Toelatingsnummer 13479 N

Taifun 360

13479 N

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1 WEDERZIJDSE ERKENNING

Gelet op de aanvraag d.d. 30 september 2010 (20100889 WERG) van

Makhteshim-Agan Holland B.V.

Arnhemseweg 87

3832 GK LEUSDEN

tot verkrijging van een wederzijdse erkenning van de toelating in België van het middel op basis van de werkzame stof glyfosaat

Taifun 360

gelet op artikel 36, Wet gewasbeschermingsmiddelen en biociden,

BESLUIT HET COLLEGE als volgt:

1.1 Uitbreiding

1. Het middel Taifun 360 is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 13479 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2. De toelating geldt tot 19 maart 2013 (gelijk aan de expiratiedatum in België).

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: Met water mengbaar concentraat

werkzame stof:	gehalte:
glyfosaat	360 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:

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

V32-NL -Middel en oplossingen ervan niet opslaan of laten overdslaan in gegalvaniseerde of metalen tanks, omdat daardoor een zeer brandbaar gas kan ontstaan (niet roken!).

Specifieke vermeldingen:

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

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

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

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

2 DETAILS VAN DE AANVRAAG

2.1 Aanvraag

Het betreft een aanvraag tot verkrijging van een toelating van het middel Taifun 360 (13479 N), een middel op basis van de werkzame stof glyfosaat. Het middel wordt aangevraagd als:

a. onkruidbestrijdingsmiddel

- in akkerbouwgewassen, fruitgewassen, groenteteelt, kruidenteelt, sierteeltgewassen, cultuurgrasland en in openbaar groen, met uitzondering van de teelt van granen bestemd voor vermeerdering of bierproductie

- op tijdelijk en permanent onbeteeld terrein;

b. bestrijdingsmiddel voor het doden van gras in cultuurgrasland en openbare grasvegetatie

2.2 Informatie met betrekking tot de stof

De werkzame stof glyfosaat is per 1 juli 2002 geplaatst op Annex ! van gewasbeschermingsrichtlijn 91/414/EG

2.3 Karakterisering van het middel

Het middel Taifun bevat de werkzame stof glyfosaat. Deze werkzame stof is al vele jaren in diverse formuleringen toegelaten. Glyfosaat behoort tot de chemische groep van glycines en is geformuleerd als glyfosaat-trimesium- of glyfosaat-ammonium-zout.

Het werkingsmechanisme van glyfosaat, na opname via de bladeren en transport in de plant, bestaat uit het verhinderen van de biosynthese van essentiële aromatische aminozuren zoals phenylalanine, tyrosine en tryptofaan. De eiwitsynthese wordt hierdoor geremd met als gevolg dat de aminozuren glutamine en glutaminezuur zich ophopen in de plant. De plant sterft binnen enkele weken volledig af.

Zodra glyfosaat in contact komt met de bodem, wordt de werkzame stof geïnactiveerd. Opname door de wortels via de grond vindt niet plaats. Wel kan bij direct wortelcontact (vergroeiing van de wortels), het middel van de ene plant naar de andere plant getransporteerd worden.

2.4 Voorgeschiedenis

De aanvraag is op 1 oktober 2010 ontvangen; op 5 augustus 2010 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 6 april 2011 is de aanvraag in behandeling genomen.

3 RISICOBEOORDELINGEN

3.1 Inleiding

De onderhavige aanvraag betreft een verzoek tot wederzijdse erkenning van de toelating in België van het gewasbeschermingsmiddel Taifun 360. Gezien de aard van de wederzijdse erkenning wordt ervan uitgegaan dat de beoordeling door België is uitgevoerd conform de Uniforme Beginselen (annex VI bij richtlijn 91/414/EEG).

Voor de beoordeling van de aspecten fysische en chemische eigenschappen, analysemethoden, werkzaamheid en delen van de aspecten risico voor de mens en risico voor het milieu refereert het Ctgb aan het toelatingsbesluit in België.

Op een aantal hieronder weergegeven voor de Nederlandse situatie specifieke punten, toetst het Ctgb zelf inhoudelijk.

3.2 Risico voor de mens

De volgende aspecten worden nationaal ingevuld:

· Arbeidsomstandigheden - nationale modellen en arbeidshygiënische strategie

· Volksgezondheid - de criteria voor residuen in volggewassen

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 beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, van Bijlage II bij dit besluit.

De beoordeling van het risico voor de volksgezondheid met betrekking tot residuen in volggewassen staat beschreven in Hoofdstuk 5, Residues van bijlage II behorende bij dit besluit.

3.3 Risico voor het milieu

De volgende aspecten worden nationaal ingevuld:

· 90–percentiel – de bodem, het grondwater, het oppervlaktewater en het sediment, en innamepunten van drinkwater uit oppervlaktewater

· Uitspoeling naar grondwater

· Persistentie – MTR

· Waterorganismen – MTR

· Waterorganismen, vogels, zoogdieren, niet-doelwitplanten, niet-doelwitarthropoden en oppervlaktewater bestemd voor de bereiding van drinkwater – drift

· RWZI

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.

3.4 Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Taifun 360 op basis van de werkzame stof glyfosaat 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, 8 juli 2011

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,



dr. D. K. J. Tommel

voorzitter

Dit middel is uitsluitend bestemd voor professioneel gebruik

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE I bij het besluit d.d. 8 juli 2011 tot toelating van het middel Taifun 360, toelatingnummer 13479 N.

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

Toegestaan is uitsluitend het gebruik als:

a. onkruidbestrijdingsmiddel

- in akkerbouwgewassen, fruitgewassen, groenteteelt, kruidenteelt, sierteeltgewassen, cultuurgrasland en in openbaar groen, met uitzondering van de teelt van granen bestemd voor vermeerdering of bierproductie

- op tijdelijk en permanent onbeteeld terrein (exclusief half-open en gesloten verhardingen);

b. bestrijdingsmiddel voor het doden van gras in cultuurgrasland en openbare grasvegetatie

Veiligheidstermijnen

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

7 dagen voor granen, droog te oogsten landbouwstambonen, - veldbonen, -voedererwten

- De termijn tussen de laatste (plaatselijke) toepassing in grasland en het beweiden of oogsten: 7 dagen

- De termijn tussen het doodspuiten van gras en een volgende teelt: 7 dagen

Het middel is uitsluitend bestemd voor professioneel gebruik.

B.

GEBRUIKSAANWIJZING

Algemeen

Taifun 360 is een herbicide met systemische werking. Het middel heeft geen werking via de grond. Het werkt tegen eenjarige en overblijvende grasachtige en tweezaadlobbige onkruiden zoals: kweekgras, riet, fioringras, aardappelopslag, klein hoefblad, akkerdistel, akkermunt, veenwortel, knolcyperus, kleefkruid, muur, varkensgras e.a. Minder gevoelig zijn: paardestaart, klaver en wikkesoorten en moerasandoorn. Mossen worden niet bestreden.

De werking is het beste als de onkruiden voldoende blad hebben ontwikkeld en niet zijn beschadigd door ziekten en plagen. De toepassing heeft het beste resultaat tijdens niet te warm, bewolkt weer met een hoge luchtvochtigheid. Het middel dient niet te worden toegepast als er kans is op aanhoudende vorst of als er binnen 4 à 6 uur na de toepassing kans bestaat op regen. Tijdens de toepassing van het middel dienen gewas en onkruid bij voorkeur droog te zijn.

Het middel kan in zeer geringe hoeveelheden al schade doen aan te sparen gewassen, de toepassing dient daarom zeer zorgvuldig te geschieden. Gebruik in dit verband een middelmatige of grove druppelgrootte.

Waterhoeveelheid bij een bespuiting m.b.v. de trekker: 200 – 400 L/ha

Per gewas maximaal 1 keer toepassen.

Toepassingen

in akkerbouwgewassen, fruitgewassen, groenteteelt, kruidenteelt, sierteeltgewassen, cultuurgrasland en in openbaar groen

A) Door middel van een bespuiting tussen de rijen zonder het gewas te raken.

De dosering aanpassen naar het oppervlak tussen de rijen.

1) Voor de bestrijding van ontwikkelde onkruiden in het algemeen

Dosering: 2 – 4 L middel per ha (Minimaal 2,8 L/ha bij sterk ontwikkeld onkruid.)

2) Voor de bestrijding van kweekgras en zuring

Dosering: 4 L middel per ha.

3) Voor de bestrijding van brandnetels, wilgeroosje, basterdwederik, weegbree, braamstruiken, samengesteldbloemigen, bijvoet, distels, boterbloem en varens.

Dosering: 5 L middel per ha.

B) Toepassing door middel van plaatselijke toediening bijvoorbeeld met onkruidstrijkers. Dit kan voor zover er voldoende hoogteverschil is tussen de teelt en de onkruiden.

Dosering: 3,3 – 5,5 L middel aanlengen tot 10 L.

Er kan een “carmoisine” kleurstof worden toegevoegd om behandelde planten te merken.

Granen (tarwe, gerst, rogge, haver, triticale en spelt) niet bestemd voor vermeerdering of bierproductie, toegepast kort voor de oogst op een afgerijpt gewas

Toepassingsstadium: Deegrijpheid. Bladeren, stengels en knopen zijn volledig geel (BBCH 85)

Voor de bestrijding van ontwikkelde onkruiden in het algemeen

Dosering: 2,8 – 4 L middel per ha.

Landbouwstambonen (drooggeoogst), toegepast kort voor de oogst op een afgerijpt gewas

Toepassingsstadium: 50% van de peulen rijp, zaden hard en droog (BBCH 85)

Voor de bestrijding van ontwikkelde onkruiden in het algemeen

Dosering: 2,8 – 4 L middel per ha.

Veldbonen (drooggeoogst), toegepast kort voor de oogst op een afgerijpt gewas

Toepassingsstadium: 50% van de peulen rijp, zaden hard en droog (BBCH 85)

Voor de bestrijding van ontwikkelde onkruiden in het algemeen

Dosering: 2,8 – 4 L middel per ha.

Voedererwten, toegepast kort voor de oogst op een afgerijpt gewas

Toepassingsstadium: 50% van de peulen rijp, zaden hard en droog (BBCH 85)

Voor de bestrijding van ontwikkelde onkruiden in het algemeen

Dosering: 2,8 – 4 L middel per ha.

Kerstsparren

Toepassingsstadium: In de herfst na verhouting van de jonge scheuten op aanplantingen van meer dan 2 jaar.

Voor de bestrijding van kweekgras

Dosering: 4 L middel per ha.

Voor de bestrijding van brandnetels, distels of varens

Dosering: 5 L middel per ha.

Cultuurgrasland

Voor de toepassingen als doodspuitmiddel

Dosering: 4 – 5 L middel per ha.

Alvorens een nieuw ander gewas te zaaien of te planten, het afstervende plantmateriaal goed door de grond werken.

Openbare grasvegetatie

Voor de toepassingen als doodspuitmiddel

Dosering: 4 – 5 L middel per ha.

Alvorens een nieuw ander gewas te zaaien of te planten, het afstervende plantmateriaal goed door de grond werken.

Tijdelijk onbeteeld terrein

Voor de bestrijding van ontwikkelde onkruiden in het algemeen of opslag

Dosering: 2 – 4 L middel per ha. (Minimaal 2,8L/ha bij sterk ontwikkeld onkruid.)

Voor de bestrijding van kweekgras en zuring:

Dosering: 4 L middel per ha.

Voor de bestrijding van brandnetels, wilgeroosje, basterdwederik, weegbree, braamstruiken, samengesteldbloemigen, bijvoet, distels, boterbloem en varens:

Dosering: 5 L middel per ha.

Permanent onbeteeld terrein (exclusief half-open en gesloten verhardingen)

Voor de bestrijding van ontwikkelde onkruiden in het algemeen

Dosering: 2 – 4 L middel per ha. (Minimaal 2,8L/ha bij sterk ontwikkeld onkruid.)

Voor de bestrijding van kweekgras en zuring

Dosering: 4 L middel per ha.

Voor de bestrijding van brandnetels, wilgeroosje, basterdwederik, weegbree, braamstruiken, samengesteldbloemigen, bijvoet, distels, boterbloem en varens.

Dosering: 5 L middel per ha.

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II bij het besluit d.d. 8 juli 2011 tot toelating van het middel Taifun 360, toelatingnummer 13479 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

Contents

Page

1. Identity of the plant protection product 3

2. Physical and chemical properties. 4

3. Methods of analysis. 4

4. Mammalian toxicology. 4

5. Residues. 9

6. Environmental fate and behaviour. 9

7. Ecotoxicology. 31

8. Efficacy. 42

9. Conclusion. 42

10. Classification and labelling. 43

Appendix 1 Table of authorised uses. 1

Appendix 2 Reference list 2

1. Identity of the plant protection product

1.1 Applicant

Makhteshim-Agan Holland B.V.

