Toelatingsnummer 13317 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 UITBREIDING TOELATING
Gelet op de aanvraag d.d. 11 februari 2014 (20140190 NLKUGB) van
BASF Nederland B.V.
Groningensingel 1
6835 EA ARNHEM
tot uitbreiding van de gebruiksdoeleinden van de toelating van het gewasbeschermingsmiddel,
op basis van de werkzame stoffen ametoctradin en dimethomorf.
Orvego
gelet op artikel 51 (EG) nr 1107/2009 en artikel 2.2 Regeling gewasbescherming en biociden,
BESLUIT HET COLLEGE als volgt:
1.1 Uitbreiding
1. Het gebruiksgebied van het middel Orvego wordt met ingang van datum dezes
uitgebreid met de toepassing in de onbedekte teelt van prei. Voor de gronden van dit
besluit wordt verwezen naar bijlage II bij dit besluit.
2. De toelating geldt tot 31 oktober 2014.
1.2 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.3 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I bij dit
besluit is voorgeschreven.
1.4 Classificatie en etikettering
Gelet op artikel 31 en artikel 65 van de Verordening EG/1107/2009 worden voorschriften
gegeven.
Orvego
13317 N
1
Dit leidt tot de volgende voorschriften:
De aanduidingen, welke moeten worden vermeld, worden hierbij vastgesteld als volgt:
aard van het preparaat: Suspensie concentraat
werkzame stof:
ametoctradin
dimethomorf
gehalte:
300 g/l
225 g/l
letterlijk en zonder enige aanvulling:
andere zeer giftige, giftige, bijtende of schadelijke stof(fen):
gevaarsymbool:
Xn
aanduiding:
Schadelijk
Waarschuwingszinnen:
R22
R52/53
-Schadelijk bij opname door de mond.
-Schadelijk voor in het water levende organismen; kan in het
aquatisch milieu op lange termijn schadelijke effecten
veroorzaken.
Veiligheidsaanbevelingen:
S21
S46
S61
-Niet roken tijdens gebruik.
-In geval van inslikken onmiddellijk een arts raadplegen en
verpakking of etiket tonen.
-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.
b. bij het toelatingsnummer een cirkel met daarin de aanduiding W.3.
Orvego
13317 N
2
De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden
aangebracht. Oude verpakkingen mogen worden opgemaakt.
2 DETAILS VAN DE AANVRAAG
2.1 Aanvraag
Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Orvego
(13317 N), een middel op basis van de werkzame stoffen ametoctradin en dimethomorf. Het
middel is bij besluit van 29 april 2010 reeds toegelaten als schimmelbestrijdingsmiddel door
middel van een gewasbehandeling in de teelt van aardappelen, bedekte teelt van sla en
veldsla. Het middel is bij dit besluit toegelaten tot 31 oktober 2014. Met onderliggende
aanvraag wordt toelating als schimmelbestrijdingsmiddel door middel van een
gewasbehandeling in de onbedekte teelt van prei gevraagd.
2.2 Informatie met betrekking tot de stof
De werkzame stof ametoctradin is goedgekeurd krachtens Verordening (EG) No 1107/2009
(Uitvoeringsverordening (EU) No 200/2013 d.d. 1 augustus 2013).
De werkzame stof dimethomorf is per 1 oktober 2007 geplaatst op Annex I van
gewasbeschermingsrichtlijn 91/414/EEG (Richtlijn 07/25/EC, d.d 23 april 2007). De stof is
goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No
540/2011 d.d. 25 mei 2011).
2.3 Karakterisering van het middel
Orvego is geformuleerd als een suspensie concentraat en bevat 300 g/l ametoctradin en 225
g/l dimethomorf.
Ametoctradin behoort tot de groep pyrimidylaminen. Ameoctradin vermindert de hoeveelheid
ATP in de doelschimmel door het binden en voorkomen van binding van complex III van de
ademhalingsketting in de mitochondria. Ametoctradin beïnvloedt de de sporulatie van
oömyceten. De stof is niet systemisch.
Dimethomorf behoort tot de ciannamic acid derivaten. Dimethomorf verstoort de vorming van
de celwand van de schimmel. Het kan tot de afbraak van de celwand leiden en tot de dood van
de cel van de schimmel. Dimethomorf heeft een werking op alle stadia van de levencyclus van
de schimmel, behalve op de sporulatie.
2.4 Voorgeschiedenis
De aanvraag is op 13 februari 2014 ontvangen; op 21 februari 2014 zijn de verschuldigde
aanvraagkosten ontvangen. Bij brief d.d. 19 juni 2014 is de aanvraag in behandeling genomen.
3 RISICOBEOORDELINGEN
De beoordeling van deze aanvraag is conform RGB (Hoofdstuk 2) en de Evaluation Manual 1.0.
