HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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1 Toelatingsnummer HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1 UITBREIDING TOELATING Gelet op de aanvraag d.d. 19 november 2013 ( UB) van VIRBAC NEDERLAND B.V. Hermesweg ND BARNEVELD tot uitbreiding van de gebruiksdoeleinden van de toelating als bedoeld in artikel 49, eerste lid, Wet gewasbeschermingsmiddelen en biociden voor de biocide, op basis van de werkzame stof permethrin gelet op artikel 44, eerste lid, Wet gewasbeschermingsmiddelen en biociden, BESLUIT HET COLLEGE als volgt: 1.1 Uitbreiding 1. Het gebruiksgebied van het middel wordt met ingang van datum dezes uitgebreid met de toepassing tot bestrijding van knutten (Culicoides) op runderen, en voor professioneel gebruik. Voor de gronden waarop dit besluit berust wordt verwezen naar bijlage II bij dit besluit. 2. De toelating geldt tot 1 mei 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 bij dit besluit is voorgeschreven. 1.4 Classificatie en etikettering 1

2 Gelet op artikel 50 Wet gewasbeschermingsmiddelen en biociden worden voorschriften gegeven. Dit leidt tot de volgende voorschriften: De aanduidingen, welke moeten worden vermeld, worden hierbij vastgesteld als volgt: aard van het preparaat: Andere vloeistoffen voor directe toepassing werkzame stof: permethrin gehalte: 37,6 g/l de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: - PICTOGRAM(MEN) pictogram: GHS02-ontvlambaar GHS05-corrosief GHS07-schadelijk GHS09-milieu SIGNAALWOORD Waarschuwing Gevarenaanduidingen H226 H290 H317 H336 H410 Ontvlambare vloeistof en damp. Kan bijtend zijn voor metalen. Kan een allergische huidreactie veroorzaken. Kan slaperigheid of duizeligheid veroorzaken. Zeer giftig voor in het water levende organismen, met langdurige gevolgen. Voorzorgsmaatregelen P102 P210 P271 P273 P280 P405 Buiten het bereik van kinderen houden. Verwijderd houden van warmte/vonken/open vuur/hete oppervlakken. Niet roken. Alleen buiten of in een goed geventileerde ruimte gebruiken. Voorkom lozing in het milieu. Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. Achter slot bewaren. Overeenkomstig de Warenwet en artikel 1, 3 en 4 van het Warenwetbesluit veilige verpakking huishoudchemicaliën dienen uitsluitend die verpakkingen van bestrijdingsmiddelen die (mede) voor niet-professioneel gebruik zijn bestemd te worden voorzien van: 2

3 tastbare gevaarsaanduiding. Behalve de 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. De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt. 2 DETAILS VAN DE AANVRAAG 2.1 Aanvraag Het betreft een aanvraag tot uitbreiding van het gebruiksgebied van het middel Tectonik Pouron (), een middel op basis van de werkzame stof permethrin. Het middel is bij besluit van 12 april 2013 reeds toegelaten als middel voor de bestrijding van vliegen op runderen. Het middel is bij dit besluit toegelaten tot 1 mei Met onderliggende aanvraag wordt toelating als middel voor de bestrijding van Culicoides op runderen gevraagd. Tevens wordt een uitbreiding voor professioneel gebruik aangevraagd. 2.2 Informatie met betrekking tot de stof is een middel op basis van permethrin. Permethrin is nog niet opgenomen in de Unielijst van werkzame stoffen onder verordening EU528/ Karakterisering van het middel is een middel op basis van permethrin. De primaire werking van permethrin is de interferentie met natriumkanalen in de insecten wat leidt tot een vertraagde depolarisatie. Daarnaast is permethrin werkzaam als repellent. 2.4 Voorgeschiedenis De aanvraag is op 19 november 2013 ontvangen; op 19 november 2013 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 22 november 2013 is de aanvraag in behandeling genomen. 2.5 Eindconclusie Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Tectonik Pour-on op basis van de werkzame stof permethrin voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu. 3

4 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, 4 april 2014 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, ir. J.F. de Leeuw voorzitter 4

