Toelatingsnummer 10319 N

Agrichem Ethofumesaat Flowable  

 

10319 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 WIJZIGING TOELATING

 

Gelet op het verzoek d.d. 1 augustus 2008 (20080709 WGGAG) van

 

AgriChem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT NB

 

 

tot wijziging van de toelating als bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden van het gewasbeschermingsmiddel, op basis van de werkzame stof ethofumesaat

 

Agrichem Ethofumesaat Flowable

 

gelet op artikel 41, tweede lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Wijziging toelating

De toelating van het middel Agrichem Ethofumesaat Flowable is bij besluit d.d. 23 februari 2007 verlengd tot 28 februari 2013. De toelating van het middel Agrichem Ethofumesaat Flowable wordt gewijzigd en is met ingang van datum dezes toegelaten voor de in bijlage I genoemde toepassingen. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

 

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: Suspensie concentraat

 

werkzame stof:

gehalte:

ethofumesaat

500 g/l

 

 

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof:  

-

 

gevaarsymbool:

aanduiding:

-

-

 

Waarschuwingszinnen: 

 

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

 

 

Veiligheidsaanbevelingen:

 

Draag geschikte handschoenen tijdens het mengen en laden.

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.4.

 

 

2 DETAILS VAN HET VERZOEK EN DE TOELATING

 

2.1 Verzoek

Het betreft een verzoek tot wijziging van de toelating van het middel Agrichem Ethofumesaat Flowable  (10319 N), een middel op basis van de werkzame stof ethofumesaat. De gevraagde wijziging betreft een verhoging van de dosering in de zaadteelt van Engels en Italiaans raaigras.

 

2.2 Informatie met betrekking tot de stof

Ethofumesaat is een bestaande werkzame stof, geplaatst op Annex I per 1 maart 2003 (Dir. 2002/37/EG d.d. 3 mei 2002).

 

2.3 Karakterisering van het middel

Agrichem Ethofumesaat Flowable is een herbicide op basis van ethofumesaat. Er zijn middelen toegelaten op basis van alleen ethofumesaat als werkzame stof, maar ook in diverse combinaties met desmedifam, fenmedifam en metamitron. Ethofumesaat behoort tot de groep van benzofuran. Het werkingsmechanisme is gebaseerd op de remming van de vetzuursynthese, waardoor onder meer de vorming van een celmembraan wordt belemmerd. De groei van de meristemen wordt geremd en de celdeling vertraagt. Deze stof heeft een systemische werking in de plant en wordt opgenomen door het wortelstelsel en het blad. De opname door het blad (incl. opnamesnelheid) neemt af naarmate de onkruiden groter zijn. Ethofumesaat werkt op éénjarige grassen en éénjarige tweezaadlobbige onkruiden.

 

2.4 Voorgeschiedenis

De aanvraag is op 4 augustus 2008 ontvangen; op 1 augustus 2008 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 28 oktober 2008 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

 

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de Regeling houdende nadere regels omtrent gewasbeschermingsmiddelen en biociden (RGB): Beoordeling RGB (Hoofdstuk 2) bestaande uit de werkinstructies RGB (tox en mil) en voor overige aspecten HTB 1.0.

 

3.1  Fysische en chemische eigenschappen

Niet beoordeeld gezien de aard van de aanvraag.

 

3.2  Analysemethoden

Niet beoordeeld gezien de aard van de aanvraag.

 

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 voorlopig 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 behorend bij het besluit van het College voor Agrichem Ethofumesaat (2) d.d. 13 juni 2008.

Het residuprofiel, de vastgestelde maximum residugehalten en de beoordeling van het risico voor de volksgezondheid zijn niet beoordeeld gezien de aard van de aanvraag.

 

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 in Bijlage II behorend bij het besluit van het College voor Agrichem Ethofumesaat Flowable d.d. 13 juni 2008 en Hoofdstuk 7, Ecotoxicology, in Bijlage II behorend 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 het middel Agrichem Ethofumesaat Flowable op basis van de werkzame stof ethofumesaat voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, Wet gewasbeschermingsmiddelen en biociden).

 

4 AFLEVER- EN/OF OPGEBRUIKTERMIJN 

 

Gezien de aard van wijziging worden geen restricties vastgesteld ten aanzien van het op de markt brengen, in voorraad houden, voorhanden hebben of gebruiken van dit middel volgens niet conform dit besluit aangepaste verpakking en etikettering (Besluit bestuursreglement regeling gewasbeschermingsmiddelen en biociden Ctgb 2007, hoofdstuk 17).

 

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, 6 februari 2009

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





dr. D. K. J. Tommel

voorzitter



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 6 februari 2009 tot wijziging van de toelating van het middel Agrichem Ethofumesaat Flowable, toelatingnummer 10319 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als onkruidbestrijdingsmiddel in de teelt van suiker- en voederbieten en in de zaadteelt van Engels en Italiaans raaigras.

 

De totale dosering in één seizoen mag niet hoger zijn dan 2 kg ethofumesaat (als werkzame stof) per hectare.

 

Toepassing met een luchtvaartuig is niet toegestaan.

 

Na gebruik in Engels en Italiaans raaigras, het gras niet vervoederen.

 

Het middel is uitsluitend bestemd voor professioneel gebruik.

 

Om terrestrische niet-doelwit planten te beschermen is de toepassing in de zaadteelt van Engels en Italiaans raaigras uitsluitend toegestaan indien er gebruik wordt gemaakt van een van onderstaande driftreducerende maatregelen en eventueel gerelateerde teeltvrije zone:

-             Verlaagde spuitboomhoogte (30 cm boven het gewas) met 50% driftreducerende doppen + kantdop

-             Sleepdoek spuittechniek

-             Teeltvrije zone van 1,6 meter

-             50% drift reducerende doppen in combinatie met een teeltvrije zone van 0,7 meter

-             75% drift reducerende doppen in combinatie met een teeltvrije zone van 0,6 meter

-             Bespuiting met luchtondersteuning en 50% of 75% drift reducerende doppen en einddop

-             Bespuiting met luchtondersteuning en een teeltvrije zone van 1,0 m.

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

Agrichem Ethofumesaat Flowable is een bodemherbicide met systemische werking via de ondergrondse delen van de onkruiden. Vochtige grond op het moment van toepassen en enige neerslag nadien bevorderen de werking. De gewassen moeten echter bij behandeling droog zijn. Met uitzondering van kamille bestrijdt Agrichem Ethofumesaat Flowable een breed spectrum éénjarige onkruiden waaronder kleefkruid. Waterhoeveelheid: 200-300 liter per ha.

 

Toepassing in de teelt van suiker- en voederbieten

Agrichem Ethofumesaat Flowable is na-opkomst alleen werkzaam in combinatie met middelen op basis van fenmedifam (157 of 160 g/l). Deze tankmenging geeft een goede bestrijding tot in het 4-6 bladstadium van de meeste tweezaadlobbige zaadonkruiden.

 

Deze combinatie komt vooral in aanmerking voor toepassing op zand- en dalgronden en specifiek voor de bestrijding van veelknopigen en kleefkruid op alle grondsoorten.

 


Dosering:

-        Vanaf het 2 bladstadium (BBCH 12) van de biet:
0,6 liter Agrichem Ethofumesaat Flowable + 3,5 liter fenmedifam per hectare.