3.1 Fysische en chemische eigenschappen
De identiteit en de fysische en chemische eigenschappen van het middel en de werkzame stof
wijzigen niet.
3.2 Analysemethoden
De analysemethoden voor de werkzame stoffen en het middel wijzigen niet. Voor de toegelaten
toepassingen voldoen de vereiste residuanalysemethoden.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor de mens verwacht.
Orvego
13317 N
3
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen
onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Het aspect werkzaamheid (inclusief fytotoxiciteit) is niet beoordeeld conform artikel 51
Verordening (EG) 1107/2009.
3.6 Eindconclusie
Bij gebruik volgens het Wettelijk Gebruiksvoorschrift is het middel Orvego op basis van de
werkzame stoffen ametoctradin en dimethomorf geen schadelijke uitwerking op de gezondheid
van de mens en het milieu.
Bezwaarmogelijkheid
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage
2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet
bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een
bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en
biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid
van het elektronisch indienen van een bezwaarschrift opengesteld.
Wageningen, 1 augustus 2014
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN,
ir. J.F. de Leeuw
voorzitter
Orvego
13317 N
4
Dit middel is uitsluitend bestemd voor professioneel gebruik
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE I bij het besluit d.d. 1 augustus 2014 tot uitbreiding van de toelating van het middel
Orvego, toelatingnummer 13317 N
Wettelijk Gebruiksvoorschrift
Toegestaan is uitsluitend het professionele gebruik als fungicide door middel van een
gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden
versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden.
Toepassingsgebied
Te bestrijden
organisme
Dosering
(middel)
per
toepassing
Aardappelen
Aardappelziekte1
0,8 L/ha
1
Maximaal
aantal
behandeling
en per
teeltcyclus
5
Minimum
interval tussen
toepassingen in
dagen
Veiligheidstermijn
in dagen
5
7
Phytophthora infestans
Het gebruik in de teelt van sla (Lactuca spp.), veldsla en prei is beoordeeld conform artikel 51 EG
1107/2009. Er is voor deze gewasbehandelingen geen werkzaamheids- en fytotoxiciteitonderzoek
uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel
gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en
verantwoordelijkheid van de gebruiker.
Toepassin Te bestrijden
Dosering
Maximaal
Minimum
Veiligheidstermijn
organisme
(middel)
aantal
interval
in dagen
gebied
per
behandelingen tussen
toepassing per teeltcyclus toepassingen
in dagen
Sla
(Lactuca
Valse meeldauw2
0,8 L/ha
3
7
14
spp.)
(bedekte
teelt)
Veldsla
(bedekte
teelt)
Valse meeldauw3
0,8 L/ha
3
7
7
0,7 L/ha
2
7
7
Prei
Papiervlekkenziekte4
(onbedekte
teelt)
2
Bremia lactaceae
3
Perenospora valerianella
4
Phytophthora porri
Orvego
13317 N
1
Toepassingsvoorwaarden
Om het grondwater te beschermen mag dit product niet worden gebruikt in
grondwaterbeschermingsgebieden voor de bedekte teelten.
Resistentiemanagement
Dit middel bevat de werkzame stoffen ametoctradin en dimethomorf. Ametoctradin behoort tot
de triazolo-pyrimidilamines. De Frac code is 45. Dimethomorf behoort tot de cinnamic acid
amides. De FRAC code is 40. Bij dit product bestaat er kans op resistentieontwikkeling. In het
kader van resistentiemanagement dient u de adviezen die gegeven worden in de
voorlichtingsboodschappen op te volgen.
Orvego
13317 N
2
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II bij het besluit d.d. 1 augustus 2014 tot uitbreiding van de toelating van het
middel Orvego, toelatingnummer 13317 N
RISKMANAGEMENT
Contents
Page
1. Identity of the plant protection product ...................................................................... 3
2. Physical and chemical properties ............................................................................... 4
3. Methods of analysis .....................................................................................................4
4. Mammalian toxicology ................................................................................................. 4
5. Residues ....................................................................................................................... 4
6. Environmental fate and behaviour ............................................................................ 15
7. Ecotoxicology ............................................................................................................. 15
8. Efficacy........................................................................................................................ 15
9. Conclusion .................................................................................................................. 15
10.
Classification and labelling .................................................................................... 16
Appendix 1 Table of authorised uses ................................................................................ 1
Appendix 2 Reference list ................................................................................................... 2
Page 2
1. Identity of the plant protection product
1.1
Applicant
BASF Nederland B.V.
Groningensingel 1
6835 EA The Netherlands
1.2
Identity of the active substance
The identity of the active substances does not change.
