposure is calculated.
4.4.4 Re-entry
Benalaxyl-M and mancozeb
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 benalaxyl-M and
mancozeb as a result of the application of Fantic M in ware and starch potatoes and leek.
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 benalaxyl-M and mancozeb during application
of Fantic M in ware and starch potatoes and leek.
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
ware and starch potatoes and leek due to exposure to benalaxyl-M and mancozeb after
application of Fantic M.

These conclusions are also valid for the simultaneous exposure to benalaxyl-M and mancozeb.
4.5 Appropriate mammalian toxicology and operator exposure endpoints relating to
the product and approved uses
See List of Endpoints.
4.6 Data requirements
None.
4.7 Combination toxicology
The formulation Fantic M 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(s) based on the individual substances.
The target organ of benalaxyl-M is the liver. The target organ of mancozeb is the thyroid. The
toxicological profiles of the two substances are different and it is therefore not expected that
combined exposure to the two active substances in Fantic M will result in an additional risk
above the estimated risks based on the individual substances, when used in accordance with
Good Agricultural Practice.
4.8 Mammalian toxicology classification and labelling
Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification)
Benalaxyl-M
Symbol: - Indication of danger: -
Risk phrases - -
Mancozeb
Symbol: Xn Indication of danger: Irritant
Risk phrases R43
R63
May cause sensitisation by skin contact
Possible risk of harm to the unborn child
The current EU classification of mancozeb based on the 21 st ATP (1994) is Xi, R37 (irritating to
respiratory system) and R43. However, in ECCO 118 (Febr. 2002), the experts could not find
any evidence of irritation to the respiratory tract. Therefore, they suggested that ECB should
reconsider the risk phrase R37 for mancozeb.
Mancozeb has been re-evaluated by ECB and a revised classification and labelling (compared
to the 21 st ATP) is presented in the 31 st ATP to Directive 67/548/EEC (Directive 2009/2/EC).
The revised ECB classification and labelling for mancozeb is R43 and R63 (Xn, Harmful). This
means that R37 is indeed not considered justified and that the ECB classification and labelling
is in agreement with the conclusions from ECCO 121 (August 2002). On 20 January 2009
Annex I of Directive 67/548/EEC is deleted by the entering into force of Regulation (EC)
1272/2008 on classification, labelling and packaging of substances and mixtures (CLP). Table
3.2 replaces Annex I to Directive 67/548/EEC. The 31 st ATP to 67/548/EEC will be included
(together with the 30th ATP) in the 1 st ATP to CLP. Although this 1 st ATP is not yet published,
Ctgb adopt the classification of mancozeb as proposed in the 31 st ATP.
pag. 31

Proposal for the classification and labelling of the formulation concerning health
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 labeling 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 R63 Possible risk of harm to the unborn child.
S phrases S36/37 Wear suitable protective clothing and gloves.
Special provisions:
DPD-phrases
- -
Plant protection DPD01 To avoid risk for man and the environment,
products phrase:
DPD-phrase
comply with the instructions for use
Child-resistant fastening obligatory? na
Tactile warning of danger obligatory? na
Explanation:
Hazard symbol: Xn is obligatory when R63 is assigned.
Risk phrases: R63 is assigned based on the active substance
mancozeb
Safety phrases: S36/37 is obligatory when R63 is assigned.
Other: -
5 Residues
Benalaxyl-M
Benalaxyl-M is an new active substance, not decided upon for inclusion in Annex I of
91/414/EEC. The List of Endpoints presented below is the most recent one from the EFSA
conclusion d.d. July 2007. The Dutch comments, when relevant, are also presented (in italics).
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered Fruits (grapes)
Rotational crops Not required for representative use
Plant residue definition for monitoring Option 1 - Benalaxyl-M;
Option 2 - benalaxyl including other mixtures of
constituent isomers including benalaxyl-M
(sum of isomers)
Plant residue definition for risk
Benalaxyl-M (IR6141)
assessment
Conversion factor (monitoring to risk
assessment)
none
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
pag. 32

Animals covered Lactating goats and laying hens
Animal residue definition for monitoring Not required for representative use
Animal residue definition for risk
assessment
Conversion factor (monitoring to risk
assessment)
Metabolism in rat and ruminant similar
(yes/no)
Not required for representative use
Not applicable
yes
Fat soluble residue: (yes/no) yes
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
Not required for representative use
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)
The stability of the racemic mixture (benalaxyl)
was tested on several vegetal substrates
(grapes, wine, potatoes and tomatoes) stored in
the dark, at a temperature below -20ºC over 3
years of storage. During this period no
appreciable degradation occurred. This can be
considered as a good indication of the stability
of each individual isomer. Indeed the racemic
benalaxyl demonstrated to remain stable for up
1110 days
It was assessed that the D-isomer (Benalaxyl-
M) does not degrade under the same storage
conditions, in fact the percentages at the last
sampling time show that even if the D-isomer
only is assumed to be responsible for the
observed variations (i.e. apparent degradation),
these are not statistically significant.
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Intakes by livestock 0.1 mg/kg diet/day: Ruminant:
no
Muscle
Liver
Kidney
Fat
Milk
Eggs
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
pag. 33
Poultry:
no
Pig:
no

Crop/processed crop Number of
studies
pag. 34
Transfer factor % Transference
*
Grapes/must 1 0.4 Not calculated
Grapes/juice 4 0.2-0.4 Not calculated
Grapes/young wine 3 0.2-0.4 Not calculated
Grapes/bottled wine 4 0.2-0.4 Not calculated
* Calculated on the basis of distribution in the different portions, parts or products as
determined through balance studies
Mancozeb
Mancozeb is an existing active substance, included in Annex I of 91/414/EEC (2005/72/EC of
22 October 2005). The List of Endpoints d.d. February 2003 presented below is the most recent
before the publishing of the final review report d.d. June 2005 (no update for Residues in 2009).
The Dutch comments, when relevant, are also presented (in italics).
Metabolism in plants (Annex IIA, point 6 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered Pulses and oilseed (soybeans), Fruiting
vegetables (tomato), Root vegetables
(potatoes, sugar beet), Cereals (wheat) 1
Rotational crops Barley, potato, radish, Swiss chard, wheat,
beet, lettuce
Plant residue definition for monitoring Mancozeb (expressed as CS2) 1
Plant residue definition for risk assessment Mancozeb (expressed as CS2) and ETU for
processed commodities
Conversion factor (monitoring to risk
Not applicable 2
assessment)
1 For the residue analysis of mancozeb, a general method of analysis for ethylenebisdithiocarbamates (EBDC’s) is
used. In this method, the concentration of the degradation product carbon disulfide (CS2) is measured. From the
level of CS2 detected, the level of dithiocarbamates can be derived.
2 As the residue definition for monitoring is the same as the residue definition for risk assessment, a conversion factor is not
applicable.
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered Lactating dairy goat, laying hens
Animal residue definition for monitoring Mancozeb (expressed as CS2)
Animal residue definition for risk assessment Mancozeb (expressed as CS2)
Conversion factor (monitoring risk assessment) Not applicable 2
Metabolism in rat and ruminant similar (Yes/No) Yes
Fat soluble residue (Yes/No) No
As the residue definition for monitoring is the same as the residue definition for risk assessment, a conversion factor is not
applicable.
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
The exposure of the consumer from
residues in rotational or succeeding crops
grown in fields previously treated with
mancozeb is insignificant.
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)
In apples, about 74% of the mancozeb

pag. 35
spiked is still present after one and two
years of frozen storage
In tomatoes, about 74% of the mancozeb
spiked is still present after two years of
frozen storage
In potatoes, about 58% of the mancozeb
spiked is still present after three months of
frozen storage
Therefore, residues of mancozeb are stable
in apples tomatoes and grapes under
conditions of frozen storage, for up to two
years. Residues of mancozeb are
moderately stable in ground potatoes under
conditions of frozen storage, for up to 3
months.
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Intakes by livestock 0.1 mg/kg diet/day Ruminant :
Yes
Poultry :
Yes
Muscle

The evaluation below for benalaxyl-M is based on data from the DAR and the summary of
residue trials with potato and leeks (Ctgb, March 2010).
Mancozeb
The evaluation below for mancozeb is based on data from the DAR the and the summary of
residue trials with potatoes and leeks (Ctgb, March 2010).
5.1.1 Metabolism in plants
Benalaxyl-M
Metabolsm was investigated with benalaxyl-M in grape (fruit as well as leaf). Reference was
made to metabolism of benalaxyl in tomato (fruit as well as leaf) and potato tubers. Since
metabolism was the same in all investigated crops and plant parts, it was concluded that
metabolism is the same for benalaxyl and benalaxyl-M in all crop categories.
Mancozeb
Metabolism was studied in pulses and oilseed (soybeans), fruiting vegetables (tomato), root
vegetables (potatoes, sugar beet) and cereals (wheat). Metabolism was found to be identical in
all categories and the main metabolite was mancozeb parent compound.
5.1.2 Metabolism in livestock
Benalaxyl-M and Mancozeb
Not relevant for the intended uses since leeks are not consumed by livestock and potatoes
contain residues levels < LOQ.
5.1.3 Residue definition (plant and animal)
Benalaxyl-M
The residue definition form onitroing and risk assessment was not dicieded by the expert
meeting and EFSA. However, at the moment the residue definition according to (EC)M
396/2005 is benalaxyl + benalaxyl-M, which will used in this evaluation and assessment.
Mancozeb
The residue definition for monitoring and risk assessment for plant and animal products is
mancozeb parent compound, expressed as total CS2.
For heated processed products, metabolite ethylenethiourea (ETU) was also identified as a
major toxicological relevant breakdown product (see 5.1.8 processing).
5.1.4 Stability of residues
Benalaxyl-M
The racemic mixture as well as the purified benalaxyl-M was found to be stable for more than 3
years in grape, wine, tomato and potatoes. Therefore, storage stability in watery matrix (potato,
leek) is covered.
Mancozeb
Storage stability was confirmed for 12 months in tomato and apple, and for 3 months in potato
tuber in the EU dossier. In the JMPR 1993 evaluations, storage stability data in wheat samples
were described. Mancozeb was found to be stable for 24 months at –20°C. For the intended
uses of Fantic M WG it is concluded that mancozeb (measured as CS2) is stable for 24 months
in watery matrices (apple, pear, onion), for 3 months in potato and for 24 months in dry
matrices (wheat).
5.1.5 Supervised residue trials
Benalaxyl-M
Potato (3x0.1 kg ai ha, interval 7-10d and PHI 14d)
pag. 36

For the national authorisation, 7 supervised residue trials in leek were submitted all dosed
within 25% margin of GAP-NL. All trials were performed with 4 applications of 350 g ai/ha,
interval 9-15d and PHI 14-15d. Residues were measured with GC/NPD method not
distinguishing between benalaxyl and benalaxyl-M against a benalaxyl standard (4 trials) or a
benalaxyl-M standard (3 trials). All trials showed a zero residue situation. For residue levels
selected see Table R1.
Leek (3x0.1 kg ai ha, interval 21d and PHI 42d)
For the national authorisation, 4 supervised residue trials in leek were submitted all dosed
within 25% margin from GAP-NL, with interval al 21d and PHI 42d. For residue levels selected
see Table R1.
Mancozeb
Potato (3x1.625 kg ai ha, interval 7-10d and PHI 14d)
In the DAR of mancozeb, 14 trials with potato in Northern Europe are described, performed
with 8-15 x 1.2-1.6 kg mancozeb/ha, interval 7d and PHI 7d. These trials are assumed to be
worst case since the cGAP-NL is only 8 x 1.5 kg mancozeb/ha, interval 7d and PHI 7d. For
residue levels selected see Table R2
The expected residues arising form the use of Fantic M WG are covered by the EU-MRL of 0.3
mg/kg for potato.
Leek (3x1.625 kg ai ha, interval 21d and PHI 60d)
For the national authorisation, 8 supervised residue trials in leek were submitted all doses
within 25% margin form GAP-NL. However, the application interval was too short (7d instead of
21d). In three trials, residues at PHI 45d were higher compared to PHI 30d which was
explained by the cold weather: since leeks remained frozen, residue did not decrease (or even
increased when expressed as mg/kg due to water loss). For residue levels selected see Table
R2.
Table R1: Selected residue levels from trials with benalaxyl-M
Crop Residue levels selected for MRL setting STMR HR
(mg/kg)
(mg/kg) (mg/kg)
potato 3x

eef cattle based on a diet of cereals (70%, MRL = 1 mg/kg) and beet tops (30%, MRL = 3
mg/kg). Based on a livestock feeding study performed at 1.6, 4.8 and 16 mg/kg dry feed no
residues above the LOQ are expected in mammalian products. The EU MRL at 0.05* mg/kg
covers the intended uses of Fantic M WG.
Poultry products
Intake of mancozeb residues was calculated in the DAR base on the uses on potato and sugar
beet leaves, and during MRL setting. Intake was about 1.2 mg/kg dry feed maximally for
poultry, based on a diet of cereal grain (70%, MRL = 1 mg/kg) and pulses (30%, MRL = 1
mg/kg). Based on a livestock feeding study performed at 1.6, 4.8 and 16 mg/kg dry feed nor
residues above the LOQ are expected in poultry products. The EU MRL at 0.05* mg/kg covers
the intended uses of Fantic M WG.
5.1.8 Processing factors
Benalaxyl-M
Since residues in leeks and potatoes are below the LOQ, no processing information is needed.
Mancozeb
For heated products metabolite ethylenethiourea (ETU) was determined as a toxicologically
relevant metabolite. From processing data on dithiocarbamates it appeared that ETU was
generally not higher than 25% of the residue level of dithiocarbamates expressed as CS2.
5.1.9 Calculation of the ADI and the ARfD
Benalaxyl-M
For benalaxyl-M the ADI is based on the NOAEL of 4 mg/kg bw/d in the 2-year carcinogenicity
study in the rat. Application of a safety factor for inter- and intraspecies differences of 100
results in an ADI of 0.04 mg/kg bw/day.
Since benalaxyl-M shows no acute toxic properties, an ARfD was not allocated.
Mancozeb
For mancozeb, the ADI is based on the NOAEL of 4.8 mg/kg bw/d in the 2-year carcinogenicity
study in the rat. Application of a safety factor for inter- and intraspecies differences of 100
results in an ADI of 0.05 mg/kg bw/day.
For ETU, the ADI is based on the NOAEL of 0.37 mg/kg bw/d in the 2-year rat study.
Application of a safety factor for inter- and intraspecies differences and for teratogenic effects of
200 results in an ADI of 0.002 mg/kg bw/day (see the List of Endpoints for mammalian
toxicology).
For mancozeb, the ARfD is based on the NOAEL of 60 mg/kg bw/d in the rat teratogenicity
study. Application of a safety factor for inter- and intraspecies differences of 100 results in an
ARfD of 0.6 mg/kg bw/day.
For ETU, the ARfD is based on the NOAEL of 5 mg/kg bw/d in the rat teratogenicity study.
Application of a safety factor for inter- and intraspecies differences of 100 results in an ARfD of
0.05 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).
5.2 Maximum Residue Levels
Benalaxyl-M
Harmonised EU-MRLs are presented in Annex III of Regulation (EC) 396/2005 for benalaxyl.
The MRL for potato as well as leeks is set at the LOQ of 0.05* mg/kg
pag. 38

Mancozeb
Harmonised EU-MRLs have recently been updated for all the dithiocarbamates including
mancozeb, in Directive 2008/17/EC (fruits and vegetables) and Directive 1998/82/EC (cereals
and animal products). The LOQ is 0.05* mg/kg and the residue is defined as the sum of CS2
(for the dithiocarbamates: maneb, mancozeb, metiram, propineb and zineb). The MRLs are
included in Annex II of Regulation (EC) 396/2005.
The MRLs for potato (0.3 mg/kg), and leek (3 mg/kg) and animal products (0.05* mg/kg) cover
the intended uses of Fantic M WG with a PHI of 60d for leeks. The proposed PHI of 42d for
leek by the applicant is not covered by the MRL of 3 mg/kg. An application to increase the MRL
from 3 to 4 mg/kg is ongoing, but not yet accepted.
The product complies with the MRL Regulation. Notification of the MRLs is not necessary.
5.3 Consumer risk assessment
Benalaxyl-M
Risk assessment for chronic exposure through diet
Based on the proposed residue tolerances, a calculation of the National Theoretical Maximum
Daily Intake (NTMDI) was carried out using the harmonised EU MRLs, EFSAs’ PRImo and the
ADI of 0.04 mg/kg bw/d.
Calculation of the NTMDI shows that maximally 9.5% of the ADI is used for the French
toddlers. The TMDII shows that 2.8% and 8.2% of the ADI is used for the Dutch general
population and for Dutch children 1-6y, respectively.
Risk assessment for acute exposure through diet
A calculation of the (N)ESTI was not carried out since no ARfD has been set.
Mancozeb
Risk assessment for chronic exposure through diet
A combined risk assessment is performed for the dithiocarbamates, following the methodology
as published by the JMPR (1996). The risk assessment is performed using the highest residue
level of CS2 from which the MRL was calculated, and the lowest ADI (propineb, 0.007 mg/kg
bw/d). To correct for the difference in molecular weight, a conversion factor was calculated: CS2
to mancozeb = 1.75. To correct for the difference in toxicity between propineb en mancozeb, a
correction factor of 0.007/0.05 = 0.14 was introduced. The combined correction factor to
correct the risk assessment for propineb to that for maneb is 0.14*1.75 = 0.245.
Mancozeb/CS2
Based on the proposed residue tolerances, a calculation of the National Theoretical Maximum
Daily Intake (NTMDI) was carried out using the National Dutch diet and the harmonised EU-
MRLs from the risk assessment as performed by RMS IT, d.d. June 2007. Calculation of the
NTMDI shows that 110% and 286% of the ADI is used for the general population and for
children, respectively.
A NEDI calculation was performed using the STMR values and a processing factor for peeling
of citrus of 0.14 from the evaluation of RMS IT. The NEDI shows that 24% and 68% of the ADI
is used for the general population and for children, respectively.
Ethylenethiourea (ETU)
Ethylenethiourea (ETU) is a metabolite of mancozeb and might be present in heated products.
From processing studies it is known that the concentration of ETU is 4 to 10 times lower than
the concentration of CS2. The ADI for ETU is only 2.5 times lower than the ADI of propineb.
Therefore, as intake of CS2 is acceptable, the intake of ETU is acceptable, too.
Risk assessment for acute exposure through diet
mancozeb
pag. 39

A calculation of the National Estimated Short Term Intake (NESTI) for mancozeb was carried
out using the National Dutch diet and the HR values and the STMRs form the residue trials.
The ESTI of mancozeb is maximally 30% of the ARfD for leeks for BE children. The NESTI is
maximally 2.2% and 2.8% of the ARfD for the Dutch general population and children of 1-6y,
respectively, both for the product leeks.
ETU
A calculation of the National Estimated Short Term Intake (NESTI) for ETU was carried out
using the National Dutch diet and a level of ETU of 25% of that of the MRL of CS2. For potato
products the MRL and STMR for ETU are 0.75 and 0.14 mg/kg, respecively. For leek products
the MRL and STMR are 0.075 and 0.0375 mg/kg, respectively. The NESTI of ETU is maximally
0.4 and 0.7 % of the ARfD for the general population and children of 1-6y, respectively, for
processed (heated) potato.
Conclusion
No risk for consumers is expected when Fantic M WG is authorised for the intended uses and
the MRL for mancozeb on leeks has been increased up to 4 mg/kg. Decision making will most
probably take place before authorisation will be granted.
The product complies with the Uniform Principles.
5.4 Data requirements
Authorisation awaits MRL setting for mancozeb on leeks.
6 Environmental fate and behaviour
For the application of Fantic M, risk assessment is done in accordance with Chapter 2 of the
RGB.
For Benalaxyl-M the List of Endpoints from the EFSA conclusion date 27 July 2007 is used for
risk assessment.
For mancozeb the risk assessment is based on the final List of Endpoints from the final review
report, June 2005 (updated June 2009).
List of Endpoints Fate/behaviour
Benalaxyl-M (27/07/2007)
For benalaxyl-M the following data gaps were identified in the EU EFSA conclusion
Assessment of the toxicological non relevance of the R isomers of the benalaxyl lysimeter
leachate metabolites F4, F7 and F8 (data gap identified by EFSA, an evaluation by the
RMS was submitted for benalaxyl 2 but not provided in an addendum for benalaxyl-M, so
not peer-reviewed by the experts)
Report detailing the Model Maker exercise employed to derive the formation fractions used
for the FOCUS GW modelling (relevant for all representative uses evaluated; data gap
identified at the time of writing the conclusion, no submission date proposed by the
applicant, refer to point 4.2.2)
2 See Portugal’s comments to questions raised during benalaxyl evaluation “Evaluation of the
toxicological relevance of metabolites leaching in groundwater according to SANCO Document 221/2000
rev. 10” (25th February 2003) in “Benalaxyl - PT response to comments of several Member-States in the
WG Legislation meeting of 27-28/11/2003” (19-12-2003)
pag. 40

The ecotoxicological relevance of the five metabolites detected above 0.1 µg/L in the
lysimeter study needs to be addressed (data gap identified by EFSA, no submission date
proposed by the applicant, refer to point 5.2)
Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)
Mineralization after 100 days ‡ Benalaxyl-M ( 14 C-U-aniline ring):
evolved CO2: 3,62% at 100 days (n=4)
methyl-N-(2, 6-xylyl)-N-malonyl-D-alaninate
(M7)
( 14 C-U-aniline ring): 14.96-24.47% at 100 DAT
(n=3)
N-(2, 6-xylyl)-N-malonyl-D-alanine (M3):
( 14 C-U-aniline ring): 18.54-26.38% at 100 DAT
(n=3)
N-(phenylacetyl)-N-(2,6-xylyl)-D-alanine
(Benalaxyl-M—acid; M9):
( 14 C-U-aniline ring): 2.06-5.94% at 15-43 DAT
(n=3)
Non-extractable residues after 100 days ‡ Benalaxyl-M ( 14 C-U-aniline ring): 21.51% at 100
days; 5.75-25.59% at 130-150 DAT (n=4)
Relevant metabolites - name and/or code,
% of applied ‡ (range and maximum)
methyl-N-(2, 6-xylyl)-N-malonyl-D-alaninate
(M7)
( 14 C-U-aniline ring): 12.91-16.62% at 100 DAT
(n=3)
N-(2, 6-xylyl)-N-malonyl-D-alanine (M3)
( 14 C-U-aniline ring): 10.36-15.70% at 100 DAT
(n=3)
N-(phenylacetyl)-N-(2,6-xylyl)-D-alanine
(benalaxyl-M—acid; M9)
( 14 C-U-aniline ring): 9.47-14.04% at 15-43 DAT
(n=3)
Methyl-N-(2, 6-xylyl)-N-malonyl-D-alaninate
(M7):
10.46-24.12% at 45-130 DAT (n=4)
N-(2, 6-xylyl)-N-malonyl-D-alanine (M3):
7.57-28.46% at 70-150 DAT (n=4)
N-(phenylacetyl)-N-(2,6-xylyl)-D-alanine
(benalaxyl-M-acid; M9):
15.20-33.32% at 45-150 DAT (n=4)
pag. 41

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)
Anaerobic degradation ‡ Available study for benalaxyl does not comply
with current standards; however, gives
indications of slower degradation under
anaerobic conditions. No further data required
for representative uses supported for EU risk
assessment.
Soil photolysis ‡ Data for Benalaxyl-M: Soil photolysis followed
the same pattern as observed under aerobic soil
degradation (in the dark) although slower; the
main degradation product was benalaxyl-M-acid
(M9) (max. 7.97% at 29 DAT).
Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)
Method of calculation Benalaxyl-M and soil metabolites of benalaxyl
(M1 and M2 or of benalaxyl-M-acid (M9) and of
regression analysis (1st order values)
Laboratory studies ‡ (range or median, with
n value, with r2 value)
methyl-N-(2, 6-xylyl)-N-malonyl-DLalaninate
(benalaxyl metabolite M1 racemate of
benalaxyl-M metabolite M7)
N-(2, 6-xylyl)-N-malonyl-DL-alanine
(benalaxyl metabolite M2 racemate of
benalaxyl-M metabolite M3)
N-(phenylacetyl)-N-(2,6-xylyl)-D-alanine
(benalaxyl-M-acid (M9))
DT50lab (20C, aerobic): ‡ 44.6, 70.0, 94.4,
145.9 days (n=4, r2= 0.79-0.98), 1st order
mean value: 90 days
DT90lab (20C, aerobic): ‡ 143 – 467 days (n=3)
DT50lab (10C, aerobic): ‡ 124.9 – 196 – 264 –
408.5 days No experimental data. Calculated by
EFSA on basis to Q10 = 2.8 (Following EFSA
PPR Panel Opinion of 8 February 2006, The
EFSA Journal (2005) 322, 1-3).
Available study for benalaxyl does not comply
with current standards; however, gives
indications of slower degradation under
anaerobic conditions. No further data required
for representative uses supported for EU risk
assessment.
DT50lab (20C, aerobic): 49-86-91 days (n=3, r2
> 0.98), 1st order ; mean value: 75 days
DT50lab (20C, aerobic): 66-106-113 days (n=3,
r2 > 0.92), 1st order
mean value: 95 days
DT50lab (20C, aerobic): 3.5-5.4–13.4days (n=3,
r2 = 0.89-0.96); mean value: 7.4 days
Degradation in the saturated zone ‡: no data,
not relevant
pag. 42

Field studies ‡ (state location, range or
median with n value)
Soil accumulation and plateau
concentration ‡
Data for benalaxyl
DT50field: ‡
Italy, bare soil (1st order)
DT50field: 49 days (n = 1)
Germany, bare soil (1st order)
DT50field: 20, 25, 71, 98 days ; mean value:
53.5 days
The active substance (benalaxyl) remained
confined in the top 0-10 cm soil layer. The
compounds methyl-N-(2, 6-xylyl)-N-malonyl-DLalaninate
and N-(2, 6-xylyl)-N-malonyl-DLalanine
were found down to 20 cm depth.
pag. 43
DT90field: ‡ 67, 84, 235, 326 days
Benalaxyl-M and N-(phenylacetyl)-N-(2,6-xylyl)-
D-alanine (benalaxyl-M-acid) are not expected
to accumulate in soil based on the respective
degradation rates. Plateau maximum
concentrations of Benalaxyl-M has been
estimated by EFSA just after last application of
benalaxyl-M in each year as 0.26 mg a.s. /kg
soil
Methyl-N-(2, 6-xylyl)-N-malonyl-D- alaninate
(M7) and N-(2,6-xylyl)-N-malonyl-D-alanine
(M3) are not expected to accumulate in soil
based on the calculation of the accumulation
potential for these metabolites. Plateau
maximum concentrations of M7 and M3
estimated just after last application of
benalaxyl-M in each year are 0.0552 and
0.0632 mg/Kg soil

