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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� 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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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


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

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:153:0001:0186:NL:PDF

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

MS version

Applicant: CBC (Europe) S.r.l Evaluator: NL, Ctgb Date: February 2018

Page 3 /22

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

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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

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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

http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=product.displayAll&language=EN&selectedID=115




Isonet T


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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


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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

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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


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Applicant: CBC (Europe S.r.l Evaluator: NL, Ctgb Date: February, 2018

Page 9 /22

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

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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

http://www.eppo.int/PPPRODUCTS/zonal_efficacy/examples/14-19647_zonal_ex_protected_ornamentals_insects.docx

http://www.eppo.int/PPPRODUCTS/zonal_efficacy/examples/14-19647_zonal_ex_protected_ornamentals_insects.docx

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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)


1

Aubergines (bedekte teelt)


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.

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