12341 N
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1. BESLUIT Op 29 juli 2014 is van Bayer CropScience SA-N.V. Energieweg 1 3641 RT MIJDRECHT
een aanvraag tot wijziging van de toelating als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) van het gewasbeschermingsmiddel GAUCHO TUINBOUW op basis van de werkzame stof imidacloprid. HET COLLEGE BESLUIT de aanvraag tot wijziging van de toelating van bovenstaand middel te honoreren. Alle bijlagen, waaronder registratierapport deel A, vormen een onlosmakelijk onderdeel van het 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 2 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 2 Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II.
GAUCHO TUINBOUW, 20145246 ZWTG
12341 N 1.4 Aflever- en opgebruiktermijn (respijtperiode) De nieuwe etikettering dient bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. Bestaande voorraden mogen worden afgeleverd en opgemaakt (artikel 17:2 Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007). Aangezien uit de beoordeling geen restricties en/of beperkingen ten opzichte van de toelating met codering W.9 voortkomen, wordt geen limiterende termijn aan het afleveren en opmaken van bestaande voorraden gesteld.
2. WETTELIJKE GRONDSLAG Besluit artikel 33 Verordening (EG) Nr. 1107/2009 Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009 Gebruikt toetsingskader Conform Rgb d.d. 13 juni 2011 en Evaluation Manual 1.1.
3. BEOORDELINGEN 3.1 Risico voor de mens Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht. 3.2 Risico voor het milieu Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht. Adequate monitoring dient uitgevoerd te worden om deze conclusie te bevestigen. Monitoring dient gestart te worden met ingang van aankomend teeltseizoen, 1 maart 2015. Details over deze monitoring staat beschreven in deel A van het registratierapport, H.3.3. 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 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.
Wageningen, 5 december 2014 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw Voorzitter
GAUCHO TUINBOUW, 20145246 ZWTG
12341 N
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 2.1 Aanvraaginformatie Aanvraagnummer: Type aanvraag:
20145246 ZWTG Aanvraag tot wijziging van de toelating van een gewasbeschermingsmiddel met Nederland als zonaal rapporteur GAUCHO TUINBOUW 6 mei 2014 29 juli 2014
Middelnaam: Verzenddatum aanvraag: Formele registratiedatum: * Datum in behandeling name: Datum compliance check: 27 november 2009 * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2.2 Stofinformatie Werkzame stof imidacloprid
•
Gehalte 70%
De stof is per 1 augustus 2009 geplaatst op Annex I van Richtlijn 91/414/EEG (Richtlijn 2008/116/EG, 15 december 2008) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd) De goedkeuring van deze werkzame stof expireert op 31 juli 2019.
2.3 Toelatingsinformatie Toelatingsnummer: Expiratiedatum: Afgeleide parallel of origineel: Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gebruikers: W-coderingen en aflever- en opgebruiktermijnen: W-codering professioneel gebruik: Vorige w-codering professioneel gebruik: Aflevertermijn professioneel gebruik: Opgebruiktermijn professioneel gebruik:
12341 N 1 februari 2024 n.v.t. Gewasbeschermingsmiddel Professioneel
10 9 n.v.t. n.v.t.
2.4 Verpakkingsinformatie Aard van het preparaat: Water dispergeerbaar poeder voor vochtige zaadbehandeling
GAUCHO TUINBOUW, 20145246 ZWTG
12341 N
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel GAUCHO TUINBOUW De etikettering van Gaucho Tuinbouw met toelatingsnummer 12341 N wijzigt niet.
GAUCHO TUINBOUW, 20145246 ZWTG
12341 N
Bijlage III: Deel A van het Registratierapport
GAUCHO TUINBOUW, 20145246 ZWTG
Part A National Assessment
Gaucho Tuinbouw Extension
Registration Report Page 6 of 18
REGISTRATION REPORT Part A
Risk Management
Product code:
102000006811
Active Substance:
imidacloprid WS 70 (700 g/kg )
Zonal Rapporteur: The Netherlands
NATIONAL ASSESSMENT
Applicant:
Bayer CropScience SA-N.V.