5 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I bij het besluit d.d. 4 april 2014 tot uitbreiding van de toelating van het middel, toelatingnummer A. WETTELIJK GEBRUIKSVOORSCHRIFT Toegestaan is uitsluitend het gebruik als middel ter bestrijding van vliegen en knutten (Culicoides) op runderen in de periode april tot en met oktober. De gebruiksaanwijzing zoals opgenomen onder B. moet worden aangehouden. Om bodem- en in het water levende organismen te beschermen dienen resten die het middel bevatten bij gebruik in de stal te worden afgevoerd naar de mestopslag. Het middel is bestemd voor professioneel en niet-professioneel gebruik. B. GEBRUIKSAANWIJZING Toepassing De totale dosis op de ruglijn van het rund aanbrengen, van de nek tot de basis van de staart met behulp van het doseercompartiment van de fles of met behulp van de bijgeleverde handspuit (2,5 liter fles). Ongeveer een vierde deel van de dosis op de nek aanbrengen. Alle dieren van een koppel tegelijk behandelen. Dosering: 10 ml per 100 kg lichaamsgewicht met een maximum van 25 ml per rund. Indien nodig, behandeling herhalen na 4 weken voor knutten en na 7 weken voor vliegen. Resistentiemanagement: In het kader van resistentiemanagement verdient het aanbeveling om niet meer dan 5 behandelingen per jaar toe te passen en mag de geadviseerde dosering niet verlaagd worden. Wissel het gebruik van (werkzame stof permethrin) af met middelen die zijn gebaseerd op werkzame stoffen uit een andere chemische groep zoals organofosfaten. Minimale wachttermijnen: Vlees: 3 dagen Melk: geen 1

6 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II bij het besluit d.d. 4 april 2014 tot uitbreiding van de toelating van het middel, toelatingnummer RISKMANAGEMENT Contents Page H.1. Introduction... 3 H.2. Identity... 3 H.3. Physical and chemical properties... 3 H.4. Analytical methods for detection and identification... 3 H.5. Efficacy... 3 H.6. Human toxicology... 5 H.7. Environment... 6 H.8. Conclusion... 9 H.9. Classification and labelling

7 H.1. Introduction H.1.1 Applicant Virbac Nederland H.1.2 Active substance Permethrin H.1.3 Product H.1.4 Function The product is used as an insecticide (PT18) for use on cattle. H.1.5 Background to the application This concerns an application to modify the field of use of an authorised biocide. H.1.6 Intended uses The proposed new fields of use of is the control of midges (Culicoides) on cattle, and the professional use of the product. H.2. Identity The identity of the product has not been changed, and therefore this assessment was not performed. Physical and chemical properties H.3. The physical and chemical properties of the product has not been changed, and therefore this assessment was not performed. Analytical methods for detection and identification H.4. The analytical methods for detection and identification have not been changed, and therefore this assessment has not been performed. H.5. Efficacy 5.1 Function is an insecticide (PT18) based on permethrin (37,6 g/l; 3.9% w/w). 5.2 Field of use envisaged The proposed field of use of is the control of flies and midges on cattle. This use is included in PT18. The product is intended for both non-professional and professional use. 3

