HET COLLEGE VOOR DE TOELATING VAN ... · zienswijzenprocedure zoals bedoeld in artikel 2:3 Besluit...
Transcript of HET COLLEGE VOOR DE TOELATING VAN ... · zienswijzenprocedure zoals bedoeld in artikel 2:3 Besluit...
15564 N
Isonet T, 20171302 NLWERG 1
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 BESLUIT
Op 11 augustus 2017 is van
CBC (Europe) Srl.
Via E. Majorana 2
20834 NOVA MILANESE
Italy
een aanvraag tot wederzijdse erkenning van een gewasbeschermingsmiddel ontvangen voor het
middel
Isonet T
op basis van de werkzame stoffen (E,Z,Z)-3,8,11-Tetradecatrien-1-yl acetate en(E,Z)-3,8-
Tetradecadien-1-yl acetate.
HET COLLEGE BESLUIT tot toelating van bovenstaand middel.
Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel
van dit besluit.
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 volgens het wettelijk gebruiksvoorschrift, letterlijk en
zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.
1.3 Classificatie en etikettering
Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende
aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden
vermeld:
� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder
“verpakkingsinformatie” in bijlage I.
� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel
A van het registratierapport, Appendix I.
� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
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Isonet T, 20171302 NLWERG 2
� De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de
voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2
van deel A van het registratierapport.
1.4 Aflever- en opgebruiktermijn (respijtperiode)
Niet van toepassing. Het betreft een nieuwe toelating.
2. WETTELIJKE GRONDSLAG
Besluit artikel 40 Verordening (EG) 1107/2009 van de Verordening (EG)
1107/2009
Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009
Gebruikt toetsingskader Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual 2.1
3. BEOORDELINGEN
3.1 Fysische en chemische eigenschappen
De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en
ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn
bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het
middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar
geacht.
3.2 Analysemethoden
De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die
vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd
gebruik.
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
Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het
werkzaam is.
Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het
Registration Report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit
beleidsregel bekendmaken delen A en B van het Registration Report.
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Isonet T, 20171302 NLWERG 3
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, 30 maart 2018
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw
Voorzitter
15564 N
Isonet T, 20171302 NLWERG 1
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
1 Aanvraaginformatie
Aanvraagnummer: 20171302 NLWERG
Type aanvraag: aanvraag tot toelating van een
gewasbeschermingsmiddel op basis van wederzijdse
erkenning
Middelnaam: Isonet T
Verzenddatum aanvraag: 11 augustus 2017
Formele registratiedatum: * 11 augustus 2017
Datum in behandeling name:
Datum compliance check:
20 oktober 2017
n.v.t.
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
Aangezien Isonet T een voor Nederland nieuwe werkzame stof bevat (zie hieronder), is de
zienswijzenprocedure zoals bedoeld in artikel 2:3 Besluit bestuursreglement regeling toelating
gewasbeschermingsmiddelen en biociden Ctgb 2007 toegepast. Er zijn geen zienswijzen ontvangen
binnen de daarvoor gestelde termijn.
2 Stofinformatie
Werkzame stoffen Gehalte
(E,Z,Z)-3,8,11-Tetradecatrien-1-yl acetate 720 g/kg
(E,Z)-3,8-Tetradecadien-1-yl acetate 83 g/kg
• De stoffen zijn per 1 september 2009 geplaatst op Annex I van Richtlijn 91/414/EEG en
vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. De
goedkeuring van deze werkzame stoffen expireert op 31 augustus 2020.
3 Toelatingsinformatie
Toelatingsnummer: 15564 N
Expiratiedatum: 31 augustus 2021
Afgeleide parallel of origineel: Origineel
Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel
Gebruikers: Professioneel
4 Verpakkingsinformatie
Aard van het preparaat:
Damp ontwikkelend product
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel Isonet T
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
-
Pictogram GHS07
GHS09
Signaalwoord Waarschuwing
Gevarenaanduidingen H315 Veroorzaakt huidirritatie.
H410 Zeer giftig voor in het water levende organismen, met langdurige
gevolgen.
Voorzorgsmaatregelen P102 Buiten het bereik van kinderen houden.
