Toelatingsnummer 12433 N

CORZAL

 

12433 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 HERREGISTRATIE TOELATING

 

Gelet op de aanvraag d.d. 16 februari 2007 (20070195 THG) van

 

Agrichem B.V.

Koopvaardijweg 9

4906 CV OOSTERHOUT NB

 

tot herregistratie van de toelatingals bedoeld in artikel 28, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor het gewasbeschermingsmiddel, op basis van de werkzame stof fenmedifam

 

CORZAL

 

gelet opartikel 39, eerste lid, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1 Herregistratie toelating

1.      De toelating van het gewasbeschermingsmiddel CORZAL, die expireert op 1 mei 2012 wordt voor de in bijlage I genoemde toepassingen verlengd onder nummer 12433. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.      De toelating geldt tot 1 januari 2022.

 

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 artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: Suspo-emulsie

 

werkzame stof:

gehalte:

fenmedifam

157 g/l

 

letterlijk en zonder enige aanvulling:

 

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

-

 

gevaarsymbool:

aanduiding:

N

Milieugevaarlijk

 

 

Waarschuwingszinnen:

R51/53 -Vergiftig voor in het water levende organismen; kan in het aquatisch milieu op lange termijn schadelijke effecten veroorzaken.

 

Veiligheidsaanbevelingen:

S49 -Uitsluitend in de oorspronkelijke verpakking bewaren.

S61 -Voorkom lozing in het milieu. Vraag om speciale instructies / veiligheidsgegevenskaart.

V31-NL -Kan bij (langdurig) contact corrosie veroorzaken bij metalen.

 

Specifieke vermeldingen:

 

DPD01 -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.

 

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

 

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

 

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

 

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

 


1.5. Aflever- en opgebruiktermijn

Er wordt geen opgebruik- en aflevertermijn toegekend: Oude verpakkingen mogen worden afgeleverd en gebruikt tot de nieuwe etiketten beschikbaar zijn.

 

2 DETAILS VAN DE AANVRAAG EN TOELATING

 

2.1 Aanvraag

Het betreft een aanvraag tot herregistratie en uitbreiding van de toelating van het middel CORZAL (12433 N), een middel op basis van de werkzame stof fenmedifam. De herregistratie wordt aangevraagd voor de toelating als herbicide in de teelt van rode biet (kroten) en suiker- en voederbieten, in alle gevallen enkel indien toegepast vr het sluiten van het gewas.Tevens wordt er een uitbreiding aangevraagd als herbicide in de onbedekte teetlt van aardbei.

 

2.2 Informatie met betrekking tot de stof

De werkzame stof fenmedifam is per 1 maart 2005 bij Richtlijn 2004/58/EG d.d. 23 april 2004 van de Europese Commissie van de Europese Gemeenschappen opgenomen in Bijlage I van Richtlijn 91/414/EEG.

De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009 (Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011, nummer 88).

 

2.3 Karakterisering van het middel

CORZAL is een, als suspo-emulsie geformuleerd, herbicide op basis van de werkzame stof fenmedifam (157 g/l).

 

Fenmedifam behoort tot de groep van de fenyl-carbamaten. Het is een selectief systemisch werkend herbicide, dat wordt opgenomen door het blad en in de houtvaten wordt getransporteerd. Fenmedifam remt de fotosynthese door onderbreking van het elektronentransport. Het middel heeft geen bodemwerking en met name breedbladige onkruiden worden bestreden.

 

De werkzame stof fenmedifam is al geruime tijd toegelaten in Nederland. De werkzame stof fenmedifam is zowel sec toegelaten als in diverse combinaties. CORZAL is sinds 2003 toegelaten in Nederland in suiker- en voederbieten en verder in kroten.

 

2.4 Voorgeschiedenis

De aanvraag is op 16 februari 2007 ontvangen; op 28 februari 2007 zijn de verschuldigde aanvraagkosten ontvangen. Bij besluit d.d. 19 augustus 2005 is Agrichem B.V. gemeld dat de aanvraag voldoet aan de bij Richtlijn 2004/58/EG d.d.23 april 2004 in Bijlage I van Richtlijn 91/414/EEG opgenomen voorwaarden voor de werkzame stof fenmedifam.

 

3 RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de RGB (Hoofdstuk 2); te weten de werkinstructies RGB (voor toxicologie en milieu) en in de RGB aangeduide (delen van de) toepasselijke versie van de HTB (in dit geval 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 gewasbeschermingsmiddelen en biociden).

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

 

3.3 Risico voor de mens

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

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

 

3.4 Risico voor het milieu

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

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

-          de gevolgen voor niet-doelsoorten.

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

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

 

3.5 Werkzaamheid

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, voldoende werkzaam is en geen onaanvaardbare uitwerking heeft op planten of plantaardige producten (artikel 28, eerste lid, sub b, onderdelen 1 en 2, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het aspect werkzaamheid staat beschreven in Hoofdstuk 8, Efficacy, in Bijlage II bij dit besluit.

 

3.6 Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel CORZAL op basis van de werkzame stof fenmedifam voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, 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, 13 januari 2012

 

 

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,





ir. P.A.E. van Erkelens

Plv. voorzitter



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 13 januari 2012 tot herregistratie en uitbreiding van de toelating van het middel CORZAL, toelatingnummer 12433 N

 

 

A.

Wettelijk gebruiksvoorschrift

 

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

- suiker- en voederbieten, mits toegepast vr het sluiten van het gewas

- onbedekte teelt van aardbei

- rode biet (kroten), mits toegepast vr het sluiten van het gewas

 

Om in het water levende organismen te beschermen is de toepassing van de enkelvoudige dosering van 6 l/ha in suiker-en voederbieten, rode bieten en aardbeien op perceelsranden die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik wordt gemaakt van 75% driftreducerende doppen.

 

Dit middel is uitsluitend bestemd voor professioneel gebruik.

 

 

B.

Gebruiksaanwijzing

 

Algemeen

CORZAL is een bladherbicide zonder bodemwerking. Het middel bestrijdt eenjarige breedbladige onkruiden. Bij voorkeur op zeer jonge onkruiden (kiembladstadium) toepassen. Minder gevoelige onkruiden zijn kamille, kleefkruid, varkensgras, perzikkruid, waterpeper en opslagplanten van koolzaad. Grassen en wortelonkruiden worden niet bestreden.

Spuiten bij groeizaam weer en bij voorkeur bij een bedekte lucht.

CORZAL dient verspoten te worden in 200-400 liter water per ha.

 

Toepassingen

 

Suiker- en voederbieten

 

Gebruik gedurende de teelt in totaal niet meer dan 6 l/ha CORZAL. Met de onkruidbestrijding dient begonnen te worden op kiemend onkruid, in de regel is dit bij opkomst van de bieten. Tussen de behandelingen dient een interval van ongeveer 7-10 dagen in acht te worden genomen.

CORZAL kan worden gemengd met voor deze toepassing toegelaten herbiciden.

De toepassing dient na opkomst van de bieten plaats te vinden en kan op diverse manieren uitgevoerd worden:

 

1. Lage Doseringen Systeem: op onkruiden in het kiembladstadium.

Dosering: 0,5 l/ha CORZAL + 0,5 l/ha Metamitron (700 g/l)+ 0,5 l/ha Ethofumesaat

(200 g/l) of 0,2 l/ha Ethofumesaat (500 g/l)

Indien gewenst kan 0,5 l/ha olie (voor deze toepassing geschikt) worden toegevoegd.

De toepassing herhalen als nieuwe onkruiden aanwezig zijn. Als de onkruiden 1-2 echte blaadjes hebben of als minder gevoelige onkruiden voorkomen kunnen de doseringen eventueel verdubbeld worden.

 

2. In het twee-blad-stadium van de bieten.

Dosering: 3 l/ha CORZAL + 1,5 l/ha Metamitron (700 g/l)

De toepassing zo nodig herhalen in het vier-blad-stadium van de bieten.

 

3. In het twee-blad-stadium van de bieten.

Dosering: 3 l/ha CORZAL + 1,5 l/ha Ethofumesaat (200 g/l) of 0,6 l/ha Ethofumesaat

(500 g/l)

De toepassing zo nodig herhalen in het vier-blad-stadium van de bieten.

Deze combinatie wordt vooral geadviseerd tegen veelknopigen en kleefkruid.

 

4. Vanaf het twee-blad-stadium van de bieten.

Dosering: 6 l/ha CORZAL

De toepassing kan tevens gefractioneerd worden uitgevoerd.

 

Onbedekte teelt van Aardbei

 

Toepassen in het vermeerderingsveld: vanaf 14-21 dagen na het uitplanten, zodra de planten goed zijn aangeslagen.

Toepassen in het productieveld: vanaf 14-21 dagen na het uitplanten (zodra de planten goed zijn aangeslagen) tot het verschijnen van de eerste bloemknoppen.

Dosering: 6 l/ha CORZAL

De toepassing kan ook gefractioneerd worden uitgevoerd.

Niet toepassen in combinatie met andere middelen; minimaal 3 dagen tussen de toepassing van CORZAL en van andere middelen in acht nemen.

 

Rode bieten (kroten)

 

De toepassing dient na opkomst van de kroten plaats te vinden en kan op twee manieren uitgevoerd worden:

 

1. Toepassen na opkomst als de kiemblaadjes van het gewas volledig zijn gestrekt.

Dosering: 4-6 l/ha CORZAL, de hoogste dosering toepassen bij onkruiden met 1-2 echte blaadjes.

 

2. In het twee-blad-stadium van het gewas.

Dosering: 3 l/ha CORZAL + 1,5 l/ha Metamitron (700 g/l)

 

 

Restricties

-        Spuit op een afgehard, droog en gezond gewas.

-        Spuit niet op een gewas dat verzwakt is door insecten, stuifschade, nachtvorst of herbiciden.

-        Spuit niet bij scherp, zonnig weer; in dit geval bij voorkeur s avonds spuiten.

 

Spuitvoorschriften

Spuit met grondig schoongemaakte apparatuur.

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


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II bij het besluit d.d. 13 januari 2012 tot herregistratie en uitbreiding van de toelating van het middel CORZAL, toelatingnummer 12433 N

 

RISKMANAGEMENT

 

 

 

Contents Page

 

 

1. Identity of the plant protection product 2

 

2. Physical and chemical properties 3

 

3. Methods of analysis 9

 

4. Mammalian toxicology 11

 

5. Residues 17

 

6. Environmental fate and behaviour 21

 

7. Ecotoxicology 36

 

8. Efficacy 71

 

9. Conclusion 74

 

10. Classification and labelling 74

 

Appendix 1 Table of authorised uses

Appendix 2 Reference List
1. Identity of the plant protection product

 

1.1 Applicant

Agrichem B.V.