Soil adsorption/desorption (Annex IIA, point 7.1.2)
Kf /Koc ‡
Kd ‡
pH dependence ‡ (yes / no) (if yes type of
dependence)
Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
Data for Benalaxyl-M:
Koc: 2005, 4226, 5675, 12346 (n=4); mean
value: 6063 mL/g
Kd: 53.03, 70.88, 86.49, 100.15
Data for benalaxyl metabolites
Methyl-N-(2, 6-xylyl)-N-malonyl-DL-alaninate
(benalaxyl metabolite M1racemate of benalaxyl-
M metabolite M7):
Koc: 151, 455, 521 (n=3); mean value: 375
mL/g
Kd: 7.039, 9.691, 21.741
N-(2,6-xylyl)-N-malonyl-DL-alanine (benalaxyl
metabolite M2 racemate of benalaxyl-M
metabolite M3):
Koc: 80, 127, 756 (n=3); mean value: 321 mL/g
Kd: 1.712, 11.563, 16.104
Data for benalaxyl-M metabolite
N-(phenylacetyl)-N-(2,6-xylyl)-alanine
(benalaxyl-M—acid, M9):
Koc: 43, 110, 285, 436 (n=4); mean value:
218.5 mL/g
Kd: 2.280, 2.562, 2.618, 4.071
Column leaching ‡ Three formulations of benalaxyl were tested
(GALBEN OE 20, GALBEN 25 WP and
GALBEN 5 GR) on standard soils (BBA 2.1,
BBA 2.2 and BBA 2.3). In all the studies less
than 2% of the applied amount (corresponding
to levels below the LOD - 25.6 g/L) were found
in the soil leachates. Metabolites were not
analysed in this study.
Aged residues leaching ‡ 30 days aged benalaxyl was applied to silty
loam soil.
86% AR was found in the soil columns with
more than 70% AR in the upper 0-15 cm soil;
14% AR was found in leachate and was
characterised as Methyl-N-(2,
6-xylyl)-N-malonyl-DL-alaninate (7.86%AR),
N-(2,6-xylyl)-N-malonyl-DL-alanine (5.56% AR)
and benalaxyl acid with 0.29% AR.
Lysimeter/ field leaching studies ‡ No lysimeter study available for benalaxyl-M.
A lysimeter study is available for benalaxyl.
Two lysimeters (I and II) with undisturbed sandy
(1.77% c.o. at 0-30 cm; 0.3% c.o. at 30-60 cm)
soil monoliths (depth 1.2 m, surface area 1.0
m2).
pag. 44

Application: 4x 0.240 Kg s.a./ha (14C-benalaxyl
formulated as GALBEN M 8-65) on May 30 to
July, 15, 2002, on tomatoes at stage BBCH 21
to 22. Product was only applied first year.
Leachate samples were taken on a weekly
basis. Reference compounds used were M1
(98.5% purity), M2 (97.4% purity) and
benalaxyl-M acid (> 98% purity). All other
radioactive fractions detected were identified by
LC-MS.
Analysis of the leachates
Leachate from year 1: Lys I 10.98%AR (17.71
µg a.s. equiv./L) and Lys II 9.39% AR (14.04 µg
a.s equiv/L)
Leachate from year 2: Lys I 1.19%AR (3.36 µg
a.s. equiv./L) and Lys II 1.87% AR (5.14 µg a.s
equiv/L)
No benalaxyl or benalaxyl-acid were detected in
the leachates.
Metabolite M1 (racemate of benalaxyl-M
metabolite M7): max.: 9.30 µg a.s.equiv./L
(160DA1T) (1.6%AR) in both Lysimeters.
Year 1 annual average: 4.7 µg a.s equiv./L also
in both Lysimeters
Year 2 annual average: 0.09 µg a.s. equiv./L
(Lys I) and 0.18 µg a.s. equiv./L (Lys II)
Metabolite M2 (racemate of benalaxyl-M
metabolite M3):
Max.: 20.25 µg a.s. equiv./L (220DA1T)
(1.0%AR).
Year 1 annual average: 8.22 µg a.s. equiv./L
(Lys I)
and 5.11 µg a.s. equiv./L (Lys II)
Year 2 annual average: 2.72 µg a.s. equiv./L
(Lys I) and 3.6 µg a.s. equiv./L (Lys II).
Benalaxyl lysimeter metabolite F4
Year 1 annual average: 1.90 µg a.s. equiv./L
(Lys I) and 1.71 µg a.s. equiv./L (Lys II).
Year 2 annual average: 0.15 µg a.s. equiv./L
(Lys I) and 0.43 µg a.s. equiv./L(Lys II).
Benalaxyl lysimeter metabolite F7
pag. 45

PEC (soil) (Annex IIIA, point 9.1.3)
Parent
Year 1 annual average: 0.9 µg a.s.equiv./L (Lys
I and II)
Year 2 annual average: 0.3 µg a.s.equiv./L (Lys
I and II)
Benalaxyl lysimeter metabolite F8
Year 1 annual average: 1.93 µg a.s. equiv./L
(Lys I) and 1.38 µg a.s. equiv./L (Lys II).
Year 2 annual average: 0.34 µg a.s. equiv./L
(Lys I) and 0.57 µg a.s. equiv./L (Lys II)
Soil analysis
At the end of the 2 years 27% to 30% AR still
remained associated to soil. The top soil layer
itself accounted for ca 6%AR. HPLC analysis of
the extracts from the 1st experimental year
showed the presence of benalaxyl, M1 M2 and
F8, however none of them exceeded 0.026
mg/kg soil.
Method of calculation DT50: 98 days
First-order kinetics
Representative worst-case from field studies
Application rate Crop: grape
% plant interception: 50%
number of applications: 4
Interval: 10 days
Application rate: 100 g as/ha
Metabolite: Methyl-N-(2, 6-xylyl)-N-malonyl-D-alaninate (M7): (Annex IIIA, point 9.1.3)
Method of calculation DT50: 90 days
First-order kinetics
Representative worst-case from laboratory
studies
Application rate Crop: grapes
% plant interception: 50%
number of applications: 4
Interval: 10 days
Application rate: 100 g as/ha (assumed M7 is
formed at a maximum of 24.12% of the applied
dose)
Molar fraction 0.9 relative to the a.s.
pag. 46

Metabolite: N-malonyl N-(2,6-xylyl)-D-alanine (M3): (Annex IIIA, point 9.1.3)
Method of calculation DT50: 98 days
First-order kinetics
Representative worst-case from laboratory
studies
Application rate Crop: grape
% plant interception: 50%
number of applications: 4
Interval: 10 days
Application rate: 100 g as/ha (assumed M3 is
formed at a maximum of 28.46% of the applied
dose)
Molar fraction 0.86 relative to the a.s.
Metabolite: N-(phenylacetyl)-N-(2,6-xylyl)-D-alanine (benalaxyl-M-acid; M9): (Annex IIIA,
point 9.1.3)
Method of calculation DT50: 13.4 days
First-order kinetics
Representative worst-case from laboratory
studies
Application rate Crop: grape
% plant interception: 50%
number of applications: 4
Interval: 10 days
Application rate: 100 g as/ha (assumed
benalaxyl-M-acid is formed at a maximum of
33.32% of the applied dose)
Molar fraction 0.96 relative to the a.s.
Route and rate of degradation in water (Annex IIA, point 7.2.1)
Hydrolysis of active substance and relevant
metabolites (DT50) ‡
(state pH and temperature)
Photolytic degradation of active substance
and relevant metabolites ‡
Readily biodegradable (yes/no) No
Degradation in water/sediment
- DT50 water ‡
- DT90 water ‡
- DT50 whole system‡
- DT90 whole system ‡
pH 4: stable (50ºC)
pH 7: stable (50ºC)
pH 9: DT50 = 11 days (50ºC) DT50 = 6.54 days
(55ºC) DT50 = 1.96 days (65ºC)DT50 = 301.3
days (25ºC extrapolated - Arrhenius)Main
hydrolysis product at pH 9 is benalaxyl-M-acid.
Not performed as no absorption at wavelenghts
> 290 nm (benalaxyl-M).
17 days (Pond) and 58 days (River) (r2 = 0.96)
57 days (Pond) and 190 days (River) (r2 = 0.96)
127 days (Pond) and 197 days (River)
406 days (Pond) and 630 days (River)
Study performed with benalaxyl
pag. 47

Mineralization Max. 0.38%AR (pond) at 100DAT
Non-extractable residues Max. 8.13%AR (pond) at 100DAT
Distribution in water / sediment systems
(active substance) ‡
Distribution in water / sediment systems
(metabolites) ‡
PEC (surface water) (Annex IIIA, point 9.2.3)
Parent
Pond: 0 h until day 2, main portion in water
phase, then active substance remains adsorbed
to the sediment with 53% at the end of the study
(100d). River: 0 h until day 30, main portion in
water phase. At day 100, 25.8% in water phase
and 43% adsorbed to the sediment.
there were no metabolites > 10 % in
water
Methyl-N-(2,6-xylyl)-N-malonyl-DL-alaninate
(benalaxyl metabolite M1 racemate of
benalaxyl-M metabolite M7) was preferentially in
water with a maximum of 7.3% AR at day 100
(River); methyl-N-
-phenylacetyl-N-(2-carboxy-6-methyl)phenyl-DL-
-alaninate and benalaxyl acid (racemate of
benalaxyl-M metabolite M9) were preferentially
in the sediment with maximums of 1.38% AR
(Pond) and 5.38% AR (Pond), respectively at
day 100.
there were no metabolites > 10 % in sediment.
Method of calculation DT50: 58 days
First-order kinetics
Representative worst-case from water sediment
study (water phase)
Application rate Crop: grape
number of applications: 4
Interval: 10 days
Application rate: 100 g as/ha
Depth of the water body: 30 cm
Main routes of entry Spray drift.
Drift values according to Rautmann et al.(2001)
for three or more applications (77th percentile):
6.9% (3m); 3.07% (5m); 1.02% (10m); 0.54%
(15m); 0.34% (20m); 0.18% (30m).
pag. 48

PEC (sediment)
Parent
Method of calculation Entry route as for surface water.
Concentration in water corresponding to the
Initial PECsw = 0.0078 mg/L (multiple
application at 3m; 6.9% drift).
1 cm sediment layer, sediment bulk density
1300 kg/m3.
% portion of the active substance in the
sediment at various time t (Psed) from water
sediment study.
Application rate Crop: grape
number of applications: 4
Interval: 10 days
Application rate: 100 g as/ha
PEC (ground water) (Annex IIIA, point 9.2.1)
Method of calculation and type of study
(e.g. modelling, monitoring, lysimeter )
Model: FOCUS-PELMO ver. 3.3.2
Crop: Grapes
Simulation period: 20 years
Mean annual concentration at 1m soil depth.
PECgw is represented by 80th percentile.
mean DT50 values of 59.6*, 74.2, 95 and 8.6
days, resp for benalaxyl-M, M1, M2 and M9
mean Koc values of 6063, 376, 321, 219 mL/g
resp. for a.s, M1, M2 and M9
Formation fractions used in the
calculation
pag. 49
f/f benalaxyl-MM9 = 0.62
f/f benalaxyl-MM7 = 0.27
f/f benalaxyl-Msink = 0.11
f/f M9M3 = 0.775
f/f M9sink = 0.225
f/f M7M3 = 0.375
f/f M7sink = 0.625
Data gap to report and justify the Model Maker
calculation used to derive these formation
fractions has been identified by EFSA at the end
of the peer review.
FOCUS scenarios for grapes: Châteaudun,
Hamburg, Kremsmünster, Piacenza, Porto,
Sevilla, Thiva.
For modelling purposes it is assumed that the
behaviour of the racemic forms of the
metabolites (M1 and M2) is identical to that of
the isomers (corresp. M7 and M93)
* First order value derived by EFSA for

Application rate 4 x 0.1 kg a.s./ha
PEC(gw)
Maximum concentration Not required
Average annual concentration
(Results quoted for modelling with FOCUS
gw scenarios, according to FOCUS
guidance)
benalaxyl-M is DT50 = 90d. No signifcant impact
expected on the values calculated for the parent
due to the high adsorption.
pag. 50
< 0.001 g/L
-Lysimeter study
On basis of the lysimeter study available for benalaxyl, the meeting of experts (EPCO 26)
concluded that it cannot be excluded that under realistic worst case situations the trigger of 0.1
g / L (and 0.75 g / L) will be exceeded by metabolites M3 and M7 and the enantiomeric pure
equivalents of F4, F7 and F8 when benalaxyl-M is applied according the proposed GAP.
Therefore, all these metabolites needed to be assessed for relevance.
With regard to the datagap identified by EFSA: The ecotoxicological relevance of the five
metabolites detected above 0.1 µg/L in the lysimeter study needs to be addressed, the
applicant submitted several data that are presented here.
Assessment of ecotoxicological relevance of metabolites M1 (=M7) and M2 (=M3)
(references from IIA 08.02.01/07M1 to IIA 08.04.02/04M2)
From the available (eco)toxicological data package for Benalaxyl and the metabolites M1 (=M7)
and M2 (=M3) it can be concluded that metabolites lacking the benzene-ring linked to the
carbonamide structure are significantly less toxic than the parent compound.
Studies with Folsomia candida are available with Benalaxyl-M and the metabolites M3 and M7.
The risk to other soil macro-organisms are considered to be low based on the results of these
studies. Studies on effects of the soil metabolites M3 and M7on soil micro-organisms are also
available. No effects >25% on soil respiration or nitrogen turnover has been observed after 28
days following treatment corresponding to 10 times the PECsoil for the metabolites. The risk to
soil micro-organisms is therefore considered to be low.
Though M7 and M3 are soil metabolites, they may reach surface water through drainage or
runoff. Acute aquatic toxicity studies have been conducted with M7 and M3, but no long term
toxicity endpoints for the metabolites are available. In order to estimate the long-term risk to
aquatic organisms, a tenth of the relevant toxicity endpoint determined for the parent compound
has been used in the risk assessment. A summary of the ecotoxicological risk assessment
(Annex III, point 10) is presented below:
M7
Organisms Toxicity Values PEC max. TER Trigger Value
Earthworms
Fish
LC50corr: >500 mg/kg soil 0.0367 TERa 13624 10
NOECcorr: 31.25 mg/kg soil (mg as/kg) TERlt 681 5
LC50:

M3
LC50: 500 mg/kg soil
NOECcorr: 62.5 mg/kg soil
0.0443
(mg as/kg)
TERa 11287
TERlt 1411
10
5
Fish
Aquatic Invertebrates
LC50:

Furthermore, no reactive group of concern is introduced into the molecules due to this oxidation
process. Therefore, the formation of these secondary metabolites in soil is considered as a
further detoxifying process of the primary metabolites.
Ctgb Response
Agreed
Metabolite F4
Also metabolite F4 can be considered as a secondary metabolite. In this case, no oxidation at
the benzylic methyl group took place as for the metabolites F7 and F8, but the carboxylic
moiety was further degraded by CO2 release. Again no reactive or critical structure was
introduced by this degradation; moreover the data available clearly indicates that the lack of the
benzylic side chain significantly reduced the toxicity of the parent molecule.
To confirm the above theoretical considerations several ecotoxicological tests were performed
with lysimeter metabolites F4, F7 and F8.
As stated before, in the frame of the EU Annex I inclusion process of benalaxyl-M (IR6141)
ISAGRO has submitted to the RMS (Portugal) in April 2009 a dossier including bioefficacy,
ecotoxicity and genotoxicity tests for metabolites F4, and an equimolar mixture of F7 and F8
(IR6141 EU dossier, postsubmission dated April 2009 – submitted separately by ISAGRO).
In the table below a summary of results.
Test species
pag. 52
Results
LC50/NOEC (mg/L)
F4
Fish acute LC50 (96h) > 100 mg/L
Daphnia magna EC50 (48h) > 100 mg/L
Alga ErC50(72h): 40.8 mg/L ; EbC50(72h): 10.1 mg/L ;
Earthworm acute LC50 (14-day) > 1000 mg/kg soil (LC50corr > 500 mg/kg)
Soil microorganism
F7/F8
Soil respiration & nitrification (28-day): no adverse effects up to 0.4 mg/kg soil
dry weight (max tested dose)
Fish acute LC50 (96h) > 100 mg/L
Daphnia magna EC50 (48h) > 100 mg/L
Alga ErC50(72h) and EbC50(72h) > 100 mg/L;
Earthworm acute LC50 (14-day) > 1000 mg/kg soil (LC50corr > 500 mg/kg)
Soil microorganism
Soil respiration & nitrification (28-day): no adverse effects up to 0.4 mg/kg soil
dry weight (max tested dose)
Risk assessments for aquatic and soil organisms were thus conducted based on the following
worst-case considerations:
As a worst case approach PECsw of lysimeter metabolites is determined by using the
maximum annual concentration found in the lysimeter study corresponding to 1.9; 0.9 and
1.93 µg/L for F4, F7 and F9 respectively (Guidance document on aquatic ecotoxicology – 6.
Metabolites); this is a very worst case approach as the rate of benalaxyl used in the lysimeter
study is more than four times higher than IR6141 max application rate.
As a very worst case approach PECs of lysimeter metabolites is determined by using the max
PECs of the parent compound for all the metabolites (0.241 mg/kg).

In the Table here below the TER calculation for each metabolite is reported.
Metabolite Risk
assessment
LC50/EC50/NOEC Max PECsoil/PECsw TER trigger
F4 Acute soil LC50 > 500 mg/kg* PECsoil = 0.241 mg/kg > 2074 100
F4 Acute aquatics EC50 = 10.1 mg/L* PECsw = 0.0019 mg/L 5315 10
F7
Acute soil LC50 > 500
mg/kg**
pag. 53
PECsoil = 0.241 mg/kg
> 2074 100
F7 Acute aquatics EC50 > 100 mg/L** PECsw = 0.0009 mg/L > 111111 10
F8
Acute soil LC50 > 500
mg/kg**
PECsoil = 0.241 mg/kg
> 2074 100
F8 Acute aquatics EC50 > 100 mg/L** PECsw = 0.00193 mg/L > 51813 10
*studies with F4; **studies with mix F7/F8
Even when using worst-case assumptions, all TER values for aquatic and soil organisms are
well above the relevant trigger values, indicating that there is no risk with regard to Benalaxyl-M
lysimeter metabolites F4, F7 and F8.
Ctgb response
Although the new submitted studies were not evaluated to full extend, the studies show that no
increased toxicity compared to the parent is to be expected. Considering the high TERs of the
parent, the risk for these metabolites is also considered to be low.
Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
Direct photolysis in air ‡ No data submitted
Quantum yield of direct phototransformation Not available for air
Photochemical oxidative degradation in air
‡
Latitude: ........... Season: .............
DT50 . 4.174 h and 12.523 h, assuming
OH-radical concentrations of 1.5 x 106/cm3 and
0.5 x 106/cm3 (Atkinson estimation)...........
Volatilization ‡ From plant surfaces: ‡ no data, not
required
Definition of the Residue (Annex IIA, point 7.3)
from soil: ‡ no data, not required
Relevant to the environment Soil: benalaxyl-M, M3, M7,M9
Surface water: benalaxyl-M
Sediment: benalaxyl-M
Groundwater: Benalaxyl-M, M7, M3, pure R
isomer of F7, pure R isomer of F4, pure R
isomer of F8 (tentatively identified as identical to
benalaxyl-M soil metabolite M2).
ir: benalaxyl-M

Monitoring data, if available (Annex IIA, point 7.4)
Soil (indicate location and type of study) No data, not required
Surface water (indicate location and type of
study)
Ground water (indicate location and type of
study)
pag. 54
No data, not required
No data, not required
Air (indicate location and type of study) No data, not required
Classification and proposed labelling (Annex IIA, point 10)
with regard to fate and behaviour data Possible candidate for
R53 May cause long-term adverse effects to
the aquatic environment
Mancozeb (from final review report, June 2005; LoEP was updated in June 2009 but there
were no changes in the aspect fate and behaviour)
Fate and behaviour in soil
Route of degradation
Aerobic:
Mineralization after 100 days: After 93-103 d: 31.5-51.8% for Mancozeb
32.2-58.2% for ETU
After 28 d: 47.2% for EU
Non-extractable residues after 100 days: After 93 d: 46.1% for Mancozeb
46.0% for ETU.
Major metabolites above 10 % of applied
active substance: name and/or code
% of applied rate (range and maximum)
Supplemental studies
Anaerobic:
Soil photolysis:
No major metabolites (> 10%)
ethylene-thiourea (ETU), max. 3.1%
ethyleneurea (EU), max. 8.5%
ethylenebisisothiocyanide sulfide (EBIS), max.
8.2%
ethylene thiuram disulphide (ETD) was detected
but in such a low amount that the interpretation of
spectrum was rather uncertain.
Maximum formation : EBIS 29.1%, ETU 24.8%,
EU 11.8%
Metabolic pathway: Mancozeb - ETU - EU - CO2
Major metabolite: EU (up to 30%) and ETU
(12%). CO2: 5% in 31 d.
Bound residues: 49.2% after 31 d.
Mancozeb does not photodegrade in dry soil. In
wet soils, oxidative processes induce a
degradation of Mancozeb that is much more
rapid than the photo-degradation process. Soil
photolysis is overlapped by other degradation

processes.
Remarks: No remarks.
Rate of degradation
Laboratory studies
DT50lab (20 °C, aerobic):
DT90lab (20 °C, aerobic):
DT50lab (20°C; aerobic):
Mancozeb: estimated in 1 to 3 hours.
Average: 1.8. n=5 (geomean: 2h)
ETU: estimated in 2 hours. n=2
0.3 to 1d; (2 Dutch soils)
EU: 4.8 to 7.6 d.
Average: 6.2. n=3, r 2 >0.94.
Mancozeb:

Kf / Koc:
Kd:
pH dependence:
Mobility
Laboratory studies:
Column leaching:
parent: Koc: 363 –2334 L/kg; n=4; average:
997.5
1/n= 0.686 - 0.777
Kf: 7.26 -11.67 L/kg
ETU: Koc: 34 –146 L/kg ; n=4;
average: 70 (shake flask)
Arithm. Mean: 69.7
1/n= 0.5522, 0.469, 0.327, 0.406
Koc: 5.2 and 2.6 L/kg (column study, 2 soils)
1/n: 0.9 (standard value)
Kf: 0.73, 0.67, 1.14, 0.51
EU: Kfoc 5, 4, 19, 11
1/n 1.04, 1.0, 0.92, 0.98
parent: Kd: 7.26 – 11.67 L/kg. Average: 9.74
ETU: Kd: 0.006 – 0.051 L/kg. Average: 0.035;
(2 Dutch soils)
EBIS: Kd 197, 92, 98, 197,135; arith.mean
144L/kg (PSD proposed values)
no for parent and ETU.
No guidelines.
2.5 cm H2O/week (375 ml) for 9 weeks
Two out of 5 soils leaching was observed (the
clay leachate contained radioactivity comprising
2 to 5% of the applied material), all other
leachates were free of detectable radioactivity.
pag. 56

Aged residue leaching:
Field studies:
Lysimeter/Field leaching studies:
Remarks:
Guideline: US-EPA 163.
Aged for 24 hours, 2320 ml deionised water
applied continuously.
Elution time varying from 1 d (sandy loam and
Washington silt loam) to 8 d (Lawrenceville silt
loam) to 34 d (incomplete elution for clay loam).
78-99% of applied dose was found in soil with
57-84% in the top 2.5 cm; the leachate varies
from 4.2 to 19% of the applied activity. No volatile
residues are observed.
Guideline: SETAC and draft OECD
Mancozeb applied at 4x the field application rate
to a humic sand soil and aged for one half-life,
52.6 hours, as determined in a preliminary test
ca. 250 mL of 0.01 M CaCl2 (200 mm of artificial
rainfal)l over a period of 48 hours.
Total percentage in the leachate was 4.2-4.7 %
of the applied radioactivity (correspondig to ETU,
EU and others); >91% of the recovered
radioactivity remained in either the application
layer or the first column segment after leaching.
Kd>4.5 L/kg
Kom >438 L/kg.
The Netherlands. Monitoring of ETU in the
uppermost groundwater.
NL field leaching study (Boland et al, 1995:
average ETU concentration under 32 potatoes
fields 0.11 µg/l, 90th percentile 0.27 µg/l (LOQ
0.05 µg/l). Relationship between soil type and
concentrations measured (higher in sandy/peat
versus clay/loam) can be hypothesized.
Application rates

Fate and behaviour in water
Abiotic degradation
Hydrolytic degradation:
Major metabolites:
pH 5 :
Mancozeb: two studies at 25 °C. DT50 (linear
regression) 2.2 and 36 hours.
pH 7:
Mancozeb: two studies at 25 °C. DT50 (linear
regression) 5.5 and 55 hours.
pH 9:
Mancozeb: two studies at 25 °C. DT50 (linear
regression) 14.1 and 16 hours.
pH 5 :
Metabolites: ETU (major), EU and EBIS (traces)
ETU: hydrolytically stable.
pH 7:
Metabolites: ETU and EBIS (major), EU (traces)
ETU: hydrolytically stable.
pH 9:
Metabolites: ETU, EU, EBIS
ETU: hydrolytically stable.
Photolytic degradation: Mancozeb: the major decomposition routes for
the a.i. are hydrolysis and oxidation, not
photolysis.
Major metabolites:
ETU: pH 7. Non sensitised: DT50 (photolysis)=
358 d; (sensitised: DT50 (photolysis)= 2.3 d).
pag. 58

Biological degradation
Readily biodegradable: No
Water/sediment study:
DT50 water:
DT90 water:
DT50 whole system:
DT90 whole system:
Distribution in water / sediment systems
(active substance)
Distribution in water / sediment systems
(metabolites)
Aquatic (20°C, 4 systems):
mancozeb major fraction:
DT50= 0.6-14.4 hours; average 4.7 hours
DT90 = 6.6-158 hours; average 57.4 hours;
mancozeb sum of complexed fraction:
DT50= 0.1-0.9 d; average 12 hours
DT90 = 1.3-4.9 d; average 3.1 d.
ETU:
DT50= 11.1, 6.1, 4.0, 6.3 d; average 6.9 d.
DT90= 36.7, 20.4, 13.3, 21.0 d; average 22.3 d.
Whole system (20°C, 4 systems):
Mancozeb: see aquatic as no a.i. was detected in
sediment.
ETU:
DT50= 11.1, 6.7, 7.4, 7.6 d; average 8.2 d.
DT90= 36.7, 22.4, 24.6, 25.3 d; average 27.2 d.
Mancozeb. No mancozeb was detected in
sediment
Water
ETU: max 48.5% at d 1
EU: max 37.5 at d 14
EBIS: max 30.9% at d 0
Accumulation in water and/or sediment: No remarks.
Sediments
ETU: max 8.1% AR at 7 d
EU: max 9.1% after 30 d
EBIS: max 3.8% after 2 d.
Degradation in the saturated zone No data submitted and no data required.
Remarks: No remarks.
Fate and behaviour in air
Volatility
Vapour pressure: 1.33 x 10 -5 Pa.
Henry's law constant: Henry's law constant is calculated from the
vapour pressure value and water solubility. KD <
5.9 x 10 -4 Pa x m 3 x mol -1 (not volatile).
pag. 59