P270 Niet eten, drinken of roken tijdens het gebruik van dit product.
P273 Voorkom lozing in het milieu.
P280C Beschermende handschoenen en beschermende kleding dragen.
P302 + P352 BIJ CONTACT MET DE HUID: Met veel water/... wassen.
P332 + P313 Bij huidirritatie: een arts raadplegen.
P391 Gelekte/gemorste stof opruimen.
P501 Inhoud/verpakking afvoeren naar ....
SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water
verontreinigt.
Aanvullende
etiketelementen
EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke
gezondheid en het milieu te voorkomen.
Isonet T
Part A – National Addendum
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Applicant: CBC (Europe) S.r.l Evaluator: NL, Ctgb Date: February 2018
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DRAFT REGISTRATION REPORT
Part A
Risk Management
Product name: Isonet T
Chemical active substance:
(E,Z,Z)-3,8,11-Tetradecatrien-1-yl acetate +
(E,Z)-3,8-Tetradecadien-1-yl acetate
60 mg/dispenser
Greenhouse (Interzonal)
Mutual Recognition
Member State: The Netherlands
Applicant: CBC (Europe) S.r.l.
Date: February 2018
Isonet T
Part A – National Addendum
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Table of Contents
1 BESLUIT ............................................................................................................ 1
1 Details of the application ................................................................................................. 5
1.1 Application background ................................................................................... 5
1.2 Letters of Access............................................................................................. 6
1.3 Justification for submission of tests and studies .............................................. 6
1.4 Data protection claims ..................................................................................... 6
2 Details of the authorization decision ................................................................................ 6
2.1 Product identity ............................................................................................... 6
2.2 Conclusion ...................................................................................................... 7
2.3 Substances of concern for national monitoring ................................................ 7
2.4 Classification and labelling .............................................................................. 7
2.4.1 Classification and labelling under Regulation (EC) No 1272/2008 ................... 7
2.4.2 Standard phrases under Regulation (EU) No 547/2011 .................................. 8
2.4.3 Other phrases (according to Article 65 (3) of the Regulation (EU) No 1107/2009) 8
2.5 Risk management ........................................................................................... 8
2.5.1 Restrictions linked to the PPP ......................................................................... 8
2.5.2 Specific restrictions linked to the intended uses .............................................. 8
2.6 Intended uses (only NATIONAL GAP) ............................................................. 9
3 Background of authorization decision and risk management ......................................... 10
3.1 Physical and chemical properties (Part B, Section 2) .................................... 10
3.2 Efficacy (Part B, Section 3) ........................................................................... 10
3.3 Efficacy data ................................................................................................. 11
3.3.1 Information on the occurrence or possible occurrence of the development of resistance 12
3.3.2 Adverse effects on treated crops ................................................................... 12
3.3.3 Observations on other undesirable or unintended side-effects ...................... 12
3.4 Methods of analysis (Part B, Section 5) ......................................................... 12
3.4.1 Analytical method for the formulation ............................................................ 12
3.4.2 Analytical methods for residues ..................................................................... 13
3.5 Mammalian toxicology (Part B, Section 6) ..................................................... 13
3.5.1 Acute toxicity ................................................................................................. 13
3.5.2 Operator exposure ........................................................................................ 13
3.5.3 Worker exposure ........................................................................................... 13
3.5.4 Bystander and resident exposure .................................................................. 13
3.6 Residues and consumer exposure (Part B, Section 7) .................................. 14
3.7 Environmental fate and behaviour (Part B, Section 8) ................................... 14
3.7.1 Predicted environmental concentrations in soil (PECsoil) ................................ 14
3.7.2 Predicted environmental concentrations in groundwater (PECgw) .................. 14
3.7.3 Predicted environmental concentrations in surface water (PECsw) ................ 14
3.7.4 Predicted environmental concentrations in air (PECair) .................................. 15
3.8 Ecotoxicology (Part B, Section 9) .................................................................. 15
3.9 Relevance of metabolites (Part B, Section 10) .............................................. 15
4 Conclusion of the national comparative assessment (Art. 50 of Regulation (EC) No 1107/2009) ........................................................................................................................... 15
5 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorization ................................................................. 15
None. Appendix 1 Copy of the proposed product label ............................................................... 15
Appendix 2 Letter of Access ........................................................................................ 17
Appendix 3 Lists of data considered for national authorization ..................................... 19
Isonet T
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PART A
RISK MANAGEMENT
1 Details of the application
Applicant:
Name: CBC (Europe) S.r.l.