Koopvaardijweg 9

4906 CV OOSTERHOUT

 

1.2 Identity of the active substance

Common name

phenmedipham

Name in Dutch

fenmedifam

Chemical name

methyl 3-(3-methylcarbaniloyloxy)carbanilate;
3-methoxycarbonylaminophenyl 3-methylcarbanilate [IUPAC]

CAS no

13684-63-4

EC no

237-199-0

 

The active substance was included in Annex I of Directive 91/414/EEC on March 1st 2005. The applicant has its own manufacturing site for phenmedipham. This source (minimum purity 970 g/kg) is considered to be equivalent with the source evaluated for the inclusion of phenmedipham in Annex I of Directive 91/414/EEC (minimum purity 970 g/kg).

 

1.3 Identity of the plant protection product

Name

CORZAL

Formulation type

SE

Content active substance

157 g/L phenmedipham

 

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

 

1.4 Function

Herbicide.

 

1.5 Uses applied for

See GAP.

 

1.6 Background to the application

It concerns a re-registration and extension.

 

1.7 Packaging details

 

1.7.1 Packaging description

Material:

HDPE-fluorinated (1 L and 10 L) or Coex-HDPE (5 L)

Capacity:

1, 5 and 10 L

Type of closure and size of opening:

Screw cap with induction seal, 50 mm opening for 1 L bottle and 63 mm opening for 5 and 10 L container

Other information

ADR compliant and UN certified

 

1.7.2 Detailed instructions for safe disposal

See application form and MSDS (no particular recommendations).

 


 

2.                  Physical and chemical properties

 

Data about the identity and the physical and chemical properties are taken from the List of Endpoints (DAR, October 2003, SANCO/4060/2001 dd 13 February 2004). Changes and/or additions are taken up in italics.

 

Identity phenmedipham

Active substance (ISO Common Name)

Phenmedipham

Chemical name (IUPAC)

methyl 3-(3-methylcarbaniloyloxy)carbanilate;
3-methoxycarbonylaminophenyl 3-methylcarbanilate

Chemical name (CA)

3-[(methoxycarbonyl)amino]phenyl (3-methylphenyl) carbamate

CIPAC No

77

CAS No

13684-63-4

EEC No (EINECS or ELINCS)

EINECS: 237-199-0

FAO Specification (including year of publication)

AGP: CP/90, (1980); min. 97.0 1 %

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

min. 970 g/kg

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

None

Molecular formula

C16H16N2O4

Molecular mass

300.3

Structural formula

 

 

 

Physical-chemical properties phenmedipham

Melting point (state purity)

142.7 C (99.2 % pure)

Boiling point (state purity)

No boiling point, decomposition begins at 147 C.

Temperature of decomposition

147 C (97 % tech.)

Appearance (state purity)

Colourless, crystalline powder, odourless (99.6% pure).

Relative density (state purity)

1.359 g/cm3 at 20 C (99.3 % pure)

Surface tension

71.2 mN/m at 20 C (98.5 % tech.)

Vapour pressure (in Pa, state temperature)

7 10 -10 Pa at 25 C (99.3 % pure)

Henrys law constant (in Pam3mol-1)

5 10 -8 Pa m3 mol 1 at 20C

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

pH 3.4: 1.8 mg/l at 20 C (99.0 % pure)

Phenmedipham decomposes at neutral or basic pH.

Solubility in organic solvents (in g/l or

mg/l, state temperature)

All in g/l at 20 C: toluene: 0.97; dichloromethane: 16.7; methanol: 36.2; acetone: 165; ethyl acetate: 56.3: isooctane 0.16

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

3.59 at 22 C and pH 4

No pH dependence

Hydrolytic stability (DT50) (state pH and temperature)

pH 5: DT50 = 119.5 h at 25 C;
pH 7: DT50 = 14.5 h at 25 C;
pH 9: DT50 = 0.16 h at 25 C;

Dissociation constant

Phenmedipham does not dissociate.

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

lmax: 205 nm, emax: 59646 l mol-1 cm-1
lmax: 237 nm, emax: 37848 l mol-1 cm-1
lmax: 274 nm, emax: 2761 l mol-1 cm-1 at pH 6.2

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

Photochemically stable.

Quantum yield of direct photo-

transformation in water at λ > 290 nm

Photochemically stable.

Photochemical oxidative degradation in air

DT50 = 6.7h

Flammability

Not to be considered as highly flammable.

Auto-flammability

148 oC

Oxidising properties

Not oxidising

Explosive properties

Not to be considered as explosive.

 

2.1              Plant protection product: CORZAL

Data on the plant protection product is based on information provided by the applicant. The range of application concentrations of the plant protection product is 0.125-3%.

 

Section

(Annex point)

Study

Guidelines and GLP

Findings

Evaluation and conclusion

B.2.2.1 (IIIA 2.1)

Appearance: physical state

GLP

Visual

Homogeneous suspo-emulsion

The observation suspo-emulsion cannot be based on visual observation. The product is a liquid.

B.2.2.2 (IIIA 2.1)

Appearance: colour

GLP

Visual

White

Acceptable

B.2.2.3 (IIIA 2.1)

Appearance: odour

GLP

Organoleptic

Light chemical smell, further characterisation not possible

Acceptable

B.2.2.4 (IIIA 2.2)

Explosive properties

GLP

Statement

Not explosive

Acceptable

B.2.2.5 (IIIA 2.2)

Oxidising properties

GLP

Statement

Not oxidising

Acceptable

B.2.2.6 (IIIA 2.3)

Flammability

 

Not applicable

 

B.2.2.7 (IIIA 2.3)

Auto-flammability

GLP

EEC A15

450C

Acceptable

B.2.2.8 (IIIA 2.3)

Flash point

GLP

EC A9

>70C

Acceptable

B.2.2.9 (IIIA 2.4)

Acidity / alkalinity

not GLP

CIPAC MT31.23

0.691% as H2SO4

Acceptable

B.2.2.10 (IIIA 2.4)

pH

GLP

CIPAC MT75.2

neat: 3.17

1% in distilled water: 3.63

Acceptable

 

B.2.2.11 (IIIA 2.5)

Surface tension

GLP

EC A5

At 19.8oC:

0.18% w/v: 45 mN/m

3.92% w/v: 35 mN/m

Acceptable.

 

 

GLP

EC A5

At 25oC:

neat product: 33 mN/m

Acceptable.

B.2.2.12 (IIIA 2.5)

Viscosity

GLP

OECD 114

119.1-167.7 mPas at 19.9-20.0oC and 51.7-103 s-1

(non-Newtonian)

Acceptable

 

 

GLP

OECD 114

77-79 mPas at 39.8 39.9oC and 129.3 s-1

62-63 mPas at 39.8 39.9oC and 219.8 s-1

(non-Newtonian)

Acceptable

B.2.2.13 (IIIA 2.6)

Relative density

GLP

EEC A3

 

D204 = 1.0345

Acceptable

B.2.2.14

(IIIA 2.6)

Bulk (tap) density

 

Not applicable

 

B.2.2.15 (IIIA 2.7)

Storage stability

not GLP

CIPAC MT46.1.3

Properties determined before and after storage for 2 weeks at 54oC in 1L HDPE container: a.i. content, appearance, wet sieve test (CIPAC MT59.3), density (EEC A3), pH (CIPAC MT75.2, neat & 1%), acidity (CIPAC MT31.2), suspensibility (CIPAC MT161, CIPAC D water, 0.17% & 3.75%, HPLC), spontaneity of dispersion (CIPAC MT160, CIPAC D water, 5%, HPLC), pourability (CIPAC MT148), stability of dilute emulsions (CIPAC MT 173, CIPAC A and D water, 0.17% & 3.75%, HPLC).

 

Chemically and physically stable. The test package remained intact without deformation.

Acceptable to demonstrate storage stability in HDPE.

The pack with content was not weighed before and after storage, but losses, if any, are likely to be insignificant (a.s. content after storage was 100.7% of that before storage).

 

 

GLP

CIPAC MT39.1

Properties determined before and after storage for 7 days at 0-0.7C: separated material (CIPAC MT39.1), a.i. content, wet sieve test (CIPAC MT59.3), density (EEC A3), pH (CIPAC MT75.2, neat & 1%), acidity (CIPAC MT31.2), suspensibility (CIPAC MT161, CIPAC D water, 0.17% & 3.75%, HPLC), spontaneity of dispersion (CIPAC MT160, CIPAC D water, 5%, HPLC), stability of dilute emulsions (CIPAC MT 173, CIPAC A and D water, 0.17% & 3.75%, HPLC).

 

No separated material. Chemically (although 4.1% decrease in a.i. content) and physically stable.

Acceptable.

B.2.2.16 (IIIA 2.7)

Shelf life

GLP

No guideline stated

Properties determined after storage for 2 years at room temperature (14-23C) in 1L HDPE container: a.i. content, appearance, wet sieve test (CIPAC MT59.3), particle size distribution (CIPAC MT187), density (EEC A3), pH (CIPAC MT75.2, neat & 1%), acidity (CIPAC MT31.2), suspensibility (CIPAC MT161, CIPAC D water, 0.17% & 3.75%, HPLC), spontaneity of dispersion (CIPAC MT160, CIPAC D water, 5%, HPLC), foaming (CIPAC MT47.2, CIPAC D water, 3.75%), pourability (CIPAC MT148), surface tension (neat, EEC A5), flash point (EEC A9), stability of dilute emulsions (CIPAC MT 173, CIPAC A and D water, 0.17% & 3.75%, HPLC).

 

Chemically and physically stable. The test package remained intact without deformation and weight loss.

Acceptable to demonstrate storage stability in HDPE.

Parameters were determined after storage only. The obtained values for all relevant parameters were within FAO specifications. The batch of the tested product was identical to that used for the accelerated storage stability study, where also initial parameters were determined and found to be acceptable.

B.2.2.17

(IIIA 2.8)

Wettability

 

Not applicable

 

B.2.2.18 (IIIA 2.8)

Persistent foaming

GLP

CIPAC MT47.2

 

3.75% v/v in CIPAC D water:

35 mL foam after 10 sec

5 mL foam after 1 minute

4 mL foam after 3 minutes

4 mL foam after 12 minutes

Acceptable.

 

B.2.2.19

(IIIA 2.8)

Suspensibility

GLP

CIPAC MT161

(HPLC)

CIPAC D water, 0.17% & 3.75%: 97% & 96%.

Acceptable.

 

B.2.2.20

(IIIA 2.8)

Spontaneity of dispersion

GLP

CIPAC MT160

(HPLC)

CIPAC D water, 5%: 97%

Acceptable.