Photolytic degradation
Direct photolysis in air: No data.
Photochemical oxidative degradation in air
DT50:
No data.
Volatilisation: Neither mancozeb nor ETU are volatile.
Remarks: No remarks.
Monitoring
Results of monitoring study ETU in groundwater in the Netherlands should be mentioned (see
list of end points for mancozeb).
The Netherlands. Monitoring of ETU in the uppermost groundwater.
This study was conducted in order to determine ETU concentrations (season 1993) in the
uppermost groundwater under flower bulb (exclusive lilies) and potato fields and to try to
identify factors influencing the potential leaching of this EBDC degradation product. The
presence of ETU in the uppermost ground water has been observed in 4 out of 16 fields that
presented extremely wet conditions. In the other 37 fields, no differences were observed in the
ETU ground water concentrations before and during and after the applications
Appendix 1: Metabolite names, codes and other relevant information of the pesticide
Fantic M with a.s. benalaxyl-M and macozeb.
The compounds shown below were found in one or more studies involving the metabolism
and/or environmental fate of benalxyl-M and mancozeb. The parent compound structure of
benalaxyl-M and mancozeb is shown first in this list and followed by degradated or related
compounds.
Compound
name
Benalaxyl-
M
Code
number(s)
M1 Metabolite
7
IUPAC name Structural
formula
98243-83-5 Methyl-N-phenylacetyl-
N-2,6-xylyl-D-alaninate
(R)-Methyl-N-malonyl-
N-(2,6-xylyl)-alaninate
C20H23NO3
C15H19NO5
pag. 60
Structure Molecular
Weight
[g/mol]
HO
O
C
H 3
O
O
N
N
CH 3
COOCH 3
CH 3
Observed in
study (% of
occurrence/
formation)
C20H23NO3 Bv
Soil (lab
degradation):
x %
Water: xx %
Sediment
(mesocosm):
Air
COOCH 3 325.4 24.12% in
soil

M2 Metabolite
3
M9 Metabolite
9
(R)-N-malonyl-N-(2,6xylyl)-alanine
(R)-N-phenylacteyl-N-
(2,6-xylyl)-alanine
C14H17NO5
C19H21NO3
pag. 61
HO
O
O
O
N
N
COOH 293.3 28.5% in soil
O
OH
311.4 33.3% in soil
F4 >0.1 µg/L
lysimeter
F7 >0.1 µg/L
lysimeter
F8 >0.1 µg/L
mancozeb [1,2ethanediylbis[carbamo
dithioato](2-)]
manganese mixture
with [1,2-ethanediylbis
[carbamodithioato] (2-
)] zinc (9CI)[ethylenebis(dithiocarbamato)]m
anganese mixture with
[ethylenebis(dithiocarb
amato)]-zinc (8CI)
EBIS Ethylenebisisothiocyanide
sulfide S
ETU ethylenethiourea
EU ethyleneurea
6.1 Fate and behaviour in soil
S
Mn
HN
HN
S
S
N
S N
N
NH
N
S
S
x
(Zn) y
lysimeter
271 parent
176 29% in soil
S 102 25% in soil
O 86 19% 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-INS 3 method. Currently
this method equals the method described in the Technical Guidance Document (TGD).
Additional guidance is presented in RIVM 4 -report 601782001/2007 5 .
3
INS: international and national quality standards for substances in the Netherlands.
4
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
NH

Preceding the harmonisation of the persistence assessment in The Netherlands with regulation
1107/EG, the EU approach for persistence assessment is followed.
For the current application this means the following:
Benalaxyl-M
The following laboratory DT50 values are available for the active substance benalaxyl-M: 44.6,
70, 94.4, 145.9 days (geomean 90 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.
In this way, the standards for persistence as laid down in the RGB are not met.
Due to the exceeding of the threshold value of 60 days for the mean DT50 (lab) for Benalaxyl-M
it must be demonstrated by means of field dissipation studies that the field DT50 is < 90 days.
The following relevant field data are provided: 20, 25, 71 and 98 days (geomean: 43 days).
From the results it is shown that the mean field DT50 is < 90 days. Therefore, the standards for
persistence as laid down in the RGB are met.
For the metabolite M1 the following DT50-values are available: 49, 86 and 91 days (geomean
72.7 days).
For the metabolite M2 the following DT50-values are available: 66, 106 and 113 days (geomean
92.5 days).
For the metabolite M9 the following DT50-values are available: 3.5, 5.4 and 13.4 days
(geomean 6.3 days).
Based on the above, the standards of persistence as laid down in the RGB are met for the
major soil metabolites M1 and M9.
Due to the exceeding of the threshold value of 90 days for the mean DT50 (lab) for metabolite
M2 (N-(2, 6-xylyl)-N-malonyl-DL-alanine (benalaxyl metabolite M2 racemate of benalaxyl-M
metabolite M3)), it must be demonstrated by means of field dissipation studies that the field
DT50 is < 90 days. There are no field values available for metabolites.
Based on the above, the proposed applications of the pesticide Fantic M do not meet the
standards for persistence as laid down in the RGB. For metabolite M2 (N-(2,
6-xylyl)-N-malonyl-DL-alanine (racemate of benalaxyl-M metabolite M3) the DT50 is > 90 days
for metabolite M2 it has to be demonstrated that application of the pesticide does not lead to
accumulation of the metabolite to the extent that it will have an unacceptable effect on nontarget-organisms.
Therefore an additional ecotoxicological assessment is needed based on the
PECplateau summed up with the PIEC from one season.
mancozeb
The laboratory DT50 values for the active substance mancozeb are estimated at 1-3 hours. The
mean DT50-value of the a.s. can thus be established to be 10% AR in soil. For the metabolite ETU the following
normalised DT50-values are available (see LoEP):4.5, 0.2, 1, 2.4, 1.3, 15.3 and 9.5 days
(geomean 2.4 days).
For the metabolite EU the following normalised DT50-values are available (see LoEP): 47.6, 4.7,
2.3, 1.4, 2.1 and 2.4 days (geomean 2.9 days).
standards for substances in the Netherlands' (INS). Revision 2007’.
pag. 62

For the metabolite EBIS the following DT50-values are available (20 ºC): 0.09, 0.13, 0.15, 0.38,
0.29, and 0.58 days (geomean 0.22 days)
Based on the above, the standards of persistence as laid down in the RGB are met for all
metabolites.
Furthermore, mancozeb contains manganese and zinc. These anorganic substances by
definition do not comply with the persistence criteria. Therefore, in previous risk assessments
Maximum Permissable Additions (MPA’s, =MTT in Dutch) have been derived. These are used
for the risk assessment. The approach from previous risk assessments has been copied below
(partly in Dutch), with some minor changes where necessary.
MPCsoil
zinc
See Table M.3 for the maximum plateau concentration after ten years over 20 cm of zinc.
The calculated value was compared to the Maximum Permissible Addition (MPA=MTT, in
which a correction for background level is incorporated) for zinc of 16 mg/kg soil based on
standard soil with organic substance content of 10% (Crommentuijn et al., 1997 6 ).
manganese
See Table M.3 for the maximum plateau concentration after ten years over 20 cm of
manganese.
The calculation of the Maximum Permissible Addition (MPA=MTT) for manganese is done
below.
In study “Determination of the MPA (Maximum Permissible Addition) for manganese in soil
according to the methods of the Netherlands, 2002” 22 studies were selected from a literature
research and evaluated according to the criteria described by Crommentuijn et al. (1997). The
results are summarised for each report to be able to derive a NOEC for manganes for soil
organisms. Only studies in which the amount of added manganese was reported were
included. When multiple similar studies are available for one species and endpoints for the
same parameter, the geometric mean NOEC is calculated. When for one species endpoints are
available for different parameters, the lowest NOEC is used. Statististical extrapolation is used
to calculate the MPA according to the method by Aldenberg en Slob. An MPA van 39 mg Mn/kg
soil dw is proposed which is based on the harmonised protocol of Kalf et al., 1999. The
available information includes 5 plant species, 4 macro-invertebrate species (among which the
earthworm Eisenia fetida and the springtail Orchesella cincta) and 9 species of funghi. Most of
the references supplied by the notifier to support the MPA for manganese were considered not
reliable or not usable. Many studies were not performed with the correct medium according to
the guidelines into force. Beside that. The applicant did not distinguish between processes and
species, which should have been done according to the TGD. Supplemental literature research
was done by RIVM. The information that was selected for processes from this literature search
are summarised in table M.2. For microbial processes and enzymatic activity an EC10 and a
NOEC is available. An EC10 can be used as NOEC whenever there is no NOEC available for
the appropriate species. The EC10 for respiration is therefore considered as NOEC, which
results in two NOEC's available. According to the TGD a safety factor of 100 has to be applied
on the lowest NOEC, because the information is at one trophic level only. This results in a final
value of 0.66 mg/kg.
Tabel M.1 Toxiciteitsgegevens van mangaan voor processen
Process Eindpunt Value
[mg/kg]
6 Crommentuijn, T., M.D. Polder, E.J. van de Plassche, 1997. Maximum Permissable Concentrations and
Negligible Concentrations for metals, taking background concentrations into account. RIVM report
601501-001.
pag. 63

Process Eindpunt Value
[mg/kg]
CO2-productie EC10 66
Nitrificatie NOEC 100
From the same literature search by RIVM geselecteerde data for terrestrial species were
selected. These are summarised in table M.3. There are only NOEC's or EC10-waarden for
plants availabel. The -values are not used because othe values are available.
Tabel M.2 Toxicity data for manganese for terrestric species
Species Endpoint Value
[mg/kg]
Oryza sativa EC10 168
Phaseolus vulgaris EC10 88
Zea mays EC10 336
Glycine max EC10 56
Triticum aestivum EC10 40
Avena sativa NOEC 400
Vigna unguiculata NOEC 600
Triticum aestivum NOEC 14,6
If the EC10-values are considered as NOEC, more than 3 NOEC's are available. As all NOEC’s
are from the sam trophic level, a factor of 100 is applied to the lowest NOEC or EC10. This
results in a value of 0.4 mg/kg. As a remarks it should be added that all plant species are
agricultural plants, there are no values for wild plants available.
Acording to the TGD, the lowest or most reliable value for either species or processes is used
as MPAsoil. In this case both MPA’s are derived based on a limited dataset, therefore, both can
be seen as equally reliable. The choice of the lowest value results in an MPAsoil based on the
available information of 0.4 mg/kg. This value is not corrected to standard soil.
RIVM collected information on natural backgroundconcentrations of manganese in different
soiltypes. Used sources are ‘het Landelijk Meetnet Bodemkwaliteit over de jaren 1993 tot 1997’
and a dataset from the report ‘Heavy metals in Dutch field soils: an experimental and
theoretical study on equilibrium partitioning’, RIVM report 607220001 (De Groot et al., 1998).
The available information results in following average manganese contents:
Acidic sandy soils (mean pH ca. 3): 33 mg/kg
Sandy soils (mean pH from ca. 5,5): 117-179 mg/kg
Sea and river clay soils: 394-803 mg/kg
Peat soils: 421 mg/kg
There is correlation between manganese content on the one hand and clay content and pH on
the other hand. Manganese content in acidic sandy soils is considered not relevant, as
agricultural soils will never have such low pH values. For manganese the MPA appears
negigible compared to background concentrations. Practically the background concentrations
should be corrected to standard soil. For manganese there is no information available to make
this correction. Therefore it is assessed if the MPA of 0.4 mg/kg represents only a small
concentration compared to the range of average background concentrations in sandy soils, clay
soils and peat soils (117-803 mg/kg).
PECsoil
The concentration of the a.s. and 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/m 3 .
pag. 64

For benalaxyl_M and metabolites M1, M2, M3 and M9 PECsoil is calculated using the input
data as reported below. Three metabolites of mancozeb; ETU, EU en EBIS, are major
metabolites in soil systems. Based on the available toxicity data (see section 7.5), it can be
concluded that they are much less toxic than their parent substance. Therefore it is assumed
that the risk assessment for soil organisms can be made on the basis of the parent substance
only. In view of this conclusion, there is no need to calculate exposure concentrations of ETU,
EU and EBIS.
The following input data are used for the calculation:
PEC soil:
Active substance benalaxyl-M:
Maximum field DT50 for degradation in soil: 98 days
Molecular mass: 325.4 g/mol
Metabolite M1:
Maximum lab DT50 for degradation in soil (20C): 91 days
Molecular mass: 294 g/mol
Correction factor: 24 (maximum observed percentage) * 0.9 (relative molar ratio = M
metabolite/M parent) = 0.22
Metabolite M2:
Maximum lab DT50 for degradation in soil (20C): 113 days
Molecular mass: 280 g/mol
Correction factor: 28.5 (maximum observed percentage) * 0.86 (relative molar ratio = M
metabolite/M parent) = 0.25
Metabolite M9:
Maximum lab DT50 for degradation in soil (20C): 13.4 days
Molecular mass: 312 g/mol
Correction factor: 33 (maximum observed percentage) * 0.96 (relative molar ratio = M
metabolite/M parent) = 0.32
Active substance mancozeb:
Maximum lab DT50 for degradation in soil: 1 days
Molecular mass: 271.3 g/mol
See Table M.3 for other input values and results.
Table M.3 PECsoil calculations (5 cm and 20 cm)
Use Substance Correction
factor
Ware- Benalaxyl-
Rate
[kg
a.s./ha]
Freq./Int
.
[days]
pag. 65
Fractio
n on
soil *
PIECsoi
l
[mg
a.s./kg]
(5 cm)
PECsoil,21d
[mg
a.s./kg]
(5 cm)
PECplateau
[mg
a.s./kg]
(20 cm)
PECplateau
+ PIECsoil
[mg
a.s./kg]
PECplat
au +
PECsoil
21d
[mg
a.s./kg]

Use Substance Correction
factor
and
starch
potatoes
M
M1
M2
M9
Mancozeb
Manganese
zinc
Leek Benalaxyl-
M
M1
M2
M9
Mancozeb
Manganese
zinc
-
0.22
0.25
0.32
-
-
0.22
0.25
0.32
-
Rate
[kg
a.s./ha]
0.1
0.022
0.025
0.032
1.625
0.1
0.022
0.025
0.032
1.625
Freq./Int
.
[days]
pag. 66
Fractio
n on
soil *
PIECsoi
l
[mg
a.s./kg]
(5 cm)
3/7 0.5 0.190
0.042
0.048
0.047
1.092
3/21 0.75 0.260
0.057
0.066
0.046
1.625
PECsoil,21d
[mg
a.s./kg]
(5 cm)
0.177
0.042
0.075
0.242
0.058
0.112
PECplateau
[mg
a.s./kg]
(20 cm)
0.00323
0.33
0.05
0.00484
0.49
0.075
PECplateau
+ PIECsoil
[mg
a.s./kg]
* fraction on soil is detemined as 1 – interception value; interception values derived from Table 1.6 in “generic
guidance for FOCUS groundwater scenarios”. The worst case interception value following from the BBCH 19-59 is
used for potato the middel value from onion for BBCH 15-49 is used for leek.
These exposure concentrations are examined against ecotoxicological threshold values in
section 7.5.
zinc
The peak concentration after ten years over 20 cm of zinc was calculated assuming a DT50 of
10.000 days (no degradation); a correction factor of 6.1*10 -3 based on zinc content in
mancozeb of 2.55%, molecular weights of 65 g/mol for zinc and 271.3 g/mol for mancozeb; and
50% interception of the crop. Applications within one year were pooled.
manganese
The peak concentration after ten years over 20 cm of manganese was calculated assuming a
DT50 of 10.000 days (no degradation); a correction factor of 0.04 based on manganese content
in mancozeb of 20%, molecular weights of 54.9 g/mol for zinc and 271.3 g/mol for mancozeb;
and 50% interception of the crop. Applications within one year were pooled.
Risk assessment
Zinc
The maximum concentration in soil after 10 years of application is compared with
representative background concentrations for the worst case uses.
See Table M.4 for results.
Table M.4 Comparison of plateau concentration with MPA zinc
Toepassing Dose rate Max Interval PECsoil (10
mancozeb freq. years) 20 cm
MPA
Ratio
PEC/MPA
[mg Zn/ kg]
[kg/ha] [day]
[mg Zn/ kg]
Potatoes 1.625 3 7 0.05 16 0.003
leek 1.625 3 21 0.075 0.005
PECplat
au +
PECsoil
21d
[mg
a.s./kg]
0.051 0.045
0.071 0.063

Table M.4 shows that the application does not lead to unacceptable accumulation of zinc in
soil. Correction for organic matter content does not influence the outcome of the risk
assessment. Therefore, the application meets the standards for persistence for zinc.
manganese
In table M.5 the expected maximum concentration after 10 years of application is compared with
representative background concentrationsfor manganese for the worst case uses.
Table M.5 assessment of mancozeb applications to background concentrations
manganese in Dutch soils
Toepassing Max. dos. Freq. Interval PECsoil (10
mancozeb
years) 20
cm
[kg w.s./
mg/kg
ha]
pag. 67
Ratio PEC
/max.
background
Ratio
PEC/min.
background
(803 mg/kg) (117 mg/kg)
Potatoes 1.625 3 7 0.33 0.0004 0.0027
leek 1.625 3 21 0.49 0.0006 0.004
From table M5 it becomes clear that the addition of manganese for the applied uses is small.
The application does not lead to unacceptable accumulation of manganese in soil.
Since it was shown that the amount of manganese and zinc in soil from the application of
mancozeb does not lead to much higher levels than the background levels already present, and
since correction for organic matter content does not influence the outcome of the risk
assessment, it can be concluded that the application meets the standards for persistence for
manganese and zinc.
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 substance (and metabolites) is calculated in the first tier
using Pearl 3.3.3 and the FOCUS Kremsmünster scenario. Input variables are the actual worstcase
application rate 0.1 kg/ha for benalaxyl-M , the crop potatoes and onions (for leek) and an
interception value appropriate to the crop of 0.5 for potatoes and 0.25 for leek. First Date of
yearly application is May 25 th (default) for potatoes and September 19 th for leek (the latest
realistic application in autumn). For metabolites all available data concerning substance
properties are regarded. Metabolites M1, M2 and M9 of benalaxyl-M are included in the
calculations as are the major metabolites of mancozeb, ETU, EU and EBIS. 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:
Benalaxyl-M:
Geometric mean DT50 for degradation in soil (20C): 90 days
Arithmetic mean Kom (pH-independent): 3517 L/kg
1/n: 0.9 (default)
Saturated vapour pressure: 59.5 x 10 -6 Pa (25 ºC)
Solubility in water: 33 mg/L (20 ºC)
Molecular mass: 325.4 g/mol
Metabolite M1 (M7):

Geometric mean DT50 for degradation in soil (20C): 72.6 days
Arithmetric mean Kom (pH-independent): 217 L/kg
1/n: 1
Arithmetic mean formation fraction: 0.27
Saturated vapour pressure: parent value
Solubility in water: 275 mg/L (pH 3.5)
Molecular mass: 293.3 g/mol
Metabolite M2 (M3):
Geometric mean DT50 for degradation in soil (20C): 92.5 days
Arithmetric mean Kom (pH-independent): 186 L/kg
1/n: 1
Arithmetic mean formation fraction: 0.775 from M9
0.375 from M1
Saturated vapour pressure: parent value
Solubility in water: 2674 mg/L (pH 2.8)
Molecular mass: 279.3 g/mol
Metabolite M9:
Geometric mean DT50 for degradation in soil (20C): 6.3 days
Arithmetric mean Kom (pH-independent): 126 L/kg
1/n: 1
Arithmetic mean formation fraction: 0.62
Saturated vapour pressure: parent value
Solubility in water: 33 mg/L (parent value)
Molecular mass: 311.4 g/mol
Other parameters: standard settings of PEARL 3.3.3
The following concentrations are predicted for the a.s. benalaxyl-M and the metabolites M1, M2
and M9 following the realistic worst case GAP, see Table M.6a.
Table M.6a Leaching of a.s. benalaxyl-M and metabolites as predicted by PEARL 3.3.3
Use Substance Rate
substance
[kg/ha]
potatoes Benalaxyl-M
M1
M2
M9
leek Benalaxyl-M
M1
M2
M9
Frequency Interval
[days]
pag. 68
Fraction
Intercepted
*
PEC
groundwater [g/L]
spring autumn
0.1 3 7 0.5; 0.8; 0.8

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).
From Table M.6a it reads that the expected leaching based on the PEARL-model calculations
for the a.s. benalaxyl-M and its metabolite M9 is smaller than 0.01 µg/L for all proposed
applications. Hence, the applications meet the standards for leaching as laid down in the RGB.
For metabolites M1 of benalaxyl-M the expected leaching based on the PEARL-model
calculations is larger than 0.01 µg/L but smaller than 0.1 µg/L. The applications meet the
standards for leaching. However, as the predicted concentration for M1 is larger than 0.01 µg/L,
a restriction on the use in groundwater protection areas should be placed on the label.
Therefore, further study into the leaching behaviour is necessary.
For metabolite M2 of benalaxyl the expected leaching based on the PEARL-model calculations
is equal to or larger than 0.1 µg/L. Therefore, further study into the leaching behaviour is
necessary.
Lysimeter/field leaching studies
No lysimeter/field leaching studies standardised to Dutch conditions are available.
In the second tier, leaching in potential area of use is evaluated using the spatial distribution
model GeoPEARL 3.3.3.
GeoPEARL
As for the metabolites M1 and M2 of benalaxyl-M the expected leaching based on the PEARLmodel
calculations is larger than 0.01 µg/L further study into leaching behaviour is necessary.
ETU, EU and EBIS have a mean DT50 smaller than 10 days and a mean Kom smaller than 10
L/kg. Because of this leaching of mancozeb, ETU and EBIS will directly be calculated with
GeoPEARL.
In Addendum 1 of the mancozeb monograph, studies are included which show that metabolite
EU is not toxic to algae, daphnids and fish (L(E)C50 > 100 mg/L) and to earthworms (LC50 > 1000
mg/kg). No effects of EU were seen in a study with soil micro organisms. The metabolite shows
no biological activity and is also not relevant for human toxicology. Hence, EU is considered not
relevant and does not have to meet the standards for leaching.
The leaching potential of substances to the shallow groundwater in the potential area of use
within The Netherlands is calculated using the GeoPEARL model. The same input data as used
in the first tier with Pearl 3.3.3. is employed. Additional input is the crop and the number of plots.
Input variables are the actual worst-case application rate 3 times 0.1 kg/ha for benalaxyl-M and
1.625 kg/ha for mancozeb, the crop, potatoes and leek and an interception values appropriate
to the applications to the crop. The following input data are used for the calculation:
GeoPEARL:
Active substance mancozeb:
Geometric mean DT50 for degradation in soil (20C): 2 hours
Arithmetic mean Kom (pH-independent): 587 L/kg
Arithmetic mean 1/n: 0.9 (default)
Saturated vapour pressure: 1.33 x 10 -5 Pa (25 ºC)
Solubility in water: 19.5 mg/L (25 ºC pH 6,6; due to the properties of the substance the solubility
is hard to determine)
Molecular weight: 271.3 g/mol
pag. 69

Metabolite ETU:
Geometric mean DT50 for degradation in soil (20C): 1.2 days (this value was determined to be
the correct DT50-value for ETU for groundwater calculations in ECCO 117); 2.4 days including
newly submitted data. The latter is used for PECgw calculation.
Arithmetic mean Kom (pH-independent): 2.2 L/kg (this value was determined to be the correct
Kom-value for ETU for groundwater calculations in ECCO 117)
Arithmetic mean 1/n: 1
Maximum fraction of occurence: 0.248
Saturated vapour pressure: 2.02 x 10 -6 Pa (25 ºC)
Solubility in water: 210.5 g/L (25 ºC)
Molecular weight: 102.2 g/mol
Metabolite EU:
Geometric mean DT50 for degradation in soil (20C): 6.1 days, 2.9 days including newly
submitted data. The latter is used for PECgw calculation.
Arithmetic mean Kom (pH-independent): 5.7 L/kg newly submitted data
Arithmetic mean 1/n: 0.985
Maximum fraction of occurence: 0.118
Saturated vapour pressure: 0.0129 Pa (25 ºC) (from Trimangol dossier)
Solubility in water: 26.5 g/L (25 ºC) (from Trimangol dossier)
Molecular weight: 86.1 g/mol
Metabolite EBIS:
Geometric mean DT50 for degradation in soil (20C): 0.12 days(from Trimangol dossier), 0.22
days including newly submitted data. The latter is used for PECgw calculation.
Kd (pH-independent): 144 L/kg
Arithmetic mean 1/n: 1
Maximum fraction of occurence: 0.291
Saturated vapour pressure: 3.9 x 10 -5 Pa (25 ºC) (from Trimangol dossier)
Solubility in water: 2.47 g/L (25 ºC) (from Trimangol dossier)
Molecular weight: 176 g/mol
The proposed metabolic route of degradation is: Mancozeb EBIS ETU EU CO2.
Other parameters: standard settings of GeoPEARL 3.3.3
For results see Table M.6b.
Table M.6b Leaching of a.s. benalaxyl-M and mancozeb and metabolites M1, M2, M9,
EBIS and ETU as predicted by GeoPEARL 3.3.3
Use Substance Rate Frequency Interval Fraction
PEC
a.s.
[kg/ha]
[days] intercepted groundwater [g/L]
spring autumn
pag. 70

leek Benalaxyl-M
M1
M2
M9
EBIS
ETU
potatoes Benalaxyl-M
M1
M2
M9
EBIS
ETU
0.1 3

studies in rats are 922.8 mg/kg bw/d for M1 and 819.2 mg/kg bw/d for M2. The NOAEL in the
90-day oral study in rat is 6.2 mg/kg bw/d for benalaxyl-M.
From the available toxicological data package for Benalaxyl, and the metabolites M1 and M2
the following conclusions can be drawn:
Neither metabolites nor the parent compound are of concern with regard to mutagenic
properties
Benalaxyl is neither carcinogenic or reproductively toxic. This can also be assumed for the
soil metabolites based on structure-activity relationship
For the consumer risk assessment the ADI of benalaxyl–M can be used as worst-case
reference value.
In EPCO meeting 28 it was concluded that metabolites M7 and M3 are not toxicologically
relevant.
In the absence of lysimeter data on Benalaxyl-M metabolites the highest annual average
concentration from lysimeter studies with Benalaxyl were used for an indicative assessment.
The highest annual average concentration are 8.18 µg a.s. equiv./L for metabolite M1 and 5.19
µg a.s. equiv./L for the metabolite M2 (see List of Endpoint benalaxyl, SANCO/4351/2000
final). The level of 0.75 g /L in groundwater was exceeded by the Benalaxyl metabolites M1
and M2, and therefore a consumer risk assessment via drinking water has to be performed.
Consumers may be exposed to metabolites through groundwater used as drinking water, a
consumer exposure/ risk assessment is performed considering the sum of possible intakes of
the metabolites from drinking water in addition to the intake through diet. Intake estimates for
adults, infants and children were based on the default assumptions laid down in the WHO
Guidelines of drinking water quality. The calculated daily intakes of M7 (=M1) and M3 (=M2)
are presented below.
Table M6c Estimated daily intakes of M7 and M3 for an adult consumer of 65.8 kg bw
consuming 2 L/day, a child of 18.4 kg consuming 1 L/ day and an bottle fed infant
of 10.2 kg consuming 0.75 L/day
Metabolite Intake in mg/ kg bw / day % ADI of benalaxyl-M (0.04
mg/kg bw/d)
Adult Child Infant Adult Child Infant
M1 (=M7) 0.000146 0.000261 0.000354 0.37 0.65 0.88
M2 (=M3) 0.000249 0.000445 0.000601 0.62 1.11 1.50
The intakes were compared to the ADI of benalaxyl-M and lead to an additional combined
contribution to the intakes through food items which corresponds to 2.4% ADI of benalaxyl-M
at the maximum.
Furthermore, the ecotoxicological relevance of the five metabolites detected above 0.1 µg/L in
the lysimeter study has been addressed (data gap identified by EFSA). The results are added
to the list of endpoints.
Monitoring data
There are no data available regarding the presence of the substance benalaxyl-M in
groundwater. Benalaxyl-M is a new substance on the Dutch market.
pag. 72

