Uitbreiding toelating

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Toelatingsnummer 14067 N
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 UITBREIDING TOELATING
Gelet op de aanvraag d.d. 19 november 2013 (20131484 UB) van
VIRBAC NEDERLAND B.V.
Hermesweg 15
3771 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
Tectonik Pour-on
gelet op artikel 44, eerste lid, Wet gewasbeschermingsmiddelen en biociden,
BESLUIT HET COLLEGE als volgt:
1.1 Uitbreiding
1. Het gebruiksgebied van het middel Tectonik Pour-on 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 2023.
1.2 Samenstelling, vorm en verpakking
De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als
waarvoor de toelating is verleend.
1.3 Gebruik
Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I bij dit
besluit is voorgeschreven.
1.4 Classificatie en etikettering
Tectonik Pour-on
14067 N
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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
Voorzorgsmaatregelen
P102
P210
P271
P273
P280
P405
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.
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:
Tectonik Pour-on
14067 N
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•
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 (14067 N), 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 2023. 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
Tectonik Pour-on is een middel op basis van permethrin. Permethrin is nog niet opgenomen in
de Unielijst van werkzame stoffen onder verordening EU528/2012
2.3 Karakterisering van het middel
Tectonik Pour-on 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.
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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
Tectonik Pour-on
14067 N
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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
Tectonik Pour-on, toelatingnummer 14067 N
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 Tectonik Pour-on (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
Tectonik Pour-on
14067 N
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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
Tectonik Pour-on, toelatingnummer 14067 N
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 .......................................................................................... 9
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H.1.
Introduction
H.1.1
Applicant
Virbac Nederland
H.1.2
Active substance
Permethrin
H.1.3
Product
Tectonik Pour-on
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 Tectonik Pour-on 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.
H.3. Physical and chemical properties
The physical and chemical properties of the product has not been changed, and therefore this
assessment was not performed.
H.4. Analytical methods for detection and identification
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
Tectonik Pour-on 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 Tectonik Pour-on 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.
Tectonik Pour-on
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This product is already authorised in NL under registration number 14067 N 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 Tectonik Pour-on onto filter paper that was
placed in Petri dishes to which adult midges (C. nubeculosus) were placed. The test showed
that the product killed 98-100% of the adult midges at a dose rate of 4 ml/m2 after 24 hours of
exposure. The recommended use of the product corresponds with 28 ml/m2 (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 Tectonik Pour-on for control
of midges on cattle considering that the authorisation is done under article 121 of the WGB.
The test and information showed that Tectonik Pour-on 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 14067 N) 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
Tectonik Pour-on
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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 Tectonik Pour-on, when used in accordance with the
proposed label (WG/GA), is expected to be also effective in controlling midges on cattle.
Tectonik Pour-on 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
Tectonik Pour-on 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 Tectonik Pour-on 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 Tectonik Pour-on.
Based on the risk assessment for Tectonik Pour-on 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 Tectonik Pour-on 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.
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H.7.
Environment
7.1 Introduction
An extension of the authorisation is requested for the biocidal product Tectonik Pour-on
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 Tectonik Pour-on that is authorised (14067 N) for the control of flies on cattle by nonprofessionals. The requested expansion concerns the application of Tectonik Pour-on 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 Tectonik Pour-on. 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
Tectonik Pour-on is currently authorised (14067 N) 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
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.
Dosage
10-25 mL product (38
g a.s./L) per animal,
every 7 weeks from
April to October
Use
concentration
0.38-0.95 g a.s
per animal
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.
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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)
Use scenario
Environmental compartments and groups of organisms
exposed
STP Freshwater*
Saltwater*
Soil** Air
Birds and
mammals
1
1,2
3
+/++
+/++
(++)
+
-
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.
++
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 Tectonik Pour-on. 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
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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 (14067 N), 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 Tectonik Pour-on for the non-professional control of flies on cattle
(14067 N) 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
Aquatic organisms
Direct / indirect
exposure
Emission to STP
Dosage
Frequency
Dosage (kg a.s. /
STP)
Persistence
Soil organisms
(soil micro-organisms
earthworms, plants)
Direct / indirect
exposure
Dosage
Frequency
Non target arthropods and Direct / indirect
bees
exposure
Leaching to groundwater
Dosage
Frequency
Fraction applied to
soil
Birds, mammals
Direct / indirect
exposure
Air
Dosage
Frequency
Emission
Similar or
lower risk?
Yes
Reason
Yes
Yes
Yes
Direct emission to surface water and
sediment is similar
No indirect emission to surface water and
sediment
‘’
‘’
‘’
‘’
No direct emission to the STP
Yes
Yes
Direct and indirect emission to soil is similar
Direct and indirect emission to soil is similar
Yes
Yes
Yes
‘’
‘’
‘’
‘’
Yes
Yes
Yes
‘’
‘’
‘’
‘’
‘’
‘’
Yes
Birds and mammals are not exposed
directly.
Indirect exposure of birds and mammals is
similar.
‘’
‘’
‘’
‘’
Direct emission to air is similar
Yes
Yes
Yes
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
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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.
H.8. Conclusion
The applicant has proven that Tectonik Pour-on, 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).
H.9. Classification and labelling
The classification and labeling of the product has not been changed.
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