Arnhemseweg 87

NL-3832 GK Leusden

1.2 Identity of the active substance

Common name	Glyphosate
Name in Dutch	Glyfosaat
Chemical name	N-(phosphonomethyl)-glycin [IUPAC]
CAS no	1071-83-6
EC no	213-997-4

The active substance was included on July 1^st, 2002 in Annex I of Directive 91/414/EEC.

Glyphosate is formulated as its variant glyphosate isopropylamine, which is considered equivalent to glyphosate as included in Annex I of Directive 91/414/EEC.

1.3 Identity of the plant protection product

Name	Taifun 360
Formulation type	SL
Content active substance	360 g/L pure glyphosate, formulated as 485.4 g/L glyphosate isopropylamine salt

For the assessment of the formulation and its proposed use we refer to the member state of the original authorisation (Belgium).

1.4 Function

Herbicide.

1.5 Uses applied for

See GAP (Appendix I).

1.6 Background to the application

It concerns an application for mutual recognition, based on an authorisation for Taifun 360 in Belgium ( 8395 / B ).

1.7 Packaging details

Material:	HDPE
Capacity:	1, 5, 10, 20L
Type of closure and size of opening:	Screw cap closure with opening respectively 45.5, 62.7, 63.4 and 48mm diameter.
Other information	UN/ADR compliant

1.7.2 Detailed instructions for safe disposal

See application form and MSDS (no particular recommendations).

2. Physical and chemical properties

For the assessment of the physical and chemical properties we refer tot the member state of the original authorisation (Belgium).

3. Methods of analysis

For the assessment of the methods of analysis we refer tot the member state of the original authorisation (Belgium).

3.4 Physical-chemical classification and labelling

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

Professional use, packaging >125 mL

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	V32-NL	Because of a high risk of formation of highly flammable gas, do not store (diluted) product in galvanised or metal tanks (do not smoke!).
Special provisions: DPD-phrases	-	-
Child-resistant fastening obligatory?			Not applicable
Tactile warning of danger obligatory?			Not applicable

Explanation:
Hazard symbol:	-
Risk phrases:	-
Safety phrases:	-
Other:	-

Supported shelf life of the formulation: 2 years.

4. Mammalian toxicology

4.1 Toxicity of the formulated product (IIIA 7.1)

For the evaluation of the toxicity of the formulated product Taifun 360, we refer to the member state of the original authorisation (BE); not classified for acute oral, dermal and inhalation toxicity or for skin and eye irritation or skin sensitisation.

4.2 Dermal absorption (IIIA 7.3)

Belgium used a value of 3% for glyphosate for dermal absorption in the risk assessment and since this application is a request for mutual recognition the value of 3% is also used in this risk assessment.

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

For toxicological data relating to non-active substances we refer to the registration report written by Belgium.

4.4 Exposure/risk assessments (Dutch specific aspect)

Overview of the intended uses

An application (request for mutual recognition) has been submitted for the authorisation of the plant protection product Taifun 360, a herbicide based on the active substance glyphosate.

Taifun 360 is a SL formulation and contains 360 g/L glyphosate.

The formulation Taifun 360 is applied by mechanical downward spraying (with and without touching the crop) and by local treatment without touching crop (wiper application). The formulation can be used in many crops during the whole year. Therefore, chronic exposure duration is applicable for the operator.

4.4.1 Operator exposure/risk

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

For glyphosate no TLV has been set. The AEL will be used for the risk assessment.

In the EU, a semi-chronic AOEL is derived. For the current application, a chronic AOEL should be derived. The calculation of the systemic AOEL for chronic exposure is based on the NOAEL of 31 mg/kg bw/d in the 2-year study with the rat, and a safety factor of 100, corrected for an oral absorption of 30%. This results in a systemic AOEL of 0.093 mg/kg bw/day (= 6.5 mg/day for a 70-kg operator/worker).

The UK used in their risk assessment the semi-chronic EU-AOEL of 0.2 mg/kg bw/d.

Exposure/risk

Exposure to glyphosate during mixing and loading and application of Taifun 360 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 formulation Taifun 360 is applied by mechanical downward spraying (with and without touching the crop and on bare soil) and by local treatment without touching crop (wiper application).

For each application method, the exposure is only estimated with the highest dose and worst-case situation. For mechanical downward spraying it is considered that the intended use on land, not under culture is worst-case since dosage and the treated area are the highest.

For the wiper application only mixing and loading is relevant since no exposure is expected during application, the actual area treated per day is estimated to be 0.1 ha.

Table T.1 Internal operator exposure to glyphosate and risk assessment for the use of Taifun 360

	Route	Estimated internal exposure ^a(mg /day)	Systemic EU-AOEL (mg/day)	Risk-index ^b
Mechanical downward spraying on various crops (5L/ha, uncovered)
Mixing/ Loading^c	Respiratory	0.09	6.5	0.01
	Dermal	10.8	6.5	1.66
Application^c	Respiratory	0.14	6.5	0.02
	Dermal	1.62	6.5	0.25
	Total	12.7	6.5	1.95
Manual application with wiper applicators (local treatment without touching crop) (5.5 L/10L water, uncovered)
Mixing/ Loading	Respiratory^d	<0.01	6.5	<0.01
	Dermal^c	0.91	6.5	0.14
	Total	0.92	6.5	0.14

a Internal exposure was calculated with:

· biological availability via the dermal route: 3% (concentrate) and 3% (spray dilution) (see 4.2)

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

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

c External exposure is estimated with EUROPOEM.

d External exposure is estimated with NL-model.

Since in the scenario “Mechanical downward spraying” the EU-AOEL is exceeded without the use of PPE, a tier 2 assessment has to be performed using the NL-AOEL.

Tier 2

Calculation of the NL-AOEL

The risk index calculated with the EU-AOEL is >1. Therefore, the Plant Protection Products and Biocides Regulations (NL: Rgb) prescribes the calculation of the risk with an AOEL based on allometric extrapolation (known as the NL-AOEL). This method takes into account the caloric demand of the species studied and results in a more specific value than the EU-AOEL for which a standard factor of 100 is applied.

The calculation of the systemic AOEL for chronic exposure is based on the NOAEL of 31 mg/kg bw/day in the 2yr study with the rat. Calculations from other studies result in higher AOELs.

Safety factors are used to compensate for the uncertainties, which arise, for example, from extrapolation from the tested species to humans and the differences between experimental circumstances, and to ensure that at the acceptable exposure level no adverse health effects will occur.

Used factors are:

· extrapolation rat ® human on basis of caloric demand 4

· other interspecies differences: 3

· intraspecies differences: (professional use) 3

· biological availability via oral route: 30%*

· weight of professional operator/worker: 70 kg

* If the absorbed dose is significantly lower (<80%) than the administered dose, this is adjusted by a correction factor equal to the percentage absorption.

AOEL_systemic: 31 x 0.3 x 70 / (4 x 3 x 3) = 18.1 mg/day

Exposure/risk

Table T.2 Internal operator exposure to glyphosate and risk assessment for the use of Taifun 360

	Route	Estimated internal exposure ^a(mg /day)	Systemic NL-AOEL (mg/day)	Risk-index ^b
Mechanical downward spraying on various crops (5L/ha, uncovered)
Mixing/ Loading^c	Respiratory	0.09	18.1	<0.01
	Dermal	10.8	18.1	0.60
Application^c	Respiratory	0.14	18.1	0.01
	Dermal	1.62	18.1	0.09
	Total	12.7	18.1	0.70

a Internal exposure was calculated with:

· biological availability via the dermal route: 3% (concentrate) and 3% (spray dilution) (see 4.2)

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

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

c External exposure is estimated with EUROPOEM.

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

4.4.2 Bystander exposure/risk

The exposure is estimated for the unprotected bystander. In Table T.3 the estimated internal exposure is compared with the systemic EU-AOEL.

Table T.3 Internal bystander exposure to glyphosate and risk assessment during application of Taifun 360

	Route	Estimated internal exposure ^a(mg /day)	Systemic EU-AOEL (mg/day)	Risk-index ^b
Bystander exposure during mechanical downward spraying on various crops (5L/ha, uncovered).
	Respiratory	0.34	6.5	0.05
	Dermal	0.05	6.5	<0.01
	Total	0.39	6.5	0.06

a External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:

· biological availability via the dermal route: 3% (see 4.2)

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

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

4.4.3 Worker exposure/risk

Shortly after application it is not necessary to perform any re-entry activities during which intensive contact with the treated crops will occur.

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 glyphosate as a result of the application of Taifun 360 in the uses applied for.

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 glyphosate during application of Taifun 360 in the uses applied for.

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 the uses applied for due to exposure to glyphosate after application of Taifun 360.

4.5 Appropriate mammalian toxicology and operator exposure end-points relating to
the product and approved uses

See List of Endpoints.

4.6 Data requirements

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

4.7 Combination toxicology

Taifun 360 contains only one active substance and it is not described that it should be used in combination with other formulations.

4.8 Mammalian toxicology classification and labelling

Proposal for the classification and labelling of the formulation concerning health

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed:

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):
Symbol:	-	Indication of danger:	-
R phrases	-	-
S phrases	-	-
Special provisions: DPD-phrases	DPD14	Safety data sheet available for professional user on request.
Plant protection products phrase: DPD-phrase	DPD01	To avoid risk for man and the environment, comply with the instructions for use
Child-resistant fastening obligatory?			n/a
Tactile warning of danger obligatory?			n/a
Explanation:
Hazard symbol:	-
Risk phrases:	-
Safety phrases:	-
Other:	The phrase DPD14 shall be assigned to preparations not classified for physico-chemical properties, health or environmental hazards, but containing at least one substance posing health or environmental hazards.

5. Residues

For the evaluation of residues of the formulated product Taifun 360 we refer to the member state of the original authorisation (Belgium), except for the aspect ‘residues in succeeding crops.

5.1 Summary of residue data

5.1.6 Residues in succeeding crops (Dutch specific aspect)

Glyphosate

Confined rotational crop studies were performed with carrots, lettuce, barley. Only very low levels of glyphosate and AMPA are present in the soil and plant tissues of rotational crops. Residues in emergency replant and rotational crops will be less than those found in the primary crop, therefore no additional risk is expected. These residues are sufficiently covered by current MRLs.

Conclusion

No risk is foreseen for consumers when authorising Taifun 360 following the intended use.

The product complies with the Uniform Principles.

5.2.1 Data requirements

None

6. Environmental fate and behaviour

For the current application of mutual recognition of Taifun 360 risk assessment is done in accordance with Chapter 2 of the RGB.

Glyphosate was included on Annex I on July 1^st, 2002 (2001/99/EG, 20/11/2001). On the basis of the proposed and supported uses, the following particular issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate:

- Groundwater: Member States must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses.

The LoEP (d.d. May 11^th, 2001) from the final review report (6511/VI/99-final, 21 January 2002) is used for the current assessment. The List of Endpoints contains both the endpoints for glyphosate as well as glyphosate trimesium. Only the endpoints for glyphosate are used since the amount of active substance in the formulation is expressed as pure glyphosate (formulated as potassium salt). For the sake of completeness the endpoints of glyphosate trimesium are listed as well. The final list of endpoints (final review report of January 2002) is used for risk assessment.

The underlying risk assessment is based on the final list of endpoints for glyphosate and on the Belgium authorisation for Taifun 360. For the Dutch specific aspects data from previous assessments is used. Furthermore, RIVM report 11265 is used for the assessment of the MPC for soil for metabolite AMPA.

List of Endpoints Fate/behaviour (May 11^th, 2001 as included in the final review report of January 2002)

Fate and behaviour in soil

Route of degradation
Aerobic:	Glyphosate	Glyphosate trimesium
Mineralization after different periods of time (%):	3 soils, 3 different ^14C labels: 46.8 – 55.3 (28 d); 5.8 – 9.3 (112 d); 34.7 – 41.4 (84 d) 2 soils: 69.7 – 80.1 (150 d) 1 soil: 32.7 (112 d) 1 soil: 79.6 (100 d)	Glyphosate 2 soils: 37 (21 d), 75 (150 d) TMS: 2 soils: 46 (9 d), 74 (150 d)
Non-extractable residues after different periods of time (%):	3 soils, 3 different ^14C labels: 8.5 – 40.3 (28 d); 4.6 – 13.5 (112 d); 16.7 – 33.9 (84 d) 2 soils: 5.1 – 8.8 (150 d) 1 soil: 13.9 (112 d) 1 soil: 8.4 (100 d)	Glyphosate 2 soils: 32 (21 d), 20 (150 d) TMS: 2 soils: 26 (9 d), 10 (150 d)
Major metabolites above 10 % of applied, name and/or code, % of applied (range and maximum)	Aminomethylphosphonic acid (AMPA) 26-29% after 14 days	Aminomethylphosphonic acid (AMPA) 15.4% after 21 days (only in one study detected), no further degradation within 70 days.

