Part A A9219B Registration Report National Assessment – Netherlands Central zone Page 1 of 159
REGISTRATION REPORT Part A
Risk Management
Switch Cyprodinil : 375g/kg Fludioxonil : 250g/kg
Central Zone Zonal Rapporteur Member State: Netherlands
NATIONAL ASSESSMENT Netherlands
Applicant: Syngenta Date: August 2013
Document Evaluator CTGB, The Netherlands Author: Date: August 2013 Part A A9219B Registration Report National Assessment – Netherlands Central zone Page 2 of 159
The summaries and evaluations contained in this registration report may be based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority that prepared it. Other registration authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this registration report unless they have received the data on which the summaries and evaluation are based, either: From the owner of the data, or From a second party that has obtained permission from the owner of the data for this purpose or, alternatively, the applicant has received permission from the data owner that the summaries and evaluation contained in this registration report may be used in lieu of the data, or Following expiry of any period of exclusive use, by offering, in certain jurisdictions, mandatory compensation, unless the period of protection of the proprietary data concerned has expired. Applicants wishing to avail of information in this registration report should seek advice from the regulatory authority to which application is made concerning the requirements in their country.
Document Evaluator CTGB, The Netherlands Author: Date: August 2013 Part A A9219B Registration Report National Assessment – Netherlands Central zone Page 3 of 159
Table of Contents
1. DETAILS OF THE APPLICATION 5 1.1. Application background 5 1.2. Annex I inclusion 6 1.3. Regulatory approach 7 1.4. Data protection claims 7 1.5. Letters of Access 7
2. DETAILS OF THE AUTHORISATION 7 2.1. Product identity 7 2.2. Classification and labelling 8 2.2.1. Classification and labelling under Directive 99/45/EC 8 2.2.2. R and S phrases under Directive 2003/82/EC (Annex IV and V) 9 2.2.3. Other phrases 9 2.3. Product uses 10
3. RISK MANAGEMENT 26 3.1. Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 26 3.1.1. Physical and chemical properties (Part B, Section 1, Points 2 and 4) 26 3.1.2. Methods of analysis (Part B, Section 2, Point 5) 26 3.1.2.1. Analytical method for the formulation (Part B, Section 2, Point 5.2) 26 3.1.2.2. Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 26 3.1.3. Mammalian Toxicology (Part B, Section 3, Point 7) 27 3.1.3.1. Acute Toxicity (Part B, Section 3, Point 7.1) 27 3.1.3.2. Operator Exposure (Part B, Section 3, Point 7.3) 28 3.1.3.3. Bystander Exposure (Part B, Section 3, Point 7.4) 28 3.1.3.4. Worker Exposure (Part B, Section 3, Point 7.5) 28 3.1.4. Residues and Consumer Exposure (Part B, Section 4, Point 8) 28 3.1.4.1. Residues (Part B, Section 4, Points 8.3 and 8.7) 28 3.1.4.2. Consumer exposure (Part B, Section 4, Point 8.10) 29
Document Evaluator CTGB, The Netherlands Author: Date: August 2013 Part A A9219B Registration Report National Assessment – Netherlands Central zone Page 4 of 159
3.1.5. Environmental fate and behaviour (Part B, Section 5, Point 9.1-9.3, 9.9) 29
3.1.5.1. Predicted Environmental Concentration in Soil (PECS) (Part B, Section 5, Points 9.4 and 9.5) 30
3.1.5.2. Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 30
3.1.5.3. Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) 32
3.1.5.4. Predicted Environmental Concentration in Air (PECAIR) (Part B, Section 5, Point 9.9) 34 3.1.6. Ecotoxicology (Part B, Section 6, Point 10) 34 3.1.6.1. Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 34 3.1.6.2. Effects on Aquatic Species (Part B, Section 6, Point 10.2) 36 3.1.6.3. Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 36 3.1.6.4. Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) 37 3.1.6.5. Effects on organic matter breakdown (Part B, Section 6, Point 10.6.7) 38 3.1.6.6. Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 38 3.1.6.7. Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 38 3.1.7. Efficacy (Part B, Section 7, Point 8) 39 3.2. Conclusions 44 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 44
APPENDIX 1 – COPY OF THE PRODUCT AUTHORISATION 44
APPENDIX 2 – COPY OF THE PRODUCT LABEL 45
APPENDIX 3 - LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION 53
Document Evaluator CTGB, The Netherlands Author: Date: August 2013 Part A A9219B Registration Report National Assessment – Netherlands Central zone Page 5 of 159
This document reviews the acceptable use conditions of new and extended uses for the plant protection product Switch (A9219B) required for registration in the Netherlands and should be reviewed in conjunction with the core assessment and national assessment of the the re-registration of this product. The new and extended uses and extended uses for A9219B are presented in the GAP table (please refer to 2.3).
This document is based on the information of Part A, re-registration in the Netherlands of A9219B, (August 2010). The new and extended uses of A9219B have no effect on the information presented in Part A, other than the GAP table.
PART A – Risk Management This document describes the acceptable use conditions required for the re-registration in the Netherlands of A9219B containing: 375 g/kg Cyprodinil which was included into Annex I of Council Directive 91/414/EEC (Commission Directive 2006/64/CE of 18 July 2006) 250 g/kg Fludioxonil which was included into Annex I of Council Directive 91/414/EEC (Commission Directive 2007/76/EC; 20 December 2007) The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addenda for the Netherlands. The information, data and assessments provided in Registration Report, Parts B include assessment of further data or information as required at national re-registration by the EU review. It also includes assessment of data and information relating to A9219B where that data have not been considered in the EU review process. Otherwise assessments for the safe use of A9219B have been made using endpoints agreed in the EU review of fludioxonil or cyprodinil. This document describes the specific conditions of use and labelling required for the Netherlands for the re-registration of A9219B. Appendix 1 of this document provides a copy of the final product authorisation for the Netherlands. Appendix 2 of this document is a copy of the approved product label for the Netherlands.
1. DETAILS OF THE APPLICATION
1.1. Application background
This application was submitted by Syngenta. The application was for approval of A9219B, a WG containing 375 g/kg cyprodinil and 250 g/kg fludioxonil and for use as a fungicide in a wide range of crops.
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1.2. Annex I inclusion
Cyprodinil
The inclusion of cyprodinil on Annex I of Directive 91/414/EEC entered into force on 1 May 2007 according to Commission Directive 2006/64/CE. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the cyprodinil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health in EFSA Scientific Report (2005) 51, 1-78 have been taken into account. The Annex I Inclusion Directive for cyprodinil (2006/64/CE) provides specific provisions which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation: - Particular attention should be given to the safety of operators and ensure that conditions of use prescribe the application of adequate personal protective equipment; - Particular attention should be given to the protection of birds, mammals and aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones. - Further studies should be submitted to confirm the risk assessment for birds and mammals and for possible presence of residues of metabolite CGA304075 in food of animal origin. These concerns were all addressed in the submission.
Fludioxonil
The inclusion of fludioxonil on Annex I of Directive 91/414/EEC entered into force on 1 November 2008 according to the Commission Directive 2007/76/EC, 20 December 2007. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fludioxonil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on EFSA Scientific Report (2007) 110, 1-85, have been taken into account. The Annex I Inclusion Directive for fludioxonil (2007/76/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation: In assessing applications to authorise plant protection products containing fludioxonil for uses other than seed treatment, Member States shall pay particular attention to the criteria in Article 4 (1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted and: - Must pay particular attention to the potential for groundwater contamination, in particular from soil photolysis metabolites CGA399833 and CGA192155, in vulnerable zones, - Must pay particular attention to the protection of fish and aquatic invertebrates. Conditions of authorisation should include risk mitigation measures, where appropriate.
Document Evaluator CTGB, The Netherlands Author: Date: August 2013 Part A A9219B Registration Report National Assessment – Netherlands Central zone Page 7 of 159
These concerns were all addressed in the submission.
1.3. Regulatory approach
To obtain re-approval the product A9219B must (where appropriate) meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed endpoints. This application was submitted in order to allow the re-registration of an already approved product in the Netherlands in accordance with the above.
1.4. Data protection claims
Where protection for data is being claimed for information supporting registration of A9219B, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7.
1.5. Letters of Access
Where Syngenta has provided the supporting data in Document K, the ownership of the data is indicated in the reference lists in Appendix 1 of the Registration Report, Part C and Part B Sections 1-7 and in Appendix 3 of Part A.
2. DETAILS OF THE AUTHORISATION
2.1. Product identity
Product Name A9219B SWITCH Authorization Number (for 12819N re-registration) Function Fungicide Applicant Syngenta Composition 375 g/kg cyprodinil 250 g/kg fludioxonil Formulation type Water dispersible granule [Code: WG] Packaging 160, 200, 300, 400 g and 1, 5, 10 kg containers
2.2. Classification and labelling
2.2.1. Classification and labelling under Directive 99/45/EC
The following is proposed in accordance with Directive 1999/45/EC as amended: Hazard symbol: Xi Irritant Irriterend N Dangerous to the Environment Milieugevaarlijk
Document Evaluator CTGB, The Netherlands Author: Date: August 2013 Part A A9219B Registration Report National Assessment – Netherlands Central zone Page 8 of 159
Risk phrases: R43 May cause sensitisation by skin contact Kan overgevoeligheid veroorzaken bij (optional for small packages <125 mL). contact met de huid. R50/53 Very toxic to aquatic organisms, may Zeer vergiftig voor in het water levende cause long term adverse effects in the organismen; kan in het aquatisch milieu aquatic environment (optional for small op lange termijn schadelijke effecten packages <125 mL). veroorzaken (optioneel voor verpakkingen <125 mL) Safety phrases: S21 When using do not smoke Niet roken tijdens gebruik.
S36/37 Wear suitable protective clothing and Draag geschikte handschoenen en S60 gloves. beschermende kleding. Deze stof en de verpakking als S61 This material and its container must be gevaarlijk afval afvoeren (optioneel disposed of as hazardous waste voor verpakkingen <125 mL). (optional for small packages <125 mL). / Was alle beschermende kleding na SPo 2 Wash all protective clothing after use gebruik (optioneel voor verpakkingen (optional for small packages <125 mL). <125 mL). DPD01 To avoid risks to man and the Volg de gebruiksaanwijzing om gevaar environment, comply with the voor mens en milieu te voorkomen. instructions for use.
Explanation: Hazard symbol: Xi is obligatory when R43 is assigned. Risk phrases: R43: The formulation was negative in two Buehler tests for skin sensitisation in the guinea pig. In addition, the formulation was negative in a Maximisation test. However, in the evaluation of this test in the DAR it was concluded that an insufficient amount of animals was used. Based on the amount of cyprodinil it is proposed to label the preparation as ‘May cause sensitisation by skin contact (R43)’. The R phrase 43 is optional for packaging below 125 mL. Safety phrases: S2, S13 and S20 are not obligatory for formulations intended for professional use only.
The Ctgb only assigns S35 to preparations with hazard-symbol T+, T, or C with respect to the toxicological aspect of the preparation in question.
S36/37 is invariably assigned by the Ctgb to all formulations labelled with Xi, R43 and is also assigned based on the risk assessment and therefore not optional for small packages.
S57 is not compulsory in combination with the assigned R phrases.
S60 and S61 are assigned to products for professional use labelled N, R50/53. S60 and S61are optional for small packages (< 125 mL). Other: -
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2.2.2. R and S phrases under Directive 2003/82/EC (Annex IV and V)
R and S phrases under Directive SPo 2 Wash all protective clothing after use. / Was alle beschermende 2003/82/EC (Annex IV and V): kleding na gebruik (optioneel voor verpakkingen <125 mL). Explanation: SPo 2 is assigned by the Ctgb to formulations containing (an) active substance(s) included in Annex I to Reg (EC) 540/2011 labelled with S36/37.
2.2.3. Other phrases
Refer to national product label.
Document Evaluator CTGB, The Netherlands Author: Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 10 of 159
2.3. Product uses
Active substance cyprodinil
Crop and/or Member Produc F G Pests or Group Formulatio Application Application rate per PHI Remarks: situation State or t name or I of pest n treatment days Country controlled (days)
(a) (b) (c) Type Conc. method growth number interval kg water kg (l) (m) (d-f) Of as kind stage & (k) between as/hL L/ha as/ha (i) (f-h) season (j) applications (days) min max min max min max min max Existing uses apples NL Switch F Pre harvest WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 1000 1250 0,300 0,375 3 in parcels next to surface storage diseases g/kg spray 81-87 water use "windhaag, e.g. Botryotinia Aug - sep venturidop, tunnelspuit" fuckeliana pears NL Switch F Pre harvest WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 1000 1250 0,300 0,375 3 in parcels next to surface storage diseases g/kg spray 81-87 water use "windhaag, e.g. Botryotinia Aug - sep venturidop, tunnelspuit" fuckeliana pears NL Switch F Stemphylium WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 1000 1250 0,300 0,375 3 in parcels next to surface vesicarium g/kg spray 71-81 water use "windhaag, May - jun venturidop, tunnelspuit" cherries NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 1250 1250 0,375 0,375 7 in parcels next to surface fuckeliana g/kg spray 61-89 water use "windhaag, Apr - jun venturidop, tunnelspuit" plums NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 1250 1250 0,375 0,375 7 in parcels next to surface fuckeliana g/kg spray 61-89 water use "windhaag, Apr - jul venturidop, tunnelspuit" currants NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0313 0,0375 1000 1200 0,375 0,375 10 in parcels next to surface white, red, fuckeliana g/kg spray 61-89 water use 75 % black Apr - aug driftreducing nozzle
Document ID:A9219B_11538 Evaluator
gooseberries NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0313 0,0375 1000 1200 0,375 0,375 10 in parcels next to surface fuckeliana g/kg spray 61-89 water use 75 % Apr - aug driftreducing nozzle blueberries NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0313 0,0375 1000 1200 0,375 0,375 10 in parcels next to surface fuckeliana g/kg spray 61-89 water use 75 % Apr - aug driftreducing nozzle grapes NL Switch F Botryotina WG 375 foliar BBCH 1 2 21 0,0300 0,0300 400 1250 0,120 0,375 21 in parcels next to surface fuckeliana g/kg spray 60-88 water use "windhaag, May - sep venturidop, tunnelspuit" strawberries NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0625 0,125 300 600 0,375 0,375 3 in parcels next to surface fuckeliana g/kg spray 61-89 water use 75 % Colletotrichum May - sep driftreducing nozzle acutatum strawberries NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0313 0,0625 600 1600 0,375 0,375 3 cultivation on substrate fuckeliana g/kg spray 61-89 and soil bound : max. 3 Colletotrichum Jan - dec applications per year acutatum (max 1 crop per year) lettuce (Lactuca NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0281 0,1125 200 800 0,225 0,225 7 spp.) fuckeliana g/kg spray 11-49 Apr - sep pulses (legume NL Switch F Botryotina WG 375 foliar BBCH 1 2 10 - 14 0,0469 0,1975 200 800 0,375 0,375 14 vegetables) with fuckeliana g/kg spray 51-79 the exception of Sclerotinia Apr - sep "spruitgroenten" sclerotiorum tomato NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 500 1250 0,150 0,375 3 fuckeliana g/kg spray 71-79 Apr - sep tulips NL Switch F Botryotina WG 375 foliar BBCH 1 4 7 - 14 0,0469 0,1875 150 400 0,188 0,281 n.a. in parcels next to surface fuckeliana g/kg spray 14-79 water use 75 % Apr - Jul driftreducing nozzle perennials NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,3 0,1 300 1000 0,300 0,300 n.a. in parcels next to surface fuckeliana g/kg spray 14-89 water use 75 % Apr - sep driftreducing nozzle
New and changed uses
Document ID:A9219B_11538 Evaluator
apples NL Switch F Pre harvest WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 1000 1250 0,300 0,375 3 in parcels next to surface storage diseases g/kg spray 81-87 water use "windhaag, e.g. Aug - sep venturidop, tunnelspuit" Gloeosporium pears NL Switch F Pre harvest WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 1000 1250 0,300 0,375 3 in parcels next to surface storage diseases g/kg spray 81-87 water use "windhaag, e.g. Aug - sep venturidop, tunnelspuit" Gloeosporium blackberry and NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0313 0,0375 1000 1200 0,375 0,375 10 in parcels next to surface raspberry fuckeliana g/kg spray 61-89 water use 75 % family (Rubus Apr - aug driftreducing nozzle spp.) lettuce (Lactuca NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0225 0,0450 500 1000 0,225 0,225 7 soil bound cultivation: spp.) fuckeliana g/kg spray 11-49 max 3 applications per Jan - dec year max. 5 crops per year are grown. The 3 applications per year can be sprayed in the same crop cycle or in different crop cycles lettuce (Lactuca NL Switch G Botryotina WG 375 foliar BBCH 1 5 10 - 14 0,0225 0,0450 500 1000 0,225 0,225 7 cultivation on substrate: spp.) fuckeliana g/kg spray 11-49 max 5 applications per Jan - dec year 5 and more crops per year are grown. The 5 applications per year can be sprayed in 2 crop cycles or in more crop cycles endive NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0281 0,1125 200 800 0,225 0,225 7 fuckeliana g/kg spray 11-49 Apr - sep
Document ID:A9219B_11538 Evaluator
endive NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0225 0,0450 500 1000 0,225 0,225 7 cultivation on substrate fuckeliana g/kg spray 11-49 and soil bound: max 3 Jan - dec applications per year max. 3 crops per year are grown. The 3 applications per year can be sprayed in the same crop cycle or in different crop cycles dry harvested NL Switch F Botryotina WG 375 foliar BBCH 1 2 10 - 14 0,0469 0,1975 200 800 0,375 0,375 28 pulses fuckeliana g/kg spray 51-79 Sclerotinia Apr - sep sclerotiorum, Ascochyta spp., Mycosphaerella spp. pulses (legume NL Switch F Ascochyta spp., WG 375 foliar BBCH 1 2 10 - 14 0,0469 0,1975 200 800 0,375 0,375 14 vegetables) with Mycosphaerella g/kg spray 51-79 the exception of spp. Apr - sep "spruitgroenten" Fruiting NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 500 1250 0,150 0,375 3 cultivation on substrate vegetables of fuckeliana g/kg spray 71-79 and soil bound : max. 3 Solanaceae Apr - sep applications per year cultivation on substrate and soil bound : max. 1 crop per year is grown Fruiting NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0300 0,0300 500 1250 0,150 0,375 3 cultivation on substrate vegetables of fuckeliana g/kg spray 71-79 and soil bound : max. 3 Cucurbitaceae Apr - sep applications per year with edible skin cultivation on substrate: max 3 crops per year are grown Soil bound cultivation: max 1 crop per year is grown carrots NL Switch F Alternaria WG 375 foliar from 1 3 12 0,0375 0,1500 200 800 0,300 0,300 7 dauci, g/kg spray BBCH 14 Sclerotinia Apr - sep sclerotiorum
Document ID:A9219B_11538 Evaluator
celeriac NL Switch F Sclerotinia WG 375 foliar from 1 2 14 0,0375 0,1500 200 800 0,300 0,300 14 sclerotiorum g/kg spray BBCH 14 Apr - sep witloof chicory NL Switch I Sclerotinia WG 375 post Okt - Apr 1 1 ------36 g product/1000 kg (forced sclerotiorum g/kg harvest witloof roots in 10 to 20 cultivation) liter water per 1000 kg witloof roots floriculture NL Switch G Botryotina WG 375 foliar BBCH 1 3 7 - 14 0,0300 0,0300 500 1200 0,150 0,360 n.a. soil bound cultivation: fuckeliana g/kg spray 14-69 max 3 applications per Jan - dec year floriculture NL Switch G Botryotina WG 375 foliar BBCH 1 6 7 - 14 0,0300 0,0300 500 1200 0,150 0,360 n.a. cultivation on substrate: fuckeliana g/kg spray 14-69 max 6 applications per Jan - dec year (max. 3 applications per crop cycle) * plants can be grown on substrate or in pots on tables or concrete floor *max 3 applications per crop cycle floriculture NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,025 0,1 300 1000 0,300 0,300 n.a. in parcels next to surface fuckeliana g/kg spray 14-69 water use 75 % Apr - sep driftreducing nozzle perennials NL Switch G Botryotina WG 375 foliar BBCH 1 3 7 - 14 0,0300 0,0300 500 1000 0,150 0,300 n.a. soil bound cultivation: fuckeliana g/kg spray 14-89 max 3 applications per Jan - dec year perennials NL Switch G Botryotina WG 375 foliar BBCH 1 6 7 - 14 0,0300 0,0300 500 1000 0,150 0,300 n.a. cultivation on substrate: fuckeliana g/kg spray 14-89 max 6 applications per Jan - dec year (max. 3 applications per crop cycle) * plants can be grown on substrate or in pots on tables or concrete floor *max 3 applications per crop cycle tree nursery NL Switch G Botryotina WG 375 foliar BBCH 1 3 7 - 14 0,0300 0,0300 250 1000 0,075 0,300 n.a. soil bound cultivation: crops fuckeliana g/kg spray 14-89 max 3 applications per Jan - dec year
Document ID:A9219B_11538 Evaluator
tree nursery NL Switch G Botryotina WG 375 foliar BBCH 1 6 7 - 14 0,0300 0,0300 250 1000 0,075 0,300 n.a. cultivation on substrate: crops fuckeliana g/kg spray 14-89 max 6 applications per Jan - dec year (max. 3 applications per crop cycle) * plants can be grown on substrate or in pots on tables or concrete floor *max 3 applications per crop cycle tree nursery NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,025 0,12 250 1200 0,300 0,300 n.a. in parcels next to surface crops fuckeliana g/kg spray 14-89 water use 75 % Apr - sep driftreducing nozzle
Extended uses by "VUG"
lambs lettuce NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0225 0,0450 500 1000 0,225 0,225 7 soil bound cultivation: fuckeliana g/kg spray 11-49 max 3 applications per Jan - dec year. max. 4 crops per year are grown. Cultivation on substrate: no common practice fresh herbs NL Switch F Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0281 0,1125 200 800 0,225 0,225 7 fuckeliana g/kg spray 11-49 Apr - sep fresh herbs NL Switch G Botryotina WG 375 foliar BBCH 1 3 10 - 14 0,0225 0,0450 500 1000 0,225 0,225 7 cultivation on substrate fuckeliana g/kg spray 11-49 and soil bound : max. 3 Jan - dec applications per year
breeding and NL Switch F Botryotina WG 375 foliar BBCH 1 2 7 - 21 0,0375 0,1500 200 800 0,300 0,300 n.a. seed production fuckeliana g/kg spray 51-89 of vegetable Apr - sep crops, herbs and ornamentals (with exception of graminaceous crops)
Document ID:A9219B_11538 Evaluator
breeding and NL Switch G Botryotina WG 375 foliar BBCH 1 2 7-21 0,0375 0,15 200 800 0,300 0,300 n.a. cultivation on substrate seed production fuckeliana g/kg spray 51-89 and soil bound : max. 3 of vegetable Apr - dec applications per year crops, herbs and ornamentals (with exception of graminaceous crops)
Document ID:A9219B_11538 Evaluator
Table A1.2 Active substance fludioxonil
Crop and/or Member Product F G Pests or Formulatio Application Application rate per PHI Remarks: situation State or name or I Group of pest n treatment days Country controlled (days)
(a) (b) (c) Type Conc. method growth number interval kg water kg (l) (m) (d-f) Of as kind (f- stage & (k) between as/hL L/ha as/ha (i) h) season application (j) s (days) min max min max min max min max Existing uses apples NL Switch F Pre harvest WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 1000 1250 0,200 0,250 3 in parcels next to storage g/kg spray 81-87 surface water use diseases e.g. Aug - "windhaag, Botryotinia sep venturidop, fuckeliana tunnelspuit" pears NL Switch F Pre harvest WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 1000 1250 0,200 0,250 3 in parcels next to storage g/kg spray 81-87 surface water use diseases e.g. Aug - "windhaag, Botryotinia sep venturidop, fuckeliana tunnelspuit" pears NL Switch F Stemphylium WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 1000 1250 0,200 0,250 3 in parcels next to vesicarium g/kg spray 71-81 surface water use May - "windhaag, jun venturidop, tunnelspuit" cherries NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 1250 1250 0,250 0,250 7 in parcels next to fuckeliana g/kg spray 61-89 surface water use Apr - jun "windhaag, venturidop, tunnelspuit" plums NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 1250 1250 0,250 0,250 7 in parcels next to fuckeliana g/kg spray 61-89 surface water use Apr - jul "windhaag, venturidop, tunnelspuit"
Document ID:A9219B_11538 Evaluator
