Toelatingsnummer 12757 N

TEPPEKI  

 

12757 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 UITBREIDING VOORLOPIGE TOELATING

 

Gelet op de aanvraag d.d. 24 juli 2006 (20060471 UGV) van

 

ISK Biosciences Europe S.A. Tour IT

AVENUE LOUISE 480 , BTE 12

1050 BRUSSEL

BELGIË

 

tot uitbreiding van de gebruiksdoeleinden van de voorlopige toelating als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden, van de voorlopige toelating voor het gewasbeschermingsmiddel, op basis van de werkzame stof flonicamid

 

TEPPEKI

 

gelet op artikel 23, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Uitbreiding

Het gebruiksgebied van het middel TEPPEKI wordt met ingang van datum dezes uitgebreid met de toepassing in pootaardappelen, zomertarwe, triticale, vruchtbomenteelt en vruchtbomenonderstammen van appel en peer, bloemisterijgewassen, bedekte teelt van bol- en knolbloemen, bloemzaadteelt, boomkwekerijgewassen en vaste planten, openbaar groen, en bedekte teelt van veredelings- en zaadteelten van groente en akkerbouwgewassen.

Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit.

De toelating geldt tot 1 december 2008.

 

1.2  Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

 

1.3  Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.

 

1.4 Classificatie en etikettering

 

Gelet op artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

1.    De aanduidingen, welke ingevolge artikel 36 van de Wet milieugevaarlijke stoffen 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:

flonicamid

50 %

 

 

op verpakkingen die (mede)  bestemd zijn voor huishoudelijk gebruik: het kca-logo

(het kca-logo is het logo voor klein chemisch afval bestaande uit een afvalbak met een kruis erdoor als opgenomen in bijlage III bij de genoemde Nadere regels)         

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof(fen):  

-

 

gevaarsymbool:

aanduiding:

 

 

Waarschuwingszinnen: 

 

Schadelijk voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

 

Veiligheidsaanbevelingen:

 

Niet roken tijdens gebruik.

Draag geschikte handschoenen en beschermende kleding, ook bij werkzaamheden aan behandeld gewas.

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

 

Specifieke vermeldingen:

 

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

 

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

 

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

 


b.      hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn
.

 

c.      bij het toelatingsnummer een cirkel met daarin de aanduiding W.1.

 

2 DETAILS VAN DE AANVRAAG

 

2.1 Aanvraag

Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel TEPPEKI (12757 N), een middel op basis van de werkzame stof flonicamid. Het middel is bij besluit van 16 december 2005 reeds toegelaten als insectenbestrijdingsmiddel in de teelt van consumptie- en zetmeelaardappelen, wintertarwe, appel en peer.

Het middel is bij dit besluit toegelaten tot 1 december 2008. Met onderliggende aanvraag wordt toelating als insectenbestrijdingsmiddel voor pootaardappelen, zomertarwe, triticale, vruchtbomenteelt en vruchtbomenonderstammen van appel en peer, bloemisterijgewassen, bedekte teelt van bol- en knolbloemen, bloemzaadteelt, boomkwekerijgewassen en vaste planten, openbaar groen, en bedekte teelt van veredelings- en zaadteelten van groente en akkerbouwgewassen gevraagd.

 

2.2 Informatie met betrekking tot de stof

De werkzame stof is genotificeerd en wordt door Frankrijk beoordeeld. Er is een concept van de Europese beoordeling beschikbaar.

Er is nog geen besluit genomen tot plaatsing van de werkzame stof op Annex I van de gewasbeschermingsrichtlijn 91/414/EEG.

 

2.3 Karakterisering van het middel

Teppeki is een insecticide op basis van flonicamid. Flonicamid behoort tot de groep waarvan de werking niet bekend of niet specifiek is (selectieve blokkering van het eetgedrag). Teppeki heeft een systemische en translaminaire activiteit en heeft een langdurige werking. De werkzame stof remt de voedselopname door de luizen, waarna deze binnen enkele dagen sterven.

Teppeki is toegelaten in Nederland ter bestrijding van luizen in consumptie- en zetmeelaardappelen, wintertarwe, appel en peer. In Frankrijk en het Verenigd Koninkrijk is het middel ook toegelaten.

 

2.4 Voorgeschiedenis

De aanvraag is op 24 juli 2006 ontvangen; op 21 juli 2006 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 1 november 2006 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is de Handleiding toelating bestrijdingsmiddelen (HTB) versie 1.0.

 

3.1  Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht (artikel 28, eerste lid, sub c en e, Wet gewasbeschermingsmiddelen en biociden).

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

 

3.2  Analysemethoden

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

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

 

3.3  Risico voor de mens

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

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

 

3.4  Risico voor het milieu

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

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

-          de gevolgen voor niet-doelsoorten.

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

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

Het profiel gedrag en lotgevallen staat beschreven in Hoofdstuk 6 in Bijlage II bij dit besluit. Het profiel Ecotoxicology staat beschreven in Hoofdstuk 7 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 gewijzigde Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is de uitbreiding voor de gevraagde doeleinden van het middel TEPPEKI op basis van de werkzame stof flonicamid voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden).

 

 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 9 mei 2008

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





(voorzitter)

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 9 mei 2008 tot uitbreiding van de toelating van het middel TEPPEKI, toelatingnummer 12757 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als insectenbestrijdingsmiddel in de teelt van:

  1. aardappelen
  2. wintertarwe, zomertarwe en triticale.
  3. appel, peer en vruchtbomenteelt en vruchtbomenonderstammen van appel en peer
  4. bloemisterijgewassen
  5. bedekte teelt van bol- en knolbloemen
  6. bloemzaadteelt
  7. boomkwekerijgewassen en vaste planten
  8. openbaar groen
  9. bedekte teelt van veredelings- en zaadteelten van groente en akkerbouwgewassen

 

Veiligheidstermijn

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

14 dagen voor aardappelen,

28 dagen voor wintertarwe, zomertarwe, triticale en

24 dagen voor appel en peer.

 

 

Om resistentieopbouw te voorkomen mag u dit product of andere producten die flonicamid bevatten, niet vaker gebruiken dan twee keer per teelt voor aardappel en granen en drie keer per seizoen in alle overige teelten.

 

Voor geïntegreerde teelten (waaronder begrepen alle kasteelten, boomteelt en fruitteelt):

Dit middel is schadelijk voor niet-doelwit arthropoden. Vermijd onnodige blootstelling.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

Teppeki is een middel met een systemische en translaminaire werking. Het middel dient toegepast te worden in het begin van de bladluispopulatieontwikkeling.

 

Voor geïntegreerde teelten geldt dat het middel schadelijk is voor niet-doelwit arthropoden en dat blootstelling van o.a. de natuurlijke vijanden vermeden moet worden.

 

Resistentiemanagement

Het middel niet vaker toepassen dan voorgeschreven.

Om de kans op resistentie te beperken is het aan te bevelen om af te wisselen met een middel uit een andere chemische groep. Na twee behandelingen dient ten tenminste één bespuiting te worden uitgevoerd met een middel met een ander werkingsmechanisme.

 


Toepassingen

 

Consumptie-, zetmeel- en pootaardappelen ter bestrijding van o.a. wegedoornluis, groene perzikluis, aardappeltopluis en vuilboomluis om zuigschade te voorkomen.

Maximaal twee maal toepassen per seizoen met een minimum interval van 21 dagen.

Dosering: 0,16 kg/ha

 

Wintertarwe, zomertarwe en triticale (met uitzondering van brouwgerst) ter bestrijding van bladluizen om zuigschade te voorkomen.

Het betreft een voorjaarstoepassing met maximaal twee toepassingen per seizoen, met een minimum interval van 21 dagen.

Dosering: 0,14 kg/ha

 

Appel en peer, vruchtbomenteelt en vruchtbomenonderstammen van appel en peer ter bestrijding van bladluizen.

Maximaal drie maal toepassen per seizoen met een minimum interval van 21 dagen. Na de tweede bespuiting een behandeling uitvoeren met een middel uit een andere chemische groep.

Dosering: 0,14 kg/ha

 

Bloemisterijgewassen, ter bestrijding van bladluizen.

Maximaal drie maal toepassen per seizoen met een minimum interval van 21 dagen. Na de tweede bespuiting een behandeling uitvoeren met een middel uit een andere chemische groep.

Dosering: 0,14 kg/ha of 0,014% (14 g/100 L water)

 

Bedekte teelt van bol- en knolbloemen, ter bestrijding van bladluizen.

Maximaal drie maal toepassen per seizoen met een minimum interval van 21 dagen. Na de tweede bespuiting een behandeling uitvoeren met een middel uit een andere chemische groep.

Dosering: 0,014% (14 g/100 L water)

 

Bloemzaadteelt, ter bestrijding van bladluizen.

Maximaal drie maal toepassen per seizoen met een minimum interval van 21 dagen. Na de tweede bespuiting een behandeling uitvoeren met een middel uit een andere chemische groep.

Dosering: 0,14 kg/ha

 

 

Boomkwekerijgewassen en vaste planten, ter bestrijding van bladluizen.

Maximaal drie maal toepassen per seizoen met een minimum interval van 21 dagen. Na de tweede bespuiting een behandeling uitvoeren met een middel uit een andere chemische groep. De werking op de beukenbladluis is niet getoetst.

Dosering: 0,14 kg/ha of 0,014% (14 g/100 L water)

 

Openbaar groen, ter bestrijding van bladluizen.

Maximaal drie maal toepassen per seizoen met een minimum interval van 21 dagen. Na de tweede bespuiting een behandeling uitvoeren met een middel uit een andere chemische groep.

Dosering: 0,14 kg/ha

 

Bedekte teelt van veredelings- en zaadteelten van groente en akkerbouwgewassen, ter bestrijding van bladluizen

Maximaal drie maal toepassen per seizoen met een minimum interval van 21 dagen. Na de tweede bespuiting een behandeling uitvoeren met een middel uit een andere chemische groep.

Dosering: 0,014% (14 g/100 L water)

 


Algemeen

Voor gewassen uit de groepen van bloemisterijgewassen, boomkwekerijgewassen, bol- en knolbloemgewassen geldt, gezien de grote variatie in gewassen en rassen, dat, indien er nog geen ervaring is opgedaan met het middel in het betrokken gewas of ras, een proefbespuiting uitgevoerd dient te worden om te zien of het gewas of ras het middel verdraagt.