Address: Via E. Majorana, 2
20834 Nova Milanese (MB)
Italy
No additional national assessment data.
1.1 Application background
Tuta absoluta is a species of moth known by the common name tomato leafminer. It is well-known and a
very serious pest of tomato crops in Europe. The larva feeds on tomato plants, producing large galleries in
leaves, burrowing in stalks, and consuming apical buds and green and ripe fruits. Under severe
infestations the damage could be up to 100%.
ISONET T is intended for use in greenhouses in agriculture. Containing the two SCLPs (E,Z,Z)-3,8,11-
Tetradecatrien-1-yl acetate and (E,Z)-3,8-Tetradecatrien-1-yl acetate makes the product suitable to
control the insect Tuta absoluta in solanacea (tomatoes, sweet peppers/bell peppers,
aubergines/eggplants) by mating disruption technique. The application is 800-1000 dispensers per
hectare. Each dispenser containing 60 mg of pure active substance. The product is applied before each
transplant of the tomato/pepper/aubergine seedlings.
The application is for a Mutual Recognition according to article 40 to 42 of Regulation 1107/2009.
The product intended for authorisation in the Netherlands is identical to and has the exact same
composition as the reference product ISONET T authorized since 20/01/2016 in Italy with authorisation
number 16510.
The product Isonet T authorized in:
Italy: authorisation no. 16510
UK: MAPP no. 17929 (MR from Italy)
Greece: authorisation no. 9076 (MR from Italy)
The product is applied in greenhouse and therefore the authorisation application respects the conditions
given in art. 40 for an authorisation under the mutual recognition procedure.
The pheromones are released in very small amounts from the dispensers in a regular way during the
period the dispensers are releasing the pheromones. Because the efficacy of a mating disruption
techniques mainly depends on the concentration of the pheromones in the air the application rate (800-
1000 dispenser/ha) in the Netherlands greenhouses should be the same as authorized in Italy.
The active substance blend (E,Z,Z)-3,8,11-Tetradecatrien-1-yl acetate + (E,Z)-3,8-Tetradecadien-1-yl
acetate belongs to the group of Straight Chain Lepidopteran Pheromones, which were finally approved by
COMMISSION IMPLEMENTING REGULATION (EU) No 918/2014 of 22 August 2014 amending
Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance
Straight Chain Lepidopteran Pheromones. The active substance blend was added to Appendix III of
Isonet T
Part A – National Addendum
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Appendix III of the Final Review report for the active substance Straight Chain Lepidopteran Pheromones
(SCLPs) SANCO/2633/08.
The OECD Series on Pesticides Number 12 ‘Guidance for Registration Requirements for Pheromones
and Other Semiochemicals Used for Arthropod Pest Control’ (ENV/JM/MONO (2001) and the
SANTE/12815/2014 rev. 5.2 “Guidance document on semiochemical active substances used in plant
protection products” noted the 19 May 2016 propose a rationale and a guidance for reduced data
requirements for pheromones/semiochemicals.
1.2 Letters of Access
The owner of other data for the active substance blend is the SCLP Task Force under IBMA International
Biocontrol Manufacturers' Association, Rue de Trèves 61, BE-1040 Brussels, Belgium.
The owner of the data for the plant protection product is also Shin-Etsu Chemical Co Ltd but the efficacy
data are owned by the applicant CBC (Europe) S.r.l.
The owner of specification and batch analysis data is Shin-Etsu Chemical Co Ltd, 6-1 Ohtemachi 2-
chome Chiyoda-ku, Tokyo 100-0004, Japan.
Letter of Access for the active substance blend is included on the application.