Date:
December 2014
Applicant Bayer CropScience
Evaluator: CTGB, The Netherlands Date: September 2014
Part A National Assessment
Gaucho Tuinbouw Extension
Registration Report Page 7 of 18
Table of Contents PART A – Risk Management
8
1
Details of the application
8
1.4
Data protection claims
8
1.5
Letters of Access
8
2
Details of the authorisation
9
2.1
Product identity
9
2.2
Classification and labelling
9
2.2.1
Classification and labelling under Regulation (EC) No 1272/2008
9
2.3
Product uses
10
3
Risk management
11
3.1
Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 11
3.1.3
Mammalian Toxicology
11
3.1.3.2
Operator Exposure
11
3.1.3.3
Bystander Exposure
12
3.1.3.4
Worker Exposure
12
3.1.6
Ecotoxicology
12
3.2
Conclusions
13
3.3
Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 13
Appendix 1 – Copy of the product authorisation
15
Appendix 2 – Copy of the product label
16
Appendix 3 - List of data submitted in support of the evaluation
18
Applicant Bayer CropScience
Evaluator: CTGB, The Netherlands Date: September 2014
Part A National Assessment
Gaucho Tuinbouw Extension
Registration Report Page 8 of 18
PART A – Risk Management An application has been submitted for extension of the authorization of the plant protection product Gaucho Tuinbouw with authorisation number 12341 N, an insecticide based on the active substance imidacloprid, meant for seed treatment including dummy pill and phytodrip. Gaucho Tuinbouw is a WS formulation and contains 700 g/kg imidacloprid. The extension is for the use in heading cabbages, the cauliflower family and the loose leaf cabbage family. This document only includes the additional data provided to support the extension for use. For the remaining data, please refer to the RR established for the re-registration authorisation of the product. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 3, 6 and Part C. This document describes the specific conditions of use and labelling required for The Netherlands for the re-registration of imidacloprid WS 70 W. Appendix 1 of this document provides a copy of the final product authorisation for The Netherlands. Appendix 2 of this document is copy of the product label for The Netherlands. Appendix 3 of this document is the reference list of the studies for which data protection is granted.
1
Details of the application
1.1
Application background
This application was submitted by Bayer CropScience SA-NV on 29 July 2014. extension of the authorization of the plant protection product Gaucho Tuinbouw with authorisation number 12341 N, an insecticide based on the active substance imidacloprid, meant for seed treatment including dummy pill and phytodrip. Gaucho Tuinbouw is a WS formulation and contains 700 g/kg imidacloprid. The extension is for the use in heading cabbages, the cauliflower family and the loose leaf cabbage family. .
1.4
Data protection claims
The reference list included in the dossier defines the list of studies and reports, submitted with the application, for which a claim for data protection was made. This claim for protection was made as the studies and reports were submitted and used as the basis for approval for the first time in The Netherlands. Based on Article 13.4b of Directive 91/414/EC Bayer S.A.S. (Bayer CropScience) claims 10 years protection for these studies and reports. The authorities confirm that these studies and reports are protected for 10 years from the date of authorisation of the product and thus can not be used for the benefit of another applicant.
1.5
Letters of Access
By a Letter of Access, Bayer CropScience SA-NV has access to all the corresponding documentation submitted by Bayer CropScience AG and which have been the basis for the decision for the inclusion of imidacloprid in Annex I of Directive 91/414/EEC. By a Letter of Access from Syngenta Limited, Bayer CropScience AG has access to generic behavioural ecology data.
Applicant Bayer CropScience
Evaluator: CTGB, The Netherlands Date: September 2014
Part A National Assessment
Gaucho Tuinbouw Extension
Registration Report Page 9 of 18
2
Details of the authorisation
2.1
Product identity
Product Name
Authorization Number (for reregistration) Function Applicant Composition Formulation type Packaging
2.2
imidacloprid WS 70 (700 g/kg) 102000006811-03 Gaucho Tuinbouw 12341 N Insecticide as seed treatment Bayer CropScience B.V. 700 g/kg imidacloprid water dispersible powder for slurry seed treatment [Code: WS] Materials: Film bag: low density polyethylene (LDPE) Capacity: Bags up to 25 kg Bags which may or may not be packed in an outer corrugated fibreboard case including: 20 x 0.20 kg 20 x 0.25 kg 10 x 1.0 kg 4 x 2.0 kg 4 x 3.0 kg 4 x 5.0 kg 1 x 10.0 kg 1 x 25.0 kg Type of closure and size of opening: Bags are “heat-sealed
Classification and labelling
2.2.1 Classification and labelling under Regulation (EC) No 1272/2008 The current classification and labelling can be maintained.