Voor de zaadteelten geldt dat aangeraden wordt om op kleine schaal te toetsen of het middel van invloed is op de kiemkracht van het gewas of ras.

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 9 mei 2008 tot uitbreiding van de toelating van het middel TEPPEKI, toelatingnummer 12757 N

 

 

RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        2

 

2.   Physical and chemical properties                  3

 

3.   Methods of analysis                                         8

 

4.   Mammalian toxicology                                      10

 

5.   Residues                                                            20

 

6.   Environmental fate and behaviour                23

 

7.   Ecotoxicology                                                    36

 

8.   Efficacy                                                               53

 

9.   Conclusion                                                        56

 

10. Classification and labelling                             56

 


1.         Identity of the plant protection product

 

1.1       Applicant

ISK Biosciences Europe S.A., Tour IT

Avenue Louise 480, BTE 12

B-1050 Brussel

België

 

1.2       Identity of the active substance

Common name

Flonicamid

Name in Dutch

Flonicamid

Chemical name

N-cyanomethyl-4-trifluoromethylnicotinamide [IUPAC]

CAS no

158062-67-0

EEG no

not allocated

 

The active substance is not included in the Annex 1 list of directive 91/414/EC. A draft assessment report (DAR) of flonicamid is available (RMS: France).

 

1.3       Identity of the plant protection product

Name

Teppeki

Formulation type

WG

Content active substance

500 g/kg pure flonicamid

 

The formulation is identical to that assessed for the inclusion of the active substance  in Annex 1 of directive 91/414/EC.

 

1.4       Function

Insecticide.

 

1.5       Uses applied for

Teppeki is claimed as a foliar treatment to control leaf aphids in seed potato, fruit trees and fruit tree rootstocks, cereals and ornamentals. The recommended application rate is 0.16 kg/ha for potatoes, 0.14 kg/ha for cereals, fruit trees and fruit tree rootstocks and 0.014% for ornamentals.

 

Uses

Dose a.s.

(g a.s./ha)

Number of applications

Interval between applications

Application time (growth stage and season)

seed potato

80

2

21

May-August

spring wheat, triticale

70

2

21

May-July

fruit tree and fruit tree rootstocks

70

3

21

April-September

Ornamentals (unprotected)

70

3

21

April-September

Ornamentals (protected)

84

3

21

Jan-Dec

Bulb flowers, tuber flowers

70

3

21

Jan-Dec

seed production of flowers

70

3

21

April-September

nursery crops and perennials

70

3

21

April-September

nursery crops and perennials

70

3

21

Jan-Dec

public green

70

3

21

April-September

breeding and seed production of arable and vegetable crops

105

3

21

Jan-Dec

 

 

1.6       Background to the application

It concerns an application for an extension of uses.

 

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.

 

1.7       Packaging details

 

1.7.1    Packaging description

Material:

HDPE

Capacity:

1L or 2L (0.5 or 1kg)

Type of closure and size of opening:

56mm opening, leak-proof cap

Other information

Not applicable (not subject to ADR requirements, because it is not classified as a dangerous good for transport)

 

1.7.2    Detailed instructions for safe disposal

See application form and MSDS.

 

 

2.      Physical and chemical properties

 

2.1              Active substance: flonicamid

Data about the identity and the physical and chemical properties are taken from the List of Endpoints (DAR, February 2006). Changes and/or additions are taken up in italics.

 

Identity

Active substance (ISO Common Name)

Flonicamid (provisionally approved ISO common name)

Chemical name (IUPAC)

N-cyanomethyl-4-trifluoromethylnicotinamide

Chemical name (CA)

N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridincarboxamide

CIPAC No

763

CAS No

158062-67-0

EEC No (EINECS or ELINCS)

not allocated

FAO Specification (including year of                                publication)

new compound, not referenced

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

minimum 960 g/kg  (based on the results of a pilot plant)

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

There are no relevant impurities, which are known to be of toxicological or environmental concern.

Molecular formula

C9H6F3N3O

Molecular mass

229.16

Structural formula

 

 

 

Physical-chemical properties

Melting point (state purity)

157.5°C PAI (99.7%)

Boiling point (state purity)

No boiling point observed PAI (99.7%)

Temperature of decomposition

306-320°C PAI (99.7%)

Appearance (state purity)

solid powder, odourless, Munsell color - N9.25/84.2%R (PAI - 99.7%)

light beige odourless solid powder (Munsell color – 10YR 9/1) (TGAI - 98.7%)

Relative density (state purity)

1.54  at 20°C (99.7%) PAI

1.531 at 20°C (98.7%) TGAI

Surface tension

47.3 mN/m at 25±1°C

47.0 mN/m at 40±1°C

Surface active TGAI (98.7%; 90% of maximum water solubility)

Vapour pressure (in Pa, state temperature)

2.55 x 10-6 Pa at 25°C

9.43 x 10-7 Pa at 20°C PAI (99.7%)

Henry’s law constant (in Pa·m3·mol-1)

4.2 x 10-8 (20°C) PAI (99.7%) (Calculation based)

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

5.2 g/L at 20°C PAI (99.7%)

(pH was not measured because neutral substance; no acidic nor basic properties)

Solubility in organic solvents (in g/l or

 mg/l, state temperature)

                            PAI (99.7%)        TGAI (98.7%)

                            (g/L) at 20°C      (g/L) at 20°C

Acetone              163.5                157.1

Ethyl acetate         34.2                  34.9

Methanol             104.3                  89.0

Dichloromethane    4.5                    4.0

Toluene                 0.55                  0.30

Hexane             0.0002              0.0003

n-Octanol                3.0                    2.6

Acetonitrile          132.8                111.4

Isopropyl alcohol   18.7                  14.7

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

POW = 1.9; log POW = - 0.3 at 29.8°C PAI (99.7%)

(pH was not measured because neutral substance; no acidic nor basic properties)

Hydrolytic stability (DT50) (state pH and temperature)

Half-lives in days radiolabeled PAI (98.5%; 9.08 MBq/mg)

pH               25°C           40°C           50°C

4                 --                --                 none

5                 none           --                 none

7                 none           --                 578

9                 204             17               9.0

Dissociation constant

pKa = 11.60 at 20 ± 1°C PAI (99.7%)

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

265 nm in neutral solution PAI (99.7%)

266 nm in acidic solution

204 and 270 nm in basic solution

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

DT50 =267 days at 23°C and pH 7 radiolabeled PAI (98.5%; 9.08 MBq/mg)

Quantum yield of direct photo-

transformation in water at λ > 290 nm

Ф = 0.000319 radiolabeled PAI
(98.5%; 9.08 MBq/mg)

Photochemical oxidative degradation in air

DT50 is estimated at 13.7 days ( 12 hour day) or 6.9 days (24 hour day).

Flammability

Not highly flammable TGAI  (98.7%)

Auto-flammability

No relative self-ignition temperature (98.7%) *

Oxidative properties

Not oxidising (statement)

Explosive properties

Not explosive (statement)

* No additional information was found in the DAR. It is assumed the relative self-ignition temperature was not determinable due to limitations of the test method.

 

2.2              Plant protection product: Teppeki

Data about plant protection product are taken from the DAR.

 

The range of the application concentration of the plant protection product is 0.014 - 0.08 %

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP

Visual

Solid, free flowing cylindrical granules

Acceptable

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP

Visual

Brown

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP

Visual

Slight odour of ammonia

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

Theoretical assessment and DSC analysis

Not explosive (DSC: < 500 J/g decomposition energy)

Acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

Theoretical assessment

Not oxidising

Acceptable

B.2.2.6 (IIIA 2.3)

Flammability

Theoretical assessment

Not highly flammable, based on the individual properties of the product components.

Acceptable

B.2.2.7 (IIIA 2.3)

Auto-flammability

Theoretical assessment

Not self-igniting, based on the individual properties of the product components.

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

 

Not applicable

 

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

 

Not applicable

 

B.2.2.10 (IIIA 2.4)

pH

GLP

CIPAC MT75.2

pH = 8.3 at 22 oC (1% dispersion)

Acceptable

B.2.2.11 (IIIA 2.5)

Surface tension

 

Not applicable

 

B.2.2.12 (IIIA 2.5)

Viscosity

 

Not applicable

 

B.2.2.13 (IIIA 2.6)

Relative density

 

Not applicable

 

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

GLP

CIPAC MT169

Density: 0.543 g/ml

Tapped density: 0.582 g/ml

Acceptable

B.2.2.14 (IIIA 2.7)

Storage stability

GLP

Stable for 2 weeks at 54 oC in HDPE

 

Properties determined before and after storage: appearance, packaging stability, a.i. content, pH, tap density, foam persistence, suspensibility, spontaneity of dispersion, wet sieve residue, particle size distribution, dust content, attrition resistance.

 

No significant changes were observed after storage.

 

Wettability was not determined after storage. This is considered acceptable, based on the overall stability of the product during storage.

Acceptable

B.2.2.15 (IIIA 2.7)

Shelf life

GLP

Stable for 2 years at ambient temperatures in HDPE

 

Properties determined before and after storage: appearance, packaging stability, a.i. content, pH, tap density, foam persistence, suspensibility, spontaneity of dispersion, wet sieve residue, particle size distribution, dust content, attrition resistance.

 

No significant changes were observed after storage.

 

Wettability was not determined after storage. This is considered acceptable, based on the overall stability of the product during storage.

Acceptable

B.2.2.16

(IIIA 2.8)

Wettability

GLP

CIPAC MT 53.3.1

1 second

Acceptable

B.2.2.17 (IIIA 2.8)

Persistent foaming

GLP

CIPAC MT47.2

0.16% in CIPAC D water: 60ml after 1 minute.

 

The test was performed at double the maximum proposed spray concentration. It is therefore assumed that foam persistence will be lower at the actual maximum spray concentration of 0.08%.

Acceptable

B.2.2.18

(IIIA 2.8)

Suspensibility

GLP

CIPAC MT168

In CIPAC D water:

0.008%: 100%

0.16%: 99.8%

 

The test was not performed in CIPAC A water. The results indicate a very effective suspensibility of the product and measurements in CIPAC A water will not likely display significantly different results.