Mancozeb and metabolites
ETU was detected in groundwater in the past on several locations. RIVM did an inventarisation of
available data (Notenboom et al., 1999, in Dutch). The results of this inventarisation are presented
in table M.7.
Table M.7: Monitoring data ETU in shallow (0 - 10 m) and deep (> 10 m) groundwater
Type of Number of Number of Median
groundwater samples detections conc.
[g/L]
95 perc.
conc.
[g/L]
maximum
conc.
[g/L]
shallow (0-10 m)
174 14 0.15 13 30
shallow (0-10 m)
26 26 5.2 34 42
Deep (> 10 m)
69 30 0.05 0.29 0.8
Locations with potatoes/sugarbeet
Locations with flowerbulbs
calculated based on detections only; no overall 90 th percentile calculated
RIVM performed several investigations to the presence of plant protectection products in
groundwater. Especially in flowerbulb growing areas high contents of ETU are detected in
groundwater. More recently than 1999 results, in a TNO study ETU was detected in groundwater
on two locations below clay soils in the ‘Flevopolders’ in concentrations > 0,1 g/L (Minnema et
al., 2000).
In another study ETU was found in the groundwater at monitoring of shallow groundwater
under potato and flowerbulb fields. No relation was found between the concentrations in the
groundwater and the dose or the number of applications. There seemed a relation with soiltype,
this could not be clearly demonstrated because of the limited number of fields per soiltype. In
shallow groundwater the 90 th percentile concentrations exceed 0.1 g/L.
In a monitoring study for deep groundwater ( Kerkdijk H., 2002) in regions with flowerbulbs or
potatoes, the overall 90 percentile of the measured concentrations in the total area of use is
25% area of use in intake zone of sample wells). Therefore,
for the application of Fantic M label restriction is required for groundwater protection areas for
the non-monitored crop leek.
Conclusions
The proposed applications of the product comply with the requirements laid down in the RGB
concerning persistence and leaching in soil if the following is considered:
Because the cultivation of leek is rather unusual in crop rotation with potatoes, the monitoring
results do not cover this crops (>25% area of use in intake zone of sample wells) a restriction
on the use in groundwater protection areas should be placed on the label for the application of
Fantic M.
Om het grondwater te beschermen mag dit product niet worden gebruikt in
grondwaterbeschermingsgebieden.
For metabolite M2 of benalaxyl-M, a higher tier assessment for persistence is performed in
Chapter 7. Ecotoxicology.
pag. 73

6.2 Fate and behaviour in water
6.2.1 Rate and route of degradation in surface water
The exposure concentrations of the active substances benalaxyl-M and mancozeb in surface
water have been estimated for the various proposed uses using calculations of surface water
concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of
the active substance. The spray drift percentage depends on the use.
The applicant proposed the following drift reducing measures:
Om het oppervlaktewater te beschermen ten behoeve van de drinkwaterbereiding is de
toepassing in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik
gemaakt wordt van 75% driftreducerende doppen.
Concentrations in surface water are calculated using the model TOXSWA. The following input
data are used for the calculation:
TOXSWA:
Benalaxyl-M:
geometric mean DT50 for degradation in water at 20C: 158 days
DT50 for degradation in sediment at 20C: 1000 days (default).
Mean Kom for suspended organic matter: 3517 L/kg
Mean Kom for sediment: 3517 L/kg
1/n: 0.9 (default)
Saturated vapour pressure: 59.5 x 10 -6 Pa (25 ºC)
Solubility in water: 33 mg/L (25 ºC)
Molecular mass: 325.4 g/mol
Active substance mancozeb:
Mean DT50 for degradation in water at 20C: 4.7 hours
DT50 for degradation in sediment at 20C: 1000 days (default).
Mean Kom for suspended organic matter: 587 L/kg
Mean Kom for sediment: 587 L/kg
1/n: 0.9 (default)
Saturated vapour pressure:1.33 x 10 -5 Pa (25ºC)
Solubility in water: 19.5 mg/L (at 25°C and pH 6.6; due to the nature of the a.s. this property is
difficult to determine)
Molecular weight: 271.3 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 (DegT50system,
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.
In Table M.8, the drift percentages and calculated surface water concentrations for the active
substances benalaxyl-M and mancozeb for each intended use are presented.
pag. 74

Table M.8 Overview of surface water concentrations for active substances benalaxyl-M
and mancozeb following spring and autumn application in the edge-of-field ditch
Use Substance Rate Freq. Inter- Drift PIEC
a.s.
[kg/ha]
val [%] [g/L] *
PEC21
[g/L] *
PEC28
[g/L] *
Spring autumn spring autumn spring autumn
Potatoes Benalaxyl-M 0.1 3 7 0.5 0.518 - 0.3845 - 0.369 -
mancozeb 1.625
3.857 0.3424 0.257
Leek Benalaxyl-M 0.1 3 21 0.5 0.390 0.232 0.256 0.033 0.254 0.047
mancozeb 1.625
3.855 3.855 0.133 0.132 0.172 0.170
*
calculated according to TOXSWA
The exposure concentrations in surface water are compared to the ecotoxicological threshold
values in section 7.2.
Monitoring data
The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl)
is used to evaluate measured concentrations of pesticides in Dutch surface water, and to
assess whether the observed concentrations exceed threshold values.
Dutch water boards have a well-established programme for monitoring pesticide contamination
of surface waters. In the Pesticide Atlas, these monitoring data are processed into a graphic
format accessible on-line and aiming to provide an insight into measured pesticide
contamination of Dutch surface waters against environmental standards.
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. At the time of the first assessment the following was concluded:
Benalaxyl-M
There are no data available in the Pesticide Atlas regarding the presence of the substance
benalaxyl-M in surface water as this substance will be new on the Dutch market.
Mancozeb and ETU
For the active substance mancozeb there are no recent data available in the Pesticide Atlas
regarding the presence of the substance. The latest data are from 2002 and are not considered
appropriate anymore.
In the Pesticide Atlas, surface water concentrations are compared to the authorisation
threshold value of 32 µg/L for mancozeb and 200 µg/L for ETU (28/2/2005, C-155.3.19,
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 the EAC for mancozeb
and 0.1 * NOEC for Daphnia for ETU) and to the indicative Maximum Permissible
Concentration (MPC) of 0.022 µg/L for mancozeb and 0.005 µg/L for ETU as presented in the
Pesticide Atlas (data source for the MPC: Zoeksysteem normen voor het waterbeheer,
http://www.helpdeskwater.nl/normen_zoeksysteem/normen.php)
pag. 75

For substance mancozeb, an MPC-INS value is available, 0.34 g/L (RIVM report 11847
October 2008, see section 7.2 for details).
The metabolite ETU were observed in the surface water (most recent data for ETU from 2007).
In Table M.9 the number of observations in the surface water are presented.
For ETU currently, the 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 (finalisation for all substances expected in 2009-2010), however, no
consequences can be drawn for the proposed application(s).
Table M.9 Monitoring data in Dutch surface water for ETU (from www.pesticidesatlas.nl,
version 2.0)
Total no of locations
(2007)
n >
authorisation
threshold
pag. 76
n > indicative/ad hoc MPC
threshold
n > MPC-INS
threshold *
43** 0 9 n.a.
* n.a.: no MPC-INS available. < : exceeding expected to be lower than with indicative/ad hoc MPC value; > :
exceeding expected to be higher than with ad-hoc MPC value
** the number of observations at each location varies between 1 and 10, total number of measurements is 164 in
2007.
The correlation of exceedings with land use is derived from the 1.0 version of the Pesticide
Atlas. Hence, the correlation is not based on the exact same monitoring data. However, this is
the best available information and therefore it is used in this assessment.
The observed exceeding for ETU cannot correlated to the proposed and already authorised
uses as for 2005- 2006 measurements no correlations were established due to the fact that the
detection limit is higher than the MPC in the pesticide atlas (LOD=0.04 g/L).
Therefore, no consequences can be drawn from the observed concentrations.
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, the Ctgb
should, on the basis of the scientific and technical knowledge and taking into account the data
submitted with the application, also judge the application according to the drinking water
criterion ‘surface water intended for drinking water production’. 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. The 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 the 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, the Ctgb has investigated whether the product under
consideration and the active substance could give cause for concern about the drinking water
criterion.
As benalaxyl-M is a new active substance, there are no data available regarding its presence in
surface water at drinking water abstraction points. At the time of the first assessment, a
preliminary decision tree was used to address this matter, while waiting for the final decision

tree that is currently under construction by the Drinking Water Criterion Project Team. The
following procedure is derived from this preliminary decision tree: Because exceeding of the
threshold value of 0.1 µg/L at drinking water abstraction points in surface water cannot be
entirely ruled out for benalaxyl-M based on the predicted exposure concentrations in the ditch
next to the arable land (as calculated with TOXSWA), an adequate risk assessment is required
to ensure that the risk of exceeding the drinking water criterion at drinking water abstraction
points in surface water is negligible. The Ctgb has established a provisional and conservative
procedure to enable expert judgement on this matter in anticipation of the final decision tree. In
this procedure, a dilution factor of 10 and a residence time of 14 days are used to estimate
surface water concentrations at the drinking water abstraction points for all proposed uses of
the product and any other products containing the same active substance.
For each use, the formula applied to arrive at the predicted concentration at the drinking water
abstraction point is PECdrinkwater = 0.1 * PIECsurface water* e (-14k) with k=ln2/DT50system. For benalaxyl-
M, the system degradation half-life of 158 days is taken.
Initially an exceeding of the drinking water criterion was calculated based on the above
approach. Ctgb required a refinement of the PEC surface water using drift reduction and/or a
RAT (relative area treated) approach. Applicant submitted a request for drift reducing measures
only.
This results in a final estimated concentration at the drinking water abstraction point of 0.086
µg/L, taking into account all authorised and proposed uses of the a.s. See Table M.7. The
applicant did not submit the more refined RAT factor approach or the currently used DROPLET
model calculations, however, the calculation as presented is worst case.
Table M.7 Overview of surface water concentrations for active substance and
metabolite(s) at the drinking water abstraction point
Use Formulation PIEC Dilution Residence PECdrinking
(TOXSWA) factor time water
abstraction
point
Potatoes Fantic M 0.518 10 14 d 0.049
Leek Fantic M 0.390 10 14 d 0.037
Sum of all
authorised
and proposed
uses
0.086
The standards for surface water destined for the production of drinking water as laid down in
the RGB are met provided that the following restriction is included on the label:
Om het oppervlaktewater te beschermen ten behoeve van de drinkwaterbereiding is de
toepassing in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik
gemaakt wordt van minimaal 75% driftreducerende doppen.
Mancozeb has been on the Dutch market for > 3 years (authorised since 01-01-1986). This
period is sufficiently large to consider the market share to be established. From the general
scientific knowledge collected by the Ctgb about the product and its active substance, the 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. The 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.
pag. 77

6.3 Fate and behaviour in air
Route and rate of degradation in air
Benalaxyl-M
The vapour pressure is 59.5 x 10 -6 Pa at 25C. The Henry constant is 23.3 x 10 -5 at 20C. The
half-life in air is4.2-12.5 hours (Atkinson).
Mancozeb
The vapour pressure is 1.33 x 10 -5 Pa at 20C. The Henry constant is < 5.9 10 -4 Pam 3 mol -1
(not volatile) at 20C. The half-life in air is not calculated.
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:
Het is verboden dit middel met een luchtvaartuig toe te passen.
Om het oppervlaktewater te beschermen ten behoeve van de drinkwaterbereiding is de
toepassing in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik
gemaakt wordt van 75% driftreducerende doppen
Based on the current assessment, the following has to be stated in the GAP/legal
instructions for use:
Om het grondwater te beschermen mag dit product niet worden gebruikt in
grondwaterbeschermingsgebieden.
Om het oppervlaktewater te beschermen ten behoeve van de drinkwaterbereiding is de
toepassing in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik
gemaakt wordt van minimaal 75% driftreducerende doppen
6.6 Overall conclusions fate and behaviour
It can be concluded that:
1. the active substance benalaxyl-M and metabolites M1 and M9 meets the standards for
persistence in soil as laid down in the RGB.
2. For metabolite M2 of benalaxyl-M, a higher tier assessment for persistence is performed
in Chapter 7. Ecotoxicology.
3. the active substance mancozeb and metabolites EU, EBIS and ETU meet the standards
for persistence in soil as laid down in the RGB.
4. all proposed applications of the active substances benalaxyl-M and mancozeb meet the
standards for leaching to the shallow groundwater as laid down in the RGB.
5. metabolites M1 and M2 of benalaxyl can be considered a non-relevant metabolite that
does not need to be assessed against the standards for leaching to shallow
groundwater as laid down in the RGB
6. all proposed applications of metabolite ETU do not meet the standards for leaching to
shallow groundwater as laid down in the RGB. When the restrictions on use as included
in the label instructions are followed, the proposed applications do meet for leaching to
shallow groundwater as laid down in the RGB.
7. all proposed applications of metabolite EBIS meets the standards for leaching to
shallow groundwater as laid down in the RGB
pag. 78

8. metabolite EU can be considered a non-relevant metabolite that does not need to be
assessed against the standards for leaching to shallow groundwater as laid down in the
RGB.
9. all proposed applications of the active substance benalaxyl-M meet the standards for
surface water destined for the production of drinking water as laid down in the RGB.
10. all proposed applications of the active substance mancozeb meet the standards for
surface water destined for the production of drinking water as laid down in the RGB.
7 Ecotoxicology
For the application of Fantic M, risk assessment is done in accordance with Chapter 2 of the
RGB.
Benalaxyl-M (IR6141) is a new substance, not decided upon for inclusion in Annex I. Decision
is pending. An EFSA risk assessment is available. For the risk assessment the List of
Endpoints of the EFSA conclusion is used (07/2007). Additions and clarifications are added in
italic.
Formulation Fantic M (IR 6141 M) is a WG formulation, containing 40 g/kg benalaxyl-M and 650
g/kg mancozeb. The formulation IR 6141 M is also included in the DAR, however in the DAR is
stated that this is a WP formulation. The applicant submitted a formulation dossier for IR 6141
M, indicating that these are new studies, but since for most studies author, study title, year of
performance and report number is identical with the corresponding studies in the DAR, it should
be assumed that these studies are already included in the DAR. However, some of those
studies are not included in the LoEP or only expressed in concentration in benalaxyl-M.
Additionally some new studies were also submitted. Therefore these new studies are
summarized and evaluated and placed below the Lists of Endpoints of the actives.
Mancozeb is placed on Annex I. For the risk assessment the final List of Endpoints of June
2005 is used (which is identical with the update of July 2009, regarding ecotoxicology).
Benalaxyl-M
List of Endpoints Ecotoxicology
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
Acute toxicity to mammals ‡ Rat: LD50 > 2000 mg/kg bw/day
Long term toxicity to mammals 5000 mg/kg (275.01 mg/kg/day for males and
401.2 mg/kg/day for females) data for benalaxyl
Acute toxicity to birds ‡ LD50 = > 2000 mg/kg bw/day
LD50 = > 5000 mg formulation (IR6142 M)/kg
bw/day
LD50 = > 2000 mg formulation (IR6141 M)/kg
bw/day ( > 1374 mg total a.s./kg)
Dietary toxicity to birds ‡ LC50 > 5000 ppm (775.2 mg/kg bw/day)
Reproductive toxicity to birds ‡ NOEC = 1000 ppm (90 mg a.s./kg bw)
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/L)
pag. 79

Laboratory tests
‡ Fish a.s. acute LC50 4.9
‡ Fish a.s. chronic NOEC 0.49
‡ Fish IR6141 M 4-65* acute LC50 1.5
1.06 (total
a.s.)
‡ Fish GALBEN M 8-65** acute LC50 0.5
0.38 (total
a.s.)
‡ D. magna a.s. acute EC50 22.8
‡ D. magna a.s. chronic NOEC 0.2
‡ D. magna IR6141 M 4-65 acute EC50 1.8
‡ D. magna GALBEN M 8-65** chronic NOEC 0.0332
‡ Green alga a.s. acute ErC50 16.5
‡ Green alga IR6141 M 4-65 acute ErC50 0.260
‡ Green alga IR6141 M 4-65 acute EbC50 0.101
‡ C. riparius a.s. chronic NOEC 3.13
* Contains 4% benalaxyl-M and 65% mancozeb
** Contains 8% benalaxyl and 65% mancozeb
Microcosm or mesocosm tests
No data submitted. Not necessary
Bioconcentration
Bioconcentration factor (BCF) ‡ 57
Annex VI Trigger:for the bioconcentration
factor
Clearance time (CT50)
(CT90)
Level of residues (%) in organisms after the
14 day depuration phase
100
< 6 h
< 14 d
2.0%
Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
Acute oral toxicity ‡ >104 g a.s./bee
>162.9 µg IR6141 M/bee
Acute contact toxicity ‡ >100 g a.s./bee
>141.3 µg IR6141 M/bee
Field or semi-field tests
No data submitted. Not considered necessary
pag. 80

Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)
Species Stage Test
Substance
Laboratory tests ‡
‡ P. persimilis adult
‡ P. cupreus adult
‡ P. cupreus adult
‡ C. carnea larvae
‡ T. cacoeciae pupae
adult
‡ S. corollae larvae
‡ T. cacoeciae adult
‡ A.
rhopalosiphi
‡ C. carnea
adult
larvae and
pupae
Field or semi-field tests
T. pyri
T. pyri
natural
population
natural
population
lab.
a.s.
lab.
GALBEN M
8-65
Dose
(kg as/ha)
0.16 and
0.48
0.240
Lab.
0.120 and
IR6141 M 4-
0.240
-65
Lab.
0.120 and
IR6141 M 4-
0.240
-65
lab.
GALBEN M
8-65
lab.
GALBEN M
8-65
ex-lab.
GALBEN M
8-65
0.240
0.240
0.0064 and
0.160
four
treatments
0.004 and
ex-lab.
0.100
IR6141 M 4-
four
-65
treatments
ex-lab.
GALBEN M
8-65
Field test
IR6141 M 4-
-65
Field test
GALBEN M
8-65
0.240 and
0.480
0.0075 and
0.100
four
treatments
0.200
four
treatments
pag. 81
Endpoint Effect Annex VI
Trigger
mortality 0% 30%
mortality
food
consumption
Mortality
food
consumption
mortality
reproduction
parasitation
efficiency
reproduction
(fecundity and
larval hatching
rate)
parasitisation
efficiency
mortality
parasitation
efficiency
mortality
reproduction
mites
abundance
mites
abundance
0%
13.6%
30%
3.3% and 0% 30%
2.2% and -4.3% 30%
91%
99.9%
30%
61.4% 30%
0% and 44% 30%
20% and 7.5%
max 24.4%
-2.2 and –4.4%
0.9%
Recovery 84 dd.
after last
treatment
No effects at drift
rate
Recovery 56 dd.
after last
treatment
30%
30%
-
-

Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)
Acute toxicity ‡ a.s.:LC50 = 236.4 * mg as/kg soil
methyl-N-malonyl-N-(2,6-xylyl)-DL-alaninate
(M3):LC50 = >500 * mg as/kg soil
N-malonyl-N-(2,6-xylyl)-DL-alanine (M7): LC50 =
>500* mg as/kg soil
Benalaxyl-M acid (M9): LC50 = >500* mg as/kg
soil
IR6141 M: LC50 = >500 * mg form./kg soil
Reproductive toxicity ‡ a.s.: NOEC = 26* mg as/kg soil
IR6141 M: NOEC = 228* mg form./kg soil
Effects on other soil macro-organisms (Annex IIA, point 8.6)
Reproductive toxicity ‡ Folsomia candida
* values corrected to take in account of
differences in o.c. between natural and artificial
soils
Methyl-N-malonyl-N-2,6-xylyl)-DL-alaninate
NOECmortality = 31.25* mg/kg soil
NOECreprod = 500* mg/kg soil
N-malonyl-N-(2,6-xylyl)-DL-alanine
NOECmortality = 500* mg/kg soil
NOECreprod = 62.5* mg/kg soil
Benalaxyl-M acid
NOECmortality = 250* mg/kg soil
NOECreprod = 500 mg/kg soil
Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)
Nitrogen mineralization ‡ Benalaxyl: no prolonged adverse effects of
benalaxyl-M at soil concentrations up to 1.65
mg a.s./kg;
methyl-N-malonyl-N-(2,6-xylyl)-DL-alaninate: no
prolonged adverse effects of M7 at soil
concentrations up to 0.5mg/kg;
N-malonyl-N-(2,6-xylyl)-DL-alanine: no
prolonged adverse effects of M3 at soil
concentrations up to 0.5 mg a.s./kg;
pag. 82

Carbon mineralization ‡ Benalaxyl: no prolonged adverse effects of
benalaxyl-M at soil concentrations up to 1.65
mg a.s./kg;
methyl-N-malonyl-N-(2,6-xylyl)-DL-alaninate: no
prolonged adverse effects of M7 at soil
concentrations up to 0.5mg/kg;
N-malonyl-N-(2,6-xylyl)-DL-alanine: no
prolonged adverse effects of M3 at soil
concentrations up to 0.5 mg a.s./kg;
Classification and proposed labelling (Annex IIA, point 10)
with regard to ecotoxicological data N; Harmful
R51/53 Toxic to aquatic organisms, may cause
long-term adverse effects in the
aquatic environment
Mancozeb
For the risk assessment the final List of Endpoints of June 2005 is used (which is identical with
the update of July 2009, regarding ecotoxicology).
List of Endpoints Ecotoxicology
Terrestrial Vertebrates
Acute toxicity to mammals: LD50>5000 mg /kg bw
ETU: Rat LD50 oral > 5000 mg/kg bw
Acute toxicity to birds: LD50>2000 mg./kg bw
Dietary toxicity to birds: LC50>5200 ppm (860 mg/kg bw/d)
Reproductive toxicity to birds: NOEL: 125 ppm (18.8 mg/kg bw/d)
Based on marked effects on reproductive
performance at 1000 ppm.
Reproductive toxicity to mammals: NOEL: 55 mg/kg bw/d
(rabbit developmental NOEL)
based on decreased maternal body weight,
increased abortions, decreased number of litters
at 80 mg a.s./kg bw/day. No foetal
developmental effects.
Aquatic Organisms
Toxicity data for aquatic species
Acute toxicity fish: Group
Laboratory tests
Test
substance
Rainbow trout Mancozeb
tech
ETU: NOEL 150 ppm (two generation study in
rat).
pag. 83
Time-scale Endpoint
Toxicity
(mg/l)
96h LC50 0.074*
0.088**

Rainbow trout Mancozeb
80% WP
Rainbow trout Penncozeb
80 WP
pag. 84
96h LC50 0.11 mg
product/l
(0.088
mg
as/L)**
96h LC50 0.18 mg
product/l
(0.15 mg
as/L)
Rainbow trout ETU 96h LC50 >490
Rainbow trout EU (study
available in
addendum
1)
96h LC50 >122
Long term toxicity fish: Rainbow trout Sancozeb Prolonged NOEC 0.66 mg
800 WP tox. test 14
days
as/L**
Fathead minnow Dithane M - early life NOEC 0.00219*
45 stage 34 d
Bioaccumulation fish: Not requested: logPow = 1.38
Acute toxicity
Daphnia magna Mancozeb 48h EC50 0.073*
invertebrate:
tech
Daphnia magna Mancozeb 24h EC50 0.014 mg
80% wdp
product /l
(0.011 mg
as/l)**
Daphnia magna Penncpzeb 48h EC50 0.47 mg
80 WP
product/l
(0.39 mg
as/l)**
Daphnia magna ETU 48h EC50 21.6
Daphnia magna EU (study
available in
addendum
1)
48h EC50 >985
Chronic toxicity Daphnia magna Mancozeb 21days NOE 0.0073*
invertebrate:
tech chronic C
Daphnia magna Sancozeb 21days NOE 0.029 mg
800 WP chronic C as/l**
Daphnia magna ETU 21days NOE 2
chronic C
Acute toxicity algae: Chlorella P. ETU 96h ErC50 6600
Selenastrum
capricor-nutum
Dithane M -
45
120h EC50 0.044***
Pseudo-kirchneriella ETU 72h ErC50 93.8
s.
static
Xenopus leavis ETU Metamorpho NOE 10
sis assay 28
d
Semi static
C
Selenastrum EU (study 96h LC50 >119
capriconutum available in
addendum
1)