Applicant Bayer CropScience
Evaluator: CTGB, The Netherlands Date: September 2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 10 of 18
2.3
Product uses
GAP-Table for extension in cabbage applied for 1
UseNo.
2
Member state(s)
3
Crop and/ or situation
4
F G or I
5
Pests or Group of pests controlled
6
7
8
Application Method / Kind
Timing / Growth stage of crop & season
10
11
12
Application rate per treatment Number / (min. Interval between applications)
kg product kg as/ha / ha
Water L/ha
13
PHI (days)
14
Remarks:
a) max. no. of applications per crop and season
b) Maximum product rate per season
min / max
c) additional remarks
1
2
3
4
5
6
NL
NL
NL
NL
NL
NL
Heading cabbages
Heading cabbages
Cauliflower family
Cauliflower family
Loose leaf cabbage family
Loose leaf cabbage family
I (coating), G (opkweek), F (uitplanten)
Aphididae, Thrips tabaci
I (coating), G (opkweek), F (uitplanten)
Aphididae, Thrips tabaci
I (coating), G (opkweek), F (uitplanten)
Aphididae, Thrips tabaci
I (coating), G (opkweek), F (uitplanten)
Aphididae, Thrips tabaci
I (coating), G (opkweek), F (uitplanten)
Aphididae, Thrips tabaci
I (coating), G (opkweek), F (uitplanten)
Aphididae, Thrips tabaci
Applicant Bayer CropScience
Seed BBCH00, Marchtreatment, September including dummy pill
na
Phytodrip
na
BBCH00, MarchSeptember
0,129
0,090
na
na
Max. planting rate = 60,000 plants/ha; 1 unit = 100,000 seeds Dose rate = 215 gram product/unit
0,129
0,090
naA
na
Max. planting rate = 60,000 plants/ha; 1 unit = 100,000 seeds Dose rate = 215 gram product/unit
Seed BBCH00, Marchtreatment, September including dummy pill
na
Phytodrip
na
BBCH00, MarchSeptember
0,129
0,090
Na
na
Max. planting rate = 60,000 plants/ha; 1 unit = 100,000 seeds Dose rate = 215 gram product/unit
0,129
0,090
na
na
Max. planting rate = 60,000 plants/ha; 1 unit = 100,000 seeds Dose rate = 215 gram product/unit
Seed BBCH00, Marchtreatment, September including dummy pill
na
Phytodrip
na
BBCH00, MarchSeptember
0,129
0,090
na
na
Max. planting rate = 60,000 plants/ha; 1 unit = 100,000 seeds Dose rate = 215 gram product/unit
0,129
0,090
na
na
Max. planting rate = 60,000 plants/ha; 1 unit = 100,000 seeds Dose rate = 215 gram product/unit
Evaluator: CTGB, The Netherlands Date: 31 January 2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 11 of 18
3
Risk management
3.1
Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles
3.1.3 Mammalian Toxicology 3.1.3.2
Operator Exposure
Calculation of the chronic AOEL / Tolerable Limit Value (TLV) For imidacloprid no TLV has been set. The AOEL will be used for the risk assessment. The formulation Gaucho Tuinbouw is applied as a seed treatment, in which seeds are treated in a closed system and the seeds are planted mechanically. The formulation can also be applied during sowing by very accurately dripping the seed by using PHYTO-DRIP®. The application can also be considered as a closed system, but operators can be exposed during mixing/loading. As the method of phyto-dripping can be used the whole year through, a chronic exposure duration is applicable for the operator. Since a chronic exposure for operators during phyto-dripping cannot be excluded, a systemic AOEL for chronic exposure will be derived. As the EU-AOEL is derived from short-term studies and the NOAEL in chronic studies lead to a lower value than the EU-AOEL, a chronic AOEL is derived and is based on the NOAEL of 5.7 mg/kg bw/d in the 2-year rat study. Application of a safety factor of 100 results in a chronic AOEL of 0.057 mg/kg bw/day (= 3.99 mg/day for a 70-kg operator). Exposure/risk The coating of seed in the Netherlands is a highly technological process which is not expected to be performed by agricultural operators but only in closed industrial systems. This industrial process is under control of industrial safety authorities and agricultural professional associations. This guarantees that both the production plants