1.3 Justification for submission of tests and studies
No additional study is submitted for the Mutual Recognition request in the Netherlands compared to the
original submission done in Italy.
1.4 Data protection claims
The product composition is considered confidential and can be found in Part C.
2 Details of the authorization decision
2.1 Product identity
Product code -
Product name in MS Isonet T
Authorisation number -
Function pheromone/attractant
Applicant CBC (Europe) S.r.l.
Active substance(s)
(incl. content)
Blend of:
720 g/kg pure (E,Z,Z)-3,8,11-Tetradecatrien-1-yl acetate
+
83 g/kg pure (E,Z)-3,8-Tetradecadien-1-yl acetate
60 mg blend/dispenser.
On average containing 960 g/kg technical blend and 803 g/kg pure active
substance blend.
Formulation type VP
Isonet T
Part A – National Addendum
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Applicant: CBC (Europe) S.r.l Evaluator: NL, Ctgb Date: February 2018
Page 7 /22
Packaging The passive polymer dispensers are sold in sealed aluminium under vacuum
envelopes
Coformulants of concern for
national authorizations
None
Restrictions related to identiy None
Mandatory tank mixtures Not applicable
Recommended tank mixtures Not applicable
2.2 Conclusion
The evaluation of the application for Isonet T resulted in the decision to grant the authorization.
2.3 Substances of concern for national monitoring
None.
2.4 Classification and labelling
2.4.1 Classification and labelling under Regulation (EC) No 1272/2008
Explanation:
Pictogram: -
The identity of all substances in the mixture that contribute to the classification of the mixture *:
- Pictogram: GHS07 Signal word: Warning GHS09 H-statements: H315 Causes skin irritation. H410 Very toxic to aquatic life with long lasting
effects. P-statements: P102 Keep out of reach of children. P270 Do not eat, drink or smoke when using this
product. P273 Avoid release to the environment. P280c Wear protective gloves and protective
clothing. P302+P352 IF ON SKIN: Wash with plenty of water/... P332+P313 If skin irritation occurs: Get medical
advice/attention. P391 Collect spillage. P501 Dispose of contents/container to .... Supplemental Hazard information:
EUH401 To avoid risks to human health and the environment, comply with the instructions for use.
SP1 Do not contaminate water with the product or its container
Child-resistant fastening obligatory? Not applicable Tactile warning of danger obligatory? Not applicable
Isonet T
Part A – National Addendum
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Applicant: CBC (Europe) S.r.l Evaluator: NL, Ctgb Date: February 2018
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H-statements: -
P-statements: P-statements were proposed by the applicant and were accepted.
Other: -
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
2.4.2 Standard phrases under Regulation (EU) No 547/2011
SP 1 Do not contaminate water with the product or its container (Do not clean application
equipment near surface water/Avoid contamination via drains from farmyards and roads).
2.4.3 Other phrases (according to Article 65 (3) of the Regulation (EU) No 1107/2009)
- None.
2.5 Risk management
2.5.1 Restrictions linked to the PPP
The authorization of the PPP is linked to the following conditions (mandatory labelling):
Operator protection:
None.
Worker protection:
None.
Integrated pest management (IPM)/sustainable use:
None.
Environmental protection
None.
Other specific restrictions
None.
2.5.2 Specific restrictions linked to the intended uses
Some of the authorised uses are linked to the following conditions in addition to those listed under point
2.5.1 (mandatory labelling):
Integrated pest management (IPM)/sustainable use: Relevant for use no.
To be applied a few days before the transplant in the greenhouse.
Environmental protection: Relevant for use no.
None.