Common name
Name in Dutch
Chemical name
CAS no
EC no
Ametoctradin
Ametoctradin
5-ethyl-6-octyl- [1,2,4]triazolo[1,5-a]pyrimidin-7-amine
865318-97-4
not assigned
The active substance was approved under Reg. (EC) No 1107/2009 on 1 August 2013
Common name
Name in Dutch
Chemical name
CAS no
EC no
Dimethomorph
Dimethomorf
(E,Z) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine
110488-70-5
404-200-2
The active substance was included in Annex I of Directive 91/414/EEC on 1 October 2007.
From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved
under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC.
1.3
Identity of the plant protection product
The identity of the plant protection product does not change.
Name
Formulation type
Content active substance
Orvego
SC
300g/L pure ametoctradin
225g/L pure dimethomorph
The formulation is identical to the formulation assessed for the approval of ametoctradin
under Reg (EC) 1107/2009.
1.4
Function
Fungicide
1.5
Uses applied for
See GAP (Appendix I).
1.6
Background to the application
It concerns a simplified extension of the authorization with minor uses.
1.7
Packaging details
1.7.1 Packaging description
Packaging details do not change.
Page 3
2. Physical and chemical properties
The physical and chemical properties of the active substance(s) and the formulation do not
change.
3. Methods of analysis
3.1 Analytical methods in technical material and plant protection product
The analytical methods for the technical material and the plant protection product do not
change.
3.2 Residue analytical methods
The proposed extension for use involves application on crops that can be extrapolated from
the current authorisation based on their crop group (matrix) and their MRL. Therefore, the
proposed extension remains within the existing risk envelope for the section residue
analytical methods for food/feed of plant and animal origin.
The residue analytical methods for air, soil and water were accepted during the assessment
which led to the original authorization of Orvego. This simplified extension does not give rise
to re-assess these residue analytical methods.
3.3
Conclusion
The proposed extension for use is covered by the risk envelope of the existing authorisation
for the section residue analytical methods.
4. Mammalian toxicology
The proposed extension for use involves an application on a crop for which the risk
assessment can be extrapolated from the current authorisation based on the method of
application and dosage (mechanical downward application with a maximum dosage of
0.7L/ha with a minimum spray volume of 200 L/ha). Therefore, the proposed extension
remains within the existing risk envelope for the section mammalian toxicology (operator,
bystander and worker).
5. Residues
List of Endpoints
Ametoctradin
The List of Endpoints presented below is taken from the Conclusion on the peer review of the
pesticide risk assessment of the active substance ametoctradin (BAS 650 F) (EFSA Journal
2012;10(11):2921).
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered
Fruits (tomato), Root & tubers (potato), Leafy
vegetables (lettuce)
Rotational crops
Confined rotational crop study at 1.5-2.0 N
Page 4
dose, no crop interception, lettuce, white
radish, spring wheat. Significant residues of
soil metabolites (>0.01 mg/kg per metabolite)
in lettuce planted 30DAT, in forage, straw and
grain of wheat planted 30, 120, 365DAT, in
radish tops planted 30, 120 and 365DAT and
radish root planted 30 and 120DAT.
Metabolism in rotational crops similar to
No: primary crops: parent only with occasional
metabolism in primary crops?
detection of metabolites, rotational crops : soil
metabolites only with occasional detection of
parent.
Processed commodities
BAS 650 F is stable upon pasteurization,
boiling and sterilization.
Study not triggered for metabolites.
Residue pattern in processed commodities
Yes
similar to residue pattern in raw
commodities? Not applicable
Plant residue definition for monitoring
BAS 650 F
Plant residue definition for risk
BAS 650 F for primary crops;
assessment
Sum of BAS 650 F, M650F03 and M650F04
expressed as BAS 650 F for rotational crops,
necessary for combined exposure/risk
assessment since metabolites may also occur
in drinking water
Conversion factor (monitoring to risk
None
assessment)
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered
Lactating goat, laying hen
Time needed to reach a plateau
Egg: 7d
concentration in milk and eggs
Milk: 5-8d
Animal residue definition for monitoring
Not necessary for representative uses
Animal residue definition for risk
Not necessary for representative uses
assessment
Conversion factor (monitoring to risk
None
assessment)
Metabolism in rat and ruminant similar
no
Page 5
(yes/no)
Fat soluble residue: (yes/no)
Yes (BAS 650 F detected in egg and hen fat)
Log Pow (BAS 650 F) 4.4 at pH 7.1
Note: The provisional animal residue definition as “ametoctradin, M65F01 and M650F06,
expressed as ametoctradin” proposed in the EFSA Reasoned opinion on ametoctradin
remains currently unaffected since the peer review did not conclude on a final animal residue
definition. Reconsideration of the provisional proposal might be necessary in future, if
additional uses will impact on the livestock dietary burden.
