HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 14689 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 WEDERZIJDSE ERKENNING Op 21 augustus 2013 is van Dow AgroSciences B.V. Prins Boudewijnlaan 41 Edegem 2650 Belgium een aanvraag tot wederzijdse erkenning van een gewasbeschermingsmiddel ontvangen voor het middel GALLANT 2000 op basis van de werkzame stof haloxyfop-p-methyl. HET COLLEGE BESLUIT tot toelating van de toepassing van bovenstaand middel in - Bieten - Droog te oogsten erwten - Wortelen - Uien - Veldboon - Vaste plantenteelt HET COLLEGE BESLUIT tot afwijzing van de toepassing van bovenstaand middel in - Winterkoolzaad Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen: - Bijlage I voor details van de aanvraag en toelating; - Bijlage II voor de etikettering; - Bijlage III voor wettelijk gebruik; - Bijlage IV voor de onderbouwing. 1.1 Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.2 Gebruik Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage III bij dit besluit is voorgeschreven. GALLANT 2000, NLWERG 1

2 14689 N 1.3 Classificatie en etikettering Mede gelet op de onder wettelijke grondslag vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen op de verpakking te worden vermeld: - De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder verpakkingsinformatie in bijlage I. - Het toelatingsnummer met een cirkel met daarin de aanduiding van de w-coderingen zoals vermeld onder toelatingsinformatie in bijlage I. - Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III. - Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. 1.4 Aflever- en opgebruiktermijn (respijtperiode) Niet van toepassing. Het betreft een nieuwe toelating. 2 WETTELIJKE GRONDSLAG Besluit artikel 40 van de Verordening (EG) 1107/2009 / artikel 80, vijfde lid, de juncto artikel 36 Wet gewasbeschermingsmiddelen en biociden Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual Zonaal 3 BEOORDELINGEN 3.1 Inleiding Gezien de aard van de wederzijdse erkenning wordt ervan uitgegaan dat de beoordeling door Duitsland 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 Duitsland. 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 IV bij dit besluit. 3.3 Risico voor het milieu De volgende aspecten worden nationaal ingevuld: Uitspoeling naar grondwater Drift naar oppervlaktewater; van toepassing op: Waterorganismen, vogels, zoogdieren, nietdoelwitplanten, niet-doelwitarthropoden en oppervlaktewater bestemd voor de bereiding van drinkwater Drinkwatercriterium oppervlaktewater. GALLANT 2000, NLWERG 2

3 14689 N 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 IV bij dit besluit. Bezwaarmogelijkheid Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld. Wageningen, 5 december 2014 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, Ir. J.F. de Leeuw Voorzitter GALLANT 2000, NLWERG 3

4 14689 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 1 Aanvraaginformatie Aanvraagnummer: Type aanvraag: Middelnaam: GALLANT 2000 Verzenddatum aanvraag: 1 augustus 2013 Formele registratiedatum: * 12 september 2013 Datum in behandeling name: Datum compliance check: NLWERG aanvraag tot wederzijdse erkenning van een gewasbeschermingsmiddel n.v.t. * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2 Stofinformatie Werkzame stof haloxyfop-p-methyl Gehalte 108 g/l De stof is per 1 januari 2011 geplaatst op Annex I van Richtlijn 91/414/EEG en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. De goedkeuring van deze werkzame stof expireert op 31 december Toelatingsinformatie Toelatingsnummer: N Expiratiedatum: 31 december 2022 Afgeleide parallel of origineel: n.v.t. Biocide, gewasbeschermingsmiddel of Gewasbeschermingsmiddel toevoegingsstof: Gebruikers: Professioneel 4 Verpakkingsinformatie Aard van het preparaat: Emulsifiable Concentrate GALLANT 2000, NLWERG 1

5 14689 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel GALLANT 2000 Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: haloxyfop-p-methyl Pictogram Signaalwoord Gevarenaanduidingen GHS05 GHS07 GHS09 GEVAAR H317 Kan een allergische huidreactie veroorzaken. H318 Veroorzaakt ernstig oogletsel H336 Kan slaperigheid of duizeligheid veroorzaken. H411 Giftig voor in het water levende organismen, met langdurige gevolgen. Voorzorgsmaatregelen P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. P302 + P352 BIJ CONTACT MET DE HUID: Met veel water en zeep wassen. P304 + P340 NA INADEMING: het slachtoffer in de frisse lucht brengen en laten rusten in een houding die het ademen vergemakkelijkt. P305 + P351 + P338 + P310 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen. Onmiddellijk een ANTIGIFCENTRUM of een arts raadplegen. P315 Onmiddellijk een arts raadplegen. P501 Inhoud/verpakking afvoeren naar inzamelpunt voor gevaarlijk of bijzonder afval. SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt. Aanvullende EUH066 Herhaalde blootstelling kan een droge of een etiketelementen gebarsten huid veroorzaken. EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen. Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee GALLANT 2000, NLWERG 1

6 14689 N HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG van het middel A. WETTELIJK GEBRUIKSVOORSCHRIFT Toegestaan is uitsluitend het professionele gebruik als onkruidbestrijdingsmiddel door middel van een na opkomstbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden. Toepassings- Gebied Bieten Droog te oogsten erwten Veldboon (voor ensilage) Wortelen Uien Vaste plantenteelt Te bestrijden organisme Eenjarige grasachtige onkruiden Eenjarige grasachtige onkruiden Eenjarige grasachtige onkruiden Eenjarige grasachtige onkruiden Eenjarige grasachtige onkruiden Eenjarige grasachtige onkruiden Dosering (middel) per toepassing Maximaal aantal toepassingen per teeltcyclus of per 12 maanden 1 L/ha 1 per teeltcyclus 90 1 L/ha 1 per teeltcyclus - 1 L/ha 1 per teeltcyclus - 1 L/ha 1 per teeltcyclus 56 1 L/ha 1 per teeltcyclus 28 1 L/ha 1 per 12 maanden Veiligheidstermijn in dagen - Toepassingsvoorwaarden Dit product mag uitsluitend machinaal toegepast worden omdat gezondheidseffecten niet zijn uit te sluiten bij handmatige toepassing. Draag geschikte handschoenen, ook bij werkzaamheden aan behandeld gewas. Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden. Om niet tot de doelsoorten behorende planten te beschermen is toepassing uitsluitend toegestaan indien in de teelt van bieten, droog te oogsten erwten, veldboon (voor ensilage), wortelen, uien en vaste plantenteelt gebruik wordt gemaakt van minimaal 50% driftreducerende spuitdoppen of luchtondersteuning. GALLANT 2000, NLWERG 1