Chronic toxicity
sediment dwelling
organism:
Higher tier studies
Not requested
Rainbow trout Dithane M -
45
Invertebrates and
phytoplankton
pag. 85
Penncozeb
80 WP
Fish Species
Sensitivity
Distribution
Study +
96 h
Invertebrate
Phytoplankto
n Mesocosm
LC50
0.073 mg
as/l
0.050 mg
as/l)
EAC 0.032 mg
as/l
Brachionus
calyciforus
Penncozeb
80 WP
Acute 24 h EC50 0.11 mg
as/L
Lymnae stagnalis Penncozeb Acute 48 h EC50 >113 mg
80 WP
as/L
Gammarus sp. Penncozeb Acute 48 h EC50 3.0 mg
80 WP
as/L
Asellus sp. Penncozeb Acute 48 h EC50 4.4 mg
*Mean measured concentration at the end of the test.
80 WP
as/L
**Nominal, analytically confirmed concentration > 80% recovery.
***Initial measured concentration.
Values in Bold were used for risk assessment
Fish Species Sensitivity Distribution Study
10 species of freshwater fish were tested for 96 hours acute toxicity in shallow (30 cm), static
sediment/water microcosms. Test material (Dithane M-45) was applied once in 5 test concentrations
under the water surface. Analytical confirmation indicated that all initial concentrations were >80% of
nominal, therefore, results were expressed as nominal initial concentrations.
The most sensitive fish species was rainbow trout 96 hours LC50 = 0.073 mg as/L (NOEC=0.050 mg
as/L). Results in the other species of fish were (96 hr LC50’s mg as/L): fathead minnow 0.57;
channel catfish 0.68; bluegill sunfish 0.84; three-spined stickleback 0.93; zebra fish 0.95; largemouth
bass 1.0; guppy 1.3; golden medaka 1.4; common carp 1.7.
Invertebrate/Phytoplankton Microcosm study
No NOECcommunity could be derived because there were still long term effects at the lowest tested
concentration (reduction of the abundance of clams). The study was conducted at pH 5.5-7:
mancozeb hydrolysed very fast in acid environment and much slower under alkaline conditions. For
this reason the study can be use in a risk evaluation of mancozeb in more or less acid surface
waters.
Invertebrate/Phytoplankton Mesocosm study
The study is adequate for risk evaluation for phyto- and zoo-planckon communities and aquatic
diptera. The Ecological Acceptable Concentration is 32 µg as/l applicable to aquatic risk assessment
scenarios involving 8 or fewer applications.
Bioconcentration
Bioconcentration factor (BCF) Not requested: logPow = 1.38
Annex VI Trigger for the bioconcentration factor
Clearance time (CT50)
(CT90)
Level of residues (%) in organisms after the 14
days depuration phase

Honeybees
Acute oral toxicity: LD50 140.6 µg as/bee
Acute contact toxicity: LD50 161.7 µg as/bee
Other arthropod species
Effects on other arthropod species
Species Stag
e
Test
Substanc
e
Dithane
M45
Dithane
M45
Dose
(kg
as/ha)
pag. 86
Endpoint Effect % Annex
VI
Trigger
Chrysoperla carnea *
larva
e
1.8 Mortality 9.4 30%
Episyrphus balteatus *
larva
e
1.8 Mortality 12.5 30%
Trichogramma
cacoeciae *
adult Dithane 1.8 Parasitic >50 30%
M45
capacity
Cydnodromus adult Dithane 2 Mortality 0 30%
californicus°
M45
Amblyseius
andersoni *
adult Mancozeb 200 g/hl Long term 37.89 30%
tech
effect
Amblyseius andersoni adult Polyram 40 Short term 25.36 30%
(S and R)°°
c80
effects (for R)
(mortality 73.45
and
fecundity)
(for S)
31.82
Long term (for R)
effect 67.87
(mortality
and
fecundity)
(for S)
Typhlodromus pyri Adult Mancozeb 3.6 Long term >75% 30%
tech
effect
Aphidius
adult Manex II 2.6 Mortality -0.4 30
rhopalosiphi°
Reduced
beneficial
capacity
36
Poecilus cupreus° adult Manex II 2.4 Mortality 0 30
Chrysoperla carnea° larva Manex II 2.4 Mortality -0.3 30
e
Reproducti
on rate
12.2
Coccinella
larva Penncozeb 2-3 Mortality 33.8 30
septempunctata° e 80
Reproducti
on rate
2.01
Aphidius
adult Sancozeb 3.5 Mortality 64.9 30
rhopalosiphi°
Field study
800 wp
Reduced
beneficial
capacity
52.8
Cydnodromus adult Dithane M 1.28 Population 40 none
californicus°°
45 (0.16 reduction (after 17
P.ulmi
kg a.i./hl)
days)
-100
(after 38

Typhlodromus pyri°° adult Dithane
Ultra WG
* Semi field test
°Laboratory test
°°Field test
2x2.0,
2x3.0
4x2.0,
2x3.0
pag. 87
Population
reduction
days)
16.7
36.7
none
Earthworms
Acute toxicity: LC50 > 299.1 mg as/kg soil
ETU and EU: LC50 > 1000* mg/kg soil. 14 d
Reproductive toxicity: NOEC: 161 mg as/kg (mortality)
NOEC: 20 mg as/kg (reproduction)
Soil micro-organisms
Nitrogen mineralisation No effects on soil microflora at dosages up to the
recommended application rates (test concentration 6.68 mg
Dithane M-45/kg dry soil)
ETU and EU caused no short-term or long-term effects (<
25% deviation from the control value after 28 days) on the
nitrogen transformation in the field soil tested at
concentrations of 0.56 and 5.6 mg/kg soil.
Carbon mineralisation No effects on soil microflora at dosages up to the
recommended application rates (test concentration 6.68 mg
Dithane M-45/kg dry soil).
ETU and EU caused no short-term or long-term effects (<
25% deviation from the control value after 28 days) on the
carbon transformation in the field soil tested at
concentrations of 0.56 and 5.6 mg/kg soil.
Non target plants (taken from DAR):
No effect on ten weed species at 4 kg a.s./ha in pre-and post emergence tests.
Additional information re-registration mancozeb products
Issgro has a LOA from DOW Agroscience for the EU-dossier as well as the re-registration
dossier. For this re-registration, several new studies were submitted. These were summarized
and evaluated by the Ctgb (08/2007); EPP consultancy (08/2008, 080801) and EC&C
(08/2008, 201106). Only the data relevant for the registration of Fantic M is included below.
Effects on bacteria used in sewage treatment
Respiration inhibition test 3-hour EC50: 24.5 mg a.i./l
Residue studies (Summarized and evaluated by the RIVM (09/2008, report 11853a01)
Table below give RUD values and DT50 values based on studies from Dow Agroscience. Also
relevant data from the DAR is included in the table, in order to give a complete overview of
relevant data. Only studies performed in Northern-Europe are used. A short summary of test
set-up is given below. In the table below, the results from these studies that can be used for
risk assessment are summarized, including he available information from the DAR.
Insect residue studies
Mealworm: Test containers with bare soil were sprayed with 1.6 kg mancozeb/ha. Five
replicates were used for each sampling time. After spraying, mealworms were released and

urrowed into the sprayed test soil. Test units were kept outside and were covered to protect
the units from rain.
Cricket: organisms were exposed to 1.6 kg mancozeb/ha on bare soil in test containers. Both
soil and organisms were sprayed. Five replicates were used for each sampling time. Containers
were placed outside and were covered to protect the containers from rain and to prevent the
organisms from escaping.
Aphids: organisms were exposed to 1.6 kg mancozeb/ha on barley leaves. Both leaves and
organisms were sprayed. Five replicates were used for each sampling time. Containers were
placed outside and were covered to protect the containers from rain and to prevent the
organisms from escaping.
Caterpillars: organisms were exposed to 1.6 kg mancozeb/ha in apple trees. Five replicates
were used for each sampling time. Control organisms were collected prior to application.
Plant residue data (leafy crops)
All leafy crop residue studies were performed at two separate locations in northern Europe,
(usually northern France). Therefore for each crop tested, two locations (i.e. two fields) are
available. Nominal application ranged from 1.6-2.0 kg mancozeb/ha. Calculated RUD values
are normalised to application after 1 kg a.s./ha. Controls were sampled before application. After
application 0.5 kg foliage was sampled in duplicate for each field at each sampling time.
For onion at the location in the UK, high residues of mancozeb were found in the control. This
field is therefore not included in the results, summarized in the table below. For pea, one field in
northern France showed irregular residue levels, without a decline in time. This could be
caused by irregular application. This trial is not used in risk assessment. All other field trials
were considered acceptable.
Plant residue studies (grasses)
Field studies were carried out in apple orchards in the UK or vineyards in northern-France. A
total of six locations were selected, with two trials per location. Nominal application ranged from
0.8-2.4 kg mancozeb/ha. Calculated RUD values are normalised to application after 1 kg
a.s./ha. Controls were sampled before application. In most fields, apple trees or vines were
sprayed, and grasses between trees were sampled. In four trials, however, grass in the fields
was directly sprayed. 0.5 kg grass was sampled in triplicate per field. One trial at which grass
was sprayed directly was considered not acceptable, because the measured residue levels
show an inconsistent pattern in time. This trial is therefore not included in the results,
summarized in the table below. All other trials are considered acceptable.
Organisms RUD
(mg/kg)
DT50
(h)
DT50
(d)
Remarks
Poecilus cupreus
2 0.083 Lab test, in the DAR 95% upper confidence
(DAR, addendum 2)
limit of 13 hours was used (and accepted),
since only 1 study was available.
Mealworm (Tenebrio
molitor)
9.36 19.9 0.83
Crickets (Acheta
domestica)
11.01 -*
Aphids
(Rhopalosiphum padi)
81.13 64 2.67
Caterpillars (Actias
selene)
3.13 -*
mean 1.19
geomean 17.8 0.74
*r 2

(mg/kg) (h) (d)
Onion (Allium cepa) 9.32 72 3.00 Low residues were found in the control.
These levels were negligible compared
Carrot (Daucus
carotta)
34.5 8.9 0.37
42.5 43 1.79
Broccoli (Brassica
oleracea)
5.46 119 4.96
7.03 -*
Courgette (Cucurbita
pepo)
41.1 83 3.46
59.8 44 1.83
Pea (Pisum sativum) 4.00 215 8.96
Data from DAR
12.7
(apple leaves) 8.0
mean 25.46 5.01
Geometric mean 3.37
Grass (in apple
orchards and
vineyards)
5.24 154 6.42
22.56 -*
16.19 -*
21.35 155 6.46
6.94 268 11.17
36.70** 120 5.00
15.94 119 4.96
31.59** 176 7.33
24.04 239 9.96
22.20 271 11.29
32.41** 282 11.75
Data from DAR 7.13 7.4 (n
= 8)
Mean 14 (indirect 7.86
spray only)
Geometric mean 7.71
*r 2

Grasses: DT50: 7.71 d RUD: 14 mg/kg (including interception) or 35.2 mg/kg
(excluding interception)
Non-target arthropods
Form. 1
Species Method Dose Dose
[g
[kg/ha] a.s./ha]
pag. 90
ageing Parameter Adverse
effects 2
Dithane Aphidius Ext.Lab 10.25 7700 Mortality 6.7
New Tec rhopalosiphi test
Reproduction 11.9
Dithane Typhlodromus Ext.Lab
Mortality
New Tec pyri test
Reproduction
Dithane Chrysoperla Ext.Lab 8.38 6290 0 Mortality 19*
New Tec carnea test
Reproduction +22
7 Mortality 0
Reproduction 4.2
10.25 7700 0 Mortality 36*
Reproduction not
assessed
7 Mortality 11
Reproduction 13.8
GF-999 Pardosa spec Ext.Lab 3200 Mortality 7
test
Food
comsumption
0
GF-999 Orius Ext.Lab 1600 Mortality 36*
laevigatus test
Reproduction +17
3200 Mortality 48*
Reproduction 32
1 Formulation Dithane New Tec = 75% mancozeb
GF-999 = 80% Mancozeb
2 Adverse effect means:
x % effect on mortality = x % increase of mortality compared to control
y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to
control
(sublethal parameters are e.g. reproduction, parasitism, food consumption)
When effects are favourable for the test organisms, a + sign is used for the sublethal
effectpercentages (i.e. increase compared to control) and a – sign for mortality
effectspercentages (i.e. decrease compared to control).
[%]
L(E)R50
[g
a.s./ha]
>7700 3
>7700 3
526
167 4
3 The toxic reference dimethoate (400 g/L) was tested at a rate 33 times higher than the
proposed rate for glass plates in the guideline (10 mL/ha v.s. 0.3 mL/ha). Since the test item
was sprayed on plants, it seems acceptable that the dose rate is higher than for glass plates in
order to ensure sufficient exposure. However, compared with data from the EU-monograph of
dimethoate, showing 78% mortality of A. rhopalosiphi at 3.6 mL Danadim/ha from spray
treatment on barley seedling, the rate of 10 mL/ha seems too high for a reliable toxic reference
result. Therefore the result of the toxic reference is considered less reliable and with that also
the test itself is considered less reliable. Also effects after 7 days of ageing are available, but
these results are not used, since fresh residues do not show any effects.
4 Result for reproduction is less reliable, because mites were not exposed during the
reproductive phase. However, ER50 is used for a first indication of the risk.

*significantly different from the control
~ around this value
Field tests predatory mites
Dithane M-45 (750 g/L mancozeb)
In a field test in France (2 sites) and Germany (1 side) Dithane M-45 was applied four to eight
times to predatory mite populations in vine. Application rates were 8 x 0.65-2.62 kg a.s./ha (0.65,
1.31, 1.64, 1.96, 1.96, 2.29, 2.62, 2.62 in France, 0.65, 0.98, 1.64, 1.96, 1.96, 1.96, 2.62, 2.62 in Germany),
interval was 7-10 days.
Mites present at the sites were mainly Typhlodromus pyri.
At four applications, reduction was 39-63%, decreasing to a reduction of 27-50% at the end of
the season (September). At the beginning of the next season (May-June), no significant effects
were found.
At 8 applications, reduction was 63-99%, decreasing to a reduction of 27-84% at the end of the
season (September). At the beginning of the next season (May-June), no significant effects
were found.
Toxic standard (propineb) still showed significant effects at the start of the next season.
In a field test in France in vine, mites and other leaf dwelling arthropods were exposed to
Dithane M-45 (GF-999). Exposure levels were single applications of 0.058, 0.128 and 1.6 kg
a.s./ha, 4 x 131 kg a.s./ha (interval 7 days) and 4 x 1. 6 kg a.s./ha (interval 7 days). Leaf
samples and aspirator samples were taken.
Effects in the single applications varied between –71 and +71%, in the leaf samples, however,
effects were not significant and no dose-response relationship could be determined. PCR
analysis of the aspirator samples showed no significant effects.
In the 4 x 0.107 kg a.s./ha treatment, no significant effects were found in the leaf samples, but
significantly increased responses (esp. on Hymenoptera) were found in the aspirator samples.
At the end of the season (September), no differences compared to the control were found.
In the 4 x 1.6 kg a.s./ha, a significant decrease of 56% was found in the predatory mite
community in the leaf samples after the 3 rd application. After the 4 th application, the reduction
was

Substance Species Soil
type
OM Duration Criterion Dose
[%] [d]
[mg
total
a.s./
GF-999 Hypoaspis
aculeifer
artificial 10 28 NOECmortality
NOEC
reproduction
Ecotox Consultancy & Constructions (100101, 03/2010)
Fantic M (4% benalaxyl-M, 65% mancozeb)
IR6141 (4% benalaxyl-M, 65% mancozeb)
Galben M (8% benalaxyl + 65% mancozeb)
Toxicity to birds and mammals
Toxicity to birds
Substance Species Method Duration
IR6141 M Colinus
virginianus
Acute
toxicity
pag. 92
kg]
2.1
4.3
Criterion Value
Remarks
Mortality was
significantly affected
(15%, according to the
applicant). However,
individual data was
missing and no
statistical recalculation
could take place. Since
this study is not
required, ths study will
not be used in risk
assessment.
Value
[d]
[mg/kg [mg total a.s./kg
bw] bw]
14 LD50 > 2000 > 1374
Toxicity aquatic organisms
Note to aquatic tox data. Studies were also submitted to the DAR, but not all studies were
included in the List of Endpoints. For some studies, endpoints in the List of Endpoints are
reported in mg formulation/L. Some endpoints were recalculated to the amount of benalaxyl (-
M)/L. However these studies did not correct for the instability of mancozeb. Therefore
endpoints are recalculated in mean measured concentrations, using the lowest mean recovery,
if necessary.
Algae
Substance Species Method Criterion Value Value
[mg product/L] total a.s
[mg/L]
IR6141 M Pseudokirchneriella subcapitata static ErC50 0.117 0.083 (m.m.)
EbC50 0.260 0.184

Invertebrates
Substance Species Method Duration Criterion Value Value
product total a.s
[h]
[mg/L] [mg/L]
IR6141 M Daphnia Flow-through 48
magna
EC50 1.8 1.27 (m.m.)
Galben M Daphnia Semi-static 21 d
magna
NOEC 0.98 0.74 (m.m.)
Fish
Substance Species Method Duration Criterion Value Value
product total a.s
[h]
mg/L] [mg/L]
IR6141 M Oncorhynchus Flow-through 96
mykiss
LC50 1.5 1.06 (m.m.)
Galben M Oncorhynchus Flow-through 96
mykiss
LC50 0.5 0.38 (m.m.)
Galben M Oncorhynchus Semi-static 21 d
mykiss
NOEC 0.097 0.072 (m.m.)
Toxicity terrestrial organisms
(Bumble)bees
Substance Species Method Duration
IR6141 M Apis
mellif
era
Criterion Value Value
[h]
product total a.s
g/bee] g/bee]
oral 48 LD50 >163 >115
contact 48 LD50 >141 >100
Non-target arthropods
Form. 1
Species Method Dose Dose
[kg total
Parameter Adverse
effects
[L/ha] a.s./ha]
2
L(E)R50
[kg
[%] as/ha]
IR6141 M Aphidius
rhopalosiphi
Lab.test Mortality 1.86
IR 6141M Aphidius Lab.test 10 1.13 Mortality -5.4 >1.13
mancozeb rhopalosiphi
free
IR6141 M Typhlodromus Lab.test
pyri
Mortality 0.12
IR 6141M Typhlodromus Lab.test 10 1.13 Mortality -3.5 >1.13
mancozeb pyri
free
1 IR6141 M = 4% benalaxyl-M + 65% mancozeb
IR 6141M mancozeb free = 113g/L benalaxyl-M
2 Adverse effect means:
x % effect on mortality = x % increase of mortality compared to control
y % effect on a sublethal parameter = y % decrease of sublethal parameter compared to control
(sublethal parameters are e.g. reproduction, parasitism, food consumption)
pag. 93

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
Acute toxicity
Substance Species Soil Duration OM Criterion Dose Dose
type [d]
product Total
[%] [mg/kg] a.s.
[mg/kg]
IR6141 M Eisenia artificial 14 10 LC50 >1000 >707.5
fetida
IR6141 M Eisenia
fetida
artificial 56 10 NOEC 456 323
Micro-organisms
Substance Dose
product
Dose Duration
[mg/kg] [mg total as/kg] [d]
IR6141 M 33.3 22.3 28 Respiration 7
Nitrification 18
Non target plants
Seedling emergence – toxicity screening test
pag. 94
Process Effect at test end Effect
[%]
at test end
> 25%
(after 100 days)
[Y/N]
Substance Species parameter Criterion Value Value
product Total
[kg/ha] a.s.
IR6141 M Avena sativa, Triticum aestivum, Zea mais,
Phaseolus vulgaris, Brassica napus,
Cucumis sativus, Lycopersicum esculentum
N
N
Biomass ER50 >5.0
[kg/ha]
>3.45
Radiotracking study for skylarks (Finch & Payne 2006): Proportion of diet obtained from
the treated area (PT)
The PT values for the skylark used in this risk assessment come from radio-tracking field work
conducted in the UK, which results were published in 2006.
PT values in beets / potatoes from radio-tracked skylarks in farmland are now publicly available
from a recent document (Finch & Payne 2006). This document is based on field work by the
Central Science Laboratory (CSL), an organization that has conducted radio-tracking studies in
arable crops in the UK on some commonly occurring farmland bird species, including the
skylark. In that study the PT data are evaluated and presented separately for winter (December
- March) and summer (April - November). Considering the use pattern (potatoes, BBCH 21),
the relevant PT data for the risk assessment are those from skylarks radio-tracked in summer.
The mean PT values calculated for skylarks in summer, as reported on page 37 of Finch &
Payne (2006), are shown the table below.
Table PT values for the skylark in beets / potatoes based on CSL radiotracking
data (Finch & Payne 2006).
Database Mean PT value 90 th %ile PT value No. of tracked individuals

All birds (Apr-Nov) 0.11 0.47 n = 59
Crop consumers only (Apr-
Nov)
0.35 0.88 n = 18
The radio-tracking study conducted by CSL (Finch & Payne 2006, page 37) provides two
different mean PT values for the skylark in beets / potatoes. The first value takes into account
all birds that were radio-tracked in the arable environments ('all birds'), whereas the
second value excludes such birds that never used beet or potato fields during radio-tracking
('crop consumers only').
Although the level of protection is still under discussion and no fixed percentile for PT is agreed
upon, the document of Finch and Payne proposed to use the 90 th percentile for regulatory
purposes. In several expert meetings, this 90 th percentile has been used as well.
Combination toxicology
Combination toxicology is assessed for formulations containing more than one active
substance, and for combinations of products, which are made according to the Instructions for
Use as a tank mixture. Based on the precautionary principle, concentration-addition is
assumed.
For pesticides the TER (Toxicity-Exposure Ratio) is used as a standard in the risk assessment
(except for bees and other non-target arthropods, where HQ-values are calculated). The TER
must be higher than a trigger value to comply with the standards.
For the combination risk assessment of formulations containing more than one active
substance and for tank mixtures the following formula is used:
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 Triggercombi = triggersubstance 1/triggersubstance 2/triggersubstance i
o 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 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.
pag. 95

7.1 Effects on birds
Birds can be exposed to the active substances benalaxyl-M and mancozeb via natural food
(sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.
The threshold value for birds is based on the trigger from the RGB. This means that Toxicity-
Exposure Ratio’s (TERs) for acute and 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 benalaxyl-M and mancozeb
Endpoint Value
Benalaxyl-M
Acute toxicity to birds: LD50 >2000 mg a.s./kg bw
Dietary toxicity to birds: LC50 775.2 mg a.s./kg bw/d
Reproductive toxicity to birds: NOEL 90 mg a.s./kg bw/d
Mancozeb
Acute toxicity to birds: LD50 >2000 mg a.s./kg bw
Dietary toxicity to birds: LC50 >860 mg a.s./kg bw/d
Reproductive toxicity to birds: NOEL 18.8 mg a.s./kg bw/d
Fantic M (in total a.s.)
Acute toxicity to birds: LD50 >1374 mg a.s./kg bw
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 leafy crops. 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 Indicator species
potatoes Leafy crops medium herbivorous and insectivorous
leek Leafy crops medium herbivorous and 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 long-term
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 timeweighted-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
(kg
pag. 96
MAF Acuteterm
ETE
LD50
(mg/kg
bw/d)
TER

pag. 97
(mg/kg
bw/d)
(trigger
10)
medium herbivorous bird
Benalaxyl-M 0.76 87 0.10 1.7 11.2 >2000 >178
mancozeb 0.76 87 1.625 1.7 183 >2000 >10.9
combination >10.3
Fantic M 0.76 87 1.725 1.7 194 >1374 >7.09
insectivorous bird
Benalaxyl-M 1.04 52 0.10 - 5.41 >2000 >370
mancozeb 1.04 52 1.625 - 87.9 >2000 >22.8
combination >21.4
Fantic M 1.04 52 1.725 - 93.3 >1374 >14.7
Table E.3b Short-term risk for birds
Substance FIR / bw RUD Application
rate
(kg
a.s./ha)
MAF
Shortterm
ETE
(mg/kg
bw/d)
LC50
(mg/kg
bw/d)
TER
(trigger
10)
medium herbivorous bird
Benalaxyl-M 0.76 40 0.10 2.0 6.08 775.2 128
mancozeb 0.76 40 1.625 2.0 98.8 >860 >8.70
combination >8.15
insectivorous bird
Benalaxyl-M 1.04 29 0.10 - 3.02 775.2 257
mancozeb 1.04 29 1.625 - 49.0 >860 >17.5
combination >16.4
Table E.3c Long-term risk for birds
Substance FIR / bw RUD Applica- MAF ftwa Longtion
rate
term ETE
(kg
a.s./ha)
(mg/kg
bw/d)
NOEL
(mg/kg
bw/d)
TER
(trigger
5)
medium herbivorous bird
Benalaxyl-M 0.76 40 0.10 2.0 0.53 3.22 90 27.9
mancozeb 0.76 40 1.625 2.0 0.53 52.4 18.8 0.36
combination 0.35
insectivorous bird
Benalaxyl-M 1.04 29 0.10 - - 3.02 90 29.8
mancozeb 1.04 29 1.625 - - 49.0 18.8 0.38
combination 0.38
Taking the results in Table E.3 into account, it appears that the TERs are below the relevant
trigger. For the acute risk, the TER based on the formulated product is >7.09. Since the toxicity
test with the product showed no mortality at the highest concentration tested and since the
combined TER based on the separate active substances is above the trigger of 10, no acute
risk is expected for the formulation. For the short-term risk and the long-term risk several
refinement options are available.