themselves and the way they are run correspond to modern standards, and that safety measures are maintained. The applicant submitted RI&Es (Risk Inventory and Evaluation) from the seed coating plants to prove that seed treatment with Gaucho Tuinbouwis performed according the requirements of chapter 4, branch 1, paragraphs 2 and 3, and chapter 4, branch 9, paragraphs 2, 3 and 4, of the working conditions decree. Therefore, a risk assessment for the operator using Gaucho Tuinbouwfor seed treatment is not required. For application of Gaucho Tuinbouwby phyto-drip, exposure to imidacloprid during mixing and loading is estimated with models. The exposure is estimated for the unprotected operator. Since the application during the process of phyto-dripping can be considered as a closed system, only the exposure during mixing and loading is calculated. The highest application rate for the Phyto-Drip® system is 0.215 kg Gaucho Tuinbouw / 100,000 seeds. Since a Phyto-Drip® system can treat 700.000 seeds per day (as indicated by the applicant), a maximum of 1.505 kg Gaucho Tuinbouw is used per day. The exposure for the unprotected operator was estimated using the NL model for mixing and loading and was above the AOEL (risk-index of 4.65). With the use of personal protective equipment (gloves during mixing and loading) the exposure was below the AOEL (risk index of 0.70) Based on the risk assessment, it can therefore be concluded that no adverse health effects are expected for the protected operator after respiratory and dermal exposure during mixing and loading activities during the application of Gaucho Tuinbouw by phyto-drip on heading cabbages, the cauliflower family, and the loose leaf cabbage family. Applicant Bayer CropScience Netherlands
Evaluator: CTGB, The Date: September
2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 12 of 18
3.1.3.3
Bystander Exposure
Bystanders should not be present during seed treatment with Gaucho Tuinbouw and therefore no exposure is expected. During sowing or planting activities of the treated seeds bystanders may exposed to dust coming off the seed during the loading of the hopper. However, the bystander exposure is expected to be only a fraction of the worker exposure. Based on the low risk-index for the worker, no exposure calculations are performed for bystanders. 3.1.3.4
Worker Exposure
The worker can be exposed to imidacloprid on the seeds during loading of the seeding equipment. Therefore, worker exposure is calculated. Calculation of the EU-AOEL / Tolerable Limit Value (TLV) Since the treated seed will be sowed during the period February-May a semi-chronic exposure duration is applicable for the worker. A semi-chronic AOEL is therefore derived. Since imidacloprid is included in Annex I of 91/414/EEC and approved under subsequently Regulation (EC) No 1107/2009, the semi-chronic EU-AOEL of 0.08 mg/kg bw/day (= 5.6 mg/day for a 70-kg worker), based on the 28- and 90-day studies in dogs, supported by subchronic neurotoxicity study in rats, is used for the risk assessment (see List of Endpoints). Exposure/risk
For the scenario loading and sowing of seeds neither an EU-wide model nor generic study data are available. Therefore, the applicant submitted an exposure study (Zietz, 2007) in which the potential dermal, actual dermal, and inhalation exposure of operators to imidacloprid during loading/sowing of Gaucho treated maize seeds under realistic field conditions was measured. The estimated exposure for the unprotected worker based on this exposure study was below the AOEL (risk-index of 0.58). It can therefore be concluded that no adverse health effects are expected for the unprotected worker after respiratory and dermal exposure during loading/sowing activities of seeds for heading cabbages, the cauliflower family, and the loose leaf cabbage family due to exposure to imidacloprid after application of Gaucho Tuinbouw.