7 14689 N Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. In bieten, wortelen en uien alleen toepassen na het 9 e bladstadium (na BBCH 19). GALLANT 2000 in vaste plantenteelt alleen toepassen van maart tot en met juli. Het verdient aanbeveling middels een proefbespuiting vast te stellen of het te behandelen gewas of ras geen schade ondervindt. Resistentiemanagement Dit middel bevat de werkzame stof haloxyfop-r. Haloxyfop-R behoort tot de aryloxyfenoxypropionaat herbiciden. De Hrac code is A. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen. GALLANT 2000, NLWERG 2

8 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE IV RISKMANAGEMENT Contents GALLANT 2000, NLWERG 1

9 1. Identity of the plant protection product 1.1 Applicant Dow AgroSciences B.V. Prins Boudewijnlaan 41 Edegem 2650 Belgium 1.2 Identity of the active substance Common name Acid: haloxyfop-p Ester: haloxyfop-p-methyl ester Name in Dutch Zuur: haloxyfop-p Ester: haloxyfop-p-methyl ester Chemical name Acid: (R)-2-[4-(3-chloro-5-trifluoromethyl-2- pyridyloxy)phenoxy]propanoic acid Ester: Methyl (R)-2-[4-(3-chloro-5- trifluoromethyl-2- pyridyloxy)phenoxy]propanoic acid CAS no Acid: Ester: EC no Acid: not applicable Ester: The active substance was included in Annex I of Directive 91/414/EEC on 1 January From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC. 1.3 Identity of the plant protection product Name GALLANT 2000 Formulation type EC Content active substance 108 g/l haloxyfop-p-methyl ester corresponding with 104 g/l haloxyfop-p For the assessment of the formulation and its proposed use we refer to the member state of the original authorisation (Germany). 1.4 Function Herbicide. 1.5 Uses applied for See GAP (Appendix I). 1.6 Background to the application Application for mutual recognition of an authorisation of a plant protection product. The application for GALLANT 2000 is based on the authorisation for GALLANT SUPER in Germany. Application in sunflower and tree nursery were withdrawn by the applicant during the evaluation (see environmental fate and behaviour). GALLANT 2000, NLWERG 2

10 1.7 Packaging details Packaging description Material: PET Capacity: 250 ml, 500 ml, 1L and 5L Type of closure and size 45 mm or 63 mm screw cap with heat sealed membrane of opening: Other information UN/ADR compliant Detailed instructions for safe disposal No particular recommendations. 2. Physical and chemical properties For the assessment of the physical and chemical properties of GALLANT 2000 we refer to the member state of the original authorisation (Germany). 3. Methods of analysis For the assessment of the methods of analysis required for GALLANT 2000 we refer to the member state of the original authorisation (Germany). 4. Mammalian toxicology 4.1 Toxicity of the formulated product (IIIA 7.1) For the evaluation of the toxicity of the formulated product GALLANT 2000, we refer to the member state of the original authorisation (Germany). 4.2 Dermal absorption (IIIA 7.3) Germany used a value of 7% for the concentrate and a value of 12% for the spray dilution for dermal absorption in the risk assessment of haloxyfop-p which were determined in an in vivo study with rats using 3 concentrations of EF-1400 (=Gallant 2000), in accordance with the EFSA guidance on dermal absorption (EFSA Journal 2012; 10(4): 2665), which is applicable to this application. The dermal absorption value of 7% of the concentrate (112 mg/l haloxyfop-r (=haloxyfop-p) methyl ester) from this study can be used for the concentrate of GALLANT 2000, which contains 108 g/l haloxyfop-p (as methyl ester). The dermal absorption value of 12% of the field dilution was determined with a ~1:450 dilution of EF-1400 containing mg/l haloxyfop-r methyl ester, while the most diluted concentration of GALLANT 2000 is a 1:800 dilution. As this difference is little, and, in addition, the study report mentions as dermal absorption value of 17% for a ~1:30 dilution of EF-1400 containing 3.79 mg/l haloxyfop-r methyl ester, the value of 12% seems acceptable to be used for the spray dilution of GALLANT Therefore, the value of 7% for the concentrate and the value of 12% for the spray dilution are used for the dermal absorption of haloxyfop-p 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 Germany. GALLANT 2000, NLWERG 3

11 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 GALLANT 2000, a herbicide based on the active substance haloxyfop-p. GALLANT 2000 is an EC formulation and contains 108 g/l haloxyfop-p. The formulation GALLANT 2000 is applied once during the cultivation period. Therefore, a semi-chronic exposure duration is applicable for the operator (including contract workers) Operator exposure/risk Calculation of the EU-AOEL / Tolerable Limit Value (TLV) For haloxyfop-p no TLV has been set. The AOEL will be used for the risk assessment. The semi-chronic EU-AOEL of mg/kg bw/day (= 0.35 mg/day for a 70-kg operator) based on the 1-year study in dogs, is used for the risk assessment (see List of Endpoints). Exposure/risk Exposure to haloxyfop-p during mixing and loading and application of GALLANT 2000 is estimated with models. The exposure is estimated for the unprotected and protector 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. Table T.1 Internal operator exposure to haloxyfop-p and risk assessment for the use of GALLANT 2000 Route Estimated internal exposure a (mg/day) Systemic EU-AOEL Risk-index b without PPE with PPE (mg/day) without PPE with PPE Mechanical downward spraying on the intended uses (uncovered, kg a.s./ha) Mixing/ Respiratory 0.01 (0.01) (0.02) Loading c Dermal Application c Respiratory 0.01 (0.01) (0.02) Dermal Total f f Manual downward spraying on the intended uses (uncovered, kg a.s./ha) Mixing/ Respiratory < 0.01 (< 0.01) 0.35 < 0.01 (< 0.01) Loading d Dermal Application e Respiratory 0.06 (0.06) (0.19) Dermal Total f a Internal exposure was calculated with: biological availability via the dermal route: 7% (concentrate) and 12% (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 (respiratory exposure) and EUROPOEM (dermal exposure). e External exposure is estimated with UK-POEM. GALLANT 2000, NLWERG 4