Short-term risk medium herbivorous bird.
Based on the refined DT50 value for mancozeb of 5.01 d and a RUD of 25.46 mg/kg, a refined
risk assessment can be carried out. With a DT50 of 5.01 days, the MAF is 1.52. See table E.5
for refined risk assessment.
Table E.5 Refinemt short-term risk for birds
Substance FIR / bw RUD Application
rate
(kg
a.s./ha)
MAF
pag. 98
Shortterm
ETE
(mg/kg
bw/d)
LC50
(mg/kg
bw/d)
TER
(trigger
10)
medium herbivorous bird
Benalaxyl-M 0.76 40 0.10 2.0 6.08 775.2 128
Mancozeb 0.76 25.46 1.625 1.52 47.8 >860 >18.0
combination >15.8
The short-term risk to medium herbivorous birds is acceptable.
Long term risk
Since benalaxyl-M does not seem to contribute to the risk to birds, the refinement is only based
on mancozeb.
RUD and Ftwa for foliage
Based on the available residue data submitted for the re-registration products of mancozeb,
refined RUD, DT50 and MAF values can be used. For herbivores, the DT50 is 5.01 d, the RUD is
25.46 mg/kg, the MAF is 1.52 and the Ftwa is 0.64 for potatoes. For leek (interval 21 days) the
MAF and Ftwa are 1.1 and 0.33 respectively For insectivores, the RUD is 21.7, which
corresponds to the new RUD for insects presented in the new guidance document on birds and
mammals (see below), the DT50 is 1.19 days and the Ftwa is 0.24 for potatoes and 0.082 for
leek.
RUD and Ftwa insects
Revised arthropod residue data became available when the Guidance Document for Birds and
Mammals (Sanco 4145/2000) was revised. This document still has a draft status in the
Netherlands, but a PPR-opinion of this GD by EFSA’s PPR-panel was published in June 2008
(Question No EFSA-Q-2006-064. The EFSA Journal (2008) 734:1-181). Based on the state of
the art the 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 EFSA 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 Table E.6 below (data taken from
Appendix 14 to the EFSA opinion). Furthermore, it was determined that a generic DT50 of 10
days can be used for arthropods.
Table E.6 Revised RUD values for arthropods
Crop/category of insects Crop stage mean 90 th percentile
Ground dwelling invertebrates
without interception 1
ground directed 7.5 13.8
applications
Ground dwelling invertebrates
with interception 2
applications directed to 3.5 9.7
crop canopies
Insects (foliar dwelling
invertebrates 3 )
whole season 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)
Additional refinements
In November 2009, a new Annex III dossier for Dithane DG NEW TEC and updated risk
assessment for the northern zone (performed by UK-CRD, the former UK-PSD) was submitted.
The applicant can use this new dossier.
In this dossier it is stressed again that potato leaves are not palatable to birds and that weeds
are not prevalent because of the active pest management to weeds. Therefore only
insectivorous birds are considered relevant in potato fields. This was also accepted in the DAR.
However, Ctgb considers that the presence of weeds in potatoes cannot be excluded.
Additional refinements from the new Annex III are presented below:
Refinement of Long Term NOAEL for Avian Reproduction
In the new Annex III dossier for Dithane DG NEW TEC it is proposed to use the geometric
mean of the chronic endpoints from the three available studies (two bird species). This was
proposed in the EFSA PR panel assessment (EFSA, 2008, sections 2.3.1-2.3.3.)
Reaction Ctgb
In the final version of the guidance document on birds and mammals it is specifically stated
that: “For reproductive studies, the endpoint from the most sensitive tested species should be
used” (EFSA Journal 2009; 7(12):1438, p:18).
Conclusion: The geometric mean NOAEL cannot be used.
Interception.
Since the crops under discussion are not palatable or very attractive to birds, exposure can
only occur via herbs and insects. Therefore interception of the crop can be relevant at later
growth stages. Acceptable interception values are taken from the new guidance document on
birds and mammals (EFSA 2009, appendix E).
The following interception values can be used in risk assessment;
Potatoes: 0.7 for late application at BBCH 40
Leek (root & stem vegetables) : 0.7 for late application at BBCH 40
Ornamentals: 0.7 for late application at BBCH 50
Risk assessment herbivorous / omnivorous species
Focal species- herbivores (omnivorous)
In the new Annex III dossier for Dithane DG NEW TEC and updated risk assessment for the
northern zone (performed by UK17.4-CRD, the former UK-PSD), to which the applicant has
access, the skylark was proposed as relevant focal species. The UK has accepted this focal
species (but call it a representative species), since it is widely distributed in Europe, exhibits
herbivory as a significant component of the overall diet and has been reported to occur in
farmland setting including field crops. These arguments are rather feeble for the choice as a
focal species, however, the skylark has already been accepted as focal species in potatoes and
other crops in the past (based on field studies). Therefore the proposed species can be
accepted.
PD skylark
In the new Annex III dossier for Dithane DG NEW TEC and updated risk assessment for the
northern zone (performed by UK17.4-CRD, the former UK-PSD) a reference is made to the
pag. 99

study of Green (1978) on diet composition for skylark. A PD of 70% invertebrates, 20% seeds
and 10% foliage was proposed. The UK has accepted this proposition however it is stated that:
‘the uncertainty in diet composition for skylark is not reduced when considering variability
potentially associated with season, ecoregion, and surrounding non-agricultural habitats.’
For another Dutch authorization, the study of Green was also used.
The study of Green (1978) was performed in three agricultural areas in east England between
November 1974 and June 1977. The areas contained at least five different crops (of spring
cereals, winter cereals, sugar beet, ryegrass, beans, clover, onions, carrots, peas and
potatoes; dominant crops were cereals and sugar beet). Diet analysis was done by faeces
sampling of wild skylarks. In total, 880 faecal samples were analysed. The PD-refinement from
the applicant is derived from Figure 3 in Green (1978)
In this study, potatoes were only present in the study area as a minor crop. Leek was not
present at all. However, the study can be used to give an indication of the skylark diet.
Based on this study, a PD of 50% green matter, 20% weed seeds and 30% invertebrates has
been used in the past for skylark in the refined exposure calculations.
At this moment, several options for refinement of the diet of the skylark are available. All
differing depending on which study and the exact foraging time. The diet from the Green (1977)
study that was accepted before is less clear, since results extrapolated from an unclear graph,
not based on clear numbers. The determined PD is therefore depending on how the table is
interpreted. All other available diets indicate a much higher amount of invertebrates in the diet.
Therefore as a general value, the diet described in the new guidance document on birds and
mammals (EFSA 2009) will be use. When this diet was constructed old data (including the
‘Green’ study was taken into account. Thus the EFSA diet is considered to be more up to date.
This means 25% dicotyledon leaves, 25% weed seeds and 50% invertebrates. The same diet
will be used for leek.
The PD-values are included in the FIR/bw-values in Table E.7a below.
PT skylark
For potatoes, the applicant refers to the report of Finch and Payne (2006). In the report a worst
case PT of 0.88 is derived for skylark, based o the 90 th %-tile for the birds that have actually
been foraging in potato field. This will be used in risk assessment.
All FIR/bw values are calculated according to EFSA 2009. The refined risk assessment for the
lark is given below in table E.7.
Table E.7a Refined long-term risk assessment for the skylark
crop food type
FIR (g
wet
weight
/ g bw)
RUD
(mg
as/kg) PT DF ftwa MAF
pag. 100
Use
rate
(kg
as/ha)
ETE
(mg
as
/kg
bw/d
potato dicot.leaves 0.130 25.46 1.00 1.00 0.53 1.06 1.625 3.02
BBCH < 40 weed seeds 0.130 40.00 1.00 1.00 0.53 1.06 1.625 4.75
arthropods 0.260 7.50 1.00 1.00 0.15 1.00 1.625 0.48
potato dicot.leaves 0.130 25.46 1.00 0.30 0.53 1.06 1.625 0.91
BBCH 40 weed seeds 0.130 40.00 1.00 0.30 0.53 1.06 1.625 1.42
arthropods 0.260 3.50 1.00 1.00* 0.15 1.00 1.625 0.22
ETE
sum
NOEL
(mg
as/kg
bw/d) TER
8.24 18.80 2.28
2.55 18.80 7.37

leek dicot.leaves 0.130 25.46 1.00 1.00 0.23 1.01 1.625 1.25
BBCH < 40 weed seeds 0.130 40.00 1.00 1.00 0.23 1.01 1.625 1.96
arthropods 0.260 7.50 1.00 1.00 0.05 1.00 1.625 0.16
leek dicot.leaves 0.130 25.46 1.00 0.30 0.23 1.01 1.625 0.37
BBCH 40 weed seeds 0.130 40.00 1.00 0.30 0.23 1.01 1.625 0.59
arthropods 0.260 3.50 1.00 1.00* 0.05 1.00 1.625 0.07
*interception already included in the RUD
pag. 101
3.37 18.80 5.58
1.04 18.80 18.12
An acceptable risk is expected for application in leek and late application in potato. Therefore
the risk to herbivorous / omnivorous birds is acceptable, provided that the following restriction
sentence is placed on the label:
Om de vogels te beschermen is toepassing in teelt van consumptie- en zetmeelaardappelen
uitsluitend toegestaan vanaf BBCH 40 (sluiting van het gewas).
Refined risk assessment insectivorous bird
As focal species, the yellow wagtail is usually proposed as focal species in agricultural crops
(FIR/bw is 0.88). This species can be used for refinement in the leafy crops and in wheat.
Furthermore it is also known that this species has a large amount of ground dwelling insects in
its diet. A ration of 0.5:0.5 is generally accepted and can still be considered worst-case. These
refinements were accepted for a wide variety of crops at EU level: leek, beets, cabbages,
carrot, flower bulbs and bulb flowers. It is assumed it can also be extrapolated to potato. (In
addition, the yellow wagtail with a diet of 0.5/0.5 ground/foliage dwelling arthropods is also in
line with the tier 1 scenario for potatoes cf. EFSA (2009).)..
Table E.7b Refined Long-term ETE and TER values for insectivorous birds in terms of
daily dose (mg/kg bw)
Crop FIR / RUD MAF Ftwa Application rate (kg long-term TER
bw (mean)
as/ha)
ETE
(mg/kg
bw/d)
Potato, 0.88 0.5*21 1.0 0.15 1.625 2.25
0.5*7.5
0.80
3.05 6.16
Leek 0.88 0.5*21 1.0 0.051 1.625 0.77
0.5*7.5
0.27
1.04 18.0
Based on the table above an acceptable risk is expected for insectivorous birds.
Metabolites
Benalaxyl-M
No concern is expected with regard to birds and mammals from plant metabolites. Plant
metabolism studies (DAR point B.7.1.5) show that the metabolic pathway is similar in all
studied crops and the a.s. is the most important compound found. The residue definition only
includes benalaxyl-M.

Mancozeb
ETU is a metabolite of mancozeb, which is mainly present in heated products as a degradation
product of dithiocarbamates. From metabolism studies it appears that ETU and to some
account also EU is formed in both hens and rats. EBIS is a confirmed metabolite in mammals.
This metabolite was also found in avian systems (see residue section) but this information was
not included in the DAR. Considering that the acute toxicity of ETU and mancozeb is
comparable and that ETU is less than ten times as toxic as its parent considering reproductive
toxicity, the risk assessment of the parent is expected to cover the risk of ETU.
Other metabolites are not of toxicological concern.
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.
Benalaxyl-M
The highest PIECwater is 1.05 g/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>2000 * 0.010) / (0.00105 * 0.0027) = >100000.
Since TER > 10, the risk is acceptable.
Mancozeb
The highest PIECwater is 7.2 g/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>2000 * 0.010) / (0.00772 * 0.0027) = >100000.
Since TER > 10, the risk is acceptable.
Considering the high 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.
Since the log Kow of mancozeb and metabolites ETU, EU and EBIS < 3 (1.4, -0.8, -0.7 and 1.6,
respectively), the potential for bioaccumulation is considered low and no further assessment is
deemed necessary for this substance.
The log Kow of benalaxyl-M is 3.68 and secondary poisoning should be taken into account.
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
Benalaxyl-M
For benalaxyl-M a BCF of 57 L/kg is available.
The highest PECwater(21) (taken from paragraph 6.2.1.) amounts 0.781 g/L = 0.000781 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) = 90 / (0.000781 * 57 *
0.21) = 9617. Since this is > 5, the risk for birds as a result of consumption of contaminated fish
is considered to be small.
Earthworms
Benalaxyl-M
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 benalaxyl-M is 3.68, the Koc is 5979 which leads to a BCFworm = 0.41 kg soil/kg
worm.
pag. 102

The highest PECsoil(21) (taken from paragraph 6.1.1) amounts 0.242 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) = 90 / (0.242 * 0.41 * 1.1) =
825. Since this is > 5, the risk for birds as a result of consumption of contaminated worms is
considered to be small.
Soil metabolites M3, M7 and M9 are relevant in soil. No information on the Kow is available.
Also no information on the toxicity to birds is available. These metabolites were taken into
account in metabolism studies. Metabolites M7 and M9 were found in rat faeces. Metabolite M3
is more polar than metalaxyl-M (see section B6 in DAR). For metabolite M3 and M7 acute
toxicity studies in rat are available in the fate section. For both metabolites the LC50 > 2000
mg/kg. Additionally, the concentration in soil is about a factor 4 lower than the parent for all
metabolites. Based on this information and since the TER for the parent is more than a factor
100 above the relevant TER, an acceptable risk is expected for 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, provided that the following restriction sentence is placed
on the label:
Om de vogels te beschermen is toepassing in teelt van consumptie- en zetmeelaardappelen
uitsluitend toegestaan vanaf BBCH 40 (sluiting van het gewas).
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.8.
Table E.8 Overview toxicity endpoints for aquatic organisms
Substance Organism Lowest Toxicity value
L(E)C50 NOEC
[g/L]
[mg/L] [mg/L]
Benalaxyl-M Acute
Algae 16.5 16500
Daphnids 22.8 22800
Fish
Chronic
4.9 4900
Daphnids 0.2 200
Fish 0.49 490
Mancozeb Acute
Algae 0.044 44
Daphnids 0.073 73
Fish
Chronic
0.074 74
Daphnids 0.0073 7.3
Fish 0.00219 2.19
ETU Acute
Algae 93.8 93800
Daphnids 21.6 21600
Fish >490 >490000
pag. 103

Substance Organism Lowest Toxicity value
L(E)C50 NOEC
[g/L]
[mg/L] [mg/L]
Chronic
Daphnids 2.0 2000
EU Acute
Algae >119 >119000
Daphnids >985 >985000
Fish >122 >122000
Fantic M (expressed Acute
in total a.s.) Algae 0.083 83
Daphnids 1.27 1270
Fish 1.06 1060
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.9 TER values for aquatic organisms are shown.
Table E.9a TER values: acute
use Substance TERst
(trigger 10)
Potatoes Benalaxyl-M
Mancozeb
Combination
Fantic M
Leek Benalaxyl-M
Mancozeb
Combination
Fantic M
TERst
(trigger 100)
TERst
(trigger 100)
Algae Daphnid Fish
spring autumn spring autumn spring autumn
15774
21797
4685
5.70
9.46
9.49
5.70
9.46
9.57
9.47
145
121
21073 35484 29119 49032 6258 10538
5.71 5.71 9.47 9.47 9.60 9.60
5.71 5.71 9.47 9.47 9.58 9.59
9.77 10.2 150 155 125 130
pag. 104

Table E.9b TER values: chronic
use Substance TERlt
(trigger 10)
Potatoes Benalaxyl-M
Mancozeb
Combination
Leek Benalaxyl-M
Mancozeb
Combination
pag. 105
TERlt
(trigger 10)
Daphnid Fish
spring Autumn Spring autumn
191
468
0.94
0.28
0.94
0.28
255 430 626
1054
0.95 0.95 0.28
0.28
0.94 0.94 0.28
0.28
Taking the results in Table E.9a and b into account, a risk for aquatic organisms cannot be
excluded. Based on the results presented above, it can be assumed that all toxicity is caused
by mancozeb and that benalaxyl-m does not contribute to the combined TER. For mancozeb a
refined risk assessment is required.
The three metabolites of mancozeb, ETU, EU en EBIS, are major metabolites in the tested
water/sediment systems. The metabolites ETU and EU of mancozeb are not assessed because
of their low ecotoxicity as compared to the parent substance (see Table E.8). Regarding EBIS,
as stated in addendum 1 to the DAR of mancozeb, it is believed that the toxicity to aquatic
organisms due to EBIS has been assessed in the course of chronic studies and the mesocosm
study, and due to the rapid degradation of Mancozeb to EBIS and its further rather rapid
degradation to ETU.
Higher tier risk assessment (refinement of the risk assessment)
Article 2.10 of the Plant Protection Products and Biocides Regulations (RGB) describes the
authorisation criterion aquatic organisms. If for the evaluation of the product a higher tier risk
assessment is necessary, a standard is to be set according to the MPC- INS 8 method
(Vlaardingen, P.L.A. van & 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. RIVM Report 601782001/2007). For the
evaluation of the risk MPC is set as the standard. An MPCwater (MAC) and MPCwater (AA)
are derived.
With respect to the higher tier risk assessment there is a differentiation between the edge-offield
ditch and the Water Framework Directive (WFD) waterbody. The higher tier risk
assessment in the drainage ditch is performed according to Directive 91/414 and hence the
Guidance Document on Aquatic Ecotoxicology. In the WFD-waterbody the MPCwater (MAC)
and MPCwater (AA) are applied. The standards in the edge-of-field ditch as well as the WFDwaterbody
should be met.
Edge-of-field ditch
An extensive second tier assessment is performed in C170.3.15 (06/2006, Fubol Gold).
The main points are given below:
From a mesocosm study an EAC of 32 µg/L can be used when a maximum of 8 applications is
proposed.
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.
8 INS: international and national quality standards for substances in the Netherlands.

Additional studies were submitted to show that non standard invertebrates were not more
sensitive than the invertebrates present in the mesocosm. For fish an HC5 of 68 g/L could be
derived, with a proposed safety factor of 2, leading to a corrected HC5 of 34 µg/L for fish. (See
for more information C170.3.15).
Based on this information, the most critical endpoint is the EAC of 32 µg/L with a safety factor
of 3, leading to a corrected EAC of 10.7 µg/L. This endpoint will be used for final risk
assessment.
The highest PIEC in water is 7.72 µg/L, which is below the EAC of 10.7 µg/L. Therefore an
acceptable risk is expected for the edge-of-field.
WFD-waterbody
By decree of the Ministry of Agriculture, Nature and Food Quality, the Ministry of Housing,
Spatial Planning and the Environment and the Ministry of Transport, Public Works and Water
Management, Ctgb has to assess from September 2009 onwards – based on an interim
assessment methodology, see C-212.6 – whether an ecotoxicological risk in the Water
Framework Directive (WFD) water bodies might occur. This is implemented by examining the
MPCwater (MAC) and MPCwater (AA) against a calculated exposure concentration in the WFD
water body.
Below the derivation of the MPCwater is described, based on RIVM report 11847a00 (09/2008).
MPCwater
The methodology for the derivation of ERLs (environmental residue levels) is described in detail
by Van Vlaardingen and Verbruggen (2007), as already stated above. The process of
MPCwater-derivation contains the following steps: data collection, data evaluation and
selection, and derivation of the MPCwater on the basis of the selected data.
The derivation of the MPC for mancozeb is based on the data available in the EU-dossier and
additional studies that were submitted to Ctgb. In addition, an on-line literature search was
performed via SCOPUS, available via www.scopus.com. This search did result in a few
references that were evaluated . Considering the rapid hydrolysis and biodegradation of
mancozeb in water (DT50 < 1 d), only those studies which based their endpoints on measured
concentrations were considered for MPC derivation. Data from the Draft Assessment Report
(DAR) were therefore re-assessed for their reliability according to the criteria given in Section
1.1.3. Studies from the US-EPA ecotox database were all included as indicative values. All data
was assigned Ri3 because the concentration of the active ingredient was not analysed. Studies
from this database would have been evaluated if it would have been likely that they could be
used to derive the MPC. This was not the case in this report.
Human toxicological threshold limits and carcinogenicity
Mancozeb is classified R37 (Irritating to respiratory system) and R43 (May cause sensitisation
by skin contact). According to the triggers as given in Table 17 of the INS-Guidance, the
MPChuman health food, water need not be derived.
Bioconcentration and biomagnification
A BCF is not available from the DAR. Since the log Kow < 3, the trigger for bioconcentration and
biomagnification is not exceeded and a risk for bioconcentration and biomagnification is not
expected. Therefore, derivation of the MPCsecondary poisoning, water is not required.
Ecotoxicological effect data
The available acute and chronic ecotoxicity data for freshwater organisms are summarised in
Table E.10. Detailed toxicity data are presented in Supplement 2, together with reliability
pag. 106

indices and an explanation of these indices (Supplement 1) . Bold values are used for MPCderivation.
There are no valid ecotoxicity data for marine species. For mancozeb, the
MPCeco,water is derived on the basis of the freshwater data alone. Bold values are used for MPCderivation.
Laboratory data
With respect to the selection of data, the following comments are made:
For Pseudokirchneriella subcapitata, the acute and chronic endpoints of the valid tests differ
by a factor of 33 and almost 23, respectively. The ErC50 of 0.59 mg/L and EC10 of 0.25 mg/L
refer to a less relevant exposure time of 48 h, and the EC50 of 0.018 mg/L and NOEC of
0.009 mg/L refer to growth without specification to growth rate or biomass. Therefore, the
lowest valid 96 h ErC50 and NOErC of 0.04 mg/L and 0.011 mg/L are selected.
For Daphnia magna the tests differ with respect to the substance tested, the experimental
set-up (Flow-trough, Static, Renewal) and the characteristics of the test medium. This leads
to a range of values that differ by almost a factor of 400. Therefore, a geometric mean of the
available values can not be used in this case. Because no proper division in subgroups can
be made, the lowest value in a well defined medium with 48 h of exposure is selected (0.073
mg/L).
For Oncorhynchus mykiss, the highest LC50 of 1 mg/L is considered as an outlier in view of
the other data. This is probably due to the use of a formulated product. Therefore, this value
is left out of the calculation of the geometric mean.
Table E.10a Acute ecotoxicity data for aquatic organisms
Endpoints
Algae
L(E)C50
[mg/L]
Remark
Pseudokirchneriella
subcapitata
0.04 see comment above
Scenedesmus subspicatus
Rotifera
1.2 growth rate
Brachionus calyciflorus
Mollusca
0.11
Lymnea stagnalis
Crustacea
> 86
Asellus spec. 4.4
Daphnia magna 0.073 see comment above
Gammarus spec.
Fish
3
Cyprinus carpio 3.6 geomean of 3.1, 5.78 and 3.7
Lepomis machrochirus 0.083
Oncorhynchus mykiss 0.10 see comment above; geomean of
0.074, 0.088, 0.18 and 0.088
Table E.10b Chronic ecotoxicity data for aquatic organisms
Endpoints
Algae
NOEC
[mg/L]
Remark
Pseudokirchneriella
subcapitata
0.011 see comment above
Scenedesmus subspicatus
Crustacea
0.06 growth rate
Daphnia magna
Fish
0.0073
Oncorhynchus mykiss 0.49
pag. 107

Endpoints NOEC
[mg/L]
Remark
Pimephales promelas 0.0034 geomean of 0.0052 and 0.0022
Semi-field data
The DAR for mancozeb presents two mesocosm studies. One (Giddings 1999) does not report
NOEC or L(E)C50 values. Analysis of the concentration of mancozeb was performed in this
study but the results were reported in nominal concentrations. Therefore the results from this
report are not suitable to derive a reliable endpoint.
The second study (Memmert 1999) did report EC20 and EC50 values but these were based on
nominal concentrations despite the fact that the degradation of mancozeb was monitored
during this study. Considering the rapid degradation of mancozeb this study is also not relevant
to derive MPC values.
Derivation of the MPCwater
MPCeco, water – ecotoxicity data
The acute base-set (fish, Daphnia, algae) is complete. Chronic NOECs are available for
species from three trophic levels, and the trophic level showing the lowest acute EC50 (algae) is
covered by the chronic data. The MPCeco, water is derived by applying an assessment factor of 10
to the lowest NOEC of 0.0034 mg/L for Pimephales promelas, resulting in an MPCeco, water of
0.34 µg/L.
MPCsp, water – secondary poisoning
Since the log Kow is < 3, the MPCwater via secondary poisoning is not derived.
MPChuman, water – human exposure
Derivation of the MPChh food, water is not triggered.
Conclusion
The only MPC derived for the water compartment is the MPCeco, water, which is therefore
selected as the final MPCwater. The MPCwater of mancozeb is 0.34 µg/L.
Risk assessment
The PECmax in the WFD-waterbody is used to compare with the MPC, for the PECmax-values
see section 6.2. The TER-values are presented in table E.11.
Table E.11 TER-values based on MPCwater of 0.34 µg/L and PECmax
Use substance PEC WFDmax [µg/L] TER based on MPCwater (AA)
value (trigger is 1)
Potatoes mancozeb 340
All uses have a TER higher than 1. Therefore, the proposed uses of the active substance
mancozeb meet the standards for aquatic organisms as laid down in the RGB.
7.2.2 Risk assessment for bioconcentration
Benalaxyl-M
For the active substance a BCF-value of 57 L/kg is available.
Since this value is below 100 L/kg, the risk for bioconcentration is small. Therefore the active
substance benalaxyl-M meets the standards for bioconcentration as laid down in the RGB.
pag. 108

Mancozeb
Considering the logPow of < 3, for mancozeb and metabolites, the risk for bioconcentration is
small. Therefore the active substance mancozeb and its metabolites meet the standards for
bioconcentration as laid down in the RGB.
7.2.3 Risk assessment for sediment organisms
Benalaxyl-M
The NOEC value for Chironomus is 3130 µg/L. When this value is examined against the PIEC
in water of 1.05 µg/L, the TER value is 2981 , which is above the trigger of 10. Therefore, the
active substance meets the standards for sediment organisms as laid down in the RGB.
Mancozeb
Mancozeb is not relevant in sediment. Metabolite ETU can be found in sediment for over 10%.
Since the NOEC for daphnids is > 0.1 mg/L (2.0 mg/L), risk for sediment organisms is
considered to be low.
Therefore, the proposed applications meet the standards for sediment organisms as laid down
in the RGB.
Conclusions aquatic organisms
The proposed applications meet the standards in both the edge-of-field ditch as well as the
WFD-water body.
7.3 Effects on terrestrial vertebrates other than birds
Mammals can be exposed to the active substances benalaxyl-M and mancozeb via natural
food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.
The threshold value for mammals is based on the trigger from the RGB. This means that the
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.12 presents an overview of toxicity data.
Table E.12 Overview of toxicity data for mammals
Endpoint Value
Benalaxyl-M
Acute toxicity to mammals: LD50 >2000 mg a.s./kg bw
Reproductive toxicity to mammals: NOEL 275 mg a.s./kg bw/d
Mancozeb
Acute toxicity to mammals: LD50 >5000 mg a.s./kg bw
Reproductive toxicity to mammals: NOEL 55 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 leafy crops. Depending on the crop
category different indicator species are chosen. Table E.13 shows which indicator species are
relevant for which uses.
Table E.13 Indicator species per use
Use Crop Indicator species
pag. 109

potatoes Leafy crops Wood mouse*
leek Leafy crops medium herbivorous
* based on available field studies it was shown that the wood mouse is the most relevant species in potatoes. Thus,
the use of a medium herbivorous mammal would underestimate the risk. Therefore first tier risk assessment will be
performed with wood mouse. When assuming that the wood mouse only eats weeds, the FIR/bw is 1.68 (see
Guidance document on birds and mammals, EFSA journal 2009, Appendix A).
Table E.14a-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.14a Acute risk for mammals
Substance FIR / bw RUD Application
rate
(kg
a.s./ha)
pag. 110
MAF
Acuteterm
ETE
(mg/kg
bw/d)
LD50
(mg/kg
bw/d)
TER
(trigger
10)
Wood mouse
Benalaxyl-M 1.68 87 0.1 1.7 24.8 >2000 >80.5
Mancozeb 1.68 87 1.625 1.7 404 >5000 >12.4
combination >10.7
medium herbivorous mammal
Benalaxyl-M 0.28 87 0.1 1.3 3.17 >2000 >631
Mancozeb 0.28 87 1.625 1.3 51.5 >5000 >97.2
combination >84.2
Table E.14b Long-term risk for mammals
Substance FIR / bw RUD Applica- MAF ftwa Longtion
rate
term ETE
(kg
a.s./ha)
(mg/kg
bw/d)
NOEL
(mg/kg
bw/d)
TER
(trigger
5)
Wood mouse
Benalaxyl-M 1.68 40 0.1 2.0 0.53 7.12 275 38.6
Mancozeb 1.68 40 1.625 2.0 0.53 116 55 0.48
combination 0.49
medium herbivorous mammal
Benalaxyl-M 0.28 40 0.1 1.3 0.53 0.77 275 356
Mancozeb 0.28 40 1.625 1.3 0.53 12.5 55 4.39
combination 4.33
Taking the results in Table E.14. into account, it appears that the acute risk is acceptable but
that a further refinement is required for the long-term risk. Since the toxicity of benalaxyl-M is
negligible, compared to mancozeb, the refinement will only be based on mancozeb
Refined risk assessment
RUD and DT50 foliage