currants NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0208 0,0250 1000 1200 0,250 0,250 10 in parcels next to white, red, fuckeliana g/kg spray 61-89 surface water use black Apr - 75 % driftreducing aug nozzle gooseberries NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0208 0,0250 1000 1200 0,250 0,250 10 in parcels next to fuckeliana g/kg spray 61-89 surface water use Apr - 75 % driftreducing aug nozzle blueberries NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0208 0,0250 1000 1200 0,250 0,250 10 in parcels next to fuckeliana g/kg spray 61-89 surface water use Apr - 75 % driftreducing aug nozzle grapes NL Switch F Botryotinia WG 250 foliar BBCH 1 2 21 0,0200 0,0200 400 1250 0,080 0,250 21 in parcels next to fuckeliana g/kg spray 60-88 surface water use May - "windhaag, sep venturidop, tunnelspuit" strawberries NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0417 0,0833 300 600 0,250 0,250 3 in parcels next to fuckeliana g/kg spray 61-89 surface water use Colletotrichum May - 75 % driftreducing acutatum sep nozzle strawberries NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0160 0,0417 600 1600 0,250 0,250 3 cultivation on fuckeliana g/kg spray 61-89 substrate and soil Colletotrichum Jan - bound : max. 3 acutatum dec applications per year (max 1 crop per year) lettuce NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0188 0,0750 200 800 0,150 0,150 7 (Lactuca spp.) fuckeliana g/kg spray 11-49 Apr - sep pulses (legume NL Switch F Botryotinia WG 250 foliar BBCH 1 2 10 - 14 0,0313 0,1250 200 800 0,250 0,250 14 vegetables) fuckeliana g/kg spray 51-79 with the Sclerotinia Apr - exception of sclerotiorum sep "spruitgroenten"
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tomato NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 500 1250 0,100 0,250 3 cultivation on fuckeliana g/kg spray 71-79 substrate and soil Apr - bound: max 3 sep applications per year. Max 1 crop per year is grown tulips NL Switch F Botryotinia WG 250 foliar BBCH 1 4 7 - 14 0,0313 0,125 150 400 0,125 0,188 n.a. in parcels next to fuckeliana g/kg spray 14-79 surface water use Apr - Jul 75 % driftreducing nozzle perennials NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,02 0,06667 300 1000 0,200 0,200 n.a. in parcels next to fuckeliana g/kg spray 14-89 surface water use Apr - 75 % driftreducing sep nozzle
New and changed uses apples NL Switch F Pre harvest WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 1000 1250 0,200 0,250 3 in parcels next to storage g/kg spray 81-87 surface water use diseases e.g. Aug - "windhaag, Gloeosporium sep venturidop, tunnelspuit" pears NL Switch F Pre harvest WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 1000 1250 0,200 0,250 3 in parcels next to storage g/kg spray 81-87 surface water use diseases e.g. Aug - "windhaag, Gloeosporium sep venturidop, tunnelspuit" blackberry and NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0208 0,0250 1000 1200 0,250 0,250 10 in parcels next to raspberry fuckeliana g/kg spray 61-89 surface water use family (Rubus Apr - 75 % driftreducing spp.) aug nozzle lettuce NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0150 0,0300 500 1000 0,150 0,150 7 soil bound (Lactuca spp.) fuckeliana g/kg spray 11-49 cultivation: max 3 Jan - applications per dec year max. 5 crops per year are grown. The 3 applications per year can be sprayed in the
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same crop cycle or in different crop cycles
lettuce NL Switch G Botryotinia WG 250 foliar BBCH 1 5 10 - 14 0,0150 0,0300 500 1000 0,150 0,150 7 cultivation on (Lactuca spp.) fuckeliana g/kg spray 11-49 substrate: max 5 Jan - applications per dec year 5 and more crops per year are grown. The 5 applications per year can be sprayed in 2 crop cycles or in more crop cycles endive NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0188 0,0750 200 800 0,150 0,150 7 fuckeliana g/kg spray 11-49 Apr - sep endive NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0150 0,0300 500 1000 0,150 0,150 7 cultivation on fuckeliana g/kg spray 11-49 substrate and soil Jan - bound: max 3 dec applications per year max. 3 crops per year are grown. The 3 applications per year can be sprayed in the same crop cycle or in different crop cycles dry harvested NL Switch F Botryotinia WG 250 foliar BBCH 1 2 10 - 14 0,0313 0,1250 200 800 0,250 0,250 28 pulses fuckeliana g/kg spray 51-79 Sclerotinia Apr - sclerotiorum, sep
Document ID:A9219B_11538 Evaluator
Ascochyta spp., Mycosphaerell a spp. pulses (legume NL Switch F Ascochyta WG 250 foliar BBCH 1 2 10 - 14 0,0313 0,1250 200 800 0,250 0,250 14 vegetables) spp., g/kg spray 51-79 with the Mycosphaerell Apr - exception of a spp. sep "spruitgroenten" Fruiting NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 500 1250 0,100 0,250 3 cultivation on vegetables of fuckeliana g/kg spray 71-79 substrate and soil Solanaceae Apr - bound : max. 3 sep applications per year cultivation on substrate and soil bound : max. 1 crop per year is grown Fruiting NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0200 0,0200 500 1250 0,100 0,250 3 cultivation on vegetables of fuckeliana g/kg spray 71-79 substrate and soil Cucurbitaceae Apr - bound : max. 3 with edible skin sep applications per year cultivation on substrate: max 3 crops per year are grown Soil bound cultivation: max 1 crop per year is grown carrots NL Switch F Alternaria WG 250 foliar from 1 3 12 0,025 0,1000 200 800 0,200 0,200 7 dauci, g/kg spray BBCH Sclerotinia 14 sclerotiorum Apr - sep celeriac NL Switch F Sclerotinia WG 250 foliar from 1 2 14 0,025 0,1000 200 800 0,200 0,200 14 sclerotiorum g/kg spray BBCH
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14 Apr - sep witloof chicory NL Switch I Sclerotinia WG 250 post Okt - 1 1 ------36 g product/1000 (forced sclerotiorum g/kg harvest Apr kg witloof roots in cultivation) 10 to 20 liter water per 1000 kg witloof roots floriculture NL Switch G Botryotinia WG 250 foliar BBCH 1 3 7 - 14 0,0200 0,0200 500 1200 0,100 0,240 n.a. soil bound fuckeliana g/kg spray 14-69 cultivation: max 3 Jan - applications per dec year floriculture NL Switch G Botryotinia WG 250 foliar BBCH 1 6 7 - 14 0,0200 0,0200 500 1200 0,100 0,240 n.a. cultivation on fuckeliana g/kg spray 14-69 substrate: max 6 Jan - applications per dec year (max. 3 applications per crop cycle) * plants can be grown on substrate or in pots on tables or concrete floor *max 3 applications per crop cycle floriculture NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,02 0,06 300 1000 0,200 0,200 n.a. fuckeliana g/kg spray 14-69 667 Apr - sep in parcels next NL Switch G Botryotinia WG 250 foliar BBCH 1 3 7 - 14 0,0200 0,0200 500 1000 0,100 0,200 n.a. soil bound to surface fuckeliana g/kg spray 14-89 cultivation: max 3 water use 75 % Jan - applications per driftreducing dec year nozzleperennial s
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perennials NL Switch G Botryotinia WG 250 foliar BBCH 1 6 7 - 14 0,0200 0,0200 500 1000 0,100 0,200 n.a. cultivation on fuckeliana g/kg spray 14-89 substrate: max 6 Jan - applications per dec year (max. 3 applications per crop cycle) * plants can be grown on substrate or in pots on tables or concrete floor *max 3 applications per crop cycle tree nursery NL Switch G Botryotinia WG 250 foliar BBCH 1 3 7 - 14 0,0200 0,0200 250 1000 0,050 0,200 n.a. soil bound crops fuckeliana g/kg spray 14-89 cultivation: max 3 Jan - applications per dec year tree nursery NL Switch G Botryotinia WG 250 foliar BBCH 1 6 7 - 14 0,0200 0,0200 250 1000 0,050 0,200 n.a. cultivation on crops fuckeliana g/kg spray 14-89 substrate: max 6 Jan - applications per dec year (max. 3 applications per crop cycle) * plants can be grown on substrate or in pots on tables or concrete floor *max 3 applications per crop cycle tree nursery NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0167 0,08 250 1200 0,200 0,200 n.a. in parcels next to crops fuckeliana g/kg spray 14-89 surface water use Apr - 75 % driftreducing sep nozzle
Extended uses by "VUG"
Document ID:A9219B_11538 Evaluator
lambs lettuce NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0150 0,0300 500 1000 0,150 0,150 7 soil bound fuckeliana g/kg spray 11-49 cultivation: max 3 Jan - applications per dec year. max. 4 crops per year are grown. Cultivation on substrate: no common practice fresh herbs NL Switch F Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0188 0,0750 200 800 0,150 0,150 7 fuckeliana g/kg spray 11-49 Apr - sep fresh herbs NL Switch G Botryotinia WG 250 foliar BBCH 1 3 10 - 14 0,0150 0,0300 500 1000 0,150 0,150 7 cultivation on fuckeliana g/kg spray 11-49 substrate and soil Jan - bound : max. 3 dec applications per year breeding and NL Switch F Botryotinia WG 250 foliar BBCH 1 2 7 - 21 0,0250 0,1000 200 800 0,200 0,200 n.a. seed fuckeliana g/kg spray 51-89 production of Apr - vegetable sep crops, herbs and ornamentals (with exception of graminaceous crops) breeding and NL Switch G Botryotinia WG 250 foliar BBCH 1 2 7-21 0,025 0,1 200 800 0,200 0,200 n.a. cultivation on seed fuckeliana g/kg spray 51-89 substrate and soil production of Apr - bound : max. 3 vegetable dec applications per crops, herbs year and ornamentals (with exception of graminaceous crops)
Document ID:A9219B_11538 Evaluator
Document ID:A9219B_11538 Evaluator
3. RISK MANAGEMENT
3.1. Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles
3.1.1. Physical and chemical properties (Part B, Section 1, Points 2 and 4)
The product A9219B is a water dispersible granule (WG). All studies have been performed in accordance with the current requirements, the critical GAP and the results are deemed to be acceptable. The appearance of the product is that of a light brown solid, with a weak, uncharacteristic odour. It is not explosive, has no oxidising properties and is not a self heating substance. In aqueous solution, it has a pH value around 9. The stability data support a shelf life of at least two years at ambient temperature. The technical characteristics of A9219B are acceptable for a water dispersible granule formulation. According to Directive 1999/45/EC as amended, the proposed labelling for physico- chemical properties for A9219B is: None. Compliance with FAO specifications: The product A9219B complies with FAO specifications. Compatibility of mixtures: No data have been provided regarding the physical and chemical compatibility of tank mixes. Nature and characteristics of the packaging: Packaging proposed for A9219B is 100, 160, 200, 300, 400 g and 1, 5, 10, 45, 400 kg containers. Information/data on packaging type, dimensions, capacity, size of opening, type of closure, resistance to and compatibility with the contents of the packaging, have been submitted, evaluated and are considered to be acceptable. Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of A9219B has been provided and is considered to be acceptable.
3.1.2. Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1. Analytical method for the formulation (Part B, Section 2, Point 5.2)
A9219B was a representative formulation in the EU review of fludioxonil. Analytical methods for determination of fludioxonil and cyprodinil, impurities and relevance of CIPAC methods in A9219B were evaluated as part of the EU review of fludioxonil. All data are considered adequate.
3.1.2.2. Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
Methods for crops and animal products: All crop and animal product analytical methods are active substance data and are required in support of the setting of EU MRLs, MSs are invited to comment as part of the EU MRL setting process (in the framework of Regulation (EC) 396/2005). Adequate EU MRLs for the uses of A9219B are in place. No further review is required.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 27 of 159
Methods for soil, water and air: All analytical methods are active substance data and were evaluated during the EU review by RMS Denmark. Additional data on methods/validation in soil and water for cyprodinil and fludioxonil have been developed and have been provided. All data are considered adequate. Methods for body fluids and tissues: Cyprodinil and fludioxonil are not classified as toxic or highly toxic, therefore analytical methods for the determination of residues in body fluids and tissue are not required.
3.1.3. Mammalian Toxicology (Part B, Section 3, Point 7)
3.1.3.1. Acute Toxicity (Part B, Section 3, Point 7.1)
A9219B was a representative formulation in the EU review of fludioxonil. All acute toxicity data on A9219B were considered adequate. A9219B containing 375 g/kg cyprodinil and 250 g/kg fludioxonil has a low toxicity in respect to acute oral, dermal and inhalation toxicity studies in the rat and is not irritating to the rabbit eye and skin. A9219B was shown not to be a skin sensitizer to the guinea pig in three skin sensitization studies (2 Buehler tests and 1 maximisation test). It was shown to be a moderate sensitizer in one maximisation test that was shown to have methodological shortcomings. Table 3.1.3.1: Summary of acute toxicological data obtained with A9219B
Parameter Species Result Classification according to [Reference] 1999/45/EC as amended
Acute oral LD50 Rat [Schoch 1994a] Tif:RAI(f); 5m + 5f >2000 mg/kg bw None [Allen 1994a] Sprague-Dawley: 5m + 5f >5000 mg/kg bw
Acute dermal LD50 Rat [Schoch 1994b] Tif:RAI(f); 5m + 5f >2000 mg/kg bw None Acute inhalation Rat [Bennick 1998] Sprague Dawley; 5m + 5f >2.51 mg/L* None Acute skin irritation Rabbit [Marty 1994] New Zealand White non-irritating None (Chbb:NZW); 3m [Glaza 1998] New Zealand White non-irritating None (Hra:NZW); 3m + 3f Acute eye irritation Rabbit [Marty 1994a] New Zealand White non-irritating None (Chbb:NZW); 3m Skin sensitization - Buehler Test Guinea Pig [Marty 1994b] Pirbright White; 10m + 10f non-sensitising None [Glaza 1998] Crl:(HA)BR; 20f non-sensitising None – Maximisation Test [de Jouffrey 1995] Dunkin Hartley; 10f non-sensitising None [Allen 1996b] + Dunkin Hartley; 20f Moderate sensitiser R43 *maximum attainable concentration +Study has methodological shortcomings, according to the applicant.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 28 of 159
3.1.3.2. Operator Exposure (Part B, Section 3, Point 7.3)
For mechanical downward spraying in the field and for the greenhouse application it can be concluded that, based on the risk assessment, no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure to cyprodinil and fludioxonil as a result of the application of Switch in the intended crops.
For the unprotected operator, adverse health effects after dermal/respiratory exposure to cyprodinil as a result of mechanical/manual upward field applications of Switch cannot be excluded. Correct use of personal protective equipment will reduce the dermal exposure and results in a sufficient reduction of the exposure to cyprodinil for these type of applications of Switch in the intended crops.
These conclusions also apply for combined exposure to cyprodinil and fludioxonil.
3.1.3.3. Bystander Exposure (Part B, Section 3, Point 7.4)
It is concluded that there is no undue risk of residential exposure or to the bystander after incidental short-term exposure to Switch.
3.1.3.4. Worker Exposure (Part B, Section 3, Point 7.5)
Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in the intended crops due to exposure to cyprodinil and fludioxonil after application of Switch.
3.1.4. Residues and Consumer Exposure (Part B, Section 4, Point 8)
3.1.4.1. Residues (Part B, Section 4, Points 8.3 and 8.7)
The applied for GAP (including new uses) is not covered by the critical EU GAP that was used for the MRL setting procedure, as the application is almost doubled. Therefore additional supervised residue trials are submitted in witloof. In the submitted study for witloof it has been demonstrated that the application rates support the GAP for the uses of A9219B in the Netherlands and that residues of cyprodinil and fludioxonil will be below the current EU MRL’s.
For the uses proposed for cyprodinil in A9219B on pome fruit, peaches, nectarines and apricots, cherries, plums, grapes, strawberries, raspberries, currant and blueberries, carrots, radish,
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 29 of 159 celeriac, bulb onions, spring onions, tomatoes, aubergines, peppers, cucurbits (edible peel), lettuce, witloof (roots for forcing), legume vegetables (fresh, with pods), legume vegetables (fresh, without pods), asparagus, celery, fennel, pulses, barley, rye and wheat all data and assessments are available in the MRL compilation dossier, which was provided with this submission (Cyprodinil, MRL Compilation Dossier, M-II Section 4). For convenience and transparancy, the relevant parts of the MRL compilation dossier were copied into Part B, Section 4. The MRLs for cyprodinil are published in Annexes of Regulation (EC) No 396/2005 or are currently in review. It has been demonstrated that the GAPs for the proposed uses of A9219B fall within the EU critical GAPs previously evaluated and or under evaluation for cyprodinil. For the uses proposed for fludioxonil in A9219B on pome fruit, peaches, nectarines and apricots, cherries, plums, grapes, strawberries, raspberries, currant and blueberries, carrots, radish, celeriac, bulb onions, spring onions, tomatoes, aubergines, peppers, cucurbits (edible peel), lettuce, witloof (roots for forcing), legume vegetables (fresh, with pods), legume vegetables (fresh, without pods), asparagus, celery, fennel, pulses, barley, rye and wheat all data and assessments are available in the MRL compilation dossier, which was provided with this submission (Fludioxonil, MRL Compilation Dossier, M-II Section 4). For convenience and transparancy, the relevant parts of the MRL compilation dossier were copied into Part B, Section 4. The MRLs for fludioxonil are published in Annexes of Regulation (EC) No 396/2005 or are currently in review. It has been demonstrated that the GAPs for the proposed uses of A9219B fall within the EU critical GAPs previously evaluated or currently under evaluation for fludioxonil.
3.1.4.2. Consumer exposure (Part B, Section 4, Point 8.10)
Based on the dietary risk assessment performed using the EFSA PRIMo model in the EU MRL review for cyprodinil, made to estimate the risk for consumers, it can be concluded that the use of product A9219B does not lead to unacceptable risk for consumers when applied according to the recommendations. Based on the dietary risk assessment performed using the EFSA PRIMo model in the EU MRL review for fludioxonil, made to estimate the risk for consumers, it can be concluded that the use of product A9219B does not lead to unacceptable risk for consumers when applied according to the recommendations.
3.1.5. Environmental fate and behaviour (Part B, Section 5, Point 9.1-9.3, 9.9)
Cyprodinil: The majority of the data presented were reviewed in the EU review. Additional new data are also provided in this submission, and appropriate endpoints were used to calculate PECS for A9219B and cyprodinil in soil, surface water, ground water and air for the intended use patterns.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 30 of 159
Fludioxonil: The majority of the data presented were reviewed in the EU review. Additional new data are also provided in this submission, and appropriate endpoints were used to calculate PECS for A9219B and fludioxonil in soil, surface water, ground water and air for the intended use patterns.
3.1.5.1. Predicted Environmental Concentration in Soil (PECS) (Part B, Section 5, Points 9.4 and 9.5)
Cyprodinil: The PEC of A9219B and cyprodinil in soil (PECS) has been assessed with the FOCUS groundwater crop interception values, where appropriate, and the worst case DT50 values agreed in Annex Point IIIA 9.2 based on new data provided for this assessment. Based on the maximum critical EU recommended use rate of 4 x 288 g a.s./ha, the maximum initial predicted environmental concentration in soil (PECS) of cyprodinil will be 1.203 mg/kg (tulips). Assuming the same application regime is used year after year, it is predicted that a plateau concentration of cyprodinil in the soil will be reached after 11 years. This is predicted to be 0.754 mg/kg for tulips, based on the conservative, worst-case acidic field DT50 of 284 days.
The PEC of CGA249287, CGA275535 and CGA321915 in soil (PECS) has been assessed with the FOCUS groundwater crop interception values, where appropriate, and the worst case DT50 values established in the EU review or agreed in Annex Point IIIA 9.1 based on new calculations/data provided for this assessment. For metabolites CGA249287, CGA275535 and CGA321915 the proposed use pattern will lead to maximum initial PECS of 0.106 mg/kg, 0.048 mg/kg and 0.029 mg/kg for the use in tulips, respectively.
The results for PECS for the active substance and its metabolites were used for the ecotoxicological risk assessment.
Fludioxonil: The PEC of A9219B and fludioxonil in soil (PECS) has been assessed with the FOCUS groundwater crop interception values, where appropriate, and the worst case DT50 values established in the EU review. Based on the maximum EU recommended use rate of 4 x 181 g a.s./ha, the maximum initial predicted environmental concentration in soil (PECS) of fludioxonil will be 0.692 mg/kg for use in tulips.
The PEC of CGA192155, CGA265378 and CGA339833 in soil (PECS) has been assessed with the FOCUS groundwater crop interception values, where appropriate, and the worst case DT50 values established in the EU review. For metabolites CGA192155, CGA265378 and CGA339833 the critical EU use pattern will lead to maximum initial PECS of 0.060 mg/kg, 0.077 mg/kg and 0.061 mg/kg, respectively (reached in the proposed use in tulip).
The results for PECS for the active substance and its metabolites were used for the ecotoxicological risk assessment.
3.1.5.2. Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)
Cyprodinil: The PEC of cyprodinil, CGA249287, CGA275535 and CGA321915 in ground water (PECGW) has been assessed with standard FOCUS scenarios to obtain outputs from the FOCUS PELMO and FOCUS PEARL models and the DT50 and KFOC values established in the EU review or agreed in Annex Point IIIA 9.2 and 9.3 based on new data provided for this assessment. The cyprodinil groundwater assessment has been conducted using the worst-case
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 31 of 159
acid field DT50 of 209 days. From the discussion under Annex Points IIIA 9.1 – IIIA 9.3, metabolites CGA249287, CGA275535 and CGA321915 are considered to be of relevance for groundwater assessment. In order to provide a conservative groundwater assessment for these metabolites, the EU agreed geomean of the laboratory data for the parent, cyprodinil, was used, 27 days. Cyprodinil has a low mobility in soil and therefore the risk to ground water is expected to be minimal. The predicted environmental concentrations (PECGW) at 1m depth for cyprodinil following 20 years use on pome/stone fruit and soft fruit at 3 x 375 g a.s./ha with 65% foliar interception, were less than 0.001 g/L in all scenarios using FOCUS-PELMO and FOCUS PEARL and a DT50 of 209 days. For vines at 2 x 450 g a.s./ha and 70% foliar interception the
PECGW at 1m depth were less than 0.001 g/L in all scenarios. For leafy vegetables at 3 x 225 g a.s./ha with a 25%, 40% and 40% foliar interception and fruiting vegetables at 3 x 375 g a.s./ha and a 80% foliar interception and strawberries at 3 x 375g a.s./ha and a foliar interception of
60% the PECGW at 1m depth were less than 0.001 g/L in all scenarios. For bulb vegetables at 3 x 375 g a.s./ha with 25%, 25% and 40% foliar interception, Root vegetables at 3 x 375 g a.s./ha with 25%, 60% and 60% foliar interception, Legumes at 3 x 375 g a.s./ha and 70% foliar interception and Tobacco at 2 x 225 g a.s./ha and 90% foliar interception and tulips at 4 x 281 g a.s. /ha at 10%, 10%, 25% and 25% foliar interception. The PECGW at 1m depth were less than 0.001 g/L in all scenarios. The potential for the metabolites CGA249287, CGA275535 and CGA321915 to leach to groundwater has been assessed in the same way. The models predict that cyprodinil and its metabolites CGA249287 and CGA275535 will not be found in ground water at concentrations greater than 0.1 μg/L. However, metabolite CGA321915 may leach to groundwater at concentrations smaller than 0.1 μg/L, but greater than 0.01 μg/L in the Kremsmünster scenario, as predicted using leaching model GeoPEARL. Therefore, based on the assessment, a restriction sentence for the use of Switch in groundwater protection area’s will be placed on the label: Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden
Fludioxonil: The PEC of fludioxonil, CGA265378, CGA339833 and CGA192155 in ground water (PECGW) has been assessed with standard FOCUS scenarios to obtain outputs from the FOCUS PELMO and FOCUS PEARL models and the KFOC values established in the EU review. From the discussion under Annex Points IIIA 9.1 – IIIA 9.3, metabolites CGA265378, CGA339833 and CGA192155 are considered to be of relevance for groundwater assessment. Fludioxonil has a low mobility in soil and therefore the risk to ground water is expected to be minimal. The predicted environmental concentrations (PECGW) at 1m depth for fludioxonil following 20 years use on pome/stone fruit and soft fruit at 3 x 250 g as/ha with 65% foliar interception, were less than 0.001 g/L in all scenarios using FOCUS-PELMO and FOCUS PEARL and a DT50 of 164 days. For vines at 2 x 300 g as/ha and 70% foliar interception the
PECGW at 1m depth were less than 0.001 g/L in all scenarios. For leafy vegetables at 3 x 150 g as/ha with a 25%, 40% and 40% foliar interception and fruiting vegetables at 3 x 250 g as/ha and a 80% foliar interception and strawberries at 3 x 300g as/ha and a foliar interception of 60% the
PECGW at 1 m depth were less than 0.001 g/L in all scenarios. For bulb vegetables at 3 x 250 g as/ha with 25%, 25% and 40% foliar interception, root vegetables at 3 x 300 g as/ha with 25%,
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 32 of 159
60% and 60% foliar interception, legumes at 3 x 300 g as/ha and 70% foliar interception, tobacco at 2 x 150 g as/ha and 90% foliar interception and and tulips at 4 x 188 g a.s. /ha at 10%,
10%, 25% and 25% foliar interception. The PECGW at 1m depth were less than 0.001 g/L in all scenarios. The models predicts that fludioxonil will not be found in ground water at concentrations greater than 0.1 μg/L. Based on the assessment, the use of fludioxonil is not expected to lead to leaching into groundwater at levels that would be unacceptable when applied according to the recommended use pattern. The potential for the metabolites CGA265378, CGA339833 and CGA192155 to leach to groundwater has been assessed in the same way. Metabolites CGA192155 and CGA339833 are the only two metabolites which show a potential to exceed the limit of 0.1 g/L, as predicted by FOCUS modelling for the specified GAP. These metabolites were assessed via the stepwise process in the guidance document on the relevance of metabolites in groundwater (SANCO/221/2000) and shown to be non-relevant.