 

B.2.2.21

(IIIA 2.8)

Dilution stability

 

Not applicable

 

B.2.2.22

(IIIA 2.8)

Dry sieve test

 

Not applicable

 

B.2.2.23

(IIIA 2.8)

Wet sieve test

GLP

CIPAC MT59.3

0.01% residue on 75 m sieve

Acceptable.

B.2.2.24

(IIIA 2.8)

Particle size distribution

GLP

Laser diffraction

5% 0.60 m

10% 0.70 m

16% 0.82 m

50% 1.68 m

84% 3.38 m

90% 4.02 m

100% 15.00 m

Acceptable.

B.2.2.25

(IIIA 2.8)

Content of dust/fines

 

Not applicable

 

B.2.2.26

(IIIA 2.8)

Attrition and friability

 

Not applicable

 

B.2.2.27 (IIIA 2.8)

Emulsifiability, re-emulsifiability and emulsion stability

 

Not applicable

 

B.2.2.28

(IIIA 2.8)

Stability of dilute emulsion

GLP

CIPAC M173

(HPLC of a.s.)

 

0.17% in CIPAC A water:

101% and 119% after 0 and 0.5 hours.

0.17% in CIPAC D water:

98% and 106% after 0 and 0.5 hours.

3.75% in CIPAC A water:

100% and 110% after 0 and 0.5 hours.

3.75% in CIPAC D water:

103% and 98% after 0 and 0.5 hours.

No measurement was performed after 4 hours, and emulsifiability after 0.5 hours in CIPAC A water was much higher than 105%. This test is however not intended and not required for suspo-emulsions, and suspensibility and dispersion characteristics were found to be satisfactory in other studies. Further information is not required.

B.2.2.29

(IIIA 2.8)

Flowability

 

Not applicable

 

B.2.2.30

(IIIA 2.8)

Pourability (rinsibility)

GLP

CIPAC MT148.1

 

Residue 2.98%

Rinsed residue 0.21%.

Acceptable.

B.2.2.31

(IIIA 2.8)

Dustability

 

Not applicable

 

B.2.2.32

(IIIA 2.8)

Adherence/ distribution to seeds

 

Not applicable

 

2.9.1

Physical compatibility with other products

not GLP

In-house method

In CIPAC D water, 20C, visual assessment, pH, temperature and residue on 250 m sieve.

Phenmedipham 157 g/L SE at 1% and 1.33% v/v physically compatible with:

Metamitron 700 g/L SC;

Ethofumesate 500 g/L SC;

Metamitron 700 g/L SC +

Ethofumesate 500 g/L SC.

All of the above combinations were tested in different order of addition of the products.

Acceptable to demonstrate compatibility with SC formulations based on metamitron and ethofumesate. The addition of oil is however also suggested on the label and no tests to demonstrate compatibility with natural and synthetic oil have been submitted.

2.9.2

Chemical compatibility with other products

 

See above.

 

 

The accelerated storage stability study and the shelf-life study were performed on the product stored in a HDPE container. In addition to HDPE fluorinated HDPE is proposed for storage of the product. Fluorinated HDPE is assumed to be at least equally stable as HDPE, but is presumably more stable. The shelf-life study therefore is assumed to have covered also fluorinated HDPE.

Compatibility testing did not include mixing with oil. Formulations containing phenmedipham, alone or with ethofumesate and/or metamitron, have been used for several decades in combination with natural and synthetic oils. On the basis of this experience mixing with oil will not lead to practical problems. No further information on compatibility is required.

 

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.

 

2.4 Data requirements

None.

 

 

3.                  Methods of analysis

 

Information on analytical methods for the technical active substance is taken from the List of Endpoints (DAR, October 2003 ,SANCO/4060/2001 dd 13 February 2004). Changes and/or additions are printed in italics. The applicant has provided a validated analytical method for the plant protection product.

 

3.1.            Analytical methods in technical material and plant protection product

Technical as (principle of method)

HPLC, reversed phase (RP-18 ) column, UV detection at 238 nm, mobile phase: acetonitrile/water/dioxane.
(Corresponds CIPAC method 77/TC/M/3.2 (revised))

Impurities in technical as (principle of method)

HPLC, reversed phase (RP-18 ) column, UV detection at 238 nm, mobile phase: acetonitrile/0.005 M pentanesulfonic acid Na-salt/dioxane.
Residual toluene by capillary GC-FID.
Residual water by Karl Fischer titration.

Preparation (principle of method)

HPLC-UV

 

Conclusion

The analytical methods for the technical active substance have been assessed in the DAR and are considered to be acceptable. Acceptable validation was submitted for the method to determine the active substance in the plant protection product, except for the recovery determination. Rather than analysing a sample of blank formulation fortified with phenmedipham, in two independent studies three different batches of formulation of known phenmedipham content were analysed. By which method the known theoretical phenmedipham content of these batches was determined was not stated in the reports. The reported recovery values, which were 102.6% (n=6, first batch), 97.9% (second batch, n=3) and 97.9% (third batch, n=3) are therefore not acceptable. Considering however that the method was based on, and not essentially different from, the CIPAC method for phenmedipham in EC formulations, and that the chromatogram of the blank formulation showed no significant interference at the retention time of phenmedipham, the method accuracy should be satisfactory, and further information is not required.

 

3.2              Residue analytical methods

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

HPLC-MS/MS; LOQ: 0.05 mg/kg (phenmedipham) in sugar beets

DFG S19 multi residue method GLC/MSD; LOQ: 0.02 mg/kg (phenmedipham) in sugar beets

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

HPLC-MS/MS; LOQ: PMP 0.05 mg/kg (all products)
(and MHPC metabolite LOQ: 0.05 mg/kg (all products))

Soil (principle of method and LOQ)

HPLC-MS/MS; LOQ: PMP 0.01 mg/kg, MHPC metabolite LOQ: 0.01 mg/kg)

Water (principle of method and LOQ)

HPLC- MS/MS; LOQ: PMP 0.01 mg/l, MHPC metabolite LOQ: 0.01 mg/l in surface and drinking water

Air (principle of method and LOQ)

HPLC-UV; LOQ: 10 g/m (phenmedipham)

Body fluids and tissues (principle of method and LOQ)

not required not toxic or very toxic

 

Based on the proposed use of the plant protection product (sugar and fodder beet, beetroot, strawberry) analytical methods for determination of residues in food/feed of plant origin are required for watery matrices.

 

Definition of the residue and MRLs for phenmedipham

Matrix

Proposed definition of the residue for monitoring

Proposed MRL

Food/feed of plant origin

phenmedipham

0.1 mg/kg (strawberry and beetroot)

 

Food/feed of animal origin

phenmedipham

0.05* mg/kg

 

Required LOQ

Soil

phenmedipham and MHPC

0.05 mg/kg (default)

Drinking water

phenmedipham and MHPC

0.1 g/L (Dutch drinking water guideline)

Surface water

phenmedipham and MHPC

0.1 g/L (HTB 1.0)

Air

phenmedipham

0.039 mg/m3 (derived from the AOEL (0.13 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.

Not applicable

 

The residue analytical methods, included in the abovementioned List of Endpoint, are suitable for monitoring of the proposed MRLs. The residue analytical methods for water, soil and air, evaluated in the DAR, are acceptable and suitable for monitoring of residues in the environment.

 

Conclusion

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

 

3.3 Data requirements

None.

 

3.4 Physical-chemical classification and labelling

 

Proposal for the classification of phenmedipham (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

 

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

S49

V31-NL

Keep only in the original container.

May cause corrosion in (prolonged) contact with metals.

 

 

 

Special provisions:
DPD-phrases

-

-

 

 

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

S49 is assigned to products with a pH lower than 4 due to possible corrosion issues.

V31-NL is assigned to products with a pH lower than 4 when diluted as a low pH may cause corrosion of metal surfaces.

Other:

-

 

Supported shelf-life of the formulation is 2 years in HDPE packaging.

 

 

4.                  Mammalian toxicology

 

List of Endpoints

Phenmedipham is an existing active substance, included in Annex I of 91/414/EEC. The final List of Endpoints presented below is taken from the final review report on phenmedipham (SANCO/4060/2001 final, d.d. 13 February 2004). Where relevant, some additional remarks/information are given in italics.

 



Absorption, distribution, excretion and metabolism in mammals (Annex IIA, point 5.1)

Rate and extent of absorption:

Rapid. 85%, based on urinary excretion in 24 30 h

Distribution:

Widely distributed, highest residues in blood (methylphenyl ring label)

Potential for accumulation:

Low potential for accumulation

Rate and extent of excretion:

Rapid. Over 90% within 24- 30 h

Toxicologically significant compounds:

Parent compound and metabolites. 3-aminophenol and 3-aminotoluene may be of special toxicological concern

Metabolism in animals:

Extensively metabolised. Oxidative/hydrolytic cleavage of parent molecule, hydroxylation of aromatic ring structures, acetylation of amino groups and further oxidation of methyl groups

 

Acute toxicity (Annex IIA, point 5.2)

Rat LD50 oral

>8000 mg/kg

Rat LD50 dermal

>2000 mg/kg

Rat LC50 inhalation

>7.0 mg/l (nose only)

Skin irritation

Non irritant

Eye irritation

Non irritant

Skin sensitization (test method used and result)

Not sensitising (M & K)

 

Short term toxicity (Annex IIA, point 5.3)

Target / critical effect

Effects on red blood cells (methemoglobinemia and hemolytic anemia) and related effects (hemosiderin deposition in spleen, liver and kidneys)

Lowest relevant oral NOAEL / NOEL

150 ppm (13 mg/kg bw/day) (90-day, rat)

Lowest relevant dermal NOAEL / NOEL

No data. Not required

Lowest relevant inhalation NOAEL / NOEL

No data. Not required

 

Genotoxicity (Annex IIA, point 5.4)

Clastogenic in vitro. Non-genotoxic in vivo (mouse bone marrow: negative for chromosome aberrations and micronuclei induction; mouse spermatogonial cells: negative for induction of chromosomal aberrations) 1

1 The genotoxic potential of phenmedipham was investigated in 13 in vitro studies (Ames test, mammalian cell gene mutation test in Chinese hamster lung fibroblasts V79 and mouse lymphoma cells, mammalian cytogenetic test in Chinese hamster ovary cells) and 5 in vivo studies (micronucleus test in mouse bone marrow and chromosome aberration test in NMRI mouse spermatogonial cells).