Supplemental studies	Glyphosate	Glyphosate trimesium
Anaerobic degradation	Mineralization after different periods of time (%): 3 soils, 3 different ^14C labels: 33.5 – 51.4 (28 d); 1.4 – 5.0 (112 d); 24.2 – 38.6 (84 d) 1 soil, < 1 (120 d) Non-extractable residues after different periods of time (%): 3 soils, 3 different ^14C-labels: 12.8 – 29.7 (28d); 0.4 – 12.0 (112 d); 15.1 – 31.6 (84d) 1 soil, 20 (120 d)	Mineralization after different periods of time (%): Glyphosate: 43 (63 d) TMS: 57 (63d) Non-extractable residues after different periods of time (%): Glyphosate: 24 (63 d) TMS: 16 (63d)

Soil photolysis:

DT50: 96 (90 d dark); 101 d (1236 d dark)

DT50 200 hours (50 ° N) AMPA: max. 24 % DT50 200 hours;No metabolites of TMS detected.

Remarks:

None.

None.

Rate of degradation
Laboratory studies	Glyphosate	Glyphosate trimesium
DT50lab (20 °C, aerobic):	DT50lab (20°C, aerobic): 4 – 180 d (20°C), mean 49 d, n=7 (first order kinetic) Ctgb: individual values 4, <7, 8, 9, 25, 110 and 180 days	Glyphosate: 3- 62 d , mean 29 d, n=8 (first order kinetic) TMS: 3-15 d, mean 7 d, n=8 (first order kinetic)
DT90lab (20 °C, aerobic):	DT90lab (20°C, aerobic): 40 – 280 d (20°C), mean 159 d,n=4 (first order kinetic)	Glyphosate: 81- 207 d n= 4(first order kinetic) TMS: 37-85 d (TMS anion), n= 4 (first order kinetic)
DT50lab (10 °C, aerobic):	DT50lab (10°C, aerobic): not submitted (see field studies)	Glyphosate:67d TMS: 70 d (8°C)
DT50lab (20°C, anaerobic):	DT50lab (20°C, anaerobic): comparable to aerobic (study one); (waterphase) 3 d, (system) 1699 d (study two)	No significant degradation.

Field studies (country or region)	Glyphosate	Glyphosate trimesium
DT50f from soil dissipation studies:	DT50f (best fit): Germany 5 (Menslage); 12 (Bad Krozingen) d; Switzerland 7 (Diegten); 21d (Egerkingen); USA: 1 d (Texas), 7 d (Ohio), 9 d (Georgia), 12 d (California), 17 d (Arizona), 31 d (Minnesota), 106 d (New York), 130 d (Iowa); Canada: 11 d (Manitoba), 16 d (Ontario), 63 d (Alberta) AMPA DT50f (best fit): Germany 218 d (Menslage); Switzerland 135; 139 d; USA: 76 d (Ohio), 93 d (Texas), 103 d (Arizona), 145 d (New York), 170 d (Georgia), 174 d (Minnesota), 240 d (California); Canada: 128 d (Manitoba), 185 d (Ontario) Ctgb: the above endpoints for field degradation of glyphosate and AMPA cannot be traced back to the studies described in the DAR (due to recalculation/kinetic fitting?). For the assessment, the bold values from this final LoEP are relied on.	DT50f (best fit): Germany: 9, 15, 17, 23, 34,34d; USA: 1.5, 1.8, 15 and 17 d AMPA DT50f (first order kinetic) : Germany: 134, 242, 316, 362, 449, 875 d ; USA: 13, 23, 37,147d .

DT90f from soil dissipation studies:	not calculated; see DT50f	DT90f: Germany: 76, 89, 113, 124, 166, 326 d; USA: 24, 48, 61, 68 d AMPA DT90f: Germany: 445, 804, 1050, 1203, 1491, 2907 d; USA: 42, 77, 124, 489d
	Glyphosate	Glyphosate trimesium
Soil accumulation and plateau concentation	Plateau concentration for AMPA: 5.62 mg/kg (mean DT50f: 697 d (first order kinetic))	Plateau concentration for AMPA: 0.91 mg/kg (mean DT50f (Germany): 396 d (first order kinetic))
Remarks: e.g. effect of soil pH on degradation rate	None.	None.

Adsorption/desorption
	Glyphosate				Glyphosate trimesium
Kf / Koc: Kd	soil type	1/n	Koc	Kd	soil type	1/n	Koc	Kd	1/n	Koc	Kd
	silty clay loam	1.16	60000	900	silt loam	0.98	25100	427	0.89	1179	20
	silt loam	0.8	3800	34	loam	0.93	2860	66	0.89	530	12
	loamy sand	0.92	22300	245	sandy loam	0.88	7880	39	0.84	1758	9
	sand	*)	32830	263	clay	1.1	180000	2340	0.93	1659	22
	sand loam	*)	50660	810
	sandy clay loam	*)	3598	50
	loamy sand	*)	884	5.3
	silt loam	*)	3404	47
	loam (sediment)	*)	17819	510
	*)The advanced adsorption isotherm test wasn't conducted because in the screening test equilibrium was not reached after 72 hours

pH dependence:

No pH-dependence

No pH dependence.

	AMPA
Kf / Koc: Kd	soil type	1/n	Koc	Kd
	clay loam	0.786	3640	76
	sand	0.904	8310	1554
	sand	0.752	1160	15
	clay loam	0.791	3330	30
	loamy sand	0.769	6920	111
	sand	0.788	24800	74

pH dependence:

No pH-dependence

Mobility

	Glyphosate	Glyphosate trimesium
Column leaching:	1. 0.12 – 1.45% as of applied in leachate (3 soils) 2. 0.03 – 6.56% as of applied in leachate (7 soils)	< 2 % as in leachate (BBA standard soils)
Aged residue leaching:	1.56, 0.22 and 0.02 % ^14C-activity in leachates 65.2, 59.0 and 2.1 % evolved as CO2 30.3, 40.4 and 97.5 % ^14C in the upper 2 cm of columns	^14C distribution after 30 days: Glyphosate-^14C: 52 % extractable (AMPA 26 %), 12 % unextractable, 33 % CO2; TMS-^14C: 10 % extractable, 21 % unextractable, 57 % CO2 0.1 % Glyphosate and 0.5% TMS in leachate, total radioactivity in leachate not given.
Lysimeter/Field leaching studies:	Not submitted.	Not submitted.
Remarks:	None.	None.

Fate and behaviour in water

Abiotic degradation
	Glyphosate	Glyphosate trimesium
Hydrolytic degradation:	pH__5____: stable (25°C)	pH___5___: stable; 25 and 40 °C (glyphosate and TMS)
	pH__7____: stable (25°C)	pH___7___: stable; 25 and 40 °C (glyphosate and TMS)
	pH__8____: stable (25°C)	pH___9___: stable; 25 and 40 °C (glyphosate and TMS)
Photolytic degradation:	DT50: 33 d (pH 5), 69 d (pH 7), 77 d (pH 9).	Glyphosate: DT50: 81 d (pH 7) 37°N TMS: stable

Biological degradation

	Glyphosate	Glyphosate trimesium
Readily biodegradable:	No.	No.
Water/sediment study:
DT50 water:	1 and 4 days (Möllerfeld and Römbke)	Glyphosate: 14 and 24 d; TMS: 4 and 3 d
DT90 water:	not calculated	Glyphosate: 46 and 80 d; TMS: 13 and11 d
DT50 whole system:	27 and 146 days (Möllerfeld and Römbke), Ctgb: recalculation to SFO with FOCUS Degradation Kinetics spreadsheet gives: DT50: 86.1 d chi2: 9.5 DT50: 37.7 d chi2: 11.7 31 and 124 days (Muttzall) Ctgb: recalculation to SFO with FOCUS Degradation Kinetics spreadsheet gives: DT50: 439.9 d chi2: 4.4 DT50: 52.6 d chi2: 7.1 Geomean 4 systems : 93.1 days, used in exposure assessment	Glyphosate: 21 and 202 (extrapol.) d; TMS: 5 and 7 d
DT90 whole system:	Not calculated	Glyphosate: 69 d; TMS: 18 and 23 d
Mineralization	18 and 24 % after 100 days (Möllerfeld and Römbke), 6 and 26 % after 91 days (Muttzall)	Glyphosate: 48 and 6 % after 100 days; TMS: 67 and 68 % after 100 days
Non-extractable residues	14 and 22 % after 100 days (Möllerfeld and Römbke), 31 and 35 % after 91 days (Muttzall)	Glyphosate: 14 and 17 % after 100 days; TMS: 7 and 8 % after 100 days
Distribution in water / sediment systems (active substance)	after 1 day: 47-64% in water, 31-44% in sediment; after 100 days 3% in water, 29-44% in sediment. In sediment: maximum 50-60% after 7 and 14 days, resp. and 30-50% after 100 days.	Glyphosate water: 1 and 5 %; sediment: 4 and 58 % TMS water: < 1%; sediment: 2 and 5 %
Distribution in water / sediment systems (major metabolites)	AMPA: if found, only in the water phase: maximum 16% after 14 days and 0.5 % after 100 days. Water/sediment studies with ^14C-AMPA (Knoch and Spirlet): 1 st system: waterphase: 101% day 0; 4% day 100; sediment: max. 41% day 59; 20% day 100; 2 nd system waterphase: 100% day 0; 1% day 59; sediment: max. 46% day 14; 32% day 100 Ctgb: no DT50 values were derived for AMPA. Based on the data presented in Addendum 2 (Knoch & Spirlet), the following SFO DT50 system values were calculated using the FOCUS Degradation Kinetics spreadsheet: - system 1: 47.8 d (chi2 5.9) - system 2: 32.8 d (chi2 11.6) geomean: 39.6 days	AMPA water: 4 and < 1 %: AMPA sediment: 18 and 3 %
Accumulation in water and/or sediment:	No accumulation	No accumulation
Degradation in the saturated zone
	Glyphosate	Glyphosate trimesium
	Not submitted.	Not submitted.
Remarks:	None.	None.

Fate and behaviour in air

Volatility
	Glyphosate	Glyphosate trimesium
Vapour pressure:	1.31 × 10^-5 Pa (25 °C, acid)	< 1 × 10^-11 Pa (20 °C)
Henry's law constant:	2.1 × 10^-7 Pa m^3 mol^-1	< 2 × 10^-9 Pa m^3 mol^-1
Photolytic degradation
	Glyphosate	Glyphosate trimesium
Direct photolysis in air:	No absorption for wavelengths > 290 nm. DT50 (water):33d (pH 5), 69 d (pH 7), 77 d (pH 9)	No absorption for wavelengths > 290 nm. DT50 (water): 81 d (pH 7) 37°N (stable for TMS)
	Glyphosate	Glyphosate trimesium
Photochemical oxidative degradation in air DT50:	DT50: 1.6 d (Atkinson estimation) Ctgb: DT50,air 1.63 hours (evaluated in RIVM report 12263)	DT50: about 1.4 hours
Volatilisation:	from plant surfaces: no significant volatilization	from plant surfaces: negligible (glyphosate and TMS)
	from soil: no significant volatilization	from soil: negligible (glyphosate and TMS)
Remarks:	None.	None.

Appendix A: Metabolite names, codes and other relevant information of the pesticide Taifun 360 with active substance glyphosate.

The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of glyphosate. The parent compound structure of glyphosate is shown first in this list and followed by degradate or related compounds.

Compound name	IUPAC name	Structural formula	Structure	Molecular Weight [g/mol]	Observed in study (% of occurrence/ formation)
Glyphosate	N-(phosphonomethyl)-glycin	C3H8NO5P		169.1	parent
AMPA	-	CH6NO3P		111.0	29 % in soil, 16 % in water

6.1 Fate and behaviour in soil

6.1.1 Persistence in soil (Dutch specific aspect)

The higher tier risk assessment on persistence in soil is a Dutch specific aspect. For the current application for mutual recognition this means that if for the evaluation of the product a higher tier risk assessment is necessary for persistence, the Belgian risk assessment cannot be used for mutual recognition and a national risk assessment has to be performed.

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:

Active substance glyphosate

For the active substance glyphosate the following laboratory DT₅₀ values are available: 4, <7, 8, 9, 25, 110 and 180 days (geomean 19.3 days, range 4 - 180 days; n=7).

Although not required, the following best-fit field DT₅₀ values considered representative for the Dutch situation are available: 7 (Ohio), 5 and 12 (Germany), 7 and 21 d (Switzerland) and 11, 16 and 63 days (several locations in Canada) (geomean 12.7 days, range 5 - 63 days; n=8).

The mean DT₅₀-value of the active substance can thus be established to be <90 days. Furthermore it can be excluded that after 100 days there will be more than 70% bound (non-extractable) residues of the initial dose together with the formation of less than 5% CO₂ of the initial dose. Herewith, the standards for persistence are met.

There is one major metabolite in soil, aminomethylphosphonic acid (AMPA), formed at a maximum of 29%. For the metabolite AMPA only best-fit field DT₅₀-values are available in the LoEP (there was no apparent degradation in lab studies, see DAR). For the risk assessment, the following DT₅₀ values were considered representative for the Dutch situation: 218 (Germany), 135 and 139 (Switzerland), 76 days (Ohio), 128 and 185d (Canada). The geomean DT50 is 139.5 days (n=6).