Acceptable

B.2.2.19

(IIIA 2.8)

Spontaneity of dispersion

GLP

CIPAC MT174

84.6%

 

No information concerning the type of water used is included in the DAR. The CIPAC handbook requires the use of CIPAC D water for this test. It is therefore assumed the test was performed in CIPAC D water.

 

The results indicate a good spontaneity of dispersion. No additional test in CIPAC A water is required.

Acceptable

B.2.2.20

(IIIA 2.8)

Dilution stability

 

Not applicable

 

B.2.2.21

(IIIA 2.8)

Dry sieve test

 

Not applicable

 

B.2.2.22

(IIIA 2.8)

Wet sieve test

GLP

CIPAC MT167

0.02%w/w on a 75 micron sieve

Acceptable

B.2.2.23

(IIIA 2.8)

Particle size distribution

GLP

CIPAC MT170

x1 = 250 μm (where Rx >= 90%)

x2 = 850 μm (where Rx =< 10%)

Acceptable

B.2.2.24

(IIIA 2.8)

Content of dust/fines

GLP

CIPAC MT171

9.2 mg

Nearly dust free

Acceptable

B.2.2.25

(IIIA 2.8)

Attrition and friability

GLP

CIPAC MT178

97.1%

 

During the EU evaluation it was noted that no additional risk for the operator is expected, because the product is not toxic by inhalation, an irritant or sensitizer.

Acceptable

B.2.2.26 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable

 

B.2.2.27

(IIIA 2.8)

Stability of dilute emulsion

 

Not applicable

 

B.2.2.28

(IIIA 2.8)

Flowability

GLP

CIPAC MT172

% test material retained on the test sieve after

5 liftings: 0% w/w

10 liftings: 0%w/w

Acceptable

B.2.2.29

(IIIA 2.8)

Pourability (rinsibility)

 

Not applicable

 

B.2.2.30

(IIIA 2.8)

Dustability

 

Not applicable

 

B.2.2.31

(IIIA 2.8)

Adherence and distribution to seeds

 

Not applicable

 

2.9.1

Physical compatibility with other products

 

Not applicable

 

2.9.2

Chemical compatibility with other products

 

Not applicable

 

 

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

 

Conclusion

The physical and chemical properties of the active substance and the plant protection product are sufficiently described by the available data. Neither the active substance nor the product has any physical or chemical properties, which would adversely affect the use according to the proposed use and label instructions.

 

2.3       Data requirements

No further data requirements.

 

 

3.         Methods of analysis

Description and data about the analytical methods are taken from the List of Endpoints (DAR, February 2006). Changes and/or additions are taken up in italics.

 

3.1.      Analytical methods in technical material and plant protection product

Technical as (principle of method)

HPLC-UV

Impurities in technical as (principle of  method)

HPLC-UV

Preparation (principle of method)

HPLC-UV

 

Conclusion

These analytical methods have been assessed in the monograph and are considered acceptable.

 

3.2              Residue analytical method

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

GC/MSD  

HPLC-MS/MS

LOQ : 0.01 mg/kg (cotton, potatoes and peach) and 0.02 mg/kg in straw for each individual compound (IKI-220 * and its metabolites TFNG, TFNA and TFNA-AM)

Confirmatory method: not required for LC-MS/MS

ILV: yes

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

HPLC-MS/MS (an enforcement method is not required due to the fact that no MRLs are proposed)

LOQ: 0.01 mg/L for milk (0.02 mg/kg a.s. sum of the residues)

LOQ: 0.01 mg/kg for poultry tissues, eggs and ruminant fat for each individual compound (0.02 mg/kg sum of the residues)

LOQ: 0.025 mg/kg for the other ruminant tissues

Confirmatory method: not required for LC-MS/MS

ILV: yes

Soil (principle of method and LOQ)

HPLC-MS/MS

LOQ: 0.005 mg/kg (parent, TFNG, TFNG-AM, TFNA, TFNA-AM and TFNA-OH )

Confirmatory method: not required for LC-MS/MS

Water (principle of method and LOQ)

HPLC-MS/MS

LOQ: 0.1 µg/L (parent, TFNA, TFNG, TFNA-AM, TFNA-OH and TFNG-AM in drinking water and surface water)

Confirmatory method: not required for LC-MS/MS

Air (principle of method and LOQ)

HPLC-UV/DAD

LOQ: 1.5 µg/m3 (parent only as definition)

Confirmatory method: UV spectra comparison. Method for water may be used as additional confirmatory technique (HPLC-MS/MS)

Body fluids and tissues (principle of method and LOQ)

Not required, non toxic compound

* IKI-220 is flonicamid.

 

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

 

Definition of the residue and proposed MRL’s for flonicamid

Matrix

Proposed definition of the residue for monitoring

Proposed MRL

Food/feed of plant origin

Flonicamid + TFNG + TFNA expressed as flonicamid

Potatoes: 0.1 mg/kg

Apples and pears: 0.2 mg/kg

Peaches: 0.3 mg/kg

Wheat: 2 mg/kg

Food/feed of animal origin

Flonicamid + TFNA-AM  expressed as flonicamid

 

 

Required LOQ

Soil

Flonicamid, TFNA, TFNA-OH, TFNG-AM, TFNG, TFNA-AM

0.05 mg/kg (default)

Drinking / ground water

Flonicamid

0.1 µg/L (Dutch drinking water guideline)

Surface water

Flonicamid, TFNA, TFNA-OH

3.1 mg/L (flonicamid NOEC for Daphnia Magna)

Air

Flonicamid

0.024 mg/m3 (derived from the AOEL (0.08 mg/kg bw/day) according to SANCO/825/00)

Body fluids and tissues

The active substance is not classified as (very) toxic thus no definition 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 methods for water, soil and air, evaluated in the monograph, are acceptable and suitable for monitoring of residues in the environment.

 

Conclusion

The submitted analytical methods meet the requirements. The methods are specific and sufficiently sensitive to enable their use for enforcement of the MRL’s and for monitoring of residues in the environment.

 

3.3       Data requirements

No further data requirements.

 

3.4       Physical-chemical classification and Labelling

 

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

No  classification is required regarding the physical and chemical properties of flonicamid.

 

Proposal for the classification and labelling of the formulation concerning physical chemical properties

Based on the profile of the substance, the  characteristics of the co-formulants, the method of application, 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:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

21

When using do not smoke

 

 

 

Special provisions:
DPD-phrases

-

-

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

The proposed labelling above is equal to the previous decision regarding the labelling of the plant protection product Teppeki (dated December 16th 2005).

 

 

4.                  Mammalian toxicology

 

List of Endpoints

The toxicological profile presented below is based on the Draft Assessment Report (DAR) prepared by the RMS France. The comments from all Member States on the DAR were reported and the open points were discussed during two expert meetings (PRAPeR 09 (November 2006) and PRAPeR 14 (January 2007)). The most recent list of endpoints available (February 2006) is presented below. Where necessary this list of endpoints is amended, based on the results of the expert meetings.

 

Absorption, distribution, excretion and metabolism in mammals

 

Rate and extent of absorption

Rapid and extensive (80 - 90% AD) over the dose range of 2 to 400 mg/kg bw

Tmax = 0.4 h (m / f) at low dose (2 mg/kg) & 0.9 / 0.5 h (m / f) at high dose (400 mg/kg)

 

Distribution

Extensive with peak tissue concentrations £ peak blood concentrations except in liver, kidney, adrenals, thyroid and GI tract.

No dose or sex-related differences

 

Potential for accumulation

None.

 

Rate and extent of excretion

Rapid mostly via urine (~ 90% AD); low biliary excretion (~ 5% AD).

No dose or sex-related differences in rate, route and extent

 

 

Metabolism in animals

Proceeds in the rat by several routes: nitrile & amide hydrolysis, N-oxidation, hydroxylation of pyridine ring leading to comparable profiles dor single and multiple dose regimens:

Urinary metabolites:

main component: IKI-220 (45.7 - 70.4% AD)

main metabolite: TFNA-AM (15.8 - 27.3% AD)

minor metabolites : TFNA-AM N-oxide (0.1 - 3.7% AD) & IKI-220 N-oxide (0.02 - 2.5% AD)

other metabolites: TFNA and conjugate, TFNG-AM, TFNA-AM N-oxide conjugate, OH-TFNA-AM (each at < 1.03% AD).

No TFNG found

Fecal metabolites:

main component: IKI-220 (0.3 - 2.0% AD)

main metabolite: mixture of TFNA-AM N-oxide conjugate / TFNA conjugate (up to 1.85% AD)

other metabolites: TFNA, TFNA-AM and N-oxide, TFNG, IKI-220 N-oxide (each at < 1.0% AD)

Bile metabolites:

main component: IKI-220 (2.5 - 3.3% AD)

main metabolite: TFNA-AM (0.6 - 1.1% AD)

no other metabolites detected

 

Toxicologically significant compounds (animals, plants and environment)

None

 

 

Acute toxicity

 

Rat LD50 oral

884 mg/kg (m), 1768 mg/kg (f)

 

Rat LD50 dermal

> 5000 mg/kg (m/f)

 

Rat LC50 inhalation

> 4.9  mg/L (m/f) 4 h (MMAD 4.8 mm)

 

Skin irritation

non irritant

 

Eye irritation

non irritant

 

Skin sensitization (test method and result)

M & K  test: not a sensitizer

 

 

Short term toxicity

 

 

Target/critical effect

Rat 28-d oral study: kidneys, liver

Relevant NOAEL 1000 ppm (º 73.8 / 81.9 mg/kg/d; m / f), based on renal granular casts (m), liver functional changes, enlargement and hepatocellular hypertrophy (both sexes) Male NOEL of 50 ppm (º 3.6 mg/kg/day) based on increased hyaline droplet formation in kidneys, mediated by male rat-specific protein, a2mglobulin .

 

Mouse(90 d-oral study: liver, hemopoietic system

NOAEL: 100 ppm (º 15.3 / 20.1mg/kg/d; m / f), based on liver hypertrophy, increased extramedullary hematopoiesis & pigment deposition in spleen. Increased pigment deposition in bone marrow & anemia.

 

Dog 90-d oral study: kidneys

NOAEL: 8 mg/kg/d , based decreased bw and food consumption in both sexes and morbidity, mild renal tubular vacuolation and mild hemorrhage at the ileocolic junction .