 


Long term toxicity and carcinogenicity (Annex IIA, point 5.5)

Target/critical effect

Effects on red blood cells (methemoglobinemia and hemolytic anemia) and related histophatological effects in spleen, liver and kidneys (increased weight, hemosiderosis, extramedullar hematopoiesis)

Lowest relevant NOAEL / NOEL

60 ppm (3 mg/kg bw/day) 2-year, rat)

Carcinogenicity

No carcinogenic potential

 

Reproductive toxicity (Annex IIA, point 5.6)

Target / critical effect Reproduction:

Reduced pup weight at parentally toxic dose levels

Lowest relevant reproductive NOAEL / NOEL

25 mg/kg bw/day (two-generation, rat) 2

Target / critical effect Developmental

Retarded ossification in rats and rabbits at maternally toxic dose levels

Lowest relevant developmental NOAEL / NOEL

Rabbit: 225 mg/kg bw/day 3

2 The NOAELs for paternal and maternal toxicity were respectively 75 and 25 mg/kg bw/day based on reduced body weight.

3 Also maternal NOAEL

 

Delayed neurotoxicity (Annex IIA, point 5.7)

 

No data. Not required.

 

Other toxicological studies (Annex IIA, point 5.8)

 

No data. Not required.

 

Medical data (Annex IIA, point 5.9)

 

Four different studies were supplied which reported cases of allergic dermatitis, photoallergic dermatosis, allergic rhinitis and toxic hepatitis in pesticide operators and field workers who had applied Betanal or Betamix formulations of phenmedipham

 


Summary (Annex IIA, point 5.10)

Value

Study

Safety factor

ADI:

0.03 mg/kg bw/day

2-year rat study

100

AOEL systemic:

0.13 mg/kg bw/day

90-day rat study

100

ARfD (acute reference dose)

Not allocated, not necessary

 

Dermal absorption (Annex IIIA, point 7.3)

 

1% (based on an absorption study in vivo in rat, and comparative in vitro penetration studies with rat and human skin). 4

4 The dermal absorption studies are performed with an EC formulation with 75 g/L phenmedipham (in the DAR the term OF (oil flowable) was used for this formulation). From the available studies it can be concluded that there was hardly any difference between the dermal absorption of the undiluted formulation (0.9%) and the 1:50 spray dilution (0.2%). Therefore, the dermal absorption will be considered 1% (worst case).

 

Local effects

Phenmedipham does not produce local effects, neither after a single nor repeated exposure.

Data requirements active substance

None.

 

4.1 Toxicity of the formulated product (IIIA 7.1)

The formulation CORZAL does not need to be classified on the basis of its acute oral (LD50 rat >2000 mg/kg bw), dermal (LD50 rat >4000 mg/kg bw), and inhalation toxicology (no study available, not required).

The formulation CORZAL is considered not irritating to skin and eyes.

The formulation CORZAL is considered not to have sensitising properties based on the properties of the active substance and the co-formulants.

 

4.1.1 Data requirements formulated product

None.

 

4.2 Dermal absorption (IIIA 7.3)

See List of Endpoints. The applicant refers to the studies in the DAR. In the DAR no details on the used formulation are provided other than it being an OF formulation containing a nominal amount of 75 g/L phenmedipham. In an additional statement from the notifier it was indicated that the used formulation in the studies in the DAR is an EC formulation and also the composition of this formulation was presented. Comparing the composition of the EC formulation used in the studies in the DAR and the SE (suspo-emulsion) formulation CORZAL (containing 157 g/L phenmedipham), it is assumed that the dermal absorption of phenmedipham formulated as CORZAL will not be higher than the dermal absorption of the EC formulation used in the dermal absorption studies in the DAR. In the available studies the undiluted formulation and spray dilution (1:50) were tested. For the current application the prescribed spray dilutions are about 1:30 - 1:400. Since the dermal absorption of the spray dilution (0.2%) was lower than of the undiluted formulation (0.9%), a dermal absorption of 1% for the concentrate and spray dilutions (see List of Endpoints) is considered relevant for the risk assessment.

 

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

None of the other formulants raise concerns that have not been addressed in the submitted studies.

 

4.4 Exposure/risk assessments

 

Overview of the intended uses

An application has been submitted for the authorisation of the plant protection product CORZAL, a herbicide based on the active substance phenmedipham.

 

CORZAL is an SE formulation (suspo-emulsion) and contains 157 g/L phenmedipham.

 

The intended uses are listed under 1.5.

 

4.4.1 Operator exposure/risk

According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers:

Tier 1: Risk assessment using the EU-AOEL without the use of PPE

Tier 2: Risk assessment using the NL-AOEL without the use of PPE

Tier 3: Refinement of the risk assessment using new dermal absorption data

Tier 4: Prescription of PPE

 

Tier 1

 

Calculation of the EU-AOEL / Tolerable Limit Value (TLV)

For phenmedipham no TLV has been set. The AOEL will be used for the risk assessment.

CORZAL can be applied 1-4 times in sugar and fodder beet during the period March-June (with a spray interval of 7-14 days), but will be applied once for the other intended uses. A semi-chronic AOEL is applicable (including contract workers).

Since phenmedipham is included in Annex I of 91/414/EEC, the semi-chronic EU-AOEL of 0.13 mg/kg bw/day (= 9.1 mg/day for a 70-kg operator), based on the 90-d study in rats is used for the risk assessment (see List of Endpoints).

 

Exposure to phenmedipham during mixing and loading and application of CORZAL is estimated with models. The exposure is estimated for the unprotected operator. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the respiratory and dermal exposure during mixing/loading and application have to be combined.

In the Table below the estimated internal exposure is compared with the systemic EU-AOEL. The exposure is only estimated with the highest dose (used in e.g. sugar- and fodder beets).

 

Table T.1 Internal operator exposure to phenmedipham and risk assessment for the use of CORZAL

 

Route

Estimated internal exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

Risk-index b

Mechanical downward spraying on sugar- and fodder beets, beetroots, and strawberry (uncovered)

Mixing/

Loadingc

Respiratory

0.047

9.1

0.01

Dermal

1.88

9.1

0.21

Applicationc

Respiratory

0.075

9.1

0.01

Dermal

0.283

9.1

0.03

 

Total

2.3

9.1

0.25

a Internal exposure was calculated with:

       biological availability via the dermal route: 1% (concentrate) and 1% (spray dilution) (see 4.2)

       biological availability via the respiratory route: 100% (worst case)

b The risk-index is calculated by dividing the internal exposure by the systemic AOEL.

c External exposure was estimated with EUROPOEM.

 

Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required.

 

4.4.2 Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. Based on the low risk-index for the operator, no exposure calculations are performed for bystanders.

 

4.4.3 Worker exposure/risk

Shortly after application it is not necessary to perform any re-entry activities during which intensive contact with the treated crop will occur. Therefore no worker exposure is calculated.

 

4.4.4 Re-entry

See 4.4.3 Worker exposure/risk.

 

Overall conclusion of the exposure/risk assessments of operator, bystander, and worker

The product complies with the Uniform Principles.

 

Operator exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to phenmedipham as a result of the application of CORZAL in sugar- and fodder beets, beetroots, and strawberry.

No additional risk is expected for the combined exposure to phenmedipham, ethofumesate and metamitron (see 4.7).

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to phenmedipham during application of CORZAL in sugar- and fodder beets, beetroots, and strawberry.

 

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 sugar- and fodder beets, beetroots, and strawberry due to exposure to phenmedipham after application of CORZAL.

 

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

See List of Endpoints.

 

4.6 Data requirements

None.

 

4.7 Combination toxicology

CORZAL contains one active substance, but a tank mixture of maximally 3 L/ha CORZAL + 1.5 L/ha metamitron (700 g/L) + if necessary, 0.5 L/ha mineral oil is prescribed on the label and a tank mixture of maximally 3 L/ha CORZAL + 1.5 L/ha ethofumesate (200 g/L). For application in a low dose system a tank mixture of 0.5-1 L/ha CORZAL + 0.5-1 L/ha metamitron (700 g/L) + 0.5-1 L/ha ethofumesate (200 g/L) is described on the label.

The combined toxicological effect of these active substances has not been investigated.

Possibly, the combined exposure to these active substances may lead to a different toxicological profile than the profile(s) based on the individual substances.

 

Ethofumesate and metamitron induce effects on the liver. The critical effect of phenmedipham is haemolytic anaemia. Based on the differences in toxicological profile, no additional risk is expected for the combined exposure to phenmedipham and metamitron or to phenmedipham and ethofumesate.

 

Metamitron and ethofumesate both induce effects on the liver. These effects could possibly be correlated to the induction of biotransformation enzymes. In that case these substances could in principle influence the toxicological effects of each other (induce or deduce). In the low dose system, a tank mixture of metamitron and ethofumesate is described (maximum of 0.7 kg/ha metamitron and 0.2 kg/ha ethofumesate).

A risk assessment for the application of metamitron and ethofumesate in sugar- and fodder beets has recently been performed in C-188.3.1 for another formulation. For 0.7 kg/ha metamitron a risk-index of 0.45 is calculated, based on C-188.3.1. For 0.2 kg/ha ethofumesate a risk-index of 0.26 is calculated, based on C-188.3.1.

The estimated combined exposure to metamitron (risk-index = 0.45) and ethofumesaat (risk-index=0.26) results in a risk-index of 0.7. Therefore, no additional risk is expected for the combined exposure to metamitron and ethofumesate, even if an additive effect will be induced by the simultaneous exposure to both substances.

 

4.8 Mammalian toxicology classification and labelling

 

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

 

Symbol:

-

Indication of danger: -

 

Risk phrases

-

-

 


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

-

-

 

 

 

Special provisions:
DPD-phrases

-

-

 

 

 

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?

Not applicable

Tactile warning of danger obligatory?

Not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

S36/37 no longer need to be assigned based on the risk assessment for the operator.

S2, S13, S20 are not obligatory for formulations intended for professional use only.

Other:

-

 

 

5.                  Residues

 

List of Endpoints

The evaluation of CORZAL is based on the most recent List of Endpoints of phenmedipham on residues (October 22nd, 2003), taking into account the provisions of the final review report (SANCO/4060/2001 dd 13 February 2004).

 

List of Endpoints

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

Plant groups covered

Root vegetables (sugar beet), leafy crops (spinach), fruits (strawberry), pulses (pea)

Rotational crops

-

Plant residue definition for monitoring

phenmedipham

Plant residue definition for risk assessment

phenmedipham

Conversion factor (monitoring to risk assessment)

-

 

Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6)

Animals covered

Cow and hen

Animal residue definition for monitoring

MHPC expressed as phenmedipham

Animal residue definition for risk assessment

phenmedipham and MHPC

Conversion factor (monitoring to risk assessment)

1*

Metabolism in rat and ruminant similar (yes/no)

Yes

Fat soluble residue: (yes/no)

potential to accumulate

* Phenmedipham was included in the residue definition for unclear reasons since it was not found in animal tissue. A conversion factor of 1 is used in the EU.