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
Field trial with carrot, cauliflower, lettuce, wheat
....................................................................
at 1N without crops interception. No residues
.......
of parent >0.01 mg/kg at except for cauliflower
(max 0.02 mg/kg) and wheat straw (max 0.04
mg/kg) at 30d replanting interval . Low to
significant residues of M650F03 and M650F04
at 30, 120 and 365DAT.
Maximum residues in rotational crops as sum
of BAS560F, M650F03 and M650F04
expressed as BAS560F: 0.058 mg/kg in carrot,
0.060 mg/kg in cauliflower, 0.037 mg/kg in
lettuce and 0.326 mg/kg in wheat grain, 1.25
mg/kg in wheat straw.
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)
BAS 650 F: 3y in watery (2y in potato tuber, 3y
....................................................................
in tomato fruit), 2y in dry matrices (cereal grain
.......
and straw).
M650F03 and M650F04: 3y in watery (2y in
potato tuber, 3y in tomato fruit), 2y in dry
matrices (cereal grain and straw)
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Ruminant: Poultry:
Pig:
Conditions of requirement of feeding studies
Page 6
Ruminant: Poultry:
Pig:
Conditions of requirement of feeding studies
Expected intakes by livestock ≥ 0.1 mg/kg
yes
no
no
Potential for accumulation (yes/no):
no
no
no
Metabolism studies indicate potential level
no
no
diet (dry weight basis) (yes/no - If yes,
specify the level)
of residues ≥ 0.01 mg/kg in edible tissues
(yes/no)
Feeding studies
Residue levels in matrices : Mean (max) mg/kg
Muscle
-
-
-
Liver
-
-
-
Kidney
-
-
-
Fat
-
-
-
Milk
-
Eggs
-
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
Crop/ process/
processed product
Number of
studies
Processing factors
Amount
Mean transfer
Yield
transferred
Factor (range)
factor
(%)
(Optional)
Potato
BAS 650 F and M650F04:
Residues were <LOQ in both raw and processed commodities. No precise numerical PF
can be set, but concentration of residues >LOQ in processed products can be excluded.
Metabolite M650F03
Chips
1
0.7
-
-
Flakes
1
0.9
-
-
Microwave boiled
2
1.7 (≥1-1.7)
-
-
Potato peel
4
1.8 (≥1-≥3.3)
-
-
Peeled potato
1
0.7
-
-
Fried potato
1
0.4
-
-
potatoes
Page 7
Cooked potato
1
0.4
-
-
Raw tomato
4
1
Canned tomatoes
4
0.017 (0.007-0.03)
-
-
Paste (ketchup)
4
0.41 (0.24-0.619)
-
-
Peeled tomatoes
4
0.02 (0.01-0.04)
-
-
Puree
4
0.63 (0.45-1.17)
-
-
Raw juice
4
0.20 (0.12-0.33)
-
-
Tomato peel
4
5.78 (1.5-12)
-
-
Washed tomatoes
4
0.25 (0.13-0.94)
-
-
Wet pomace
4
1.27 (1.1-1.41)
-
-
Tomato fruit
BAS 650 F
* Calculated on the basis of distribution in the different portions, parts or products as
determined through balance studies.
Dimethomorph
The List of Endpoints presented below is taken from the Conclusion on the peer review of the
pesticide risk assessment of the active substance dimethomorph (EFSA Scientific Report
(2006) 82, 1-69).
Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6)
Plant groups covered
Fruit (grapes, tomato); tuber (potato); leafy
(lettuce)
Rotational crops
Lettuce, soybean, radish and wheat
Plant residue definition for monitoring
Dimethomorph
Plant residue definition for risk
Dimethomorph (valid for application by foliar
assessment
spray only)
Conversion factor (monitoring to risk
assessment)
Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)
Animals covered
lactating goat, laying hen
Animal residue definition for monitoring
Dimethomorph (for poultry and milk this is to
be considered as a default residue definition)
Animal residue definition for risk
Dimethomorph (for poultry and milk this is to
assessment
be considered as a default residue definition)
Conversion factor (monitoring to risk
assessment)
Metabolism in rat and ruminant similar
Yes
(yes/no)
Fat soluble residue: (yes/no)
No (log Po/w 2.7)
Page 8
Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)
Rotational crop studies with radioactive
material as well as field trial with unlabeled
parent compound show that residues of
dimethomorph above 0.05 mg/kg in crops
grown in rotation are highly unlikely.