From the results it is shown that the mean field DT50 is > 90 days. Based on the above, the proposed applications of the pesticide Taifun 360 do not meet the standards for persistence as laid down in the RGB. Because the field DT₅₀ is > 90 days, it has to be demonstrated that application of the pesticide does not lead to accumulation of metabolite AMPA to the extent that it will have an unacceptable effect on non-target-organisms. In order to prevent this, the sum of the concentrations in which metabolite AMPA is present 2 years after the last application after 10 years of annual application in the upper 20 cm of the soil where the pesticide has been applied (Gp,10) (see Table M.1), should not exceed the MPC-INS value for soil organisms.

MPCsoil

In RIVM report 11265a01 the MPC (maximum permissible concentration, Dutch: MTR) for soil is derived for metabolite AMPA (see the conclusion of the report given below).

Acute toxicity data are available for algae, protozoa, crustaceans, and fish. Only for algae from the same study a NOEC is available. According to the TGD, however, a MPC cannot be derived on the bases of a NOEC for algae only. The MPC_{eco, water} is thus derived according to the methods of TGD, applying an assessment factor of 1000 on the lowest acute toxicity value. This results in a MPC_{eco, water} of 79.7 μg/L.

According to the INS-Guidance (Section 2.2.2.8), the endpoint of earthworms cannot be used for the derivation of the MPC_{eco, soil} because the test concentration was not high enough to determine the NOEC or L(E)C₅₀. As a consequence, the MPC_{eco, soil} should be derived applying equilibrium partitioning on aquatic ecotoxicity data. Using the log Koc of 3.50 and the Henry coefficient of 1.25 x 10^-15 The MPC_{soil, EqP} is 14.82 mg/kg dw soil for standard soil with 10% OM.

The most critical MPC_{human, soil} for exposure via leaf crops (7.248 x 10^-7 kg/kg_{wwt soil}) is equivalent to 2.416 mg/kg dw for standard soil at 10% OM.

The following MPCs are derived:

MPC_{eco, water} = 0.0797 mg/L

MPC_{soil, EqP} = 14.82 mg/kg

MPC_{human, soil} = 2.41 mg/kg

The lowest MPC for soil is the MPC based on aquatic data and is 0.0797 mg/kg.

PECsoil (Gp,10)

The concentration of AMPA in soil 2 years after 10 succeeding years of application (Gp,10) is needed for the persistence risk assessment. The Gp,10 is calculated for the upper 20 cm of soil using a soil bulk density of 1500 kg/m³. See Table M.1 for results.

The following input data are used for the Gp,10 calculation:

PEC soil:

Active substance glyphosate:

Maximum (relevant) field DT₅₀ for degradation in soil: 63 days

Molecular mass: 169.1 g/mol

Metabolite AMPA:

Maximum (relevant) field DT₅₀ for degradation in soil (20°C): 218 days

Molecular weight: 111.0 g/mol

Correction factor: 0.29 (max. % observed) x 0.66 (relative molar ratio = M metabolite/M parent) = 0.191

The Gp,10 of metabolite AMPA of active substance glyphosate is derived based on a R% of 33.5%.This R% is the result of a PEARL 3.3.3 calculation of an application in maize of 1 kg/ha on May 25^th with the Dutch standard scenario based on:

Active substance glyphosate:

Geometric mean DT₅₀ for degradation in soil (20°C): 19.3 days.

Arithmetic mean K_om (pH-independent): 12868 L/kg (n=8, excluding the sediment data)

Arithmetic mean 1/n: 0.96 (n=3, only for studies in which a 1/n was determined)

Saturated vapour pressure: 1.31 x 10^-5 Pa (25 °C, acid, LoEP phys-chem properties)

Solubility in water: 10.5 ± 0.2 g/l (pH 2, 20 °C, 995 g/kg, LoEP phys-chem properties)

Molecular mass: 169.1 g/mol

Metabolite AMPA:

Geometric mean field DT₅₀ for degradation in soil (20°C): 139.5 days (no lab data available)

Arithmetic mean K_om (pH-independent): 4656 L/kg (n=6)

Arithmetic mean 1/n: 0.80 (n=6)

Maximum formation fraction: 1.0

Saturated vapour pressure: 1.31 x 10^-5 Pa (25°C; parent)

Solubility in water: 10.5 ± 0.2 g/l (20°C; parent)

Molecular mass: 111.0 g/mol

Other parameters: standard settings of PEARL 3.3.3

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

Table M.1 PECsoil calculations (Gp,10)

Use	Substance	Rate [kg a.s./ha]	Frequency/ Interval [days]	Fraction on soil *	R% ^**	PECsoil 20 cm (Gp,10) [mg a.s./kg]
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	glyphosate AMPA	1.80 0.344	1 / n.a.	1	- 33.5	- 0.0194
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green – spot treatment	glyphosate AMPA	2.376 0.454	1 / n.a.	1	- 33.5	- 0.0256
Cereals (wheat, barley, rye, oats, triticale, spelt)	glyphosate AMPA	1.44 0.275	1 / n.a.	1	- 33.5	- 0.0155
Dry harvested common bean and vicia bean	glyphosate AMPA	1.44 0.275	1 / n.a.	1	- 33.5	- 0.0155
Fodder peas	glyphosate AMPA	1.44 0.275	1 / n.a.	1	- 33.5	- 0.0155
Christmas trees	glyphosate AMPA	1.80 0.344	1 / n.a.	1	- 33.5	- 0.0194
Land, temporary not under culture	glyphosate AMPA	1.80 0.344	1 / n.a.	1	- 33.5	- 0.0194
Land, permanently not under culture	glyphosate AMPA	1.80 0.344	1 / n.a.	1	- 33.5	- 0.0194
Pasture	glyphosate AMPA	1.80 0.344	1 / n.a.	1	- 33.5	- 0.0194
Amenity Grass fields	glyphosate AMPA	1.80 0.344	1 / n.a.	1	- 33.5	- 0.0194

* fraction on soil is determined as 1 – interception%. As a worst case an interception of 0 is used.

** R% = expected percentage of the metabolite AMPA remaining in the upper 20 cm soil layer 1 year after an effective dose to the soil of 1 kg a.s./ha. R% is calculated using Pearl 3.3.3.

Risk assessment

The MPC for soil for AMPA is set to 0.0797 mg/kg. The log Kow of AMPA is < 2, (-2.17, estimated by KOWWIN), therefore no recalculation of the MPC to 4.7% O.M. is necessary. The highest Gp,10 is reached in the use at pasture renovation and is 0.0256 mg/kg. Since the Gp,10 is lower than the MPCsoil for metabolite AMPA (threshold exceeding factor 0.32), it is concluded that the standards for persistence as laid down in the RGB are met for all proposed uses.

6.1.2 Leaching to shallow groundwater (Dutch specific aspect)

Leaching to shallow ground water is a Dutch specific aspect. For the current application for mutual recognition this means that the Belgium risk assessment for leaching to ground water cannot be used for mutual recognition and a national risk assessment has to be performed.

Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater.

The leaching potential of the active substance and metabolite is calculated in the first tier using Pearl 3.3.3 and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate 2.376 kg a.s./ha, the crop winter cereals (default) and an interception value appropriate to the uses of 0 as worst case. Date of yearly application is May 25^th (default spring) and November 1^st (default autumn). Since various uses have applications until October also an assessment for October 1^st was performed for the uses concerned.

For metabolites all available data concerning substance properties are regarded. Metabolite AMPA 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:

Active substance glyphosate:

Geometric mean DT₅₀ for degradation in soil (20°C): 19.3 days.

Arithmetic mean K_om (pH-independent): 12868 L/kg (n=8, excluding the sediment data)

Arithmetic mean 1/n: 0.96 (n=3, only for studies in which a 1/n was determined)

Saturated vapour pressure: 1.31 x 10^-5 Pa (25 °C, acid, LoEP phys-chem properties)

Solubility in water: 10.5 ± 0.2 g/l (pH 2, 20 °C, 995 g/kg, LoEP phys-chem properties)

Molecular mass: 169.1 g/mol

Q10: 2.2

Metabolite AMPA:

Geometric mean field DT₅₀ for degradation in soil (20°C): 139.5 days (no lab data available)

Arithmetic mean K_om (pH-independent): 4,656 L/kg (n=6)

Arithmetic mean 1/n: 0.80 (n=6)

Maximum fraction of occurrence: 0.29

Saturated vapour pressure: 1.31 x 10^-5 Pa (25°C; parent)

Solubility in water: 10.5 ± 0.2 g/l (20°C; parent)

Molecular mass: 111.0 g/mol

Q10: 2.2

Other parameters: standard settings of PEARL 3.3.3

The following concentrations are predicted for the active substance glyphosate and its metabolite AMPA following the realistic worst case GAP, see Table M.2.

Table M.2 Leaching of active substance glyphosate and metabolite AMPA as predicted by PEARL 3.3.3

Use	Substance	Rate substance [kg/ha]	Frequency/ Interval [days]	Fraction Inter-cepted**	PEC groundwater [mg/L]
					spring	autumn
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	glyphosate AMPA	1.80 *	1 / n.a.	0	<0.001 <0.001	<0.001 <0.001
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green – spot treatment	glyphosate AMPA	2.376 *	1 / n.a.	0	<0.001 <0.001	<0.001 <0.001
Cereals (wheat, barley, rye, oats, triticale, spelt)	glyphosate AMPA	1.44 *	1 / n.a.	0	<0.001 <0.001	n.r.
Dry harvested common bean and vicia bean	glyphosate AMPA	1.44 *	1 / n.a.	0	<0.001 <0.001	n.r.
Fodder peas	glyphosate AMPA	1.44 *	1 / n.a.	0	<0.001 <0.001	n.r.
Christmas trees	glyphosate AMPA	1.80 *	1 / n.a.	0	n.r.	<0.001 <0.001
Land, temporary not under culture	glyphosate AMPA	1.80 *	1 / n.a.	0	<0.001 <0.001	<0.001 <0.001
Land, permanently not under culture	glyphosate AMPA	1.80 *	1 / n.a.	0	<0.001 <0.001	<0.001 <0.001
Pasture	glyphosate AMPA	1.80 *	1 / n.a.	0	<0.001 <0.001	<0.001 <0.001
Amenity Grass fields	glyphosate AMPA	1.80 *	1 / n.a.	0	<0.001 <0.001	<0.001 <0.001

* calculated via transformation scheme

** fraction intercepted is determined as 0 which represents a worst case situation.

n.r.: not relevant

Results of Pearl 3.3.3 using the Kremsmünster scenario are examined against the standard of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable groundwater protection areas (NL-specific situation).

From Table M.2 it reads that the expected leaching based on the PEARL-model calculations for the active substance glyphosate and its metabolite AMPA is smaller than 0.01 µg/L for all proposed applications. Hence, the applications meet the standards for leaching as laid down in the RGB.

Non-relevant metabolites

AMPA is the major metabolite of glyphosate in soil and water. For this metabolite it has been demonstrated in C-122.3.5 d.d. 12 June 2002 that it is toxicologically non-relevant for the assessment for leaching to groundwater.

For AMPA the following applies:

• Efficacy: The metabolite AMPA has no properties concerning efficacy.
• Human toxicology: Regarding the results of the available tests the metabolite AMPA is considered toxicologically non-relevant. (For further details see the List of Endpoints for human toxicology).
• Ecotoxicology:
• Aquatic organisms:
• Algae: NOEC = 79.7 mg/L (complies with criterion: NOEC >1 mg/L)
• Aquatic invertebrates: EC₅₀ = 691 mg/L (complies with criterion: EC₅₀ >100 mg/L)
• Fish: LC₅₀ = 520 mg/L (complies with criterion: LC₅₀ >100 mg/L)
• Earthworms:

There is no study available addressing the acute toxicity of AMPA to earthworms, but a 56-d chronic study is provided: NOEC ≥ 28.1 mg/kg. This value is approximately 40 times higher than the maximum PEC₀ for AMPA in soil. Furthermore for glyphosate the acute 14-d LC₅₀ >1000 mg/kg. In this study also considerable amounts of AMPA were formed (peak concentrations of AMPA are reached after 14 days in soil degradation studies). Consequently AMPA is assumed to be non-toxic to earthworms.

• Soil micro-organisms:

There is no study available addressing the toxicity of AMPA to soil micro-organisms, but from studies with the active ingredient glyphosate it shows that at relevant concentrations following use there are no effects on soil micro-organisms. In this study also considerable amounts of AMPA were formed (peak concentrations of AMPA are reached after 14 days in soil degradation studies). Consequently AMPA is assumed to be non-toxic to soil micro-organisms at relevant concentrations following use.

• Birds:

There are acute and sub-acute studies addressing the acute toxicity of AMPA to birds submitted, which show that AMPA is very slightly toxic to birds.