 

Residues in succeeding crops (Annex IIA, point 6.6, Annex IIIA, point 8.5)

 

-

 

Stability of residues (Annex IIA, point 6 introduction, Annex IIIA, point 8 introduction)

 

Parent compound is stable at 10 oC for at least 5 months in processed commodities of sugar beets (cosettes, dry pulp and molasses).

Parent compound is stable at 20 oC for at least 24 months in sugar beets.

 

Residues from livestock feeding studies (Annex IIA, point 6.4, Annex IIIA, point 8.3)

Intakes by livestock 0.1 mg/kg diet/day:

Ruminant:

Yes

Poultry:

Yes

Pig:

no studies

Muscle

-

4 ng/g (skeletal muscle)

3 ng/g (skeletal muscle/ breast)

-

Liver

112 ng/g (MPC label)

150 ng/g (PC label)

16 ng/g

-

Kidney

140 g/g (MPC label)

150 ng/g (PC label)

-

-

Fat

-

7 ng/g (peritoneal fat)

-

Milk

8 ng/g (MPC label)

18 ng/g (PC label)

-

-

Eggs

-

16 ng/g

-

 

Processing factors (Annex IIA, point 6.5, Annex IIIA, point 8.4)

Crop/processed crop

 

Number of studies

Transfer factor

% Transference

Sugar beet/ sugar

4

 

 

Sugar beet/ molasses

1

 

 

Sugar beet/ wet pulp

2

 

 

Sugar beet/ dry pulp

2

 

 

Sugar beet/ pulp

2

 

 

Sugar beet/ thick juice

2

 

 

Sugar beet/ thin juice

2

 

 

Sugar beet/ diffusion juice

2

 

 

Sugar beet/ lime cake

2

 

 

Sugar beet/ cosettes

1

 

 

Sugar beet/ mother lye

1

 

 

Sugar beet/ cuts

1

 

 

Strawberry/ jam

1

 

 

 

Comments on/additions to List of Endpoints

In the evaluation table (Doc. 4082/2001 rev. 1-2 (13.11.2003)), data requirements to be dealt with at member state level were identified. The data requirement includes a metabolism study on strawberries which was submitted and evaluated nationally.

 

5.1              Summary of residue data

Only points that need clarification to the data in the List of Endpoints or that are not covered in the List of Endpoints, are discussed below.

 

5.1.1 Metabolism in plants

In the DAR, metabolism studies were performed with root vegetables (sugar beet), leafy crops (spinach), fruits (strawberry) and pulses (pea). Evaluation table Doc. 4082/2001 rev. 1-2 (13.11.2003) reports that the metabolism studies on strawberry and pea are not satisfactory.

A metabolism study on strawberry applied with 1007 g ai/ha at BBCH 13 showed that total residues at harvest are 0.022 mg/kg. Phenmedipham parent accounted for 0.004 mg/kg. Eight other fractions were present comprising for 0.007 mg/kg each.

 

5.1.3 Residue definition (plant and animal)

The metabolism shows that no residues are present which are suitable as marker molecule for monitoring and no fractions were present relevant for risk assessment.

The current residue definition for monitoring and risk assessment (phenmedipham parent only) has been confirmed.

The residue definition for monitoring and risk assessment of plant products is phenmedipham.

 

The residue definition for monitoring of animal products is Phenmedipham (Methyl-N-(3-hydroxyphenyl) carbamate (MHPC) expressed as phenmediphan). The residue definition for risk assessment is phenmedipham and MHPC. However, it is unclear why phenmedipham is included, as it is not found in animal tissue. A conversion factor of 1 is therefore used in the EU.

 

5.1.5 Residue data

Sugar and fodder beet (GAP: 1x0.942 kg ai/ha)

In the Draft assessment report (DAR) for phenmedipham, numerous supervised residue trials in sugar beet and fodder beet in Northern Europe are available. The intended use for this application is equal to the supported use in the DAR (maximally 960 g as/ha/season). Three hundred residue trials were conducted with 0.32 to 4 kg as/ha. In 288 trials the residues were ≤ 0.1 mg/kg at PHI 18-192d. A sufficient number of residue trials is available.

For sugar beet the analysed residue values ranged from <0.01 to 0.3 mg/kg and from <0.01 to 1.2 mg/kg for roots and leaves, respectively. For fodder beet the analysed residue values ranged from <0.02 to <0.1 mg/kg and from <0.02 to <0.05 mg/kg for roots and leaves, respectively. Residue data are given in Table R.1.

 

Beetroot (GAP: 1x0.942 kg ai/ha)

Beetroot can be extrapolated from sugar beet or fodder beet.

 

Strawberries (GAP: 1x0.942 kg ai/ha, before flowering)

The MRL proposal of Finland (SCoFCAH October 2005) contained four residue trials from the DAR with 0.96 kg ai/ha in strawberry before flowering. Residue levels were found to be < LOQ (<0.01 or <0.05 mg/kg). Residue data are given in Table R.1.

 

Table R1: Selected residue levels from trials with phenmedipham

Crop

Residue levels selected for MRL setting (mg/kg)

STMR

(mg/kg)

HR

(mg/kg)

Sugar beet

300 residue trials were conducted with 0.32 to 4 kg as/ha. In 288 trials the residues were ≤ 0.1 mg/kg at PHI 18-192d

-

-

Beetroot

Extrapolation form sugar/fodder beet

 

 

Strawberry

<0.01; < 0.01; < 0.05; <0.05

0.03

0.05

 

5.1.6 Residues in succeeding crops

Due to fast degradation and strong adsorption in soil, no detectable residues are present in succeeding crops.

 

5.1.8 Processing factors

Processing studies with sugar beet are available in the DAR on phenmedipham. As no detectable residue levels (<0.02-<0.1 mg/kg) were present at harvest, no processing factor could be derived.

 

5.1.9 Calculation of the ADI and the ARfD

Calculation of the ADI

The ADI is based on the NOAEL of 3 mg/kg bw/d in the 2-year rat study. Application of a safety factor for inter- and intraspecies differences of 100 results in an ADI of 0.03 mg/kg bw/day (see the List of Endpoints for mammalian toxicology).

 

Calculation of the ARfD

No ARfD is derived since phenmedipham shows no acute toxic properties.

 

5.2 Maximum Residue Levels

MRLs have been established in Annex II and IIIb of (EC) 396/2005. The MRLs of 0.1 mg/kg for strawberry, 0.1 mg/kg for sugar beet and 0.1 mg/kg for beetroot cover the intended use of CORZAL.

 

The product complies with the MRL Regulation. Notification of the MRL is not necessary.

 

5.3 Consumer risk assessment

Risk assessment for chronic exposure through diet

A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSAs PRIMo rev.2 and the previously mentioned MRLs. Calculation of the TMDI shows that maximal 11.0 % of the ADi is used for the UK toddler diet. The TMDI uses 2.0 and 5.1 % of the ADI for the general population and for children, respectively.

 

Risk assessment for acute exposure through diet

Since no ARfD is derived, a calculation of the National Estimated Short Term Intake (NESTI) is not necessary.

 

Conclusion

No risk for the consumer due to the exposure to phenmedipham is expected when authorising CORZAL.

 

5.4 Data requirements

None.

 


 

6.                  Environmental fate and behaviour

 

F the current application of CORZAL, risk assessment is done in accordance with Chapter 2 of the RGB.

 

The ecotoxicological assessment showed that there were exceedings of the threshold values for aquatox. The applicant proposed the following restriction sentence:

 

Om in het water levende organismen te beschermen is de toepassing van de enkelvoudige dosering van 6 l/ha in suiker-en voederbieten, rode bieten en aardbeien op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik wordt gemaakt van 75% driftreducerende spuitdoppen.

 

Due to this sentence some PECsw values were re-calculated (see paragraph 6.2,
Table M.3).

 

List of Endpoints Fate/behaviour

Phenmedipham is an old substance, placed on Annex I since 1 March 2005. For the risk assessment the final List of endpoints is used (SANCO/4060/2001 dd 13 February 2004). Additions are placed in italic.

 

List of Endpoints Fate/behaviour

 

Fate and Behaviour in the Environment

 


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

PMP: Mineralization after 100 days

 

CO2 evolved:

13.3 16.5 % of AR within 120 days, AP 14C-labelled, low temperature/low moisture (n=1)

9.7 11.3 % of AR within 120 days, phenoxy ring U-14C labelled (n=3)

PMP: Non-extractable residues after 100 days

 

63.6 64.1 % of AR within 120 days, AP 14C-labelled, low temperature/low moisture (n=1)

71.3 73.8 % of AR within 120 days

phenoxy ring U-14C labeled (n=3)

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

MHPC max 14 % of AR at day 14 (n=1)

APMP max 4 % of AR after 56 days (n=1)

(label position AP)

MHPC max 54 % at day 5 (n=1, ring-U-labelled)

MHPC: Mineralization after 100 days

From MHPC: ca. 10 % CO2 within 7 days (n=3)

MHPC: Non-extractable residues after 100 days

From MHPC: 80-83 % within 7 days (n=3)

 

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

Anaerobic degradation

 

CO2 evolved 6.6 % of AR,

NER 74.3 % of AR after 97 days,

MHPC max 19 % of AR after 32 days

(label position AP, n=1)

Soil photolysis

 

DT50 79 hours on irradiated soil

photochemical products:

3-aminophenol and 3-methoxycarbonylaminophenol

max 17.8 % of AR (sum of all polar products)

after 105 hours of irradiation

(n=1)

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

Method of calculation

laboratory: 1st order kinetics

computer program by Timme

 

Laboratory studies (range or median, with n value, with r2 value)

 

PMP

DT50lab (22C, aerobic): 14.1 days (n=1, r2 = 0.934)

Normalised to 20 C by using Q10 of 2.2: 16.4 days

DT50lab (20C, aerobic): 26, 42, 43 d, mean=37 days (n=3, r2 = 0.932 - 0.953)

 

DT90lab (22C, aerobic): 47 days (n=1, r2 = 0.934)

Normalised to 20 C by using Q10 of 2.2: 55 days

DT90lab (20C, aerobic): 85, 138, 143 days (n=3, r2 = 0.932 0.953)

 

DT50lab (11C, aerobic): 25 days,

DT90lab (11C, aerobic): 105 days

 

PMP

DT50lab (22C, anaerobic): 12.5 days (n=1, r2 = 0.934)