3.1.5.3. Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)
Cyprodinil For the National Authorisation surface water assessments using the TOXSWA GUI Version 1.0 and the National Guidelines for the Netherlands have been provided for the EU critical GAP. Using the standard drift values for application to pome/stone fruit, the PECSW values were not greater than 30.3 g/L and 4.82 g/L for cyprodinil and CGA249287 respectively. Application to vines is covered by application to pome/stone fruit, as the application rate is equal, but number of applications is lower (2) and interval longer (21 days) for application to vines.
Using reduced drift values, the PECSW of cyprodinil was calculated to be not greater than 4.241
g/L for application to pome/stone fruit. The PECSED of cyprodinil was calculated to be not greater than 400 g/kg for application to pome/stone fruit .
Using the standard drift values for application to legumes and root vegetables, the PECSW values were not greater than 3.91 g/L and 0.656 g/L for cyprodinil and CGA249287 respectively. For application to bulb vegetables, the PECSW values were not greater than 3.56 g/L and 0.598 g/L for cyprodinil and CGA249287 respectively.
For application to legumes and root vegetables the PECSED values for the top 1 cm were not greater than 385 g/kg and 17.63 g/kg for cyprodinil and CGA249287 respectively. For application to bulb vegetables the PECSED values in the top 1 cm were not greater than 352.5 g/kg and 15.8 g/kg for cyprodinil and CGA249287 respectively.
Using the standard drift values for application to fruiting vegetables, the PECSW values were not greater than 4.15 g/L and 0674 g/L for cyprodinil and CGA249287 respectively. For application to leafy vegetables, the PECSW values were not greater than 3.12 g/L and 0.523 g/L for cyprodinil and CGA249287 respectively.
For application to fruiting vegetables the PECSED values for the top 1 cm were not greater than 398.8 g/kg and 18 g/kg for cyprodinil and CGA249287 respectively. For application to leafy
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 33 of 159
vegetables the PECSED values in the top 1 cm were not greater than 315 g/kg and 14.63 g/kg for cyprodinil and CGA249287 respectively.
Using the standard drift values for application to tulips the PECSW values were not greater than 3.892 g/L and 0669 g/L for cyprodinil and CGA249287 respectively. For application to tulips the PECSED values for the top 1 cm were not greater than 393.8 g/kg and 14.4 g/kg for cyprodinil and CGA249287 respectively. Using the standard drift values for non soil bound application to floriculture in glasshouse (six applications) the PECSW values were not greater than 0.398 g/L and 0.065 g/L for cyprodinil and CGA249287 respectively. For non soil bound application to floriculture the PECSED values for the top 1 cm were not greater than 47 g/kg and 2.66 g/kg for cyprodinil and CGA249287 respectively. These TOXSWA endpoints are used in the assessments provided in the Part B Section 6 Addendum for the Netherlands. Fludioxonil: For the National Authorisation surface water assessments have been presented for the critical EU GAP using the TOXSWA GUI Version 1.0 and the National Guidelines for the Netherlands has been provided and evaluated by zRMS for the NL GAP, thus within the risk envelope of the EU GAP. Using the standard drift values for application to pome /stone fruit, the
PECSW values were not greater than 9.364 g/L and 4.1 g/L for cyprodinil and CGA192155 respectively. Application to vines is covered by application to pome/stone fruit, as the application rate is equal, but number of applications is lower (2) and interval longer (21 days) for application to vines. With reduced spray drift, the maximum PECSed values for fludioxonil in pome/stone fruit was reduced to 1.604 µg/kg. Spring PECSW values were 1.54, 1.39, 1.05, 0.926, 1.39, 1.04 and 0.262 µg/L for fruiting, root, bulb, leafy vegetables, legumes, tulips and floriculture (glasshouse, substrate) respectively. In the sediment compartment, the predicted environmental concentrations in the top 1 cm of the sediment layer occurred from applications to pome/stone fruit, with maximum PECSed values of 6475 µg/kg and 43.9 µg/kg for fludioxonil and CGA192155 respectively.
With reduced spray drift, the maximum PECSed values for fludioxonil in pome/stone fruit was reduced to 1109 µg/kg. In tulips, the maximum PECSed value for fludioxonil was 1285 µg/kg.
These TOXSWA endpoints are used in the assessments provided in the Part B Section 6 Addendum for the Netherlands.
3.1.5.4. Predicted Environmental Concentration in Air (PECAIR) (Part B, Section 5, Point 9.9)
Cyprodinil: The fate and behaviour in air of cyprodinil was evaluated during the EU review. No additional studies have been performed. It is not expected that cyprodinil would be present in air for extended time periods or be transported over long distances or into the stratosphere. Fludioxonil: The fate and behaviour in air of fludioxonil was evaluated during the EU review. No additional studies have been performed. It is not expected that fludioxonil would be present in air for extended time periods or be transported over long distances or into the stratosphere.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 34 of 159
Implications for labelling resulting from environmental fate assessment: A9219B is classified as N; R53, Dangerous to the environment, according to Directive 1999/45/EC as amended, based on the ready biodegradability properties of cyprodinil and fludioxonil. As a plant protection product, the instructions for use should be followed to avoid risks to man and the environment. Based on the assessment, a restriction sentence for the use of Switch in groundwater protection area’s will be placed on the label: Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwaterbeschermingsgebieden
Om in het water levende organismen te beschermen is de toepassing: in de onbedekte teelt van neerwaarts bespoten boomkwekerijgewassen: in spillen in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien maximaal 3 bespuitingen worden uitgevoerd in opzetters uitsluitend toegestaan in percelen die niet grenzen aan oppervlaktewater; in overige, neerwaarts bespoten boomkwekerijgewassen uitsluitend toegestaan indien gebruik wordt gemaakt van minimaal 75 % driftreducerende spuitdoppen
3.1.6. Ecotoxicology (Part B, Section 6, Point 10)
3.1.6.1. Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
Birds
Although A9219B was assessed as a representative formulation in the EU review of fludioxonil, the effects on birds from all the critical uses proposed for A9219B have not been evaluated in either the EU review of the cyprodinil or fludioxonil. Therefore, all risk assessments and supporting data for A9219B with the proposed use pattern are provided and are considered adequate. The risk assessment for effects on birds is carried out according to the latest EFSA Guidance document draft of the ‘EFSA Guidance Document on Risk Assessment for Birds and Mammals 20091. The acute, short-term and long-term risks of A9219B to birds were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with cyprodinil and fludioxonil, and maximum residues occurring on food items following applications according to the proposed use pattern. Risk of secondary poisoning has also been assessed, as both cyprodinil and fludioxonil have log POW values >3.0. (In the Part B Section 6 Addendum for the Netherlands, the assessments are re-visited with the national PECSW values and are considered adequate).
1European Food Safety Authority; Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA. EFSA journal 2009; 7(12):1438. [139 pp.]
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 35 of 159
The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute and short-term risk and 5 for long-term risk (including secondary poisoning), indicating that the risk to birds is acceptable following use of A9219B according to the proposed use pattern.
Terrestrial vertebrates (other than birds)
Although A9219B was assessed as a representative formulation in the EU review of fludioxonil, the effects on mammals from all the critical uses proposed for A9219B have not been evaluated in either the EU review of the cyprodinil or fludioxonil. Therefore data on A9219B are evaluated, and risk assessments for A9219B with the proposed use pattern are provided and are considered adequate. The acute and long-term risks of A9219B to wild mammals were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with cyprodinil and fludioxonil, and maximum residues occurring on food items following applications according to the use pattern. Risk of secondary poisoning has also been assessed, as both substances have log POW values of >3.0. (In the Part B Section 6 Addendum for the Netherlands, the assessments are re-visited with the national PECSW values and are considered adequate) The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk. For the long-term risk, the TERs exceed the trigger of 5 for most scenarios. For leafy crops, the TER for cyprodinil is 4.9 for voles and is consided acceptable. However when considering combination toxicology, the combined TER is 3.2 and a further assessment is required. When taking into account the exact application rate, the risk is acceptable when only one application occurs before BBCH 50. When considering two applications before BBCH 50, the TER is still below the combined TER is still 3.4. However, the also assuming an interception of 30% for growth stages 40-49, the Combined TER is 4.9. Taking into account that the risk assessment is still worst-case concerning PT, PD; and that the chronic endpoints showed no effects at the highest application ate; the risk is considered to be acceptable. An acceptable risk is expected for secondary poisoning. .
3.1.6.2. Effects on Aquatic Species (Part B, Section 6, Point 10.2)
Although A9219B was assessed as a representative formulation in the EU review of fludioxonil, the effects on aquatic organisms for A9219B according to the entire proposed EU GAP have not been evaluated. Data on A9219B are evaluated, and risk assessments for A9219B with the proposed critical EU use pattern are provided and are considered adequate. In the Part B Section 6 Addendum for the Netherlands, the risk assessments for A9219B are provided with the endpoints from the Section 5 Addendum for the Netherlands. Risk assessment for fish – For use in vines and pome/stone fruit, the risk to fish is acceptable following use of A9219B according to the proposed use pattern following implementation of drift reduction (1%). Risk assessment for aquatic invertebrates – Higher tier refinement of the risk assessment was required for both cyprodinil and fludioxonil. For cyprodinil, endpoints from acute invertebrate tests were used to define a species sensitivity distribution (SSD), which allows the level of risk to be assessed probabilistically. Also, two mesocosm studies were conducted. For fludioxonil, one
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 36 of 159 mesocosm was conducted. For use in vines and pome/stone fruit, the risk to aquatic invertebrates is acceptable following use of A9219B according to the proposed use pattern following implementation of drift reduction (1%). Risk assessment for algae - For use in vines and pome/stone fruit, the risk to algae is acceptable following use of A9219B according to the proposed use pattern following implementation of drift reduction (1%). In conclusion, acceptable risk to aquatic organisms was achieved for use in vines and pome/stone fruit following use of A9219B according to the proposed use pattern following implementation of drift reduction (1%). Mitigation is not required for the other crop groupings. Studies of the acute toxicity of A9219B for fish, daphnia and algae showed that this product should be labelled as very toxic for aquatic organisms, due to its toxicity to fish/daphnia/algae. Hence, phrases R50/53 very toxic to aquatic organisms, may cause long term adverse effects in the aquatic environment should be added to the product label.
3.1.6.3. Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)
Bees
Although A9219B was assessed as a representative formulation in the EU review of fludioxonil, the effects on bees from all the critical uses proposed for A9219B have not been evaluated in either the EU review of the cyprodinil or fludioxonil. Therefore data on A9219B are evaluated, and these risk assessments for A9219B with the proposed critical EU use pattern are considered adequate. The risk of A9219B to honey-bees was assessed from hazard quotients between toxicity endpoints, estimated from acute oral and contact studies with cyprodinil, fludioxonil and A9219B, and the maximum EU single application rate of 1200 g formulation/ha (450 g cyprodinil/ha and 300 g fludioxonil/ha). All the hazard quotients for cyprodinil and fludioxonil are less than 50, indicating that the risk to bees is acceptable following use of A9219B according to the proposed use pattern.
Other non-target arthropods
Effects on non-target arthropods other than bees for A9219B have not been evaluated as part of the EU review for cyprodinil but was included in the fludioxonil EU review. The conclusion of the EU review was that effects for fludioxonil formulated as A9219B, were below the Annex VI trigger of 30% indicating that A9219B is acceptable. However, the critical EU GAP is more extensive that provided for EU review and therefore data on A9219B are evaluated, and risk assessments for A9219B with the proposed critical EU use pattern are provided and are considered adequate. The in-field HQ values were above the trigger value indicating potential risk to in-field non-target arthropods following use of A9219B according to the proposed use pattern. The risk assessment was refined using higher tier studies, namely extended laboratory (some including an aged-residue component) and semi field studies were conducted. By comparing the lethal and sublethal endpoints from these higher tier studies with the predicted environmental rate of the
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 37 of 159 test substance it was concluded that the risk to in-field non-target arthropods is acceptable following use of A9219B according to the proposed use pattern. Off-crop, the HQ values are below the trigger value indicating that the risk to off-crop non-target arthropods is acceptable following use of A9219B according to the proposed use pattern.
3.1.6.4. Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)
Although A9219B was assessed as a representative formulation in the EU review of fludioxonil, the effects on earthworms and other soil non-target macro-organisms for all the critical EU uses of A9219B, and taking account of new data provided in this submission, have not been evaluated as part of the EU review for cyprodinil or fludioxonil. Data on A9219B are therefore evaluated, and risk assessments for A9219B with the proposed use pattern are provided and are considered adequate.
Earthworms
The acute and long-term risk of A9219B to earthworms was assessed from acute and long-term toxicity exposure ratios (TERs) between the selected toxicity endpoints for cyprodinil, fludioxonil and their metabolites, and the maximum PECS. The acute and chronic TER values for cyprodinil, fludioxonil and their metabolites are greater than the Annex IV triggers of 10 and 5, respectively, indicating that the risk to earthworms is acceptable following use of A9219B according to the proposed use pattern.
Other soil non-target macro-organisms
The risk of A9219B to other non-target soil macro-organisms, as represented by Folsomia candida, was assessed from toxicity exposure ratios (TERs) between the toxicity endpoints and the maximum PECS. The TER value is greater than the recommended trigger of 5, indicating that the risk to soil macro-organisms, as represented by F. candida, is acceptable following use of A9219B according to the proposed use pattern.
3.1.6.5. Effects on organic matter breakdown (Part B, Section 6, Point 10.6.7)
Cyprodinil and fludioxonil have been shown to pose a low risk to earthworms, micro-organisms and other soil macro-organisms (collembola); all organisms involved in organic matter breakdown in the field. In addition, the respective DT90 field for cyprodinil (in neutral to alkaline soils) and fludioxonil are < 365 days. Cyprodinil and fludioxonil are therefore not expected to pose an unacceptable risk to organic matter breakdown following the recommended use of A9219B and no litterbag study is required. However, it has been demonstrated that cyprodinil is potentially more persistent in acidic soils therefore a litterbag study has been conducted for cyprodinil in acidic soil conditions. The risk of cyprodinil and fludioxonil to organic matter decomposition was evaluated by comparison of the PECS with no-effect concentrations from a litter-bag test with A9219B.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 38 of 159
The NOEC value for cyprodinil and fludioxonil are approximately 1.7- and 5-fold greater than the corresponding PECS values, respectively; indicating that cyprodinil and fludioxonil in A9219B do not pose an unacceptable risk to organic matter breakdown.
3.1.6.6. Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
Although A9219B was assessed as a representative formulation in the EU review of fludioxonil, the effects on soil microbial activity from all the EU critical uses proposed for A9219B have not been evaluated in either the EU review of the cyprodinil or fludioxonil. Therefore data on A9219B are evaluated, and risk assessments for A9219B with the proposed EU use pattern are provided and are considered adequate. The risk of A9219B to soil micro-organisms was evaluated by comparison of no-effect concentrations, derived from laboratory tests, with PECS.
All no effect levels exceed the relevant PECS values by a factor of at least 2, indicating that A9219B does not pose an unacceptable risk to soil micro-organisms.
3.1.6.7. Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)
Non-Target Plants - Terrestrial
Although A9219B was assessed as a representative formulation in the EU review of fludioxonil, the effects on non-target terrestrial plants from all the EU critical uses proposed for A9219B have not been evaluated in either the EU review of the cyprodinil or fludioxonil. Therefore data on A9219B are evaluated, and risk assessments for A9219B with the proposed EU use pattern are provided and are considered adequate. No studies with the formulation are available. The available tests with different formulations showed no effects at any application rate. Unfortunately these application rates were too low to give TERs > 5. Data from the efficacy section show that no to very limited effects are found in a very wide variety of crops, when exposed to single application rates. Worst-case TERs based on these screening rates are > 3.0 (pome fruits) and > 4.0 (grape) and > 5 for all other crops. Considering the large amount of species tested, the risk is considered to be acceptable.
Non-Target Plants - Aquatic Tests on aquatic plants are not required as A9219B is not a herbicide, however aquatic plant data were considered in the EU review for fludioxonil and cyprodinil and an assessment of the effects of A9219B on aquatic plants is provided and is adequate. Other non-target species (Flora and Fauna) Tests on other non-target species are not required. Implications for labelling resulting from ecotoxicological assessment: A9219B is classified as N; R50/53 according to Directive 1999/45/EC as amended, based on aquatic toxicity data for the product. As a plant protection product, the instructions for use should be followed to avoid risks to man and the environment
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 39 of 159
Mitigation measures (drift reduction) is required for the use in apple and pome fruit. For IPM uses a warning sentence should be included on the label. See below (in Dutch):
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel, peer, kers, pruim en druif in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan na 1 mei en indien gebruik gemaakt wordt van één van de volgende maatregelen: o er gespoten wordt met een tunnelspuit, of o er gebruik wordt gemaakt van een windhaag op de rand van het rijpad en éénzijdige bespuiting van de laatste bomenrij, of o er in de eerste 20 meter grenzend aan het oppervlaktewater gebruik wordt gemaakt van een venturi-dop in combinatie met een éénzijdige bespuiting van de laatste bomenrij.
Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden.
3.1.7. Efficacy (Part B, Section 7, Point 8)
Re-registration of existing uses (see core dossier for evaluation) It concerns the re-registration of Switch in The Netherlands for use in apple, pear, cherries, plums, currants, gooseberries, blueberries, grapes, strawberries, raspberries, blackberries, lettuce (except lambs lettuce), endive, fresh pulses (with and without pods), protected tomato, tulip, floriculture, tree nursery crops and perennials. For some of these crops trials have been submitted in the core BAD of Switch and have been evaluated in the core dossier. In the core dossier the tested uses were positively evaluated. As for re-registration not all uses need to be tested, the data generated with the tested uses can be extrapolated to the non-tested uses. As a consequence, it was concluded that based on the trial results and expert judgement, Switch is effective as a fungicide in the control of various diseases in a range of crops and that the application does not give adverse side effects to an unacceptable level when applied according to Good Agricultural Practices. However, in protected tomato and protected floriculture phytotoxicity was recorded. A warning sentence should be included on the label text recommending small scale test sprays if no experience is gained yet with the crop varieties to be treated.
The re-registration of Switch for the currently claimed uses has been confirmed.
New and extended uses (see national addendum for evaluation)
Fresh and dry harvested pulses
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 40 of 159
For the extension of the control of Ascochyta spp. (9 trials) and Mycosphaerella spp. (8 trials) in dry harvested pulses and fresh pulses (with and without pods) trials have been carried out in the Maritime zone and were submitted in the core BAD. In the trials, the evaluated dose rate of 1.0 kg Switch per ha gave moderate levels of control of Ascochyta spp.. The level of control was comparable to or better than that given by the reference product. The evaluated dose rate of 1.0 kg Switch per ha generally gave low-to-moderate levels of control of Mycosphaerella pinodes. The level of control was generally comparable to that given by the reference product. Based on the trial results and expert judgement, it can be concluded that Switch is effective as a fungicide for the control of Ascochyta pisi and Mycosphaerella pinodes in pea and for the control of Botrytis and Sclerotinia in bean and pea. Extrapolation of the effectiveness against these diseases in pea (and bean) is possible to all fresh pulses and dry harvested pulses. All crop species belong to the same Leguminoseous family and the difference in dry and fresh pulses is based only the on varieties and method of cultivation. The plant architecture, crop development and plant-pathogen interaction are comparable among all species and for all purposes of cultivation. This is also applicable for the aspect of crop safety and it can be concluded that the application does not give adverse side effects to an unacceptable level when applied according to Good Agricultural Practices in fresh pulses and dry harvested pulses.
Apple and pear For the extension of the control of Gloeosporium rot in apple and pear, 17 trials have been carried out in the Maritime zone and were submitted in the core BAD. In apple, the evaluated dose rate of 0.8-1.0 kg Switch per ha gave a variable level of control. The level of control was comparable to or better than that given by the reference product based on tolylfluanide. In pear, in 5 out of 7 trials no disease was present or the disease pressure was too low to make an evaluation possible. The evaluated dose rate of 0.8-1.0 kg Switch per ha gave a moderate levels of control in the 2 trials. The level of control was comparable to or better than that given by the reference product based on tolylfluanide.
Based on the trial results and expert judgement, it can be concluded that Switch is effective as a fungicide for the control of Gloeosporium spp. in apple and pear and that the application does not give adverse side effects to an unacceptable level when applied according to Good Agricultural Practices
Carrot In the trials in carrot, the proposed dose rate of 0.8 kg/ha Switch gave in general moderate to variable levels of control of Sclerotinia sclerotiorum and Alternaria dauci. However, the control given by Switch was in all trials at least comparable to and often better than the control given by the reference product. In the effectiveness trials, Switch at a dose rate of 0.8 kg/ha did not show any phytotoxicity to the carrot crop. In addition to the trial results it needs to be mentioned that
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 41 of 159
Switch has an authorisation for the control of both fungi in carrot at a dose rate of 0.8 kg/ha in the United Kingdom. Based on the trial results and expert judgement, it can be concluded that Switch is effective as a fungicide for the control of Sclerotinia sclerotiorum and Alternaria dauci in carrot and that the application does not give adverse side effects to an unacceptable level when applied according to Good Agricultural Practices.
Celeriac In the trials in celeriac, the proposed dose rate of 0.8 kg/ha Switch gave in general moderate to variable levels of control of Sclerotinia sclerotiorum. However, the control given by Switch was in all trials at least comparable to and often better than the control given by the reference product. In the effectiveness trials, Switch at a dose rate of 0.8 kg/ha did not show any phytotoxicity to the celeriac crop. In addition to the trial results it needs to be mentioned that Switch has an authorisation for the control of Sclerotinia sclerotiorum in celeriac at a dose rate of 0.8 kg/ha in the United Kingdom. Based on the trial results and expert judgement, it can be concluded that Switch is effective as a fungicide for the control of Sclerotinia sclerotiorum in celeriac and that the application does not give adverse side effects to an unacceptable level when applied according to Good Agricultural Practices.
Witloof chicory For the extended use in the forcery of witloof chicory for the control of Sclerotinia sclerotiorum 5 trials were carried out from 2008 till 2010 in The Netherlands (4 trials) and Belgium (1). Switch was applied at the proposed dose rate of 36 g/1000 kg roots during the cold storing of the chicory roots prior to forcery. It was generally found that Switch showed significant control of Sclerotinia sclerotiorum on roots and heads of witloof chicory when applied during the cold storing. The number of infected roots was decreased and the number of healthy, marketable heads was increased as compared to the untreated control. Application of Switch to the roots did not have a negative impact on crop stand. The control of Sclerotinia sclerotiorum given by Switch was generally significantly better than given by reference Contans WG and the untreated control and significantly less than the control given by reference Rovral Aquaflo. Based on the trial results, expert judgement and the fact that Switch has an authorisation in witloof chicory in Belgium for the same use, it is justified to conclude that Switch is effective as a fungicide for the control of Sclerotinia sclerotiorum in the forcery of witloof chicory and that the application does not give adverse side effects to an unacceptable level when applied according to Good Agricultural Practices.
Protected fruiting vegetables of Solanaceae Currently, Switch has a registration for the control of Botryotinia fuckeliana in tomato. According to the extrapolation document “Possibilities for extrapolation of efficacy and crop
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 42 of 159 safety of crop protection products”(CTB, May 2004) and based on expert judgement, extrapolation of effectiveness data is possible from protected tomato to protected fruiting vegetables of Solanaceae. An extension of its use to protected solanaceae is intended. In order to do so 4 additional crop safety trials were conducted in protected eggplant in The Netherlands in 2009 and 2010. In the trials Switch was applied 3 times at the proposed dose rate of 80 g/hl and at the double dose rate of 160 g/hl. In the trials 3 applications with Switch can cause phytotoxicity and visible residues to the leaves, especially when the plants are young and when applications are made under limited light conditions. In other periods of the year and on older plants no phytotoxicity and visible residues occurred. In all trials conducted no phytotoxicity and visible residues were found on stems and fruits. Although phytotoxicity was found in some trials crop stand was never influenced negatively and did not differ from the untreated control and reference Rovral Aquaflo. Crop safety data generated in protected eggplant can be extrapolated to all protected fruiting vegetables of Solanaceae. Based on the trial results, expert judgement, extrapolation possibilities and the experience with Switch in practice in the past, it can be used safely on protected solanaceae. However, on the product label should be stated that phytotoxicity on the leaves might occur when Switch is applied on young plants under limited light conditions.