Zonodig na 10-14 dagen een tweede bespuiting uitvoeren met 0,6 liter Agrichem Ethofumesaat Flowable + 3,5 liter fenmedifam per hectare. Tijdelijk kan enige gewasbeschadiging optreden, vooral van kleine bietenplantjes. De eerste 2 echte blaadjes moeten daarom bij alle bieten min. 1 cm groot zijn alvorens een behandeling wordt uitgevoerd en de onderstaande restricties dienen opgevolgd te worden.

 

-        Vanaf het 4 bladstadium (BBCH 14) van de biet:
1,0 liter Agrichem Ethofumesaat Flowable + 5,0 liter fenmedifam per hectare als enkelvoudige behandeling.

 

Mengvoorschriften

Agrichem Ethofumesaat Flowable toegepast in combinatie met middelen op basis van fenmedifam:

-           Giet 20-50 liter water in de tank

-           Voeg fenmedifam toe en zet het roersysteem in werking

-           Voeg water toe tot de helft van de benodigde hoeveelheid

-           Voeg Agrichem Ethofumesaat Flowable toe

-           Vul verder aan met water

 

Laat de roerinrichting in werking, zowel bij het vullen van de tank als tijdens het spuiten.

 

Restricties:

-        Spuit op een afgehard en gezond bietengewas, dat niet verzwakt is door insecten, stuifschade, nachtvorst of herbiciden.

-        Spuit niet bij maximale dagtemperatuur boven 18 °C en niet bij scherp zonnig weer. In deze gevallen bij voorkeur ‘s avonds spuiten.

 

Toepassing in de zaadteelt van Engels en Italiaans raaigras

Agrichem Ethofumesaat Flowable bestrijdt duist, windhalm, straatgras, muur en herderstasje in de zaadteelt van Engels en Italiaans raaigras. Het effect op graanopslag is wisselvallig.

 

Tijdstip van toepassen:

Agrichem Ethofumesaat Flowable kan worden gespoten vanaf het moment dat het raaigras 2 spruiten heeft gevormd. Bij toepassing na de oogst van de dekvrucht dient het raaigras afgehard te zijn. Behandeling niet herhalen. Spuit op een gezond gewas.

Dosering:

-   3,0 liter per hectare, indien duist en windhalm kleiner zijn dan 3 spruiten

-   4,0 liter per hectare, indien reeds 3-5 spruiten zijn gevormd.

Grotere duist of windhalm wordt niet meer bestreden.

 

Opvolgende gewassen:
Om schade te voorkomen als gevolg van eventuele residuen van ethofumesaat in de grond moet voor het zaaien of planten eerst kerend worden geploegd, bijvoorbeeld bij een nateelt van wintergranen of bij een mislukte teelt. Bij mislukken van een gewas waarin Agrichem Ethofumesaat Flowable werd toegepast kunnen de volgende gewassen na kerend ploegen gezaaid of geplant worden: suiker- en voederbieten, maïs, bruine bonen, tuinbonen, raaigrassen, erwten, spinazie, knolselderij, wortelen, zaai- en plantuien.

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 6 februari 2009 tot wijziging van de toelating van het middel Agrichem Ethofumesaat Flowable, toelatingnummer 10319 N

 

RISKMANAGEMENT

 

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product          2

 

2.   Physical and chemical properties                    2

 

3.   Methods of analysis                                           2

 

4.   Mammalian toxicology                                        5

 

5.   Residues                                                              5

 

6.   Environmental fate and behaviour                  5

 

7.   Ecotoxicology                                                      5

 

8.   Efficacy                                                               23

 

9.   Conclusion                                                        24

 

10. Classification and labelling                             24

 


1.         Identity of the plant protection product

 

1.1       Applicant

Agrichem B.V.

Koopvaardijweg 9

4906 CV  OOSTERHOUT NB

 

1.2       Identity of the active substance

ISO Common name

ethofumesate

Name in Dutch

ethofumesaat

Chemical name

(±)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-ylmethanesulfonate

CAS nr

26225-79-6

EEG nr

247 525-3

 

The active substance is considered to be equivalent to the active substance as included in Annex I of directive 91/414/EEC on March 1st 2003.

 

1.3       Identity of the plant protection product

Name

Agrichem Ethofumesaat Flowable

Formulation type

SC

Content active substance

ethofumesate (pure): 500 g/L (~44.2%w/w)

 

The formulation was not part of the assessment of the active substance for inclusion in the Annex 1 of 91/414/EEC.

 

1.4       Function

Herbicide.

 

1.5       Uses applied for

The uses applied for do not change (maximal dosage 2.0 kg/ha).

 

1.6       Background to the application

It concerns a change in the instructions for use: an increase of the dosage from 1.8 kg/ha to 2 kg/ha for application on Perennial ryegrass and Italian ryegrass (seed production). The decision of the Board dated 13th of June 2008, however, was based on a dosage of 2 kg/ha for application on Perennial ryegrass and Italian ryegrass (seed production). Hence, the assessment of the 2kg/ha dosage can be found in the assessment belonging to the decision of the Board dated 13th of June 2008.

 

1.7       Packaging details

Packaging details do not change.

 

 

2.                  Physical and chemical properties

 

The chapter Physical and Chemical properties, described in the Decision of the Board d.d. the 13th of June, 2008 remains unchanged.

 

3.                  Methods of analysis

 

The chapter Methods of Analysis, described in the Decision of the Board d.d. the 13th of June, remains unchanged besides some minor changes (references to studies of products used), which have no effect on the assessment. Because of the references used, the assessment is copied completely into this chapter.

 

Description and data about the analytical methods concerning ethofumesate are taken from the List of Endpoints (DAR, March 2003). Changes and/or additions are taken up in italics.

 

The applicant has provided analytical methods and validation for the technical active substance and the plant protection product.

 

3.1.      Analytical methods in technical material and plant protection product

Technical as (principle of method)

GC-FID / GC-MS

Impurities in technical as (principle of  method)

GC-FID / GC-MS

Preparation (principle of method)

GC-FID method based on Analytical Methods for pesticides and plant growth regulators, volume X (1978)

or

HPLC-UV (225nm), which is based on CIPAC method 233

 

Conclusion

The submitted analytical methods for technical active substance and the formulation are considered acceptable.

 

3.2       Residue analytical methods

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

Not required

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

Not required

Soil (principle of method and LOQ)

Residues of ethofumesate in soil samples were extracted with acetone, concentrated, extracted with dichloro­methane, concen­trated to dryness, re-dissolved, cleaned-up on silica or Florisil, and analysed by HPLC-UV or GC-MS. LOQ = 0.01-0.05 mg/kg.

Water (principle of method and LOQ)

Water & drinking water: Samples were extracted with dichloromethane, concentrated to dryness, re-dissolved in cyclohexane and analysed by GC-FPD. LOQ = 0.05-0.1 µg/l.

Surface water: SPE extraction, GC-MS. LOQ = 0.1 µg/l.

Air (principle of method and LOQ)

A volume of air was drawn through a RP-18 cartridge. Ethofumesate was eluted with isopropanol, concentrated to dryness, re-dissolved, and analysed by GC-MS. LOQ = 0.02-0.1 mg/m3.

 

Body fluids and tissues (principle of method and LOQ)

Not required, non toxic compound

 

The product Agrichem Ethofumesaat Flowable is used on fodder and sugar beets. No residues are expected on food/feed of plant or animal origin. Therefore, no residue analytical methods are required for crops or animal products.