The mean RUD values on leafy crops of 24.46 mg/kg and DT50 value of 3.37 days, can be
used in risk assessment (see also section 7.1).
RUD and DT50 insects.
For mancozeb, a DT50 on invertebrates of 0.74 days is available.
Revised arthropod residue data became available when the Guidance Document for Birds and
Mammals (Sanco 4145/2000) was revised. This document still has a draft status, but a PPRopinion
of this GD by EFSA’s PPR-panel was published in June 2008 (Question No EFSA-Q-
2006-064. The EFSA Journal (2008) 734:1-181). Based on the state of the art the 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 EFSA 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 Table E.15 below (data taken from Appendix 14 to the
EFSA opinion). Furthermore, it was determined that a DT50 can be used for arthropods.
Table E.15 Revised RUD values for arthropods
Crop/category of insects Crop stage mean 90 th percentile
Ground dwelling invertebrates
without interception 1
ground directed 7.5 13.8
applications
Ground dwelling invertebrates
with interception 2
applications directed to 3.5 9.7
crop canopies
Insects (foliar dwelling
invertebrates 3 )
whole season 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)
PD
Several options for PD refinement can be found in public literature. Below three accepted
options are available. These options are based on literature from Pelz (1989), Rogers (1989;
cited in Rogers & Gorman, 1995) and Niethammer & Krapp (1978). More information can be
found in the PPR opinion on methamidophos. The possible PD scenarios are given below.
food type Woodmouse A Woodmouse B Woodmouse C
green plant matter 50%
weed seeds 25% 30% 70%
invertebrates 25% 70% 30%
Table E.16a-b gives the refined risk assessment for mammals. The PD has been used in the
calculation of the FIR/bw, according to the PSD calculator.
Table E.16a refined long-term risk assessment for the woodmouse in potatoes.
Mancozeb
crop stage food type FIR (g
wet
weight
/ g bw)
Woodmouse
A
50%
green
plant
matter
RUD
(mg
as/kg)
PT DF ftwa MAF Use
rate
(kg
as/ha)
pag. 111
ETE
(mg
as
/kg
bw/d
0.210 25.46 1.00 1.00 0.53* 1.06* 1.625 4.88
ETE
sum
NOEL
(mg
as/kg
bw/d)
TER
(trigge
5)

Woodmouse
B
Woodmouse
C
25% weed
seeds
25%
arthropods
30% weed
seeds
70%
arthropods
70% weed
seeds
30%
arthropods
*Based on a DT50 of 3.37 days and an interval of 7 days.
**Based on a DT50 of 0.74 days and an interval of 7 days
0.105 40.00 1.00 1.00 0.53* 1.06* 1.625 3.83
0.105 7.50 1.00 1.00 0.15** 1.00 1.625 0.090
0.095 40.00 1.00 1.00 0.53* 1.06* 1.625 3.47
0.221 7.50 1.00 1.00 0.15** 1.00 1.625 0.40
0.152 40.00 1.00 1.00 0.53* 1.06* 1.625 5.55
0.065 7.50 1.00 1.00 0.15** 1.00 1.625 0.12
Table E.16b Long-term risk for medium herbivorous mammals
Substance FIR / bw RUD Applica- MAF ftwa Longtion
rate
term ETE
(kg
a.s./ha)
pag. 112
(mg/kg
bw/d)
NOEL
(mg/kg
bw/d)
8.91 55.00 6.
3.87 55.00 14.
5.67 55.00 9.7
TER
(trigger
5)
medium herbivorous mammal
Mancozeb 0.28 25.46 1.625 1.01* 0.23* 2.69 55 20.4
*Based on a DT50 of 3.37 days and an interval of 21 days.
Based on the calculations presented above, an acceptable risk is expected for mammals.
Metabolites
Benalaxyl-M
No concern is expected with regard to birds and mammals from plant metabolites. Plant
metabolism studies (DAR point B.7.1.5) show that the metabolic pathway is similar in all
studied crops and the a.s. is the most important compound found. Residue definition only
includes benalaxyl-M.
Mancozeb
ETU is a metabolite of mancozeb, which is mainly present in heated products as a degradation
product of dithiocarbamates. From metabolism studies it appears that ETU and to some
account also EU is formed in both hens and rats. EBIS is a confirmed metabolite in mammals
Considering that the acute toxicity of ETU and mancozeb is comparable and that ETU is less
than ten times as toxic as its parent considering reproductive toxicity, the risk assessment of
the parent is expected to cover the risk of ETU.
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.
Benalaxyl-M
The highest PIECwater is 1.05 g/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>2000* 0.010) / (0.00105 * 0.00157) = >100000.

Since TER 10, the risk is acceptable.
Mancozeb
The highest PIECwater is 7.72 g/L. It follows that the risk of drinking water is (LD50 * bw) /
(PIEC*DWI) = (>5000 * 0.010) / (0.00772 * 0.00157) =>100000.
Since TER > 10, the risk is acceptable.
Considering the high TER values, a low 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.
Since the log Kow of mancozeb and metabolites ETU, EU and EBIS < 3 (1.4, -0.8, -0.7 and 1.6,
respectively), the potential for bioaccumulation is considered low and no further assessment is
deemed necessary for this substance
Fish
Benalaxyl-M
For benalaxyl-M a BCF of 57 L/kg is available.
The highest PECwater(21) (taken from paragraph 6.2.1.) amounts 0.781 g/L = 0.000781 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) = 275 / (0.000781 *57 *
0.13) = 47519. Since this is > 5, the risk for mammals as a result of consumption of contaminated
fish is considered to be small.
Earthworms
Benalaxyl-M
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 benalaxyl-M is 3.68, the Koc is 5979 which leads to a BCFworm = 0.41 kg soil/kg
worm.
The highest PECsoil(21) (taken from paragraph 6.1.1) amounts 0.242 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) = 275 / (0.242 * 0.41* 1.4) =
1980. Since this is > 5, the risk for mammals as a result of consumption of contaminated worms
is considered to be small.
Soil metabolites M3, M7 and M9 are relevant in soil. No information on the Kow is available.
These metabolites were taken into account in metabolism studies. Metabolites M7 and M9
were found in rat faeces. Metabolite M3 is more polar than metalaxyl-M (see section B6 in
DAR). For metabolite M3 and M7 acute toxicity studies in rat are available in the fate section.
For both metabolites the LC50 > 2000 mg/kg. Additionally, the concentration in soil is about a
factor 4 lower than the parent for all metabolites. Based on this information and since the TER
for the parent is more than a factor 100 above the relevant TER, an acceptable risk is expected
for 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.
pag. 113

Conclusions mammals
The product complies with the RGB.
7.4 Effects on bees
The risk assessment for bees is based on the ratio between the highest single application rate
and toxicity endpoint (LD50 value). An overview of the risk at the proposed uses is given in
Table E.17.
Table E.17 Risk for bees
Use Substance Application rate LD50 Rate/LD50 Trigger
value
[g a.s./ha] [µg/bee]
Potatoes and leek Benalaxyl-M 100
>100
Mancozeb
Combination
1625
140.6
Fantic M 1725 >100
pag. 114

Table E.19 HQ-values for A. rhopalosiphi and T. pyri for benalaxyl-M
Application rate
(kg a.s./ha)
MAF 1 Drift factor/
Vegetation factor 2
pag. 115
Safety
factor 2
LR50
(kg a.s./ha)
In-field
A. rhopalosiphi 0.1 2.3 - - >1.13 1.13 1.13 1.13

eginning of the next season, it is shown that recovery can occur in in-field and off-field
situations, within a relevant period.
Additionally, a standard laboratory test showed a maximum effect of 25% on Hypoaspis
aculeifer at 3.2 kg mancozeb/ha.
Based on all the information presented above, it can be concluded that short-term effects can
be expected, but that mites will recover within a relevant period, both in-field and off-field.
Therefore no long-term effects on predatory mites are expected.
Additional species
In the DAR of benalaxyl-M several studies are available which were performed with IR6141 M
(4% benalaxyl-M, 65% mancozeb, formulation comparable to Fantic M). Reported dose rates in
the DAR are based on the amount of benalaxyl-M. No lethal and sublethal effects were found at
0.24 kg benalaxyl-M/ha for Poecilus cupreus and Chrysoperla carnea, corresponding to 4.14 kg
total a.s./ha. This rate is higher than the highest proposed rate of 2.3*1.725 kg a.s./ha.
Therefore a low risk is expected for other arthropods.
The applicant has put the following warning sentence on the label:
Dit middel is gevaarlijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling.
This sentence is only relevant for in-door uses and IPM-uses. For proposed uses this sentence
is not relevant, and not necessary. Therefore it can be removed from the label.
The proposed application of the product therefore meets with the standards as laid down in the
RGB.
7.5.2.1 Earthworms
The acute risk for earthworms is calculated as TER-value (trigger value 10). Since the logPow
of the active substance benalaxyl-M > 2, a correction to the reference soil containing 4.7 %
organic matter is necessary. For mancozeb and its metabolite, the logPow < 2 and no
correction is required. Exposure is expressed as the initial PEC soil. PEC soil is calculated in
section 6.1.1. Table E.21 presents endpoints, PECsoil and TER values.
Table E.21 Overview of soil concentrations and acute TERs for earthworms
use. Substance LC50corr PIEC soil TER Trigger
[mg/kg] [mg/kg]
value
Leek Benalaxyl-M 236.4 0.260 909 10
(worst- M2/3 >500 0.0718* >6964 10
case) Mancozeb >299.1 1.625 >184 10
Combination
>153
10
Fantic M >332.5 1.885 >176
*PIEC + PEC plateau
Metabolites M3, M7, M9, ETU and EU have LC50 values higher than for the parent, while the
PIEC is expected to be lower than the PIEC for the parent. Therefore a low risk is expected for
these metabolites
About EBIS, the ECCO 117 meeting concluded that it is not a relevant soil metabolite of
mancozeb because it was not found in any of the soil degradation studies.
In view of the results presented in Table E.21, a low risk for earthworms is expected at all
proposed uses.
pag. 116

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.22.
Table E.22 Overview of soil concentrations and chronic TERs for earthworms
Use Substance NOECcorr PIEC soil TER Trigger
[mg/kg] [mg/kg]
value
Leek Benalaxyl-M
26 0.260 100
5
(worstcase)
Mancozeb
20 1.625 12.3
Combination
11.0
Fantic M 152 1.885 80.6
The chronic threshold value for earthworms resulting from exposure to the active substances is
not exceeded. The proposed applications of the product therefore meet the standards as laid
down in the RGB.
No chronic earthworm study is available for metabolite M2/3, which should be available since it
concerns a persistent metabolite. However, given the low acute toxicity to earthworms and the
low risk for Folsomia candida and soil micro-organisms (see below) from this metabolite, the
risk is considered to be acceptable.
7.5.2.2 Other soil macro-organisms
Also for other soil macro-organisms data are available for benalaxyl-M and metabolites M2/3,
and M7. No information is available for mancozeb, but this is not required. A long-term TERvalue
is calculated. Examination of the PIEC or PECplateau + PIEC takes place against the
trigger of 0.2 * NOEC. See Table E.23.
Table E.23 Overview of soil concentrations and chronic TERs for other soil macro-
organisms
Use Substance Organism NOECcorr
[mg/kg]
Leek
(worstcase)
Benalaxyl-M Folsomia
candida
M2/3 Folsomia
candida
M7 Folsomia
candida
*PIEC + PEC plateau
pag. 117
PIECsoil or :
PECplateau +
PIECsoil
[mg/kg]
TER Trigger
value
250 0.260 962 5
31.25 0.071* 440 5
62.5 0.057 1096 5
The TER value for other soil macro-organisms resulting from exposure to the active substance
benalaxyl-M and metabolites M2/3 and M7 meet the trigger of 5.
7.5.3 Effects on soil micro-organisms
In the tested soils no effects are observed on nitrogen transformation and carbon respiration
processes at relevant application rates of 22.3 mg total a.s./kg soil with the formulation Fantic
M. Since the reduction percentage is below 25% after 28 days, the standards from the RGB
regarding soil micro-organisms are met.
Also for metabolites M3 and M7 and metabolites ETU and EU, no effects were found at
relevant application rates. About EBIS, the ECCO 117 meeting concluded that it is not a

elevant soil metabolite of mancozeb because it was not found in any of the soil degradation
studies.
7.5.4 Effects on activated sludge
For benalaxyl-M no EC50 value is available.
For mancozeb an EC50 value of 24.5 mg/L is available.
However, 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
Recently a new view on the off-crop evaluation zone for non-target plants has changed the
appropriate drift values (see Evaluation Manual, Chapter 7). The risk assessment for nontarget
plants is now based on an off-crop situation with a drift percentage of 4.7%. The
exposure thus equals 0.047 * the application rate *MAF (in case of multiple application). MAFvalues
are taken from ESCORT 2.
A TER is calculated with the lowest EC50 value from a laboratory test with higher plants and the
exposure concentration. The EC50 is >3.45 kg total a.s./ha for all species tested. See table E.23
for TER calculation.
Table E.23: Overview of exposure concentrations and TERs for non target plants
Use Substance Dose
[kg
a.s.
Potatoes
(worstcase)
Fantic M
(total a.s.)
MAF. Drift% (off- Exposure EC50 TER Trigger
field (kg [kg
value
/ha]
exposure) a.s./ha) a.s./ha]
1.725 2.3 4.7 0.186 >3.45 >18.5 5
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.
Considering the acceptable risk of metabolite M2/3 for earthworms (acute), soil macroorganisms
and soil micro-organisms, metabolite M2/3 meets the standards for persistence.
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
Based on the profile of the substance, the provided toxicology of the preparation and the
characteristics of the co-formulants, the following labeling of the preparation is proposed:
Symbol: N Indication of danger: Dangerous for the
pag. 118

environment
R phrases R50/53 Very toxic to aquatic organisms, may cause
long-term adverse effects in the aquatic
environment
S phrases S60 This material and its container must be
disposed of as hazardous waste.
S61 Avoid release to the environment. Refer to
Special provisions
(DPD-phrases) :
special instructions/safety data sheets.
- -
Explanation:
Hazard symbol: Assigned based on the toxicity of the product for aquatic
organisms.
Risk phrases: R50 is assigned based on the toxicity of both mancozeb
and the product for aquatic organisms, R53 is added
because of the concentration of benalaxyl-M in the
product.
Safety phrases: Assigned to products for professional use labelled N,
R50/53
Other: -
The following restriction sentences were proposed by the applicant:
Dit middel is gevaarlijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling.
Het is verboden dit middel met een luchtvaartuig toe te passen.
Based on the current assessment, the following has to be stated in the legal instructions
for use:
In the WG (legal instructions):
Om de vogels te beschermen is toepassing in teelt van consumptie- en zetmeelaardappelen
uitsluitend toegestaan vanaf BBCH 40 (sluiting van het gewas).
Note: the following warning sentences can be removed from the label; they are not relevant
anymore:
Het is verboden dit middel met een luchtvaartuig toe te passen.
Dit middel is gevaarlijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling.
7.9 Overall conclusions regarding ecotoxicology
It can be concluded that:
1. metabolite M2/3 meets the standards for persistence in soil as laid down in the RGB.
2. all proposed applications of the formulated product Fantic M meet the standards for
birds as laid down in the RGB, provided that a restriction sentence is placed on the
label.
3. all proposed applications of the formulated product Fantic M meet the standards for
aquatic organisms as laid down in the RGB.
4. the active substance benalaxyl-M meets the standards for bioconcentration as laid
down in the RGB.
pag. 119

5. the active substance mancozeb meets the standards for bioconcentration as laid down
in the RGB.
6. all proposed applications of the formulated product Fantic M meet the standards for
mammals as laid down in the RGB.
7. all proposed applications of the formulated product Fantic M meet the standards for
bees as laid down in the RGB.
8. all proposed applications of the formulated product Fantic M meet the standards for
non-target arthropods as laid down in the RGB.
9. all proposed applications of the formulated product Fantic M meet the standards for
earthworms as laid down in the RGB.
10. all proposed applications of the formulated product Fantic M meet the standards for soil
micro-organisms as laid down in the RGB.
11. all proposed applications of the formulated product Fantic M meet the standards for
activated sludge as laid down in the RGB
12. all proposed applications of the formulated product Fantic M meet the standards for
non-target plants as laid down in the RGB
8 Efficacy
This evaluation is partly based on the summary and evaluation of Fantic M prepared by Linge
Agroconsultancy on behalf of the applicant (Report: Lds08mabeno03).
8.1 Efficacy evaluation
Dose justification
Potato
For dose rate finding no trials were performed in The Netherlands. However, in Denmark 3
dose justification trials were conducted in 2005. Fantic M was applied at dose rates 0.625, 1.25
and 2.5 kg/ha (proposed dose rate). Higher rates were not tested. In all trials, the Fantic M
dose rates were applied 12 times.
In the trials, a clear dose response was found for foliar blight control, with 2.5 kg/ha showing
the best control.
In 1 trial, no significant differences in tuber blight control were found between the dose rates
while in another trial no tuber blight was found. In 1 trial, the control of tuber blight given by 2.5
kg/ha was somewhat better than the control found by 0.625 and 1.25 kg/ha.
In 2 trials, a clear dose response was found for tuber yield, with 2.5 kg/ha showing the highest
yield. In 1 trial, the yield of healthy tubers in plots treated with 2.5 kg/ha was somewhat higher
than the yield found in plots treated with 1.25 kg/ha and significantly higher than the yield found
in plots treated with 0.625 kg/ha.
Based on the above results and based on the knowledge that:
- the circumstances for P. infestans development in The Netherlands are more favourable
than in Denmark
- the variation in genetic background of P. infestans isolates in The Netherlands is larger
than in Denmark
- the P. infestans isolates in The Netherlands are more virulent than in Denmark
- a comparable standard product based on metalaxyl-M + mancozeb is applied and
authorised at a dose rate of 2.5 kg/ha
- the content of benalaxyl-M + mancozeb in Fantic M is more or less comparable to the
content of metalaxyl-M + mancozeb in the standard product authorised in The
Netherlands
- metalaxyl-M and benalaxyl-M are comparable active ingredients, with comparable
modes of action and both belonging to the chemical group of the phenylamides;
it is justified to assume that 2.5 kg/ha Fantic M is the optimum dose rate for potato late blight
(Phytophthora infestans) control in potatoes.
pag. 120

Leek
In The Netherlands, 8 trials (4 in 2006 and 4 in 2007) were carried out in leek for dose rate
finding. Fantic M was applied at dose rates 1.5 and 2.5 kg/ha (proposed dose rate). Higher
dose rates were not tested. One trial in 2007 cannot be used for dose rate finding since the
disease pressure was too low.
In 2006, the number of white tip disease spots per leaf in plots treated with 1.5 kg/ha was in 2
trials comparable to and in 2 trials somewhat higher than the number found in plots treated with
2.5 kg/ha. In 2007, the percentage leaf area infected in plots treated with 1.5 kg/ha was in 1
trial comparable to, in 1 trial somewhat higher than and in 1 trial significantly higher than the
percentage found in plots treated with 2.5 kg/ha.
Based on the results and on expert judgement, it is justified to assume that 2.5 kg/ha Fantic M
is the optimum dose rate for white tip disease (Phytophthora porri) control in leek.
Effectiveness
Potato
In 2005 and 2006, 14 effectiveness trials have been conducted in The Netherlands (4 in 2005),
Denmark (3 in 2005 and 2 in 2006) and Sweden (3 in 2005 and 2 in 2006), to assess the
effectiveness of Fantic M, applied at the proposed dose rate of 2.5 kg/ha, in controlling
Phytophthora infestans in potatoes.
The number of trials was sufficient and the pest pressure was generally high enough to make
an evaluation possible.
The Netherlands
In the 4 Dutch trials, Fantic M was applied 2 or 3 times as part of a spray programme with a
protectant fungicide. Fantic M was applied when the first late blight symptoms were found in the
untreated guard rows. The control of potato late blight (based on percentage leaf area infected)
by 2 or 3 applications with 2.5 kg/ha Fantic M was good and comparable to the control given by
2 or 3 applications with the standard product based on metalaxyl-M + mancozeb.
Tuber blight was assessed in 1 trial. No differences in tuber blight control were found between
2 or 3 applications with Fantic M and 2 or 3 applications with the standard product based on
metalaxyl-M + mancozeb.
Yield was assessed in 1 trial. No differences in tuber yield were found between 2 or 3
applications with Fantic M and 2 or 3 applications with the standard product based on
metalaxyl-M + mancozeb.
Denmark
In 3 Danish trials conducted in 2005, 2.5 kg/ha Fantic M was applied whole season long. The
control of potato late blight (based on percentage leaf area infected) by 2.5 kg/ha Fantic M was
in 1 trial somewhat better than and in 2 trials comparable to the control found in plots treated
with the standard product based on fluazinam.
The control of tuber blight by 2.5 kg/ha Fantic M was in 1 trial somewhat less than and in 1 trial
comparable to the control found in plots treated with the standard product based on fluazinam.
In 1 trial, no tuber blight was found.
The yield of healthy tubers in plots treated with 2.5 kg/ha Fantic M was in all trials comparable
to the yield found in plots treated with the standard product based on fluazinam.
In 2 Danish trials conducted in 2006, Fantic M was applied once or twice as part of a spray
programme with a protectant fungicide. Fantic M was applied when the first late blight
symptoms were found in the untreated control.
In 1 trial, the disease pressure was too low to assess the effectiveness of Fantic M in
controlling Phytophthora infestans in potatoes.
pag. 121

In 1 trial, the control of potato late blight (based on percentage leaf area infected) by 1
application with 2.5 kg/ha Fantic M was comparable to the control given by 1 application with
the standard product based on metalaxyl-M + mancozeb and the standard product based on
fluazinam, sprayed season long. The control of potato late blight (based on percentage leaf
area infected) by 2 applications with 2.5 kg/ha Fantic M was somewhat less than the control
given by 2 applications with the standard product based on metalaxyl-M + mancozeb and
comparable to the control found in plots treated with the standard product based on fluazinam,
sprayed season long.
In 1 trial, no significant differences in tuber blight control and tuber yield were found between 1
or 2 applications with 2.5 kg/ha Fantic M, 1 or 2 applications with the standard product based
on metalaxyl-M + mancozeb and the standard product based on fluazinam, sprayed season
long.
In 3 Swedish trials in 2005, 2.5 kg/ha Fantic M was applied twice as a block treatment in
alternation with a protectant fungicide based on fluazinam. In all trials, 2.5 kg/ha Fantic M
controlled leaf and tuber blight very well. The control was in general comparable to or
somewhat better (not significant) than the control of leaf and tuber blight given by 2 applications
with the standard product based on metalaxyl-M + mancozeb and based on fluazinam sprayed
season long. No significant differences in yield between Fantic M and the standard products
based on metalaxyl-M + mancozeb and based on fluazinam were found.
In 2 Swedish trials conducted in 2006, Fantic M was applied once or twice as part of a spray
programme with a protectant fungicide. Fantic M was applied when the first late blight
symptoms were found in the untreated control.
In 1 trial, the disease pressure was too low to assess the effectiveness of Fantic M in
controlling Phytophthora infestans in potatoes.
In 1 trial, the control of potato late blight (based on percentage leaf area infected) by 1 or 2
applications with 2.5 kg/ha Fantic M was comparable to the control given by 1 or 2 applications
with the standard product based on metalaxyl-M + mancozeb and the standard product based
on fluazinam, sprayed season long.
In 1 trial, no significant differences in tuber blight control and tuber yield were found between 1
or 2 applications with 2.5 kg/ha Fantic M, 1 or 2 applications with the standard product based
on metalaxyl-M + mancozeb and the standard product based on fluazinam, sprayed season
long.
Leek
In 2006 and 2007, 8 effectiveness trials in leek have been conducted in The Netherlands. The
effectiveness of Fantic M, applied at the proposed dose rate of 2.5 kg/ha, in controlling
Phytophthora porri in leek was compared to the effectiveness of the standard products based
on propamocarb-hydrochloride and boscalid+pyraclostrobin. Fantic M was applied with an
application interval of approximately 21 days and the standard products with an interval of 10-
14 days. In 1 treatment, 2.5 kg/ha Fantic M was applied curatively. All products were applied in
combination with a fungicide based on tebuconazole. One trial could not be used for
effectiveness evaluation since the disease pressure was too low.
In general, the disease pressure was low. The number of trials is sufficient.
In all trials, Fantic-M gave a good control of white tip disease.
In 2006, the number of white tip disease spots per leaf in plots treated 4-5 times with Fantic M
was in 3 trials comparable to and in 1 trial significantly higher than the number found in plots
treated 6 times with the standard product based on boscalid+pyraclostrobin. The number of
white tip disease spots per leaf in plots treated 4-5 times with Fantic M was in 3 trials
significantly less than and in 1 trial comparable to the number found in plots treated 6 times
with the standard product based on propamocarb-hydrochloride. Fantic M applied 4 times
curatively showed the same results as Fantic M applied 4-5 times preventively.
pag. 122

In 2007, the percentage leaf area infected in plots treated 5 times with Fantic M was in 3 trials
comparable to the percentage found in plots treated 8 times with the standard product based
on boscalid+pyraclostrobin. The percentage leaf area infected in plots treated 5 times with
Fantic M was in 1 trial somewhat less than, in 1 trial significantly less than and in 1 trial
comparable to the percentage found in plots treated 8 times with the standard product based
on propamocarb-hydrochloride.
The percentage leaf area infected in plots treated 2-3 times curatively with Fantic M was in 1
trial comparable to and in 2 trials significantly higher than the percentage found in plots treated
8 times with the standard product based on boscalid+pyraclostrobin. The percentage leaf area
infected in plots treated 2-3 times curatively with Fantic M was in 1 trial higher than and in 2
trials comparable to the percentage found in plots treated 8 times with the standard product
based on propamocarb-hydrochloride.
Combination product
No data on the benefit of the combination product were available. However, due to the long
lasting knowledge of and experience with mancozeb and the fact that applications with
benalaxyl-M as a solo product will ultimately lead to resistance within phytophthora isolates and
thus result into reduced effectiveness, it is not necessary to conduct additional trials for
showing the benefit of the combination product. The combination of both active ingredients
results in a product with good preventive, curative and systemic activity with a reduced risk for
resistance development.
Conclusion
The product complies with the Uniform Principles because it does in accordance with article 2.1
control Phytophthora infestans in potatoes and Phytophthora porri in leek.
8.2 Harmful effects
8.2.1 Phytotoxicity
Potato
Assessments on phytotoxicity were carried out in 14 effectiveness trials conducted in potato in
2005 (4 in The Netherlands, 3 in Denmark and 3 in Sweden) and 2006 (2 in Denmark and 2 in
Sweden). Fantic M was applied at the proposed dose rate of 2.5 kg/ha. The products were
applied 1-12 times.
In none of the effectiveness trials phytotoxicity was observed. Furthermore, no adverse effect
on crop condition was found.
Leek
In 8 effectiveness trials in leek conducted in 2006 (4 in The Netherlands) and 2007 (4 in The
Netherland), phytotoxicity of 4-5 applications with 2.5 kg/ha Fantic M was assessed.
In none of the effectiveness trials phytotoxicity was observed. Furthermore, no adverse effect
on crop condition was found.
8.2.2 Yield
Potato
Yield was determined in 11 effectiveness trials conducted in potato in 2005 (1 in The
Netherlands, 3 in Denmark and 3 in Sweden) and 2006 (2 in Denmark and 2 Sweden). The
yield of 1-12 applications with Fantic M, applied at the proposed dose rate of 2.5 kg/ha, was
compared to the yield of 1-3 applications of the standard product based on metalaxyl-M +
mancozeb applied in a spray programme with a protectant fungicide and to the yield of the
standard product based on fluazinam sprayed whole season long (8-12 applications).
In The Netherlands, the yield in plots treated 2-3 times with Fantic M (as part of a spray
programme with a protectant fungicide) was comparable to the yield found in plots treated 2-3
times with the standard product based on metalaxyl-M + mancozeb.
pag. 123