Crops grown in rotation: beans, carrots,
lettuce, radish, soybean, spinach and wheat
Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)
Stable
Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)
Ruminant
Poultry
Pig
Intakes by livestock ≥ 0.1 mg/kg diet/day:
Conditions of requirement of feeding studies
Expected intakes by livestock ≥ 0.1 mg/kg
diet
(dry weight basis) (yes/no - If yes, specify
the
level)
Potential for accumulation (yes/no):
Metabolism studies indicate potential level
of
residues ≥ 0.01 mg/kg in edible tissues
(yes/no)
no
no
no
no
no
no
no
no
no
Feeding studies
Residue levels in matrices : Mean (max) mg/kg
Muscle
Liver
Kidney
Fat
Milk
Although not
required a
feeding
study in
lactating
cow performed
with an
overdosing
factor of 25 is
available
demonstrating
that
no residues of
dimethomorph
and
its metabolites
Z67/Z69 and
CUR
7117 were
found
below the LOQ
(0.02 mg/kg) in
Page 9
Not required Not required
Not required
Not required
Not required
Not required
Not required
Not required
all matrices
Eggs
Not required
Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)
Crop/processed crop
Number of studies
Transfer factor
Grapevines
1 basis study with 4
trials
% Transference
*
Pomace: 40 –
60
Pomace Red wine:
2.9, 3.0
White wine: 1.2, 2.3
Wine Red wine:
0.36, 0.67
White wine: 0.49,
Wine: 25 – 50
0.60
Follow up studies
0.14, 0.17, 0.22,
(wine)
0.24, 0.24, 0.25,
red grapes
0.29, 0.30, 0.31,
0.31, 0.32, 0.34,
0.36, 0.47, 0.56,
0.58, 0.70
Mean: 0.34
Follow up studies
0.06, 0.11, 0.14,
(wine)
0.15, 0.30, 0.34,
white grapes
0.49
Mean: 0.23
Hops
2 studies, 5 trials
3 - 5 (drying of
Beer: 69
cones)
Brewers’ yeast:
<<1 (<0.001 – 0.004 44
dry cones to beer)
Spent hops: 12
* Calculated on the basis of distribution in the different portions, parts or products as
determined through balance studies
Comments on/additions to List of Endpoints
Ametoctradin (BAS 650F): No comments.
Dimethomorph: No comments.
5.1
Summary of residue data
For ametoctradin (BAS 650F) the following assessment is based on the Draft Assessment
Report (December 2010), Addendum to the DAR (March 2012), Conclusion on the peer
review of the pesticide risk assessment of the active substance ametoctradin (BAS 650 F)
(EFSA Journal 2012;10(11):2921), and EFSA Reasoned Opinion on the modification of the
existing MRLs for ametoctradin in various commodities (EFSA Journal 2012;10(6):2771). For
dimethomorph the following assessment is based on the Draft Assessment Report (May,
2004), Conclusion on the peer review of the pesticide risk assessment of the active
substance dimethomorph (EFSA Scientific report (2006) 82, 1-69), and EFSA Reasoned
Opinion: Review of the existing maximum residue levels (MRLs) for dimethomorph according
to Article 12 of Regulation (EC) No 396/2005, (EFSA Journal 2011;9(8):2348). For both
active substances, additional supervised residue trials on leek have been submitted and are
summarised (Ctgb, June 2014).
Page 10
Only points that are not covered by the List of Endpoints or that need clarification are
discussed below.
5.1.1 Metabolism in plants
Ametoctradin
Metabolism of ametoctradin was investigated in lettuce, potato and tomato. Ametoctradin
was the main metabolite detected in lettuce and tomato. In mature potato tubers the parent
compound was detected in low amounts: 3,6%TRR. Main metabolites detected were
metabolite M650F03 (40% TRR) and M650F04 (27%TRR).
Dimethomorph
Metabolism of dimethomorph was investigated in grapes, tomatoes, potatoes and lettuce.
The metabolic pattern is similar in all studied crops.
The degradation of dimethomorph was limited. At harvest, the unchanged parent compound
represented the major portion of the radioactive residues in all investigated plants (86.5 % –
83 % of the TRR in grapes and grape leaves, respectively; 93 % of the TRR in lettuce; 70.5
% of the TRR in potato green matter with very low TRR in potato tubers: 0.056 mg/kg and
0.003 mg/kg in tuber peels and peeled tubers, respectively). Only relatively small amounts of
metabolites were detected; none of them is expected to contribute significantly to the
toxicological burden.
5.1.2 Metabolism in livestock
Ametoctradin
Metabolism of ametoctradin was investigated in ruminants and poultry (laying hens and
lactating goats). In poultry the most abundant residues were the parent compound
ametoctradin and metabolite M650F01. In goats the parent compound was not detected and
metabolites M650F01 and M650F06 were the main residues.
During the metabolism studies, the animals were dosed with ametoctradin (BAS 650F), while
if animals are exposed to the rotational crops metabolites, M650F03 and M650F04 could be
present as possible residues. It was concluded during the peer review (EFSA Journal
2012;10 11:2921) that the behaviour of metabolites M650F03 and M650F04 could be
addressed by the available animal studies due to structural similarity to the parent compound
and metabolites M650F01 and M650F06, and additional studies with metabolites M650F03
and M650F04 in animals are not necessary.