 

Definition of the residue and MRL’s for ethofumesate

Matrix

Definition of the residue for monitoring

MRL

Food/feed of plant origin

No definition of the residue is proposed. The product is not used on or near edible crops

 

Food/feed of animal origin

No definition of the residue is proposed. No relevant residues are expected to occur in food/feed of animal origin.

 

 

Required LOQ

Soil

ethofumesate

0.05 mg/kg

Drinking water

ethofumesate

0.1 µg/L (Dutch drinking water guideline)

Surface water

ethofumesate

0.1 µg/L (HTB 1.0)

Air

ethofumesate

0.75 mg/m3 (derived from the AOEL 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.

not applicable

 

The residue analytical methods for water, soil and air, evaluated in the DAR, 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 monitoring of residues in the environment.

 

3.3       Data requirements

None.

 

3.4       Physical-chemical classification and labelling

 

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

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

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

 

Based on the profile of the substance, the provided toxicology of the preparation, 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

-

-

 

 

 

Special provisions:
DPD-phrases

-

-

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

Supported shelf life of the formulation: 2 years

 

 

4.                  Mammalian toxicology

 

The chapter Mammalian toxicology does not change, since the assessment performed in the Decision of the Board dated 13th of June 2008 was carried out using the maximal dosage of 2 kg/ha for application on Perennial ryegrass and Italian ryegrass (seed production).

 

 

5.                  Residues

 

The chapter Residues does not change, since the assessment performed in the Decision of the Board dated 13th of June 2008 was carried out using the maximal dosage of 2 kg/ha for application on Perennial ryegrass and Italian ryegrass (seed production): The application for authorisation of the plant protection product Agrichem Ethofumesaat Flowable in Italian and Perennial ryegrass does not concern crops used for food or feed (use of Perennial and Italian ryegrass as well as the straws after harvest of the seeds is prohibited as livestock feed). Therefore, a further assessment of the residual behaviour of ethofumesate is not necessary. The additional risk for consumers is considered to be negligible.

 

 

6.                  Environmental fate and behaviour

 

The chapter Environmental fate and behaviour does not change, since the assessment performed in the Decision of the Board dated 13th of June 2008 was carried out using the maximal dosage of 2 kg/ha for application on Perennial ryegrass and Italian ryegrass (seed production).

 

 

7.                  Ecotoxicology

 

The chapter Ecotoxicology does not change, since the assessment performed in the Decision of the Board dated 13th of June 2008 was carried out using the maximal dosage of 2 kg/ha for application on Perennial ryegrass and Italian ryegrass (seed production). However, there are some very minor changes (due to erratic references to studies or products) in the chapter Ecotoxicology belonging to the Decision of the Board dated 13th of June 2008, which have no effect on the assessment. After correction, the assessment is copied completely into this chapter.

 

The ethofumesate beta taskforce (including Agrichem) has submitted new studies, which are equivalent to the studies from the DAR. Since the endpoints of the new studies are comparable with the endpoints from the DAR, the definitive List of Endpoints from the DAR is used for the risk assessment. Comments and additions are given in italic. Some studies and statements submitted for re-registration (the decision of the Board d.d. 23rd of February 2007) are used.

 

List of Endpoints Ecotoxicology

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

Acute toxicity to mammals

LD50>8000 mg/kg bw, rat and mouse

Acute toxicity to birds

LD50>2000 mg/kg bw, mallard duck, quail

Dietary toxicity to birds

LC50>5200 mg/kg feed, mallard duck, quail

NOEC 2600 mg/kg feed

Reproduction toxicity to mammals

NOAEL 300 mg as/kg bw, rabbit, teratogenicity, foetal

Reproduction toxicity to birds

NOEL >406 mg/kg bw per day (>3000 mg/kg feed)

 

Toxicity data for aquatic species (most sensitive species of each group)

(Annex IIA, point 8.2, Annex IIIA, point 10.2)

Group

Test substance

Time-scale

Endpoint

Toxicity

(mg as/l)

Laboratory tests

Fish

ethofumesate

96 hours

Mortality

LC50 11

Daphnia

ethofumesate

48 hours

Immobilisation

EC50 14

Green algae

ethofumesate

96 hours

Biomass

EC50 3.9

Fish

Tramat 500

96 hours

Mortality

LC50 ca 13

Daphnia

Tramat 500

48 hours

Immobilisation

EC50 ca 30

Algae

Ethofumesate 50SC

96 hours

Biomass

EC50 3.2

Lemna sp

ethofumesate

14 days

Biomass

IC50 >50

NOEC 4.3

Fish

ethofumesate

21 days

Sublethal effects

NOEC 0.8

Daphnia

ethofumesate

21 days

Reproduction

NOEC 0.32

Chironomus sp

ethofumesate

28 days

Reproduction

NOEC>5.0

Microcosm or mesocosm tests

no data

 


Bioconcentration

Bioconcentration factor (BCF)

144, based on total radioactivity

Annex VI Trigger:for the bioconcentration factor

100

Clearance time           (CT50)

                      (CT90)

< 1 day

< 3 days

 

Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)

Acute oral toxicity

>50 µg/bee

Acute contact toxicity

>50 µg/bee

 

Field or semi-field tests

No significant effects of Betanal Progress (formulation with co-actives) at treatment with 6% solution (200 l/ha, 1.5 kg ethofumesate/ha) in semi-field test.

 


Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)

Species

Stage

Test

Substance

Dose

(kg/ha)

Endpoint

Adverse effect1

Annex VI

Trigger

Laboratory tests

Aleochora bilineata

adult

Tramat 500

1.25

kg as/ha

Mortality, egg production and viability

no effects

30%

Poecilus cupreus

adult

Tramat 500

2.0 kg as/ha

Mortality

no effects

30%

Chrysoperla carnea

larvae

Tramat 500

2% solution

ca 2.0 kg as/ha

Mortality, egg production and viability

no adverse effects

30%

Chrysoperla carnea

larvae

Betanal Progress

3% solution

0.8 kg etho-fumesate/ha

Mortality, egg production and viability

slight reduction

30%

Coccinella septempunctata

larvae

Betanal Progress

3% solution

0.8 kg etho-fumesate/ha

Mortality

no effects

30%

Syrphus corollae

larvae

Betanal Progress

2% solution

 

Mortality, pupation, hatching, viable offspring

slightly reduced performance of treated larvae

30%

Poecilus cupreus

 

adult

Betanal Progress

1.5%solution

0.8 kg etho-fumesate/ha

Mortality, number of pupae fed

no effects

30%

Aleochora bilineata

adult

Betanal Progress

1% solution

0.4 kg etho-fumesate/ha

Parasitic efficiency

no effects

 

 

Aleochora bilineata

adult

Ethosat

1 kg as /ha

Parasitic efficiency

no effects

30%

 

1 Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal parameter compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

 

When effects are favourable for the test organisms, a + sign is used for the sublethal effect percentages (i.e. increase of e.g. reproduction) and a – sign for mortality effect percentages (i.e. decrease of mortality).

 

Field or semi-field tests

no data

 

Effects on earthworms (Annex IIA, point 8.4, Annex IIIA, point 10.6)

Acute toxicity

14 days LC50 134 mg/kg soil (Eisenia andrei)

Reproductive toxicity

56 day NOEL>25 mg as/kg soil (Eisenia foetida)

 

Effects on other soil non-target macro-organisms

No data available

-

 

Effects on soil micro-organisms (Annex IIA, point 8.5, Annex IIIA, point 10.7)

Nitrogen mineralization

Max 28% inhibition 14 days after treatment with Betanal Progress at normal field rate (6.5 mg/kg) in a 60 days study. No treatment related effects in majority of studies at 4 – 20 kg as/ha.