Protected fruiting vegetables of Cucurbitaceae Currently, Switch has a registration for the control of Botryotinia fuckeliana in tomato.According to the extrapolation document “Possibilities for extrapolation of efficacy and crop safety of crop protection products”(CTB, May 2004) and based on expert judgement, extrapolation of effectiveness data is possible from protected tomato to protected fruiting vegetables of Cucurbitaceae.
The extended use of Switch for the control of Botryotinia fuckeliana in protected cucurbitaceae is new. Therefore, 8 crop safety trials were conducted in protected cucumber in The Netherlands in 2009 and 2010. In the trials Switch was applied 3 times at the proposed dose rate of 80 g/hl and at the double dose rate of 160 g/hl. In the trials 3 applications with Switch can cause some phytotoxicity and visible residues to the leaves, especially when the plants are young and when applications are made under limited light conditions. In other periods of the year and on older plants no phytotoxicity and visible residues occurred. In all trials conducted no phytotoxicity and visible residues were found on stems and fruits. Although some phytotoxicity was found in some trials crop stand was never influenced negatively and did not differ from the untreated control and reference Rovral Aquaflo. Crop safety data generated in protected cucumber can be extrapolated to all protected fruiting vegetables of Cucurbitaceae. Based on the trial results, expert judgement, extrapolation possibilities and the experience with Switch in practice in the past, it can be used safely on protected cucurbitaceae. However, on the
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 43 of 159 product label should be stated that some phytotoxicity on the leaves might occur when Switch is applied on young plants under limited light conditions.
New uses in minor crops For the control of Botryotinia fuckeliana in protected lambs lettuce, radish, herbs and nursery and seed production of arable, vegetable and fruit crops, herbs and ornamentals no trials have been submitted. As these crops are listed as minor crops in The Netherlands, these uses can be claimed on the label of Switch through a so called “VUG”. In this case no effectiveness data need to be submitted and these uses can be claimed on the product label of Switch as far as it concerns effectiveness.
Overall conclusion Based on the presented data, extrapolation possibilities and expert judgement it can be concluded that Switch is effective for the control of Ascochyta pisi, Mycosphaerella pinodes, Botrytis and Sclerotinia in fresh pulses and dry harvested pulses, the control of Gloeosporium spp. in apple and pear, the control of Sclerotinia sclerotiorum and Alternaria dauci in carrot, the control of Sclerotinia sclerotiorum in celeriac, the control of Sclerotinia sclerotiorum in the forcery of witloof chicory, the control of Botryotinia fuckeliana in protected fruiting vegetables of Solanaceae and the control of Botryotinia fuckeliana in protected fruiting vegetables of Cucurbitaceae. The application of Switch in the various crops does not give adverse side effects to an unacceptable level when applied according to Good Agricultural Practices. However, on the product label should be stated that phytotoxicity on the leaves might occur when Switch is applied on young plants under limited light conditions in protected fruiting vegetables of Solanaceae and Cucurbitaceae.
The following restriction sentence is placed on the label: “Na toepassing van Switch op jonge planten en onder slechte lichtcondities in de bedekte teelt van vruchtgroenten van Solanaceae en vruchtgroenten van Cucurbitaceae met eetbare schil kunnen fytotoxische reacties op het blad optreden.”
3.2. Conclusions
An authorisation can be granted.
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
-
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 44 of 159
Appendix 1 – Copy of the product authorisation
Evaluator to insert details of the product authorisation for country.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 45 of 159
Appendix 2 – Copy of the product label
A. WETTELIJK GEBRUIKSVOORSCHRIFT
Toegestaan is uitsluitend het gebruik als schimmelbestrijdingsmiddel door middel van een gewasbehandeling in: a. de teelt van peulvruchten b. de teelt van appel en peer c. de onbedekte teelt van kers en pruim d. de teelt van aardbei e. de onbedekte teelt van aalbes, kruisbes, blauwe bes en druif f. de onbedekte teelt van braam- en framboosachtigen g. de teelt van sla (Lactuca spp.) en andijvie h. de teelt van witlof (trekteelt) i. de bedekte teelt van veldsla j. de onbedekte teelt van peulgroenten met uitzondering van spruitgroenten k. de bedekte teelt van vruchtgroenten van Cucurbitaceae met eetbare schil l. de bedekte teelt van vruchtgroenten van Solanaceae m. de teelt van wortelen n. de onbedekte teelt van knolselderij o. de teelt van aromatische kruidgewassen p. de teelt van tulp q. de teelt van bloemisterijgewassen r. de teelt van boomkwekerijgewassen s. de vaste plantenteelt t. in de veredelingsteelt en basiszaadproductie van groentegewassen, kruiden en sierteeltgewassen (met uitzondering van grasachtigen)
Per jaar zijn maximaal 2 toepassingen toegestaan in peulvruchten, peulgroenten, knolselderij, druif en de veredelingsteelt en basiszaadproductie van groentegewassen, kruiden en sierteeltgewassen (met uitzondering van grasachtigen), 4 toepassingen in tulp, 1 toepassing in witlof, 5 toepassingen in sla (Lactuca spp., bedekte substraatteelt), 6 toepassingen in bloemisterijgewassen (bedekte substraatteelt), vaste plantenteelt (bedekte substraatteelt) en boomkwekerijgewassen (bedekte substraatteelt) en 3 toepassingen in de overige vermelde gewassen.
Om het grondwater te beschermen mag dit product niet worden gebruikt in grondwater- beschermingsgebieden.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 46 of 159
Om in het water levende organismen te beschermen is de toepassing: in de onbedekte teelt van neerwaarts bespoten boomkwekerijgewassen: in spillen in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien maximaal 3 bespuitingen worden uitgevoerd in opzetters uitsluitend toegestaan in percelen die niet grenzen aan oppervlaktewater; in overige, neerwaarts bespoten boomkwekerijgewassen uitsluitend toegestaan indien gebruik wordt gemaakt van minimaal 75 % driftreducerende spuitdoppen
Om in het water levende organismen te beschermen is de toepassing in de teelt van appel, peer, kers, pruim en druif in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan na 1 mei en indien gebruik gemaakt wordt van één van de volgende maatregelen: o er gespoten wordt met een tunnelspuit, of o er gebruik wordt gemaakt van een windhaag op de rand van het rijpad en éénzijdige bespuiting van de laatste bomenrij, of o er in de eerste 20 meter grenzend aan het oppervlaktewater gebruik wordt gemaakt van een venturi-dop in combinatie met een éénzijdige bespuiting van de laatste bomenrij.
Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden.
Resistentiemanagement Dit middel bevat de werkzame stoffen cyprodinil en fludioxonil. Cyprodinil behoort tot de anilinopyrimidinen, de Frac code is 9. Fludioxonil behoort tot de fenylpyrrolen, de Frac code is 12. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.
Na toepassing van Switch op jonge planten en onder slechte lichtcondities in de bedekte teelt van vruchtgroenten van Solanaceae en vruchtgroenten van Cucurbitaceae met eetbare schil kunnen fytotoxische reacties op het blad optreden.
Dit middel is uitsluitend bestemd voor professioneel gebruik.
Veiligheidstermijnen De termijn tussen de laatste toepassing en de oogst mag niet korter zijn dan: - 3 dagen voor appel, peer, aardbei, vruchtgroenten van Solanaceae en Cucurbitaceae met eetbare schil
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 47 of 159
- 7 dagen voor kers, pruim, sla (Lactuca spp) en andijvie, wortelen, veldsla en aromatische kruidgewassen - 10 dagen voor aalbes, kruisbes, blauwe bes, braam- en framboosachtigen - 14 dagen voor peulgroenten en knolselderij - 21 dagen voor druif - 28 dagen voor peulvruchten
B Gebruiksaanwijzing
Algemeen Switch heeft een preventieve werking tegen o.a. grauwe schimmel (Botryotinia fuckeliana). Om de kans op het optreden van verminderde gevoeligheid te beperken, is het aan te bevelen Switch af te wisselen met andere voor Botryotinia fuckeliana bestrijding toegelaten middelen met een ander werkingsmechanisme.
Het middel heeft effect op niet-doelwit arthropoden, waaronder natuurlijke vijanden. Bij geïntegreerde teelten dient hiermee rekening gehouden te worden. Vermijd daarom onnodige blootstelling.
Het gebruik in de teelt van aromatische kruidgewassen, de veredelingsteelt en basiszaadproductie van groentegewassen, kruiden en sierteeltgewassen en de bedekte teelt van veldsla is beoordeeld conform de “vereenvoudigde uitbreidingsprocedure”. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren, voordat het middel gebruikt wordt. Gebruik van dit middel in deze toepassingsgebieden, komt voor risico en verantwoordelijkheidvan de gebruiker.
Toepassingen
Peulvruchten, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana), sclerotiënrot (Sclerotinia sclerotiorum) en vlekkenziekten (Ascochyta spp. en Mycosphaerella spp.) Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Dosering: 1 kg middel per ha
Appel, ter bestrijding van bewaarrot veroorzaakt door o.a. Botryotinia fuckeliana en Gloeosporium.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 48 of 159
Vanaf ongeveer 3 weken voor de oogst, afhankelijk van het spuitinterval (10-14 dagen), twee tot drie behandelingen uitvoeren. Dosering: 0,08% (80 gram middel per 100 liter water); per behandeling maximaal 1 kg per ha toepassen.
Peer, ter bestrijding van bewaarrot veroorzaakt door o.a. Botryotinia fuckeliana en Gloeosporium. Vanaf ongeveer 3 weken voor de oogst, afhankelijk van het spuitinterval (10-14 dagen), twee tot drie behandelingen uitvoeren. Dosering: 0,08% (80 gram middel per 100 liter water); per behandeling maximaal 1 kg per ha toepassen.
Peer, ter bestrijding van zwartvruchtrot (Stemphylium vesicarium). Onder voor zwartvruchtrot gunstige omstandigheden of zodra eerste symptomen worden verwacht een behandeling uitvoeren. Afhankelijk van ziektedruk en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Dosering: 0,08% (80 gram middel per 100 liter water); per behandeling maximaal 1 kg per ha toepassen.
Onbedekte teelt van kers en pruim, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Dosering: 0,08% (80 gram middel per 100 liter water); per behandeling maximaal 1 kg per ha toepassen.
Onbedekte teelt van aardbei, ter bestrijding van vruchtrot veroorzaakt door Botryotinia fuckeliana en Colletotrichum acutatum. Vanaf het begin van de bloei toepassen met een interval van 10 tot 14 dagen. Bij Botrytis- en Colletotrichum-gevoelige gewassen verdient onder vochtige weersomstandigheden een interval van 10 dagen de voorkeur. Dosering: 1 kg middel per ha
Bedekte teelt van aardbei, ter bestrijding van vruchtrot veroorzaakt door Botryotinia fuckeliana en Colletotrichum acutatum. Vanaf het begin van de bloei toepassen met een interval van 10 tot 14 dagen. Bij Botrytis- en Colletotrichum-gevoelige gewassen verdient onder vochtige omstandigheden een interval van 10 dagen de voorkeur. Dosering: 1 kg middel per ha
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 49 of 159
Onbedekte teelt van aalbes (rode bes, witte bes, zwarte bes), kruisbes en blauwe bes, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Dosering: 1 kg middel per ha
Onbedekte teelt van druif, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. De behandeling, indien nodig, na ongeveer 21 dagen herhalen. Dosering: 0,08% (80 gram middel per 100 liter water); per behandeling maximaal 1 kg per ha toepassen.
Onbedekte teelt van braam- en framboosachtigen, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Dosering: 1 kg middel per ha
Sla (Lactuca spp.), andijvie en aromatische kruidgewassen ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Zie opmerking gevoeligheid. Dosering: 0,6 kg middel per ha
Witlof (trekteelt), ter bestrijding van sclerotiënrot (Sclerotinia sclerotiorum) Bij het in opslag brengen van de witlofpennen een bespuiting op de transport band uitvoeren. Voor een goede bevochtiging is een hoeveelheid van 10 tot 20 liter spuitvloeistof per 1000 kg witlofpennen voldoende. Dosering: 36 gram middel per 1000 kg witlofpennen.
Bedekte teelt van veldsla ter bestrijding van grauwe schimmel (Botryotinia fuckeliana).
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 50 of 159
Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Zie opmerking gevoeligheid. Dosering: 0,6 kg middel per ha
Onbedekte teelt van peulgroenten met uitzondering van spruitgroenten, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana), sclerotiënrot (Sclerotinia sclerotiorum) en vlekkenziekten (Ascochyta spp. en Mycosphaerella spp.) Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Dosering: 1 kg middel per ha
Bedekte teelt van vruchtgroenten van Cucurbitaceae met eetbare schil (b.v. komkommer, augurk, pattison) ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk en groeisnelheid de behandeling na 10 tot 14 dagen herhalen. De toepassing dient plaats te vinden door middel van een gerichte bespuiting op de stengels van de planten. Toepassing op jonge planten en op het blad kan, in het bijzonder onder lichtarme omstandigheden, schade veroorzaken. Dosering: 0,08% (80 gram middel per 100 liter water); per behandeling maximaal 1 kg per ha toepassen.
Bedekte teelt van vruchtgroenten van Solanaceae (b.v. tomaat, paprika en aubergine), ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk en groeisnelheid de behandeling na 10 tot 14 dagen herhalen. De toepassing dient plaats te vinden door middel van een gerichte bespuiting op de stengels van de planten. Toepassing op jonge planten en op het blad kan, in het bijzonder onder lichtarme omstandigheden, schade veroorzaken. Dosering: 0,08% (80 gram middel per 100 liter water); per behandeling maximaal 1 kg per ha toepassen.
Onbedekte teelt van wortelen, ter bestrijding van loofverbruining (Alternaria dauci) en sclerotiënrot (Sclerotinia sclerotiorum) Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 12 dagen herhalen. Dosering: 0,8 kg middel per ha
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 51 of 159
Onbedekte teelt van knolselderij, ter bestrijding van sclerotiënrot (Sclerotinia sclerotiorum) Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 14 dagen herhalen. Dosering: 0,8 kg middel per ha
Tulp, ter bestrijding van vuur (Botryotinia tulipae). Vanaf opkomst van het gewas toepassen met een interval van 7 tot 14 dagen. Dosering: 0,5 – 0,75 kg middel per ha De lage dosering toepassen bij een kort spuitinterval; bij hoge infectiedruk of bij een lang spuitinterval de hoge dosering toepassen.
Bedekte teelt van bloemisterijgewassen, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 7 tot 14 dagen herhalen. Zie opmerking gevoeligheid. Dosering: 0,08% (80 gram middel per 100 l water)
Onbedekte teelt van bloemisterijgewassen, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Zie opmerking gevoeligheid. Dosering: 0,8 kg middel per ha
Bedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 7 tot 14 dagen herhalen. Zie opmerking gevoeligheid. Dosering: 0,08% (80 gram middel per 100 liter water)
Onbedekte teelt van boomkwekerijgewassen en vaste planten, ter bestrijding van grauwe schimmel (Botryotinia fuckeliana).
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 52 of 159
Onder voor grauwe schimmel gunstige omstandigheden of zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 10 tot 14 dagen herhalen. Zie opmerking gevoeligheid. Dosering: 0,8 kg middel per ha
Veredelingsteelt en basiszaadproductie van groentegewassen, kruiden en sierteeltgewassen (met uitzondering van grasachtigen), ter bestrijding van grauwe schimmel (Botryotinia fuckeliana). Zodra de eerste symptomen worden waargenomen een behandeling uitvoeren. Afhankelijk van ziektedruk, groeisnelheid en weersomstandigheden de behandeling na 7 tot 21 dagen herhalen. Zie opmerking gevoeligheid. Dosering: 0,8 kg middel per ha
Opmerking gevoeligheid bloemisterijgewassen, boomkwekerijgewassen, vaste planten Tussen gewassen en cultivars bestaan er grote verschillen in gevoeligheid voor Switch. Het is daarom noodzakelijk om in gewassen of cultivars waar nog geen ervaring met Switch is opgedaan, door middel van een proefbespuiting op kleine schaal vast te stellen of het betreffende gewas of cultivar het middel verdraagt.
Appendix 3 - List of data submitted in support of the evaluation
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 2 / 1994 A9219B - Chemical composition Y SYN 01 (batch: P.312002) N Y Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Münchwilen AG, Münchwilen, Switzerland, 21956 GLP, not published Syngenta File No CGA173506/0694
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 53 of 159
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 2 / 1998 A9219B - Chemical composition Y SYN 02 (batch: P.712072) N Y Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection Münchwilen AG, Münchwilen, Switzerland, 61572 GLP, not published Syngenta File No CGA173506/5108 KIIIA 2 / 2009 A9219B - Storage stability and shelf Y SYN 03 & life statement (2 weeks 54°C) in bag Y Y KIIIA 2.7.1 made of paper/PETP/Al/PE / 02 & Syngenta KIIIA 2.8.1 Syngenta Crop Protection, / 02 & Münchwilen, Switzerland, KIIIA 2.8.2 Not GLP, not published / 02 & Syngenta File No A9219B_11423 KIIIA 2.8.3.1 / 02 & KIIIA 2.8.3.2 / 02 & KIIIA 2.8.5.2 / 02 & KIIIA 2.8.6.3 / 02 & KIIIA 2.8.6.5 / 02 KIIIA 2.1 / 1995 A9219B - Physico-chemical Y SYN 01 & properties (colour, odour, physical N Y KIIIA 2.6.2 state, bulk density, spontaneity of / 01 & dispersion, sieve analysis, KIIIA flowability) 2.8.3.2 / Novartis Crop Protection AG, Basel, 01 & Switzerland KIIIA Ciba-Geigy Münchwilen AG, 2.8.6.1 / Münchwilen, Switzerland, 28229 01 & GLP, not published KIIIA Syngenta File No CGA173506/0696 2.8.8.1 / 01 KIIIA 2.2.1 1995 A9219B - Explosive properties Y SYN / 01 Novartis Crop Protection AG, Basel, N Y Switzerland Ciba-Geigy Ltd., Basel, Switzerland, PP-94-66C-EXP GLP, not published Syngenta File No CGA173506/0700
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 54 of 159
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 2.2.2 1995a A-9219 B - Oxidizing properties of Y SYN / 01 solids N Y Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Basel, Switzerland, PP-94-66C-OXP GLP, not published Syngenta File No CGA173506/0697 KIIIA 2.3.2 1995b A-9219 B - Flammability of solids Y SYN / 01 Novartis Crop Protection AG, Basel, N Y Switzerland Ciba-Geigy Ltd., Basel, Switzerland, PP-94-66C-FLS GLP, not published Syngenta File No CGA173506/0698 KIIIA 2.3.3 1995c A9219B - Self-heating properties of Y SYN / 01 solids N Y Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Basel, Switzerland, PP-94-66C-BCC GLP, not published Syngenta File No CGA173506/0699 KIIIA 2.4.2 1995a A9219B - Physico-chemical Y SYN / 01 & properties (aspect, pH-value, N Y KIIIA 2.8.1 wettability, wet sieve residue, / 01 & dustiness, suspensibility, persistent KIIIA 2.8.2 foaming) / 01 & Novartis Crop Protection AG, Basel, KIIIA Switzerland 2.8.3.1 / Ciba-Geigy Münchwilen AG, 01 & Münchwilen, Switzerland, 28228 KIIIA GLP, not published 2.8.5.2 / Syngenta File No CGA173506/0695 01 & KIIIA 2.8.6.3 / 01 KIIIA 2.7.1 1995 A-9219B - Chemical stability (2 Y SYN / 01 weeks 54°C) N Y Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection Münchwilen AG, Münchwilen, Switzerland, 28231 GLP, not published Syngenta File No CGA173506/0944
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 55 of 159
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 2.7.1 2011 A-9219B - Storage stability and Shelf Y SYN / 02 Life Statement (2 weeks 54°C) in Y Y packaging made of HDPE. Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 10467092 GLP, not published Syngenta File No A9219B_11420 KIIIA 2.7.5 2001 Report on product stability (2 years Y SYN / 01 20°C, box with inner bag (PE- N Y laminate with water vapour barrier, EVOH) Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 44004565 Not GLP, not published Syngenta File No CGA173506/5366 KIIIA 2.7.5 2006 A-9219 B - A.I. suspensibility and a.i. Y SYN / 02 spontaneity of dispersion after Y Y storage for more than 2 years at ambient temperature Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 116223 Not GLP, not published Syngenta File No CGA173506/6856 KIIIA 2.7.5 2006a A-9219 B - Nominal size range after Y SYN / 03 storage for more than 2 years at Y Y ambient temperature Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 116227 GLP, not published Syngenta File No CGA173506/6869 KIIIA 2.7.5 2006b A-9219 B - Attrition resistance after Y SYN / 04 storage for more than 2 years at Y Y ambient temperature Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 116254 Not GLP, not published Syngenta File No CGA173506/6865
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 56 of 159
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 2.7.5 2008 A9219B - Persistent foaming of Y SYN / 05 batch SMO5G989 after storage for Y Y more than 2 years at ambient temperature Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 118436 Not GLP, not published Syngenta File No CGA173506/7410 KIIIA 2.7.5 2011 Statement ‘A9219B: physical Y SYN / 06 & chemistry questions from Ctgb’. Y Y KIIIA Syngenta, 22 Feb 2011. 2.8.3.1 KIIIA 2.7.5 2013 A9219B – Storage stability and shelf Y SYN / 07 life statement (2 years 20 oC) in Y Y packaging made of HDPE Syngenta Crop Protection Münchwilen AG, Switzerland Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 10539269 GLP, not published Syngenta Study No TK0058668 KIIIA 1999 Final report on physico-chemical Y SYN 2.8.6.5 / properties (attrition resistance of N Y 01 granules) Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection Münchwilen AG, Münchwilen, Switzerland, 79742 Not GLP, not published Syngenta File No CGA173506/5109 KIIIA 3.3.1 2010 A9219B GAP FINAL PI0001858 Y SYN / 01 & Syngenta Crop Protection AG, Basel, Y Y KIIIA 7.3 / Switzerland, 01 & Not GLP, not published KIIIA1 Syngenta File No A9219B_11487 8.3 / 01 & KIIIA1 9.1 / 01 & KIIIA1 10 / 01 KIIIA 4.1.3 1997 Report on resistance of packaging Y SYN / 01 material (2 years 20°C) - box with N Y inner bag Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection Münchwilen AG, Münchwilen, Switzerland, 28249 GLP, not published Syngenta File No CGA173506/0941
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 57 of 159