 

Rat 90d- oral study: kidneys, liver

Relevant NOAEL: 1000 ppm (º 60.0 / 72.3mg/kg bw/day, m / f) based on hyaline droplets, granular casts and tubular basophilia in kidneys, hepatocellular hypertrophy in males, and hepatocellular hypertrophy and cytoplasmic vacuolation of renal tubular cells in females.

Male NOEL of 50 ppm (º 3.1mg/kg bw/da based on increased hyaline droplet formation in kidneys at ³200 ppm, mediated by male rat-specific protein, a2mglobulin.

 

Dog 52-w oral study: hemopoietic system

NOEL: 8 mg/kg/bw/d (both sexes) based on increased reticulocyte counts

 

Lowest relevant oral NOAEL / NOEL

Dog 90-d and 52 w oral: NOAEL 8 mg/kg/d

 

Lowest relevant dermal NOAEL / NOEL

Rat 28-day dermal NOEL: 1000 mg/kg/d (maximum dose tested)

 

Lowest relevant inhalation NOAEL / NOEL

> 4.9 mg/L (see acute study ; 4h)

Genotoxicity

 

 

 

No genotoxic potential (6 studies including a mouse Comet assay in colon, liver and lung

 

Long term toxicity and carcinogenicity

 

 

Target/

critical effect

Rat chronic toxicity/carcinogenicity study: kidneys, liver

NOAEL 200 / 1000 ppm (º 7.32 / 44.1 mg/kg/d; m/f),based on hyaline droplets in renal tubular epithelium, granular casts, tubular basophilia, and increased incidence of chronic nephropathy in males (hyaline droplets in renal tubular epithelium at 200 ppm considered not adverse) and on mild anemia, liver dysfunction, hepatocellular hypertrophy, cytoplasmic vacuolation in renal proximal tubular epithelium and increased incidence of chronic nephropathy in females.

Not carcinogenic.

 

1st Mouse oral carcinogenicity study: lungs, liver, hemopoietic system

NOAEL < 250 ppm (º 29 / 38 mg/kg/d; m/f), based on increased incidence of lung tumors, lung hyperplasia/hypertrophy, hepatic hypertrophy, and extramedullary hematopoiesis .

 

2nd Mouse oral carcinogenicity study:

NOAEL 80 ppm (º 9.995 and 11.85 mg/kg bw/d; m/f), based on increased incidences of pulmonary hyperplasia/hypertrophy in the terminal bronchiolar region in both sexes, and an increased incidence of pulmonary adenomas in males at 250 ppm.

 

Lowest relevant oral NOAEL / NOEL

2 year rat oral study : 7.32 mg/kg/d

 

Carcino

genicity

Increased incidence of lung tumors in mice only: not relevant to human risk assessment (species and strain-specificity, threshold, non-genotoxic mechanism, and effect fully reversible on withdrawal of treatment

 

Reproductive toxicity

 

 

Reproductive target/critical effect

Rat 2-generation study

No adverse effects on reproductive performance of parental generations, or survival of F1 and F2 offspring

NOAEL for all effects (parents and offspring): 300 ppm  based on hyaline droplet deposition and degenerative renal tubular lesions in males; reduced ovary/adrenal weights and renal tubular vacuolation in parental females; delayed vaginal opening, reduced uterus weight in weanlings & reduced 17b-estradiol in F1 females

 

Lowest relevant reproductive NOAEL / NOEL

NOAEL: 28.2 mg/kg bw/d (rat 2-generation study)

 

Developmental target / critical effect

Rat developmental toxicity study: not teratogenic

Maternal NOEL: 100 mg/kg bw/d (increased placental weight, hepatocellular hypertrophy and renal tubular vacuolation).

Fetal NOEL: 100 mg/kg bw/d (increased incidence of cervical rib).

Rabbit developmental toxicity study: not teratogenic.

Maternal NOEL: 7.5 mg/kg bw/d (reduced weight gain and food consumption).

Fetal NOEL: 2.5 mg/kg bw/d 2

 

Lowest relevant developmental NOAEL / NOEL

2.5 mg/kg bw/d (rabbit developmental toxicity study).

 

Neurotoxicity / Delayed neurotoxicity

 

 

 

Rat acute oral neurotoxicity study:  NOAEL for neuropathological effects: 600 / 1000 mg/kg (m / f).

Rat 13-w oral neurotoxicity study: NOAEL (neurotoxicity) > 10000 ppm  (º 625 and 722 mg/kg bw/day; m/f)

 

Other toxicological studies (Annex IIA, point 5.8)

Acute oral toxicology of metabolites

TFNA oral LD50:     >2000 mg/kg.  No clinical signs

TFNA-AM oral LD50:   >2000 mg/kg.  No clinical signs

TFNA-OH oral LD50:   >2000 mg/kg.  No clinical signs

TFNG oral LD50:    >2000 mg/kg.  No clinical signs

TFNG-AM oral LD50:   >2000 mg/kg.  No clinical signs

Genotoxicity testing of metabolites

Bacterial reverse mutation assays:  negative for TFNA;

TFNA-AM; TFNA-OH; TFNG and TFNG-AM.

90-day toxicity studies on metabolites

TFNA: NOAEL 2000 / 5000 ppm  (º 136 and 409 mg/kg bw/d; m/f)

TFNG: NOAEL 2000 / 5000 ppm  (º 135 and 411 mg/kg bw/d; m/f)

 

Medical data

 

 

Not applicable. This product has not been commercialized.

No adverse health effects have been reported in manufacturing plant personnel

 

Summary

 

 

 

 

Value

 

Study

 

Safety factor

 

ADI

0.025 mg/kg bw/day 2

Developmental rabbit study

100

 

AOEL

0.025 mg/kg bw/day2

Developmental rabbit study

100

 

ARfD

0.025 mg/kg bw/day2

Developmental rabbit study

100

 

2 New (lower) values than originally proposed. These new values are the result of the discussions in PRAPeR 14. In this meeting the NOAEL for developmental effects in rabbits was lowered to 2.5 mg/kg bw/day .

 

Dermal absorption

 

 

 

Absorbed dose 7.31% and dermal delivery 7.46% 24 h post dosing (worst values used for the concentrate) ; RMS used a 10 % default value for the diluted formulation)3

 

 

 

3 In PRAPeR 9 a new dermal absorption study with the dilution was available. Based on the discussion in this  meeting the values for dermal absorption were set at 12.8% for the concentrated formulation and 47.3 % for the dilution.

 

Data requirements active substance

No additional data requirements are identified.

 

4.1       Toxicity of the formulated product (IIIA 7.1)

The formulation Teppeki does not need to be classified on the basis of its acute oral (LD50 rat >2000 mg/kg bw), dermal (LD50 rat >2000 mg/kg bw), and inhalation toxicology (LC50 rat > 5.3 mg/L).

The formulation Teppeki does not need to be classified for dermal irritation, eye irritation or skin sensitisation (Buehler).

 

4.1.1    Data requirements formulated product

No additional data requirements are identified.

 

4.2       Dermal absorption (IIIA 7.3)

In PRAPeR 9 a new dermal absorption study with the dilution was available. Based on the discussion in this  meeting the values for dermal absorption were set at 12.8% for the concentrated formulation and 47.3 % for the dilution.

 

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

Other formulants: no reason for toxicological concern.

 

4.4       Exposure/risk assessments

 

Overview of the intended uses

Teppeki is a WG formulation and contains 500g/kg flonicamid. The formulation Teppeki is applied by mechanical downward spraying or manual downward spraying (field applications) or manual downward spraying in ornamentals in greenhouse. The formulation is applied 1-3 times during the period April – September (most crops), May – August (seed potatoes) or all year (greenhouse applications) with intervals of 21 days and with a maximum dose of 0.16 kg formulation / ha for field applications and 0.21 kg formulation / ha for greenhouse applications. Therefore, a semi-chronic exposure duration is applicable for the operator (including contract workers) for most crops while chronic exposure can be expected in greenhouses, especially for workers.

 

Calculation of the AOEL

Flonicamid 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 / chronic exposure is based on the NOAEL of 2.5 mg/kg bw/day in the developmental study with the rabbit and a safety factor of 100. This results in a systemic AOEL of 0.025 mg/kg bw/day (= 1.75 mg/day for a 70-kg operator/worker).

 


4.4.1    Operator exposure/risk

Exposure to flonicamid during mixing and loading and application of Teppeki is estimated with models. The exposure is estimated for the unprotected operator. In the Table below the estimated internal exposure is compared with the systemic AOEL. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

The maximum dose in the field is 0.08 kg/ha flocinamid for field applications and the maximum dose in the greenhouse is 0.105 kg/ha flocinamid.

Table T.1 Internal operator exposure to flonicamid and risk assessment for the use of Teppeki

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

Mechanical  downward spraying in seed potatoes, spring wheat, triticale, spelt, fruit trees and fruit tree rootstocks ,ornamentals, seed growing of flowers, nursery crops and perennials

Mixing/

Respiratory

<0.01

1.75

<0.01

Loading

Dermal

0.13

1.75

0.07

Application

Respiratory

0.01

1.75

<0.01

Dermal

1.14

1.75

0.65

 

Total

1.29

1.75

0.74

Manual  downward spraying on ornamentals, seed growing of flowers and public green

Mixing/

Loading

Respiratory

<0.01

1.75

<0.01

Dermal

0.06

1.75

0.03

Application

Respiratory

<0.01

1.75

0.02

Dermal

6.8

1.75

3.9

 

Total

6.9

1.75

3.9

Manual  downward spraying on ornamentals, bulbflowers, tuberflowers, nursery crops  and perennials, breeding and seed production of arable and vegetable crops (greenhouse)

Mixing/

Loading/application

Respiratory

0.11

1.75

0.06

Dermal

9.9

1.75

5.7

 

Total

10.0

1.75

5.7

a       External exposure was estimated by  EUROPOEM (mechanical downward spraying,application) NL-model (mechanical and manual downward spraying, mixing/loading), UK-POEM (manual downward application) and NL-model greenhouse (greenhouse). Internal exposure was calculated with:

·       biological availability via the dermal route:   concentrate 12.8%, spray dilution 47.3% (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.

 

4.4.2        Bystander exposure/risk

 

The bystander exposure for field applications is estimated with EUROPOEM II. Only the application with the highest bystander exposure (seed potatoes) is given.