Dimethomorph
Metabolism of dimethomorph was investigated in laying hens and lactating goats. The study
in the laying hens showed that dimethomorph was rapidly eliminated. The parent compound
dimethomorph was present in fat, gizzard, skin and excreta. Other metabolites were also
identified: Z67/Z69 in liver, kidney, muscle; WL 376084 in yolks, muscle, heart, gizzard and
excreta; CUR 7216 in yolks; and Z43 in yolks, plasma and kidney.
In the goat studies, the parent compound was a major residue identified in plasma, kidney,
liver, heart, muscle and fat. Additionally, metabolites Z67/Z69 were identified in liver, kidney
and bile, WL376084 in kidney, Z43 in bile. In milk metabolite CUR 7117 was identified as a
main metabolite.
5.1.3 Residue definition (plant and animal)
Ametoctradin
In plants the residue definition for risk assessment differs for primary and succeeding crops.
In primary crops the residue definition is ametoctradin (BAS 650F), in rotational crops: sum
of BAS 650F, M650F03, M650F04, expressed as BAS 650F. For monitoring the residue
definition is parent compound BAS 650F in all crops.
The residue definition for animal is not set and it is also not necessary for the requested use.
Page 11
Dimethomorph
In plants the residue definition for monitoring is parent compound dimethomorph. For risk
assessment the residue definition is parent compound dimethomorph, valid only for
application by foliar spray, which covers the requested use in this application.
In animals the residue definition for risk assessment and monitoring is dimethomorph (for
poultry and milk this is to be considered as a default residue definition).
5.1.4 Stability of residues
Ametoctradin
Stability of ametoctradin was previously evaluated in the DAR. It was shown that
ametoctradin (BAS 650F) is stable in watery matrices (2 years in potato tuber and 3 years in
tomato fruit) and for 2 years in dry matrices (cereal grain/straw).
Dimethomorph
Dimethomorf is stable up to 24 months in high water content matrices (potatoes, tomatoes,
broccoli, spinach), high acid (grapes), and high oil (rape seed) in frozen conditions (at -18°C).
5.1.5 Supervised residue trials
Ametoctradin
(Leek, cGAP-NL: 2x0.21 kg as/ha, 7 days interval, PHI 7 days)
Dimethomorph
(Leek, cGAP-NL: 2x 0.16 kg as/ha, 7 days interval, PHI 7 days)
Eight supervised trials were performed with ametoctradin (BAS 650F) and dimethomorph in
leek in NEU. The application rate was slightly higher than the proposed cGAP-NL, however,
within 25% difference, which is considered acceptable. At a PHI of 7 days, which is
according to the proposed use in NL, the residue levels are shown in Table R1 and R2. The
current EU-MRL for ametoctradin in leek is 5 mg/kg and for dimethomorph is 1.5 mg/kg. The
MRLs for both active substances are covered by the available trials.
Leek is a major crop, therefore, eight trials are required. There is a sufficient amount of trials
available.
Table R1: Selected residue levels from trials with ametoctradin (BAS 650F)
STMR
Crop
Residue levels (mg/kg)
(mg/kg)
Leek
0.47, 0.51; 0.63; 0.71;1.4; 2.2; 2.4; 2.5
1.055
HR
(mg/kg)
2.5
The resiude levels in cursive are taken from a PHI of 14 days
Table R2: Selected residue levels from trials with dimethomorph
STMR
HR
Crop
Residue levels (mg/kg)
(mg/kg)
(mg/kg)
Leek
0.056; 0.078; 0.1; 0.14; 0.17; 0.19; 0.26;
0.155
0.55
0.55
5.1.6 Residues in succeeding crops
Ametoctradin
Metabolism of ametroctradin in succeeding crops was evaluated in the DAR. Rotational
crops (lettuce, white radish, spring wheat) were planted at plant back intervals of 30, 120 and
365 days after treatment (DAT) of bare soil (1.44 kg as/ha). The parent compound
ametoctradin was detected in minor concentrations. In all crops at all plant back intervals
significant concentration of metabolites M650F03 and M650F04 (>0.01 mg/kg) taken up from
soil was detected.
Two field rotational studies were performed. In the first study the active substance was
applied at a rate of 0.96 kg as/ha on bare soil. Rotational crops were planted (wheat, carrot,
Page 12
cauliflower and lettuce) with a plant back interval of 30, 120 and 365 DAT. Residues of both
metabolites in succeeding crops were highest at 30 DAT. Residues of metabolite M650F03
at other plant back intervals were <0.015 mg/kg. Residues of metabolite M650F04 in crops
planted 120 DAT were ≤0.01 mg/kg and in crops planted at 365 DAT residues were 0.029
mg/kg in wheat straw, 0.016 mg/kg in cauliflower and ≤0.01 mg/kg in other edible crops.