8 This product is already authorised in NL under registration number with a restricted claim for the control of flies on cattle by non-professionals. 5.3 Effects on target organisms and efficacy Efficacy data submitted and evaluation of data This product is already authorised for the control of the control of flies on cattle by nonprofessionals. In this evaluation only the claim for control of midges on cattle is evaluated and the use of the product by professionals to control flies and midges on cattle. A new laboratory test against midges (Culicoides) was provided as well as additional information from literature on the efficacy of permethrin against midges. The laboratory test was performed by applying onto filter paper that was placed in Petri dishes to which adult midges (C. nubeculosus) were placed. The test showed that the product killed % of the adult midges at a dose rate of 4 ml/m 2 after 24 hours of exposure. The recommended use of the product corresponds with 28 ml/m 2 (20 ml per 200 kg of cow). The provided literature review showed that other Culicoides species were killed or knocked down by permethrin at dose levels of 17 ml product/200 kg, a dose range comparable to the dose advised on the label. The tests were performed on clipped hair taken from treated calves and tested in the laboratory to adult midges. Sufficient knock-down effects on Culicoides continued for a period of 28 days after treatment. The available information was sufficient to evaluate the efficacy of for control of midges on cattle considering that the authorisation is done under article 121 of the WGB. The test and information showed that is expected to be effective in controlling midges on cattle during 4 weeks at the use concentration as specified on the WG/GA. For efficacy there are no additional requirements for professional use for this type of product, hence the product can be used by both professionals and non professionals for the control of flies and midges on cattle. Evaluation of the label (WG/GA) The applicant has provided a WG/GA in Dutch. This has been adapted to our standards. The frequency of re-treatment has been differentiated into 4 weeks for efficacy against Culicoides and 7 weeks against flies. 5.4 Mode of action The following information is provided: The primary insecticidal mode/site of action of permethrin is interference with the voltage-gated sodium channels of insects. Permethrin is a contact poison and is primarily taken up through the extremities. Closure of the sodium channels is delayed during depolarization, causing acute neurotoxicity. Permethrin is also an effective repellent. 5.5 Limitations on efficacy including resistance General limitations No limitations are mentioned. Resistance and resistance management strategies For the first authorization (registration number ) several literature studies were submitted showing the occurrence of resistance of target organisms to permethrin. Therefore a paragraph was added to the WG/GA to use the product not more than 5 times a year and to 4

9 alternate its use with products based on another group of active ingredients such as organophosphates. This sentence will be maintained. 5.6 Overall conclusions of efficacy Based on the data submitted and considering that the evaluation is done under article 121 of the WGB, it can be concluded that, when used in accordance with the proposed label (WG/GA), is expected to be also effective in controlling midges on cattle. can be used to control flies and midges on cattle by both professionals and non-professionals. H.6. Human toxicology 6.1 Product application An application has been submitted for the extension of the authorisation of the biocidal product for the control of Culicoides in cattle and for professional use. The formulation is currently authorized for the control of flies in the cattle and for non-professional use (authorization number 14067N). The formulation contains 3.9% w/w (37.6 g/l) permethrin as an active substance. 6.2 Toxicity of the formulated product The composition of the formulation remains unchanged, therefore the classification and labelling of the formulation do not change. 6.3 Risk characterisation for human health An application for the extension of authorization to professional use and for the control of Culicoides in the cattle has been submitted by the applicant. In this risk assessment the expected exposure of professional users is compared to the exposure of non-professional users under the current authorization 14067N. The maximal applied dose (10 ml per 100 kg bw, with a maximum of 25 ml per animal) and the use frequency (no more than 5 applications per year) are the same for both professional and non-professional users and for the control of flies and Culicoides. Based on the risk assessment for non-professional users under the authorization 14067N, no adverse health effects are expected for the unprotected nonprofessional users after dermal and respiratory exposure to permethrin as a result of the application of for the control of flies in the cattle. Considering that the maximal dose level and the application frequency remain the same for professional users and for the control of Culicoides, exposure to permethrin will be the same for the professional users. Therefore this conclusion can also be applied to the risk assessment for the professional users and the control of Culicoides of. Based on the risk assessment for under authorization 14067N, no adverse health effects are expected for the general public by indirect exposure. Considering the intended dose level and application frequency remain unchanged, this conclusion can also be applied to the risk assessment for the current extension of authorization. 6.4 Overall conclusions for the aspect human health Based on the comparable risk assessment, it was concluded that no adverse health effects are expected for the unprotected professional user after dermal and respiratory exposure to permethrin as a result of the use of to control flies and Culicoides in the cattle, when used in accordance to the WG/GA. Furthermore, when used according to the WG/GA, no adverse health effects are expected for the general public by indirect exposure to permethrin as a result of the application of Tectonik Pour-on to control flies and Culicoides in the cattle. 5