 


Table T.2 Internal bystander exposure to flonicamid and risk assessment for the use of Teppeki

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

 

Mechanical  downward spraying

 

 

Respiratory

0.02

1.75

0.01

 

Dermal

0.03

1.75

0.02

 

Total

0.05

1.75

0.03

a       External exposure was estimated by  EUROPOEMII. Internal exposure was calculated with:

·       biological availability via the dermal route:   47.3% (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.

 

During spraying operations there should be no bystanders present in the greenhouse. No exposure to bystanders is therefore expected for greenhouse applications.

 

4.4.3        Worker exposure/risk

Shortly after application it is not necessary to perform any re-entry activities in seed potatoes, spring wheat, triticale, spelt, fruit trees and fruit tree rootstocks and public green during which intensive contact with the treated crop will occur. Therefore no worker exposure is calculated for these applications

 

For applications in ornamentals, bulb flowers, tuberflowers ,seed growing of flowers, nursery crops and perennials, breeding and seed production of arable and vegetable crops the exposure is estimated for the unprotected worker. In the Table below the estimated internal exposure is compared with the systemic AOEL. Only the application with the highest worker exposure is given (bulbflowers and tuberflowers for field applications and breeding and seed production of arable and vegetable crops for greenhouses).

 

 

Table T.2 Internal worker exposure to flonicamid and risk assessment for the use of Teppeki

 

Route

Estimated internal exposure a (mg /day)

Systemic

AOEL

(mg/day)

Risk-index b

 

Worker exposure field

 

 

Respiratory*

-

1.75

-

 

Dermal

5.0

1.75

2.8

 

Total

5.0

1.75

2.8

Worker exposure greenhouse

 

 

Respiratory

0.03

1.75

0.02

 

Dermal

7.5

1.75

4.3

 

Total

7.5

1.75

4.3

a       External exposure was estimated by  EUROPOEMII. Internal exposure was calculated with:

·       biological availability via the dermal route:   47.3% (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.

*No model available

 


4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

Exposure of the general population can occur when entering public green after treatment with Teppeki. The highest exposure can be expected for activities with the highest contact with treated plants, i.e. playing, sunbathing etc. on lawns. The use of Teppeki is against aphids on leaves. This means application on bushes etc., not on lawns. Contact with the general public with these plants will be very limited. Therefore estimation of exposure at re-entry after application of Teppeki in public green is not estimated. It may be expected that exposure of the general public at re-entry will be much lower than the exposure of workers in ornamentals.

 

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 flonicamid as a result of the mechanical application of Teppeki in seed potatoes, spring wheat, triticale, spelt, fruit trees and fruit tree rootstocks, ornamentals, seed growing of flowers, nursery crops and perennials (mechanical).

 

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected operator after respiratory exposure to flonicamid as a result of the manual application of Teppeki in ornamentals, seed growing of flowers, bulbflowers, tuberflowers, nursery crops and perennials, public green and breeding and seed production of arable and vegetable crops.

 

For the unprotected operator, adverse health effects after dermal exposure to flonicamid as a result of the manual application of Tepekki  in ornamentals, seed growing of flowers, bulbflowers, tuberflowers, nursery crops and perennials, public green and breeding and seed production of arable and vegetable crops  cannot be excluded. Correct use of personal protective equipment can reduce the dermal exposure by a factor of 6. This results in a sufficient reduction of the exposure to flonicamid for these applications.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the bystander after dermal and respiratory exposure to flonicamid as a result of the application of Teppeki in seed potatoes, spring wheat, triticale, spelt, fruit trees and fruit tree rootstocks ,ornamentals, bulbflowers, tuberflowers, seed growing of flowers, nursery crops and perennials, public green and breeding and seed production of arable and vegetable crops.

 

Worker exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in seed potatoes, spring wheat, triticale, spelt, fruit trees and fruit tree rootstocks and public green, due to exposure to flonicamid after application of Teppeki.

 

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after respiratory exposure to flonicamid as a result of the application of Teppeki in ornamentals, bulbflowers, tuberflowers, seed growing of flowers, nursery crops and perennials, breeding and seed production of arable and vegetable crops due to exposure to flonicamid after application of Teppeki.

 

For the unprotected worker, adverse health effects after dermal exposure during re-entry activities in ornamentals, bulbflowers, tuberflowers, seed growing of flowers, nursery crops and perennials, breeding and seed production of arable and vegetable crops  due to exposure to flonicamid after application of Teppeki cannot be excluded. Correct use of personal protective equipment can reduce the dermal exposure by a factor of 6. This results in a sufficient reduction of the exposure for the re-entry activities after application of Teppeki in ornamentals, bulb flowers, tuberflowers, seed growing of flowers, nursery crops and perennials, breeding and seed production of arable and vegetable crops.

 

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

See List of endpoints.

 

4.6       Data requirements

Based on this evaluation, no additional data requirements are identified.

 

4.7       Combination toxicology

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

 

4.8       Mammalian toxicology classification and labelling

 

Proposal for the classification of the active ingredient (symbols and R phrases)
(EU classification)

 

Symbol:

Xn

Indication of danger: Harmful

 

Risk phrases

R22

Harmful is swallowed

 

·       PRAPeR 14 considered the necessity for R40 (Limited evidence of a carcinogenic effect) and/or R63 (Possible risk of harm to the unborn child), but did not decide on this point. The Working Group Classification and Labeling of EBC will be informed on this point.

 

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 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:

-

Indication of danger:

-

R phrases

-

-

S phrases

36/37d-NL

Wear suitable protective clothing and gloves, also when handling treated crops.

Special provisions:
DPD-phrases

DPD14

Safety data sheet available for professional user on request.

Plant protection products phrase:
DPD-phrase

DPD01

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

Child-resistant fastening obligatory?

n.a

Tactile warning of danger obligatory?

n.a

 


 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

S36/37d-NL is assigned, based on the risk assessment for the operator and worker exposure.

Other:

The phrase DPD14 shall be assigned to preparations not classified for physico-chemical properties, health or environmental hazards, but containing at least one substance posing health or environmental hazards.

 

 

5.      Residues

 

List of Endpoints

The List of Endpoints below is the most recent version of February 2006. It is based on the Draft Assessment Report (DAR) prepared by the RMS France and the Addendum on residues of February 2006. Flonicamid was discussed lately in the PRAPeR Round 3 meetings (February 2007). The toxicology meeting revised the previously set ADI and ARfD, but no new information on residues was presented and discussed. Since the active substance is still in the process of evaluation/discussion, the residue profile below should be regarded as provisional.

 

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

 

 

Plants groups covered

Cereals (wheat), root vegetable (potato) and fruit (peach)

 

Rotational crops

none

 

Plant residue definition for monitoring

Flonicamid + TFNG+TFNA expressed as flonicamid

 

Plant residue definition for risk assessment

Flonicamid , TFNG, TFNA expressed as flonicamid

 

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)

 

 

Animals covered

Goat and hen

 

Animal residue definition for monitoring

flonicamid+TFNA-AM  expressed as flonicamid

 

Animal residue definition for risk assessment

flonicamid+TFNA-AM  expressed as flonicamid

 

Conversion factor (monitoring to risk  assessment)

None

 

Metabolism in rat and ruminant similar (yes/no)

Yes

 

Fat soluble residue (yes/no)

No

 

Residue in succeeding crops

 

 

 

Study not required

 

Stability of residues

 

 

 

Stable for at least a period of 18 months on crops and for at least 15 months on bread

Stable for at least a period of 13 months on hen and for at least 9 months on goat

 

Residues from livestock feeding studies

     Dose : 10 ppm

 

Intakes by livestock < 0.1 mg/kg bw/day

Ruminant:
TFNA-AM
[mg/kg]

Poultry:
TFNA-AM
[mg/kg]

 

Pig:

yes/no

 

Muscle

< 0.025

0.0490

 

Not required

 

Liver

< 0.025

0.0538

 

Kidney

< 0.025

-

 

Fat

< 0.005

0.0216

 

Milk

< 0.01*

-

 

Eggs

-

0.0725*

 


 

Processing factors

 

Crop/processed crop

 

Number of studies

Transfer factor

Wheat:            bread (whole meal)

4

0.28 – 0.86 (mean: 0.58)

Peach:   canned peach

4

0.33 – 1.44 (mean : 0.65)

              fruit juice

 

0.33 – 1.67 (mean : 0.92)

              jam

 

0.44 – 2.33 (mean : 1.32)

              purée

 

0.67 – 1.00 (mean : 0.89)

 

 

 

*   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

Not applicable.

 

5.1       Summary of residue data

The residue profile of flonicamid is described in the List of Endpoints. For the present application for extension of the field of use, no new studies have been submitted, but reference was made to the information in the DAR and to information submitted with the initial application for registration of Teppeki. Teppeki was authorised in C-163.3.8 of April 12th, 2006.

 

5.1       Summary of residue data

 

5.1.1    Metabolism in plants

See List of Endpoints. The metabolism was investigated in three crops (potato, wheat and peach) and was similar in these three categories. The residue definition is therefore valid for all crops.

 

5.1.5    Residue data

Amongst the uses evaluated in C-163.3.8 were those in ware and industrial potatoes and in winter wheat. The GAPs for these uses are identical to those for the uses in seed potato and in spring wheat and triticale, for which an extension is requested. Seed potato may be extrapolated from ware- and industrial potato, and spring wheat and triticale may be extrapolated from winter wheat. The MRL, STMR and HR values presented in C-163.3.8 may be used to evaluate the uses for which extension of the field of use is requested.

 

Potato

Twelve residue trials are available with potato in Northern Europe. Trials were performed with 2 application of 0.08 kg a.s./ha and a  PHI of 14 days. The analysed residue values amount 9x0,03, 0,04, 2x0,05 mg/kg

 

Cereals

Twelve residue trials are available with wheat in Northern Europe. Trials were performed with 2 applications of 0,07 kg a.s./ha and a PHI of 28 days. The analysed residue values amount: 0,08, 0,14, 0,16, 017, 0,23, 0,24, 0,36, 0,48, 0,55, 0,59, 0,62, 1,20 mg/kg.

 

5.1.6    Residues in succeeding crops

This information is not required since the average DT50 of flonicamid and soil metabolites in soil is £1.6 days.