Carbon mineralization

Slight effect at maximum recommended field rate (2.0 mg as/ha) in one study. No treatment related effects in majority of studies.

 

Effects on non-target flora and fauna

Effects of three co-formulations with desmedipham and phenmedipham. Weight reduction.

EC50 9 – 29 g ethofumesate/ha. Stellaria media the most sensitive species.

Effects of ethofumesate on growth of 28 species; weed and crop species, grasses and broadleaved.

Approximately half of the species were affected by more than 25% at the lowest treatment rate (63 g as/ha)

Effects of ethofumesate on non-target fauna including insects, diseases, molluscs, endoparasites, bacteria and nematodes.

No serious effects were identified for any of the tested species.

 

Additional information provided by Agrichem (summarized and evaluated by the Ctgb, 04/2008))

Based on residue data from grass crops, included in the DAR of ethofumesate (non-protected data). Based on these residu trials, eleven studies were considered suitable for residue decline calculation and initial residual values on crop. All studies were preformed  in N-EU, with a single application of 2.0 kg a.s./ha.

 

trial

Residue (t = 0)

[mg a.s./kg plant]

DT50

[days]

RUD

[(mg a.s.*ha)/

(kg a.s.plant*kg a.s.)

1

159

6.52

79.6

2

257

4.31

129

3

43.6

3.57

21.8

4

205

1.93

103

5

107

10.82

53.7

6

107

2.75

83.3

7

240

3.49

120

8

121

2.16

60.5

9

168

3.51

84.3

10

223

2.05

112

11

224

3.44

112

Mean

174

4.05

87.7

Geomean

 

3.53

 

 

Agrichem Ethofumesate Flowable (500 g/L SC)

Several studies with the formulated product are available. These are evaluated by the RIVM (report 10284a01, 05/2006)

 

For toxicity of the formulation to bees, non-target arthropods, earthworms and microorganisms, the applicant refers to the data for Agrichem Ethofumesate (2) (evaluated by the RIVM, report 10255A00, 03/2006). From the available data it appears that the 200 EC formulation is more toxic than the 500 SC formulation, especially for non-target arthropods (see T. pyri). The data of Agrichem Ethofumesate (2) can be used as worst-case formulation for present risk assessment.

 

Toxicity aquatic organisms

Algae

Substance

Species

Method

Duration

 

[h]

Criterion

Value

 

[mg product/L]

Value

 

[mg a.s./L]

Agrichem Ethofumesaat Flowable

Pseudokirchneriella subcapitata

static

72

ErC50

28.2

12.0

 

 

72

NOErC

1.90

0.81

 

 

72

EbC50

10.7

4.55

 

 

 

72

NOEbC

<1.90

<0.81

 

Invertebrates

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[mg/L]

Value

a.s.

[mg/L]

Agrichem Ethofumesaat Flowable

Daphnia

magna

static

48

EC50

38.3

16.3

 

Fish

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

mg/L]

Value

a.s.

[mg/L]

Agrichem Ethofumesaat Flowable

Oncorhynchus

mykiss

static

96

LC50

38.8

16.5

 

Toxicity terrestrial organisms

 

Non-target arthropods

Form.1

Species

Method

Dose

 

[L/ha]

Dose

[kg a.s. /ha]

Parameter

Adverse effects2

[%]

LR50

[kg as/ha]

Agrichem Ethofumesaat Flowable

Typhlodromus pyri

Lab.test

4

2.0

Mortality

Reproduction

0

1.0

>2.0

 

1 Formulation Agrichem Ethofumesaat Flowable = 500 g ethofumesate/L SC

 

2 Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal parameter compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

 

When effects are favourable for the test organisms, a + sign is used for the sublethal effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

 

Earthworms sublethal toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem Ethofumesaat Flowable

Eisenia

fetida

10

NOEC

223.6

100

 

Formulation Agrichem Ethofumesaat (2) (Ethofumesate 200 g/L EC).

Several studies with the formulated product Agrichem ethofumesaat (2) are available. The studies are evaluated by the RIVM (report 10255A00, 03/2006). An additional study was submitted by the applicant. This was summarized and evaluated by the Ctgb (02/2008). This study is indicated with *.

 

Toxicity aquatic organisms

 

Algae

Substance

Species

Method

Duration

 

[h]

Criterion

Value

 

[mg product/L]

Value

 

[mg a.s./L]

Agrichem ethofumesaat (2)

Desmodesmus subspicatus

static

72

ErC50

39.1

8.4

 

 

 

72

NOErC

3.1

0.67

 

 

 

 

72

EbC50

41.5

8.9

 

 

 

72

NOEbC

6.25

1.34

 

Invertebrates

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[mg/L]

Value

a.s.

[mg/L]

Agrichem ethofumesaat (2)

Daphnia

magna

static

48

EC50

53.4

11.5

 

Fish

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

mg/L]

Value

a.s.

[mg/L]

Agrichem ethofumesaat (2)

Oncorhynchus

mykiss

static

96

LC50

NOEC

17.7

12.5

3.8

2.7

 

Toxicity terrestrial organisms

 

(Bumble)bees

Substance

Species

Method

Duration

 

[h]

Criterion

Value

product

[μg/bee]

Value

a.s.

[μg/bee]

Agrichem ethofumesaat (2)

Apis mellifera

oral

48

LD50

>488

>105

 

 

contact

96

LD50

442

95

 

Non-target arthropods

Form.1

Species

Method

Dose

 

[L/ha]

Dose

[kg a.s. /ha]

Parameter

Adverse effects2

[%]

LR50

[kg as/ha]

Agrichem ethofumesaat (2)

Typhlodromus pyri

Lab.test

10

2.0

Mortality

Reproduction

96

100

 

Agrichem ethofumesaat (2)

Typhlodromus pyri

Lab.test

0.74-3.8

0.15-0.75

Mortality

 

 

0.4

Agrichem ethofumesaat (2)

Aphidius rhopalosiphi

Lab.test

10

2.0

Mortality

Reproduction

88

65

 

Agrichem ethofumesaat (2)

Aphidius rhopalosiphi

Lab.test

1.3-13

0.25-2.6

Mortality

 

2.0

Agrichem ethofumesaat (2)

Chrysoperla carnea

Lab.test

10

2.0

Mortality

Reproduction

17.9

+7

 

Agrichem ethofumesaat (2)

Poecilus cupreus

Lab.test

5.0

1.0

Mortality

Consumption

0

16

 

Extended lab test*

 

 

 

 

 

Agrichem ethofumesaat (2)

Typhlodromus pyri

Ext.Lab.test

5.0-20

1.0-4.0

Mortality

Reproduction

 

6.5

2.41

>4.0

 

1 Formulation Agrichem ethofumesaat (2) = 200 g ethofumesate/L EC

 

2 Adverse effect means:

x % effect on mortality = x % increase of mortality compared to control

y % effect on a sublethal parameter = y % decrease of sublethal parameter compared to control

(sublethal parameters are e.g. reproduction, parasitism, food consumption)

 

When effects are favourable for the test organisms, a + sign is used for the sublethal effectpercentages (i.e. increase compared to control) and a – sign for mortality effectspercentages (i.e. decrease compared to control).