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 4.2.2 1997a A-9219 B, Effectiveness of the Y SYN / 01 cleaning procedure for the N Y application equipment Syngenta Crop Protection AG, Basel, Switzerland Novartis Crop Protection Münchwilen AG, Münchwilen, Switzerland, Not GLP, not published Syngenta File No CGA173506/0942
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 1994 A9219B - Analytical Method CGA Y SYN 5.2.1 / 173506/CGA 219417 in formulation N Y 01 Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Basel, Switzerland, AF-1125/1 Not GLP, not published Syngenta File No CGA173506/0570 KIIIA 1994a A9219B - Validation of Analytical Y SYN 5.2.1 / Methods (AF-1125/1) N Y 02 Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Münchwilen AG, Münchwilen, Switzerland, 20015 GLP, not published Syngenta File No CGA173506/0575 KIIIA 5.4 2004 RESIDUE ANALYTICAL METHOD Y SYN / 01 FOR THE DETERMINATION OF Y Y CYPRODINIL AND ITS METABOLITES CGA249287, CGA275535 AND CGA321915 IN SOIL Syngenta Crop Protection AG, Basel, Switzerland Syngenta - Jealott’s Hill, Bracknell, United Kingdom, RAM 425/01 GLP, not published Syngenta File No CGA219417/1229
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 58 of 159
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 5.4 2004 Cyprodinil: Validation of an Y SYN / 02 Analytical Method for the Y Y determination of Residues of Cyprodinil and its Metabolites CGA249287, CGA275535 and CGA321915 in Soil Syngenta Crop Protection AG, Basel, Switzerland Syngenta, Jealott’s Hill, United Kingdom, RJ3504B GLP, not published Syngenta File No CGA219417/1221 KIIIA 5.4 2004 Residue Analytical Method for the Y SYN / 03 Determination of Fludioxonil in Soil Y Y Syngenta Crop Protection AG, Basel, Switzerland Syngenta - Jealott’s Hill, Bracknell, United Kingdom, RAM 423/01 Not GLP, not published Syngenta File No CGA173506/5941 KIIIA 5.4 2004a Long Term Residue Study with Y SYN / 04 Fludioxonil (CGA173506) in or on Y Y Grapes and Soil in Switzerland Syngenta Crop Protection AG, Basel, Switzerland Syngenta - Jealott’s Hill, Bracknell, United Kingdom, RJ3493B GLP, not published Syngenta File No CGA173506/5940 KIIIA 5.6 2007 Fludioxonil - Residue Analytical Y SYN / 01 Method for the Determination of Y Y Residues of Fludioxonil and its Metabolites CGA192155 and CGA339833 in Water Syngenta Crop Protection AG, Basel, Switzerland Syngenta - Jealott’s Hill International, Bracknell, Berkshire, United Kingdom, GRM 025.01A Not GLP, not published Syngenta File No CGA173506/7219
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 59 of 159
Annex Year Title Data Owner Data Study protection (SYN = point Source (where different from Protectio relied claimed Syngent company) n on Y/N a) Granted Company, Report No. GLP or GEP status (where relevant) Published or Unpublished KIIIA 5.6 2007 Fludioxonil (CGA173506) - Y SYN / 02 Validation of a Residue Analytical Y Y Method (GRM025.01A) for the Determination of Residues of Fludioxonil and its Metabolites CGA192155 and CGA339833 in Water Syngenta Crop Protection AG, Basel, Switzerland Syngenta - Jealott’s Hill International, Bracknell, Berkshire, United Kingdom, T003490-06-REG GLP, not published Syngenta File No CGA173506/7220 Maritime zone
Annex point Year Title Data Owner Data Studies protecti protectio relied Source (where different SYN = on n on? Y/N from company) Synge claimed granted? nta Company, Report No. Y/N Y/N GLP or GEP status (where relevant) Published or Unpublished
KIIIA 6 2010 Biological Assessment Y SYN N Y Dossier for A9219B (Switch): Registration Report part B section 7 - Efficacy data and information - detailed summary fruits and vegetables, core assessment. Syngenta, September 2010
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 60 of 159
KIIIA 6 2010 Biological Assessment Y SYN N Y Dossier for A9219B (Switch): Registration Report part B section 7 - Efficacy data and information - detailed summary ornamentals, core assessment. Syngenta, October 2010 Grape
6/Annex_Mar_ 2005 FLB51 : soutien du Y SYN Y Y switch - efficacité sur Grape 01 botrytis, SYN France, FRMS0F0152005, GEP, Not published
6/Annex_Mar_ 2008 FGR10 : Evaluer Y SYN Y Y l'efficacité de la nouvelle Grape 02 formulation A8240D contre le botrytis de la vigne, BIOTECK, FRBKZF0342008, GEP, Not published
6/Annex_Mar_ 2008 FGR10 : Evaluer Y SYN Y Y l'efficacité de la nouvelle Grape 03 formulation A8240D contre le botrytis de la vigne, BIOTECK, FRBKZF0352008, GEP, Not Published
6/Annex_Mar_ 2007 FLB50ME163 (GE) - Y SYN Y Y ESV botrytis soutien Grape 04 gamme, SYN France, FRMETF1632007, GEP, Not Published
6/Annex_Mar_ 2007 FLB50ME164 (GE) - Y SYN Y Y ESV botrytis soutien Grape 05 gamme, SYN France, FRMETF1642007, GEP, Not published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 61 of 159
6/Annex_Mar_ 2009 A8240D Geoxe WG & Y SYN Y Y SYN520453+A8240D - Grape 06 Registration trials on Grapes against Botrytis cinerea SYN France, FRPHZF0302009, GEP, Not published
6/Annex_Mar_ 2005 Bericht über die Prüfung Y SYN Y Y der Wirksamkeit von Grape 07 Pflanzenschutzmitteln an Weinreben, SLVA WE, 05-80-03, GEP, Not Published
6/Annex_Mar_ 2005 Versuchsbericht der Y SYN Y Y amtlichen MittelPrüfung Grape 08 2005, DLR RP, Dido21-09-8, GEP, Not Published
6/Annex_Mar_ 2005 Versuchsbericht der Y SYN Y Y amtlichen MittelPrüfung Grape 09 2005, DLR RP,KIMth19-09-4, GEP, Not Published
6/Annex_Mar_ 2005 Versuchsbericht der Y SYN Y Y amtlichen MittelPrüfung Grape 10 2005, DLR RP,KöSp05-105, GEP, Not Published
6/Annex_Mar_ 2006 Versuchsbericht der Y SYN Y Y amtlichen MittelPrüfung Grape 11 2006, DLR RP, KiMt27-09-3, GEP, Not Published
6/Annex_Mar_ 2008 Einflub auf die Garung Y SYN Y Y von traubenmost und die Grape 12 sensorisch wahrnehmbaren Eigenschaften bei wein, WBI FR, 1221-1223, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 62 of 159
6/Annex_Mar_ 2002 Versuchsbericht der Y SYN Y Y Grape 13 amtlichen Mittelprüfung 2002, Applikationsdaten zur Prüfung von SYD 21380F gegen Botrytis, SLFA Neustadt/W, 02BotNW1, GEP, Not Published
6/Annex_Mar_ 1994 Versuchsbericht der Y SYN Y Y Grape 14 amtlichen MittelPrüfung 1994, Ergebnisse der Prüfung von CGD 20450 F gegen Botrytis, SLVA BAD Kreuznach, Not Pertinent, Not Published
6/Annex_Mar_ 1995 Versuchsbericht der Y SYN Y Y Grape 15 amlichen MittelPrüfung 1995, Ergebnisse der Prüfung von CGD 20450 F gegen Botrytis, SLFA Neustadt, BOCGD951, Not Pertinent , Not Published
6/Annex_Mar_ 1995 Versuchsbericht für die Y SYN Y Y Grape 16 Prüfung im Zulassungsverfarhen, Bekämpfung von Botrytis cinerea Pers. An Reben, Staatliches Weinbauninstitut, FR/WBI/BOTRY//95, Not Pertinent, Not Published
Eggplant
6/Annex_Mar_ 2009 Essai d’efficacité en Y SYN Y Y Eggplant 01 protection contre le botrytis sur fruit en aubergine sous abri, Hortis Aquitaine, H0907, GEP, Not Published
Tomato
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 63 of 159
6/Annex_Mar_ 2005 Control of Botrytis Y Y Tomato 1 Cinerea in Tomatoes, Proeftuin Zwaagdijk, G0555, NLTO0F7182005, GEP, Not Published
6/Annex_Mar_ 2005 Control of Botrytis Y SYN Y Y Tomato 2 Cinerea in Tomatoes, Proeftuin Zwaagdijk, G0556, NLTO0F7192005, GEP, Not Published
6/Annex_Mar_ 2005 Control of Botrytis Y SYN Y Y Tomato 3 Cinerea in Tomatoes, Proeftuin Zwaagdijk, G0557, NLTO0F7202005, GEP, Not Published
6/Annex_Mar_ 2005 Efficacy trial for Switch Y SYN Y Y Tomato 4 against Botrytis cinerea in tomato, Applied Plant Research Glasshouse Horticulture, 41111082, 41103318, GEP, Not Published
6/Annex_Mar_ 2007 Switch 62.5 WG : Crop Y SYN Y Y Tomato 5 safety in covered fruit vegetables, SYN, FFVE01H3- 2006NL, NLVE0F1082006, GEP, Not Published
6/Annex_Mar_ 2007 Switch 62.5 WG : Crop Y SYN Y Y Tomato 6 safety in covered fruit vegetables, SYN, FFVE01H3- 2006NL, NLVE0F1092006, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 64 of 159
6/Annex_Mar_ 2007 Switch 62.5 WG : Crop Y SYN Y Y Tomato 7 safety in covered fruit vegetables, SYN, FFVE01H3- 2006NL, NLVE0F1102006, GEP, Not Published
6/Annex_Mar_ 2007 Switch 62.5 WG : Crop Y SYN Y Y Tomato 8 safety in covered fruit vegetables, SYN, FFVE01H3- 2006NL, NLVE0F2132006 , GEP, Not Published
Carots
6/Annex_Mar_ 2005 Efficacité des fongicides Y SYN Y Y Carots 1 pour lutter contre l’alternaria et l’oidium en végétation sur carotte Unilet, CA05BPE*D24b, GEP, Not Published
6/Annex_Mar_ 2006 FCA01-Etude de Y SYN Y Y Carots 2 l’efficacité de la formulation ORTIVA TOP et de SWITCH sur alternaria et odium de la carotte, SYN, FRAM0F0732006, GEP, Not Published
6/Annex_Mar_ 2006 FCA01-Etude de Y SYN Y Y Carots 3 l’efficacité de la formulation ORTIVA TOP et de SWITCH sur alternaria et odium de la carotte, SYN, FRTB0F0122006, GEP, Not Published
6/Annex_Mar_ 2007 FCA01- Evaluation du Y SYN Y Y Carots 4 SYN520, du A13703 et du Switch sur alternaria et oidium de la carotte, SYN, FRBNZF 015 2007, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 65 of 159
6/Annex_Mar_ 2007 FCA01- Evaluation du Y SYN Y Y Carots 5 SYN520, du A13703 et du Switch sur alternaria et oidium de la carotte, SYN, FRTBZF0572007, GEP, Not Published
6/Annex_Mar_ 2004 Lutte contre la Y SYN Y Y Carots 6 sclerotiniose de la carotte, Unilet, CA04BPEQ37b, GEP, Not Published
6/Annex_Mar_ 2005 Lutte contre la Y SYN Y Y Carots 7 sclerotiniose de la carotte, Unilet, CA05BPEQ25a, GEP, Not Published
6/Annex_Mar_ 2005 Lutte contre la Y SYN Y Y Carots 8 sclerotiniose de la carotte, Unilet, CA05BPEQ25b, GEP, Not Published
6/Annex_Mar_ 2006 Lutte contre la Y SYN Y Y Carots 9 sclerotiniose de la carotte, Unilet, CA06BPEQ135a, GEP, Not Published
6/Annex_Mar_ 2006 Lutte contre la Y SYN Y Y Carots 10 sclerotiniose de la carotte, Unilet, CA06BPEQ135b, GEP, Not Published
6/Annex_Mar_ 2006 Evaluation of A9219B Y SYN Y Y Carots 11 for the control of sclerotinia and other foliar diseases, ADAS, XAC1515, GEP, Not Published
6/Annex_Mar_ 2006 Evaluation of A9219B Y SYN Y Y Carots 12 for the control of sclerotinia and other foliar diseases, ADAS, XAC1512, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 66 of 159
6/Annex_Mar_ 2004 Lutte contre la Y SYN Y Y Carots 13 sclerotiniose de la carotte, Unilet, Ca04BPEQ37a, GEP, Not Published
6/Annex_Mar_ 2005 Efficacité des fongicides Y SYN Y Y Carots 14 pour lutter contre l’alternaria et l’oidium en végétation sur carotte, Unilet, CA05BPED24a, GEP, Not Published
6/Annex_Mar_ 2007 FCA01- Evaluation du Y SYN Y Y Carots 15 SYN520, du A13703 et du SWITCH sur alternaria et oidium de la carotte, SYN, FRAJZF0662007, GEP, Not Published
6/Annex_Mar_ 2007 Efficacité des fongicides Y SYN Y Y Carots 16 pour lutter contre l’alternaria et l’oidium sur carotte, Unilet, CA07BPED10a, GEP, Not Published
6/Annex_Mar_ 2007 Efficacité des fongicides Y SYN Y Y Carots 17 pour lutter contre l’alternaria et l’oidium sur carotte, Unilet, CA07BPED10b, GEP, Not Published
6/Annex_Mar_ 2007 Efficacité des fongicides Y SYN Y Y Carots 18 pour lutter contre l’alternaria et l’oidium sur carotte, Unilet, CA07BPED10c, GEP, Not Published
6/Annex_Mar_ 2007 Efficacité des fongicides Y SYN Y Y Carots 19 pour lutter contre l’alternaria et l’odium sur carotte, Unilet, CA07BPED10d, GEP, Not published
Celeriac
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 67 of 159
6/Annex_Mar_ 2005 Lutte contre la Y SYN Y Y Celeriac 1 sclerotiniose du céléri branche Unilet, CB05BPEQ40a, GEP, Not Published
6/Annex_Mar_ 2007 Lutte contre la Y SYN Y Y Celeriac 2 sclerotiniose du céléri branche, Unilet, CB07BPEQ132, GEP, Not Published
6/Annex_Mar_ 2004 Lutte contre la Y SYN Y Y Celeriac 3 sclerotiniose du céléri branche, Unilet, CB04BPEQ3a, GEP, Not Published
6/Annex_Mar_ 2004 Lutte contre la Y SYN Y Y Celeriac 4 sclerotiniose du céléri branche, Unilet, CB04BPEQ3b, GEP, Not Published
6/Annex_Mar_ 2005 Lutte contre la Y SYN Y Y Celeriac 5 sclerotiniose du céléri branche, Unilet CB05BPE Q40b, GEP, Not Published
Bulb Veg
6/Annex_Mar_ 2009 SWITCH-Efficacy Y SYN Y Y Bulb Veg 1 against Botrytis and sclerotinia on onions Anadiag SA, FRASZF0092009, GEP, Not Published
6/Annex_Mar_ 2008 Olympus and Ortiva : Y SYN Y Y Bulb Veg 2 Control of Botrytis in Onions (direct seeded) SYN, NLON0F2222008, GEP, Not Published
6/Annex_Mar_ 2009 Olympus and Ortiva : Y SYN Y Y Bulb Veg 3 Control of Botrytis in Onions (direct seeded), SYN, NLON0F8102008, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 68 of 159
6/Annex_Mar_ 2009 SYN, FRASZF0172009, Y SYN Y Y Bulb Veg 4 GEP, Not Published
Leafy Veg
6/Annex_Mar_ 2000 T03-sclerotinia sur Y SYN Y Y Leafy Veg 1 laitue, SYN, FRBJ0F0032000, GEP, Not Published
Witloof Chicory
6/Annex_Mar_ 2002 Lutte contre Sclerotinia : Y SYN Y Y Witloof Evaluation du M3110 Chicory 1 appliqué par trempage avant forçage, FNPE, 01P0164, GEP, Not Published
6/Annex_Mar_ 2002 Lutte contre Sclerotinia : Y SYN Y Y Witloof Evaluation du M3110 Chicory 2 appliqué par trempage avant forçage, FNPE, 01p0132b, GEP, Not Published
6/Annex_Mar_ 2003 Lutte contre Sclerotinia : Y SYN Y Y Witloof Evaluation du M3110 Chicory 3 appliqué par trempage avant forçage,FNPE, 02p0152, GEP, Not Published
6/Annex_Mar_ 2003 Lutte contre sclerotinia : Y SYN Y Y Witloof Evaluation du M3110 Chicory 4 appliqué par trempage avant forçage, FNPE, 02p0155, GEP, Not Published
6/Annex_Mar_ 2004 Lutte contre Sclerotinia : Y SYN Y Y Witloof Evaluation de l’efficacité Chicory 5 du M3110- raciness Roye FNPE, 03p0123c, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 69 of 159
6/Annex_Mar_ 2003 Lutte contre le Y SYN Y Y Witloof Sclerotinia sclerotiorum, Chicory 6 agent de pourriture des chicons d’endive au forçage, CATE, GEP, Not Published
6/Annex_Mar_ 2004 Lutte contre Sclerotinia : Y SYN Y Y Witloof Sélectivité du M3110- Chicory 7 racines Roye FNPE, 03p0123a, GEP, Not Published
6/Annex_Mar_ 2004 Lutte contre Sclerotinia Y SYN Y Y Witloof Sclerotiorum : agent de Chicory 8 pourriture des chicons d’endive au forçage, sélectivité du produit expérimental SWITCH sur endive au forçage CATE, GEP, Not Published
Bean
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Bean 1 Sclerotinia, efficacité de fongicides à la floraison, Unilet, H95BPED143A, Not pertinent, Not Published
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Bean 2 Sclerotinia, efficacité de fongicides à la floraison, Unilet, H95BPED143B, Not Pertinent, Not Published
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Bean 3 Sclerotinia, efficacité de fongicides à la floraison, Unilet, H95BPED143C, Not Pertinent, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 70 of 159
6/Annex_Mar_ 1996 Lutte contre Botrytis et Y SYN Y Y Bean 4 Sclerotinia à la floraison du haricot, Unilet, H96BPED77A, Not Pertinent, Not Published
6/Annex_Mar_ 1996 Lutte contre Botrytis et Y SYN Y Y Bean 5 Sclerotinia à la floraison du haricot, Unilet, H96BPED77b, Not Pertinent, Not Published
6/Annex_Mar_ 1996 Lutte contre Botrytis et Y SYN Y Y Bean 6 Sclerotinia à la floraison du haricot, Unilet, H96BPED77C, Not Pertinent, Not Published
6/Annex_Mar_ 1996 Essai Sclerotinia et Y SYN Y Y Bean 7 Botrytis sur Haricot vert, CIBA, FLJ0F07396, Not Pertinent, Not Published
6/Annex_Mar_ 1998 Lutte contre Sclerotinia Y SYN Y Y Bean 8 et Botrytis à la floraison du haricot Unilet, H98BPED37a, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Sclerotinia Y SYN Y Y Bean 9 et Botrytis à la floraison du haricot Unilet, H98BPED37b, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Sclerotinia Y SYN Y Y Bean 10 et Botrytis à la floraison du haricot Unilet, H98BPED37c, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Sclerotinia Y SYN Y Y Bean 11 et Botrytis à la floraison du haricot Unilet H98BPEQ37a, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 71 of 159
6/Annex_Mar_ 1998 Lutte contre Sclerotinia Y SYN Y Y Bean 12 et Botrytis à la floraison du haricot Unilet, H98BPEQ37b, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Sclerotinia Y SYN Y Y Bean 13 et Botrytis à la floraison du haricot, Unilet, H98BPEQ37c, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Sclerotinia Y SYN Y Y Bean 14 et Botrytis à la floraison du haricot, Unilet, H98BPEQ37d, GEP, Not Published
6/Annex_Mar_ 1999 Lutte contre Sclerotinia Y SYN Y Y Bean 15 et Botrytis à la floraison du haricot, Unilet, H99BPED44a, GEP, Not Published
6/Annex_Mar_ 1999 Lutte contre Sclerotinia Y SYN Y Y Bean 16 et Botrytis à la floraison du haricot, Unilet, H99BPED44b, GEP, Not Published
6/Annex_Mar_ 2000 Lutte contre sclerotinia Y SYN Y Y Bean 17 et Botrytis à la floraison du haricot, Unilet, H00BPEA20, GEP, Not Published
6/Annex_Mar_ 2000 Lutte contre sclerotinia Y SYN Y Y Bean 18 et botrytis à la floraison du haricot, Unilet, H00BPEQ20a, GEP, Not Published
6/Annex_Mar_ 2000 Lutte contre sclerotinia Y SYN Y Y Bean 19 et botrytis à la floraison du haricot, Unilet, H00BPEQ20b, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 72 of 159
6/Annex_Mar_ 2001 Lutte contre sclerotinia à Y SYN Y Y Bean 20 la floraison du haricot, Unilet, H01BPED42b, GEP, Not Published
6/Annex_Mar_ 2001 Lutte contre sclerotinia à Y SYN Y Y Bean 21 la floraison du haricot, Unilet, H01BPED42a, GEP, Not Published
6/Annex_Mar_ 2002 Lutte contre sclerotinia Y SYN Y Y Bean 22 et botrytis à la floraison du haricot, Unilet, H02BPEA25a, GEP, Not Published
6/Annex_Mar_ 2002 Lutte contre sclerotinia Y SYN Y Y Bean 23 et Botrytis à la floraison du haricot, Unilet, H02BPEQ25a, GEP, Not Published
6/Annex_Mar_ 2000 Lutte contre sclerotinia Y SYN Y Y Bean 24 et Botrytis à la floraison du haricot, Unilet H00BPED20a, GEP, Not Published
6/Annex_Mar_ 2000 Lutte contre sclerotinia Y SYN Y Y Bean 25 et Botrytis à la floraison du haricot, Unilet, H00BPED20b, GEP, Not Published
6/Annex_Mar_ 2001 Lutte contre sclerotinia à Y SYN Y Y Bean 26 la floraison du haricot, Unilet, H01BPEA42a, GEP, Not Published
6/Annex_Mar_ 2001 Lutte contre sclerotinia à Y SYN Y Y Bean 27 la floraison du haricot, Unilet, H01BPEA42b, GEP, Not Published
6/Annex_Mar_ 2001 Lutte contre sclerotinia à Y SYN Y Y Bean 28 la floraison du haricot, Unilet, H01BPEQ42a, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 73 of 159
6/Annex_Mar_ 2001 Lutte contre sclerotinia à Y SYN Y Y Bean 29 la floraison du haricot, Unilet, H01BPEQ42b, GEP, Not Published
6/Annex_Mar_ 2002 Lutte contre sclerotinia Y SYN Y Y Bean 30 et Botrytis à la floraison du haricot, Unilet, H02BPEA25b GEP, Not Published
6/Annex_Mar_ 2002 Lutte contre sclerotinia Y SYN Y Y Bean 31 et Botrytis à la floraison du haricot, Unilet, H02BPEQ25b GEP, Not Published
Pea
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Pea 1 anthracnose, efficacité des fongicides à la floraison, Unilet, POIS95BPED13a, Not Pertinent, Not Published
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Pea 2 anthracnose : efficacité des fongicides à la floraison, Unilet, POIS95BPED13b, Not Pertinent, Not Published
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Pea 3 Anthracnose, efficacité des fongicides à la floraison, Unilet, POIS95BPE13c, Not Pertinent, Not Published
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Pea 4 anthracnose : efficacité des fongicides à la floraison Unilet, POIS95BPE13d, Not Pertinent, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 74 of 159
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Pea 5 anthracnose : efficacité des fongicides à la floraison, Unilet, POIS95BPEQ13b, Not Pertinent, Not Published
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Pea 6 anthracnose : efficacité de fongicides à la floraison, Unilet, POIS95BPEQ13c, Not Pertinent, Not Published
6/Annex_Mar_ 1998 Lutte contre Botrytis- Y SYN Y Y Pea 7 sclerotina-anthracnose : efficacité des fongicides à la floraison, Unilet, POIS98BPED16a, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Botrytis- Y SYN Y Y Pea 8 Sclerotina-Anthracnose : efficacité des fongicides à la floraison Unilet, POIS98BPED16d, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Botrytis- Y SYN Y Y Pea 9 sclerotinia-anthracnose : efficacité des fongicides à la floraison, Unilet, POIS98BPEQ16a, GEP, Not Published
6/Annex_Mar_ 1998 Lutte contre Botrytis- Y SYN Y Y Pea 10 Sclerotinia-anthracnose : efficacité des fongicides à la floraison, Unilet, POIS98BPEQ16b, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 75 of 159
6/Annex_Mar_ 1999 Lutte contre Botrytis- Y SYN Y Y Pea 11 Sclerotinia-Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS99BPED2a, GEP, Not Published
6/Annex_Mar_ 1999 Lutte contre Botrytis- Y SYN Y Y Pea 12 Sclerotinia-Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS99BPED2b, GEP, Not Published
6/Annex_Mar_ 1999 Lutte contre Botrytis- Y SYN Y Y Pea 13 Sclerotinia-Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS99BPED2c, GEP, Not Published
6/Annex_Mar_ 1999 Lutte contre Botrytis- Y SYN Y Y Pea 14 Sclerotinia-Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS99BPEQ2b, GEP, Not Published
6/Annex_Mar_ 1996 Lutte contre Botrytis et Y SYN Y Y Pea 15 anthracnose : efficacité des fongicides à la floraison, Unilet, POIS96BPED9c, GEP, Not Published
6/Annex_Mar_ 1996 Lutte contre Botrytis et Y SYN Y Y Pea 16 anthracnose : efficacité des fongicides à la floraison, Unilet, POIS96BPEQ9a, Not Pertinent, Not Published
6/Annex_Mar_ 1996 Lutte contre Botrytis et Y SYN Y Y Pea 17 Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS96BPEQ9b, Not Pertinent, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 76 of 159
6/Annex_Mar_ 1999 Lutte contre Botrytis- Y SYN Y Y Pea 18 Sclerotinia-Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS99BPEQ2c, Not Pertinent, Not Published
6/Annex_Mar_ 2004 Vining pea : Efficacy Y SYN Y Y Pea 19 and crop tolerance à A14111B against the main economic diseases of peas, PGRO, trial 1, GEP, Not Published
6/Annex_Mar_ 1995 Lutte contre Botrytis et Y SYN Y Y Pea 20 Anthracnose : efficacité de fongicides à la floraison sur pois de conserve, Unilet, POIS95BPEQ13a, Not Pertinent, Not Published
6/Annex_Mar_ 1998 Lutte contre Botrytis- Y SYN Y Y Pea 21 Sclerotina-Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS98BPED16c, GEP, Not Published
6/Annex_Mar_ 1999 Lutte contre Botrytis- Y SYN Y Y Pea 22 Sclerotinia-Anthracnose : efficacité des fongicides à la floraison, Unilet, POIS99BPEQ2a, GEP, Not Published
6/Annex_Mar_ 2004 Vining pea : Efficacy Y SYN Y Y Pea 23 and crop tolerance à A14111B against the main economic diseases of peas, PGRO, trial2, GEP, Not Published
Strawberry
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 77 of 159
6/Annex_Mar_ 2001 Fungicides, Y SYN Y Y Strawberry 1 RSF, 01/CAELSGOR, GEP, Not Published
6/Annex_Mar_ 2001 Fungicides, Y SYN Y Y Strawberry 2 RSF, 01/ BCELSVEL, GEP, Not Published
6/Annex_Mar_ 2001 Fungicides, Y SYN Y Y Strawberry 3 RSF, 01/BCELSWID, GEP, Not Published
6/Annex_Mar_ 2001 Fungicides, Y SYN Y Y Strawberry 4 RSF, 01/BCELSHER, GEP, Not Published