DT90lab (22C, anaerobic): 42 days (n=1, r2 = 0.934)

Metabolites:

MHPC

 

DT50lab (22C, aerobic): 12 days (n=1, r2 = 0.748) Ctgb: value is according to SFO using TopFit (in fact the value is 11.6 d, see Addendum 1 Vol 3, using Arrhenius a DT50 of 13.6 d is derived for 20 C)

DT90lab (22C, aerobic): 38 days (n=1, r2 = 0.748)

DT50lab (20C, aerobic): 0.1, 0.2, 0.3 days (n=3,

r2 = 0.992 - 0.999) NB square root kinetics

DT90lab (20C, aerobic): 1.2, 2.3, 2.9 days (n=3,

r2 = 0.992 - 0.999)

MHPC

DT50lab (20C, anaerobic): 49 days (n=1, r2 = 0.930)

DT90lab (20C, anaerobic): 161 days (n=1, r2 = 0.930)

APMP

DT50lab (22C, aerobic): 16.7 days (n=1, r2 = 0.993)

DT90lab (22C, aerobic): 55.5 days (n=1, r2 = 0.993)

APMP

DT50lab (20C, anaerobic): 70 days (n=1, r2 = 0.982)

DT90lab (20C, anaerobic): 231 days (n=1, r2 =0.982)

degradation in the saturated zone

no data submitted nor required

Field studies (state location, range or median with n value)

first order kinetics, DT50f:

Germany, bare soil, four sites:

5.8 days at pH 5.0,

9.0 days at pH 6.9,

15.7 days at pH 7.1,

39.9 days at pH 6.0,

mean 17.6 days (n=4, r2 not available, 1st order)

Ctgb: geomean 13.5 days

USA, California, one site:

sandy loam, on red beet stage 4-6 leaf:

13.3 days at pH 7.0 (n=1, r2 not available, 1st order)

 

metabolites: no DT50 values calculated in the field studies

 

DT90f: Germany, sites described above:

range 30 - 133 days, mean 82 days (n=4 , r2 not available, 1st order)

 

For PECsoil calculation the median DT50f of 15.5 days from the German field studies was used.

 

For FOCUS gw modelling the DT50lab of 25 days was used for PMP, and 7 days for MHPC.

Soil accumulation and plateau concentration

no data submitted nor required

 

Soil adsorption/desorption (Annex IIA, point 7.1.2)

Kf /Koc

PMP

 

 

 

 

 

 

 

MHPC

 

 

 

 

 

 

 

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

dependence)

Koc:

PMP:

657, 934, 1072, mean = 888, 1/n = 0.821, 0.865, 0.854

(soil samples, n = 3, equilibrium time 2.5 hours)

 

469, 728, mean = 599, 1/n = 0.82, 0.84

(sediments, n=2, equilibrium time 3 hours)

 

Koc:

MHPC: 212, 138, 58, 470, mean = 220, 1/n = 0.515, 0.699, 0.949, 0.805 (n = 4, one outlier excluded)

 

Kd:

MHPC: 0.57 - 4.8

 

Yes, due to the hydrolysis processes which indirect affect the adsorption of parent. No dependence for the metabolites.

 

For FOCUS gw modelling with FOCUS_PEARL v. 1.1.1 following median Kom values were used:

PMP: 422, 1/n = 0.84

MHPC: 101, 1/n = 0.752

 

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

Column leaching

PMP:

 

 

 

 

 

 

 

 

 

 

 

 

 

PMP:

 

 

 

 

 

 

 

 

 

 

 

 

PMP:

 

 

 

 

 

 

 

 

MHPC:

 

 

1) Guideline: US EPA subdiv. N, para 163.1

Precipitation: 920 ml corresponding to 50.8 cm rainfall in 10 days (92 ml/d)

Soils: 2 soils, label positions AP and T

Use rate: 0.825 kg/ha (AP) and 1.1 kg/ha (T)

Leachate: total residue 0.33 - 0.45 % of AR in leachates, not characterized further

Soil columns: total residue 88.1 92.6 % of AR in soil columns (mainly in the top 5 cm), NER 43.1 53.1 % and 34.9 60.4 % extractable of it

Volatiles 3.72 7.27 % of AR during the leaching period.

 

2) Guideline: US EPA subdiv. N, para 163.1

Precipitation: 560 mm in 5 days

Soil: 2 soils, label positions AP and T

Use rate 1.65 kg/ha

Leachate: total residue 0.6 - 2.3 % of AR in leachates, not characterized further

Soil columns: total residue 89.5 95.4 % of AR in soil columns (mainly in the top 10 cm), extractable 26 64 % of it, mainly unchanged parent

Volatiles not trapped.

 

 

3) Guideline: BBA

Precipitation: 200 ml/day for 2 days

Soils: 3 soils, label position AP

Use rate: 1.5 kg/ha

Leachate: total residue <0.5 % of AR in leachates, not characterized further

Soil columns: total residue > 93 % of AR, mainly in the top 5 cm.

 

Guideline: TNO in-house method

Precipitation: 140 ml/day for 3 days, corresponding to 30 cm of rainfall in 3 days

Soils: 2 soils, humic sand and loam

Use rate: 0.5 mg MHPC/column

Leachate: 47.2 - 47.7 % of AR in leachates in the loam soil, not detected in the humic sand soil

Soil columns: In the humic sand the main part of the activity remained in the soil layers 12-24 cm, in the loam soil the activity was evenly distributed to the layers 6-30 cm, and only traces were located in the top 5 cm.

Aged residues leaching

 

1) Guideline: BBA

Soils: 1 soil, German standard soil 2.1

Use rate: 960 g/ha, label position T

Aged at 20 degrees C, 40 % MWHC, for 33 days

Precipitation: 2 days irrigation of 200 mm

Leachate: 0.48 % of AR was found in the leachate, not characterized further

Soil column: 96.2 % of AR remained in soil, mainly in the top 10 cm

Volatiles: 5.7 % of AR.

 

2) Guideline: EPA Vol 40, No 123, Part II, 1975

Soils: 2 soils, German standard soils 2.2 and 2.3

Use rate: 1.25 kg/ha, label position AP

Aged at 25-30 degrees C, 70 % MWHC, for 30 days

Precipitation: 45 days irrigation of 125 mm/day

Leachate: 0.58 and 1.66 % of AR was found in the leachates, not characterized further

Soil column: 99.1 112.9 % of AR remained in the soil, mainly in the top 6 cm. The aged soil was not analysed further for the metabolites.

 

3) Guideline: EPA Vol 40, No 123, Part II, 1975

Soils: 2 soils, German standard soils 2.2 and 2.3

Use rate: 1.65 kg/ha on soil 2.2 and 1.25 kg/ha on soil 2.3, label position T

Aged at 25-30 degrees C, 75 % MWHC, for 30 days

Precipitation: 45 days irrigation of 125 mm/day

Leachate: 1.37 - 1.83 % of AR was found in the leachates, not characterized further

Soil column: 72.9 88.7 % of AR remained in the soil, mainly in the top 5 cm. The aged soil was not characterized further for the metabolites.

Lysimeter/ field leaching studies

 

1) Location: UK

Study type: lysimeter

Soils: loamy sand, low content of organic matter

Number of applications: one single application of 0.942 kg/ha in the first year, study continued over 2 years

Crops: sugar beet + wheat

Average annual rainfall: 757 mm (1st year), 948 mm (2nd year)

Average annual leachate volume: 200 mm/ first year (25 % of the precipitation), 445 mm/ second year (47 % of the precipitation)

% radioactivity in the leachate (max/year): after 2 years totally 0.8 - 1.1 % of AR was leached

Peak annual average concentrations: total radioactive residues 1.28 1.9 mg/l in the first year, 1.1 1.33 mg/l in the second year (40 % of AR in leachate attributed to humic acid type fragments and up to 27 % incorporated with naturally occurring compounds), MHPC 0.006 mg/l, PMP could not be detected in any of the samples (LOD = 0.03 mg/l as a.s.equivalents).

 

2) Location: Germany

Study type: lysimeter

Soils: loamy sand with low organic matter content

Number of applications: 1.0 kg/ha either once or in two successive years, study continued for up to 3 years

Crops: sugar beet (1 or 2 successive years) + wheat

Average annual rainfall: 860 mm/year (cumulative sum of 2582 mm within 3 years)

Average annual leachate volume: 428 mm

% radioactivity in the leachate (max/year): after 2 years totally 0.22 - 0.32 % of AR was leached

Peak annual average concentrations: total radioactive residues 0.314 0.805 mg/l (water soluble humic acid-type components, due to the low radioactivity the further characterization was not possible). MHPC was calculated as <0.01 mg as equivalents/l. (LOQ = 0.017 mg/l for PMP and 0.010 mg/l for MHPC).

 

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)

DT50 DT90 r2

pH 4: 259 d 861 d -0.9726

pH 5: 47 d 156 d -0.9958

pH 7: 12 h 39 h -0.9922

pH 9: 7 min 24 min -0.9860

(25 oC, 1st order kinetics)

Hydrolysis products:

MHPC formed:

pH 4: max 8.0 % of AR after 672 h

pH 5: max 38.0 % of AR after 720 h

pH 7: completely after 72 h

pH 9: completely after 30 min

 

MHPC is hydrolytically stable at pH 4, 5, 7, 9 under sterile conditions and at 50 oC over 120 h.

Photolytic degradation of active substance and

relevant metabolites

no degradation (artificial light source, λ > 290 nm)

Readily biodegradable (yes/no)

no

Degradation in - DT50 water

water/sediment - DT90 water

 

- DT50 whole system

- DT90 whole system

 

 

MHPC: - DT50 water

- DT90 water

- DT50 whole system

- DT90 whole system

 

 

Mineralisation

NER in sediment

 

 

 

 

Distribution in water / sediment systems (active

substance)

 

 

 

 

 

 

Distribution in water / sediment systems

(metabolites)

0.1 0.3 days (t/1st order, r2 = 0.989, 0.544, n=2)

0.6 3.4 days (t/1st order, r2 = 0.989, 0.544, n=2)

 

0.11, 0.12, 0.18 days (1st order kinetics, r2 = 0.942 0.978, n=3) geomean 0.133 d

0.38, 0.40, 0.60 days (1st order kinetics, r2 = 0.942 0.978, n=3)

 

10-21 days (apparent DT50 determined visually)

not available

 

10.6, 23.9, 24.9 days (1st order kinetics, r2 = 0.942 0.978, n=3) geomean = 18.5 d

35.3, 79.4, 82.8 days (1st order kinetics, r2 = 0.942 0.978, n=3)

 

CO2: 14 - 30 % of AR at study end after 126 days (n=2)

NER in sediment: max.55 - 78 % of AR after 70/35 days,

50 % at study end after 126 days, n=2)

 

1 - 2 % of AR in water phase and

51 - 55 % in sediment after 126 days

(non-sterilised samples, 2 label positions, 2 systems),

44 - 51 % of AR in water and

39 - 44 % in sediment after 126 days (sterilised samples, 1 label position, 2 systems).