12 f PPE: gloves and coverall during mixing and loading and application. Based on the risk assessment, it can be concluded that adverse health effects cannot be excluded for the unprotected and protected operator after respiratory and dermal exposure to haloxyfop-p due to manual downward spraying as a result of the application of GALLANT 2000 in the intended uses Bystander exposure/risk The exposure is estimated for the unprotected bystander. In Table T.2 the estimated internal exposure is compared with the systemic EU-AOEL. Table T.2 Internal bystander exposure to haloxyfop-p and risk assessment during application of GALLANT 2000 Route Estimated internal exposure a (mg/day) Systemic EU-AOEL (mg/day) Risk-index b Bystander exposure during application in the intended uses (0.108 kg a.s./ha, 200 L/ha) Respiratory Dermal Total a External exposure was estimated with EUROPOEM II. Internal exposure was calculated with: biological availability via the dermal route: 12% (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 Worker exposure/risk Crop inspection tasks may occur shortly after application. Therefore, worker exposure is calculated. In Table T.3 the estimated internal exposure is compared with the systemic EU- AOEL. A work period of 2 hours/day is considered appropriate and a TC value for hand harvesting ornamental flowers is used since ornamental flowers in terms of morphology, leaf area index and work tasks are considered as a suitable worst case surrogate for inspection activities in oil seed rape (winter), beet (sugar, fodder), bean (field), dry harvested peas, sunflower, carrot, and onion. In perennials and tree nursery shortly after application it is possible to perform re-entry activities during which intensive contact with the treated crop will occur. In Table T.3 the estimated internal exposure is compared with the systemic EU-AOEL. Table T.3 Internal operator exposure to haloxyfop-p and risk assessment for the use of GALLANT 2000 Route Estimated internal exposure a (mg/day) Systemic EU-AOEL Risk-index b without PPE with PPE (mg/day) without PPE with PPE Crop inspection in oil seed rape (winter), beet (sugar, fodder), bean (field), dry harvested peas, sunflower, carrot, onion (0.108 kg a.s./ha) Respiratory - c - c c - c Dermal Total d d Re-entry activities in perennials and tree nursery (0.108 kg a.s./ha) Respiratory - c - c c - c Dermal GALLANT 2000, NLWERG 5

13 Route Estimated internal exposure a (mg/day) Systemic EU-AOEL Risk-index b without PPE with PPE (mg/day) without PPE with PPE Total d d a External exposure was estimated with EUROPOEM II. Internal exposure was calculated with: biological availability via the dermal route: 12% (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 No model is available to calculate the respiratory internal exposure. However, the respiratory internal exposure can be considered negligible in view of the fact that the uses concern field activities (outdoors) and no spraying of the product occurs during re-entry activities. d PPE: gloves Re-entry See Worker exposure/risk. Overall conclusion of the exposure/risk assessments of operator, bystander, and worker The product complies with the Uniform Principles. Operator exposure Regarding mechanical downward spraying, for the unprotected operator, adverse health effects after dermal exposure to haloxyfop-p as a result of the application of GALLANT 2000 in the intended uses cannot be excluded. Correct use of personal protective equipment will reduce the dermal exposure and results in a sufficient reduction of the exposure to haloxyfop-p for the application of GALLANT 2000 in the intended uses. Regarding manual downward spraying, based on the risk assessment, it can be concluded that adverse health effects cannot be excluded for the unprotected and protected operator after respiratory and dermal exposure to haloxyfop-p due to manual downward spraying as a result of the application of GALLANT 2000 in the intended uses. The following restriction sentence is proposed: Dit product mag uitsluitend machinaal toegepast worden omdat gezondheidseffecten niet zijn uit te sluiten bij handmatige toepassing. 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 haloxyfop-p during application of GALLANT Worker exposure For the unprotected worker, adverse health effects after dermal exposure during re-entry activities in the intended uses due to exposure to haloxyfop-p after application of GALLANT 2000 cannot be excluded. Correct use of personal protective equipment will reduce the dermal exposure and results in a sufficient reduction of the exposure for the re-entry activities after application of GALLANT 2000 in the intended uses. The following restriction sentence is proposed: Draag geschikte handschoenen, ook bij werkzaamheden aan behandeld gewas. 4.5 Appropriate mammalian toxicology and operator exposure endpoints relating to the product and approved uses See List of Endpoints. GALLANT 2000, NLWERG 6