6/Annex_Mar_ 2001 Fungicides, Y SYN Y Y Strawberry 5 RSF, 01/BCELSHER2, GEP, Not Published
6/Annex_Mar_ 2007 Strawberry GEP- Y SYN Y Y Strawberry 6 Development of SYN520453 against Botrytis, SYN, DESWZF5422006, GEP, Not Published
6/Annex_Mar_ 2007 Strawberry GEP- Y SYN Y Y Strawberry 7 Development of SYN520453 against Botrytis, SYN, DESWZF5432006, GEP, Not Published
6/Annex_Mar_ 2000 Comparison of switch Y SYN Y Y Strawberry 8 and teldor against botrytis on strawberries with 1000l/ha and 2000 l/ha, SYN, DESW0F5882000, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 78 of 159
6/Annex_Mar_ 2000 Comparison of switch Y SYN Y Y Strawberry 9 and tedor against Botrytis on strawberries with 100l/h and 2000l/ha, SYN, DESW0F5892000, GEP, Not Published
6/Annex_Mar_ 1996 Botrytis- Y SYN Y Y Strawberry 8 Bekämpfungsversuch 1996, PSD Karlsruhe, Not Pertinent, Not Published
6/Annex_Mar_ 2008 Gnomonia an Eerdbeere Y SYN Y Y Strawberry 9 (in anlehnung an die Botrytis – Richtlinie) 2008, Landwirtschaftliches technologiezentrum augustenberg, SYD21680 FEB2-2008, GEP, Not Published
Rubus
6/Annex_Mar_ 1999 Grey mould (Botrytis) in Y SYN Y Y Rubus 1 raspberries, RP Freiburg, Trial 1, GEP, Not Published
6/Annex_Mar_ 1999 Grey mould (Botrytis) in Y SYN Y Y Rubus 2 raspberries, LfL Dresden, Trail 2, GEP, Not Published
6/Annex_Mar_ 2000 Grey mould (Botrytis) in Y SYN Y Y Rubus 3 raspberries, LBP Freising, Trial 3, GEP, Not Published
6/Annex_Mar_ 2000 Nye fungicid mot Y SYN Y Y Rubus 4 Graskimmel i bringebaer, Planteforsk Plantevernet, Trail 4, GEP, Not Published
6/Annex_Mar_ 1998 Landwirtschaftskammer Y SYN Y Y Rubus 5 Weser-Ems, Trial 5,6,7, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 79 of 159
6/Annex_Mar_ 2005 Switch 62.5WG ; crop Y SYN Y Y Rubus 6 tolerance in various small fruits, SYN, NLVH0F3172005, ref 21, 22, 23, 24, GEP, Not Published
Ribes
6/Annex_Mar_ 2000 Fruit rot (Botrytis-grey Y SYN Y Y Ribes 1 mould) in currants SLFA Neustadt a.d.W., Trial 8, GEP, Not Published
6/Annex_Mar_ 2001 Colletotrichum and Y SYN Y Y Ribes 2 Botrytis in redcurrants, OVB Jork, Trial 9, GEP, Not Published
6/Annex_Mar_ 2002 Botrytis fruit rot in Y SYN Y Y Ribes 3 redcurrants, SLFA Neustadt a.d.W., Trial 10, GEP, Not Published
6/Annex_Mar_ 1999 Fruit rot (Botrytis) in Y SYN Y Y Ribes 4 cultivated blueberries, OVA Jork, Trial 11, GEP, Not Published
6/Annex_Mar_ 2005 Switch 62.5 WG ; crop Y SYN Y Y Ribes 5 tolerance in various small fruits, SYN, NLVH0F2202005, GEP, Not Published
6/Annex_Mar_ 2005 Switch 62.5 WG ; crop Y SYN Y Y Ribes 6 tolerance in various small fruits, SYN, NLVH0F2212005, Trial 26, 27, 28, GEP, Not Published
Pome Fruit
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 80 of 159
6/Annex_Mar_ 2003 Control of storage in Y SYN Y Y Pome Fruits 1 apple (pre-harvest) with Geoxe and Switch, SYN, NLAP0F122- 2002, GEP, Not Published
6/Annex_Mar_ 2003 Control of storage in Y SYN Y Y Pome Fruits 2 apple (pre-harvest) with Geoxe and Switch, SYN, NLAP0F129- 2002, GEP, Not Published
6/Annex_Mar_ 2003 Switch : competitor Y SYN Y Y Pome Fruits 3 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F1202003, GEP, Not Published
6/Annex_Mar_ 2003 Switch : competitor Y SYN Y Y Pome Fruits 4 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F1212003, GEP, Not Published
6/Annex_Mar_ 2003 Switch : competitor Y SYN Y Y Pome Fruits 5 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F712-2003, GEP, Not Published
6/Annex_Mar_ 2003 Switch : competitor Y SYN Y Y Pome Fruits 6 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F7132003, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 81 of 159
6/Annex_Mar_ 2006 Biological efficacy Y SYN Y Y Pome Fruits 7 evaluation of switch (37.5 & 25.0 WG) against storage diseases on apple and pear by means of preharvest treatments, RSF, 03/BWGDHERSYN, GEP, Not Published
6/Annex_Mar_ 2006 Biological efficacy Y SYN Y Y Pome Fruits 8 evaluation of switch (37.5 & 25.0 WG) against storage diseases on apple and pear by means of preharvest treatments, RSF, 03/BWCONVEGISYN GEP, Not Published
6/Annex_Mar_ 2005 Apple Gep – Efficacity Y SYN Y Y Pome Fruits 9 of A9219B on post harvest diseases, by pre harvest applications, SYN, DESW0F5402004, GEP, Not Published
6/Annex_Mar_ 2006 Switch 62.5 WG : crop Y SYN Y Y Pome Fruits 10 safety and efficacy against storage diseases in apple when applied pre-harvest, SYN, NLAP0F1072004, GEP, Not Published
6/Annex_Mar_ 2006 Switch 62.5 WG : crop Y SYN Y Y Pome Fruits 11 safety and efficacy against storage diseases in apple when applied pre-harvest, SYN, NLAP0F1162004, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 82 of 159
6/Annex_Mar_ 2006 Switch 62.5 WG : crop Y SYN Y Y Pome Fruits 12 safety and efficacy against storage diseases in apple when applied pre-harvest, SYN, NLAP0F1072004, GEP, Not Published
6/Annex_Mar_ 2006 Switch 62.5 WG : crop Y SYN Y Y Pome Fruits 13 safety and efficacy against storage diseases in apple when applied pre-harvest, SYN, NLAP0F1172004, GEP, Not Published
6/Annex_Mar_ 2006 Switch : competitor Y SYN Y Y Pome Fruits 14 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F1222004, GEP, Not Published
6/Annex_Mar_ 2006 Switch : competitor Y SYN Y Y Pome Fruits 15 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F1232004, GEP, Not Published
6/Annex_Mar_ 2006 Switch : competitor Y SYN Y Y Pome Fruits 16 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F7032004, GEP, Not Published
6/Annex_Mar_ 2006 Switch : competitor Y SYN Y Y Pome Fruits 17 comparison for the control of storage diseases in pear when applied pre-harvest, SYN, NLPR0F7042004, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 83 of 159
6/Annex_Mar_ 2006 Biological efficacy Y SYN Y Y Pome Fruits 18 evaluation of Switch (37.5 & 25.0 WG) against storage diseases on apple and pear by means of preharvest treatments, RSF, 04M/Pezima/Gold/JR/ SYN/GEP-57, GEP, Not Published
6/Annex_Mar_ 2006 Biological efficacy Y SYN Y Y Pome Fruits 19 evaluation of Switch (37.5 & 25.0 WG) against storage diseases on apple and pear by means of preharvest treatments, RSF, 04M/Botrci/Conf/V2/ SYN/GEP-56, GEP, Not Published
6/Annex_Mar_ 2004 PSD TU, SYD 21020 F- Y SYN Y Y Pome Fruits 20 01, GEP, Not Published
6/Annex_Mar_ 2004 PSD TU, SYD 21020 F- Y SYN Y Y Pome Fruits 21 02, GEP, Not Published
6/Annex_Mar_ 2006 Switch (37.5 % Y SYN Y Y Pome Fruits 22 cyprodinil – 25% fludioxonil WG) on fresh and processed apples in apple sauce, Proefcentrum fruitteelt v.z.w., 05M/Pezima/Gold/JR/ SYN/GEP-62, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 84 of 159
6/Annex_Mar_ 2007 Biological efficacy Y SYN Y Y Pome Fruits 23 evaluation of Switch (37.5 & 25.0 WG) against Storage diseases on apple and pear by means of preharvest treatments, trial 2005, Proefcentrum fruitteelt v.z.w., 05M/Botrci/Conf/V2/ SYN/GEP-61, GEP, Not Published
6/Annex_Mar_ 2005 PSA HA, SYD 21020 Y SYN Y Y Pome Fruits 24 FAP 1-2005, GEP, Not Published
6/Annex_Mar_ 2005 PSA HA, SYD 21020 Y SYN Y Y Pome Fruits 25 FAP 2-2005, GEP, Not Published
6/Annex_Mar_ 2005 LFP ST, SYD 21020 Y SYN Y Y Pome Fruits 26 FAP4-2005, GEP, Not Published
6/Annex_Mar_ 2006 LTZ AUG, SYD 21020 Y SYN Y Y Pome Fruits 27 FAP 4-2006, GEP, Not Published
6/Annex_Mar_ 2007 LWK NS, Y SYN Y Y Pome Fruits 28 SYD21020FAP1-2006, GEP, Not Published
6/Annex_Mar_ 2007 LWK NS, Y SYN Y Y Pome Fruits 29 SYD2102FAP2-2006, GEP, Not Published
6/Annex_Mar_ 2004 Middelenproef tegen Y SYN Y Y Pome Fruits 30 zwartvruchtrot (Stemphylium vesicarium), Praktijkonderzoek Plant & Omgeving B.V., 2004- 47B, GEP, Not Published
6/Annex_Mar_ 2005 Middelen tegen Y SYN Y Y Pome Fruits 31 zwartvruchtrot (Stemphylium vesicarium), Praktijkonderzoek Plant & Omgeving B.V., 2005- 21, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 85 of 159
6/Annex_Mar_ 2006 Vensterproef Y SYN Y Y Pome Fruits 32 Stemphylium vesicarium op peer met Switch, Praktijkonderzoek Plant & Omgeving B.V., 3261022200, GEP, Not Published
Cherry and plum
6/Annex_Mar_ 1998 Bestrijding van vruchtrot Y SYN Y Y Cherry 1 bij zoete kersen en pruim, Koninklijk Opzoekingsstation van Gorsem, FF97/22(212), GEP, Not Published
6/Annex_Mar_ 1999 Bestrijding van vruchtrot Y SYN Y Y Cherry 2 bij zoete kers, Koninklijk Opzoekingsstation van Goersem, FF99/14 (315) 99/MFLAPNEE, GEP, Not Published
6/Annex_Mar_ 2005 Switch 62.5 WG ; crop Y SYN Y Y Cherry 3 tolerance in various small fruits, SYN, NLVH0F1302005, GEP, Not Published
6/Annex_Mar_ 2005 Switch 62.5 WG ; crop Y SYN Y Y Cherry 4 tolerance in various small fruits, SYN, NLVH0F1312005, GEP, Not Published
6/Annex_Mar_ 2005 Switch 62.5 WG ; crop Y SYN Y Y Cherry 5 tolerance in various small fruits, SYN, NLVH0F1322005, GEP, Not Published
6/Annex_Mar_ 2005 Switch 62.5 WG ; crop Y SYN Y Y Cherry 6 tolerance in various small fruits, SYN, NLVH0F1332005, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 86 of 159
6/Annex_Mar_ 2000 Beschrijving van Y SYN Y Y Cherry 7 vruchtrot bij zoete kersen en pruim, Koninklijk Opzoekingsstation van Goersem, FF 97/22 (212) 98/MFBLEFTC, GEP, Not Published
Seed
6/Annex_Mar_ 2006 Marché porte-graine : Y SYN Y Y Seed 1 Protection phytosanitaire contre le phoma (1ère et 2ème année), FNAMS, P0534, P0634, GEP, Not Published
Mediterranean zone
Annex point Yea Title Data Owner Data Studies r protection protecio relied Source (where SYN = claimed n on? different from Syngenta Y/N granted? Y/N company) Y/N Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Grape
6/Annex_Med_ 2004 CHORUS 50 WG, Y SYN Y Y efficacy against Grape 01 Botrytis and other rots on grapes SYN, FFGR02E4- 2004ES ESNWZF3422004, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 87 of 159
6/Annex_Med_ 2004 CHORUS 50 WG, Y SYN Y Y efficacy against Grape 02 Botrytis and other rots on grapes SYN, FFGR02E4- 2004ES ESNWZF3432004, GEP, Not Published
6/Annex_Med_ 2008 GEOXE 50 WG, Y SYN Y Y registration trials Grape 03 against Botrytis on grapes SYN, FDGR01D4- 2008PT PTBMZF0012008, GEP, Not Published
6/Annex_Med_ 2004 FGR08 - Efficacité de Y SYN Y Y traitements Grape 04 insecticides ou fongicides dans la prévention des mycotoxines en vigne. SYN, FFGR08F4-2004FR, FRPPZF0192004, GEP, Not Published
6/Annex_Med_ 2004 FGR08 - Efficacité de Y SYN Y Y traitements Grape 05 insecticides ou fongicides dans la prévention des mycotoxines en vigne. SYN, FFGR08F4- 2004FR FRPPZF0202004, GEP, Not Published
6/Annex_Med_ 2005 FGR08 - Efficacité de Y SYN Y Y traitements Grape 06 insecticides ou fongicides dans la prévention des mycotoxines en vigne. SYN, FRPPZF0562005
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 88 of 159
6/Annex_Med_ 2005 FGR08 - Efficacité de Y SYN Y Y traitements Grape 07 insecticides ou fongicides dans la prévention des mycotoxines en vigne. SYN, FFGR08F4- 2005FR FRPPZF0572005, GEP, Not Published
6/Annex_Med_ 2006 FGR08 - effiacté de Y SYN Y Y SWITCH et SEKOYA Grape 08 sur Aspergillus et OTA, SYN, FFGR08F3- 2006FR FRPPZF0142006, GEP, Not Published
6/Annex_Med_ 2006 FGR08 - effiacté de Y SYN Y Y SWITCH et SEKOYA Grape 09 sur Aspergillus et OTA, SYN, FFGR08F3- 2006FR FRPPZF0152006, GEP, Not Published
6/Annex_Med_ 2005 Switch tank mix Y SYN Y Y compatibility on table Grape 10 grapes, SYN, FFGR33E4- 2005ES ESES0F4042005, GEP, Not Published
6/Annex_Med_ 2005 Switch tank Y SYN Y Y compatibility on table Grape 11 grapes, SYN, FFGR33E4- 2005ES ESSE0F4052005, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 89 of 159
6/Annex_Med_ 2003 FGR21 - Effets non Y SYN Y Y intentionnels de Grape 12 produits fongicides sur la vinification et la qualité des vins et eaux de vie, SYN, FRCNZF0702003, GEP, Not Published
6/Annex_Med_ 2004 Etude de effets non Y SYN Y Y intentionnels de Grape 13 produits phytopharmaceutiques (fongicides) sur l’élaboration et la qualité des vins, ITV France,03/06/SY/M7, GEP, Not Published
6/Annex_Med_ 2003 FGR21 - Effets non Y SYN Y Y intentionnels de Grape 14 produits fongicides sur la vinification et la qualité des vins et eaux de vie SYN, FRBYZF0752003, GEP, Not Published
6/Annex_Med_ 2004 Etudes des effets non Y SYN Y Y intentionnels de Grape 15 produits phytopharmaceutiques (fongicides) sur l’élaboration et la qualité des vins, ITV France, 03/06/SY/M7, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 90 of 159
6/Annex_Med_ 2003 Influencia del Y SYN Y Y tratamentio con Grape 16 «switch » aplicado en vina en la d.o. ribeiro sobre la fermentacion alcoholica y la calidad de los vinos obtenidos, Estacion de viticultura e enoloxia de galicia, Spanish trial 2002, GEP, Not Published
6/Annex_Med_ 2001 Sperimentazone su Y SYN Y Y marciumi secondary Grape 17 dei grappoli di cultivar ad uva da vino (anno 2000), Il centro di Ricerca e Sperimentazione in Agricoltura «Basile Caramia», Test 1- 12 (2000), GEP, Not Published
6/Annex_Med_ 2002 Il centro di Ricerca e Y SYN Y Y Sperimentazione in Grape 18 Agricoltura «Basile Caramia», Test 1-14 (2001), GEP, Not Published
6/Annex_Med_ 2003 Relazione finale della Y SYN Y Y sperimentazione Grape 19 contro i marciumi secondari del grappolo, anno 2002. Il centro di Ricerca e Sperimentazione in Agricoltura «Basile Caramia», Test 1-19 (2002), GEP, Not Published
Eggplant Y SYN
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 91 of 159
6/Annex_Med_ 1995 ensayos para la Y SYN Y Y obtencion del registro Eggplant 1 del fungici da switch en los cultivos horticolas de berenjena, pepino y tomate, para el control de botrytis spp. SYN, ES030F0421995, Not Pertinent, Not Published
6/Annex_Med_ 1995 control de botrytis Y SYN Y Y cinerea en hortalizas Eggplant 2 protegi- das con switch. alternancia con dicarboximidas y comparacion con scala. SYN, ES030F0431995, Not Pertinent, Not Published
Tomato
6/Annex_Med_ 2000 switch / tomate / Y SYN Y Y botrytis: efecto en el Tomato 1 almacenam iento del fruto despues de aplicaciones en campo, SYN, ESSE0F0122000, GEP, Not Published
6/Annex_Med_ 2000 switch / tomate / Y SYN Y Y botrytis: efecto en el Tomato 2 almacenam iento del fruto despues de aplicaciones en campo SYN, ESSE0F0132000, GEP, Not Published
6/Annex_Med_ 2004 OPA in vegetables Y SYN Y Y against Botrytis Tomato 3 cinerea SYN Spain, ESSE0F2072004, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 92 of 159
6/Annex_Med_ 2008 SYN520453: Control Y SYN Y Y de Botrytis en Tomato 4 Horticolas, solo y en mezcla con Ciprodinil SYN Spain, ESSEZF2012008, GEP, Not Published
Pepper
6/Annex_Med_ 1996 ensayos para la Y SYN Y Y obtencion del registro Pepper 1 del fungici da switch en pimiento para el control de botrytis. SYN, ES030F0071996, Not Pertinent, Not Published
6/Annex_Med_ 1996 ensayos para la Y SYN Y Y obtencion del registro Pepper 2 del fungici da switch en pimiento para el control de botrytis. SYN, ES03F0081996, Not Pertinent, Not Published
6/Annex_Med_ 1997 evaluar la eficacia de Y SYN Y Y la mezcla en tanque de Pepper 3 cga279202 y cga219417 contra botrytis en tomate, pimiento y fresal. SYNt, ESSE0F0141997, GEP, Not Published
Cucurbits
6/Annex_Med_ 1994 control de botrytis Y SYN Y Y cinerea en hortalizas Cucurbit 1 protegi- das, con cga219417+cga17350 6 (3:2) wg 62.5 y cga 219417 en mezclas. SYN, ES040F0071994, Not Pertinent, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 93 of 159
6/Annex_Med_ 1994 control de botrytis Y SYN Y Y cinerea en hortalizas Cucurbit 2 protegi- das, con cga219417+cga17350 6 (3:2) wg 62.5 y cga 219417 en mezclas. SYN, ES040F0081994, Not Pertinent, Not Published
6/Annex_Med_ 1995 ensayos para la Y SYN Y Y obtencion del registro Cucurbit 3 del fungici da switch en los cultivos horticolas de berenjena, pepino y tomate, para el control de botrytis spp. SYN, ES030F0401995, Not Pertinent, Not Published
6/Annex_Med_ 1995 ensayos para la Y SYN Y Y obtencion del registro Cucurbit 4 del fungici da switch en los cultivos horticolas de berenjena, pepino y tomate, para el control de botrytis spp. SYN, ES030F0461995, Not Pertinent, Not Published
Bulb veg
6/Annex_Med_ 1999 efficacy of switch 62,5 Y SYN Y Y wg against botrytis Bulb veg 1 squam osa on onion. SYN, IT7GZF0491999, GEP, Not Published
6/Annex_Med_ 2000 efficacy of switch 62,5 Y SYN Y Y wg against botrytis Bulb veg 2 squam osa on onion. SYN, IT7FZF0172000, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 94 of 159
6/Annex_Med_ 2001 Registration trial on Y SYN Y Y Switch 62,5 wg Bulb veg 3 against Botrytis squamosa on onion . Evaluation of the efficacy of the mixture Switch + Ortiva on downy mildew and grey mould. SYN, IT03ZF0402001, GEP, Not Published
6/Annex_Med_ 2001 Registration trial on Y SYN Y Y Switch 62,5 wg Bulb veg 4 against Botrytis squamosa on onion . Evaluation of the efficacy of the mixture Switch + Ortiva on downy mildew and grey mould. SYN, IT03ZF0412001, GEP, Not Published
6/Annex_Med_ 2009 Switch : Efficacy Y SYN Y Y against Botrytis and Bulb veg 5 sclerotinia on garlic, Not Specified, FRASZF0102009, GEP, Not Published
Leafy Veg
6/Annex_Med_ 2008 SWITCH: Y SYN Y Y Comparación con Leafy Veg 1 SIGNUM para control de Botrytis SYN, ESSEZF4052008, GEP, Not Published
6/Annex_Med_ 2008 SWITCH: Y SYN Y Y Comparación con Leafy Veg 2 SIGNUM para control de Botrytis SYN, ESSEZF4062008, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 95 of 159
6/Annex_Med_ 2000 T04-sensibilité des Y SYN Y Y laitues au switch, Leafy Veg 3 SYN, FRBJ0F0042000, GEP, Not Published
6/Annex_Med_ 2000 T02-Botrytis sur Y SYN Y Y laitue, Leafy Veg 4 SYN, FRCV0F0062000, GEP, Not Published
6/Annex_Med_ 2000 T02-botrytis sur laitue Y SYN Y Y Leafy Veg 5 SYN, FRKKP0F0012000, GEP, Not Published
6/Annex_Med_ 2000 T02-Botrytis sur Y SYN Y Y laitue, Leafy Veg 6 SYN, FRMR0F0032000, GEP, Not Published
6/Annex_Med_ 2000 T03-sclerotinia sur Y SYN Y Y laitue Leafy Veg 7 SYN, FRFP0F0012000, GEP, Not Published
6/Annex_Med_ 2000 T03-sclerotinia sur Y SYN Y Y laitue Leafy Veg 8 SYN, FRLG0F0012000, GEP, Not Published
Bean
6/Annex_Med_ 1997 ensayos para la Y SYN Y Y obtencion del registro Bean 1 del fungici da switch en judia verde para el control de botrytis y/o sclerotinia. SYN, ESSE0F0111997, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 96 of 159
6/Annex_Med_ 1997 ensayos para la Y SYN Y Y obtencion del registro Bean 2 del fungici da switch en judia verde para el control de botrytis y/o sclerotinia. SYN, ESSE0F0131997, GEP, Not Published
Pea
6/Annex_Med_ 2009 SWITCH - Efficacy Y SYN Y Y against botrytis and Pea 1 sclerotinia on Beans and Peas SYN, ITCEZF4102009, GEP, Not Published
Fennel
6/Annex_Med_ 2002 Registration of Switch Y SYN Y Y 62.5 WG against Fennel 1 Sclerotinia spp. on fennel SYN, IT07ZF0282002, GEP, Not Published
6/Annex_Med_ 2002 Registration of Switch Y SYN Y Y 62.5 WG against Fennel 2 Sclerotinia spp. on fennel SYN, IT09ZF0382002, GEP, Not Published
6/Annex_Med_ 2003 Registration of Switch Y SYN Y Y 62.5 WG against Fennel 3 Sclerotinia spp. on fennel SYN, IT09ZF0212003, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 97 of 159
6/Annex_Med_ 2003 Registration of Switch Y SYN Y Y 62.5 WG against Fennel 4 Sclerotinia spp. on fennel SYN, IT07ZF0502003, GEP, Not Published
6/Annex_Med_ 2004 Registration of Switch Y SYN Y Y 62.5 WG against Fennel 5 Sclerotinia spp. on fennel SYN, IT07ZF0452004, GEP, Not Published
6/Annex_Med_ 2004 Registration of Switch Y SYN Y Y 62.5 WG against Fennel 6 Sclerotinia spp. on fennel SYN, IT07ZF0462004, GEP, Not Published
Strawberry
6/Annex_Med_ 2002 Compte rendu d’essai Y SYN Y Y officiel en date du 29- Strawberry 1 11-2001, S.R.P.V. Aquitaine, HM01451, GEP, Not Published
6/Annex_Med_ 2002 Compte rendu d’essai Y SYN Y Y official en date du 03- Strawberry 2 12-2001, S.R.P.V. Aquitaine, HM01452, GEP, Not Published
6/Annex_Med_ 2002 Rapport de synthèse Y SYN Y Y essais : HM01451 et Strawberry 3 HM01452 S.R.P.V. Aquitaine, HM01451, HM01452, GEP, Not Published
6/Annex_Med_ 2002 Compte rendu d’Essai Y SYN Y Y Officiel en date du 22- Strawberry 4 10-02, F.RE.D.O.N. Aquitaine, HM02115, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 98 of 159
6/Annex_Med_ 2002 Compte rendu d’Essai Y SYN Y Y Officiel en date du 25- Strawberry 5 10-02, F.RE.D.O.N. Aquitaine, HM02116, GEP, Not Published
6/Annex_Med_ 2002 Rapport de synthèse Y SYN Y Y des essais HM02115 et Strawberry 6 HM02116, S.R.P.V. Aquitaine, HM02115 et HM02116, GEP, Not Published
6/Annex_Med_ 2008 SWITCH: Y SYN Y Y Comparación con Strawberry 7 SIGNUM para control de Botrytis SYN, ESSWZF1022008, GEP, Not Published
6/Annex_Med_ 2008 SWITCH: Y SYN Y Y Comparación con Strawberry 8 SIGNUM para control de Botrytis SYN, ESSWZF1032008, GEP, Not Published
6/Annex_Med_ 2008 SWITCH: Y SYN Y Y Comparación con Strawberry 9 SIGNUM para control de Botrytis SYN, ESSWZF1042008, GEP, Not Published
6/Annex_Med_ 2002 ORTIVA ON Y SYN Y Y STRAWBERRIES, Strawberry 10 POST-HARVEST EFFECT AFTER FIELD APPLICATIONS. SYN, ESSW0F2032002, GEP, Not Published
Rubus
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 99 of 159
6/Annex_Med_ 2008 Annexe 6 : Données Y SYN Y Y élémentaires relatives Rubus 1 à l’essai efficacité ESSWZF1042007, GEP, Not Published
6/Annex_Med_ 2008 Annexe 7 : Données Y SYN Y Y élémentaires relatives Rubus 2 à l’essai efficacité ESSWZF2102007, GEP, Not Published
Pome Fruits
6/Annex_Med_ 2006 Stemphyliose du Y SYN Y Y Poirier, Pome Fruit 1 Station d’Expérimentation “La Pugère”, PUGPH06019, GEP, Not Published
6/Annex_Med_ 2007 Fruits-Switch in pear Y SYN Y Y Stemphylium and Pome Fruit 2 other deseases, SYN, IT030F0232007, GEP, Not Published
6/Annex_Med_ 2007 FRUITS- SWITCH in Y SYN Y Y pear Stemphylium and Pome Fruit 3 other diseases SYN, IT0040F0442007, GEP, Not Published
6/Annex_Med_ 2007 APPLE: Fludioxonil Y SYN Y Y and fluazinam against Pome Fruit 4 Alternaria SYN, IT02ZF0302007, GEP, Not Published
6/Annex_Med_ 2005 Efficacy of Y SYN Y Y Fludioxonil solo or Pome Fruit 5 Switch on post harvest diseases, by pre harvest applications. Servei Sanitat Vegetal Leida, ESCOZF0012005, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 100 of 159
6/Annex_Med_ 2005 Efficacy of Y SYN Y Y Fludioxonil solo or Pome Fruit 6 Switch on post harvest diseases, by pre harvest applications. SYN, ESNE0F2382005
6/Annex_Med_ 2005 FAP02- Efficacité et Y SYN Y Y Homologation du Pome Fruit 7 Fludioxonil en traitement de Pré- récolte contre les maladies de conservation des pommes (CA), SYN, FSYN043905, GEP, Not Published
6/Annex_Med_ 2006 FAP01- Efficacité et Y SYN Y Y Homologation du Pome Fruit 8 Fludioxonil en traitement de Pré- Récolte contre les maladies de conservation des pommes, SYN, FSYN052803, GEP, Not Published
Stone Fruit
6/Annex_Med_ 2002 Informe Final ensayo Y SYN Y Y de registro, product : Stone Fruit 1 SWITCH, SYN, ESNEZF1382002, GEP, Not Published
6/Annex_Med_ 2004 Informe final ensayo Y SYN Y Y de registro : Producto : Stone Fruit 2 Switch, SYN, ESSWZF1162004, GEP, Not Published