 

*Summarized and evaluated by the Ctgb (02/2008)

 

Earthworms acute toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem ethofumesaat (2)

Eisenia fetida

5

LC50

366.1

71.8

 

 

 

NOEC

131

25.7

 

Earthworms sublethal toxicity

Substance

Species

OM

 

[%]

Criterion

Dose

product

[mg/kg]

Dose

a.s.

[mg/kg]

Agrichem ethofumesaat (2)

Eisenia fetida

5

NOECrep

90.7

17.8

 

Micro-organisms

Substance

Soil type

Dose

product

[mg/kg]

Dose

a.s

[mg/kg]

Duration

 

[d]

Process

Maximal

effect

[%]

After

...

[d]

Effect

at end

> 25%

at day 28

[Y/N]

Agrichem ethofumesaat (2)

sandy loam

2.7

13.4

9.38

46.88

28

respiration

7.0

7.4

8

1-28

N

N

Nitrification test was considered not reliable, since variation coefficient in the control was > 15% at day 7 and nitrate formation decreased after 7 and 14 days.

 

7.1       Effects on birds

Birds can be exposed to the active substance ethofumesate via natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.

 

The threshold value for acute and short-term exposure for birds is set at 0.1 times the LD50 and LC50 value, and the threshold value for chronic exposure is set at 0.2 times the NOEC value. This means that TERs (Toxicity-Exposure Ratio’s) for acute and short-term exposure should be ³ 10 and TER for chronic exposure should be ³ 5.

Table E.1 presents an overview of toxicity data.

 

Table E.1 Overview of toxicity data for birds for substance ethofumesate

 

Endpoint

Value

Acute toxicity to birds:

LD50

>2000 mg a.s./kg bw

Dietary toxicity to birds:

LC50

>5200ppm ~ >1820 mg a.s./kg bw/d!

Reproductive toxicity to birds:

NOEL

406 mg a.s./kg bw/d

1 Endpoints should be expressed in daily dose. Since no data on food intake rate and body weight of the tested birds in the dietary and reproductive studies are available, the endpoints are recalculated to daily dose based on the default values as recommended in the EFSA PPR-opinion on azinphos-methyl (factor 0.35 and 0.15 for the LC50 and NOEC value resp.).

 

7.1.1    Natural food and drinking water

 

Sprayed products

Procedures for risk assessment for birds comply with the recommendations in the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000).

For the current application, uses can be categorized as grassland. Depending on the crop category, different indicator species are chosen. Table E.2 shows which indicator species are relevant for which uses.

 

Table E.2. Indicator species per use

No.

Use

Crop

Indicator species

1

ryegrass

grassland

large herbivorous and insectivorous

 

Table E.3.a-c shows the estimated daily uptake values (ETE, Estimated Theoretical Exposure) of ethofumesate for acute, short-term and long-term exposure, using the Food Intake Rate of the indicator species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a time-weighted-average factor (fTWA, only for long term) and the application rate. For uses with frequency of > 1, a MAF (Multiple Application Factor) may be applicable. The ETE is calculated as application rate * (FIR/bw) * RUD * MAF [* fTWA, only for long term].

 

Table E.3a Acute ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop (uses no.)

Indicator species

FIR / bw

RUD (90%)

MAF

Application rate (kg as/ha)

Acute ETE

(mg/kg bw/d)

Grassland

Large herbivorous bird

0.44

142

-

2.0

125

 

Insectivorous bird (small insects)

1.04

52

-

2.0

108

 

 

Table E.3b Short-term ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop (uses no.)

Indicator species

FIR / bw

RUD (mean)

MAF

Application rate (kg as/ha)

Short-term ETE

(mg/kg bw/d)

Grassland

Large herbivorous bird

0.44

76

-

2.0

66.88

 

Insectivorous bird (small insects)

1.04

29

-

2.0

60.32

 

Table E.3c Long-term ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop (uses no.)

Indicator species

FIR / bw

RUD (mean)

MAF

fTWA

Application rate (kg as/ha)

Long-term ETE

(mg/kg bw/d)

Grassland

Large herbivorous bird

0.44

76

-

0.53

2.0

33.45

 

Insectivorous bird (small insects)

1.04

29

-

-

2.0

60.32

 

Based on the ETE-values in Table E.3a-c the TER-values for the acute, short-term and long-term risk are presented in table E.4.

 

Table E.4 Toxicity Exposure Ratios for exposure of birds to ethofumesate in food

Time scale

Substance

Toxicity (LD50/ LC50/ NOEL)

ETE value  (mg a.s./kg bw/d)

TER value

Trigger value

Crop ryegrass, Large herbivorous birds

Acute

ethofumesate

>2000

125

>16.0

10

Short-term

ethofumesate

>1820

66.88

>27.2

10

Long-term

ethofumesate

406

33.45

12.4

5

Crop ryegrass, Insectivorous birds

Acute

ethofumesate

>2000

108

>18.5

10

Short-term

ethofumesate

>1820

60.32

>30.2

10

Long-term

ethofumesate

406

60.32

6.73

5

 

Taking the results in Table E.4 into account, it appears that the proposed use meets the standards.

 

drinking water

The risk from exposure through drinking surface water is calculated for a small bird with body weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIECwater is 9.52 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000* 0.010) / (0.00952 * 0.0027) = >100000

Since TER ³ 10, the risk is acceptable. 

 


7.1.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms.

Since the log Kow of ethofumesate < 3 (2.7) the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

 

Hence, the proposed use meets the standards for secondary poisoning.

 

Conclusions birds

The product meets the standards

 

7.2       Effects on aquatic organisms

7.2.1    Aquatic organisms

The risk for aquatic organisms for the various uses of the active substance ethofumesate is assessed by comparing toxicity values with surface water exposure concentrations from section 6.2. Risk assessment is based on toxicity-exposure ratio’s (TERs).

Toxicity data for aquatic organisms are presented in Table E.5 for the active substance ethofumesate. Because the application for authorisation concerns a herbicide, also the effects on macrophytes (aquatic plants) are evaluated.

 

See Table E.5 for the acute and chronic toxicity values to be used in the risk assessment.

 

Table E.5 Overview toxicity endpoints for the active substance

Substance

Organism

Lowest

Toxicity value

 

 

L(E)C50 [mg/L]

NOEC

[mg/L]

[mg/L]

ethofumesate

Acute

 

 

 

 

Algae

3.9

 

3900

 

Daphnids

14

 

14000

 

Fish

11

 

11000

 

Macrophytes

> 50

 

>50000

 

Chronic

 

 

 

 

Daphnids

 

0.32

320

 

Fish

 

0.8

800

Agrichem Ethofumesaat Flowable

Acute

 

 

 

 

Algae

4.55

 

4550

 

Daphnids

16.3

 

16300

 

Fish

16.5

 

16500

 

These toxicity values are compared to the surface water concentrations calculated in section 6.2. Trigger values for acute exposure are 100 for daphnids and fish (0.01 times the lowest L(E)C50-value) and 10 for algae and macrophytes (0.1 times the lowest EC50-value). Trigger values for chronic exposure are 10 for daphnids and fish (0.1 times the lowest NOEC-values).

For acute and chronic risk, the initial concentration is used (PIEC).  

In table E.6. TER values for aquatic organisms are shown. Since the endpoints for the a.s. are lower than for the formulation, risk assessment will be performed based on the endpoints of the a.s.