 

MHPC: 60 - 70 % of AR within 1 - 2 days

1 % of AR after 126 days

 

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

Direct photolysis in air

not studied, no data required

Photochemical oxidative degradation in air (DT50)

6.7 hours derived by the Atkinson method of calculation

Volatilization

from plant surfaces: no data

 

from soil: no data

 

Major Components of the Environmental Residue (Annex IIA, point 7.3)

Relevant to the environment

 

 

Soil: phenmedipham, MHPC

Water: phenmedipham, MHPC

Air: phenmedipham

 

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

Soil (indicate location and type of study)

no data submitted nor required

Surface water (indicate location and type of study)

no data submitted nor required

Ground water (indicate location and type of study)

no data submitted nor required

Air (indicate location and type of study)

no data submitted nor required

 

Tank mix: information ethofumesate and metamitron

 

Endpoints ethofumesate

Ethofumesate is an existing substance, placed on Annex I. For the risk assessment the final List of Endpoints is used.

 

Endpoints metamitron

Metamitron is an existing substance, is placed on Annex I (01/09/2009). A DAR is available, RMS is UK. For the risk assessment endpoints from the DAR (08/2007) is used, Dutch comments are included. Since ethofumesate and metamitron are only proposed in a tankmix, only the relevant information (used for PEC calculations) is given below.

 

Parameter

Endpoint/unit

Ethofumesate

Metamitron

Degradation in soil

Worst-case field DT50 (days)

250

22

Sorption

Kom (L/kg)

85.3 for soil (n=11), 207.7 for sediment (n=2)

70.9 for soil (n=15)

Degradation in water

DT50system (days)

114.6 d (calculated by Ctgb, geomean based on only simple first order kinetics, n=2, ind. values 125 and 105 d)

11.1(geomean)

Volatility

Vapour pressure (Pa)

6.5 x 10-4 Pa (25C)

7.44x 10-7 Pa (25C)

Solubility in water

mg/L

50 mg/L (25C)

1770 mg/L

Molar mass

g/mol

286.3

202.2

 

6.1 Fate and behaviour in soil

 

6.1.1 Persistence in soil

Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion persistence. If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPC-INS[1] method. Currently this method equals the method described in the Technical Guidance Document (TGD). Additional guidance is presented in RIVM[2]-report 601782001/2007[3].

 

For the current application this means the following:

 

phenmedipham

The following laboratory DT50 values are available for the active substance phenmedipham: 42, 26 and 43 days (average 37 days, geomean 29.6 d). 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.

 

Available field studies show first order kinetics DT50f values of 5.8, 9.0, 15.7 and

39.9 days (Germany, bare soil, n=4) with a geomean of 13.5 days.

 

For the metabolite MHPC (maximum observed 54 %) the following DT50-values are available: 12 (SFO), 0.1, 0.2, 0.3 (best fit all square root kinetics) days. The value of 12 days (11.6 d) was derived at 22 C, Ctgb recalculated to 20 C using Arrhenius yielding a value of 13.6 days. The geomean is 0.53 d.

 

In the photolysis study described in the DAR and List of Endpoints, 2 major metabolites were observed, total AR was 18.5 %. Major metabolites were 3-aminophenol and MHPC. The last one is listed in the List of Endpoints as 3-methoxycarbonylaminophenol, while in the DAR (top of B.8) it is defined as methyl-(3-hydroxy phenyl)carbamate. This appears to be a nomenclature issue, which is backed up by the remark in the summary on degradation in soil section: MHPC was the main product of the photolysis, too.

 

The amount of MHPC formed by photolysis is covered by the higher % formed in the standard aerobic test. It is unknown what part of the 18.5 % AR is caused by 3-aminophenol. However, as it was stated that MHPC was the main product of the photolysis (interpreted as more than half which means that the % AR 3-aminophenol would be < 10 %), the metabolite 3-aminophenol is not addressed further.

 

Based on the above, the standards of persistence are met.

 

PECsoil

The concentration of phenmedipham and metabolite MHPC, as well as for the substances present in the tank mix, in soil is needed to assess the risk for soil organisms (earthworms, micro-organisms). The PECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m3.

 

The PIEC for the metabolite is only calculated for the use with the highest application rate (sugar beet, single application) and covers all other uses.

 

The logKow of phenmedipham is 3.59, therefore also the PEC21d is calculated to account for secondary poisoning. Since the log Kow of ethofumesate, metamitron and metabolite MHPC is < 3 (2.7, 0.96, 0.92), no risk assessment for secondary poisoning is necessary.

 

The following input data are used for the calculation:

 

PEC soil:

 

Phenmedipham:

Worst case field DT50 for degradation in soil (20C): 39.9 days

 

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

Worst case lab DT50 for degradation in soil (20C): 13.6 days

 

Molecular weight: 167.2 g/mol

Correction factor: 0.54 (formation % metabolite) * 0.557 (relative molar ratio = M metabolite/M parent) = 0.30

 

Ethofumesate:

Worst case field DT50 for degradation in soil: 250 days

 

Molecular weight: 286.3 g/mol

 

Metamitron:

Worst-case field DT50 for degradation in soil: 22 days

 

Molecular weight: 202.2 g/mol

 

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

 

Table M.1 PECsoil calculations (5 cm)

Use

Substance

Correction factor

Rate

[kg a.s./ha]

Freq./

interval

Fraction on soil

PIECsoil

5 cm

[mg a.s./kg]

PECsoil

21 days,

[mg a.s./kg]

sugar and fodder beet (1a)

Phenmedipham

MHPC

-

0.30

0.94

0.29

1/-

0.8

1.00

0.31

0.84

-

sugar and fodder beet (tank mix with ethofumesate) (1b)

Phenmedipham

Ethofumesate

 

0.47

0.30

2/10

0.8

0.92

0.63

0.77

-

sugar and fodder beet (tank mix with metamitron) (1c)

Phenmedipham

Metamitron

 

0.47

1.05

2/10

0.8

0.92

1.94

0.77

-

sugar and fodder beet (LDS) (1d)

Phenmedipham

Metamitron Ethofumesate

 

0.16

0.70

0.20

4/7

0.8

0.57

2.21

0.83

0.48

-

-

Beet root (2a)

Phenmedipham

 

0.94

1/-

0.8

1.00

0.84

Beet root (2b)

Phenmedipham

Metamitron

 

0.47

1.05

1/-

0.8

0.50

1.12

0.42

Strawberries (3)

Phenmedipham

 

0.94

1/-

0.8

1.00

0.84

 

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

 

6.1.2        Leaching to shallow groundwater

Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater. The leaching potential of the active substance phenmedipham and metabolite MHPC is calculated in the first tier using Pearl 2.2.2. and the FOCUS Kremsmnster scenario. The other substances present in the tank mix are not assessed since combination risk is not relevant for groundwater.

 

Input variables are the actual worst-case application rate [up to 0.94 kg/ha], the crop [sugar beets for all beet applications, and winter cereals for the other crops] and an interception value appropriate to the crop of [default fraction on soil 0.8]. First date of yearly application is May 25th.

For metabolites all available data concerning substance properties are regarded. Metabolite MHPC is included in the calculations. No other metabolites occurred above > 10 % of AR, > 5 % of AR at two consecutive sample points or had an increasing tendency. The following input data are used for the calculation:

 

 

 

PEARL:

 

Phenmedipham:

Geomean DT50 for degradation in soil (20C): 29.6 days (n=4)

Mean Kom (pH-independent): 515.1 L/kg

1/n: 0.85

 

Saturated vapour pressure: 7.0x 10-10 Pa (25C)

Solubility in water: 0.0018 g/L (20C at pH 3.4, decomposes at neutral/basic pH)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

Mean DT50 for degradation in soil (20C): 13.6 d (only SFO value)

Mean Kom (pH-independent): 127.6 L/kg

1/n: 0.74

 

Maximum fraction of occurrence: 0.54

 

Saturated vapour pressure: see parent

Solubility in water: see parent

Molecular weight: 167.2 g/mol

 

Other parameters: standard settings of PEARL 2.2.2

 

The following concentrations are predicted for the a.s. phenmedipham and the metabolite MHPC following the realistic worst case GAP, see Table M.2.

 

Table M.2 Leaching of a.s. phenmedipham and metabolite MHPC as predicted by PEARL 2.2.2

No./ Use

Substance

Rate substance [kg/ha]

Frequency

Interval [days]

Fraction

intercepted

PEC* groundwater [mg/L]

Sugar beets and fodder beets, single application (1a)

Phenmedipham

MHPC

0.94

-

1

-

0.2

< 0.001

< 0.001

Sugar beets and fodder beets, tank mix with ethofumesate (1b)

Phenmedipham

MHPC

0.47

 

2

10

0.2

< 0.001

< 0.001

Sugar beets and fodder beets, tank mix with metamitron (1c)

Phenmedipham

MHPC

0.47

 

2

10

0.2

< 0.001

< 0.001

Sugar and fodder beets, LDS with ethofumesate + metamitron (1d)

Phenmedipham

MHPC

0.16

 

4

7

0.2

< 0.001

< 0.001

Beet root (2a)

Phenmedipham

MHPC

0.94

1

-

0.2

< 0.001

< 0.001

Beet root, tank mix with metamitron (2b)

Phenmedipham

MHPC

0.47

 

1

-

0.2

< 0.001

< 0.001

Strawberry (3)

Phenmedipham

MHPC

0.94

1

-

0.2

< 0.001

< 0.001

 

Results of Pearl 2.2.2. using the Kremsmnster scenario are examined against the standard of 0.01 g/L. This is the standard of 0.1 g/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. phenmedipham and its metabolite MHPC is smaller than 0.01 g/L for all proposed applications. Hence, the applications meet the standards for leaching as laid down in the RGB.

 

Lysimeter studies

Phenmedipham

Two lysimeter studies are available in the DAR. In both studies, the concentrations of phenmedipham and MHPC could not be detected or were < 0.01 g/L. These lysimeter studies are not standardised to the Dutch conditions. Since no leaching is expected, this is not necessary.

 

Monitoring data

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

 

Conclusions

The proposed applications of the product comply with the requirements laid down in the RGB concerning persistence in soil and leaching to groundwater.