Isonet T
Part A – National Addendum
MS version
Applicant: CBC (Europe S.r.l Evaluator: NL, Ctgb Date: February, 2018
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2.6 Intended uses (only NATIONAL GAP)
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 as/ha a) max. rate per appl. b) max. total rate per crop/season
Water L/ha min / max
Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms)
3 NL Tomato, pepper, aubergine
G Tuta absoluta (GNORAB)
Dispensers
Some days before or immediately after the transplant.
crop stage: BBCH 12 Before first flight of insect
a) 1 b) 1
n.a. a) 800-1000 dispenser/ha
a) 60 g as/ha (blend with 53.8 mg (E,Z,Z)-3,8,11-Tetradecatrien-1-yl acetate and 6.2 mg (E,Z)-3,8-Tetradecadien-1-yl acetate)
n.a. n.a. Distribute dispensers evenly over the greenhouse. Double dose along edges and at beginning and at the end of rows Continuous release rate of pheromones: 60 mg in 120 days
Isonet T
Part A – National Addendum
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Applicant: CBC (Europe S.r.l Evaluator: NL, Ctgb Date: February, 2018
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3 Background of authorization decision and risk management
According to Regulation 1107/2009 article 40(1c) the holder of an authorisation granted in accordance
with Article 29 may apply for an authorisation for the same plant protection product, the same use and
under the comparable agricultural practices in another Member State under the mutual recognition
procedure in the following case: the authorisation was granted by a Member State for use in greenhouses,
or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant
products, or for seed treatment, regardless of the zone to which the reference Member State belongs. The
Italian authorisation of Isonet T is for greenhouse only.
Because the product data requirements for operator, consumer, human health in general, environmental
fate and ecotoxicology can be largely waived based on OECD guideline no. 12. the only specific national
specific risk assessments carried out for this MR in The Netherlands is for the aspect fate and behaviour.
The specific measures to take for the use, storage and disposal are fully described in the label itself and
the MSDS provided to the customers.
3.1 Physical and chemical properties (Part B, Section 2)
The product Isonet T is a VP formulation. Studies have been performed in accordance with the current
requirements as expressed in OECD series on pesticides no.12, the critical GAP and the results are
deemed to be acceptable. The formulation that has been evaluated is a colourless or light yellow
transparent liquid with mild waxy and sweet odour, with a flash points higher than 110°C, auto-
flammability of 283°C, and a density of 0.902 g/cm3 and without explosive or oxidizing properties. The
pH, surface tension and dynamic/kinematic viscosity have not been determined as this is not required for
an pheromone in a dispenser product. The stability of the product stored in commercial packaging
(passive polymer dispensers in sealed aluminium under vacuum envelopes) for 1 year at 5°C is found
acceptable. The storage stability for 1 year at 25°C was also tested, however the active substance
decreased more than 5% and therefore it is recommended to state on the product label to store the product
at a maximum temperature of 5°C. Its technical characteristics are acceptable for a VP formulation.
Implications for labelling: Store the product at a maximum temperature of 5°C.
3.2 Efficacy (Part B, Section 3)
It concerns a mutual recognition from Italy. It concerns use in protected cultivation of fruiting vegetables.
Greenhouses are seen as one zone for registration purposes, however according to EFSA guidance
(SANCO/12184/2014) not all protected structures can be seen as greenhouses. Furthermore the EPPO
standard on principles of zonal data production and evaluation (PP1/278(1) states that during evaluation
of a dossier the climatic circumstances over the whole zone should be considered if authorisation is
sought for a complete climatic zone; this has been further clarified in zonal efficacy examples that are
presented on the EPPO website. There is a specific example that looks at authorisations for an insecticide
in greenhouses :
http://www.eppo.int/PPPRODUCTS/zonal_efficacy/examples/14-
19647_zonal_ex_protected_ornamentals_insects.docx
Isonet T
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It can therefore be concluded that a comparison of climatic circumstances is needed to see if the
authorisation in Italy can be considered relevant for the Netherlands, there are however also arguments in
favour of easier extrapolation between member states due to the nature of this specific product.
The product is a mating disruption pheromone. There is specific EPPO guidance available for mating
disruption pheromones (EPPO PP1/264). One of the main concerns for pheromone efficacy are border
effects (or migration of pests from outside the treated area), these are likely less of a concern in the
Netherlands, as it concerns a use in protected crops. Migration from outside of the treated area is likely to
be very low. Pheromones are products that are selective and that fit within an IPM framework and that
can reduce the need to apply chemical products; for low risk products there is more room for
extrapolation. Based on expert judgement it can be expected that efficacy of the product will be similar in
the Netherlands, pest pressure in southern Europe is expected to be similar or worse, while the mode of
action (pheromone) is expected to be unaffected by climate. Furthermore the product also has
authorisations in other maritime zone member states (UK, also by mutual recognition from Italy).