10 H.7. Environment 7.1 Introduction An extension of the authorisation is requested for the biocidal product containing the active substance permethrin (37.6 g/l; 3.9%w/w ). The notifier indicated that it is possible to make a comparative assessment with the reference product that is authorised () for the control of flies on cattle by nonprofessionals. The requested expansion concerns the application of for the control of Culicoides on cattle by professionals. The comparative assessment procedure prescribes that a simplified regime is accepted for the environmental aspect if the requested authorisation has a similar risk. It must be determined whether no additional risk for the environment is expected for the requested application in comparison with the already authorised application of the product. As part of the simplified procedure comparativeness of the referred and the requested application are tested for the following aspects: 1. The type and scale of the use; 2. Use concentrations; 3. Emission to air, STP, surface water and soil for the application phase, the in-service phase and the waste phase of the product; 4. Risk assessment (section 7.3); 5 Risk mitigating methods (section 7.4). 7.2 Evaluation is currently authorised () for the non-professional control of flies on cattle. An expansion of the authorised application is requested for the professional control of Culicoides on cattle. An overview of the uses is listed in Table E.1. Table E.1. Overview of intended uses (in bold the information on the requested expansion of the application is stated) Product name Tectonik Pour-on Application Dosage Use concentration Insecticide for the professional and non-professional ml product ( g a.s control of flies and Culicoides on cattle (PT18). The g a.s./l) per animal, per animal product is to be poured on the back of the animal every 7 weeks from from head to tail. The product is left on the animal. April to October 1. The type and scale of the use Comparison of the scale of use is performed qualitatively only. Expansion of the nonprofessional use to professional use will increase the scale of use as a whole. The nonprofessional, however, has less animals compared to the professional. Subsequently the nonprofessional use will imply a relatively smaller area treated as compared to the professional use. The risk assessment performed for the non-professional use already covers the professional use of the product as it was based on herd sizes for professional farmers because no exposure models for non-professional farmers are available (worst-case approach). Therefore it can be concluded that the type and scale of the use of the requested application in comparison with the authorised application is equal. 2. Use concentrations The use concentration of the active substance in the expanded application for the professional control of Culicoides on cattle is equal to the concentration of the active substance in the authorised application for the non-professional control of flies on cattle. In the risk characterisation section is elaborated that this will not influence the outcome of the risk assessment. 6

11 3. Emission to air, STP, surface water and soil for the application phase, the in-service phase and the waste phase of the product Emission routes Various phases in the life cycle of a product may cause emissions and environmental exposure. In the risk assessment, emissions from the application phase, service life and waste phase of the product are considered. Emissions from a.i. production and product formulation are not part of the risk assessment. The foreseeable routes of entry into the environment during the application phase, service life and waste phase are listed in Table E.2. Table E.2. Foreseeable routes of entry into the environment on the basis of the use envisaged (in bold the information on the requested expansion of the application is stated) Environmental compartments and groups of organisms exposed Use scenario STP Freshwater* Saltwater* Soil** Air Birds and mammals Insecticide for the professional and non-professional control of flies and Culicoides on cattle (PT18). The product is to be poured on the back of the animal from head to tail. The product is left on the animal /++ 1,2 - +/++ 3 (++) + ++ Compartment directly exposed + Compartment indirectly exposed (++) Compartment potentially exposed (but unlikely significant concern due to a.s. hazard data and scale of exposure) 1 Direct emission to an STP and subsequent indirect emission to surface water by professionals is unlikely as waste water holding manure has to be discharged to slurry pits. Discharge to the STP is not allowed. 2 Run off and drainage to surface water of treated manure spread on grassland or arable land is not taken into account in the risk assessment (in line with the national assessment of plant protection products). 3 Soil and groundwater are exposed after manure application to land. In the Netherlands, surplus sludge of public STPs is not applied for fertilization and soil improvement of agricultural soil. Exposure of soil and groundwater via STP surplus sludge application is not considered relevant. * Including sediment ** Including groundwater, bees and non-target arthropods Residues of insecticides applied on the back of cattle can deposit on the stable floor or soils due to spilling or hosing off treated cattle. As a result, insecticides will generally reach directly or indirectly the environmental compartments used in the risk assessment: i.e. surface water, sediment, groundwater, soil and air. Therefore, indoor receiving materials should be considered as intermediate compartments. The major emission routes after in- or outdoor application of insecticides concern the waste phase. Two potential emission routes are identified: 1) Indirect exposure of soil and groundwater after distribution of manure on land from indoor treated cattle or direct emission to these compartments during outdoor use of the product. In line with the current national assessment of plant protection products, run off and drainage to surface water of treated manure spread on grassland or arable land is not taken into account in the risk assessment. Direct emission to surface water after spreading manure on land is not expected as the agricultural practice includes incorporation of manure. The relevant environmental compartments therefore are soil and groundwater for both indoor and outdoor use of. During outdoor use, also surface water can be indirectly exposed by transport of insecticide residues from treated cattle or by spills via runoff and/or via agricultural drainage systems. 2) Emission of diluted liquid waste stream from indoor cleaning activities. As a matter of fact 7