In Denmark in 2005, the yield in plots treated 12 times with Fantic M was comparable to the
yield found in plots treated 12 times with the standard product based on fluazinam. In 2006, the
yield in plots treated 1-2 times with Fantic M (as part of a spray programme with a protectant
fungicide) was comparable to the yield found in plots treated 1-2 times with the standard
product based on metalaxyl-M + mancozeb and to the yield found in plots treated whole season
long with the standard product based on fluazinam.
In Sweden in 2005, the yield in plots treated twice with Fantic M (as part of a spray programme
with a protectant fungicide) was comparable to the yield found in plots treated twice with the
standard product based on metalaxyl-M + mancozeb and to the yield found in plots treated
whole season long with the standard product based on fluazinam. In 2006, the yield in plots
treated 1-2 times with Fantic M (as part of a spray programme with a protectant fungicide) was
comparable to the yield found in plots treated 1-2 times with the standard product based on
metalaxyl-M + mancozeb and to the yield found in plots treated whole season long with the
standard product based on fluazinam.
Starch content and starch yield
Starch content and starch yield was determined in 3 effectiveness trials conducted in potato in
Denmark in 2005. The starch content and starch yield of 12 applications with Fantic M, applied
at the proposed dose rate of 2.5 kg/ha, was compared to the yield of 12 applications with the
standard product based on fluazinam.
In all trials, no significant differences in starch content and starch yield were found between
plots treated with Fantic M and the standard product based on fluazinam.
Leek
No yield was determined in the effectiveness trials and is also not a requirement for fungicide
trials in leek.
8.2.3 Effects on succeeding crops or substitution crops
Based on the experience with and the knowledge of products based on phenylamide active
ingredients (benalaxyl-M) and mancozeb, it is not to be expected that applications with Fantic
M will have an impact on succeeding and substitution crops.
8.2.4 Effects on plants or plant products to be used for propagation
Not relevant, since authorisation is claimed for in ware and starch potatoes and leek which are
not used for propagation.
8.2.5 Effects on adjacent crops
Based on the experience with and the knowledge of products based on phenylamide active
ingredients (benalaxyl-M) and mancozeb, it is not to be expected that applications with Fantic
M will have an impact on adjacent crops.
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
Fantic M is formulated as a water dispersible granule containing 4.0% w/w benalaxyl-M and
65.0% w/w mancozeb. Mancozeb belongs to the group of the dithiocarbamates. It has a
preventive, multi-site action and the risk of resistance development is very low. Mancozeb has
been used extensively for many years in Europe in spray programmes to control late blight of
potato, alone and in mixtures with other fungicides. To date there is no evidence of any
resistance or loss of sensitivity of P. infestans strains to mancozeb.
pag. 124

The risk of resistance to phenylamide fungicides is known and is assumed to be high
based on evidence of mutation at target site in model organisms. FRAC classifies this
chemical group as high risk (FRAC code 4).
As a consequence, a resistance management strategy has been advised for the use of Fantic
M in potatoes for the control of P. infestans. The proposed Fantic M product label recommends
that, to reduce the risk of resistance developing, Fantic M should make up no more than 3
sprays in the intended blight control spray programme.
It is considered that rigorous implementation of this strategy when the product is used in
commercial potato blight control spray programmes will ensure that the risk of the development
of P. infestans resistance to Fantic M will be greatly diminished.
Also in leek the maximum number of applications is limited to 3.
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 / Data requirements
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.
As a consequence of the withdrawal of the application for increase of the MRL of mancozeb in
leek, the application for the use on leek has been withdrawn by the applicant.Please be aware
that the risk assessment has not been updated to exclude leek.
10. Classification and labelling
Proposal for the classification and labelling of the formulation
Based on the profile of the substance, the provided toxicology of the preparation, the
characteristics of the 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: Xn Indication of danger: Harmful
N Indication of danger: Dangerous for the
environment
R phrases R50/53 Very toxic to aquatic organisms, may cause
long-term adverse effects in the aquatic
environment
R63 Possible risk of harm to the unborn child.
pag. 125

S phrases S8 Keep container dry.
S36/37 Wear suitable protective clothing and gloves.
S60 This material and its container must be
disposed of as hazardous waste.
S61 Avoid release to the environment. Refer to
Special provisions:
DPD-phrases
Plant protection
products phrase:
DPD-phrase
special instructions/safety data sheets.
- -
DPD01 To avoid risk for man and the environment,
comply with the instructions for use
Child-resistant fastening obligatory? not applicable
Tactile warning of danger obligatory? not applicable
Based on the current assessment, the following has to be stated in the legal instructions
for use:
In the WG (legal instructions):
Eerst de tank voor de helft vullen met water, vervolgens onder voortdurend roeren het middel toevoegen
en de tank verder met water vullen. Tijdens het opspuiten moet de spuitvloeistof in beweging worden
gehouden.”
Om het grondwater te beschermen mag dit product niet worden gebruikt in
grondwaterbeschermingsgebieden.
Om het oppervlaktewater te beschermen ten behoeve van de drinkwaterbereiding is de
toepassing in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik
gemaakt wordt van minimaal 75% driftreducerende doppen
Om de vogels te beschermen is toepassing in teelt van consumptie- en zetmeelaardappelen
uitsluitend toegestaan vanaf BBCH 40 (sluiting van het gewas).
Note: the following warning sentences can be removed from the label; they are not relevant
anymore:
Het is verboden dit middel met een luchtvaartuig toe te passen.
Dit middel is gevaarlijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling.
pag. 126

Appendix 1 Table of uses
pag. 1

pag. 2

Appendix 2 Reference list
This appendix serves only to give an indication of which data have been used for decision taking 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.
Part A - List of Annex II data submitted in support of the evaluation
OECD
Annex
point
Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Enclosure 1 2007 Estimation of the degradation rates of IR6141 and its
metabolites in soil N-(phenylacetyl)-N-(2,6-xylyl)-alanine
(IR6141 acid), Methyl-N-(2,6-xylyl)-N-malonyl-alaninate
(Mono-acid, M1) and N (2,6-xylyl)-N-malonyl-alanin (Bi-acid,
M2) that have been used in environmental fate modelling.
KIIA 5
confirmatory
data
KIIA 5
confirmatory
data
IIA
08.02.01/07
M1
IIA
08.02.01/08
M2
SCC, Report n. 165-040
2008 Active substance: mancozeb
An oral (dietary) developmental neurotoxicity study of
mancozeb in rats final report
WIL Research Laboratories, LLC
DAS report no.: WIL-641002
Masterfile no.: ER 127.02
GLP
Unpublished
2008 Active substance: mancozeb
A dietary exposure and dose range-finding developmental
neurotoxicity study of mancozeb in rats
WIL Research Laboratories, LLC
DAS report no.: WIL-641001
Masterfile no.: ER 127.03
GLP
Unpublished
1997a 96-hour acute toxicity study in rainbow trout with Methyl-N-
Malonyl-N-2,6-Xylyl-DL-Alaninate.
NOTOX Report No: 211005 +
(BIOLAB 97/9590-1) GLP, Unpublished
1997b 96-hour acute toxicity study in rainbow trout with N-Malonyl-
N-2,6-Xylyl-DL-Alanine. NOTOX
Report No: 210994 + (BIOLAB 97/9590-2) GLP,
Unpublished
pag. 3
Data
protection
claimed
Y/N
Owner
Y ISAGRO
Application number Date of
submission*
(in case of an earlier submission (for
an earlier application))
N DAS 20080319 THG 27
November
2009
N DAS 20080319 THG 27
November
2009
Y ISAGRO
Y ISAGRO

OECD
Annex
point
IIA
08.02.04/03
M1
IIA
08.02.04/04
M2
IIA
08.02.06/03
M1
IIA
08.02.06/04
M2
IIA
08.02.01/09
*
IIA
08.02.01/10
*
IIA
08.02.04/05
*
IIA
08.02.04/06
*
IIA
08.02.06/05
*
Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
1997a Methyl-N-Malonyl-N-2,6-Xylyl-DL-Alaninate: Acute
immobilization study in Daphnia magna.
RBM Report No: 970568 +
(BIOLAB 97/9590-3) GLP, Unpublished
1997b N-Malonyl-N-2,6-Xylyl-DL-Alanine: Acute immobilization
study in Daphnia magna. RBM
Report No: 970570 + (BIOLAB 97/9590-5) GLP,
Unpublished
1997c Methyl-N-Malonyl-N-2,6-Xylyl-DL-Alaninate: Algal growth
inhibition study. RBM Report
No:970569 + (BIOLAB 97/9590-4) GLP, Unpublished
1997d N-Malonyl-N-2,6-Xylyl-DL-Alanine: Algal growth inhibition
study. RBM
Report No:970571+(BIOLAB 97/9590-6) GLP, Unpublished
2008 Acute Toxicity Testing of F4 (D-isomer) in Rainbow Trout
(Oncorhynchus mykiss) (Teleostei, Salmonidae).
eurofins-GAB GmbH,
report No.: S08-01646
GLP, Unpublished
2008 Acute Toxicity Testing of F7+F8 in Rainbow Trout
(Oncorhynchus mykiss) (Teleostei, Salmonidae).
eurofins-GAB GmbH
report No.: S08-03168
GLP, Unpublished
2008 Assessment of Toxic Effects of F4 (D-Isomer) on Daphnia
magna using the 48 h. Acute Immobilisation Test.
eurofins-GAB GmbH
report No.: S08-01636
GLP, Unpublished
2008 Assessment of Toxic Effects of F7+F8 on Daphnia magna
using the 48 h Acute Immobilisation Test.
eurofins-GAB GmbH
report No.: S08-3169
GLP, Unpublished
2008 Testing of Toxic Effects of Test item: F4 (D-isomer) to the
Single Cell Green Alga Desmodesmus subspicatus
eurofins-GAB GmbH
report No.: S08-01639
GLP, Unpublished
pag. 4
Data
protection
claimed
Y/N
Owner
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Application number Date of
submission*
(in case of an earlier submission (for
an earlier application))

OECD
Annex
point
IIA
08.02.06/06
*
IIA
08.04.01/07
*
IIA
08.04.01/08
*
IIA
08.05/05*
IIA
08.05/06*
Year Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
2008 Testing of Toxic Effects of Test item: F7+F8 to the Single
Cell Green Alga Desmodesmus subspicatus.
eurofins-GAB GmbH
report No.: S08-03170
GLP, Unpublished
2008 Acute Toxicity of F4 (D-isomer) on Earthworms, Eisenia
fetida Using an Artificial Soil Test.
eurofins-GAB GmbH
report No. S08-01527
GLP, Unpublished
2008 Acute Toxicity of F7+F8 on Earthworms, Eisenia fetida Using
an Artificial Soil Test. eurofins-GAB GmbH
report No. S08-03211
GLP, Unpublished
2008 Assessment of the Side Effects of F4 (D-isomer) on the
Activity of the Soil Microflora..
Eurofins-GAB GmbH
report No.: S08-01526
GLP, Unpublished
2009 Effects of F7+F8 on the activity of the soil microflora
(nitrogen and carbon transformation tests).
Biochem agrar Labor fur biologische und chemische Analytik
GmbH
report No. 09 10 48 006 C/N
GLP, Unpublished
*EU Post-submission 10 (May 2009)
Annex
point
Section 1
pag. 5
Data
protection
claimed
Y/N
Owner
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Y ISAGRO
Part B - List of Annex III data submitted in support of the evaluation
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 Application
number*
Application number Date of
submission*
(in case of an earlier submission (for
an earlier application))
Date of
submission*

Annex
point
IIIA 5.2.2/01
in
Doc J; see
under IIIA
1.2.3
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
2007 Development and validation of
an analytical method for the
determination of the content of
active ingredients in IR6141 M.
GAB, Isagro S.p.A., Report No.
20065011/01-PCVE
GLP
Unpublished
IIIA 2.1/01 2006 IR6141 M: physical and
chemical characterization.
Determination of appearance
(physical state, colour and
odour).
GAB, Italy, report no.
20065011/01-PCAP
Isagro S.p.A.
GLP
Unpublished
IIIA 2.2.1/01 2006 IR6141 M Explosive properties.
Siemens, Germany, report no.
20060581.01
Isagro S.p.A.
GLP
Unpublished
IIIA 2.2.2/01 2006 IR6141 M: Oxidising properties.
GAB, Italy, report no.
20065011/01-PCOP
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
Y Isagro
pag. 6
Owner 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
IIIA 2.3.2/01 2006 IR6141 M: Determination of
flammability (solids).
GAB, Italy, report no.
20065011/01-PCFS
Isagro S.p.A.
GLP
Unpublished
IIIA 2.3.3/01 2006 IR6141 M Auto-flammability
(solids-determination of relative
self-ignition temperature).
Siemens, Germany, report no.
20060581.02
Isagro S.p.A.
GLP
Unpublished
IIIA 2.4.2/01 2006 IR6141 M: physical and
chemical characterization.
Determination of pH (1%
dispersion).
GAB, Italy, report no.
20065011/01-PCPH
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
pag. 7
Owner 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
IIIA 2.6.2/01 2006 IR6141 M: physical and
chemical characterization.
Determination of tap density.
GAB, Italy, report no.
20065011/01-PCTW
Isagro S.p.A.
GLP
Unpublished
IIIA 2.7.1/01 2006 IR6141 M: Determination of
active ingrdients content.
GAB, Italy, report no.
20065011/01-PCAI
Isagro S.p.A.
GLP
Unpublished
IIIA 2.7.5/01 2007 Interim report. IR6141 M:
physical and chemical
characterization. Determination
of shelf life at ambient
temperature (after 12 months of
storage).
GAB, Italy, report no.
20065011/01-PCRT
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
pag. 8
Owner 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
IIIA 2.7.5/02 2008 Final report. IR6141 M: physical
and chemical characterization.
Determination of shelf life at
ambient temperature (after 24
months of storage).
GAB, Italy, report no.
20065011/01-PCRT
Isagro S.p.A.
GLP
Unpublished
IIIA 2.8.1/01 2006 IR6141 M: physical and
chemical characterization.
Determination of wettability.
GAB, Italy, report no.
20065011/01-PCWP
Isagro S.p.A.
GLP
Unpublished
IIIA 2.8.2/01 2006 IR6141 M: physical and
chemical characterization.
Determination of persistent
foam.
GAB, Italy, report no.
20065011/01-PCPF
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
pag. 9
Owner Application
number*
Y Isagro 20090938TG
V
Y Isagro
Y Isagro
Date of
submission*
E-mail April 9 th 2009

Annex
point
IIIA
2.8.3.1/01
IIIA
2.8.3.1/02
(=P02.08.3b)
IIIA
2.8.3.2/01
IIIA
2.8.5.2/01
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
2006 IR6141 M: physical and
chemical characterization.
Determination of suspensibility.
GAB, Italy, report no.
20065011/01-PCSG
Isagro S.p.A.
GLP
Unpublished
2009 Suspensibility of Fantic M WG.
Letter by Isagro S.p.A. dated
24/4/2009.
Non-GLP
Unpublished
2006 IR6141 M: physical and
chemical characterization.
Determination of dispersibility.
GAB, Italy, report no.
20065011/01-PCDW
Isagro S.p.A.
GLP
Unpublished
2006 IR6141 M: physical and
chemical characterization.
Determination of wet sieving.
GAB, Italy, report no.
20065011/01-PCWG
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
Y Isagro
pag. 10
Owner Application
number*
Date of
submission*

Annex
point
IIIA
2.8.6.1/01
IIIA
2.8.6.3/01
IIIA
2.8.6.5/01
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
2006 IR6141 M: physical and
chemical characterization.
Determination of particle size
distribution.
GAB, Italy, report no.
20065011/01-PCDD
Isagro S.p.A.
GLP
Unpublished
2006 IR6141 M: physical and
chemical characterization.
Determination of dustiness.
GAB, Italy, report no.
20065011/01-PCDU
Isagro S.p.A.
GLP
Unpublished
2006 IR6141 M: physical and
chemical characterization.
Determination of attrition
resistance.
GAB, Italy, report no.
20065011/01-PCAR
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
pag. 11
Owner Application
number*
Date of
submission*

Annex
point
IIIA
2.8.8.1/01
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
2006 IR6141 M: physical and
chemical characterization.
Determination of flowability.
GAB, Italy, report no.
20065011/01-PCFL
Isagro S.p.A.
GLP
Unpublished
IIIA 2.15/01 2006 IR6141 M: physical and
chemical characterization.
Determination of water.
GAB, Italy, report no.
20065011/01-PCWT
Isagro S.p.A.
GLP
Unpublished
IIIA 4.1.1/02 2006 Prototype approval certificate
packagings, large packagings
and intermediate bulk
containers 30/07/2006.
The Italian Pulp and Paper
Research Institute on behalf of
Ministry of Transport, Italy,
report no. 00125-06
Isagro S.p.A.
not GLP
non-published
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
pag. 12
Owner 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
IIIA 4.2.1/01 2002 IR6141/Mancozeb 4/65 WP
Effectiveness of the cleaning
procedure., Report No. 009/02
IRG-CCF,
Not GLP, Unpublished
Section 3
IIIA 7.1.1/01 2007 IR6141 M. Acute oral toxicity
study in rats (acute toxicity
class method).
RTC, Italy, report no. 61100
Isagro S.p.A.
GLP
Unpublished
IIIA 7.1.2/01 2007 IR6141 M. Acute dermal toxicity
study in rats.
RTC, Italy, report no. 61110
Isagro S.p.A.
GLP
Unpublished
IIIA 7.1.4/01 2007 IR6141 M. Acute dermal
irritation study in rabbits.
RTC, Italy, report no. 61130
Isagro S.p.A.
GLP
Unpublished
IIIA 7.1.5/01 2007 IR6141 M. Acute eye irritation
study in the rabbit.
RTC, Italy, report no. 61120
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
Y Isagro
Y
pag. 13
Owner Application
number*
Isagro
Date of
submission*

Annex
point
Year
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
IIIA 7.1.6/01 2007 IR6141 M. Delayed dermal
sensitisation study in guinea
pigs (Magnusson and Kligman
test).
RTC, Italy, report no. 61140
Isagro S.p.A.
GLP
Unpublished
Section 4
IIIA 8.1.1. 1998 CS2 – Magnitude of the
residues in leeks harvested at
different dates after treatment
with the preparation DITHANE
M45® (mancozeg) in Northern
France (R 97.3.)
GLP study
IIIA 8.1.1. 1997 CS2 – Magnitude of the
residues in leeks harvested at
different dates after treatment
with the preparation DITHANE
M45® (mancozeg) in Northern
France (R 95.3.)
GLP study
Data
protection
claimed
Y/N
Y
pag. 14
Owner Application
number*
Isagro
Y Dow
AgroSci
ences
Y Dow
AgroSci
ences
FANTIC M
WG
20080938
TGV
FANTIC M
WG
20080938
TGV
Date of
submission*
24/4/2009
24/4/2009

Annex
point
IIIA 8.3/01
part 1 t/m 5
Year Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
2004 IR6141 residues in leek after
applications of Fantic M WP.
Four harvest trials in Northern
Europe in 2003.
Isagro Ricerca, Italy, report no.
2406
Isagro S.p.A.
GLP
Unpublished
IIIA 8.3/02 1998 Benalaxyl residues in potatoes
treated with IR6141-M Field trial
in Marson (51-Marne), North of
France, 1997.
Isagro Ricerca, Italy, report no.
2230 (97 F PT EM P/A)
Isagro S.p.A.
GLP
Unpublished
IIIA 8.3/03 2001 IR6141 and benalaxyl residues
in potatoes treated with IR6141
M and with GALBEN M. Field
trials at Mourmelon Le Petit,
Dampierre sur Moivre and
Faux-Vesigneul (Reims-France,
2000).
Isagro Ricerca, Italy, report no.
2319
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
pag. 15
Owner 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
IIIA 8.3/04 2008 IR6141 residues in potato after
three applications of IR6141 M.
Two harvest and two decline
trials in Northern Europe in
2007.
Isagro Ricerca, Italy, report no.
RA.07.16
Isagro S.p.A.
GLP
Section 5
IIIA 9.6.1/02
IIIA 9.6.1/03
2
2
Unpublished
(14-C)-Ethylene urea, a
metabolite of mancozeb:
Adsorption/Desorption in soil
Covance Laboratories
DAS Report No.: 295/162-
D2149
(Masterfile Number) ER 111.03
GLP: Y
Unpublished
Study for the
Adsorption/Desorption
Determination of Metiram
Metabolite 243959 (BF222-
EBIS) on Five European Soils
BASF Aktiengesellschaft,
Germany
DAS Report No.: 2002/1005329
(Masterfile number) ER 103.8
GLP: Y
Unpublished
Data
protection
claimed
Y/N
Y Isagro
pag. 16
Owner Application
number*
Y D 20080319
THG
Y D 20080319
THG
Date of
submission*
27 November 2009
27 November 2009

Annex
point
Year
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Section 6
IIIA 10.5.1/01 2006 A rate-response laboratory test
to determine the effects of
IR6141 M on the parasitic wasp,
Aphidius rhopalosiphi
(Hymenoptera, Braconidae).
Mambo-Tox Ltd. UK, report no.
ISA-06-7
Isagro S.p.A.
GLP
Unpublished
IIIA 10.5.1/02 2006 A rate-response laboratory test
to determine the effects of
IR6141 M on the predatory
mite, Typhlodromus pyri (Acari:
Phytoseiidae).
Mambo-Tox Ltd. UK, report no.
ISA-06-5
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
pag. 17
Owner 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
IIIA 10.5.1/03 2006 A rate-response laboratory test
to determine the effects of
"IR6141 M mancozeb free" on
the parasitic wasp, Aphydius
rhopalosiphy (Hymenoptera,
Braconidae).
Mambo-Tox Ltd. UK, report no.
ISA-06-8
Isagro S.p.A.
GLP
Unpublished
IIIA 10.5.1/04 2006 A rate-response laboratory test
to determine the effects of
"IR6141 M mancozeb free" on
the predatory mite,
Typhlodromus pyri (Acari:
Phytoseiidae).
Mambo-Tox Ltd. UK, report no.
ISA-06-6
Isagro S.p.A.
GLP
Unpublished
IIIA 10.7.1/01 2006 Effects of Fantic M (IR6141 M)
on the activity of soil microflora
(Carbon transformation test).
BioChem Agrar, Germany,
report no. 06 10 48 161 C
Isagro S.p.A.
GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
pag. 18
Owner 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
IIIA 10.7.1/02 2006 Effects of Fantic M (IR6141 M)
on the activity of soil microflora
(Nitrogen transformation test).
BioChem Agrar, Germany,
report no. 06 10 48 161 N
Isagro S.p.A.
GLP
IIIA
10.8.1.1/01
IIIA
10.8.1.1/01A
m
Section 7
Unpublished
2001 IR6141 M. Seed germination,
seedling emergence,
phytotoxicity on non-target
plants.
Isagro Ricerca, Italy, report no.
IR6141M 06.01
Isagro S.p.A.
GEP – not GLP
Unpublished
2006 Report Amendment 1.
IR6141 M. Seed germination,
seedling emergence,
phytotoxicity on non-target
plants.
Isagro Ricerca, Italy, report no.
IR6141M 06.01
Isagro S.p.A.
GEP – not GLP
Unpublished
Data
protection
claimed
Y/N
Y Isagro
Y Isagro
Y Isagro
pag. 19
Owner 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
IIIA 6/01 2005 Biological Assessment Dossier
Fantic M
Fungicide for the control of
Phytophthora infestans on
potato.
Isagro Ricerca
Not GEP
Unpublished
IIIA 6/02 2005 F-05-212: Control of
Phytophthora infestans in ware
potatoes, De Bredelaar B.V.,
Elst, The Netherlands
IIIA 6/03 2005 05584-1/05584-2/05584-3:
Efficacy of Fantic M (WP) and
Fantic M (WG) against potato
late blight (P. infestans) and
early blight (Alternaria solani) in
potatoes, in 2005, Danish
Institute of Agricultural
Sciences, Flakkebjerg,
Denmark
IIIA 6/04 2005 151316/151317/151318:
Testing Fantic M in potato,
Swedish University of
Agricultural Sciences Plant
Protection Biology, Alnarp,
Sweden
Data
protection
claimed
Y/N
Y Isagro
Y MA
Y MA
Y MA
pag. 20
Owner 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
IIIA 6/05 2006 06560-1/06560-2: Efficacy of
Fantic M WG, MCW 465 and
MCW 853 against potato late
blight (Phytophthora infestans)
in potatoes , 2006, Danish
Institute of Agricultural
Sciences, Flakkebjerg,
Denmark
IIIA 6/06 2006 151556/151557: Testing Fantic
M in potato, Swedish University
of Agricultural Sciences Plant
Protection Biology, Alnarp,
Sweden
IIIA 6/07 2006 F-06-219 (APD06-057): Control
of Phytophthora porri in leek,
De Bredelaar B.V., Elst, The
Netherlands
IIIA 6/08 2007 F-07-213 (APD07-050: Control
of Phytophthora porri in leek,
De Bredelaar B.V., Elst, The
Netherlands
Data
protection
claimed
Y/N
Y MA
Y MA
Y MA
Y MA
pag. 21
Owner 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
IIIA 6.6/01 2008 Appendix 8 Compilation of Tier
II summaries. Part 4 Section 7.
Efficacy Data and Information
The Netherlands
Fantic M Wettable granules
(WG) containing 4% benalaxyl-
M and 65% mancozeb against
Phytophthora i. on potatoes and
Phytophthora p. on leek.
Makhteshim-Agan Holland B.V.
-
Unpublished
Y MA
* in case of an earlier submission (for an earlier application)
pag. 22
Owner Application
number*
Date of
submission*