Based on the data listed above it can be concluded that the metabolite AMPA can be considered as non-relevant for leaching (although the more recent stepwise approach from the GD on non-relevant metabolites was not exactly followed). Only a first tier leaching assessment is performed. For the currently proposed uses, there was no exceeding of the trigger.

Lysimeter/field leaching studies

No lysimeter studies are available for glyphosate.

Monitoring data

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90^th percentile.

The active substance glyphosate and its metabolite AMPA were observed in the groundwater of sampling points around a groundwater abstraction point [Bannink, 1999[4]]. No residues of glyphosate or AMPA were found at the filter depth, which ranged from 6 to 32 m below soil surface. In Table M.3a observed concentrations in the shallow groundwater are presented.

Table M.3a Monitoring data for glyphosate in groundwater (1999)

Location/year	Detection limit [µg/L]	a/n*	Mean conc. [mg/L]	Maximum conc. [mg/L]
Groundwater protection area Helmond, 1999	0.05	0 / n**	<0.05	<0.05

* number of observations above detection limit (a)/total number observations (n).

** the total number of samples could not be retrieved.

More recent data are presented in RIVM Rapport 607310001/2007. Monitoring data were collected in 2006 in the framework of groundwater monitoring for the WFD starting situation (so-called nulmeting) in the Dutch provinces Drenthe, Flevoland, Friesland, Gelderland, Groningen, Noord-Holland, Overijssel, Utrecht and Zeeland. See Table M.3b.

Table M.3b Monitoring data for glyphosate in groundwater (2006)

Location/year	Detection limit [µg/L]	a/n*	Mean conc. [mg/L]	Maximum conc. [mg/L]	P90 conc. [mg/L]
The Netherlands, 2006	Varies between 0.1 and 1.5	4/691	0.01	4.74	< 0.20

* number of observations above detection limit (a)/total number observations (n).

It must be noted that (page 19 of the report, translated by Ctgb) “no check was performed on the measurements as is required for use of the data in registration assessment, as this was not included in the current project remit. Presented values can therefore not be used as such in registration procedures.”

As the P90 value given is below the detection limit (which is 0.2 µg/L for the deep groundwater samples) and the data cannot be considered entirely suitable for use in the registration process, no consequences are drawn from the data.

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 (Dutch specific aspect)

Article 2.10c of the Plant Protection Products and Biocides Regulations (RGB) prescribes the use of Dutch specific drift percentages. Since the Netherlands has its own national drift values, the exposure concentrations of the active substance glyphosate and its metabolite AMPA in surface water have been estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percentage depends on the use.

The applicant proposed the following restriction on the label (instructions for use):

Op percelen die grenzen aan watergangen is de toepassing uitsluitend toegestaan met gebruik van doppen uit de driftreductieklasse van tenminste 75%.

Concentrations in surface water are calculated using the model TOXSWA. The following input data are used for the calculation:

TOXSWA:

Active substance glyphosate:

Geometric mean DT₅₀ for degradation in water at 20°C: 93.1 days (geomean of 4 SFO system values in the LoEP, endpoints recalculated by Ctgb using the study data in the DAR)

DT₅₀ for degradation in sediment at 20°C: 1000 days (default).

Arithmetic mean K_om for suspended organic matter: 12868 L/kg (n=8, excluding the sediment data)

Arithmetic mean K_om for sediment: 12868 L/kg (n=8, excluding the sediment data)

Arithmetic mean 1/n: 0.96 (n=3, only for studies in which a 1/n was determined)

Saturated vapour pressure: 1.31 x 10^-5 Pa (25°C, acid, LoEP phys-chem properties)

Solubility in water: 10.5 ± 0.2 g/l (pH 2, 20°C, 995 g/kg, LoEP phys-chem properties)

Molecular mass: 169.1 g/mol

Q10: 2.2

Metabolite AMPA:

Geometric mean DT₅₀ for degradation in water at 20°C: 39.6 days (geomean of 2 systems, endpoints calculated by Ctgb)

DT₅₀ for degradation in sediment at 20°C: 1000 days (default)

Arithmetic mean K_om for suspended organic matter: 4656 L/kg (n=6)

Arithmetic mean K_om for sediment: 4656 L/kg (n=6)

Arithmetic mean 1/n: 0.80 (n=6)

Saturated vapour pressure: 1.31 x 10^-5 Pa (25°C, parent)

Solubility in water: 10.5 ± 0.2 g/l (20°C, parent)

Molecular mass: 111.0 g/mol

Correction factor: 0.16 (max. % observed) x 0.66 (relative molar ratio = M metabolite/ M parent) = 0.11

Q10: 2.2

Other parameters: standard settings TOXSWA

When no separate degradation half-lives (DegT₅₀ values) are available for the water and sediment compartment (accepted level P-II values), the system degradation half-life (DegT₅₀-system, level P-I) is used as input for the degrading compartment and a default value of 1000 days is to be used for the compartment in which no degradation is assumed. This is in line with the recommendations in the FOCUS Guidance Document on Degradation Kinetics.

For metabolites, the level M-I values are used (system DegT₅₀ value) only, since level M-II criteria have not been fully developed under FOCUS Degradation Kinetics. In the case of AMPA, a DT₅₀ system has been calculated by Ctgb (see also LoEP).

In Table M.4, the drift percentages and calculated surface water concentrations for the active substance glyphosate and its metabolite AMPA for each intended use are presented.

Table M.4 Overview of surface water concentrations in the edge-of-field ditch for active substance glyphosate and metabolite AMPA following spring/autumn application

Use	Substance	Rate a.s. [kg/ha]	Freq./ Inter-val [days]	Drift [%]	PIEC [mg/L]^*	PEC21 [mg/L]^*	PEC28 [mg/L]^*
					spring	spring	spring
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	2.076 0.264	1.899 0.242
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green – spot treatment	glyphosate AMPA	2.376 0.261	1 / n.a.	0.5	5.196 0.601	2.740 0.348	2.507 0.319
Cereals (wheat, barley, rye, oats, triticale, spelt)	glyphosate AMPA	1.44 0.158	1 / n.a.	0.5	3.149 0.364	1.660 0.211	1.519 0.194
Dry harvested common bean and vicia bean	glyphosate AMPA	1.44 0.158	1 / n.a.	0.5	3.149 0.364	1.660 0.211	1.519 0.194
Fodder peas	glyphosate AMPA	1.44 0.158	1 / n.a.	0.5	3.149 0.364	1.660 0.211	1.519 0.194
Land, temporary not under culture	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	2.076 0.264	1.899 0.242
Land, permanently not under culture	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	2.076 0.264	1.899 0.242
Pasture	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	2.076 0.264	1.899 0.242
Amenity Grass fields	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	2.076 0.264	1.899 0.242
					autumn	autumn	autumn
Christmas trees	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	0.528 0.061	0.400 0.046
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	0.528 0.061	0.400 0.046
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green – spot treatment	glyphosate AMPA	2.376 0.261	1 / n.a.	0.5	5.196 0.601	0.697 0.081	0.527 0.061
Land, temporary not under culture	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	0.528 0.061	0.400 0.046
Land, permanently not under culture	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	0.528 0.061	0.400 0.046
Pasture	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	0.528 0.061	0.400 0.046
Amenity Grass fields	glyphosate AMPA	1.80 0.198	1 / n.a.	0.5	3.936 0.456	0.528 0.061	0.400 0.046

^* calculated according to TOXSWA

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

Monitoring data

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90^th percentile.

The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the observed concentrations exceed threshold values. Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters. In the Pesticide Atlas, these monitoring data are processed into a graphic format accessible on-line and aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards. Recently, the new version 2.0 was released. This new version of the Pesticide Atlas does not contain the land use correlation analysis needed to draw relevant conclusions for the authorisation procedure. Instead a link to the land use analysis performed in version 1.0 is made, in which the analysis is made on the basis of data aggregation based on grid cells of either 5 x 5 km or 1 x 1 km.

Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation threshold and the MPC (ad-hoc or according to INS) threshold. For examination against the drinking water criterion, another database (VEWIN) is used, since the drinking water criterion is only examined at drinking water abstraction points. For the assessment of the proposed applications regarding the drinking water criterion, see next section.

Active substance glyphosate

The active substance glyphosate was observed in the surface water (most recent data from 2009). In Table M.5a the number of observations in the surface water are presented.

In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 64 µg/L (27/07/2005, C-160.3.11, consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.1*EC₅₀ algae) and to the indicative Maximum Permissible Concentration (MPC) of 77 µg/L as presented in the Pesticide Atlas (data source for the MPC: Zoeksysteem normen voor het waterbeheer, http://www.helpdeskwater.nl/normen_zoeksysteem/normen.php).

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, however, no consequences can be drawn for the proposed applications.

Table M.5a Monitoring data of glyphosate in Dutch surface water

Total no of locations (2009)	n > authorisation threshold	n > indicative/ad hoc MPC threshold	n > MPC-INS threshold *
373 **	0	0	n.a.

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with ad hoc MPC value; > : exceeding expected to be higher than with the ad hoc MPC value

** the number of observations at each location varies between 1-30, total number of measurements is 1641 in 2009.

The correlation of exceedings with land use is derived from the 1.0 version of the Pesticide Atlas. Hence, the correlation is not based on the exact same monitoring data. However, this is the best available information and therefore it is used in this assessment. As there is no exceeding of the ad hoc MPC or the authorisation threshold, no further correlation analysis is performed.

Metabolite AMPA of glyphosate

The metabolite AMPA was observed in the surface water (most recent data from 2009). In Table M.5b the number of observations in the surface water are presented. In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold value of 8980 µg/L (27/06/2002, C-122.3.5, consisting of first or higher tier acute or chronic ecotoxicological threshold value, including relevant safety factors, which is used for risk assessment, in this case 0.1*EC₅₀ algae) and to the indicative Maximum Permissible Concentration (MPC) of 79.7 µg/L as presented in the Pesticide Atlas (data source for the MPC: Zoeksysteem normen voor het waterbeheer, http://www.helpdeskwater.nl/normen_zoeksysteem/normen.php).

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, however, no consequences can be drawn for the proposed applications.

Table M.5b Monitoring data for AMPA in Dutch surface water

Total no of locations (2009)	n > authorisation threshold	n > indicative/ad hoc MPC threshold	n > MPC-INS threshold *
373 **	0	0	n.a.

* n.a.: no MPC-INS available. < : exceeding expected to be lower than with ad hoc MPC value; > : exceeding expected to be higher than the ad hoc MPC value.

** the number of observations at each location varies between 1-30, total number of measurements is 1641 in 2009.

The correlation of exceedings with land use is derived from the 1.0 version of the Pesticide Atlas. Hence, the correlation is not based on the exact same monitoring data. However, this is the best available information and therefore it is used in this assessment. As there is no exceeding of the ad hoc MPC or the authorisation threshold, no further correlation analysis is performed.

Drinking water criterion

Article 2.10b of the Plant Protection Products and Biocides Regulations (RGB) describes the use of the 90^th percentile. Assessment of the drinking water criterion is in principle not a Dutch national specific criterion however the interpretation is done in a Dutch specific way.

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’. The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 1635[5].

Substances are categorized as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years).

- For new substances, a preregistration calculation is performed.

- For existing substances, the assessment is based on monitoring data of VEWIN (drinking water board).

o If for an existing substance based on monitoring data no problems are expected by VEWIN, Ctgb follows this VEWIN assessment.

o If for an existing substance based on monitoring data a potential problem is identified by VEWIN, Ctgb assesses whether the 90^th percentile of the monitoring data meet the drinking water criterion at each individual drinking water abstraction point.

Active substance glyphosate

Glyphosate has been on the Dutch market for > 3 years (authorised since 25/02/1990). This period is sufficiently large to consider the market share to be established. The existing active substance glyphosate -and also its metabolite AMPA- is included in the most recent list of substances of concern due to its presence in surface water at drinking water abstraction points as established by VEWIN/Ctgb. Therefore, an adequate risk assessment is needed. There are monitoring data concerning the presence of glyphosate at drinking water abstraction points.

In earlier assessments of glyphosate-based products the monitoring data set of 2001-2004 was evaluated. The following was concluded (copied from C-205.3.3):

There are monitoring data concerning the presence of glyphosate in drinking water abstraction points located in the Rhine and Meuse river. Based on the fact that in almost one third of all samples the 0.1 µg/L threshold is exceeded and also the 90^th percentile is above the threshold (overall 90^th-percentile value: 0.192 µg/L), it is expected that there is concern for drinking water. In the re-registration of nine glyphosate-containing products this issue was addressed. The outcome is given below: Restriction to DOB on hardened surfaces will meet the threshold for drinking water. Therefore, Ctgb decides to allow professional use on hardened surfaces only via DOB or a similar certified system.

For formulations for which application on hardened surfaces is not applied for, no restrictions for the use on hardened surfaces have to be included on the label. In the assessment of the re-registration of Roundup Evolution (Decision of the Board d.d. 16 May 2008) this issue is completely assessed.