 


Table E.6a TER values for active substance ethofumesate: acute

No./use

 

Substance

TERst

(trigger 10)

TERst

(trigger 100)

TERst

(trigger 100)

TERst

(trigger 10)

 

 

Algae

Daphnid

Fish

Macrophytes

ryegrass

ethofumesate

410

1470

1160

>5250

 

Table E.6b TER values for active substance ethofumesate: chronic

Use

 

Substance

TERlt

(trigger 10)

TERlt

(trigger 10)

 

 

Daphnid

Fish

ryegrass

ethofumesate

33.6

84.0

 

Taking the results in Table E.6a and b into account, the acute TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 100 and the acute TERs for algae and Lemna are above the relevant Annex VI triggers of 10. The chronic TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 10. Thus, it appears that for the active substance ethofumesate the proposed use meets the standards for aquatic organisms.

 

7.2.2    Risk assessment for bioconcentration

For the active substance a BCF-value of 144 L/kg is available. 

Since the BCF is above 100(0) L/kg and the substance ethofumesate is not ready biodegradable, there is a risk for bioconcentration.

According to the guidance document on aquatic ecotoxicology the following points should be checked:

1)      Direct long-term effects in fish due to bioconcentration;

2)      Secondary poisoning for birds and mammals;

3)      Biomagnification in aquatic food chains

Ad 1) An ELS study should be available if 100 < BCF < 1000 and EC50 a.s. < 0.1 mg/L. A FLS should be available if BCF > 1000. These triggers are not exceeded for ethofumesate. 

Ad 2) From the assessment of birds and mammals it appears that there is no risk on secondary poisoning through fish.

Ad 3) Required if the BCF > 1000 and the elimination in the BCF study within 14 days < 95% and the DT90 water > 100 days). These triggers are not exceeded.

 

Hence, the active substance ethofumesate meets the standards for bioconcentration.

 

7.2.3    Risk assessment for sediment organisms

The NOEC value for Chironomus is 5000 µg/L. When this value is examined against the PIEC in water of 9.52, the TER value is 525 and the trigger value of 10 is exceeded. Therefore, the active substance ethofumesate meets the standards for sediment organisms.

 

Conclusions aquatic organisms

The proposed application of the product meets the standards.

 

7.3       Effects on terrestrial vertebrates other than birds

Mammals can be exposed to the active substance ethofumesate via natural food (sprayed insects, seeds, leafs), drinking water and as a result of secondary poisoning.

 

The threshold value for acute exposure for mammals is set at 0.1 times the LD50 value, and the threshold value for chronic exposure is set at 0.2 times the NOEC value. This means that TER (Toxicity-Exposure Ratio) for acute exposure should be ³ 10 and TER for chronic exposure should be ³ 5. Dietary toxicity is not taken into account for mammals.

Table E.7 presents an overview of toxicity data.

 

Table E.7 Overview of toxicity data for mammals for substance ethofumesate

 

Endpoint

Value

Acute toxicity to mammals:

LD50

>8000 mg a.s./kg bw

Reproductive toxicity to mammals:

NOEL

300 mg a.s./kg bw/d

 

7.3.1    Natural food and drinking water

Sprayed products

Procedures for risk assessment for mammals comply with the recommendations in the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (Sanco/4145/2000).

For the current application, uses can be categorized as grassland. Depending on the crop category different indicator species are chosen. Table E.8 shows which indicator species are relevant for which uses.

 

Table E.8 Indicator species per use

No.

Use

Crop

Indicator species

1

Ryegrass

Grassland

small herbivorous 

 

Table E.9a-b show the estimated daily uptake values (ETE, Estimated Theoretical Exposure) of ethofumesate for acute and long-term exposure, using the Food Intake Rate of the indicator species (FIR) divided by the body weight of the indicator species (bw), the Residue per Unit Dose (RUD), a time-weighted-average factor (fTWA, only for long term) and the application rate. For uses with frequency of > 1, a MAF (Multiple Application Factor) may be applicable.

 

Table E.9a Acute ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop (uses no.)

Indicator species

FIR / bw

RUD (90%)

MAF

Application rate (kg as/ha)

Acute ETE

(mg/kg bw/d)

Grassland

Small herbivorous mammal

1.39

142

-

2.0

395

 

Table E.9b Long-term ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop (uses no.)

Indicator species

FIR / bw

RUD (mean)

MAF

fTWA

Application rate (kg as/ha)

Long-term ETE

(mg/kg bw/d)

Grassland

Small herbivorous mammal

1.39

76

-

0.53

2.0

112

 

Based on the ETE-values in Table E.9a-b the TER-values for the acute and long-term risk are presented in table E.10.

 

Table E.10 Toxicity Exposure Ratios for exposure of mammals to ethofumesate in food

Time scale

Substance

Toxicity (LD50/NOEL)

ETE value  (mg a.s./kg diet/bw/d)

TER value

Trigger value

Crop Ryegrass, small herbivorous mammal

Acute

ethofumesate

>8000

395

>20.3

10

Long-term

ethofumesate

300

112

2.68

5

 

Taking the results in Table E.10 into account, it appears that a long-term risk to mammals for the proposed uses cannot be excluded.

The applicant states the following in their own risk assessment:

 

“For long-term exposure, the TER for mammals is below the trigger of 5.

However, the worst-case situation is not quite realistic and the risk assessment can be refined considering some risk mitigation factors. For example, it should be noted that Ethofumesate 200 g/l EC is applied only once. It is not expected that ethofumesate will remain bioavailable for a long period due to several natural occurring processes (e.g. degradation, uptake and metabolism by soil and plants, dilution by rain etc.). It is therefore very unlikely that mammals are exposed to the maximum residue levels of ethofumesate for a long time.

Furthermore, it is highly unlikely that mammals would forage within the crop for a long period. Most wild mammals have varied diets depending on what seasonal food items are available and therefore it is most unlikely that they would only eat grass containing ethofumesate residues for a long period.”

 

Reaction Ctgb

No information on the loss of residues on ryegrass has been submitted. Therefore it is not known how long residues of ethofumesate remains on the crop. It is agreed that mammals are not exposed to the maximum residue for a long time, but a ftwa factor has been included in the risk assessment to compensate for the time period. No further information about diet composition, time spend in the crop etc. has been submitted. More information is required to refine the long-term risk to mammals.

Hence, it must be demonstrated by means of an adequate risk assessment that there are no unacceptable effects under field conditions after application of the plant protection product according to the proposed GAP, for example a study into the actual decline of the residue on the crop, or well supported PT or PD refinements.

 

Refined risk assessment

The applicant refers to residue data from established grasslands. From these studies it appears that the mean RUD is 87, and the geometric mean DT50 is 3.53 days. A new long-term ETE calculation and risk assessment is given in Tables E.11 en E.12.

 

Table E.11 Long-term ETE in terms of daily dose (mg/kg bw) for ethofumesate

Crop

Indicator species

FIR / bw

RUD (mean)

MAF

fTWA

Application rate (kg as/ha)

Long-term ETE (mg/kg bw/d)

Grassland

Small herbivorous mammal

1.39

87

-

0.24

2.0

58.05

 

Based on the ETE-values in Table E.11a-b the TER-values for the acute and long-term risk are presented in table E.12.

 

Table E.12 Toxicity Exposure Ratios for exposure of mammals to ethofumesate in food

Time scale

Substance

Toxicity (LD50/NOEL)

ETE value  (mg a.s./kg diet/bw/d)

TER value

Trigger value

Crop Ryegrass, small herbivorous mammal

Long-term

ethofumesate

300

58.05

5.17

5

 

Based on this refined risk assessment, an acceptable risk is expected for mammals (TER >5).