6/Annex_Med_ 2004 Informe final ensayo Y SYN Y Y de registro: Producto Stone Fruit 3 Switch, SYN, ESNE0F2192004; GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 101 of 159
6/Annex_Med_ 2004 Informe final ensayo Y SYN Y Y de registro, producto: Stone Fruit 4 Switch, SYN, ESNE0F1342004, GEP, Not Published
6/Annex_Med_ 2005 Informe final ensayo Y SYN Y Y de registro, producto: Stone Fruit 5 Switch, SYN, ESSWZF2182005, GEP, Not Published
6/Annex_Med_ 2002 Informe Final ensayo Y SYN Y Y de registro : producto Stone Fruit 6 SWITCH, SYN; ESNEZF1312002, GEP, Not Published
6/Annex_Med_ 2003 Informe Final ensayo Y SYN Y Y de registro, Producto : Stone Fruit 7 Switch, SYN, ESNEZF1172003, GEP, Not Published
6/Annex_Med_ 2004 Informe final ensayo Y SYN Y Y de registro, product : Stone Fruit 8 switch, SYN, ESNE0F1362004, GEP, Not Published
6/Annex_Med_ 2005 Informe final ensayo Y SYN Y Y de registro, product: Stone Fruit 9 switch, SYN, ESNEZF1322005, GEP, Not Published
6/Annex_Med_ 2004 Informe final de Y SYN Y Y ensayo de registro, Stone Fruit 10 product : SWITCH, SYN, ESSE0F4042004, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 102 of 159
6/Annex_Med_ 2004 Informe final de Y SYN Y Y registro, producto : Stone Fruit 11 SWITCH, SYN, ESSE0F4052004, GEP, Not Published
6/Annex_Med_ 2004 Informe final de Y SYN Y Y registro, producto: Stone Fruit 12 Switch, SYN, ESNE0F2092004, GEP, Not Published
6/Annex_Med_ 2004 Informe final ensayo Y SYN Y Y de registro, producto: Stone Fruit 13 SWITCH, SYN, ESSW0F2082004, GEP, Not Published
6/Annex_Med_ 2005 Informe final ensayo Y SYN Y Y de registro, producto : Stone Fruit 14 Switch, SYN, ESSWZF3082005, GEP, Not Published
6/Annex_Med_ 2005 Informe final ensayo Y SYN Y Y de registro, producto: Stone Fruit 15 SWITCH, SYN, ESCEZF1202005, GEP, Not Published
6/Annex_Med_ 2004 Informe final ensayo Y SYN Y Y de registro, producto : Stone Fruit 16 SWITCH, SYN, ESNE0F2102004, GEP, Not Published
6/Annex_Med_ 2005 Informe final ensayo Y SYN Y Y de registro, producto: Stone Fruit 17 Switch, SYN, ESCE0F1212005, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 103 of 159
6/Annex_Med_ 2006 SCORE, Switch, Y SYN Y Y Chorus, registration Stone Fruit 18 trials on cherries SYN, ESCEZF1262006, GEP, Not Published
Tobacco
6/Annex_Med_ 2004 Efficacité de produits à Y SYN Y Y l’égard de la Tobacco 1 sclérotiniose (Sclérotinia sclerotiorium) sur tabac en plein champ, Institut du tabac, N_Z0436, GEP, Not Published
6/Annex_Med_ 2005 Efficacité de produits à Y SYN Y Y l’égard de la Tobacco 2 sclérotiniose (Sclérotinia sclerotiorium) sur tabac en plein champ, Institut du tabac, N_Z05-38, GEP, Not Published
6/Annex_Med_ 2007 Efficacité de produits à Y SYN Y Y l’égard de la Tobacco 3 sclérotiniose (Sclérotinia sclerotiorium) sur tabac en plein champ, Institut du tabac, NZ0730, GEP, Not Published
North East zone
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 104 of 159
Annex point Year Title Data Owner Data Studies protection protection relied Source (where SYN = claimed granted? on? Y/N different from Syngenta Y/N Y/N company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished
Tomato
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ skutecznosci fungicydu Switch Tomato 01 62.5 WG w ochronie pomidorow przed chorobami w uprawie pod oslonami, Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2002/1, GEP, Not Published
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ skutecznosci fungicydu Switch Tomato 02 62.5 WG w ochronie pomidorow przed chorobami w uprawie pod oslonami, Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2002/2, GEP, Not Published
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ skutecznosci fungicydu Switch Tomato 03 62.5 WG w ochronie pomidorow przed chorobami w uprawie pod oslonami, Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2003/1, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 105 of 159
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ skutecznosci fungicydu Switch Tomato 04 62.5 WG w ochronie pomidorow przed chorobami w uprawie pod oslonami, Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2003/2, GEP, Not Published
Bean
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Bean 1 skutecznosci fungicydu Switch 62.5 WG w ochronie fasoli szparagowej przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2002/1, GEP, Not Published
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Bean 2 skutecznosci fungicydu Switch 62.5 WG w ochronie fasoli szparagowej przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2002/2, GEP, Not Published
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Bean 3 skutecznosci fungicydu Switch 62.5 WG w ochronie fasoli szparagowej przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2003/1, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 106 of 159
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Bean 4 skutecznosci fungicydu Switch 62.5 WG w ochronie fasoli szparagowej przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2003/2, GEP, Not Published
Peas
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Pea 1 skutecznosci fungicydu Switch 62.5 WG w ochronie grochu przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2002/1, GEP, Not Published
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Pea 2 skutecznosci fungicydu Switch 62.5 WG w ochronie grochu przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2002/2, GEP, Not Published
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Pea 3 skutecznosci fungicydu Switch 62.5 WG w ochronie grochu przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2003/1, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 107 of 159
6/Annex_North 2009 Ocena biologicznej Y SYN Y Y East_ Pea 4 skutecznosci fungicydu Switch 62.5 WG w ochronie grochu przed chorobami Zaklad Ochrony Roslin, Pracownia Fitopatologii, Trial 2003/2, GEP, Not Published
Strawberry
6/Annex_North 2007 The evaluation of Y SYN Y Y East_ biological efficacy of Strawberry 1 the product SWITCH 62,5 WG used at the doses 0,8 kg/ha and 1,2 kg/ha against grey mould ( Botrytis cinerea Pers.) in strawberry. Research institute of pomology and floriculture in skierniewice, OR/21/2007/2A/I, GEP, Not Published
6/Annex_North 2008 The evaluation of Y SYN Y Y East_ biological efficacy of Strawberry 2 the product SWITCH 62,5 WG used at the doses 0,8 kg/ha and 1,2 kg/ha against grey mould ( Botrytis cinerea Pers.) in strawberry. Research institute of pomology and floriculture in skierniewice, OR/27/2008/1A, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 108 of 159
6/Annex_North 2002 The evaluation of Y SYN Y Y East_ biological efficacy of Strawberry 3 the product SWITCH 62,5 WG used at the doses 0,8 kg/ha and 1,2 kg/ha against grey mould ( Botrytis cinerea Pers.) in strawberry. Research institute of pomology and floriculture in skierniewice, OR/8/2002/II, GEP, Not Published
Raspberry Y SYN Y Y
6/Annex_North 2005 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 1 62,5 WG used at doses 0,8 and 1,0 kg/ha against the sprout necrosis (Didymella applantata Niessl. and Botrytis cinerea Pers.) in raspberry, Research institute of pomology and floriculture in skierniewice, OR/18/2005/1, GEP, Not Published
6/Annex_North 2005 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 2 62.5 WG used at doses 0.8 and 1.0 kg/ha against grey mould (Botrytis cinerea Pers.) in raspberry, Research institute of pomology and floriculture in skierniewice, OR/18/2005/2, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 109 of 159
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 3 62.5 WG used at doses 0.8 and 1.0 kg/ha against grey mould (Botrytis cinerea Pers.) in raspberry, Research institute of pomology and floriculture in skierniewice, OR/23/2005/1/I, GEP, Not Published
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 4 62.5 WG used at doses 0.8 and 1.0 kg/ha against grey mould (Botrytis cinerea Pers.) in raspberry, Research institute of pomology and floriculture in skierniewice, OR/23/2005/1/II, GEP, Not Published
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 5 62.5 WG used at doses 0.8 and 1.0 kg/ha against grey mould (Botrytis cinerea Pers.) in raspberry, Research institute of pomology and floriculture in skierniewice, OR/23/2005/1/III, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 110 of 159
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 6 62.5 WG used at doses 0.8 and 1.0 kg/ha against grey mould (Botrytis cinerea Pers.) in raspberry, Research institute of pomology and floriculture in skierniewice, OR/23/2005/1/IV, GEP, Not Published
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 7 62.5 WG used at doses 0.8 and 1.0 kg/ha against the sprout necrosis in raspberry (Didymella applantata Niessl, Botrytis cinerea Pers.), Research institute of pomology and floriculture in skierniewice, OR/23/2005/2/I, GEP, Not Published
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 8 62.5 WG used at doses 0.8 and 1.0 kg/ha against the sprout necrosis in raspberry (Didymella applantata Niessl, Botrytis cinerea Pers.), Research institute of pomology and floriculture in skierniewice, OR/23/2005/2/II, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 111 of 159
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 9 62.5 WG used at doses 0.8 and 1.0 kg/ha against the sprout necrosis in raspberry (Didymella applantata Niessl, Botrytis cinerea Pers.), Research institute of pomology and floriculture in skierniewice, OR/23/2005/2/III, GEP, Not Published
6/Annex_North 2006 The efficacy of the Y SYN Y Y East_ Raspberry fungicide SWITCH 10 62.5 WG used at doses 0.8 and 1.0 kg/ha against the sprout necrosis in raspberry (Didymella applantata Niessl, Botrytis cinerea Pers.), Research institute of pomology and floriculture in skierniewice, OR/23/2005/2/IV, GEP, Not Published
Floriculture trials Indoor experimentation
Annex Year Title Data Owner Data Studies point protecti protecti relied Source (where different SYN = on on on? Y/N from company) Syngent claimed granted a Company, Report No. Y/N ? Y/N GLP or GEP status (where relevant) Published or Unpublished
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 112 of 159
6/Annex_Tr 1995 Compte Rendu d’essai Y SYN Y Y ialReferenc officiel en date du 24-08- e 1 95, Botrytis du rosier, Service de la Protection des végétaux, E495010, Not Pertinent, Not Published
6/Annex_Tr 1995 Lutte contre le botrytis Y SYN Y Y ialReferenc cinerea sur culture e 2 ornementale, S.A. Ciba-Geigy, FRLF0F0221995, Not Pertinent, Not Published
6/Annex_Tr 1995 Tester l’efficacité et la Y SYN Y Y ialReferenc sélectivité d’un nouveau e 3 fongicide, C.D.H.R.O., 95H21, Not Pertinent, Not Published
6/Annex_Tr 1995 Test sélectivité M3110 sur Y SYN Y Y ialReferenc Gerbera, e 4 SCRADH, Not Pertinent, Not Published
6/Annex_Tr 1995 Test sélectivité M3110 sur Y SYN Y Y ialReferenc rosier, e 5 SCRADH, Not Pertinent, Not Published
6/Annex_Tr 1995 Botrytis sur Hortnsia Y SYN Y Y ialReferenc (M3110) e 6 BHR, Not Pertinent, Not Published
6/Annex_Tr 1995 Lutte contre le Botrytis Y SYN Y Y ialReferenc avec le M 3110 (Ciba) sur e 7 cyclamen, I.F.H.P., 95.14, Not Pertinent, Not Published
6/Annex_Tr 1995 Lutte chimique contre le Y SYN Y Y ialReferenc Botrytis , e 8 I.F.H.P., 169-95, Not Pertinent, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 113 of 159
6/Annex_Tr 1996 Lutte contre le botrytis Y SYN Y Y ialReferenc cinerea sur cultures e 9 ornementales, S.A. Ciba-Geigy, FRLF0F0501996, Not Pertinent, Not Published
6/Annex_Tr 1996 Lutte contre le botrytis Y SYN Y Y ialReferenc cinerea sur cultures e 10 ornementales, S.A. Ciba-Geigy, FRFP0F0011996, Not Pertinent, Not Published
6/Annex_Tr 1996 Lutte contre le botrytis Y SYN Y Y ialReferenc cinerea sur cultures e 11 ornenmentales, S.A. Ciba-Geigy, FRFP0F0021996, Not Pertinent, Not Published
6/Annex_Tr 1996 Lutte contre le Botrytis sur Y SYN Y Y ialReferenc cultures ornementales, e 12 S.A. Ciba-Geigy, FRFP0F0031996, Not Pertinent, Not Published
6/Annex_Tr 1996 Lutte contre le Botrytis sur Y SYN Y Y ialReferenc cultures ornementales, e 13 S.A. Ciba-Geigy, FRLF0F0511996, Not Pertinent, Not Published
6/Annex_Tr 1996 Etudier la sélectivité de Y SYN Y Y ialReferenc l’association 219417 + e 14 173506 sur rosiers, S.A. Ciba-Geigy, FRFP0F0141996, Not Pertinent, Not Published
6/Annex_Tr 1996 Tester l’efficacité et la Y SYN Y Y ialReferenc sélectivité d’un nouveau e 15 fongicide, C.D.H.R., 96H26, Not Pertinent, Not Published
6/Annex_Tr 1996 Tester l’efficacité et la Y SYN Y Y ialReferenc sélectivité d’un nouveau e 16 fongicide, C.D.H.R., 96H27, Not Pertinent, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 114 of 159
6/Annex_Tr 1996 Etude de l’efficacité d’un Y SYN Y Y ialReferenc anti-botrytis sur Hortensia, e 17 B.H.R., Not Pertinent, Not Published
6/Annex_Tr 1996 Lutte chimique contre le Y SYN Y Y ialReferenc Botrytis, e 18 I.F.H.P., 188-96, Not Pertinent, Not Published
6/Annex_Tr 1997 Lutte contre le botrytis sur Y SYN Y Y ialReferenc cultures ornementales, e 19 S.A. Ciba-Geigy, FRFP0F0511997, Not Pertinent, Not Published
6/Annex_Tr 1997 Lutte contre le botrytis sur Y SYN Y Y ialReferenc cultures ornementales, e 20 S.A. Ciba-Geigy, FRLF0F0031997, Not Pertinent, Not Published
6/Annex_Tr 2000 Crop safety of Lex 9715 in Y SYN Y Y ialReferenc ornmentals, e 21 Novartis Agro Benelux, SF-99-1001, GEP, Not Published
6/Annex_Tr 2000 Crop safety of Lex 9715 in Y SYN Y Y ialReferenc ornmentals, e 22 Novartis Agro Benelux, SF-99-1002, GEP, Not Published
6/Annex_Tr 2000 Crop safety of Lex 9715 in Y SYN Y Y ialReferenc ornmentals, e 23 Novartis Agro Benelux, SF-99-1003, GEP, Not Published
6/Annex_Tr 2000 Control of Grey Mould Y SYN Y Y ialReferenc (Botrytis Cinerea = e 24 Botrytis Fuckeliana) in ornementals, Novartis Agro Benelux, SF-99-13-01, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 115 of 159
6/Annex_Tr 2000 Control of Grey Mould Y SYN Y Y ialReferenc (Botrytis Cinerea = e 25 Botrytis Fuckeliana) in ornementals, Novartis Agro Benelux, SF-99-13-02, GEP, Not Published
6/Annex_Tr 2000 Control of Grey Mould Y SYN Y Y ialReferenc (Botrytis Cinerea = e 26 Botrytis Fuckeliana) in ornementals, Novartis Agro Benelux, SF-99-13-03, GEP, Not Published
6/Annex_Tr 2000 Control of Grey Mould Y SYN Y Y ialReferenc (Botrytis Cinerea = e 27 Botrytis Fuckeliana) in ornementals, Novartis Agro Benelux, SF-99-13-04, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Lex 9404 Y SYN Y Y ialReferenc and Lex 9715 in pot plants, e 28 Novartis Agro Benelux, SF 99-14-01, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Lex 9404 Y SYN Y Y ialReferenc and Lex 9715 in pot plants, e 29 Novartis Agro Benelux, SF 99-14-02, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Lex 9404 Y SYN Y Y ialReferenc and Lex 9715 in pot plants, e 30 Novartis Agro Benelux, SF 99-14-03, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Switch 62.5 Y SYN Y Y ialReferenc WG in ornementals, e 31 Novartis Agro Benelux, NLSF0F0412000, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Switch 62.5 Y SYN Y Y ialReferenc WG in ornementals, e 32 Novartis Agro Benelux, NLSF0F0422000, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 116 of 159
6/Annex_Tr 2000 Crop Safety of Switch 62.5 Y SYN Y Y ialReferenc WG in ornementals, e 33 Novartis Agro Benelux, NLSF0F0432000, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Switch 62.5 Y SYN Y Y ialReferenc WG in ornementals, e 34 Novartis Agro Benelux, NLSF0F0442000, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Switch 62.5 Y SYN Y Y ialReferenc WG in ornementals, e 35 Novartis Agro Benelux, NLSF0F0452000, GEP, Not Published
6/Annex_Tr 2000 Crop Safety of Switch 62.5 Y SYN Y Y ialReferenc WG in ornementals, e 36 Novartis Agro Benelux, NLSF0F0462000, GEP, Not Published
6/Annex_Tr 2000 Control of Botrytis cinerea Y SYN Y Y ialReferenc in ornamentals with Switch e 37 62,5 WG., Novartis Agro Benelux, NLSF0F0432000, GEP, Not Published
6/Annex_Tr 2000 Control of Botrytis cinerea Y SYN Y Y ialReferenc in ornamentals with Switch e 38 62,5 WG., Novartis Agro Benelux, NLSF0F0502000, GEP, Not Published
6/Annex_Tr 2000 Visible residue of Switch Y SYN Y Y ialReferenc 62.5 WG in ornementals, e 39 Novartis, NLSF0F047200, GEP, Not Published
6/Annex_Tr 2000 Visible residue of Switch Y SYN Y Y ialReferenc 62.5 WG in ornementals, e 40 Novartis, NLSF0F048200, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 117 of 159
6/Annex_Tr 1999 Etude de la sélectivité du Y SYN Y Y ial M3110 (anti-botrytis) en Reference culture de Gerbera sous 54 serre), C.R.E.A.T., GEP, Not Published
6/Annex_Tr 1999 Etude de la sélectivité du Y SYN Y Y ial M3110 (anti-botrytis) en Reference culture de cyclamen en pot 55 sous serre, C.R.E.A.T., GEP, Not Published
6/Annex_Tr 1999 Etude de la sélectivité du Y SYN Y Y ial M3110 (anti-botrytis) en Reference culture de rosiers sous 56 serre, C.R.E.A.T., GEP, Not Published
6/Annex_Tr 2000 Beheersing en biologische Y SYN Y Y ialReferenc bestrijding van schimmels, e 41 Bestrijding van Botrytis in stekken van Acer Boomteeltpraktijkonderzoe k – Boskoop, 1305-13, GEP, Not Published
6/Annex_Tr 2000 Beheersing en biologische Y SYN Y Y ialReferenc bestrijding van schimmels, e 42 Bestrijding van Botrytis in stekken van Clematis Boomteeltpraktijkonderzoe k – Boskoop, 1305-14, GEP, Not Published
6/Annex_Tr 2002 Bestrijding van Botrytis in Y SYN Y Y ialReferenc stekken van Clematis, e 43 Praktijkonderzoek plant & omgeving, 311305-18a, GEP, Not Published
6/Annex_Tr 2002 Bestrijding van Botrytis in Y SYN Y Y ialReferenc stekken van Juniperus, e 44 Praktijkonderzoek plant & omgeving, 311305-19a, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 118 of 159
6/Annex_Tr 2006 Switch 62.5 WG: Crop Y SYN Y Y ialReferenc Safety in tree nursery stock, e 46 Syngenta, NLNS0F123- 2005, GEP, Not Published
6/Annex_Tr 2006 Switch 62.5 WG: Crop Y SYN Y Y ialReferenc Safety in tree nursery stock, e 47 Syngenta, NLNS0F124- 2005, GEP, Not Published
6/Annex_Tr 2006 Switch 62.5 WG: Crop Y SYN Y Y ialReferenc Safety in tree nursery stock, e 48 Syngenta, NLNS0F613- 2005, GEP, Not Published
6/Annex_Tr 2006 Switch 62.5 WG: Crop Y SYN Y Y ialReferenc Safety in tree nursery stock, e 49 Syngenta, NLNS0F614- 2005, GEP, Not Published
6/Annex_Tr 2005 Control of Botrytis cinerea Y SYN Y Y ialReferenc in tree nursery stock, e 52 Agro Research International, ARI-05F- 088-03, GEP, Not Published
6/Annex_Tr 2005 Control of Botrytis cinerea Y SYN Y Y ialReferenc in tree nursery stock, e 53 Agro Research International, ARI-05F- 088-04, GEP, Not Published
6/Annex_Tr 2005 Acquisition de references Y SYN Y Y ialReferenc sur la sélectivité de e 57 produits phytopharmaceutiques. Etude de la sélectivité de Switch sur plants de pépinière, B.H.R, GEP, Not Published
6/Annex_Tr 2005 Etude de la sélectivité de Y SYN Y Y ialReferenc différents fongicides e 58 utilisés contre l’apparition de taches foliaires contre le Botrytis ou le Mildiou sur Hebe et azalées, CATE, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 119 of 159
Maritime zone
Annex Year Title Data Owner Data Studies point protecti protecti relied Source (where different SYN = on on on? Y/N from company) Syngent claimed granted? a Company, Report No. Y/N Y/N GLP or GEP status (where relevant) Published or Unpublished
6/Annex_Tr 1999 Etude de l’intérêt de Y SYN Y Y ialReferenc nouvelles matières actives e 59 contre le marssonina du rosier, Staphyt, F99-16- 02(G19),FNOV-99-23-14, GEP, Not Published
6/Annex_Tr 1999 Etude de l’intérêt de Y SYN Y Y ialReferenc nouvelles matières actives e 60 contre l’oïdium du rosier, Staphyt, F99-16-01, FNOV-99-22-05, GEP, Not Published
6/Annex_Tr 1999 Etude de l’intérêt de Y SYN Y Y ialReferenc nouvelles matières actives e 61 contre la rouille du rosier, Staphyt, F 99-16-05, FNOV-99-22-00,GEP, Not Published
6/Annex_Tr 1999 Etude de l’intérêt de Y SYN Y Y ialReferenc nouvelles matières actives e 62 contre le marssonina du rosier, Staphyt, F99-16-03, FNOV 99 44 79, GEP, Not Published
6/Annex_Tr 2003 A9219B, a wettable Y SYN Y Y ialReferenc granule containing 25% e 67 fludioxonil and 37.5% cyprodinil for the protective control of Botrytis tulipae in tulips. Syngenta Crop Protection BV. BAD. 01/00 Supplement 1. Not published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 120 of 159
6/Annex_Tr 2005 Control of Botrytis cinerea Y SYN Y Y ialReferenc in tree nursery stock, e 50 Agro research International, ARI-05-F- 088-01, GEP, Not Published
6/Annex_Tr 2005 Control of Botrytis cinerea Y SYN Y Y ialReferenc in tree nursery stock, e 51 Agro research International, ARI-05-F- 088-02, GEP, Not Published
6/Annex_Tr 2005 Beheersstrategie voor Y SYN Y Y ialReferenc Botrytis Paeoniae in pioen , e 45 Effectiviteit van bestrijding van bovengrondse aantasting, Praktijkonderzoek Plant & Omgeving, PP04111-1044, GEP, Not Published
6/Annex_Tr 2000 Essai de sélectivité de 3 Y SYN Y Y ialReferenc spécialités commerciales, e 63 C.D.H.R, CDHRC 00PB3, GEP, Not Published
6/Annex_Tr 2001 Test de sélectivité de Y SYN Y Y ialReferenc Botryl,Chess,et Lusty sur e 64 Marix, Arexhor, Fev-01-Maj, GEP, Not Published
6/Annex_Tr 2005 Essai sélectivité de produits Y SYN Y Y ialReferenc phytosanitaires en vue e 65 d’extension d’homologation par assimilation-arbres et arbustes, switch C.D.H.R., 05HP02, GEP, Not Published
6/Annex_Tr 2005 Etude de la sélectivité de Y SYN Y Y ialReferenc différents fongicides e 58 utilisés contre l’apparition de taches foliaires contre le Botrytis ou le Mildiou sur Hebe et azalées, CATE, GEP, Not Published
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 121 of 159
Mediterranean zone
Annex Year Title Data Owner Data Studies point protecti protecti relied Source (where different SYN = on on on? Y/N from company) Syngent claimed granted? a Company, Report No. Y/N Y/N GLP or GEP status (where relevant) Published or Unpublished
6/Annex_Tr 1999 Etude de l’intérêt de SYN Y Y ialReferenc nouvelles matières actives e 66 contre la rouille du rosier, Staphyt, F991604(G18), GEP, Not Published
6/Annex_Tr 1995 Ortensia per vaso fiorito : Y - Y Y ialReferenc lotta chimica alla muffa e 68 grigia, Ricarda e sperimentazione, Divapra-Patologia vegetale, Università di torino, Centro regionale di sperimentazione e assistenza agricola, Not Pertinent, Published
National Addendum Data Used Y/N Annex Year Title Data Owner protect point protect Source (where different from ion ion company) grante claime d Y/N Company, Report No. d Y/N GLP or GEP status (where relevant) Published or Unpublished IIIA 2010 Biological Assessment Y Syngent N Y 6.0/01 Dossier for Switch, a Syngenta Unpublished IIIA 2012 Addendum to core Y Syngent N Y 6.0/02 Biological Assessment a Dossier, Syngenta Crop Protection B.V.
