HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 BESLUIT
Op 14 juli 2017 is van
DuPont de Nemours (Nederland) B.V.
Postbus 145
3300 AC DORDRECHT
een aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating ontvangen voor het middel
DuPont HARMONY SX
op basis van de werkzame stof thifensulfuron-methyl.
HET COLLEGE BESLUIT tot uitbreiding van bovenstaand middel.
Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit.
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.
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 bij dit besluit.
- Het toelatingsnummer met een cirkel met daarin de aanduiding van de W-codering zoals vermeld onder “toelatingsinformatie” in bijlage I bij dit besluit.
- De etikettering zoals opgenomen in bijlage II bij dit besluit.
- Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in bijlage III bij dit besluit.
- Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
1.4 Aflever- en opgebruiktermijn (respijtperiode)
Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt.
2 WETTELIJKE GRONDSLAG
Besluit artikel 51 Verordening (EG) Nr. 1107/2009 en artikel 2.2 Rgb Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Conform Rgb d.d. 13 juni 2011 en Evaluation Manual 1.1.
3 BEOORDELINGEN
De beoordeling van deze uitbreiding kleine toepassing is gebaseerd op de bestaande toelating en de eindpunten van de werkzame stof zoals in de onderliggende beoordeling gebruikt. Bij de verlenging van de goedkeuring van de werkzame stof op 1 november 2016 zijn nieuwe eindpunten van
toepassing geworden. Deze uitbreiding dient daarmee opgenomen te worden in de op handen zijnde aanvraag tot verlenging van de middeltoelating.
3.1 Fysische en chemische eigenschappen
De identiteit en de fysische en chemische eigenschappen van het middel en de werkzame stof wijzigen niet.
3.2 Analysemethoden
De analysemethoden voor de werkzame stoffen en het middel wijzigen niet. Voor de toegelaten toepassingen voldoen de vereiste residuanalysemethoden.
3.3 Risico voor de mens
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.
3.4 Risico voor het milieu
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.
3.5 Werkzaamheid
Gelet op artikel 51 Verordening (EG) 1107/2009 is de aanvraag niet beoordeeld voor het aspect werkzaamheid (inclusief fytotoxiciteit).
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 8030, 6710 AA, EDE.
Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.
Ede, 29 december 2017
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw Voorzitter
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
1 Aanvraaginformatie
Aanvraagnummer: 20171186 NLKUG
Type aanvraag: aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating
Middelnaam: DuPont HARMONY SX
Formele registratiedatum: * 14 juli 2017 Datum in behandeling name: 14 augustus 2017 Datum compliance check: N.v.t.
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2 Stofinformatie
Werkzame stof Gehalte
thifensulfuron-methyl 500 G/KG
De stof thifensulfuron-methyl is per 1 juli 2002 geplaatst op Annex I van Richtlijn 91/414/EEG (2001/99/EG d.d. 20 november 2001) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d.
25 mei 2011 goedgekeurd. De renewal van de stof was op 1 november 2016.
De goedkeuring van deze werkzame stof expireert op 31 oktober 2031.
3 Toelatingsinformatie
Toelatingsnummer: 14710 N
Expiratiedatum: 1 juli 2019
Afgeleide of parallel: n.v.t.
Biocide, gewasbeschermingsmiddel of toevoegingsstof:
Gewas
Gebruikers: Professioneel
W-codering professioneel gebruik: W1
4 Aflever- en opgebruiktermijnen voor oude etiket Vorige W-codering professioneel gebruik: - Aflevertermijn professioneel gebruik: nvt Opgebruiktermijn professioneel gebruik: nvt
5 Verpakkingsinformatie
Aard van het preparaat:
Wateroplosbaar granulaat
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel DuPont HARMONY SX
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
Pictogram GHS09
Signaalwoord Waarschuwing
Gevarenaanduidingen H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen.
Voorzorgsmaatregelen SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt.
P273 Voorkom lozing in het milieu.
P391 Gelekte/gemorste stof opruimen.
P501 Inhoud/verpakking afvoeren naar ....