 

drinking water

The risk from exposure through drinking from surface water is calculated for a small mammal with body weight 10 g and a DWI (daily water intake) of 1.57 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIECwater is 9.52 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>8000 * 0.010) / (9.52 * 0.00157) = >100000

Since TER ³ 10, the risk is acceptable. 

 

7.3.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish and worms.

Since the log Kow of ethofumesate < 3 (2.7), the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

 

Conclusions mammals

The product meets the standards for mammals.

 

7.4       Effects on bees

The risk assessment for bees is based on the ratio between the highest single application rate and toxicity endpoint (LD50 value). An overview of the risk at the proposed uses is given in Table E.13.

 

Table E.13 Risk for bees

Use

Substance

Application rate

LD50

Rate/LD50

Trigger value

 

 

[g a.s./ha]

[µg a.s./bee]

 

 

Ryegrass

Ethofumesate

Agrichem ethofumesate (2)1

2000

2000

>50

95

<40

21

50

1Agrichem ethofumesaat (2) is considered a worst-case formulation compared to Agrichem Ethofumesaat Flowable

 

Since the ratio rate/LD50 is below 50, the risk for bees is considered to be low. Hence, all proposed uses meet the standards for bees.

 

Conclusions bees

The product meets the standards.

 

7.5       Effects on any other organisms (see annex IIIA 10.5-10.8)

7.5.1    Effects on non-target arthropods

For Agrichem Ethofumesaat Flowable only a LR50 study for T.pyri is available. For the other non-target arthropods the applicant refers to the data from Agrichem ethofumesaat (2), which is considered a worst-case formulation.

The risk for non-target arthopods is assessed by calculating Hazard Quotients. For  this, Lethal Rate values (LR50) are needed. Based on LR50-values from studies with the two standard species Aphidius rhopalosiphi (LR50 = 2.0 kg a.s./ha) and Typhlodromus pyri (LR50 >2.0 kg a.s./ha) an in-field and an off-field Hazard Quotient (HQ) can be calculated according to the assessment method established in the SETAC/ESCORT 2 workshop and described in the HTB (v 1.0). Hazard Quotients should be below the trigger value of 2 to meet the standards. The resulting Hazard Quotients are presented in Table E.14a.

 


Table E.14a HQ-values for A. rhopalosiphi and T. pyri 

 

Application rate

(kg a.s./ha)

MAF1

Drift factor/

Vegetation factor2

Safety

factor2

LR50

(kg a.s./ha)

HQ

In-field

 

 

 

 

 

 

A. rhopalosiphi

2.0

1

-

-

2.0

1.0

T. pyri

2.0

1

-

-

>2.0

<1.0

Off-field

 

 

 

 

 

 

A. rhopalosiphi

2.0

1

0.01

10

2.0

0.10

T. pyri

2.0

1

0.01

10

0.4

<0.1

1: Multiple Application Factor

2: off-field: drift factor = 10%, vegetation dilution factor = 10, safety factor = 10 (default values)

 

As the above table shows, both in- and off-field HQ values are below the trigger value of 2. for both standard species Therefore an acceptable risk is expected and no further refinements are required. Hence, the proposed application of the product meets with the standards.

 

7.5.2    Earthworms

The acute risk for earthworms is calculated as TER-value (trigger value 10). Since the logPow of the active substance > 2, a correction to the reference soil containing 4.7 % organic matter is necessary. The test with Agrichem ethofumesaat (2) was performed at 5% o.m. and a correction for organic matter is therefore not required. Exposure is expressed as the initial PEC soil. PEC soil is calculated for a soil layer of 5 cm taking into account the application rate, application frequency, fraction on soil, soil bulk density, and degradation of the substance (see also section 6.1.1). Table E.15 presents the PECsoil and the TERs for the active substance.

 

Table E.15 Overview of soil concentrations and acute TERs for ethofumesate

Use

Substance

Application rate

[kg a.s./ha]

Freq.

Interval

 

[day]

Fraction on soil

PIEC soil

[mg a.s./kg]

LC50corr

 

[mg a.s./kg]

TER

Trigger value

ryegrass

Ethofumesate

2.0

1

-

0.4

1.07

62.98

58.9

10

 

Agrichem ethofumesaat (2)1

2.0

1

-

0.4

1.07

71.8

67.1

10

1Agrichem ethofumesaat (2) is considered a worst-case formulation compared to Agrichem Ethofumesaat Flowable

           

In view of the results presented in Table E.15, a low risk for earthworms is expected at the proposed use.

 

Subletal studies are available for both the a.s. and the formulated product Agrichem Ethofumesaat Flowable, therefore a subchronic risk assessment is performed.

 

In the subchronic risk assessment for earthworms, a long-term TER-value is calculated. Examination of the PIEC takes place against the trigger of 0.2*NOEC. See Table E.16. This value is examined against the initial PEC soil (see above). 

 

Table E.16 Overview of soil concentrations and chronic TERs for ethofumesate

Use

Substance

Appli-cation rate

[kg a.s./ha]

Freq.

Inter-val

 

[day]

Frac-tion on soil

PIEC soil

[mg/kg]

NOECcorr

 

[mg a.s./kg]

TER

Trig-ger value

ryegrass

Ethofumesate

2.0

1

-

0.4

1.07

11.75

11.0

5

 

Agrichem Ethofumesaat Flowable

2.0

1

-

0.4

1.07

47

43.9

5

           

The chronic TERs exceed the trigger of 5. The proposed application of the product therefore meets the standards.

 

7.5.3    Effects on soil micro-organisms

In the tested soils no effects are observed on carbon metabolism processes at relevant application rates of 13.4 a.s./kg with the formulation Agrichem ethofumesaat (2).

After 28 days the effects percentage was below 25%. The nitrification test with the formulated product was considered not reliable, since variation coefficient in the control was > 15% at day 7 and nitrate formation decreased after 7 and 14 days.

From the List of Endpoints can be learned that no effects on nitrification processes > 25 % after 28 days were observed at several studies, performed at concentration rates between 4 and 20 kg a.s. /ha.

 

The proposed application of the product therefore meets the standards.

 

7.5.4    Effects on activated sludge

For the proposed uses no exposure of activated sludge is expected. Therefore, the proposed applications comply with the standards for activated sludge.

 

7.5.5    Effects on non target-plants

The risk assessment for non-target plants is based on an off-crop situation with a drift percentage of 10%. The exposure thus equals 0.1 * the application rate.

The lowest ER50 is for Triticum aestivum: 0.207 kg a.s./ha for seedling emergence and 0.236 kg a.s./ha for vegetative vigour

 

See table E.17:

 

Table E.17 Overview of exposure concentrations and TERs for non target plants

Use

Substance

Dose

[kg a.s. /ha]

MAF.

Drift% (off-field exposure)

Exposure

(kg a.s./ha)

EC50

[kg a.s./ha]

TER

Trigger value

Ryegrass

Ethofumesate

2.0

-

10

0.2

0.207

1.04

5

*Based on a formulation containing phenmedipham, ethofumesate and desmedipham.

 

The ratio between EC50 and the exposure concentration is 0.045 and thus < 5. The risk for non-target plants is considered to be high.