3.3 Efficacy data
Because applications of pheromones is different from standard products, and because correct application
is important to achieve good efficacy, specific label advice is required. The label advice is in line with the
advice found on the Italian label, the following translations were provided by the applicant:
Greenhouses with low population pressure of T. absoluta can be adequately protected by mating
disruption. With mid and high pest population pressure is it necessary to set up an integrated strategy
with insecticides especially during the first years of the method application. At the beginning of the crop
cycle in the greenhouse, set up a knock-down treatment to reduce populations and combine to improve
the control. The use of insecticides does not affect the dispenser performance, it is therefore possible to
intervene at any time. Mated females from neighboring greenhouses or from other sources of infestation
can cause unexpected damages. Adopting all the good agronomical practices to reduce the population
of the pest. Periodically inspect fruits to verify eventual attacks and intervene with insecticides where
and when needed.
Monitoring traps must be placed inside the greenhouses (at least 2 traps/greenhouse, depending on
greenhouse dimension). Traps must be placed at around 0.5 - 1 m height. Traps must be checked at least
every 2 to 3 days (at least 2 times/week).
Double the dosages along the edges and at the beginning and at the end of the rows. Twist loosely the
dispensers on the support wires. Distribute evenly the dispensers inside the greenhouse.
The sentences proposed were translated quite literally by the applicant, the first was slightly adapted as it
gives too detailed advice, such advice can still be given in off label advice but does not need to be placed
on the label. The resulting sentence reads : The product is only suitable for low pest pressure, in case of
high pressure apply in combination with other insecticides.
In Dutch the sentences are:
Het middel is alleen geschikt bij lage plaagdruk, bij hoge plaagdruk gebruiken in combinatie met andere insectenbestrijdingsmiddelen. In de kas moeten controlevallen worden geplaatst (op z’n minst 2 vallen per kas, afhankelijk van de kasomvang). Vallen moeten geplaatst worden op 0,5 -1 meter hoogte. Vallen moeten ten
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minste om de 2 tot 3 dagen (minstens 2 keer per week) worden gecontroleerd op plaagorganismen. Breng de dispenser een paar dagen voor het verplanten in de kas. Verdeel de dispensers gelijkmatig over de kas, gebruik dubbele doseringen langs de randen en aan het begin en einde van de rijen. Draai de dispensers losjes aan de steundraden.
3.3.1 Information on the occurrence or possible occurrence of the development of resistance
The following is stated by the applicant:
A pheromone is a chemical substance which is secreted by an individual of a species and causes a
specific reaction in another member of the same species. By definition therefore in the case of the
SCLPs, they should only affect the species for which they are targeted. This species specificity is brought
about by the fact that the ‘receiving’ individual has specific chemical sensors on its antennae that pick
up the species-specific signal from the ‘emitting’ individual. Development of resistance or cross-
resistance would contradict the entire biological reason for emitting such pheromones by the insects.
Resistance due to mating disruption techniques has never been observed even with more than 20 years
of application. The Insecticide Resistance Action Committee (IRAC) does not consider pheromones as
possible resistance developing chemicals.
The Netherlands do not fully agree with the above statement. Selection pressure is exerted by the product,
therefore there is a possibility for resistance to develop. However we agree that due to the importance of
pheromones to the life cycle of insects, the risk is relatively low. A restriction sentence is not needed as
currently no resistance is known against this or similar products.
3.3.2 Adverse effects on treated crops
It concerns a mutual recognition. Reference is made to the evaluation by Italy.
3.3.3 Observations on other undesirable or unintended side-effects
It concerns a mutual recognition. Reference is made to the evaluation by Italy.
3.4 Methods of analysis (Part B, Section 5)
3.4.1 Analytical method for the formulation
The method is based on a gas chromatography with FID detection.
Validation parameter Result
Specificity No significant interfering peaks were observed.
Linearity R, correlation coefficients were 1.0 for the two active substances.