Aanvullende etiketelementen
EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG van het middel DuPont HARMONY SX
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Wettelijk Gebruiksvoorschrift
Toegestaan is uitsluitend het professionele gebruik als onkruidbestrijdingsmiddel door middel van een na opkomst behandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden Toepassings-
gebied
Te bestrijden organisme Dosering (middel) per toepassing
Maximaal aantal toepassingen per teeltcyclus
Veiligheidstermijn in dagen of uiterst
gewasstadium waarop toegepast mag worden
maïs éénjarige
breedbladige onkruiden
15 g/ha 1 -
voedergrasland zuring1 45 g/ha 1 14 dagen tussen toepassing en maaien en/of
beweiden
1 Zuring (Rumex spp.)
Het gebruik in de teelt van sojaboon is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbehandeling uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en verantwoordelijkheid van de gebruiker.
Toepassingsgebied Te bestrijden organisme Dosering (middel) per toepassing
Maximaal aantal toepassingen per teeltcyclus
Toepassingsgebied Te bestrijden organisme Dosering (middel) per toepassing
Maximaal aantal toepassingen per teeltcyclus
sojaboon éénjarige breedbladige onkruiden 15 g/ha 1
Toepassingsvoorwaarden
Voor maïs: de toepassing van HARMONY® SX kan in bepaalde maïsrassen gewasschade veroorzaken.
Voor voedergrasland: in het algemeen is HARMONY® SX veilig voor witte klaver. Echter bij ongunstige omstandigheden kan een tijdelijke lichte vergeling en/of onderdrukking optreden.
Resistentiemanagement
Dit middel bevat de werkzame stof thifensulfuron-methyl. Thifensulfuron-methyl behoort tot de sulfonylureumverbindingen. De Hrac code is B. 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.
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE IV
RISKMANAGEMENT
Contents
1 Identity of the plant protection product ... 2
2 Physical and chemical properties ... 2
3 Methods of analysis ... 3
4 Mammalian toxicology ... 5
5 Residues ... 10
6 Environmental fate and behaviour ... 13
7 Ecotoxicology ... 13
8 Efficacy ... 13
9 Conclusion ... 13
10 Classification and labelling... 13
Appendix 1 Table of authorised extensions ... 15
Appendix 2 Reference list ... 17
1 Identity of the plant protection product
1.1 Applicant
Du Pont de Nemours (Nederland) B.V.
Baanhoekweg 22 NL-3313 LA Dordrecht The Netherlands
1.2 Identity of the active substance
The identity of the active substance(s) does not change.
Common name Thifensulfuron-methyl Name in Dutch Thifensulfuron-methyl
Chemical name Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2- ylcarbamoylsulfamoyl)thiophene-2-carboxylate
CAS no 79277-27-3
EC no Not allocated
The active substance was included in Annex I of Directive 91/414/EEC on 1 July 2002. 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
The identity of the plant protection product does not change.
Name DuPont HARMONY SX
Formulation type SG (Soluble Granules)
Content active substance 500 g/kg pure Thifensulfuron-methyl
The formulation is identical to that assessed for the inclusion of the active substance in Annex I of Directive 91/414/EEC.
1.4 Function Herbicide
1.5 Uses applied for See GAP (Appendix I).
1.6 Background to the application
It concerns a simplified extension of the authorization with minor uses.
1.7 Packaging details Packaging details do not change.
2 Physical and chemical properties
The physical and chemical properties of the active substance(s) and the formulation do not change.
3 Methods of analysis
3.1 Analytical methods in technical material and plant protection product
The analytical methods for the technical material and the plant protection product do not change.
3.2 Residue analytical methods
As the MRL/matrix combination soyabean (high oil content) cannot be extrapolated from the existing authorization (e.g. the maize matrix with high starch/dry content) and no analytical method is available in the DAR of the active substance, the applicant has provided two analytical methods for the determination of thifensulfuron-methyl residues in soya beans used for residue trials.
Study 1:
Title MAGNITUDE OF THIFENSULFURON METHYL RESIDUES IN SOYBEAN FOLLOWING FOLIAR APPLICATIONS OF THIFENSULFURON METHYL (DPX-M6316) 50SG – NORTHERN EUROPE – 2012.
Charles River Analytical Method No. 1551, based on DuPont- 13412, Revision No. 1 and DuPont-13412, Supplement No. 1 Study director(s) A. Aitken, D. Brown
Applicant/Sponsor E. I. du Pont de Nemours and Company, Wilmington, Delaware 19898, USA Laboratory Charles River, Tranent,Edinburgh, EH33 2NE, UK.