In the second study the active substance was applied at a rate of 0.96 kg as/ha on bare soil
and at 120 DAT winter wheat was planted. In all plant parts parent compound was below
LOQ (0.01 mg/kg). In mature grain metabolite M650F03 ranged from <0.01 to 0.013 mg/kg
and in straw 0.016-0.135 mg/kg. Metabolite M650F04 was present in grain in concentration
<0.01-0.3 mg/kg and in straw 0.01-1.01 mg/kg. It was concluded in the EFSA Reasoned
Opinion (EFSA Journal 2012;10(6):2771) that significant residues of ametoctradin and its
metabolites M650F03 and M650F04 are not likely to occur in rotational/succeeding crops
provided that ametoctradin is used on leek according to proposed GAP. Furthermore, the
defended GAP in this Reasoned Opinion is more critical than the GAP of the current
application.
Dimethomorph
Metabolism of dimethomorph in succeeding crops was evaluated in the DAR. The parent
compound and metabolites Z67 and Z69 were identified in small amounts (up to 0.04 mg/kg).
Four field trials were conducted with rotational crops (carrot, spinach and beans) sowed
within 30 days after the last application of dimethomorph on potatoes (3x 0.18 kg as/ha). In
general, the residues of dimethomorph were below the LOQ (0.01 mg/kg), however, in some
samples (dry beans, early harvest of carrot of spinach) residues could be detected above the
LOQ. The highest residue was detected in spinach: 0.09 mg/kg at 72 days after the last
treatment.
The intended use of the current application for extension of authorisation is within the risk
envelope of the existing authorisation regarding rotational crops. Therefore, no further
evaluation is required.
5.1.7 Residues from livestock feeding studies
Ametoctradin
The requested crop of the current application for authorisation is not used as feed for
animals, therefore, livestock feeding studies are not required. With respect to possible
residues resulting from rotational crops which might be used as feed for animals, it was
concluded in the EFSA Reasoned Opinion (EFSA Journal 2012;10(6):2771) that significant
residues of ametoctradin and its metabolites M650F03 and M650F04 are not likely to occur
in rotational/succeeding crops provided that ametoctradin is used on leek according to
proposed GAP. Furthermore, the defended GAP in this Reasoned Opinion is more critical
than the GAP of the current application.
Dimethomorph
The requested crop is not used as feed for animals, therefore, livestock feeding studies are
not required in this application. However, a livestock feeding study in lactating cow is
evaluated in the DAR. Dimethomorph and its metabolites (Z67/Z69, CUR 7117) were found
below LOQ (0.02mg/kg) in all matrices, except in liver at the highest dose (high overdose:
250x).
Page 13
5.1.8 Processing factors
Ametoctradin
Ametoctradin was shown to be stable under representative food processing conditions.
Additional processing studies are not required, since the TMDI of leek is below the trigger
value of 10% ADI.
Dimethomorph
Dimethomorph is hydrolytically stable under processing conditions (sterilization, baking,
brewing, boiling and pasteurisation). For the available processing factors (for grapes and
hopes) reference can be made to the List of Endpoints presented above. Further processing
studies are not required for the current application.
5.1.9 Calculation of the ADI and the ARfD
Ametoctradin
Calculation of the ADI
The ADI is based on the NOAEL of 1000 mg/kg bw/d based on an overall NOAEL (1000
mg/kg bw/d). Application of a safety factor for inter- and intraspecies differences of 100
results in an ADI of 10 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).
No ARfD is derived, since ametoctradin has no acute toxic properties.
Dimethomorph
Calculation of the ADI
The ADI is based on the NOAEL of 5 mg/kg bw/d in the one year dog study. Application of a
safety factor for inter- and intraspecies differences of 100 results in an ADI of 0,05 mg/kg
bw/day (see the List of Endpoints for mammalian toxicology).
Calculation of the ARfD
The ARfD is based on the NOAEL of 60 mg/kg bw/d in the rat developmental study.
Application of a safety factor for inter- and intraspecies differences of 100 results in an ARfD
of 0,6 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).
5.2
Maximum Residue Levels
Ametoctradin
Temporary EU-MRLs are present in IIIA of Regulation (EC) 396/2005.
The product complies with the MRL Regulation. Notification of MRLs is not necessary.
Dimethomorph
Harmonised EU-MRLs are present in Annex II of Regulation (EC) 396/2005.
The product complies with the MRL Regulation. Notification of MRLs is not necessary.
5.3
Consumer risk assessment
Ametoctradin (BAS 650F)
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA
PRIMo rev. 2.0, containing all available Member State diets, and the temporary EU-MRLs.
The maximum TMDI is 0.6 % of the ADI for French toddlers. The TMDI is 0.3 % and 0.5 %
of the ADI for the Dutch general population and Dutch children ages 1-6, respectively.