 


5.1.9    Calculation of the ADI and the ARfD

See List of Endpoints section mammalian toxicology. The ADI is 0.025 mg/kg bw/day, based on the  developmental study with rabbits and applying a safety factor of 100. The ARfD is 0.025 mg/kg bw/day, based on the same developmental study with rabbits and applying a safety factor of 100.

 

5.2       Maximum Residue Levels

EU MRLs of flonicamid have not been established yet. The proposed EU MRLs are listed below. The proposed EU MRLs for potato and cereals are identical to those proposed in C-163.3.8 for these crops based on trials in Northern Europe. The risk assessment of the uses for which extension is requested may be based on these proposed MRLs from the Draft Assessment Report:

 

Apple, pears

0.2 mg/kg

 

Peaches

0.3 mg/kg

 

Potatoes

0.1 mg/kg

 

Cereals (wheat, barley, triticale)

2 mg/kg

 

Eggs

0.05 mg/kg

 

milk

0.02* mg:kg

 

fat ( poultry and ruminant)

0.02* mg/kg

 

muscle (poultry and ruminant)

0.02* mg/kg(A)

offal (poultry and ruminant)

0.02* mg/kg(A)

(A) The analytical method was validated down to 0.03 mg/kg.

 

5.3       Consumer risk assessment

Risk assessment for chronic exposure through diet

A calculation of the National Theoretical Maximum Daily Intake (NTMDI) was carried out using the National Dutch diet and the proposed EU-MRLs from the Draft Assessment Report (omitting values set at the LOQ of the analytical method).

Calculation of the NTMDI shows that 19% and 46% of the ADI is used for the general population and for children, respectively.

 

Risk assessment for acute exposure through diet

A calculation of the National Estimated Short Term Intake (NESTI) was carried out using the National Dutch diet (‘large portion sizes’; 97,5 percentile from dietary data), the UK ‘unit weights’ and the above mentioned provisional EU-MRLs for cereals and eggs.

The NESTI uses at the most 36% and 72% of the ARfD (cereals) for the general population and for children, respectively.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to flonicamid is currently expected. The product complies with the Uniform Principles.

 

5.4       Data requirements

None.

 

 


6.      Environmental fate and behaviour

 

For the risk assessment the most recent LOEP (02/2006) is used. Comments are given in italics.

 

List of Endpoints Fate/behaviour 

 


Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1)

Mineralization after 100 days

47-56.6 % after 30 d (4 soils)

Non-extractable residues after 100 days

29.6-43.3 % after 30 d (4 soils)

Relevant metabolites - name and/or code, % of applied (range and maximum)

TFNA : 12.2-36.4 % after 1-3 d

TFNA-OH : 12.1-21.3 % after 2-7 d

TFNG-AM : 7.8-10.2 % after 0.3-2 d

TFNG : < 3.9 %

TFNA-AM : 7.6 % after 7 d

 

Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2)

Anaerobic degradation

 

No data provided, not required (April-July applications)

Soil photolysis

 

DT50 : 53 d (dark) and 22 d (continous artificial light) on dry soil

TFNG-AM : 13.8 % (dark), 29.5 % (light) after 15 d

Negligible role of photodegradation

           

Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1)

Method of calculation

1st order, R2 > 0.94

Laboratory studies (range or median, with n value,

with r2 value)

DT50lab (20°C, aerobic):

Flonicamid : 0.7-1.8 d (mean 1.1 d), 4 soils (pH 6.2-7.2)

TFNA : 0.29-0.46 d (mean 0.4 d), 3 soils (pH 5.7-6.8)

TFNA-OH : 1.0-2.6 d (mean 1.6 d), 3 soils (pH 5.7-6.8)

TFNG-AM : 0.2-1.0 (mean 0.5 d), 3 soils (pH 6.2-7.0)

TFNG : 0.1-1.1 d (mean 0.5 d), 3 soils (pH 5.7-6.8)

TFNA-AM : 1.0-2.6 d (mean 1.6 d), 3 soils (pH 6.2-7.0)

 

DT90lab (20°C, aerobic):

Flonicamid : 2.3-6.0 d (mean 3.5 d)

TFNA : 1.0-1.5 d (mean 1.3 d)

TFNA-OH : 3.4-8.7 d (mean 5.4 d)

TFNG-AM : 0.6-3.3 (mean 1.6 d)

TFNG : 0.4-3.5 d (mean 1.5 d)

TFNA-AM : 3.4-8.5 d (mean 5.2 d)

 

DT50lab (10°C, aerobic):

Flonicamid : 2.4 d

TFNA : 0.99 d

TFNA-OH : 4.5 d

TFNG-AM : 0.7 d

TFNG : 0.3 d

TFNA-AM : 4.8 d

 

DT50lab (20°C, anaerobic):

No data, not required (April-July applications)

 

 

degradation in the saturated zone:

 

Field studies (state location, range or median with

n value)

DT50f: : no data, not required

 

DT90f: : no data, not required

Soil accumulation and plateau concentration

No data, not required

 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

Kd

pH dependence (yes / no) (if yes type of

dependence)

Flonicamid      Kd : 0.03-0.17 L/kg

                        Kdoc : 2.5-8.7 L/kg (mean 5.9)

                        4 soils (pH 6.5-7.6)

TFNA              Kd : < 0.02 L/kg

                        Kdoc : < 3.0 L/kg (mean about 2.0)

                        4 soils (pH 5.7-7.2)

TFNA-OH        Kd : < 0.06 L/kg

                        Kdoc : < 4.4 L/kg (mean about 3.0)

                        4 soils (pH 5.7-7.2)

TFNG-AM        Kd : 0.04-0.32 L/kg

                        Kdoc : 5.5-13.2 L/kg (mean 9.2)

                        4 soils (pH 5.6-7.2)

TFNG              Kd : < 0.03 L/kg

                        Kdoc : < 4.0 L/kg (mean about 1.6)

                        4 soils (pH 5.7-7.2)

TFNA-AM        Kd : 0.03-0.20 L/kg

                        Kdoc : 2.8-12.1 L/kg (mean 6.2)

                        9 soils (pH 5.6-8.1)

 

Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)

Column leaching

No data provided, not required

Aged residues leaching

No data provided, not required

Lysimeter/ field leaching studies

No data provided

 

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)

pH 4 : flonicamid and TFNA are stable

 

pH 7: flonicamid and TFNA are stable

 

pH 9 : DT50 204 d (25° C), 17.1 d (40° C), 9.0 d (50° C)

TFNG-AM : 65.1 % after 20 d at 50° C

TFNG : 85.7 % after 120 d at 50° C

TFNA : stable

Photolytic degradation of active substance and

relevant metabolites

pH 7 , 23° C : stable (dark), DT50 267 d (continous artifical light).

Negligible role of photodegradation (Φ = 0.000319)

Readily biodegradable (yes/no)

No

Degradation in    - DT50 water

water/sediment    - DT90 water

                            - DT50 whole system

                            - DT90 whole system

30.3-37.3 d (1st order)

100.5-123.8 d

 

35.7-43.6 d (1st order)

118.7-144.8 d

Mineralization

15.6-59.1 % (136-145 d)

Non-extractable residues

38.4-75.4 % (136-145 d)

 

Distribution in water / sediment systems (active

substance)

Max. 17.8-43.7 % after 3 d due to high sediment:water ratio (1:4) and to high OC content up to 10.2 % (DT50 41-69 d)

Distribution in water / sediment systems

(metabolites)

TFNA : max. 9.6 % in water after 30 d (apparent DT50 60 d) and 9.2 % in sediment after 42 d (apparent DT50 59 d).

TFNA-OH : max. 12.5 % in water after 42 d (apparent DT50 49 d) and < 2.2 % in sediment.

TFNG : < 3.7 % in water and < 2.7 % in sediment.

TFNA-AM : < 0.9 % in water and < 1.1 % in sediment.

 

Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)

Direct photolysis in air

 

Quantum yield of direct phototransformation

 

Photochemical oxidative degradation in air

Latitude: ................  Season: .................   DT50 ..13.7 d (12 h day) for KOH 0.779 x 10-12 cm3 molecule-1 sec-1 and [OH] 1.5 x 106 radicals per cm3

Volatilization

from plant surfaces: no data provided

 

from soil: no data provided

 

Definition of the Residue (Annex IIA, point 7.3)

Relevant to the environment

 

 

Soil : flonicamid, TFNA, TFNA-OH, TFNG-AM, TFNG, TFNA-AM

            residue : flonicamid

Groundwater : flonicamid

Surface water : flonicamid, TFNA, TFNA-OH

            residue : flonicamid

Sediment : flonicamid

Air : flonicamid

 

Monitoring data, if available (Annex IIA, point 7.4)

Soil (indicate location and type of study)

No data

Surface water (indicate location and type of study)

No data

Ground water (indicate location and type of study)

No data

Air (indicate location and type of study) 

No data

 

Classification and proposed labelling (Annex IIA, point 10)

with regard to fate and behaviour data

R53

 

 

 

6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil

The Board for the authorization of plant protection products and biocides in the Netherlands (Ctgb) has to evaluate persistence in compliance with the INS[1] method. The ‘decision tree’, has been laid down in the RIVM[2] report 601506008/2005: ‘Persistence of plant protection products in soil; a proposal for risk assessment.

However, this decision tree is currently still under development, which means that it cannot be put into practice immediately. The new procedure for the assessment of persistence of plant protection products for authorization will be implemented in the near future.

 

As long as the mentioned RIVM report has not been laid down by the competent authorities, the Ctgb will fall back on the tried and tested method which has hitherto been in use for evaluating applications for the authorisation of plant protection products.

 

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 method. This method is the same as the method described in the TGD to set a predicted no-effect concentration (PNEC).

 

For the current application this means the following:

 

Flonicamid

The following mean laboratory DT50 value is available for the active substance flonicamid: 1.1 days (range 0.7-1.8 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 are met.

 

For the metabolites TFNA, TFNA-OH en TFNG-AM the mean DT50-values are respectively: 0.4, 1.6 and 0.5 days.

Herewith, the standards of persistence are met.