Hence, the formulations based on glyphosate were allowed to stay on the market provided that for the professional uses on hardened surface restrictions in the use were included. At that time, the certification of the aimed application technique (DOB) was not yet possible and therefore the restriction could not be set very stringent yet (techniques in line with DOB or other certified techniques were put on the label).

Several years have now passed since the implementation of the new label with restrictions and new monitoring data are available. There are indications from specific monitoring campaigns that the threshold value is not met yet. Recently therefore, an analysis was made of the available monitoring data after the entry into force of the restrictions for hardened surfaces, to evaluate whether this restricted use has led to meeting the standards.

(NB this analysis was done in the framework of a policy advice of Ctgb by decree of the Ministry of Spatial Planning, Housing and the Environment, dated October 2009).

Only the data from RIWA-Meuse and Rhine from 2007 and onward have been included in the analysis to prevent complications of the analysis due to the expected trend reversion. This analysis will also be the basis for the current assessment of the drinking water criterion for glyphosate (and AMPA).

The relevant monitoring data indicate that concentrations at drinking water abstraction points have decreased substantially on almost every abstraction point, but the 90^th percentile of several abstraction points are still above 0.1 µg/L. See Table M.6.

Table M.6 Monitoring data for glyphosate at drinking water abstraction points from surface water in the period 2007 – 2009 (after implementing restrictions for professional use on hardened surfaces)

Abstraction point	Number of measurements above detection limit/ Number of measurements [n/N]	Number of measurements above drinking water limit/ Number of measurements [n/N]	90-percentile [μg/L]
A’dam Rijnkanaal (=Nieuwersluis)	34/57	4/57	0.0900
Andijk	12/55	0/55	0.0600
Brakel	17/48	6/48	0.1000
Drentsche Aa	18/56	12/56	0.1672
Heel	23/26	18/26	0.2200
Nieuwegein	34/57	4/57	0.0840
Petrusplaat (=Keizersveer)	42/51	18/51	0.1600
Scheelhoek (=Haringvliet/ Stellendam)	16/32	1/32	0.0790

Therefore, glyphosate is expected to exceed the drinking water criterion. On the basis of the monitoring campaign, which was the incentive for performing the above analysis, it has been decided to restrict the professional uses on hardened surface to certified DOB practice (which is now possible), in order to achieve the expected improvement of the water quality at drinking water abstraction points.

As it was demonstrated by the analysis made in the re-registration process that applications to crops or bare soil (not: hardened surfaces) hardly contribute to the drinking water problem, it is argued that the currently proposed applications are not expected to lead to a deterioration of the situation.

Hence, although the standards for surface water destined for the production of drinking water as laid down in the RGB are not met for glyphosate, it is considered that the proposed applications are permissible.

Metabolite AMPA of glyphosate

The VEWIN has included AMPA on the list of substances of concern for drinking water.

The same new data set (after introduction of the restrictions for use on hardened surfaces) as available for glyphosate is also available for AMPA. An analysis of the data shows that the 90^th percentile is above the drinking water limit at all drinking water abstraction points. See Table M.7.

Table M.7 Monitoring data for AMPA at drinking water abstraction points from surface water in the period 2007 – 2009 (after implementing restrictions for professional use on hardened surfaces)

Abstraction point	Number of measurements above detection limit/ Number of measurements [n/N]	Number of measurements above drinking water limit/ Number of measurements [n/N]	90-percentile [μg/L]
A’dam Rijnkanaal (=Nieuwersluis)	56/57	56/57	0.674
Andijk	45/55	45/55	0.326
Brakel	48/48	48/48	1.230
Drentsche Aa		No data available
Heel	26/26	26/26	1.600
Nieuwegein	57/57	57/57	0.684
Petrusplaat (=Keizersveer)	50/51	50/51	1.600
Scheelhoek (=Haringvliet/ Stellendam)	30/32	32/32	0.717

It must be noted that the detection limit for most abstraction points is 0.1 µg/L. Furthermore AMPA is known to have more sources than only glyphosate (e.g., detergents). Again, also for AMPA the exposure is governed almost entirely by the use of glyphosate on hardened surfaces, and it has been analysed that applications to crop and/or bare soil hardly contribute to the observed surface water concentrations at drinking water abstraction points.

Additionally, the metabolite is declared non-relevant for groundwater. The groundwater assessment is in fact a drinking water assessment, hence the non-relevance could in principle be extrapolated to surface water destined for the production of drinking water. This is sustained by the Guidance Document (GD) on non-relevant metabolites where it is stated in the introduction that: “This guidance document focuses on groundwater, though the general approach may also be applicable for the regional management of surface water resources intended for the abstraction of drinking water in Member States.”

For the proposed uses there is no exceeding of the “normal” groundwater limit of 0.1 µg/L (leaching assessment). In contrast, the monitoring data at abstraction points show that for surface water the 90^th percentile concentration is 1.20 µg/L, which is above 0.75 µg/L and below 10 µg/L.

The determination of non-relevance depends on the level of exposure concentrations. Several “threshold of concern values” are included in the step-wise procedure in the Guidance document for non-relevance of metabolites. These threshold values consist of a concentration of 0.75 µg/L (above which a full consumer exposure assessment has to be made) and a concentration of 10 µg/L (above which the decision for allowing the substance is a risk managers’ responsibility). This means that for AMPA a consumer risk assessment has to be made according to Step 5 of the GD: “Metabolites which have passed steps 1 to 3 and for which levels of estimated concentrations of metabolites in groundwater (as defined in Step 2) lie between 0.75 µg/L (from Step 4) and 10 µg/L[6] will require a refined assessment of their potential toxicological significance for consumers.

[….]

As provided [..] for step 4, also in step 5 the question must be addressed whether there are other sources of exposure for consumers but groundwater. The permissible exposure of consumers via water is calculated on the basis of a daily consumption of 2 L/day and taking into account exposure from all other routes, if appropriate.”

The consumer exposure calculation for AMPA is based on the following input parameters:

Weight adult population: 63 kg

Weight child 1—6 years: 17 kg

ADI for AMPA: 0.3 mg/kg BW day-1 (derived from glyphosate)

Intake of drinking water: 2 L for adults, for children both a 1 L (realistic estimate) and a 2 L (extreme worst-case) assessment is made

yields:

- a TMDI (Theoretical Maximum Daily Intake) of 2.4 µg/adult a day, equivalent to 0.038 µg/kg BW day-1. This is 0.013 % of the ADI;

- a TMDI (Theoretical Maximum Daily Intake) of 1.2 µg/child a day, equivalent to 0.071 µg/kg BW day-1. This is 0.024 % of the ADI;

- a TMDI (Theoretical Maximum Daily Intake) of 2.4 µg/child a day, equivalent to 0.141 µg/kg BW day-1. This is 0.047 % of the ADI.

The exposure is negligible. Hence there is no concern from a consumer exposure perspective.

Based on the results of the consumer risk assessment, it can be concluded that metabolite AMPA is also non-relevant for surface water destined for the production of drinking water. On the basis of all the above arguments, the proposed uses meet the standards for drinking water with regard to AMPA.

Conclusion drinking water criterion

All proposed applications of the product comply with the RGB.

6.3 Fate and behaviour in air

Route and rate of degradation in air

Assessment of fate and behaviour in air is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Belgium).

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

See List of End-points.

6.5 Data requirements

None

The following restriction sentences were proposed by the applicant:

Op percelen die grenzen aan watergangen is de toepassing uitsluitend toegestaan met gebruik van doppen uit de driftreductieklasse van tenminste 75%. (to be confirmed by the ecotoxicological assessment)

Based on the current assessment, the following has to be stated in the GAP/legal instructions for use:

Op percelen die grenzen aan watergangen is de toepassing uitsluitend toegestaan met gebruik van doppen uit de driftreductieklasse van tenminste 75%. (to be confirmed by the ecotoxicological assessment)

6.6 Overall conclusions fate and behaviour

It can be concluded that:

1. the active substance glyphosate meets the standards for persistence in soil as laid down in the RGB.
2. metabolite AMPA meets the standards for persistence in soil as laid down in the RGB.
3. all proposed applications of the active substance glyphosate meet the standards for leaching to the shallow groundwater as laid down in the RGB.
4. all proposed applications of metabolite AMPA meet the standards for leaching to shallow groundwater as laid down in the RGB. Furthermore, AMPA has been declared non-relevant for groundwater.
5. the proposed applications of the product comply with the RGB with regard to the standards for surface water destined for the production of drinking water.

7. Ecotoxicology

The underlying risk assessment is based on the final list of endpoints for glyphosate and on the Belgium authorisation for Taifun 360.

List of Endpoints Ecotoxicology

Glyphosate

Glyphosate was included on Annex I on July 1^st, 2002 (2001/99/EG, 20-11-2001).

The LoEP (d.d. May 11^th, 2001) from the final review report (6511/VI/99-final, 21 January 2002) is used for the current assessment. The endpoints list contains both the endpoints for glyphosate as well as glyphosate trimesium. Only the endpoints for glyphosate are used since the amount of active substance in the formulation is expressed as pure glyphosate (formulated as isopropylamide salt). For the sake of completeness the endpoints of glyphosate trimesium are listed as well.

In the review report, no particular issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate.

Terrestrial Vertebrates

	Glyphosate	Glyphosate-trimesium
Acute toxicity to mammals:	LD50 > 2000 mg/kg bw	lowest LD50 748 mg/kg bw
Acute toxicity to birds:	LD50 > 2000 mg/kg bw AMPA > 2250 mg/kg bw	lowest LD50 950 mg/kg bw
Dietary toxicity to birds:	LC50 >4640 ppm (1624 mg/kg bw/d)* AMPA >5620 ppm (1967 mg/kg bw/d)*	LC50 > 5000 ppm
Reproductive toxicity to birds:	NOEC 200 ppm (30 mg/kg bw/d)*	NOEC 712 ppm
Short term oral toxicity to mammals:	NOAEL/NOEL 150 mg/kg bw/d (90 d, rat)	NOAEL/NOEL 25 mg/kg bw/d (90 d, rat)

* Recalculated to daily dose based on default factors for dietary and reproduction studies of 0.35 and 0.15 resp. (based on EFSA-opinion on azinphos-methyl)

Aquatic Organisms

	Glyphosate-IPA	Glyphosate-trimesium	Glyphosate acid (1^st metabolite) (= a.s.)	AMPA
Acute toxicity fish: EC50	>1000 mg /L	1800 mg/L	38 mg/L	>180
Long term toxicity fish: NOEC	917 mg /L	50 mg/L	25 mg/L
Bioaccumulation fish:	Not relevant	Not relevant	Not relevant
Acute toxicity invertebrate: EC50	930 mg /L	12 mg/L	40 mg/L	>180
Chronic toxicity invertebrate: NOEC	455 mg /L	1.1 mg/L	30 mg/L
Chronic toxicity algae EC50	72.9 mg/L	0.72 mg/L	0.64 mg/L (168 h)	89.8
Chronic toxicity sediment dwelling organism:	Not tested	Not tested	Not tested
Long-term toxicity aquatic plants: EC50	53.6 mg/L	1.0 mg/L	12 mg/L

Honeybees

	Glyphosate	Glyphosate-trimesium
Acute oral toxicity:	LD50: 100 µg as/bee	LD50: > 400 mg as/bee
Acute contact toxicity:	LD50: > 100 µg as/bee	LD50: > 400 mg as/bee

Other arthropod species

Test species Test method	Glyphosate % Effect	Glyphosate-trimesium % Effect
Typhlodromus pyri Lab on inert substrate	Lifecycle: 100 % mortality (3.6 kg as/ha)	Lifecycle: 100 % mortality (5.760 kg as/ha) LR50: 0.211 kg as/ha
Typhlodromus pyri Lab natural substrate on leaves	Lifecycle: 89 % mortality (7.720 kg as/ha)	LR50: 5.089 kg as/ha
Typhlodromus pyri Lab natural substrate on plants	Lifecycle: 30 % mortality; 0 % effect on fertility (3.708 kg as/ha)	---
Aphidius rhopalosiphi Lab on inert substrate	Adult: 100 % mortality	Adults: 100 % mortality (5.76 kg as/ha) LR50: 0.043 kg as/ha
Aphidius rhopalosiphi Lab natural substrate on plants	Adult: 25 % mortality; 6 % effect on fertility (3.720 kg as/ha)	---
Aphidius rhopalosiphi Lab natural substrate on leaves	---	LR50:> 8.4 kg as/ha
Orius insidiosus Lab on inert substrate	---	Lifecycle: 95 % mortality (5.760 kg as/ha)
Chrysoperla carnea Lab on inert substrate	Larval stage: 53 % mortality (0.712 kg as/ha)	---
Chrysoperla carnea Lab on inert substrate	Larval stage: 59 % mortality; 20 % effect on fertility (3.708 kg as/ha)	---
Drino inconspicua Lab on inert substrate	---	Adults: 56 % mortality; 76 % effect on parasitization (2.4 kg as/ha)
Pterostichus melaniarius Lab on inert substrate	---	Adults: 26.7% mortality (3.6 kg as/ha) Adults: 10% mortality (7.2 kg as/ha)
Aleochara bilineata Lab on inert substrate	Lifecycle: 1% parasitation capacity (1.63 kg as/ha)	---
Bembidion lampros Semifield	Adult: 0% mortality (4,890 kg as/ha)	---
Poecilus cupreus Lab on inert substrate	Adult: 0% mortality; 31% effect on food uptake (3.6 kg as/ha)	---
Trechus quadristriatus Lab on inert substrate	Adult: 14% mortality (3.6 kg as/ha)	---
Pardosa spp. Lab on inert substrate	Adult: 56% mortality (3.7 kg as/ha)	Adults: 4 % mortality (3.6 kg as/ha) Adults: 0% mortality (7.2 kg as/ha)

Earthworms

	Glyphosate	Glyphosate trimesium
Acute toxicity:	LC50 > 480 mg as/kg	LC50 > 1000 mg as/kg
Reproductive toxicity:	NOEC 28.79 mg/kg (IPA-salt)	NOEC 28.79 mg/kg (IPA-salt)

Soil micro-organisms

	Glyphosate	Glyphosate-trimesium
Nitrogen mineralization:	No effects up to 18 kg as/ha	No effects up to 18 kg as/ha
Carbon mineralization:	No effects up to 18 kg as/ha	No effects up to 18 kg as/ha

Effects op waste water treatment

Glyphosate has no effect on respiration of activated sludge, EC₅₀ is > 100 mg/L.