Sponsor-ID DuPont-34800
Report No. Charles River Study No. 697111
GLP Yes
Published No
Validation criteria
Principle of the method. Homogenize using a handheld homogeniser with 90 mL 75: 25 (v/v) Acetonitrile: 20 mM Potassium Phosphate, pH 7, twice.
Centrifuge and combine extracts. Wash extract with Hexane, concentrate under a flow of nitrogen, pass through an ENV SPE cartridge. Elute using a solution of 25 mM Ammonium hydroxide in methanol. Concentrate eluate to less than 0.75 mL then reconstitute in 90:10 (v/v) 50 mM Ammonium Acetate: Acetonitrile.
Chromatographic parameters HPLC: Phenomenex Luna 3μ Phenyl-Hexyl (150 x 4.6mm) Triple quadrupole mass spectrometer (MS/MS) in positive ionization mode.
Specificity Two ion transitions m/z 388.2 -> 167.2 and 388.2 -> 205.0. No interference ≥ 30% of the LOQ on the RT of thifensulfuron-methyl in control and treated soybean.
Linearity 7 point calibration curve standard in solvent ranging from 0.2 – 10 ng/mL, Y=3.24e+004X + 377, r=1.0000
Repeatability Not provided.
Accuracy At 0.01 mg/kg (n=2) 98.0%, at 0.1 mg/kg (n=2) 101.5% (mean 100%
n=4)
LOD 0.003 mg/kg
LOQ 0.01 mg/kg (n=2)
Matrix effect Not determined.
Conclusion The analytical method has not been validated in compliance with the requirements of SANCO/825/00 rev. 8.1 or SANCO/3029/99 rev.
4, as no repeatability results are provided and no matrix effect has been determined and only 2 fortification levels were used for recovery. However, the method can be found fit for the intended purpose for the determination of thifensulfuron-methyl in soybeans as pre-registration method, nevertheless the method is not suitable validated to be used as a post-registration method for monitoring or enforcement puposes.
Study 2:
Title MAGNITUDE OF RESIDUES OF THIFENSULFURON METHYL IN SOYABEAN FOLLOWING APPLICATIONS OF HARMONY (DPX-M6316) 75% WG – NORTHERN EUROPE, SEASON 2001.
Based on Analytical method described in DuPont Report No. AMR-431-85 rev. 1 (p.8-11)
Study director(s) D. Zenide
Applicant/Sponsor Du Pont de Nemours (Deutschland) GmbH, Du Pont Strasse 1, D-61352 Bad Homburg v.d.H, Germany
Laboratory Battelle, Geneva Research Centres, Agrochemical Product Development 7, route de Drize, 1227 Carouge/Geneva, Switserland.
Sponsor-ID DuPont-6411
Report No. Battelle Study No. FA-11-01-02
GLP Yes
Published No
Validation criteria
Principle of the method. Weigh 25 g of sample into 250 mL centrifuge flask, add 100 mL extraction solvent (75 mL ethyl acetate + 25 mL 0.1M NaHCO3).
Adjust pH to 3 and homogenize for 1 min and centrifuge for 5 min.
at 2500 rpm. Repeat three more times with 75 mL ethyl acetate.
Combine all the extracts in a 500 mL funnel. Evaporate to4-5 on a rotary evaporator and transfer to a Sovirel and evaporate to dryness under a gentle stream of nitrogen. Dissolve in 1 mL ethyl acetate, sonicate and add 4 mL of n-Hexane. Condition 2 g silica cartridge with 5 mL n-Hexane and 5 mL n-Hexane/ethyl acetate (8/2). Transfer the sample (5mL) on the cartridge and rinse the cartridge with 5 mL n-Hexane. Elute with 5 mL ethyl acetate + 1% acetic acid. Evaporate to dryness and dissolve in mobile phase to final volume of 5 mL.
Inject 20µL of this sample on a HPLC-PCD.
Chromatographic parameters HPLC-PCD (254 nm), column µPorasil 10µm x 30 cm x 3.9 m ID from Waters.
Specificity No interference ≥ 30% of the LOQ on the RT of thifensulfuron- methyl in control and untreated soybean.
Linearity 5 calibration points standard in solvent ranging from 0.025 µg/mL – 0.5 µg/mL (0.5 ng – 10 ng injected). Y=20.51X – 0.096.
Repeatability Not determined.
Accuracy At 0.01 mg/kg (n=1) 78.1%, at 0.1 mg/kg (n=1) 82.5% (mean 80.3%
n=2)
LOD Not provided.