3.1.6 Ecotoxicology The current document only considers the additional data for birds provided to support the extension for use in heading cabbage, cauliflower family, loose leaf cabbage family, which could not be authorised during the re-registration procedure. The long-term risk to birds was found to be acceptable for the generic focal species of the EFSA guidance document based on refined PD, PT and residue levels. For the acute risk assessment, refined residue levels and a geomean acute toxicity endpoint are available. Based on these, the acute risk to the generic focal species from EFSA ‘small omivorous bird’ was found to be acceptable. However, an acute risk to the ‘medium herbivorous bird’ cannot be excluded. To refine this risk, the applicant relied on extrapolation from field and laboratory feeding behaviour data from a different season and with a different crop stage. Ctgb considered that more conservatism was needed for the use of these data, and calculated a shorter timeframe in which the lethal dose could be reached than the applicant. Also, the applicant stated that avoidance will play a role to prevent adverse effects, but no data are available at the relevant dose and for the relevant food type to substantiate this claim. Another of the applicant’s Applicant Bayer CropScience Netherlands
Evaluator: CTGB, The Date: September
2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 13 of 18
arguments builds on the lack of reported deaths of wood pigeons on cabbage fields between 2007 and 2014, the period of registration of Gaucho Tuinbouw. However, a lack of incident reporting is not sufficient to conclude on a lack of effects, especially for a non-conspicuous and not particularly popular species such as the wood pigeon. To prove a lack of effects in the field, targeted monitoring needs to be performed. Aditionally, the applicant provided the weight of cabbage seedlings. Based on this, the amount of cabbage plants that need to be eaten or pecked at to reach a toxic level can be calculated. Based on the feeding behaviour information, it is theoretically possible that a pigeon fulfills its daily dietary requirement with cabbage plants only; the time required to eat this amount of cabbage leaves is feasible within a day. However, it is questionable whether farmers will allow so many pigeons to feed in these amounts that the pigeon population is harmed. The applicant states that if pigeons would eat significant amounts of small cabbage plants, farmers would take action in order to protect their crops. Wood pigeon, stock dove, crow, jackdaw and rook are all known to cause damage to cabbage crops (source: The Dutch Faunafonds, see http://www.faunafonds.nl/index.asp?p=245). Farmers are advised to take measures to prevent damage by birds (chasing away and, for wood pigeon only, hunting). Thus, since damage occurs, the measures taken by farmers apparently do not prevent foraging of herbivorous birds on cabbage fields at all times. Furthermore, the risk assessment calculations and the higher tier argumentation are focussed at the wood pigeon and possibly do not cover the risk to all relevant species. In conclusion, the applicant presented a lot of information on the potential risk to herbivorous birds feeding on cabbage seedlings. Several of the arguments were not or only partly accepted by Ctgb. However, it was shown that quite a large amount of plants would need to be eaten or damaged to reach a toxic level in the wood pigeon. Whether this will happen to so many individual birds as to damage the population, is uncertain, especially considering the damage control (chasing away/hunting) that will be done by farmers. Therefore, it is proposed to perform targeted monitoring on fields on which Gaucho Tuinbouw is used as seed treatment in cabbage crops, to monitor the acute effect on birds in the field. All potentially affected bird species should be included in this monitoring. It can be concluded that: 1. the proposed application of the active substance imidacloprid in cabbages is expected to meet the standards for birds as laid down in the RGB. Adequate monitoring needs to be performed to confirm this conclusion.
3.2
Conclusions The product is expected to complies with the uniform principles for the use in cabbages. Adequate monitoring needs to be performed to confirm this conclusion.
3.3
Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation
Ecotoxicology 1
IIIA 10.1
Adequate post-registration monitoring needs to be performed to confirm that the acute risk to birds is acceptable.
Applicant Bayer CropScience Netherlands
Evaluator: CTGB, The Date: September
2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 14 of 18
Explanation: The information submitted by the applicant indicates that population effects to the wood pigeon from the use of Gaucho Tuinbouw on cabbage plants are not likely, because of measures taken by farmers to prevent crop damage by birds. This needs to be confirmed with targeted monitoring on fields on which Gaucho Tuinbouw is used as seed treatment in cabbage crops. This monitoring should be performed by skilled observers, should include adequate carcass search checks, should cover the area around the fields to which affected birds may move or be moved, and should not only focus on the wood pigeon but also include other herbivorous species potentially at risk. The monitoring protocol needs to be developed together with Ctgb.
Applicant Bayer CropScience Netherlands
Evaluator: CTGB, The Date: September
2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 15 of 18
Appendix 1 – Copy of the product authorisation Refer to the covering letter.