Accuracy The accuracy was higher than 99% for the active substances.
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Precision The RSDs for active substances were below 0.2%.
Conclusion: GC-FID for measuring SCLPs has been the method of choice for many years. The results
from the submitted study indicate that specificity, linearity, accuracy and precision are fully acceptable,
and the method is therefore suitable for measuring the two active substances contained in the dispenser
formulation. The requirements of SANCO/3030/99 rev.4 11/07/00 have been met.
3.4.2 Analytical methods for residues
The VP formulation vaporising pheromones at quantities similar to the natural background level and
below the trigger value of 375 g/ha set by the OECD guideline no.12 [Guidance for Registration
Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest Control (OECD
2001)]. Further according to the guideline analytical methods for residues or information on the stability
of working solutions are not required.
The pheromone release from dispenser at a level below 375 g/ha will not pose a risk for residues on crops
or commodities, no residue methods is therefore required, and no MRL shall be set.
All data requirements can be waived.
Analytical methods for soil, water and air are not required according to the OECD Series on Pesticides
No. 12 [Guidance for Registration Requirements for Pheromones and Other Semiochemicals Used for
Arthropod Pest Control (OECD 2001)], therefore all data requirements can be waived as indicated by the
OECD guideline.
3.5 Mammalian toxicology (Part B, Section 6)
3.5.1 Acute toxicity
No study provided specifically for the product. Classification and labelling was based on the calculation
rules in accordance with Regulation 1272/2008.
3.5.2 Operator exposure
The application concerns the greenhouse use of a semio-chemical via dispensers. The evaluation carried
out by Italy was in accordance with the OECD Guidance No 12 (Guidance for Registration Requirements
for Pheromones and Other Semiochemicals Used for Arthropod Pest Control ENV/JM7MONO (2001)
12). Since this request for authorisation concerns a mutual recognition the evaluation as carried out by
Italy is accepted. Based on this evaluation it was concluded that exposure will be within the natural
background level and the use of Isonet T is therefore expected to have no impact on the operator, worker,
bystander and resident.
3.5.3 Worker exposure
See 3.5.2.
3.5.4 Bystander and resident exposure
See 3.5.2.
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3.6 Residues and consumer exposure (Part B, Section 7)
Residues and consumer exposure is not a Dutch specific aspect. Please refer to the evaluation of the
Italian authorities.
3.7 Environmental fate and behaviour (Part B, Section 8)
For passive dispenser VP application of SCLPs the environmental fate end-points are not required.
The OECD guideline no.12 states that test data on a compound will only be required if its use will result
in environmental contamination exceeding natural background levels. Application rates of up to 375 g
SCLP/ha/yr are generally understood to result in exposure levels which are comparable to natural
emissions and safe for non-target species (Maloney 1999). The product use results in a 198.85 g as /ha/y.
No studies have been conducted on the formulated product for the determination of fate and behaviour in
soil, environmental data requirements are waived as exposure is unlikely to exceed natural exposure rates.
According to OECD Series on Pesticides (Number 12): Guidance for Registration Requirements for
Pheromones and Other Semiochemicals Used for Arthropod Pest Control ENV/JM/MONO (2001)12.
Two studies were provided concerning readily biodegradability in order to cope with proposed product
classification. The proposed classification by the applicant was not taken into consideration by the Italian
Ministry for the product authorisation.
In consideration of the product characteristics (closed retrievable dispenser in VP formulation), of the
application method and the very low release rates of the active substance no significant entry of the active
substance in soil, water or sediment is expected to occur, no specific risk assessment is therefore
necessary for The Netherlands.
According to OECD Guidance No. 12 (ENV/JM/MONO(2001)12, an application threshold of up to 375g
SCLPs/ha·year is considered appropriate to reflect the natural concentration levels of SCLPs. That means
that outdoor application rates up to 375 g a.s./ha·year can be considered to result in exposure levels
comparable to natural emissions and therefore safe for the environment.