LOQ 0.01 mg/kg
Matrix effect Not determined
Standard/extract stability Standard stability was determined to be stable for3 months stored at -20˚C.
Extraction efficiency Not provided.
Conclusion The analytical method has not been validated in compliance with the requirements of SANCO/825/00 rev. 8.1 or SANCO/3029/99 rev.
4, as no repeatability results are provided and no matrix effect has been determined and only one fortification level was used for recovery. However, the method can be found fit for the intended purpose for the determination of thifensulfuron-methyl in soybeans as pre-registration method, nevertheless the method is not suitable validated to be used as a post-registration method for monitoring or enforcement puposes.
Although the analytical methods have not been validated in compliance with the requirements of SANCO/825/00 rev. 8.1 or SANCO/3029/99 rev. 4, the methods can be found fit for the intended purpose for the determination of thifensulfuron-methyl in soybeans.
3.3 Conclusion
The proposed extension for use is covered by the risk envelope of the existing authorisation for the section residue analytical methods.
3.4 Physical-chemical classification and labelling
Classification and labelling of the formulation does not change.
4 Mammalian toxicology
The proposed extension for use involves an application on soybean for which the risk assessment for the bystander, resident and worker can be extrapolated from the current authorisation based on the method of application and dosage (downward application with a maximum dosage of 7.5 g
a.s./ha).Therefore, the proposed extension remains within the existing risk envelope for the bystander, resident and worker.
For the operator, mechanical downward spraying is within the risk envelope of the existing authorisation. However for this minor use in soybean manual downward spraying cannot be
excluded. A risk assessment is performed for manual downward spraying for the operator, since this application method is not covered by the existing risk envelope.
List of Endpoints
The final List of Endpoints presented below is taken from the final Review Report on thifensulfuron- methyl (SANCO/7577/VI/97 – final, d.d. 12 December 2001). Where relevant, some additional remarks/information are given in italics.
1 Toxicology and metabolism
Absorption, distribution, excretion and metabolism in mammals
Distribution: Widely
Potential for accumulation: No accumulation Rate and extent of excretion: > 90 % in 96 h, urine Toxicologically significant compounds: Parent compound
Metabolism in animals: Radioactivity mainly excreted as the parent compound in rat and goat
Acute toxicity
Rat LD50 oral: LD50 > 5000 mg/kg bw Rat LD50 dermal: LD50 > 2000 mg/kg bw Rat LC50 inhalation: LC50 > 7.9 mg/l
Skin irritation: No t irritat in g
Eye irritation: Not irritating
Skin sensitization (test method used and result):
Not sensitising (Magnusson and Kligman test)
Short term toxicity
Target / critical effect: No target identified / decreased body weight gain and food consumption
Lowest relevant oral NOAEL / NOEL: 7 mg/kg bw/d, 90 d oral rat
The lowest NOEL was 1.3 mg/kg bw/d in the 1 y dog study but was not considered relevant for setting AOEL
Lowest relevant dermal NOAEL / NOEL: No data , No t requ ired Lowest relevant inhalation NOAEL / NOEL: No data, Not required
Genotoxicity Negative
Long term toxicity and carcinogenicity
Target / critical effect: Not identified / decreased body weight gain Lowest relevant NOAEL: 0.96 mg/kg bw/d, 2 y rat
Carcinogenicity: Negative
Reproductive toxicity
Target / critical effect - Reproduction: Not identified / decreased body weight gain Lowest relevant reproductive NOAEL /
NOEL:
43 mg/kg bw/d, maternal toxicity 175 mg/kg bw/d, reproductive toxicity Target / critical effect - Developmental
toxicity:
Retarded ossification (rat) Lowest relevant developmental NOAEL /
NOEL:
200 mg/kg bw/d, maternal and developmental toxicity (rat)
Delayed neurotoxicity No data , no co nce rn fro m o ther stu dies
Other toxicological studies No other studies submitted (not necessary)
Medical data No occupational or accidental poisoning reported
Summary
Value Study Safety factor
ADI: 0.01mg/kg bw/d 2 y rat 100
AOEL systemic: 0.07 mg/kg bw/d 90 d rat 100
AOEL inhalation: Not allocated ( not necessary)
AOEL dermal: Not allocated ( not necessary)
ARfD (acute reference dose): Not allocated ( not necessary)
Dermal absorption 10% default value ( no study required)
Local effects
Thifensulfuron-methyl does not produce local effects, neither after a single nor repeated exposure.