Applicant Bayer CropScience Netherlands
Evaluator: CTGB, The Date: September
2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 16 of 18
Appendix 2 – Copy of the product label Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als insectenbestrijdingsmiddel door middel van een zaadbehandeling (inclusief dummy pill of Phyto-drip) in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden Toepassingsgebied Sla (Lactuca spp) (bedekte opkweek ten behoeve van onbedekte teelt) Andijvie (bedekte opkweek ten behoeve van onbedekte teelt) Sluitkoolachtigen (bedekte opkweek ten behoeve van onbedekte teelt) Bloemkoolachtigen (bedekte opkweek ten behoeve van onbedekte teelt) Bladkoolachtigen (bedekte opkweek ten behoeve van onbedekte teelt)
Te bestrijden organisme Bladluis1,2
Bladluis2,3 Trips4
Dosering (middel) per toepassing 114 gram per 100.000 zaden 171 gram per 100.000 zaden 114 gram per 100.000 zaden 171 gram per 100.000 zaden 215 gram per 100.000 zaden
Bladluis2,3 Trips4
215 gram per 100.000 zaden
Bladluis2,3 Trips4
215 gram per 100.000 zaden
Bladluis1,2
1
Groene slaluis (Nasonovia ribisnigri) Groene of rode perzikluis (Myzus persicae) 3 Melige koolluis (Brevicoryne brassicae) 4 Trips (Thrips tabaci) 2
Toepassingsvoowaarden In de teelt van sla (Lactuca spp) en andijvie mogen maximaal 100.000 planten per hectare worden uitgeplant indien de dosering van 171 gram per 100.000 zaden wordt toegepast. In de teelt van kolen mogen maximaal 60.000 planten per hectare worden uitgeplant. Bij inzet van de dummy pill techniek dient het meegezaaide dummy zaad van hetzelfde gewas te zijn als het levende zaad. Om bijen en andere bestuivende insecten te beschermen mogen in de teelt van sla en andijvie gedurende 10 maanden na het zaaien of uitplanten geen voor bijen aantrekkelijke gewassen geplant of gezaaid worden. Om in het water levende organismen te beschermen is het in de bedekte teelten (opkweek op substraat) niet toegestaan om ongezuiverd drainwater op het oppervlaktewater te lozen. Het te
Applicant Bayer CropScience Netherlands
Evaluator: CTGB, The Date: September
2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 17 of 18
lozen drainwater mag uitsluitend worden geloosd, nadat het te lozen drainwater geleid wordt door een werkende zuiveringsvoorziening: o Deze zuiveringsvoorziening dient te bestaan uit één van onderstaande combinaties van technieken: • H2O2 + MDUV + actief koolfilter of • H2O2 + LDUV + actief koolfilter of • Ozon + actief koolfilter • Een andere door het bevoegd gezag gelijkwaardig verklaarde techniek o De zuiveringsvoorziening wordt tenminste éénmaal per jaar op de goede werking gecontroleerd en onderhouden door een deskundige op het gebied van zuiveringsvoorzieningen. o Een bewijs van de controle en het onderhoud is binnen de inrichting aanwezig en op aanvraag direct te tonen.
Applicant Bayer CropScience Netherlands
Evaluator: CTGB, The Date: September
2014
Part A National Assessment
Gaucho Tuinbouw
Registration Report Page 18 of 18
Appendix 3 - List of data submitted in support of the evaluation Not included in reference list from the applicant, but referred to in risk assessment from the applicant and used by Ctgb: Annex point Year Title Data Studies / reference Source (where different from company) protection relied on y/n number Company, Report No. granted GLP or GEP status (where relevant) y/n Published or Unpublished n.a. 1977 A woodpigeon (Columba palumbus) N Y feeding preference explained by a digestive bottle-neck Location:Oxford, Journal:Journal of Applied Ecology, Volume:14, Pages:815 - 826, Year:1977, Report No.: Lit. 9622, Edition Number: M369335-01-1 GLP/GEP: n.a., published. n.a.
1978
Woodpigeon feeding behaviour at brassica N sites. A field and laboratory investigation of woodpigeon feeding behaviour during adoption and maintenance of a brassica diet Journal:Animal Behaviour, Volume:26, Pages:778-790, Year:1978, Report No.: M491115-01-1, Edition Number: M-49111501-1 GLP/GEP: n.a., published
Applicant Bayer CropScience Netherlands
Y
Evaluator: CTGB, The Date: September
2014