 

PECsoil

The concentration of flonicamid and metabolites in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PECsoil for spray applications is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m3. The following input data are used for the calculation:

 

PEC soil:

 

Active substance flonicamid:

Mean DT50 for degradation in soil (20°C):  1.1 days

Molecular weight: 229.2 g/mol

 

Metabolite TFNA:

Mean DT50 for degradation in soil (20°C):  0.4 days

Molecular weight: 190.2 g/mol

Correction factor: 0.364 (formation fraction metabolite) * 0.83 (relative molar ratio = M metabolite/M parent) = 0.302

 

Metabolite TFNA-OH:

Mean DT50 for degradation in soil (20°C):  1.16 days

Molecular weight: 206.3 g/mol

Correction factor: 0.213 (formation fraction metabolite) * 0.90 (relative molar ratio = M metabolite/M parent) = 0.192

 

Metabolite TFNG-AM:

Mean DT50 for degradation in soil (20°C):  0.5 days

Molecular weight: 247.5 g/mol

Correction factor: 0.102 (formation fraction metabolite) * 1.08 (relative molar ratio = M metabolite/M parent) = 0.110

 

See Table M.1 for other input values and results.

 

Table M.1 PECsoil calculations (5 cm)

Use

Substance

Rate

[kg a.s./ha]

Freq.

Fraction on soil

PECsoil

5 cm

[mg a.s./kg]

Seed potatoes

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.08

0.024

0.015

0.0088

2

0.70

0.075

0.022

0.014

0.0082

Cereals

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.07

0.021

0.013

0.0077

2

0.70

0.065

0.020

0.012

0.0072

Fruit tree and fruit tree rootstocks

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.07

0.021

0.013

0.0077

3

0.50

0.047

0.014

0.0087

0.0051

Ornamentals

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.084

0.025

0.016

0.0093

3

 

0.70

0.078

0.023

0.015

0.0087

Bulb flowers, tuber flowers,

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.07

0.021

0.013

0.0077

3

0.70

0.065

0.020

0.012

0.0072

Seed growing of flowers

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.07

0.021

0.013

0.0077

3

0.70

0.065

0.020

0.012

0.0072

Tree nursery crops and perennials

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.07

0.021

0.013

0.0077

3

0.70

0.065

0.020

0.012

0.0072

Public green

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.07

0.021

0.013

0.0077

3

0.50

0.047

0.014

0.0087

0.0051

Breeding and seed growing of arable and vegetable crops

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.105

0.036

0.020

0.012

3

0.70

0.098

0.034

0.019

0.011

 

These exposure concentrations are examined against ecotoxicological threshold values in section 7.5.2.

 

6.1.2    Leaching to shallow groundwater

The leaching potential of the active substance and metabolites is calculated in the first tier using Pearl 2.2.2. and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate in breeding material [0.105 kg/ha], the crop [default worst case: winter cereals] and an interception value appropriate to the crop of 0.7. First date of yearly application is 25/05/1980 for spring and 01/11/1980 for autumn (default). For metabolites all available data concerning substance properties are regarded. Metabolites are modelled as parent. The application rate is corrected for formation rate and molecular weight relative to the parent substance. The following input data are used for the calculation:

 

PEARL:

 

Active substance flonicamid:

Mean DT50 for degradation in soil (20°C):  1.1 days

Mean Kom (pH-independent): 5.9 L/kg.

 

Saturated vapour pressure: 9.43 x 10-7 Pa (20°C)

Solubility in water: 5.2 g/L (20°C)

Molecular weight: 229.2 g/mol

 

Metabolite TFNA:

Mean DT50 for degradation in soil (20°C):  0.4 days

Mean Kom (pH-independent): 2.0 L/kg.

Molecular weight: 190.2 g/mol

Correction factor: 0.364 (formation fraction metabolite) * 0.83 (relative molar ratio = M metabolite/M parent) = 0.302

 

Metabolite TFNA-OH:

Mean DT50 for degradation in soil (20°C):  1.16 days

Mean Kom (pH-independent): 3.0 L/kg.

Molecular weight: 206.3 g/mol

Correction factor: 0.213 (formation fraction metabolite) * 0.90 (relative molar ratio = M metabolite/M parent) = 0.192

 

Metabolite TFNG-AM:

Mean DT50 for degradation in soil (20°C):  0.5 days

Mean Kom (pH-independent): 6.2 L/kg.

Molecular weight: 247.5 g/mol

Correction factor: 0.102 (formation fraction metabolite) * 1.08 (relative molar ratio = M metabolite/M parent) = 0.110

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for the a.s. flonicamid and the metabolites TFNA, TFNA-OH and TFNG-AM following spring and autumn applications, see Table M.2.

 


Table M.2 Leaching of a.s. flonicamid and metabolites TFNA, TFNA-OH and TFNG-AM as predicted by PEARL 2.2.2

Use

Substance

Rate substance

Frequency

Interval

Fraction

intercepted

PEC

groundwater

PEC groundwater

 

 

[kg/ha]

 

 [days]

 

spring

[mg/L]

autumn [mg/L]

Breeding material

Flonicamid

TFNA

TFNA-OH

TFNG-AM

0.105

0.036

0.020

0.012

3

21

0.3

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

 

Results of Pearl 2.2.2. using the Kremsmünster scenario are examined against the standard of 0.01 µg/l. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

 

From Table M.2 it reads that the expected leaching based on the PEARL-model calculations for the a.s. flonicamid and its metabolites is smaller than 0.01 µg/L for the worst-case application in breeding material. Hence, all applications meet the standards for leaching as laid down in the Regulation of Uniform Principles for Plant protection products for the proposed applications. 

 

Lysimeter/field leaching studies

No lysimeter or field leaching studies are available

 

Monitoring data

There are no data available regarding the presence of the substance flonicamid in groundwater.

 

Conclusions

The proposed applications of the product comply with the requirements concerning persistence and leaching in soil.

 

6.2       Fate and behaviour in water

 

6.2.1    Rate and route of degradation in surface water

The exposure concentrations of the active substance Flonicamid and metabolites TFNA and TFNA-OH in the surface water are 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. Concentrations in surface water are calculated using the model TOXSWA. For the active substance and the metabolites the following input is required (all on the basis of mean values):

 

TOXSWA:

Active substance flonicamid:

DT50 for degradation in water at 20°C:  39.7 days

DT50 for degradation in sediment at 20°C: 10000 days (default).

 

Kom for suspended organic matter: 19 L/kg.

Kom for sediment: 19 L/kg.

 

Saturated vapour pressure: 9.43 x 10-7 Pa (20°C)

Solubility in water: 5.2 g/L (20°C)

Molecular weight: 229.2 g/mol

 

Metabolites TFNA:

DT50 for degradation in water at 20°C:  60 days

DT50 for degradation in sediment at 20°C: 10000 days (default).

 

Kom for suspended organic matter: 2.0 L/kg

Kom for sediment: 2.0 L/kg

 

Molecular weight: 190.2 g/mol

Correction factor: 0.096 (formation fraction metabolite) * 0.83 (relative molar ratio = M metabolite/ M parent) = 0.080

 

Metabolites TFNA-OH:

DT50 for degradation in water at 20°C:  49 days

DT50 for degradation in sediment at 20°C: 10000 days (default).

 

Kom for suspended organic matter: 3.0 L/kg

Kom for sediment: 3.0 L/kg

 

Molecular weight: 206.3 g/mol

Correction factor: 0.102 (formation fraction metabolite) * 0.90 (relative molar ratio = M metabolite/ M parent) = 0.092

 

Other parameters: standard settings TOXSWA

 

Because there is no standard method to determine separate degradation rates in water and sediment from the water/sediment study, the DT50 system is used for the water phase and degradation in the sediment is assumed to be zero, which is simulated using a DT50 value of 10000 days.

 

In Table M.3, the drift percentages and calculated surface water concentrations for the active substance flonicamid and its metabolites for the worst-case use in fruit trees, before 1 May are presented. Furthermore, for all field uses and for the worst case glasshouse application initial concentrations are presented for the benefit of the drinking water risk assessment. All uses have intervals of 21 days. Only spring concentrations were calculated because they will be higher than autumn concentrations.

 

Table M.3 Overview of surface water concentrations for active substance and metabolites

Use

Substance

Rate a.s.

[kg/ha]

Freq.

[kg/ha]

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

 

 

 

 

 

Spring

 

spring

 

spring

 

Fruit tree and fruit tree rootstocks (before 1 May)

Flonicamid

0.07

3

17

10.2

 

7.02

 

7.55

 

TFNA

TFNA-OH

0.0056

0.0064

 

 

0.841

0.952

 

0.589

0.662

 

0.633

0.712

 

Fruit tree and fruit tree rootstocks (after 1 May)

Flonicamid

0.07

3

7

4.2

 

 

 

 

 

TFNA

TFNA-OH

0.0056

0.0064

 

 

0.346

0.392

 

 

 

 

 

Seed potatoes

Flonicamid

0.08

2

1

0.6739

 

 

 

 

 

TFNA

TFNA-OH

0.0064

0.0073

 

 

0.0558

0.0629

 

 

 

 

 

Cereals

Flonicamid

0.07

2

1

0.5897

 

 

 

 

 

TFNA

TFNA-OH

0.0056

0.0064

 

 

0.0488

0.0551

 

 

 

 

 

Ornamentals; Seed growing of flowers; Tree nursery crops and perennials; Public green  

Flonicamid

0.07

3

1

0.600

 

 

 

 

 

TFNA

TFNA-OH

0.0056

0.0064

 

 

0.0049

0.056

 

 

 

 

 

Tree nursery crops: ‘opzetters’

Flonicamid

TFNA

TFNA-OH

0.07

0.0056

0.0064

3

2.8

1.68

0.139

0.157

 

 

 

 

 

Tree nursery crops: ‘spillen’

Flonicamid

TFNA

TFNA-OH

0.105

0.0084

0.0096

3

0.8

0.48

0.045

0.051

 

 

 

 

 

Worst case glasshouse application

Flonicamid

TFNA

TFNA-OH

0.105

0.0084

0.0096

3

0.1

0.090

0.006

0.006

 

 

 

 

 

* calculated according to TOXSWA

 

All other glasshouse applications, both spring and autumn applications, have lower expected concentrations.

 

These exposure concentrations are compared to the ecotoxicological threshold values in section 7.2.

 

Monitoring data

There are no data available regarding the presence of the substance flocinamid in surface water.  