Data requirements active substance
No additional data requirements are identified.
4.1 Toxicity of the formulated product (IIIA 7.1)
The formulation DuPont HARMONY SX does not need to be classified on the basis of its acute oral (LD50 rat >5000 mg/kg bw), dermal (LD50 rat >5000 mg/kg bw), and inhalation toxicology (no study, not required).
The formulation DuPont HARMONY SX is considered not irritating to skin and eyes.
The formulation DuPont HARMONY SX does not have sensitising properties in a Maximisation test.
4.1.1 Data requirements formulated product No additional data requirements are identified.
4.2 Dermal absorption (IIIA 7.3)
The original authorisation was based on a mutual recognition.
Germany used a value of 100% for both the concentrate and spray dilution for dermal absorption in the risk assessment and these values were used for the mutual recognition. For the current minor use extension the same values are used.
4.3 Available toxicological data relating to non-active substances (IIIA 7.4)
The available toxicological data relating to non-active substances will be taken into account in the classification and labelling of the formulated product.
An application has been submitted for the minor use extension of the authorisation of the plant protection product DuPont HARMONY SX, a herbicide based on the active substancethifensulfuron- methyl.
DuPont HARMONY SX is a SG (water soluble granule) formulation and contains 500 g/kg thifensulfuron-methyl.
4.4.1 Operator exposure/risk
According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers:
Tier 1: Risk assessment using the EU-AOEL without the use of PPE Tier 2: Risk assessment using the NL-AOEL without the use of PPE
Tier 3: Refinement of the risk assessment using new dermal absorption data Tier 4: Prescription of PPE
Tier 1
Calculation of the EU-AOEL / Tolerable Limit Value (TLV)
For thifensulfuron-methyl no TLV has been set. The AOEL will be used for the risk assessment.
Since thifensulfuron-methyl is included in Annex I of 91/414/EEC and approved under Regulation (EC) 1107/2009, the semi-chronic EU-AOEL of 0.07 mg/kg bw/day (= 4.9 mg/day for a 70-kg operator), based on the 90-day study with rats, is used for the risk assessment.
Exposure/risk
Exposure to thifensulfuron-methyl during mixing and loading and application of
DuPont HARMONY SX 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.
Table T.1 Internal operator exposure to thifensulfuron-methyl and risk assessment for the use of DuPont HARMONY SX
Route Estimated internal exposure a (mg/day)
Systemic EU-AOEL (mg/day)
Risk-index b
Manual downward spraying on soybean (0.0075 kg a.s./ha, uncovered) Mixing/
Loadingc
Respiratory 0.004 4.9 <0.01
Dermal 0.50 4.9 0.10
Applicationd Respiratory 0.006 4.9 <0.01
Dermal 5.10 4.9 1.04
Total 5.61 4.9 1.14
a Internal exposure was calculated with:
• biological availability via the dermal route: 100% (concentrate) and 100% (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 the NL-model for mixing and loading.
d External exposure is estimated with UK POEM.
Since the EU-AOEL is exceeded without the use of PPE, a higher tier assessment has to be performed using the NL-AOEL.
Tier 2
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 semi-chronic exposure is based on the NOAEL of 1.3 mg/kg bw/day in the 1-year study with the dog. 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 dog→ human on basis of caloric demand 1.4
• other interspecies differences: 3
• intraspecies differences: (professional use) 3
• biological availability via oral route: 100%*
• 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.
AOELsystemic: 1.3 x 100 x 70 / (1.4 x 3 x 3) = 7.22 mg/day
Table T.2 Internal operator exposure to thifensulfuron-methyl and risk assessment for the use of DuPont HARMONY SX
Route Estimated internal exposure a (mg/day)
Systemic NL-AOEL (mg/day)
Risk-index b
Manual downward spraying on soybean (0.0075 kg a.s./ha, uncovered) Mixing/
Loadingc
Respiratory 0.004 7.22 <0.01
Dermal 0.50 7.22 0.07
Applicationd Respiratory 0.006 7.22 <0.01
Dermal 5.10 7.22 0.71
Total 5.61 7.22 0.78
a Internal exposure was calculated with:
* biological availability via the dermal route: 100% (concentrate) and 100% (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 the NL-model for mixing and loading.
d External exposure is estimated with UK POEM.
Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment is not required.
4.4.2 Bystander exposure/risk
of application and dosage (downward application with a maximum dosage of 7.5 g a.s./ha).
Therefore, the proposed extension remains within the existing risk envelope.
4.4.3 Worker exposure/risk
The proposed extension for use involves an application on soybean for which the risk assessment for the worker can be extrapolated from the current authorisation, based on the method of application and dosage (downward application with a maximum dosage of 7.5 g a.s./ha) in vegetable crops.
Therefore, the proposed extension remains within the existing risk envelope.
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 thifensulfuron-methyl as a result of the application of DuPont HARMONY SX in soybean.
Bystander exposure
The bystander and resident exposure is within the risk envelope of the existing authorisation. It is concluded that no adverse health effects are expected for the unprotected bystander or resident due to exposure to thifensulfuron-methyl during application of DuPont HARMONY SX in soybean.
Worker exposure
The worker exposure is within the risk envelope of the existing authorisation. It is concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in soybean due to exposure to thifensulfuron-methyl after application of DuPont HARMONY SX.
The current classification and labelling of the formulation can be maintained.
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 No additional data required.
4.7 Combination toxicology
DuPont HARMONY SX contains only one active substance and it is not described that it should be used in combination with other formulations.
5 Residues
5.1 Summary of residue data
The following assessment is based on MRL review of the active substance thifensulfuron methyl (EFSA Journal 2012;10(8):2863), and study evaluation document: 20171184 Harmony SAVA res V01, Ctgb, 2017.
5.1.1 Metabolism in plants
The metabolism of thifensulfuron-methyl was investigated in field grown wheat following foliar spray application of radiolabelled active substance at the application rate of 74-80 g as/ha at the 5 leaves stage. The elimination of thifensulfuron-methyl was rapid (approximately 2 days). Total residues in mature forage and straw were in the range of 0.45-0.80 mg/kg for the radiolabelled test material. No significant residues (<0.01 mg/kg) of the parent compound or its metabolites in mature wheat grain were detected two months after treatment. An additional metabolism study on soya bean was reported by the RMS during the Member State consultation. No significant residues (≤ 0.01 mg/kg) of the parent compound or its metabolites in soybean seed or pods were detected at harvest (100 days after treatment). Therefore the residue definition for risk assessment and enforcement was
thifensulfuron-methyl. This residue definition is limited to the evaluated foliar use on cereals and pulses & oilseeds.
The requested use of thifululfuron-methyl as a foliar application on soya beans is covered by the metabolism data available.
5.1.2 Metabolism in livestock
In the peer review the metabolism of thifensulfuron-methyl was investigated in lactating goats. The study demonstrated that the major metabolic pathway involved cleavage of the carboxyl ester linkage, resulting in the formation of thifensulfuron acid. Oxidative O-demethylation occurred to a limited extent. The major residue in milk, muscle and tissues was thifensulfuron-methyl. The general metabolic pathways in rodents and ruminants were found to be comparable; the findings in
ruminants can therefore be extrapolated to pigs.
5.1.3 Residue definition (plant and animal)
The residue definition for both plants and animals for enforcement and risk assessment is the parent thifensulfuron-methyl.
5.1.4 Stability of residues
Thifensulfuron-methyl is proven to be stable for at least42 months and 24 months at -20 °C in dry commodities (wheat grain and corn respectively). In high oil commodities (cotton seed)
thifensulfuron-methyl is proven to be stable for a period of 14 months at -20 °C. The available storage stability data covers the intended use of soybean and the storage stability time in the supervised residue trials.
5.1.5 Supervised residue trials
Soybean (cGAP-NL: field broadcast spray, 1x7.5 kg as/ha, BBCH 10-16 after emergence, PHI=n.a.) In the existing authorisation use on maize and fodder grass is authorised. The requested use on soybean does not fall within the existing risk envelope. Therefore the applicant provided two studies with thifensulfuron-methyl on soybean. Four trials performed in Austria according to the proposed cGAP are previously evaluated during the Article 12 MRL review (EFSA Journal 2012;10(8):2863). The residues in soya bean are all below the LOQ of 0.01 mg/kg.
A new study investigating the residues after application of thifensulfuron-methyl in four NEU trails on soybean are evaluated by Ctgb within this application (20171186 SAVA Harmony). The trails were considered acceptable and all residues in mature soybean seed were below the LOQ of 0.01 mg/kg.