Effects on non target plants (taken from monograph)

Seven dicotyl and 4 monocotyl weed species were tested according to UP EPA guidelines on seed germination and seedling emergence. Also a test on vegetative vigour was carried out on 10 species. In the seedling emergence test no effects > 50% were found at the highest dose tested. The EC50 is > 5.7 kg a.s./ha. In the vegetative vigour test, significant effects were found in plant height and plant weight at 5.1 kg a.s./ha.

Soil non-target micro-organisms (taken from DAR)

Substance	Medium type	Duration [h]	pH	T [°C]	Species	Effect	Value [mg/L]	Remarks
Glyphosate	growth medium	16	n.a.	27 ± 5	Pseudomonas putida	IC50	>100	None
						NOEC	100

Non-target organisms (Flora en fauna) (taken from DAR)

Effects of glyphosate acid on germination of terrestrial plants 28 days after application

Substance	Species	Soil type	OM [%]	pH	T [°C]	Duration [d]	Effect	Value [kg/ha]
glyphosate acid	Cyperus rotundus	loamy sand	1.0	6.4	9.0-45.5	28	NOEL	>4.48
	Avena sativa	loamy sand	1.0	6.4	10.0-42.0	28	NOEL	>4.48
	Triticum aestivum	loamy sand	1.0	6.4	10.0-42.0	28	NOEL	>4.48
	Zea mays	loamy sand	1.0	6.4	9.0-45.5	28	NOEL	>4.48
	Allium cepa	loamy sand	1.0	6.4	10.0-42.0	28	NOEL	>4.48
	Beta vulgaris	loamy sand	1.0	6.4	10.0-42.0	28	NOEL	>4.48
	Lactuca sativa	sand	0.7	6.5	12.0-33.5	28	NOEL	>4.48
	Brassica napus	loamy sand	1.0	6.4	10.0-42.0	28	NOEL	>4.48
	Cucumis sativus	loamy sand	1.0	6.4	9.0-45.5	28	NOEL	>4.48
	Glycine max	sand	0.7	6.5	13.0-39.5	28	NOEL	>4.48
	Abelmoschus Esculentus	sand	0.7	6.5	13.0-39.5	28	NOEL	>4.48
	Rheum rhaponticum	loamy sand	1.0	6.4	12.0-33.5	28	NOEL	>4.48

Effects of glyphosate acid on terrestrial plants (vegetative vigour)

Substance	Species	Soil type	OM [%]	pH	T [°C]	Duration [d]	Effect	Value [kg/ha]
glyphosate acid	Cyperus rotundus	loamy sand	1.0	6.4	9.0-45.5	28	EC50^1	1.253
	Avena sativa	sand	1.1	5.4	10.0-42.0	28	EC50^1	0.376
	Triticum aestivum	sand	1.1	5.4	10.0-42.0	28	EC50^1	0.242
	Zea mays	sand	1.1	5.4	9.0-45.5	28	EC50^1	0.423
	Beta vulgaris	sand	1.1	5.4	10.0-42.0	28	EC50^1	0.377
	Lactuca sativa	loamy sand	1.0	6.4	8.0-27.0	28	EC50^1	0.402
	Raphanus sativus	sand 2	1.0	6.7	8.0-27.0	28	EC50^1	0.417
	Brassica napus	sand 2	1.0	6.7	10.0-42.0	28	EC50^1	0.149
	Cucumis sativus	sand	1.1	5.4	9.0-45.5	28	EC50^1	0.254
	Glycine max	loamy sand	1.0	6.4	9.0-45.5	28	EC50^1	0.358
	Abelmoschus Esculentus	loamy sand	1.0	6.4	9.0-45.5	28	EC50^1	0.346
							HC5	0.15

¹: most sensitive EC₅₀ obtained from either damage and dry weight endpoints

7.1 Effects on birds (Dutch specific aspect)

The risk assessment for birds via sprayed food (via natural food and secondary poisoning via earthworms) is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorisation (Belgium).

The risk assessment for birds via surface water (drinking water and secondary poisoning via fish) is a Dutch specific aspect, since surface water concentrations are calculated based on national drift values.

drinking water

The risk from exposure through drinking surface water is calculated for a small bird with body weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIEC_water is 5.196 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000 * 0.010) / (5.196 * 0.0027) = > 1425598.

Since TER > 10, the risk is acceptable.

7.1.2 Secondary poisoning

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

Since the log Kow of all relevant substances < 3 (glyphosate: -2.8; metabolite AMPA: <2), the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

Conclusions birds

The application for mutual recognition of the product complies with the RGB for exposure of birds via surface water and secondary poisoning.

7.2 Effects on aquatic organisms (Dutch specific aspect)

7.2.1 Aquatic organisms

Since the Netherlands has its own national drift values, the exposure concentrations of the active substance glyphosate and metabolite AMPA in surface water have been estimated based on these drift values (see PECsw in section 6.2).

The risk for aquatic organisms is assessed by comparing toxicity values with surface water exposure concentrations from section 6.2. Risk assessment is based on toxicity-exposure ratio’s (TERs). Toxicity data for aquatic organisms are presented in Table E.1. Because the application for authorisation concerns a herbicide, also the effects on macrophytes (aquatic plants) are evaluated.

Table E.1 Overview toxicity endpoints for aquatic organisms

Substance	Organism	Lowest		Toxicity value
		L(E)C50 [mg/L]	NOEC [mg/L]	[mg/L]
Glyphosate	Acute
	Algae	0.64		640
	Daphnids	40		40000
	Fish	38		38000
	Macrophytes	12		12000
	Chronic
	Daphnids		30	30000
	Fish		25	25000
AMPA	Acute
	Algae	89.8		89800
	Daphnids	>180		>180000
	Fish	>180		>180000
	Macrophytes

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

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

In table E.2 TER values for aquatic organisms are shown.

Table E.2a TER values: acute

Use	Substance	PECsw [mg a.s./L]	TERst (trigger 10)	TERst (trigger 100)	TERst (trigger 100)	TERst (trigger 10)
			Algae	Daphnid	Fish	Macrophytes
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	glyphosate	3.936	163	10163	9654	3049
	AMPA	0.456	196930	>394737	>394737
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green - spot treatment	glyphosate	5.196	123	7698	7313	2309
	AMPA	0.601	149418	>299501	>299501
Cereals	glyphosate	3.149	203	12702	12067	3811
	AMPA	0.364	246703	>494505	>494505
Dry harvested common bean and vicia bean	glyphosate	3.149	203	12702	12067	3811
	AMPA	0.364	246703	>494505	>494505
Fodder peas	glyphosate	3.149	203	12702	12067	3811
	AMPA	0.364	246703	>494505	>494505
Christmas trees	glyphosate	3.936	163	10163	9654	3049
	AMPA	0.456	196930	>394737	>394737
Land, temporary not under culture	glyphosate	3.936	163	10163	9654	3049
	AMPA	0.456	196930	>394737	>394737
Land, permanently not under culture	glyphosate	3.936	163	10163	9654	3049
	AMPA	0.456	196930	>394737	>394737
Pasture	glyphosate	3.936	163	10163	9654	3049
	AMPA	0.456	196930	>394737	>394737
Amenity grass fields	glyphosate	3.936	163	10163	9654	3049
	AMPA	0.456	196930	>394737	>394737

Table E.2b TER values: chronic

Use	Substance	PECsw [mg a.s./L]	TERlt (trigger 10)	TERlt (trigger 10)
			Daphnid	Fish
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	glyphosate	3.936	7622	6352
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green - spot treatment	glyphosate	5.196	5774	4811
Cereals	glyphosate	3.149	9527	7939
Dry harvested common bean and vicia bean	glyphosate	3.149	9527	7939
Fodder peas	glyphosate	3.149	9527	7939
Christmas trees	glyphosate	3.936	7622	6352
Land, temporary not under culture	glyphosate	3.936	7622	6352
Land, permanently not under culture	glyphosate	3.936	7622	6352
Pasture	glyphosate	3.936	7622	6352
Amenity grass fields	glyphosate	3.936	7622	6352

Taking the results in Table E.2and b into account, the acute TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 100 and the acute TERs for algae and Lemna are above the relevant Annex VI triggers of 10. The chronic TERs for fish and Daphnia magna are above the relevant Annex VI triggers of 10. Thus, it appears that for the active substance glyphosate the proposed uses meet the standards for aquatic organisms as laid down in the RGB.

Note that the PECs were calculated using 75% drift reducing nozzles. From an ecotoxicological point of view, these drift reducing nozzles are not necessary.

7.2.2 Risk assessment for bioconcentration

Since the log Kow of all relevant substances < 3 (glyphosate: -2.8; metabolite AMPA: <2), the potential for bioconcentration is considered low and no further assessment is deemed necessary.

7.2.3 Risk assessment for sediment organisms

There are no data regarding the toxicity of glyphosate for sediment organisms. Since the NOEC for daphnids is over 0.1 mg/L the risk for sediment organisms is considered to be low. Therefore these data are not necessary.

AMPA is less toxic than glyphosate on the acute scale. Since for glyphosate no risk for sediment organisms is expected, the risk for sediment organisms for metabolite AMPA is considered to be low as well.

In conclusion, the active substance glyphosate meets the standards for sediment organisms.

Conclusions aquatic organisms

The proposed applications meet the standards for aquatic organisms.

7.3 Effects on terrestrial vertebrates other than birds (Dutch specific aspect)

The risk assessment for mammals via sprayed food (via natural food and secondary poisoning via earthworms) is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorisation (Belgium).

The risk assessment for mammals via surface water (drinking water and secondary poisoning via fish) is a Dutch specific aspect, since surface water concentrations are calculated based on national drift values.

drinking water

The risk from exposure through drinking from surface water is calculated for a small mammal with body weight 10 g and a DWI (daily water intake) of 1.57 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). In the first instance, acute exposure is taken into account. The highest PIEC_water is 5.196 mg/L. It follows that the risk of drinking water is (LD50 * bw) / (PIEC*DWI) = (>2000 * 0.010) / (5.196 * 0.00157) = >2451665.

Since TER > 10, the risk is acceptable.

7.3.2 Secondary poisoning

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

Since the log Kow of all relevant substances < 3 (glyphosate: -2.8; metabolite AMPA: <2), the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

Conclusions mammals

The application for mutual recognition of the product complies with the RGB.

7.4 Effects on bees

The risk assessment for bees is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Member State).

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

7.5.1 Effects on non-target arthropods (Dutch specific aspect)

In-field

The in-field risk assessment for non-target arthropods in accordance with ESCORT2 is not based on drift values and is therefore not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorisation (Belgium).

Off-field (Dutch specific aspect)

For the off-field risk assessment on non-target arthropods in accordance with ESCORT2, drift values are used to estimate the off-crop risk for the two standard species A. rhopalosiphi and T. pyri. Since the Netherlands have their own national drift values, the off-field risk assessment is a national specific aspect.

The risk for non-target arthopods is assessed by calculating Hazard Quotients. For this, Lethal Rate values (LR₅₀) are needed. In the laboratory studies with the active substance, no LR50 was determined. Therefore, Hazard Quotient values are not calculated. Instead, the effects seen in the studies will be compared to the expected off-field dose rate. Off-field exposure rates are calculated as application rate * MAF (Multiple Application Factor) * (drift factor/vegetation distribution factor) * safety factor. As the intended use concerns only one application, the MAF is omitted from the calculation. The calculated off-field exposure rate is presented in Table E.3. A drift percentage of 10% is assumed. For herbicide treatments in large fruit, the drift percentage is 2.2%. When calculating the off-field exposure rate for comparison with tested rates, the substrates and test conditions used for testing should be considered. The vegetation distribution factor is only applicable for tests that were performed in 2-dimensional systems (i.e. glass plates or leaves). The safety factor is 10 for Tier 1 tests (glassplates) and 5 for higher tier tests. The highest off-field dose rates are printed bold.