14 4.6 Data requirements None. 4.7 Combination toxicology GALLANT 2000 contains only one active substance and it is not described that it should be used in combination with other formulations. 5. Residues For the aspect Residues and risk for consumers we refer to the member state of the original authorisation (Germany). The Guidelines for the generation of data concerning residue data Appendix C 7524/VI/95 rev.2 require that the residue situation in rotational crops must always be considered if, after the treated crop has been harvested (or in the event of early ploughing), it is possible to sow or plant a crop which can be used as a foodstuff and/or feed. Since the product was assessed according to the Uniform Principles by the member state of the original authorisation, residues in succeeding crops need no further consideration. 6. Environmental fate and behaviour Risk assessment is done in accordance with Chapter 4 of the BGB published in the Bulletin of Acts and Decrees (Staatsblad) 594 of November 30 th 2011 and Chapter 2 of the Rgb published in the Government Gazette (Staatscourant) of December 2 nd Haloxyfop-P is an approved active substance. Note: Haloxyfop-P is the ISO common name for the substance formerly referred to by the synonym Haloxyfop-R (introduced by DOW AgroSciences) which is in common use but without official status. This conclusion refers to the ISO common name haloxyfop-p. Additional information submitted by the applicant and considered relevant for the authorisation of GALLANT 2000 or comments/additions from Ctgb are added in italics. List of Endpoints Fate/behaviour Haloxyfop-P (EFSA conclusion (2009; 7(11): 1348). Route of degradation (aerobic) in soil (Annex IIA, point ) Mineralization after 100 days 20 o C 14 C-phenyl labelling: 32 % AR after 90 days (n=1) 20 o C 14 C-pyridine labelling: 1.0, 2.5, 2.9, 3.3 % AR after 91 days and 6.2, 6.3 % AR after 90 days (n=6) 10 o C 14 C- pyridine labelling: 1.3 % AR after 90 days (n=1) Non-extractable residues after 100 days 20 o C 14 C-phenyl labelling, sterile: 0.2 % AR after 90 days (n=1) 20 o C 14 C-phenyl labelling: 44 % AR after 90 days (n=1) GALLANT 2000, NLWERG 7

15 20 o C 14 C- pyridine labelling: 3.4, 31, 32, 35 % AR after 91 days and 28, 38 % AR after 90 days (n=6) 10 o C 14 C- pyridine labelling: 33 % AR after 90 days (n=1) Relevant metabolites - name and/or code, % of applied (range and maximum) 20 o C 14 C-phenyl labelling, sterile: 12 % AR after 90 days (n=1) Haloxyfop-R (DE-535 acid): 20 o C 14 C-phenyl and -pyridine labelling: Range: % AR (n=6) Max: % AR (n=6) % (sterile) (n=1) DE-535 phenol: 20 o C 14 C- pyridine labelling: Range: % AR (n=6) Max: % AR (n=6) DE-535 pyridinol: 20 o C 14 C- pyridine labelling: Range: % AR (n=6) Max: % AR (n=6) DE-535 pyridinone: 20 o C 14 C- pyridine labelling: Range: % AR (n=6) Max: % AR (n=6) Route of degradation in soil - Supplemental studies (Annex IIA, point ) Anaerobic degradation Degradation after 120 days: Haloxyfop-R methyl ester: > 99 % (n=2) Metabolites: DE-535 phenol: 33 % (n=1) DE-535 pyridinol: 72 % (n=1) DE-535 pyridinone: 26 % (n=1) Soil photolysis Max conc. of metabolites after application of DE- 535: Haloxyfop-R: 89 % (3 days) (n=2) DE-535 phenol: 0.8 % (3-7 days) (n=2) DE-535 pyridinol: 0.4 % (3 days) (n=2) DE-535 pyridinone: not detected (n=2) Photodegradation of haloxyfop-r methyl ester after GALLANT 2000, NLWERG 8

16 irradiation for 41 equivalent sunlight days: 91 % (n=1) Degradation of haloxyfop-r in dark control: 99 % (n=1) Max conc. of metabolites after irradiation for 41 equivalent sunlight days: Haloxyfop-R: 83 % (2-25 sunlight days) (n=1) DE-535 phenol: 5 % (4.8 sunlight days) (n=1) Max conc. of metabolites in dark control: Haloxyfop-R: 92 % (2 days, approximately constant) (n=1) DE-535 phenol: 9.1 % (5 days) (n=1) Rate of degradation in soil (Annex IIA, point , Annex IIIA, point 9.1.1) Method of calculation Aerobic studies Haloxyfop-P methyl ester: first order Haloxyfop-P methyl ester + Haloxyfop-P combined: SFO and FOMC kinetics according to recommendations of FOCUS (2006) DE-535 phenol: three compartment decay curve with accumulation phase or two compartment decay curve with accumulation phase DE-535 pyridinol: first order formation and one compartment decay curve with accumulation phase Laboratory studies (range or median, with n value, with r 2 value) Anaerobic studies Fitting of single- or two-phase exponential models with accumulation phase Haloxyfop-R methyl ester 10 o C: DT 50lab = 0.5 d (n=1), r 2 = 0.99 DT 90lab = 1.7 d (n=1) 20 o C: DT 50lab = d, average < 0.5 d (n=7) r 2 = DT 90lab = d, average 0.98 d (n=7) DT 50lab (sterile) = 0.5 d (n=1) r 2 = 0.98 DT 90lab (sterile) = 1.6 d (n=1) DT 50lab (anaerobic) = 0.14, 0.16 d, average 0.15 d (n=2) DT 90lab (anaerobic) = 0.46, 0.52 d, average 0.49 d (n=2) Haloxyfop-P GALLANT 2000, NLWERG 9

17 first order formation and one compartment decay curve with accumulation phase or two compartment decay curve with accumulation phase 10 oc: DT50lab = 20.6 d (n=1) r2 = 0.90 DT90lab = 68 d (n=1) Haloxyfop-P methyl ester + haloxyfop-p ( parent ) 20 oc: FOMC d (DT90/3.32), Geometric mean 25.8 d, (n=6) chi2 error 3.74 to % (for risk assessment use) DT90lab = FOMC d, (n=6) DT50lab(anaerobic) = 333, 842 d, average 588 (n=2) r2 = 1 (no decimals) DT90lab(anaerobic) = 1106, 3394 d, average 2250 (n=2) DE-535 phenol 10 o C: DT 50lab = 44.6 d (n=1) r 2 = 0.95 DT 90lab = 131 (n=1) 20 o C: DT 50lab = d, average 43 d (n=6) r 2 = DT 50lab (anaerobic) = 281 d (n=1) r 2 = DT 90lab (anaerobic) = 1088 d (n=1) DE-535 pyridinol 10 o C: DT 50lab = 508 d (n=1) r 2 = 0.94 DT 90lab = 1615 d (n=1) 20 o C: DT 50lab = d, average 237 d (n=6) r 2 = DT 90lab = d, average > 605 d (n=6) DT 50lab (anaerobic) = 49 d (n=1) r 2 = DT 90lab (anaerobic) = 292 d (n=1) DE-535 pyridinone 20 oc: Data gap identified in PRAPeR Teleconference TC18 DT50lab(anaerobic) = 306 d (n=1) r2 = DT90lab(anaerobic) = 1017 d (n=1) GALLANT 2000, NLWERG 10