All residues of thifensulfuron-methyl in mature soybean seeds are below the LOQ of 0.01 mg/kg. The current EU-MRL in soybean is 0.01* mg/kg and an exceedance of the current MRL is therefore not expected when the product is applied according to the requested GAP.
Table R1: Selected residue levels from trials with thifensulfuron-methyl
Crop Residue levels (mg/kg) STMR
(mg/kg)
HR (mg/kg)
soybean 8x<0.01 mg/kg 0.01 0.01
5.1.6 Residues in succeeding crops
The metabolism of thifensulfuron-methyl in rotational crops peas, beetroot, sunflower and wheat has been evaluated in the Draft Assessment Report prepared by France in 1996. Field studies on residues in succeeding crops are not required as thifensulfuron-methyl dissipates rapidly in soil without exposing crops to significant soil residual concentrations. Based on the rapid degradation of thifensulfuron-methyl in soil and the findings of the above metabolism studies, detectable residues are not expected in rotational crops.
5.1.7 Residues from livestock feeding studies
Thifensulfuron-methyl is authorised for use on several crops that might be fed to livestock, including soya beans. The median and maximum dietary burdens were calculated in the Article 12 MRL review using the agreed European methodology, including soybean . The calculated dietary burdens for all livestock groups, except poultry, were found to exceed the trigger value of 0.1 mg/kg DM.
According to the above mentioned metabolism study, it is concluded that, after exposure to the maximum dietary burden (about 25 times lower than the dose level of the metabolism studies), residue levels in ruminants and swine commodities are expected to remain below the default MRL of 0.01 mg/kg as defined by Regulation (EC) No 396/2005. Hence, no livestock feeding study is needed.
5.1.8 Processing factors
As quantifiable residues of thifensulfuron-methyl are not expected in the treated crops, there is no need to investigate the effect of industrial or household processing. In addition, the chronic exposure does not exceed 10 % of the ADI.
5.1.9 Calculation of the ADI and the ARfD
The Acceptable Daily Intake (ADI) of thifensulfuron-methyl is 0.01 mg/kg bw per day based on the 2 year rat toxicity study, with an uncertainty factor (UF) of 100.
During the renewal of thifensulfuron-methyl an ARfD was set at 2 mg/kg bw. Previously no ARfD was set.
5.2 Maximum Residue Levels
EU-MRLs are present in Regulation (EU) No 617/2014.
5.3 Consumer risk assessment
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev.
2.0, containing all available Member State diets, during most recent Review of the existing MRLs for thifensulfuron-methyl (EFSA Journal 2012;10(8):2863).
The maximum TMDI is 3.8% of the ADI for Dutch children, with the highest contributor milk and milk products. The TMDI is 1.1% of the ADI for the Dutch general population.
Risk assessment for acute exposure through diet
With such a high ARfD and residue levels in soybean seeds below 0.01 mg/kg, an acute risk to the consumer is not expected.
Conclusion
Based on the assessment for residues, no risk for the consumer due to the exposure to thifensulfuron-methyl is currently expected. The current EU-MRL in soybean is 0.01* mg/kg,
therefore, based on the available data and supervised residue trials provided by the applicant within this application, MRL exceedance is not expected. The requested use on soybean can be authorized within this application.
6 Environmental fate and behaviour
Conclusion for environmental aspects persistence in soil and leaching to groundwater, emission to surface water and sediment, drinking water criterion and monitoring data
The new uses of DuPont HARMONY SX applied for in soybean have an equal (or lower) risk for persistence in soil, leaching to groundwater, and emission to surface water and sediment as the already authorised uses. The drinking water criterion is met.
The available and most recent monitoring data in groundwater and surface water have been reviewed and have no consequences for the proposed uses.
7 Ecotoxicology
Conclusion with respect to comparability for ecotoxicological aspects
The risk of the applied use in soybean is equal to or lower than the risk of the authorised uses with regard to the environment for the aspects birds and mammals, aquatic organisms, bees, non-target arthropods, soil organisms, non-target plants and activated sludge.
8 Efficacy
The uses applied for are minor uses. According article 51 of Regulation no.1107/2009 no efficacy data is needed.
9 Conclusion
The extensions comply with the Uniform Principles.
10 Classification and labelling
Classification and labelling do not change.