Table E.3 Glyphosate off-field exposure rates for the use of Taifun

	Application rate (kg a.s./ha)	Drift factor ^1	Vegetation factor ^2	Safety Factor ^3	Off-field exposure rate (kg a.s./ha)^4
					Inert	Extended 2D	Extended 3D
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	1.8	0.1	1 or 10	5 or 10	0.180	0.090	0.900
Fruit growing^5	1.8	0.022	1 or 10	5 or 10	0.040	0.020	0.198
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green - spot treatment	2.376	0.1	1 or 10	5 or 10	0.238	0.119	1.188
Fruit growing^5	2.376	0.022	1 or 10	5 or 10	0.052	0.026	0.261
Cereals	1.44	0.1	1 or 10	5 or 10	0.144	0.072	0.720
Dry harvested common bean and vicia bean	1.44	0.1	1 or 10	5 or 10	0.144	0.072	0.720
Fodder peas	1.44	0.1	1 or 10	5 or 10	0.144	0.072	0.720
Christmas trees	1.8	0.1	1 or 10	5 or 10	0.180	0.090	0.900
Land, temporary not under culture	1.8	0.1	1 or 10	5 or 10	0.180	0.090	0.900
Land, permanently not under culture	1.8	0.1	1 or 10	5 or 10	0.180	0.090	0.900
Pasture	1.8	0.1	1 or 10	5 or 10	0.180	0.090	0.900
Amenity grass fields	1.8	0.1	1 or 10	5 or 10	0.180	0.090	0.900

¹: off-field: drift factor = 10% for all crops except for large fruit (2.2%)

²: off-field: vegetation distribution factor = 1 for comparison with tests performed in 3-dimensional systems (plants) and 10 for comparison with tests performed in 2-dimensional systems (glassplates or leaves)

³: off-field: safety factor = 10 for Tier 1 tests and 5 for higher tier tests

⁴: off-field: rate to be compared to the study exposure rate on inert substrate, or on natural substrate (2-dimensional systems or 3-dimensional systems)

⁵: For large fruit, the drift factor is 2.2% rather than 10% and therefore treated separately

In laboratory studies, adverse effects >50% were seen on T.pyri and A.rhopalosiphi at 3.6 kg a.s./ha. On natural substrate, effects were <50% at 3.708 kg a.s./ha. This rate should be compared to the calculated off-field exposure rates for comparison with tests conducted on 3 dimensional systems (maximum value: 1.188 kg a.s./ha). The off-field exposure rate is much lower than the tested dose rate of 3.7 kg a.s./ha for all uses except the spot wise treatment in arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture and public green. However, as this latter proposed use comprises a spot wise treatment, it is not expected that large areas will be sprayed simultaneously. Therefore effects on the population level are not expected, and recovery can take place more quickly than after large field applications. It can be assumed that no long-term effects will exist.

Effects on A.bilineata, P.cupreus and T.quadristriatus are <50% at a dose of at least 7 times the highest off-field dose (calculated for comparison with tested rates on inert substrate, maximum off-field rate 0.238 kg a.s./ha). Effects on B.lampros are <50% at a dose of 4.89 kg a.s./ha, which is 4 times higher than the highest off-field dose of 1.188 kg a.s./ha (calculated for comparison with higher tier tests with 3D exposure).

For Pardosa spp., a study on inert substrate showed 56% mortality at the high dose of 3.7 kg a.s./ha. Effects on this species are expected to be acceptable at the much lower off-field dose (calculated for comparison with test rates on inert substrate, maximum off-field exposure rate 0.238 kg a.s./ha) based on the fact that only slightly more than 50% mortality was seen while exposure is expected to be more worst-case in laboratory studies.

For C.carnea, results are unclear since doses of 0.712 and 3.708 kg a.s./ha lead to effects on mortality just above 50% in laboratory studies. However, also for this species a low risk is expected from glyphosate, since the studies were worst-case and the off-field dose will be much lower than the tested dose. Hence, the standards for non-target arthropods as laid down in the RGB are met.

7.5.2 Earthworms

The risk assessment for earthworms is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Belgium).

7.5.3 Effects on soil micro-organisms

The risk assessment for soil micro-organisms is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Belgium).

7.5.4 Effects on activated sludge (Dutch specific aspect)

The risk assessment for activated sludge is a Dutch specific aspect. However, for the proposed uses no exposure of activated sludge is expected. Therefore, the proposed applications comply with the standards for activated sludge as laid down in the RGB.

7.5.5 Effects on non target-plants (Dutch specific aspect)

According to the Terrestrial guidance document (Sanco/10329/2002) spray drift is considered to be the key exposure route for non-target plants in the off-field area. Since the Netherlands have their own national drift values, the risk assessment for non-target plants is a national specific aspect. The risk assessment for non-target plants is performed below.

The risk assessment for non-target plants is based on an off-crop situation with a drift percentage of 4.7% except for large fruit (2.2%). The exposure is calculated as drift factor * application rate. A TER is calculated with the lowest EC₅₀ value from a laboratory test with higher plants and the exposure concentration. The lowest EC₅₀ is 0.242 kg a.s./ha for Triticum aestivum (vegetative vigor test). See table E.4 for TER calculation.

Table E.4 Overview of exposure concentrations and TERs for non target plants

Use	Dose [kg a.s. /ha]	Drift% (off-field exposure)	Exposure (kg a.s./ha)	EC50 [kg a.s./ha]	TER	Trigger value
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	1.8	4.7	0.085	0.242	2.9	5
Fruit growing	1.8	2.2	0.040	0.242	6.1	5
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green - spot treatment	2.376	4.7	0.112	0.242	2.2	5
Fruit growing – spot treatment	2.376	2.2	0.052	0.242	4.6	5
Cereals	1.44	4.7	0.068	0.242	3.6	5
Dry harvested common bean and vicia bean	1.44	4.7	0.068	0.242	3.6	5
Fodder peas	1.44	4.7	0.068	0.242	3.6	5
Christmas trees	1.8	4.7	0.085	0.242	2.9	5
Land, temporary not under culture	1.8	4.7	0.085	0.242	2.9	5
Land, permanently not under culture	1.8	4.7	0.085	0.242	2.9	5
Pasture	1.8	4.7	0.085	0.242	2.9	5
Amenity grass fields	1.8	4.7	0.085	0.242	2.9	5

The ratio between EC₅₀ and the exposure concentration is > 5 for large fruit for the regular treatment. Therefore, the risk for non-target plants is considered to be low for this use. For the other uses, the risk to non-target plants should be refined. For glyphosate, an HC₅ of 0.15 kg a.s/.ha is available, calculated from the EC50 values in the vegetative vigor test. The risk assessment based on this HC₅ is given below.

Table E.5 Overview of exposure concentrations and refined TERs for non target plants

Use	Dose [kg a.s. /ha]	Drift% (off-field exposure)	Exposure (kg a.s./ha)	HC5 [kg a.s./ha]	TER	Trigger value
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green	1.8	4.7	0.085	0.150	1.8	1
Fruit growing	1.8	2.2	0.040	0.150	1.8	1
Arable farming, fruit growing, vegetable growing, herbs, ornamentals, pasture, public green - spot treatment	2.376	4.7	0.112	0.150	1.3	1
Fruit growing – spot treatment	2.376	2.2	0.052	0.150	2.9	1
Cereals	1.44	4.7	0.068	0.150	2.2	1
Dry harvested common bean and vicia bean	1.44	4.7	0.068	0.150	2.2	1
Fodder peas	1.44	4.7	0.068	0.150	2.2	1
Christmas trees	1.8	4.7	0.085	0.150	1.8	1
Land, temporary not under culture	1.8	4.7	0.085	0.150	1.8	1
Land, permanently not under culture	1.8	4.7	0.085	0.150	1.8	1
Pasture	1.8	4.7	0.085	0.150	1.8	1
Amenity grass fields	1.8	4.7	0.085	0.150	1.8	1

Based on the results presented in the table above, the risk to non-target plants is low for all intended uses.

In conclusion, the product complies with the RGB.

Conclusions any other organisms

The proposed application of the product complies with the RGB for the aspects activated sludge, non-target arthropods (off-field) and terrestrial non-target plants.

7.6 Appropriate ecotoxicological end-points relating to the product and approved uses

See List of End-points.

7.7 Data requirements

-

The following restriction sentences were proposed by the applicant:

Op percelen die grenzen aan watergangen is de toepassing uitsluitend toegestaan met gebruik van doppen uit de driftreductieklasse van tenminste 75%.

Based on the current assessment, the following has to be stated in the GAP/legal instructions for use:

-

The applicant has withdrawn the proposal.

7.8 Classification and Labelling

Proposal for the classification and labelling of the formulation concerning the environment (Dutch specific aspect)

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

Symbol:	N	Indication of danger:	Dangerous for the environment.
R phrases	R51/53	Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
S phrases	S61	Avoid release to the environment. Refer to special instructions/safety data sheets.
Special provisions (DPD-phrases) :	-	-

Explanation:
Hazard symbol:	Assigned based on the toxicity of the a.s. glyphosate
Risk phrases:	Assigned based on the toxicity of the a.s. glyphosate
Safety phrases:	Assigned to products labelled N, R51/53
Other:	-

Based on the current assessment, the following has to be stated in the GAP/legal instructions for use:

In the WG (legal instructions):

-

7.9 Overall conclusions regarding the environment

It can be concluded that:

1. all proposed applications of the active substance glyphosate meet the standards for birds (exposure via surface water; secondary poisoning) as laid down in the RGB.
2. all proposed applications of the active substance glyphosate meet the standards for aquatic organisms as laid down in the RGB.
3. the active substance glyphosate meets the standards for bioconcentration as laid down in the RGB.
4. all proposed applications of the active substance glyphosate meet the standards for mammals (exposure via surface water; secondary poisoning) as laid down in the RGB.
5. all proposed applications of the active substance glyphosate meet the standards for non-target arthropods (off-field) as laid down in the RGB.
6. all proposed applications of the active substance glyphosate meet the standards for activated sludge as laid down in the RGB.
7. all proposed applications of the active substance glyphosate meet the standards for non-target plants as laid down in the RGB

8. Efficacy

The product is authorised in Belgium for the claimed uses. Climatological and environmental circumstances relevant for the aspect efficacy in the claimed uses in The Netherlands are comparable to those in Belgium. The cultivation methods are similar in both countries and there are no country-specific situations for the use of Taifun 360 as an herbicide in the claimed uses.

8.1 Efficacy evaluation

For the evaluation of the aspect ‘Efficacy’ we refer to the evaluation of the member state of the original authorisation (Belgium).

8.2 Harmful effects

For the evaluation of the aspect ‘Harmful effects’ we refer to the evaluation of the member state of the original authorisation (Belgium).

8.3 Resistance

For the evaluation of the aspect ‘Resistance’ we refer to the evaluation of the member state of the original authorisation (Belgium).

8.4 For vertebrate control agents: impact on target vertebrates

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

8.5 Any other relevant data / information

None.

9. Conclusion

The authorisation of the product is based on mutual recognition of the authorisation in Belgium of the product Taifun 360. For the evaluation is referred to the original authorisation, as Belgium has adopted the Uniform Principles.

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

The product is considered to comply with the Uniform Principles. 

10. Classification and labelling

Proposal for the classification and labelling of the formulation

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

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):
-
Symbol:	N	Indication of danger:	Dangerous for the environment.
R phrases	R51/53	Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
S phrases	S61	Avoid release to the environment. Refer to special instructions/safety data sheets.
	V32-NL	Because of a high risk of formation of highly flammable gas, do not store (diluted) product in galvanised or metal tanks (do not smoke!).
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?			-
Tactile warning of danger obligatory?			-

Appendix 2 Reference list

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[1] INS: international and national quality standards for substances in the Netherlands.

[2] RIVM: National institute of public health and the environment.

[3] 601782001/2007: P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision 2007’.

[4] Bannink, A. (1999) Bestrijdingsmiddelen in het grondwaterbeschermingsgebied Helmond 1999. ’s Hertogenbosch, The Netherlands: N.V. Waterleidingmaatschappij Oost-Brabant. Report no. WOB.BI2803, (in Dutch) 49pp.

[5] Adriaanse et al. (2008). Development of an assessment methodology to evaluate agricultural use of plant protection products for drinking water production from surface waters - A proposal for the registration procedure

in the Netherlands. Alterra-Report 1635

[6] This limit value of 10 µg/L is selected for pragmatic reasons. It is also the current limit value defined in the Drinking Water Directive for chlorinated aliphatic hydrocarbons such as trichlorethene. Some degradation products of pesticides may belong into this chemical category. Note that some other products may also belong to other defined categories in Drinking Water Directive and are, therefore, subject to a different limit.

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