18 Field studies (state location, range or median with n value) Kinetics: Persistence end-points: Bi-exponential model for haloxyfop-p and three exponent model for DE-535 pyridinol. Modelling end-points: Normalisation for temperature then - Haloxyfop-P: FOMC kinetics according to recommendations of FOCUS (2006) DE-535 pyridinol: SFO kinetics with linear degradation scheme ( parent pyridinol) Persistence end-points: Spring/summer application, 1 L/ha EF-1400 Haloxyfop-P Germany (Niedersachsen): DT50 = 12 d, DT90 = 119 d, r2 = (n=1) Germany (Baden-Wurttemberg): DT50 = 13 d, DT90 = 53 d, r2= (n=1) France (Bas-Rhin): DT50 = 19 d, DT90 = 248 d, r2 = (n=1) France (Champagne): DT50 = 12 d, DT90 = 59 d, r2= (n=1) DE-535 pyridinol Germany (Niedersachsen): DT50 = 165 d, DT90 = 549 d, r2 = (n=1) Autumn application, 1 L/ha EF-1400 Haloxyfop-P Germany (Schenkenberg): DT50 = 27 d, DT90 = 362 d, r2 = 0.98 (n=1) Germany (Klostergut): DT50 = 6 d, DT90 = 241 d, r2= 0.99 (n=1) Germany (Ismaning): DT50 = 5 d, DT90 = 297 d, r2= 0.98 (n=1) DE-535 pyridinol Germany (Klostergut): DT50 = 38 d, DT90 = 412 d, r2= 0.82 (n=1) Germany (Ismaning): DT50 = 193 d, DT90 = 640 d, r2= 0.72 (n=1) Modelling end-points: Spring and autumn applications Haloxyfop-P - DT d (30.2 days geometric mean of FOMC DT50s/3.32, n=7), chi2 GALLANT 2000, NLWERG 11

19 error 5.13 to %. DE-535 pyridinol - DT d (63 d geometric mean of SFO DT50s, n=7), chi2 error 11.4 to 33.6 %. Spring application, 1 L/ha EF-1400 Field study at 4 sites in Germany, Poland and France, DT50s not determined. Haloxyfop-P declined from µg/kg to 2.8 to 8.4 µg/kg after 180 days. DE-535 pyridinol detected at max 3.7 to 6.9 µg/kg at days DE-535 phenol detected at max <LOQ to 11.2 µg/kg at 7-14 days DE-535 pyridinone detected at <LOQ Soil accumulation and plateau concentration Calculated maximum plateau concentrations found immediately after application (or metabolite peak): Haloxyfop-R methyl ester PECmax plateau = 144 µg/kg soil Haloxyfop-R PECmax plateau = 119 µg/kg soil DE-535 phenol PECmax plateau = 14.9 µg/kg soil DE-535 pyridinol PECmax plateau = 54.4 µg/kg soil DE-535 pyridinone PECmax plateau = 13.9 µg/kg soil Soil adsorption/desorption (Annex IIA, point 7.1.2) K f /K oc Haloxyfop-R methyl ester: GALLANT 2000, NLWERG 12

20 K d ph dependence (yes / no) (if yes type of dependence) No test due to rapid hydrolysis. Haloxyfop-R: Sorption: Koc: ml/g (n = 8) Kd: ml/g (n = 8) Soil horizon from a lysimeter (30-60 cm): Koc: 60.4 ml/g (n=1) Soil horizon from a lysimeter ( cm): Koc: 55.3 ml/g (n=1) DE-535 phenol: Sorption: Koc: ml/g (n = 7) Kd: ml/g (n = 7) DE-535 pyridinol: Sorption: Koc: ml/g (n = 7) Kd: ml/g (n = 7) DE-535 pyridinone: Sorption: Koc: ml/g (n = 7) Kd: ml/g (n = 7) As no attempt at Freundlich determinations for all the compounds has taken place (a single concentration was investigated), a 1/n = 1 should be used for modelling purposes. Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2) Column leaching Aged residues leaching Lysimeter/ field leaching studies No data No data Late spring study (Fraunhofer Institut, Schmallenberg-Grafschaft, Germany) Crop: sugar beet (1st year) and winter wheat (2nd year) Application rate: 112 g a.s./ha or 212 g a.s./ha Leachate: 1. year: 490 mm; 2. year: 470 mm Total % AR leached at 112 g a.s./ha: 1. year: 0.12; 2. year: 0.17 Total % AR leached at 212 g a.s./ha: 1. year: 0.38; GALLANT 2000, NLWERG 13