During the peer review, an open point was identified: to update the risk assessment with
intake of M650F03 and M650F04 via rotational plants. Additionally, a potential for dietary
intake of both metabolites through drinking water was taken into consideration. This issues
were addressed by RMS The Netherlands in an Addendum to the DAR (March 2012). It was
concluded that no risk is expected for consumers due to consumption of residues via
rotational crops and drinking water.
Page 14
As no ARfD was derived for ametoctradin, a risk assessment for acute exposure was not
performed.
Dimethomorph
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA
PRIMo rev. 2.0, containing all available Member State diets, and the harmonized EU-MRLs.
The maximum TMDI is 44 % of the ADI for WHO Cluster diet B. The TMDI is 20,3 % and
29,6 % of the ADI for the Dutch general population and Dutch children ages 1-6,
respectively.
Risk assessment for acute exposure through diet
A calculation of the Estimated Short Term Intake (ESTI) was carried out using EFSA PRIMo
rev. 2.0 and the harmonised EU-MRLs . The highest percentage of the ESTI is 14,7 % of the
ARfD for leek for the Belgium adult. ESTI values for the other commodities in all other
consumer diets are all lower.
Conclusion
Based on the assessment for residues, no risk for the consumer due to the exposure to
ametoctradin and dimethomorph is currently expected.
The product complies with the Uniform Principles
6. Environmental fate and behaviour
Conclusion for environmental aspects persistence in soil and leaching to
groundwater, emission to surface water and sediment, drinking water criterion and
monitoring data
The new uses of Orvego applied for in leek have an equal (or lower) risk for persistence in
soil, leaching to groundwater, and emission to surface water and sediment as the already
authorised uses. The drinking water criterion is met.
The available and most recent monitoring data in groundwater and surface water have been
reviewed and have no consequences for the proposed uses.
7. Ecotoxicology
Conclusion with respect to comparability for ecotoxicological aspects
The risk of the applied use in leek is equal to or lower than the risk of the authorised uses
with regard to the environment for the aspects birds and mammals, aquatic organisms, bees,
non-target arthropods, soil organisms, non-target plants and activated sludge.
8. Efficacy
The uses applied for are minor uses. According article 51 of Regulation no.1107/2009 no
efficacy data is needed.
9. Conclusion
The product complies with the Uniform Principles.
Page 15
10. Classification and labelling
Classification and labelling of the formulation does not change.
Page 16
Appendix 1 Table of authorised uses
1
UseNo.
2
Member
state(s)
3
Crop and/
or situation
4
F
G
or
I
5
Pests or Group
of pests
controlled
6
7
8
10
Application
Method /
Kind
Timing / Growth
stage of crop &
season
Number / (min.
Interval between
applications)
11
12
Application rate per treatment
L product /
ha
kg as/ha
Water
L/ha
13
PHI
(days)
14
Remarks:
a) max. no. of applications per crop and
season
b) Maximum product rate per season
min /
max
c) additional remarks
Minor uses
5
NL
leek
F
Phytophthora
porri
spray
BBCH 11-48
(JanuaryDecember)
2
(7 days)
Page 1 of 2
0,7
Ametoctradin: 2000,21
1000
Dimethomorph:
0,16
7
1 cropcycle per year
Appendix 2 Reference list
This appendix serves only to give an indication of which data have been used for decision making for the first time; as a result of concurring
applications for authorisations, the data mentioned here may have been used for an earlier decisions as well. Therefore, no rights can be
derived from this overview.
Deze appendix geeft een indicatief overzicht van de gegevens die voor het eerst gebruikt zijn ten behoeve van een besluit; het kan echter
voorkomen dat (onder andere) door een samenloop van aanvragen, de hier opgenomen gegevens al eens eerder gebruikt zijn. Aan dit
overzicht kunnen dan ook geen rechten ontleend worden.
Annex Year Title
Point
KIIIA
8.3.1/1
KIIIA
8.3.1/3
2010 BAS 651 00 F - Determination of residues of BAS 650 F
and Dimethomorph in leek (RAC plant without roots)
following two treatments with BAS 651 00 F (300 g/L
BAS 650 F / 225 g/L Dimethomorph) under field
conditions in Northern Europe in 2009
2011 Determination of residues of BAS 550 F and BAS 650 F
in leek after two applications of BAS 651 00 F in
Germany, Netherlands, United Kingdom and Belgium,
2010
Company
Report No.
Published or
Unpublished
GLP
Owner
Application
number
Harlan Laboratories
Ltd., Itingen,
Switzerland
2010/1093252
Unpublished
Yes
BASF
20140190
BioChem agrar
Labor fuer
biologische und
chemische Analytik
GmbH, Gerichshain,
Germany Fed.Rep.
2011/1135914
Unpublished
Yes
BASF
20140190
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