In consequence, environmental fate studies with arthropod pheromones will only be required if their use
is expected to result in an environmental contamination that exceeds the natural environmental levels. The
maximum application rate for Isonet-T is 198.85 g a.s./ha·year (0.0227 (= 0.060 (g/disp.) x 1000 (disp./
ha) / 110 (days) / 24 (h/day)) g/h/ha x (24 h/day) x 365 (days)), and therefore no impact on in soil, water
or sediments is expected to occur.
Therefore, this product complies with the OECD 12. Since Isonet T complies with the OECD 12 the
product registration can be granted.
3.7.1 Predicted environmental concentrations in soil (PECsoil)
None.
3.7.2 Predicted environmental concentrations in groundwater (PECgw)
None.
3.7.3 Predicted environmental concentrations in surface water
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(PECsw)
None.
3.7.4 Predicted environmental concentrations in air (PECair)
None.
3.8 Ecotoxicology (Part B, Section 9)
The VP formulation vaporises pheromones at quantities similar to the natural background level under
high pest pressure and below the trigger value of 375 g/ha set by the OECD guideline no.12 [Guidance
for Registration Requirements for Pheromones and Other Semiochemicals Used for Arthropod Pest
Control (OECD 2001)]. As this level is comparable to naturally occurring emissions of pheromones
during an infestation, it is expected to have no impact on public health, non-target organisms, or the
environment.
Isonet T has a maximum application rate of 1000 dispensers per hectare and with 60 mg
SCLPs/dispenser and at least 110 days of SCLPs release by the vapour phase only the release rate can be
calculated to be 22.7 mg/h/ha. A possible natural release rate from lepidopteran insects according to
SANTE/12815/2014 rev. 5.2 “Guidance document on semiochemical active substances used in plant
protection products” has been estimated to be 15.7 mg/h/ha (B. Iversen, 2017, KCP 9.3). Overall it can be
concluded that the release rate from the plant protection product Isonet T is within one order of magnitude
from the estimated natural release rate from lepidopteran insects and the risk characterisation is therefore
concluded and no further assessment is necessary.
3.9 Relevance of metabolites (Part B, Section 10)
No relevant metabolites.
No specific risk assessment deemed necessary for The Netherlands.
4 Conclusion of the national comparative assessment (Art. 50 of Regulation (EC) No 1107/2009)
None.
5 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorization
None.
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Appendix 1 Copy of the proposed product label
Wettelijk Gebruiksvoorschrift Het middel is uitsluitend toegelaten als insectenbestrijdingsmiddel voor professioneel gebruik door middel van feromonen middels automatische dispensers in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.1 Ctgb juni 2015) onder de vermelde toepassingsvoorwaarden.
Toepassingsgebied Werkzaamheid getoetst op
Dosering* middel per toepassing
Maximaal aantal toepassingen per 12 maanden
Tomaten (bedekte teelt)
Tomatenmineermot1 800-1000** dispensers per hectare
1
Paprika (bedekte teelt)
Tomatenmineermot1 800-1000** dispensers per hectare
1
Aubergines (bedekte teelt)
Tomatenmineermot1 800-1000** dispensers per hectare
1
1 Tomatenmineermot (Tuta absoluta) * Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen. **Afhankelijk van plaagdruk en afmeting van de kas. Overige toepassingsvoorwaarden Het middel is alleen geschikt bij lage plaagdruk, bij hoge plaagdruk het middel toepassen in combinatie met andere insectenbestrijdingsmiddelen. In de kas moeten controle vallen worden geplaatst (op z’n minst 2 vallen per kas, afhankelijk van de kas omvang). Vallen moeten geplaatst worden op 0,5 -1 meter hoogte. Vallen moeten ten minste om de 2 tot 3 dagen (minstens 2 keer per week) worden gecontroleerd. Breng de dispenser een paar dagen voor het verplanten in de kas. Verdeel de dispensers gelijkmatig over de kas, gebruik dubbele doseringen langs de randen en aan het begin en einde van de rijen. Draai de dispensers losjes aan de steundraden. Gebruik bij het ophangen van de dispensers handschoenen. Bewaar het product bij een temperatuur van maximaal 5°C.
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Appendix 2 Letter of Access
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Appendix 3 Lists of data considered for national authorization
None.