 

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 phenmedipham and metabolite MHPC in surface water have been estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. Also the substances prescribed in the tank mixes (metamitron and ethofumesate) are calculated to assess combination toxicology.

 

Since the application is a post-emergence herbicidal treatment, it is assumed that aircraft application is not relevant.

 

The applicant proposed the following restriction sentence:

 

Om in het water levende organismen te beschermen is de toepassing van de enkelvoudige dosering van 6 l/ha in suiker-en voederbieten, rode bieten en aardbeien op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik wordt gemaakt van 75% driftreducerende spuitdoppen.

 

The spray drift percentage depends on the use. Concentrations in surface water are calculated using the model TOXSWA. The following input data are used for the calculation:

 

TOXSWA:

 

Phenmedipham

Geomean DT50 for degradation in water at 20C: 0.133 days

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

 

Kom for suspended organic matter: 347.5 L/kg (derived from sediment studies)

Kom for sediment: 347.5 L/kg

1/n: 0.83

 

Saturated vapour pressure: 7 x 10-10 Pa (25 C)

Solubility in water: 0.0018 g/L (20C at pH 3.4, decomposes at neutral/basic pH)

Molecular weight: 300.3 g/mol

 

Metabolite MHPC:

Geomean DT50 for degradation in water at 20C: 18.5 days

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

 

Mean Kom for suspended organic matter: 127.6 L/kg

Mean Kom for sediment: 127.6 L/kg

1/n: 0.74

 

Molecular weight: 167.2 g/mol

Formation fraction: 70% formation * 0.56 (g/mol M1/g/mol parent)=0.39

 

Ethofumesate

Geomean DT50 for degradation in water at 20C: 114.6 days (only SFO fits taken into account)

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

 

Kom for suspended organic matter: 207.7 L/kg

Kom for sediment: 207.7 L/kg

1/n: 0.9 (default)

 

Saturated vapour pressure: 6.5 x 10-4 Pa (25 C)

Solubility in water: 0.05 g/L (25 C)

Molecular weight: 286.3 g/mol

 

Metamitron

Geomean DT50 for degradation in water at 20C: 11.1 days

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

 

Kom for suspended organic matter: 71.9 L/kg

Kom for sediment: 71.9 L/kg

1/n: 0.77

 

Saturated vapour pressure: 7.44 x 10-7 Pa (25 C)

Solubility in water: 1.77 g/L (25 C)

Molecular weight: 202.2 g/mol

 

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 phenmedipham and its metabolite MHPC for each intended use are presented. Also the substances prescribed in the tank mixes are calculated to assess combination toxicology.

 

In view of the difference in half-lives of parent and metabolite, the concentration of metabolite MHPC is calculated for both single as multiple uses.

 

Table M.3 Overview of surface water concentrations for active substance phenmedipham and metabolite MHPC as well as for the tank mix substances ethofumesate and metamitron following spring application

No/ Use

Substance

Rate a.s.

[kg/ha]

Freq./

inter-val

Drift

[%]

PIEC

[mg/L] *

PEC21

[mg/L] *

PEC28

[mg/L] *

Sugar beets and fodder beets, single application (1a)

Phenmedipham

MHPC

0.94

0.37

1

1

4.47

1.76

0.09

1.35

0.07

1.24

Sugar beets and fodder beets, single application (1a)

Phenmedipham

MHPC

0.94

0.37

1

0.5 1

2.23

0.88

0.045

0.67

0.034

0.62

Sugar beets and fodder beets, tank mix with ethofumesate (1b)

Phenmedipham

MHPC

Ethofumesate

0.47

0.18

0.30

2 (10 d)

1

2.23

1.50

2.64

0.09

1.15

2.28

0.07

1.04

2.05

Sugar beets and fodder beets, tank mix with metamitron (1c)

Phenmedipham

MHPC

Metamitron

0.47

0.18

1.05

2 (10 d)

1

2.23

1.50

8.48

0.09

1.15

5.97

0.07

1.04

5.54

Sugar and fodder beets, LDS with ethofumesate + metamitron (1d)

Phenmedipham

MHPC

Metamitron Ethofumesate

0.16

0.06

0.70

0.20

4 (7d)

1

0.76

0.88

9.62

3.31

0.05

0.69

7.24

2.73

0.05

0.63

6.73

2.53

Beet root (2a)

Phenmedipham

MHPC

0.94

0.37

1

1

4.47

1.76

0.09

1.35

0.07

1.24

Beet root (2a)

Phenmedipham

MHPC

0.94

0.37

1

0.5 1

2.23

0.88

0.045

0.67

0.034

0.62

Beet root, tank mix with metamitron (2b)

Phenmedipham

MHPC

Metamitron

0.47

0.18

1.05

1

1

2.23

0.86

5.00

0.05

0.65

3.52

0.03

0.60

3.17

Strawberry (3)

Phenmedipham

MHPC

0.94

0.37

1

1

4.47

1.76

0.09

1.35

0.07

1.24

Strawberry (3)

Phenmedipham

MHPC

0.94

0.37

1

0.5 1

2.23

0.88

0.045

0.67

0.034

0.62

* calculated according to TOXSWA

1 drift percentage for 75 % drift mitigation measures

 

The exposure concentrations in surface water are compared to the ecotoxicological threshold values in section 7.2.

 

Monitoring data

The pesticide atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the observed concentrations exceed threshold values.

Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters. In the pesticide atlas, these monitoring data are processed into a graphic format accessible on-line and aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards. This is for each substance represented in an aggregated way by (among others) a set of maps with grid cells of either 5 x 5 km or 1 x 1 km.

The active substance phenmedipham was observed in the surface water (most recent data from 2005-2006). In Table M.4 the number of observations in the surface water are presented.

In the pesticide atlas, surface water concentrations are compared to the authorisation threshold value 4.1 g/L (dated 05-03-07, C-179.3.7) consisting of first or higher tier acute or chronic ecotoxicological threshold value used for risk assessment (in this case 0.01*EC50 Daphnia) and to the Maximum Permissible Concentration (MPC) as established in the Fourth National Policy Document on Water Management (value 0.5 g/L, May 2007).

Currently, this MPC value is not harmonised, which means that not all available ecotoxicological data for this substance are included in the threshold value. In the near future and in the framework of the Water Framework Directive, new quality criteria will be developed which will include both MPC data as well as authorisation data.

The currently available MPC value is reported here for information purposes. Pending this policy development (finalisation for all substances expected in 2009-2010), however, no consequences can be drawn for the proposed application(s).

 

Table M.4 Monitoring data in Dutch surface water (from www.pesticidesatlas.nl)

Total no of observations

(2005-2006)

n > authorisation threshold

 

n > MPC threshold

4th Document water management

n > MPC-INS threshold *

227

0

0

n.a.

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with 4th Document MPC value; > : exceeding expected to be higher than with 4th Document MPC value

 

No exceeding of the threshold values occurred.

 

Drinking water criterion

It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) that when considering an application, the Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion surface water intended for drinking water production. No mathematical model for this aspect is available. This means that any data that is available cannot be adequately taken into account. It is therefore not possible to arrive at a scientifically well-founded assessment according to this criterion. The Ctgb has not been given the instruments for testing surface water from which drinking water is produced according to the drinking water criterion. In order to comply with the Courts decision, however - from which it can be concluded that the Ctgb should make an effort to give an opinion on this point and as provisional measure, to avoid a situation where no authorisation at all can be granted during the development of a model generation of the data necessary, the Ctgb has investigated whether the product under consideration and the active substance could give cause for concern about the drinking water criterion.

 

Phenmedipham has been on the Dutch market for > 3 years (authorised since 04-04-1996). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met.

 

6.3 Fate and behaviour in air

 

Route and rate of degradation in air

Phenmedipham

The vapour pressure is 7.0x 10-10 Pa at 25C. The Henry constant is 5 x 10-8 Pa x m3 mol-1 at 20C. The half-life in air is 6.7 hours.

 

Since at present there is no framework to assess fate and behaviour in air of plant protection products, for the time being this issue is not taken into consideration.

 

 

6.4 Appropriate fate and behaviour end-points relating to the product and approved uses

See List of Endpoints.

 

6.5 Data requirements

None.

 

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

Om in het water levende organismen te beschermen is de toepassing van de enkelvoudige dosering van 6 l/ha in suiker-en voederbieten, rode bieten en aardbeien op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien gebruik wordt gemaakt van 75% driftreducerende spuitdoppen. (to be confirmed by ecotoxicological assessment)

 

6.6 Overall conclusions fate and behaviour

It can be concluded that:

1.      the active substance phenmedipham and metabolite MHPC meet the standards for persistence in soil as laid down in the RGB.

2.      all proposed applications of the active substance phenmedipham and metabolite MHPC meet the standards for leaching to the shallow groundwater as laid down in the RGB.

3.      all proposed applications of the active substance phenmedipham and metabolite MHPC meet the standards for surface water destined for the production of drinking water

 

 

7.                  Ecotoxicology

 

Risk assessment is done in accordance with HTB 1.0 for products based on
- active substances which have already been placed on Annex I of directive 91/414/EEC

- new active substances;

for other plant protection products, HTB 0.2 applies.

This means that for the current application of CORZAL, risk assessment is done in accordance with HTB 1.0.

 

Phenmedipham

Phenmedipham is an existing substance, placed on Annex I since 1 March 2005. For the risk assessment the final List of Endpoints is used (SANCO/4060/2001 dd 13 February 2004). Additions are placed in italic.

 


Effects on Non-target Species

 

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

Acute toxicity to mammals

rat: LD50 >320 mg a.i./kg body weight (formulation >2000 mg/kg)

phenmedipham technical: > 5000 mg /kg bw (taken from DAR)

Acute toxicity to birds

mallard duck: LD50 and NOEL >2100 mg/kg body weight

mallard duck & japanese quail: LD50 >2500 mg/kg body weight, NOEL 2500 mg/kg

as in the first study with mallard no effects were found, the higher NOEL value from the last study could be used in the risk assessment

Dietary toxicity to birds

mallard duck : NOEC 2000 mg/kg feed

bobwhite quail: NOEC 5000 mg/kg feed

Reproductive toxicity to birds

bobwhite quail: NOEC 1200 mg/kg feed ( = 121 mg a.s./kg bw/d, taken from DAR)

Reproductive toxicity to mammals

3-generation rat study: NOAEL 100 mg/kg corresponding to 6.8 mg PMP/kg b.w./day

 

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

recalculated based on initially measured concentrations

Toxicity

(mg/l)

 

Laboratory tests

PMP:

 

 

 

 

Rainbow trout

technical phenmedipham

96 hours

LC50

1.71

Rainbow trout