However, as on 1st January 2018 an amendment of the Activity Decree will come into force, some of the restriction sentences that have been included on the Legal Instruction for the existing
authorisation will become unnecessary. Therefore the following restriction sentences will be included on the Legal Instructions:
Voor maïs: de toepassing van HARMONY® SX kan in bepaalde maïsrassen gewasschade veroorzaken.
Resistentiemanagement
Dit middel bevat de werkzame stof thifensulfuron-methyl. Thifensulfuron-methyl behoort tot de sulfonylureumverbindingen. De Hrac code is B. 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.
Appendix 1 Table of authorised extensions
PPP (product name/code): DuPont HARMONY SX Formulation type: GR
Active substance 1: thifensulfuron methyl Conc. of as 1: 500 g/kg
Safener: - Conc. of safener: -
Synergist: - Conc. of synergist: -
Applicant: DuPont de Nemours (Nederland) B.V. Professional use:
Zone(s): The Netherlands Non professional use:
Verified by MS: n.v.t.
Field of use: herbicide
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Use- No. (e)
Member state(s)
Crop and/
or situation
(crop destination / purpose of crop)
F, Fn, Fpn G, Gn, Gpn or I
Pests or Group of pests controlled
(additionally:
developmental stages of the pest or pest group)
Application Application rate PHI
(days)
Remarks:
e.g. g
safener/synergist per ha
(f)
Method / Kind
Timing / Growth stage of crop &
season
Max. number a) per use b) per crop/
season
Min. interval between applications (days)
kg or L product / ha
a) max. rate per appl.
b) max. total rate per crop/season
g or kg as/ha
a) max. rate per appl.
b) max. total rate per crop/season
Water L/ha
min / max
Minor uses according to Article 51
1 NL Soyabean GLXMA
(Glycine max)
F Annual broadleaf weeds broadcast spray
BBCH 10-16, after emergence, spring
a) 1 b) 1
n.a a) 15 g
product/ha b) 15 g product/ha
a) 7.5 g as/ha b) 7.5 g as/ha
150 / 400
n.a. -
Remarks table heading:
(a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR)
(b) Catalogue of pesticide formulation types and international coding system CropLife International Technical Monograph n°2, 6th Edition Revised May 2008
(c) g/kg or g/l
(d) Select relevant
(e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1
(f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.
Remarks columns:
1 Numeration necessary to allow references
2 Use official codes/nomenclatures of EU Member States
3 For crops, the EU and Codex classifications (both) should be used; when relevant, the use situation should be described (e.g. fumigation of a structure)
4 F: professional field use, Fn: non-professional field use, Fpn: professional and non- professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the
common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at the moment of application must be named.
6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated.
7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of application
8 The maximum number of application possible under practical conditions of use must be provided.
9 Minimum interval (in days) between applications of the same product
10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products.
11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha).
12 If water volume range depends on application equipments (e.g. ULVA or LVA) it should be mentioned under “application: method/kind”.
13 PHI - minimum pre-harvest interval
14 Remarks may include: Extent of use/economic importance/restrictions
Appendix 2 Reference list
This appendix serves only to give an indication of which data have been used for decision making for the first time; as a result of concurring applications for authorisations, the data mentioned here may have been used for an earlier decisions as well. Therefore, no rights can be derived from this overview.
Deze appendix geeft een indicatief overzicht van de gegevens die voor het eerst gebruikt zijn ten behoeve van een besluit; het kan echter voorkomen dat (onder andere) door een samenloop van aanvragen, de hier opgenomen gegevens al eens eerder gebruikt zijn. Aan dit overzicht kunnen dan ook geen rechten ontleend worden.
Annex point
Year Title
Source (where different from company) Company, Report No.
GLP or GEP status (where relevant) Published or Unpublished
Data protection claimed Y/N
Owner
NLKUG 2002 Magnitude of Residues of Thifensulfuron Methyl in SoyaBean Following Application of Harmony (DPX- M6316) 75% WG – Northern Europe, Season 2001 Battelle, Geneva Research Centres, DuPont-6411 GEP: yes
Published: No
Y DuPont
NLKUG 2013 Magnitude of Thifensulfuron Methyl Residues in Soybean Following Foliar Applications of
Thifensulfuron Methyl (DPX-M6316) 50SG – Northern Europe – 2012
Charles River, DuPont-34800 GEP: yes
Published: no
Y DuPont