 

Based on the available data, a HC5 can be calculated, based on the available values for vegetative vigour. For all species tested, the vegetative vigour test obtained lower endpoints, than the seedling emergence test, except for T. aestivum. For the latter species, the endpoint for vegetative vigour and seedling emergence is considered comparable, and also for this species, the endpoint for vegetative vigour can be used for HC5 calculation.

 

See Table E.18 for input and HC5 determination.

 


Table E.18 EC50 values and calculated HC5 value for non-targetplants

Species

parameter

Criterion

Value

ethofumesate

[kg a.s./ha]

Allium cepa

Biomass

ER50

7.27

Triticum aestivum

Biomass

ER50

0.234

Brassica napus

Biomass

ER50

3.2

Glycine max

Biomass

ER50

0.586

Linum usitatissimum

Biomass

ER50

0.475

Lycopersicon esculentum

Biomass

ER50

0.250

HC5

 

 

0.072

 

When using the HC5-value, no safety factor is needed. With an expected exposure of 0.20 kg a.s./ha , the TER is 0.072/0.20 = 0.36, which is still below the relevant trigger of 1.

 

The applicant stated that if spray drift is reduced to 3.5% (compared to 10%) the risk is acceptable. Exposure is then 2.0 kg a.s./ha * 0.035 = 0.070 kg a.s./ha, which is lower than the calculated HC5 value.

 

The applicant proposes several drift reducing measures, as described in WUR Report note 513, Spray drift and required bufferzones -  An off-field evaluation of an Agrichem herbicide used in grass seed and beet crops in the Netherlands, J.C. Van de Zande et al (2008).

 

The following measures were proposed:

 

Conventional spraying technique combined with:

- Reduced boom height (30 cm above crop canopy), combined with 50% drift reducing nozzles and an end nozzle

- A Slapduk spraying system

- A crop free buffer zone of 1.6 m

- 50% drift-reducing nozzles and an end nozzle, combined with a crop free buffer zone of 0.7 m

- 75% drift-reducing nozzles and an end nozzle combined with a crop free buffer zone of 0.6 m

Air-assisted spraying technique combined with:

- 50% drift-reducing nozzles and an end nozzle

- 75% drift reducing nozzles and an end nozzle

- A crop free buffer zone of 1.0 m

 

The Ctgb agrees with the proposed measures. With these measures, the risk to non-target plants is considered to be acceptable and the standards are met.

 

Conclusions any other organisms

The product meets the standards for the aspect non-target plants, when drift-reducing measurements are included on the label.

 

7.6       Appropriate ecotoxicological endpoints relating tot the product and approved uses

See List of Endpoints.

 

7.7       Data requirements

None.

 


7.8       Classification and labelling

 

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

 

Symbol:

N

Indication of danger: Dangerous for the environment.

 

Risk phrases

R51/53

Toxic to aquatic organisms may cause long-term adverse effects in the aquatic environment.

 

Proposal for the classification and labelling of the formulation concerning the environment

 

Based on the profile of the substance, the provided toxicology of the preparation and the characteristics of the co-formulants, the following labelling of the preparation is proposed:

 

Symbol:

-

Indication of danger:

-

R phrases

52/53

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

 

 

 

S phrases

61

Avoid release to the environment. Refer to special instructions/safety data sheets.

 

 

 

 

In the GAP/instructions for use the following has to be stated:

- Om in het water levende organismen te beschermen is de toepassing middels een luchtvaartuig niet toegestaan op percelen die grenzen aan oppervlaktewater.

 

-          Om terrestrische niet-doelwit planten te beschermen is de toepassing uitsluitend toegestaan indien er gebruik wordt gemaakt van een van onderstaande driftreducerende maatregelen:

 

-        Verlaagde spuitboomhoogte (30 cm boven het gewas) met 50% driftreducerende doppen + kantdop

-        Sleepdoek spuittechniek

-        Teeltvrije zone van 1,6 meter

-        50% drift reducerende doppen in combinatie met een teeltvrije zone van 0,7 meter

-        75% drift reducerende doppen in combinatie met een teeltvrije zone van 0,6 meter

-        Bespuiting met luchtondersteuning en 50% of 75 % drift reducerende doppen en einddop

-        Bespuiting met luchtondersteuning en een teeltvrije zone van 1,0 m.

 

7.9       Overall conclusions regarding the environment

It can be concluded that:

  1. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for birds.
  2. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for aquatic organisms.
  3. the active substance ethofumesate meets the standards for bioconcentration.
  4. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for mammals.
  5. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for bees.
  6. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for non-target arthropods.
  7. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for earthworms.
  8. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for soil micro-organisms.
  9. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for activated sludge.
  10. all proposed applications of the formulated product Agrichem ethofumesaat flowable meet the standards for non-target plants.

 

 

8.                  Efficacy

 

Recently, Agrichem Ethofumesaat Flowable has been authorised for the use in seed production of Perennial ryegrass and Italian ryegrass at a maximum dose rate of 1.8 kg ethofumesaat per ha.

In the past, Agrichem Ethofumesaat Flowable had an authorisation for the use in seed production of Perennial ryegrass and Italian ryegrass. A maximum dose rate of 2.0 kg ethofumesaat per ha had initially been applied for. Efficacy studies had demonstrated that the efficacy of Agrichem Ethofumesaat Flowable on weeds in Perennial and Italian ryegrass did not differ from the reference product based on 500 g/l ethofumesaat (Tramat 50 SC). Although the reference product had been authorized for the use in seed production of Perennial ryegrass and Italian ryegrass at a maximum dose rate of 2.0 kg ethofumesaat per ha, Agrichem Ethofumesaat Flowable was authorised at a maximum dose rate of 1.5 kg ethofumesaat per ha. In the past, no argumentation had been provided for the difference between these maximum dose rates for the use in seed production of Perennial and Italian ryegrass.

At the re-registration, the use in seed production of Perennial ryegrass and Italian ryegrass was withdrawn. This was, however, not decided based on efficacy grounds. There is no reason to expect that the efficacy of the product has changed. Seed production of Perennial ryegrass and Italian ryegrass in practice has not changed either. As a consequence, the product is still effective against mono- and dicotyledonous weeds in seed production of Perennial ryegrass and Italian ryegrass. In addition, it is not to be expected that the product will give harmful effects.

A maximum dose rate of 2.0 kg ethofumesaat per ha in seed production of Perennial and Italian ryegrass is therefore acceptable for Agrichem Ethofumesaat Flowable.

 

Conclusion

The product complies with the Uniform Principles because, in accordance with article 2.1, it controls the claimed weeds to the required level of control, and it does not, in accordance with article 2.2., induce any unacceptable side effects on plants or plant products, when used and applied in accordance with the proposed label, and it complies with the Uniform Principles, article 2.1.3 as the level of control on the long term is not influenced by the use of this product because of the possible build up of resistance.

 

8.4       For vertebrate control agents: impact on target vertebrates

Because no vertebrates are controlled, this point is not relevant.

 

8.5       Any other relevant data / information

None


 

9.                  Conclusion

 

The product complies with the Uniform Principles.

 

The evaluation is in accordance with the Uniform Principles laid down in appendix VI of Directive 91/414/EEC. The evaluation has been carried out on basis of a dossier that meets the criteria of appendix III of the Directive.

 

 

10.      Classification and labelling

 

The classification and labelling of the product does not change.

 

 

Appendix 1  Table of authorized uses

The table of authorized uses does not change.

 

Appendix 2  Reference list

No data were submitted.