12 most indoor surfaces will be cleaned and treated cattle can be hosed off. The cleaning step will lead to releases to manure storage. Discharge of manure on the sewage system or on surface water is not permitted and therefore not a likely route of entry into the environment. Farmers collect manure and liquid manure waste streams and spread these on land. The amount of manure to be used for fertilization is controlled by nitrogen and phosphorus immission standards. 7.3 Risk characterisation for the environment In the risk assessment of the authorised application for the non-professional control of flies on cattle (), the risk has been assessed for aquatic and sediment organisms, microorganisms in the STP, birds, mammals, soil organisms, bees and non-target arthropods which is based on a quantitative approach. It was concluded that the authorised product, when used in accordance with the proposed label (WG/GA), complies with the environmental standards and will not cause unacceptable effects on the environment provided that (residues of) the products are discharged to the slurry pit. In the table below an overview is presented of the risk assessment on basis of a comparison of the authorised application of for the non-professional control of flies on cattle () and the potential risk of the requested extended application for the professional control of Culicoides on cattle. For each aspect the risk is assessed qualitatively. Table E.3 overview of risks per environmental aspect Environmental aspect Item Similar or lower risk? Aquatic organisms Direct / indirect Yes exposure Reason Direct emission to surface water and sediment is similar No indirect emission to surface water and sediment Dosage Yes Frequency Yes Emission to STP Dosage (kg a.s. / Yes No direct emission to the STP STP) Persistence Yes Direct and indirect emission to soil is similar Soil organisms (soil micro-organisms Direct / indirect exposure Yes Direct and indirect emission to soil is similar earthworms, plants) Dosage Yes Frequency Yes Non target arthropods and Direct / indirect Yes bees exposure Leaching to groundwater Dosage Yes Frequency Yes Fraction applied to Yes soil Birds, mammals Direct / indirect exposure Yes Birds and mammals are not exposed directly. Indirect exposure of birds and mammals is similar. Dosage Yes Frequency Yes Air Emission Yes Direct emission to air is similar 7.4 Evaluation of precautionary and risk mitigation measures in the WGGA To prevent direct emission to STP, soil and water after indoor application the following risk mitigation measure is included in the proposed label (draft WG/GA): To protect water living organisms and soil organisms, residues containing the product need to be removed to the manure deposit when used in animal housing. It is not allowed to discharge residues containing the product to the sewer, soil, and/or surface water [Om 8

13 bodem- en in het water levende organismen te beschermen dienen resten die het middel bevatten bij gebruik in de stal te worden afgevoerd naar de mestopslag]. No additional measures to protect the environment (risk mitigation measures) are required. 7.5 Overall conclusion Based on a comparable risk assessment, it can be concluded that the product Tectonik Pouron, when used in accordance with the proposed Legal Instructions for Use (WG/GA), complies with the environmental standards and will not cause unacceptable effects on the environment provided that (residues of) the products are discharged to the slurry pit. Conclusion H.8. The applicant has proven that, under the proposed Legal Conditions for Use and the Directions for Use (WG/GA), is sufficiently effective and that no unacceptable risk is expected to human health, the person who uses the product and the environment (Art. 121 jo art. 49 first paragraph Dutch 2007 Plant Protection Products and Biocides Act). Classification and labelling H.9. The classification and labeling of the product has not been changed. 9