21 2. year: 0.33 Annual average µg as eq/l in leachate at 112 g a.s./ha: 1. year: 0.04; 2. year: 0.03 Annual average µg as eq/l in leachate at 212 g a.s./ha: 1. year: 0.15; 2. year: 0.16 Haloxyfop-R and DE-535 Pyridinol were < 0.02 µg/l and < 0.05 µg/l at the 112 and 212 g/ha application rate, respectively. The majority of the remaining radioactivity in the soil was contained within the top 30 cm of the soil column. Spring study (Covance Laboratories, Muenster, Germany) Crop: sugar beet (1st year) and winter wheat (2nd year) Application rate: 108 g a.s./ha Leachate: 1. year: 248 mm; 2. year: 634 mm Total % AR leached; lys 1: 1. year: 0.49; 2. year: 2.06 Total % AR leached; lys 2: 0.40; 2. year: 1.94 Annual average µg as eq/l in lys 1: 1. year: 0.20; 2. year: 0.34 Annual average µg as eq/l in lys 2: 1. year: 0.37; 2. year: 0.58 Haloxyfop-R methyl ester, haloxyfop-r and DE- 535 phenol were each below µg as eq/l. DE-535 pyridinol peaked at and µg as eq/l week 99 in lysimeter 1 and 2, respectively. Metabolite U1 = trifluoroacetic acid (TFA) with annual average concentrations of and µg/l, respectively, the first year and and µg/l, respectively, the second year. Autumn study (Covance Laboratories, Muenster, Germany) Crop: winter oilseed rape Application rate: 108 g a.s./ha Leachate: 1. year: 188 mm; 2. year: 494 mm Total % AR leached; 54 g a.s./ha: 1. year: 0.03; 2. year: 1.9 Total % AR leached; 108 g a.s./ha: 0.17; 2. year: 1.7 GALLANT 2000, NLWERG 14

22 Annual average µg as eq/l; 54 g a.s./ha: 1. year: 0.035; 2. year: 0.15 Annual average µg as eq/l;108 g a.s./ha: 1. year: 0.20; 2. year: 0.67 Haloxyfop-R methyl ester and DE-535-phenol: each < µg as eq/l. Haloxyfop-R first year average annual concentrations: and µg as eq/l for lysimeters treated at 54 g a.s./ha and and µg as eq/l for lysimeters treated at 108 g a.s./ha. Second year: Haloxyfop-R < µg as eq/l for all lysimeters. DE-535 pyridinol, annual average concentrations: < µg/l for the four lysimeters the first year and µg/L the second year. Trifluoroacetic acid (TFA) leached with annual average concentrations the second year at and µg/l, respectively, for the two lysimeters treated at 54 g a.s./ha and and µg TFA/L for the two lysimeters treated at 108 g a.s./ha. PEC (soil) (Annex IIIA, point 9.1.3) Method of calculation Application rate Worst-case continuous and time weighted average soil concentrations calculated when the plateau concentration is reached. The assumptions are even distribution in the top 5 cm layer and a bulk density of 1.5 g/cm3. Spray deposition is assumed to be 100 %. No interception, no losses due to surface runoff, leaching and volatilisation. Max concentrations of the metabolites haloxyfop-r, DE-535 Phenol, DE- 535 Pyridinol and DE-535 Pyridinone were set to 100, 12, 52 and 11 % as eq., respectively. Where available longest realistic field DT 50 was used, in the other longest realistic lab DT 50 was used. Because of the inconsistency between the the calculation model and the kinetic evaluation of the degradation rates for haloxyfop-r, DE-535 phenol and DE-535 pyridinone, only initial values can be considered valid 1. Maximum application rate: One time 108 g a.s./ha. 1 New PECsoil calculations are not required as no risk was identified for terrestrial organisms with the initial PECsoil GALLANT 2000, NLWERG 15

23 Route and rate of degradation in water (Annex IIA, point 7.2.1) Hydrolysis of active substance and relevant metabolites (DT 50 ) (state ph and temperature) 20 o C: Haloxyfop-R methyl ester: ph 4: Stable. ph 7: DT 50 = 43 d ph 9: DT 50 = 0.63 d natural water, ph 8: 3 d Photolytic degradation of active substance and relevant metabolites metabolites: Haloxyfop-R: max 99.1 %AR (ph 9) unknown 1: max 2.3 %AR (ph 9) unknown 2: max 2.9 %AR (ph 7) Xenon light source, continuous irradiation Haloxyfop-R methyl ester at 20 o C, ph 5 sterile buffer: Haloxyfop-R methyl ester: DT 50 = 20 d, DT 90 = 67 d Haloxyfop-R: Not observed in test DE-535 furan: max. 18.6% AR (irradiated samples) Haloxyfop-R methyl ester at 20 o C, natural water (ph 8.5): Haloxyfop-R methyl ester: DT 50 = 2 d, DT 90 = 7 d Haloxyfop-R: DT 50 = 8 d, DT 90 = 24 d Readily biodegradable (yes/no) Degradation in water/sediment Haloxyfop-R at 20 o C, ph 5 sterile buffer: Haloxyfop-R: DT 50 = 12 d, DT 90 = 41 d No Two different systems meaning that n=2 for all data Kinetic: first order kinetic based on optimised rate constants from modelling with MODELMAKER. Haloxyfop-R methyl ester: water: DT 50 = d sediment: DT 50 = d total: DT 50 = d Haloxyfop-R: water: DT 50 = d sediment: DT 50 = 46.2 d > 1 year total: DT 50 = d DE-535 pyridinol: not available GALLANT 2000, NLWERG 16

24 Mineralization 14 C-phenyl labelling: 49 and 53 % after 100 days (n=1) Non-extractable residues Distribution in water / sediment systems (active substance) 14 C-pyridinol labelling: 3.8 and 11.5 % after 100 days (n=1) Total amount: %AR (100 d) (n=4) 4.54 % AR (30 d) (sterile system) (n=2) Haloxyfop-R methyl ester: 14 C-phenyl labelling: Water: max % AR at 0d; ND after 7 d (n=2) Sediment: max % AR at 0d; ND after 7 d (n=2) Distribution in water / sediment systems (metabolites) 14 C- pyridine labelling: Water: max % AR at 0d; ND after 2-7 d (n=2) Sediment: max % AR at 0d; ND after 2-7 d (n=2) Haloxyfop-R: 14 C-phenyl labelling: Water: max % AR after 7-30 d (n=2) Sediment: max % AR after 30 d (n=2) 14 C-pyridine labelling: Water: max % AR after 1 d (n=2) Sediment: max % AR after 7-14 d (n=2) DE-535 pyridinol: 14 C-phenyl labelling: Can not be detected with that labelling. 14 C-pyridine labelling: Water: max % AR after d (n=2) Sediment: max % AR after d (n=2) DE-535 phenol: 14 C-phenyl labelling: Water: max % AR after 7 d (n=2) Sediment: max % AR after d (n=2) 14 C-pyridine labelling: Water: max % AR after 1-7 d (n=2) Sediment: max % AR after 100 d (n=2) GALLANT 2000, NLWERG 17