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 Act Administrative Law)) that the Ctgb should for an authorisation, on the basis of the scientific and technical knowledge, considering the data submitted with the application, also test against the drinking water criterion as regards surface water intended for drinking water production. A mathematical model for this aspect is not available. This means that possibly available data cannot be taken into account adequately. It is therefore not possible to arrive at a scientifically well-based assessment of an expectation for this criterion. The Ctgb has not been given the instruments for testing surface water from which drinking water is produced against the drinking water criterion. In order to meet the Court decision, however - from which it can be concluded that the Ctgb should make an effort to arrive at a judgement on this point – and as transitional period, to prevent that not a single authorisation can be granted in the period during which a model is being developed and data need to be generated for the application for authorisation, the Ctgb has investigated whether the product under consideration and the active substance could give cause for concern about the drinking water criterion.

 

As flonicamid is a new active substance, there are no data available regarding its presence in surface water at drinking water abstraction points. At the moment, a preliminary decision tree is used to address this matter, while waiting for the final decision tree that is currently under construction by the Drinking Water Criterion Project Team (expected in 2007). 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 flonicamid 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. When expected concentrations are between 0.1 and 0.5 µg/L, post registration monitoring is required at the so-called blue junctions (as established in the Water Framework Directive). These are situated upstream from drinking water abstraction points. Thus, when the surface water concentrations at these locations are below 0.1 µg/L, it can be considered sufficiently certain that there will be no exceeding of the drinking water threshold at the drinking water abstraction points.

 

For flonicamid, TFNA and TFNA-OH, this procedure results in the following estimated concentrations: see Table M. (based on mean degradation half-lives of 39.7, 60 and 49 days, respectively).

 

Table M.3 Overview of drinking water concentrations for active substance and metabolites

Use

Substance

PIEC

 

 

[mg/L]

 

PIEC after dilution factor 10

 

[mg/L]

PEC after residence time of 14 days

[mg/L]

 

Fruit tree and fruit tree rootstocks (before 1 May)

Flonicamid

10.2

 

1.02

 

0.905

 

TFNA

TFNA-OH

0.841

0.952

 

0.0841

0.0952

 

0.0777

0.0763

 

Fruit tree and fruit tree rootstocks (after 1 May)

Flonicamid

4.2

 

0.42

 

0.373

 

TFNA

TFNA-OH

0.346

0.392

 

0.0346

0.0392

 

0.0319

0.0314

 

Seed potatoes

Flonicamid

0.6739

 

0.06739

 

0.0598

 

TFNA

TFNA-OH

0.0558

0.0629

 

0.00558

0.00629

 

0.0052

0.0051

 

Cereals

Flonicamid

0.5897

 

0.05897

 

0.0523

 

TFNA

TFNA-OH

0.0488

0.0551

 

0.00488

0.00551

 

0.0045

0.0044

 

Ornamentals; Seed growing of flowers; Tree nursery crops and perennials; Public green  

Flonicamid

0.600

 

0.0600

 

0.0532

 

TFNA

TFNA-OH

0.0049

0.056

 

0.00049

0.0056

 

0.0005

0.0004

 

Tree nursery crops: ‘opzetters’

Flonicamid

TFNA

TFNA-OH

1.68

0.139

0.157

 

0.168

0.0139

0.0157

 

0.1490

0.0128

0.0126

 

Tree nursery crops: ‘spillen’

Flonicamid

TFNA

TFNA-OH

0.48

0.045

0.051

 

0.048

0.0045

0.0051

 

0.0426

0.0042

0.0041

 

Worst case glasshouse application

Flonicamid

TFNA

TFNA-OH

0.090

0.006

0.006

 

0.0090

0.0006

0.0006

 

0.0080

0.0006

0.0005

 

 

 

 

 

 

 

 

 

 

Considering the above it is clear that for the active substance flonicamid, some uses of Teppeki exceed the drinking water criterion on their own, and that the total sum of all applications of Teppeki exceeds the drinking water criterion as well. For the metabolites TFNA and TFNA-OH, individual uses do not exceed the drinking water criterion, but the sum of all applications together does.


 

The applicant has provided an adequate risk assessment based on the RAT approach. The following formulas are applied:

 

PECsw2drw =  PECsw TOXSWA * fuseintensity * fdissipation

 

In which:

 

PECsw2drw = PEC calculated for the drinking water abstraction point.

 

 

 

The used input values in formulas is listed below:

 

·         DT50 water (system value): 39.7 days

·         Travelling time: 6 days (default value from WG implementation drinking water criterion)

·         Market share: 0.4 (default value)

·         Drift area: 0.5 (default value).

 

See Table M.4 for PECdrinking water after following the RAT approach (applicant values).

 

Table M.4 Overview of drinking water concentrations for active substance flonicamid following the RAT approach

Use

Area crop

(ha)

Area NL

(ha)

RAT

Fmarket

Fdrift relevant area

Fuse intensity

fdissipation

PIEC

(µg/L)

PECsw2drw

(µg/L)

Already registered uses

Apple

Pear

Winter wheat

Potato consumption

Starch potato

9562.12

6914.14

121501.6

 

69477.96

49592.2

4152803

0.00230

0.00166

0.02926

 

0.01673

 

0.01194

0.4

0.5

0.000461

0.000333

0.005852

 

0.003346

 

0.002388

0.90

 

10.2

10.2

0.5897

 

0.6739

 

0.6739

0.00423

0.00306

0.00312

 

0.00203

 

0.00145

Uses applied for

Fruit tree and fruit tree rootstocks (before May 1st)

Seed potato

Spring wheat

Triticale

Ornamentals (field)

Ornamentals (glass, incl. bulbs and seed growing)

Tree nursery crops/perennials (field)

Tree nursery crops/perennials (glass)

Seed growing vegetables (glass)

Breeding material vegetables (glass)

Public green

1418.06

 

 

 

37428.40

19621.51

3694.30

27395.77

 

5381.12

 

 

 

12649.62

 

 

402.68

 

 

144.20

 

 

206.50

 

 

 

26675.00

4152803

0.00034

 

 

 

0.00901

0.00472

0.00089

0.00660

 

0.00130

 

 

 

0.00305

 

 

0.00010

 

 

0.00003

 

 

0.00005

 

 

 

0.00642

0.4

0.5

6.83E-5

 

 

 

0.001803

0.000945

0.000178

0.001319

 

0.000259

 

 

 

0.000609

 

 

1.94E-5

 

 

6.94E-6

 

 

9.95E-6

 

 

 

0.001285

0.90

10.2

 

 

 

0.6739

0.5897

0.5897

0.60

 

0.09

 

 

 

1.68

 

 

0.09

 

 

0.09

 

 

0.09

 

 

 

0.60

0.00063

 

 

 

0.00109

0.00050

0.00009

0.00071

 

0.00002

 

 

 

0.00092

 

 

1.57E-6

 

 

5.63E-7

 

 

8.06E-7

 

 

 

0.00069

Total sum

392065.15

4152803

-

-

-

-

-

-

0.0185

 

The sum of the expected PECsw2drw for flonicamid is 0.0185 µg/L. For metabolite TFNA and TFNA-OH, values of 0.014 and 0.017 µg/L are calculated respectively (tables provided by applicant but not shown). Thus, for all substances concerned the summed PECsw2drw values are clearly below 0.1 µg/L.

 

The followed approach is considered acceptable. Although the uses are grouped slightly different compared to the initial Ctgb assessment, this is considered acceptable since it is more conservative (higher PIEC values taken into account).

 

However, it seems that the applicant used the parent DT50 value of 39.7 days to characterise the metabolite degradation half-life, while in fact it is 90 and 49 days for TFNA and TFNA-OH respectively.

This means that the fdissipation is not 0.90 for the metabolites but instead should be 0.96 (TFNA) and 0.92 (TFNA-OH). In view of the small effect this will have on the calculated PECsw2drw combined with the large safety margin for the metabolites it is expected that the sum of the concentrations of the various uses will not exceed 0.1 µg/L for either metabolite.

 

Hence, the applications meet the standards for surface water destined for the production of drinking water.

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

Flonicamid

The vapour pressure is 9.43 x 10-7 Pa at 20°C. The Henry constant is 4.2 x 10-8 at 20°C. At present there is no framework to assess fate and behaviour in air of plant protection products.

 

6.4       Appropriate fate and behaviour endpoints relating to the product and approved uses

See List of Endpoints.

 

6.5       Data requirements

-

 


6.6              Overall conclusions fate and behaviour

It can be concluded that:

  1. the active substance flonicamid, and its metabolites TFNA, TFNA-OH and TFNG-AM meets the standards for per­sis­tence in soil.
  2. all proposed applications of the active substance flonicamid, and its metabolites TFNA, TFNA-OH and TFNG-AM meet the standards for leaching to the shallow groundwater.
  3. all proposed applications of the formulation Teppeki meet the standards for surface water destined for the production of drinking water. 

 

 

7.      Ecotoxicology

 

For the risk assessment the most recent LOEP (02/2006) is used. Comments are given in italics.

 

List of Endpoints Ecotoxicology

 

Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)

Toxicity to mammals

Short-term LD50 = 884 mg a.s./kg bw

Long-term NOEL (multigeneration) = 7.32 mg a.s./kg bw/d*

Acute toxicity to birds

LD50 (quail, boths sexes) > 2000 mg a.s./kg bw

LD50 (duck, male) = 2621 mg a.s./kg bw

LD50 (duck, female) = 1591 mg a.s./kg bw

Dietary toxicity to birds

LD50 (quail) > 411 mg a.s./kg bw/d

LD50 (duck) > 301.8 mg a.s./kg bw/d

Reproductive toxicity to birds

NOEL (quail) = 90 mg a.s./kg bw/d

NOEL (duck) = 59 mg a.s./kg bw/d

*Endpoint has changed during EU reviewing process. The NOEAL was first changed to 28.3 mg/kg bw/d, but at PRAPeR 08, the meeting agreed with an NOAEL of 25 mg/kg bw/d. This value will be used in the refined risk assessment.

 

Toxicity data for aquatic species  (Annex IIA, point 8.2,  Annex IIIA, point 10.2)

Group

Test substance

Time-scale

Endpoint

Toxicity

(mg/L)

Laboratory tests

O. mykiss

a.s.

acute

LC50-96 h

> 100 mg a.s./L

O. mykiss

IKI-220 50%WG

acute

LC50-96 h

> 51 mg a.s./L

L. macrochirus

a.s.

acute