25 PEC (surface water) (Annex IIIA, point 9.2.3) Method of calculation Main routes of entry The worst-case concentrations in surface water are calculated for a model system defined by - a water volume with a depth of 0.3 meter - one application at 108 g a.s./ha - spray drift at 1 m of 2.77 % Haloxyfop-R methyl ester: DT 50 water = 0.28 days Haloxyfop-R: DT 50 water = 54.6 days. Max. conversion factor = 86 % DE-535 pyridinol: DT 50 water = 20.6 days. Max. Conversion factor = % based on the concentration of DE-535-pyridinol (33.13%) + the precoursers haloxyfop-r (17.85%) and DE-535- phenol (5.26%). Worst-case continuous and time weighted average surface water concentrations calculated at a distance 1 m from source are shown in the table below. Spray drift of 2.77 % in a distance of 1 meter Spray drift (2.77%) and runoff/drainage (15%) GALLANT 2000, NLWERG 18

26 DE-535-furan PECsw has been calculated for the aqueous photolysis product, DE-535-furan, using the FOCUS Steps 1-2 calculator. Application rate: 104 g haloxyfop-p/ha in winter oil seed rape and sugar beet in North and South Europe. Maximum concentration of DE-535-furan in the water phase is set to 7 %. Koc: 0 ml/g (surrogate assuming no sorption). DT50 water: 0.9 days (photolysis DT50 in natural water; DAR, B.8.4.6). DT50 soil/sediment/water: 1000 d (FOCUS default since no data). This approach means that no degradation of the precursor DE-535 and the DE-535 furan is accounted for in the time period from application until the surface water is reach via run-off and/or drainage. The maximum initial PECsw equals to µg/l. PEC (sediment) Method of calculation Application rate A worst-case scenario for haloxyfop-r methyl ester, haloxyfop-r and DE-535 Pyridinol concentrations in sediment are calculated for a model system defined by - sediment depth = 5 cm - sediment bulk density = 1.3 g/cm3 - one application at 108 g a.s./ha - spray drift at 1 m of 2.77 % - contribution from run-off/erosion and/or drainage flow: 15% of the application rate, according to FOCUS step 1 (worst-case loading) - assuming 100 % of applied substance that reaches the surface water also reaches the sediment and mixes with the top 5 cm. Haloxyfop-R methyl ester DT 50 sed = 0.20 d Haloxyfop-R: DT 50 sed > 1 year (= 365 d). Max. Conversion factor = 86 % DE-535 pyridinol: DT 50 sed > 1 year (= 365 d). Max. Conversion factor = % based on the concentration of DE-535-pyridinol (33.13%) + the precoursers H haloxyfop-r (17.85%) and DE-535- phenol (5.26%). 108 g a.s./ha PEC (ground water) (Annex IIIA, point 9.2.1) Method of calculation and type of study (e.g. modelling, monitoring, lysimeter ) Because of the inconsistency between the the 1st order kinetic used in the FOCUS PELMO model and the kinetic evaluation of the degradation rates, the PECgw values reported below should be considered with caution and should be confirmed by new FOCUSgw modeling (data gap identified in EPCO 21). The new FOCUSgw modeling should also take into account the agreed input parameters in PRAPeR Teleconference TC18. GALLANT 2000, NLWERG 19

27 Haloxyfop-R: DT 50 = 11.4 d; K OC = 54 DE-535 Phenol: DT 50 = 36.1 d; K OC = 761 DE-535 Pyridinol: DT 50 = 230 d; K OC = 42 DE-535 Pyridinone: DT 50 = 226 d; K OC = 31 Application rate 108 g a.s./ha. Each metabolite was modeled separately representing worst case scenarios as applications at their corresponding maximum amounts seen in the laboratory studies, corrected for molecular weight differences. The maximum amounts used, expressed in % as eqv. were 100 % DE-535 acid, 36.9 % DE-535 pyridinol, 7.6 % DE-535 Phenol and 9.4 % DE-535 pyridinone. Please note from Annex B that the last three maximum amounts should be corrected. Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3) Direct photolysis in air Quantum yield of direct phototransformation No data No data Photochemical oxidative degradation in air Latitude: Not stated Season: Not stated DT 50 : days (12-hour day). Volatilization The volatilisation of haloxyfop-r methyl ester from soil and plant surfaces was investigated in one study. Results of the plant tests showed that 19 and 20% of the applied radioactivity had volatilised from the plant leaves after 24 hours. There was no effect of application rate. Losses from soil were lower at only 2% of applied amounts at both rates. PEC (air) Method of calculation Expert judgement based on vapour pressure (5.5 x 10-5 Pa for haloxyfop methyl ester) and information on volatilisation from plants and soil Definition of the Residue (Annex IIA, point 7.3) Relevant to the environment Soil: haloxyfop-p methyl ester (DT 90 < 3 d), haloxyfop-p, DE-535 pyridinol, DE-535 pyridinone and DE-535 phenol. Ground water: haloxyfop-p methyl ester, haloxyfop-p, DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone. Surface water: haloxyfop-p methyl ester, haloxyfop-p, DE-535 pyridinol and DE-535-furan. Air: haloxyfop-p methyl ester and haloxyfop-p Monitoring data, if available (Annex IIA, point 7.4) GALLANT 2000, NLWERG 20

28 Soil (indicate location and type of study) Surface water (indicate location and type of study) Ground water (indicate location and type of study) Air (indicate location and type of study) No data No data In a total of 143 samples from 101 sites in Germany and France haloxyfop2 has not been detected (< 0.1 µg/l). No data Classification and proposed labelling (Annex IIA, point 10) with regard to fate and behaviour data R53 Not readily biodegradable (cf. Annex B ) Additional studies: Havens, P.L. (2011). Calculation of Field Kinetics for Haloxyfop-P and its Soil Metabolites using FOCUS-Kinetics Methodology - Temperature Effects Only and Updated Q10 From the report of Havens (2011) normalised DT50 field values are available for the parent haloxyfop-p (DE-535 acid) and its metabolite DE-535 pyridinol: Accepted DT 50 values for the parent DE-535 acid: 30.7, 69.2, 24.1, 22.9, 16.7 and 17.3 days (geometric mean 26.4 days) Accepted DT50 values for metabolite DE-535 pyridinol: 116.3, 62.4, 46.5, 90.1, 26.8 and 87.9 days (geometric mean 64.4 days) Accepted formation fraction: , , , , and (arithmetic mean f.f: Appendix A: Metabolite names, codes and other relevant information of the plant protection product GALLANT 2000 with active substance Haloxyfop-P-methyl. The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of active substance haloxyfop-p (-methyl-ester). The parent compound structure of haloxyfop-p-methyl-ester/haloxyfop-p is shown first in this list and followed by degradates or related compounds. Compoun d name Haloxyfop- P-methylester DE-535 acid (Haloxyfop- P) IUP AC nam e Structural formula C16H13ClF 3NO4 C15H11ClF 3NO4 Structure N F 3 C Cl N F 3 C Cl O O Molecula r Weight [g/mol] Observed in study (% of occurrence/ formation) H 3 C Parent H O O- CH 3 substance C H 3 O O H O OH Soil: formation fraction 91% Water/sediment : % AR after 30 days (in water). 33.7% AR (in sediment) GALLANT 2000, NLWERG 21

29 Compoun d name DE-535 phenol IUP AC nam e Structural formula Structure F 3 C N O OH Molecula r Weight [g/mol] Observed in study (% of occurrence/ formation) Soil: formation fraction 12.6% DE-535 pyridinol F 3 C Cl N OH Soil: formation fraction 52% Cl Water/sediment : 19.7% AR after 59 days (waterphase). 16.4% AR sedimentphase. DE-535 pyridinone F 3 C N CH Soil: formation fraction 11% O DE-535 furan Cl 327 Water: Photolysis 18.6% 6.1 Fate and behaviour in soil Persistence in soil The risk assessment of persistence in soil is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorisation in Germany with the name of GALLANT SUPER (authorisation number /00) Leaching to shallow groundwater Leaching to shallow ground water is a Dutch specific aspect. For the current application for mutual recognition this means that the German 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. Ctgb notes that based on the initial risk assessment the intended uses sunflower and tree nursery were excluded from the GAP. Furthermore the earliest indicated BBCH stage was increased to BBCH20 for the intended uses beet (sugar, fodder), carrot and onion, resulting in the following interception values appropriate to the crop stage: 0.7 for beet (sugar and fodder), 0.6 for carrot and 0.25 for onion. Furthermore the applicant provided a statement for the use of the normalised field DT50 values as modelling endpoints for the parent and metabolite DE-535 pyridinol. Based on the non-normalised field data presented in Addendum 2 of the DAR Ctgb agrees with this statement. The PECgw values for DE-535 acid and DE-535 pyridinol were re-calculated with the normalised values obtained from the study of Havens (2011). Furthermore the Kom values and 1/n values were altered according to the values used in the German risk assessment. GALLANT 2000, NLWERG 22

30 The leaching potential of the active substance Haloxyfop-P-methyl, Haloxyfop-P (DE-535 acid) and its metabolites, DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone is calculated in the first tier using Pearl and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate kg/ha (for the intended use oilseed rape) and kg/ha (for all other uses), the crop oilseed for oilseed rape (winter), the crop sugar beet for beet (sugar and fodder), the crop field beans for beans (field) and dry harvested peas, the crop winter cereals for sunflower, perennials and tree nursery, the crop carrot for carrot and the crop onion for onion. Furthermore an interception value appropriate to the crop stage was used: of 0.4 for oil seed rape (winter), 0.7 for beet (sugar and fodder), 0.25 for beans (field), 0.35 for dry harvested peas, 0.6 for carrot, 0.25 for onion and 0 for perennials. Date of yearly application is November 1 st for oil seed rape (autumn scenario). Date of yearly application is May 25 th (default date for spring applications) for the proposed uses on beet (sugar, fodder), bean (field), dry harvested peas, sunflower, carrot and onion. For perennials and tree nursery dates of yearly application are May 25 th and November 1 st. For metabolites all available data concerning substance properties are regarded. Metabolites DE-535 acid (=Haloxyfop-P), DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone are 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 Haloxyfop-P-methyl (ester): Median DT 50 for degradation in soil (20 C): 0.5 days (n=7) K om for suspended organic matter: 10 L/kg (default; no value available due to rapid hydrolysis) K om for sediment: 10 L/kg (default; no value available due to rapid hydrolysis) 1/n: 0.9 (default for active substance) Saturated vapour pressure: 5.5 * 10-5 Pa (25 o C) Solubility in water: 9.1 mg/l (20 o C) Molecular mass: g/mol No calculation required (used for transformation scheme in pearl). Plant uptake factor: 0.0 Q10: 2.2 Haloxyfop-P (DE-535 acid): Geometric mean field DT 50 for degradation in soil (20 C): 26.4 days *(Havens (2011) Median laboratory DT 50 for degradation in soil (20 C): 26.2 days (n=6) Arithmetic mean K om (ph-independent): 29.6 L/kg (n=4) Arithmetic mean: 0.93 (n=4) Maximum fraction of occurence: 0.91 * 0.96 (relative molar ratio = M metabolite/m parent) = 0.87 Saturated vapour pressure: 4.0 * 10-6 Pa (25 o C) Solubility in water: 375 mg/l (20 o C) dit is unbuffered GALLANT 2000, NLWERG 23