Unpublished
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 122 of 159
Data Used Y/N Annex Year Title Data Owner protect point protect Source (where different from ion ion company) grante claime d Y/N Company, Report No. d Y/N GLP or GEP status (where relevant) Published or Unpublished IIIA 2011 Advice report Core Y Syngent N Y 6.0/03 Assessment Central a Zone, Linge Agroconsultancy B.V.
Lds11syngenta04
Unpublished
IIIA 2012 Advice report National Y Syngent N Y 6.0/03A Addendum to Core a Assessment Central Zone, The Netherlands. Linge Agroconsultancy B.V., Lda12syngenta07. Unpublished
IIIA 2009 Bestrijding Sclerotinia in Y Syngent Y Y 6.1/04 witlof 2008/2009 a Proeftuin Zwaagdijk, G08268, G08269 GEP, unpublished IIIA 2010 Bestrijding Sclerotinia in Y Syngent Y Y 6.1/05 witlof a Proeftuin Zwaagdijk, 10403, 10404 GEP, unpublished IIIA 2011 Wortelbehandeling met Y Syngent Y Y 6.2/06 Switch a Nationale Proeftuin voor Witloof, 3_1011_010 GEP, unpublished
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 123 of 159
Data Used Y/N Annex Year Title Data Owner protect point protect Source (where different from ion ion company) grante claime d Y/N Company, Report No. d Y/N GLP or GEP status (where relevant) Published or Unpublished IIIA 2010 Selectiviteit van Switch in Y Syngent Y Y 6.2/07 komkommer en aubergine a Proeftuin Zwaagdijk, 09575-09633, 10550- 10554 GEP, unpublished
Annex Title Data Owner Included in EU Data Study point Source (where different from protection submission/ protection used company) claimed Y/N SYN = review granted Company, Report No. Syngenta Y/N GLP or GEP status (where Y/N Y/N relevant) Published or Unpublished KIIIA CGA 173506 + CGA 219417 Y SYN Y N Y 7.1.1 / WG 62.5 (A-9219 B) - Acute 01 oral toxicity in the rat. Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Stein, Switzerland, 933182 GLP, not published Syngenta File No CGA173506/0453 KIIIA CG 215 WG - Acute oral Y SYN Y N Y 7.1.1 / toxicity (limit test) in the rat. 02 Novartis Crop Protection AG, Basel, Switzerland Safepharm Laboratories Ltd., Shadlow, United Kingdom, SPL 184/075 GLP, not published Syngenta File No CGA173506/0949 KIIIA CGA 173506 + CGA 219417 Y SYN Y N Y 7.1.2 / WG 62.5 (A-9219 B) - Acute 01 dermal toxicity in the rat. Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Stein, Switzerland, 933183 GLP, not published Syngenta File No CGA173506/0452
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 124 of 159
Annex Title Data Owner Included in EU Data Study point Source (where different from protection submission/ protection used company) claimed Y/N SYN = review granted Company, Report No. Syngenta Y/N GLP or GEP status (where Y/N Y/N relevant) Published or Unpublished KIIIA CGA 173506 + CGA 219417 Y SYN Y N Y 7.1.3 / WG 62.5 (A-9219 B) - Acute 01 inhalation toxicity study in rats Novartis Crop Protection AG, Basel, Switzerland Stillmeadow Inc., Houston, USA, 4311-98 GLP, not published Syngenta File No CGA173506/1156 KIIIA Acute dermal Y SYN Y N Y 7.1.4 / irritation/corrosion study in the 01 rabbit. Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Stein, Switzerland, 933184 GLP, not published Syngenta File No CGA173506/0458 KIIIA Primary dermal irritation study Y SYN Y N Y 7.1.4 / of CGA 173506 / CGA 219417 02 62.5WG (A-9219 B) in rabbits Novartis Crop Protection AG, Basel, Switzerland Covance Laboratories, Madison WI, USA, 428-98 / 80405573 GLP, not published Syngenta File No CGA173506/5290 KIIIA CGA 173506 + CGA 219417 Y SYN Y N Y 7.1.5 / WG 62.5 (A-9219 B) - Acute 01 eye irritation/corrosion study in the rabbit. Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Stein, Switzerland, 933185 GLP, not published Syngenta File No CGA173506/0463 KIIIA CGA 173506 + CGA 219417 Y SYN Y N Y 7.1.6 / WG 62.5 (A-9219 B) - Skin 01 sensitization test in the Guinea pig - Buehler test. Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Stein, Switzerland, 933186 GLP, not published Syngenta File No CGA173506/0487
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 125 of 159
Annex Title Data Owner Included in EU Data Study point Source (where different from protection submission/ protection used company) claimed Y/N SYN = review granted Company, Report No. Syngenta Y/N GLP or GEP status (where Y/N Y/N relevant) Published or Unpublished KIIIA Dermal sensitization study of Y SYN Y N Y 7.1.6 / CGA 173506 / CGA 219417 02 62.5WG (A-9219 B) in Guinea pigs - closed patch technique (EPA Guideline 81-6) Novartis Crop Protection AG, Basel, Switzerland Covance Laboratories, Madison WI, USA, 429-98 / 80405575 GLP, not published Syngenta File No CGA173506/5292 KIIIA CGA 173506 + CGA 219417 Y SYN Y N Y 7.1.6 / WG 62.5 (A-9219 B) - Skin 03 sensitization test in Guinea pigs (Maximization method of Magnusson B. and Kligman A.M.). Novartis Crop Protection AG, Basel, Switzerland Centre International de Toxicologie C.I.T., Evreux, France, 12321 TSG GLP, not published Syngenta File No CGA173506/0586 KIIIA CG 215 WG - Magnusson & Y SYN Y N Y 7.1.6 / Kligman Maximization study in 04 the Guinea pig. Novartis Crop Protection AG, Basel, Switzerland Safepharm Laboratories Ltd., Shadlow, United Kingdom, SPL 184/080 GLP, not published Syngenta File No CGA173506/0954 KIIIA Refined operator risk N SYN N N N 7.3.1 / assessment for A9219B 01 Syngenta European Product Registration, Basel, Switzerland, Not GLP, not published Syngenta File No A9219B_11505
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 126 of 159
Annex Title Data Owner Included in EU Data Study point Source (where different from protection submission/ protection used company) claimed Y/N SYN = review granted Company, Report No. Syngenta Y/N GLP or GEP status (where Y/N Y/N relevant) Published or Unpublished KIIIA Summary Report zur Studie N IVA Y N Y 7.3.1 / EF 94-02-03 - Operator 02 Exposure in Greenhouse During Practical Use of Plant Protection Products Novartis Crop Protection AG, Basel, Switzerland ECON Forschung und Bewertungskonzepte, Ingelheim, Germany, ef 94-02- 03 Not GLP, not published Syngenta File No N/0687 KIIIA Final Report - Operator N IVA Y N Y 7.3.1 / Exposure in Greenhouses (German 03 during Practical Use of Plant Authority Protection Products report) Novartis Crop Protection AG, Basel, Switzerland ECON Forschung und Bewertungskonzepte, Ingelheim, Germany, EF 94- 02-03 Not GLP, not published Syngenta File No N/0688 KIIIA Switch 62.5 WG: Y SYN N Y Y 7.3.3 / Determination of Dermal and 01 Inhalation Exposure to Operators during Mixing/Loading and Application using SWITCH 62.5 WG (Water Dispersible Granules Formulation of 375 g/kg Cyprodinil) with Open Cabin Tractor mounted Air Assisted Sprayers applied to Grapes, Italy 2006 Syngenta - Jealott’s Hill, Bracknell, United Kingdom Harlan Laboratories Ltd., Zelgliweg 1, 4452 Itingen, Switzerland, A44346 GLP, not published Syngenta File No A9219B_11511
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 127 of 159
Annex Title Data Owner Included in EU Data Study point Source (where different from protection submission/ protection used company) claimed Y/N SYN = review granted Company, Report No. Syngenta Y/N GLP or GEP status (where Y/N Y/N relevant) Published or Unpublished KIIIA Measurements of dislodgeable Y SYN N Y Y 7.5.1 / foliar residues of cyprodinil on 01 leaves in vineyards after application of switch 62.5 WG (water dispersible granules formulation of 375 g/kg cyprodinil), Italy 2006 Syngenta - Jealott’s Hill, Bracknell, United Kingdom RCC Ltd., Itingen, Switzerland, A54990 GLP, not published Syngenta File No A9219B_11422 KIIIA Dermal absorption of [Phenyl- Y SYN Y N Y 7.6.1 / U-14C] CGA 219417 01 formulated as SWITCH R 62.5 WG (A-9219 B) in the rat. Novartis Crop Protection AG, Basel, Switzerland Novartis - Basel, Basel, Switzerland, 028AM04 GLP, not published Syngenta File No CGA219417/0898 KIIIA Dermal absorption of [Phenyl- Y SYN Y N Y 7.6.1 / U-14C] CGA 173506 02 formulated as SWITCH R 62.5 WG (A-9219 B) in the rat. Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection AG, Basel, Switzerland, 023AM02 GLP, not published Syngenta File No CGA173506/1396 KIIIA SWITCH 62.5 WG (A-9219B): Y SYN N Y Y 7.6.2 / In Vitro Absorption Of 01 Cyprodinil Through Rat Epidermis Syngenta Crop Protection AG, Basel, Switzerland Central Toxicology Laboratory (CTL), Cheshire, United Kingdom, JV1864 GLP, not published Syngenta File No CGA173506/6644
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 128 of 159
Annex Title Data Owner Included in EU Data Study point Source (where different from protection submission/ protection used company) claimed Y/N SYN = review granted Company, Report No. Syngenta Y/N GLP or GEP status (where Y/N Y/N relevant) Published or Unpublished KIIIA SWITCH 62.5 WG (A-9219B): Y SYN N Y Y 7.6.2 / In Vitro Absorption Of 02 Cyprodinil Through Human Epidermis Syngenta Crop Protection AG, Basel, Switzerland Central Toxicology Laboratory (CTL), Cheshire, United Kingdom, JV1865 GLP, not published Syngenta File No CGA173506/6677 KIIIA Fludioxonil/Cyprodinil 62.5 WG Y SYN Y Y Y 7.6.2 / (A9219B): In Vitro Dermal 03 Absorption of Fludioxonil Through Rat Epidermis Syngenta Crop Protection AG, Basel, Switzerland Central Toxicology Laboratory (CTL), Cheshire, United Kingdom, JV1872/REG GLP, not published Syngenta File No CGA173506/6555 KIIIA Fludioxonil/Cyprodinil 62.5 WG Y SYN Y Y Y 7.6.2 / (A9219B): In Vitro Dermal 04 Absorption of Fludioxonil Through Human Epidermis Syngenta Crop Protection AG, Basel, Switzerland Central Toxicology Laboratory (CTL), Cheshire, United Kingdom, JV1871/REG GLP, not published Syngenta File No CGA173506/6554
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 129 of 159
Annex Year Title Data Owner Included Data Studies point protection in EU protection relied upon Source (where different from claimed submissio granted company) Y/N n/ review Y/N y/n Company, Report No. Y/N GLP or GEP status (where relevant) Published or Unpublished
IIIA 2011 Determination of the decline of Y Syngenta N Y Y 8.3.1/01 the residues of cyprodinil and fludioxonil in witloof chicory after one root application with A9219B in the Netherlands, 2009-2010. Research Company for Plant Protection De Bredelaar BV, Report No. R09-12-NL-01 GLP Unpublished
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010 Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent N N Y 01 and One Metabolite using TOXSWA GUI v 1.0 and the National Guidelines for The Netherlands Following Applications to Vines, Pome/Stone Fruit, Vegetables and Legumes (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/30 Not GLP, not published Syngenta File No CGA173506_11492
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 130 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010 Fludioxonil - A Leaching Y SYN 9.6.1 / Assessment for Parent N N Y 01 and Soil Metabolites (CGA265378, CGA339833 and CGA192155) using the FOCUS Groundwater Scenarios Following Foliar Applications to Apples, Vines and Soft Fruit (Q10 = 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom Syngenta - Jealott’s Hill, Bracknell, United Kingdom, RAJ0772B Not GLP, not published Syngenta File No CGA173506_11482
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010a Fludioxonil - A Leaching Y SYN 9.6.1 / Assessment for Parent N N Y 02 and Soil Metabolites (CGA265378, CGA339833 and CGA192155) using the FOCUS Groundwater Scenarios Following Foliar Applications to Tomatoes, Cabbage and Strawberries (Q10 = 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom Syngenta - Jealott’s Hill, Bracknell, United Kingdom, RAJ0773B Not GLP, not published Syngenta File No CGA173506_11483
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 131 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010b Fludioxonil - A Leaching Y SYN 9.6.1 / Assessment for Parent N N Y 03 and Soil Metabolites (CGA265378, CGA339833 and CGA192155) using the FOCUS Groundwater Scenarios Following Foliar Applications to Onions, Carrots, Field Beans and Tobacco (Q10 = 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom Syngenta - Jealott’s Hill, Bracknell, United Kingdom, RAJ0774B Not GLP, not published Syngenta File No CGA173506_11484
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010 Fludioxonil: Non- Y SYN 9.6.2 / relevance of Y Y Y 01 environmental metabolites in groundwater following foliar use Syngenta European Product Registration, Basel, Switzerland, EPR07031 Not GLP, not published Syngenta File No CGA173506_11502
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Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 132 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010b Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent Y 03 using the FOCUS Surface Water Scenarios at Step 3 Following Applications to Fruiting Vegetables, Leafy Vegetables and Legumes (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/27 GLP, not published Syngenta File No CGA173506_11489
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010c Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent N N Y 04 using the FOCUS Surface Water Scenarios at Step 3 Following Applications to Root and Bulb Vegetables (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/28 Not GLP, not published Syngenta File No CGA173506_11490
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Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 133 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010d Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent N N Y 05 using the FOCUS Surface Water Scenarios at Step 3 Following Applications to Tobacco (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/29 Not GLP, not published Syngenta File No CGA173506_11491
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010 Fludioxonil : A Fate Y SYN 9.7.1 / Assessment of Parent N N Y 01 & and Three Metabolites KIIIA1 Using the FOCUS 9.8.1 / Surface Water Scenarios 01 at Steps 1 & 2 Following Application of Fludioxonil to Vines, Pome/Stone Fruit, Vegetables, Legumes and Tobacco Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/25 Not GLP, not published Syngenta File No CGA173506_11487
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 134 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010a Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent N N Y 02 using the FOCUS Surface Water Scenarios at Steps 3 & 4 Following Applications to Vines and Pome/Stone Fruit (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/26 GLP, not published Syngenta File No CGA173506_11488
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010b Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent N 03 using the FOCUS Surface Water Scenarios at Step 3 Following Applications to Fruiting Vegetables, Leafy Vegetables and Legumes (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/27 GLP, not published Syngenta File No CGA173506_11489
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 135 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010c Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent N N Y 04 using the FOCUS Surface Water Scenarios at Step 3 Following Applications to Root and Bulb Vegetables (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/28 Not GLP, not published Syngenta File No CGA173506_11490
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010d Fludioxonil : A Fate Y SYN 9.7.1 / Assessment for Parent N N Y 05 using the FOCUS Surface Water Scenarios at Step 3 Following Applications to Tobacco (Q10 2.58) Syngenta - Jealott’s Hill, Bracknell, United Kingdom tecsolve, North Ascot, United Kingdom, tecsolve/2010/env/29 Not GLP, not published Syngenta File No CGA173506_11491
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 136 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2009 CGA321915- Calculation Y SYN 9.1.1 / of Kinetic Endpoints from Y Y Y 01 Laboratory Study Data According to FOCUS Kinetics Guidelines. Syngenta - Jealott’s Hill, Bracknell, United Kingdom Syngenta - Jealott’s Hill, Bracknell, United Kingdom, RAJ0682B Not GLP, not published Syngenta File No CGA321915_10000
THIS IS CONFIDENTIAL INFORMATION KIIIA 2008 Cyprodinil Unix 75 WG Y SYN 9.2.1 / Formulation (A8779A): Y Y Y 01 Dissipation in or on Soil in North West France 2006 (Buleon, Brittany) Syngenta - Jealott’s Hill, Bracknell, United Kingdom CEMAS, North Ascot, United Kingdom, T012635-05-REG GLP, not published Syngenta File No CGA219417_10882 KIIIA 2009 Amendment Cyprodinil Y SYN 9.2.1 / Unix 75 WG Formulation Y Y Y 01a (A8779A): Dissipation in or on Soil in North West France 2006 (Buléon, Brittany) Syngenta - Jealott’s Hill, Bracknell, United Kingdom CEMAS, North Ascot, United Kingdom, T012635-05-REG Version 2, T012635-05- REG GLP, not published Syngenta File No CGA219417_11352
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 137 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA 2008a Cyprodinil Unix 75 WG Y SYN 9.2.1 / Formulation (A8779A): Y Y Y 02 Dissipation in or on Soil in North West France 2006 (Ploermel, Brittany) Syngenta - Jealott’s Hill, Bracknell, United Kingdom CEMAS, North Ascot, United Kingdom, T014351-05-REG GLP, not published Syngenta File No CGA219417_10881 KIIIA 2009 Amendment Cyprodinil Y SYN 9.2.1 / Unix 75 WG Formulation Y Y Y 02a (A8779A): Dissipation in or on Soil in North West France 2006 (Ploermel, Brittany) Syngenta - Jealott’s Hill, Bracknell, United Kingdom CEMAS, North Ascot, United Kingdom, T014351-05-REG Version 2, T014351-05- REG GLP, not published Syngenta File No CGA219417_11351 KIIIA1 2009 Cyprodinil 750 g/kg WG: Y SYN 9.2.1 / Residues in/on soil, Y Y Y 03 Northern Germany in 2006-2007 (Test product: A8779A) Syngenta - Jealott’s Hill, Bracknell, United Kingdom Syngenta Agro GmbH, Maintal, Germany, T014353-05-REG GLP, not published Syngenta File No A8779A_10001
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 138 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2009a Cyprodinil 750 g/kg WG: Y SYN 9.2.1 / Residues in/on soil, Y Y Y 04 Southern Germany in 2006-2007 (Test product: A8779A) Syngenta - Jealott’s Hill, Bracknell, United Kingdom Syngenta Agro GmbH, Maintal, Germany, T014352-05-REG GLP, not published Syngenta File No A8779A_10002 KIIIA1 2008 Cyprodinil - Kinetic Y SYN 9.2.1 / Modelling Evaluation of N N Y 05 Data from Field Soil Residue Studies Normalised to 20°C (Q10 2.58) and pF2 Syngenta - Jealott’s Hill, Bracknell, United Kingdom Battelle UK Ltd., Ongar, United Kingdom, NC08036B Not GLP, not published Syngenta File No CGA219417_11333
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010 Determination of the un- Y SYN 9.2.1 / normalised field DT50 in N Y Y 06 Osterhofen-Gergweis soil according to FOCUS Kinetics Guidelines (2006). Syngenta - Jealott’s Hill, Bracknell, United Kingdom Syngenta - Jealott’s Hill, Bracknell, United Kingdom, Not GLP, not published Syngenta File No CGA219417_11409
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 139 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 1995 Soil Y SYN 9.3 / 01 adsorption/desorption of Y Y Y Pyrimidinyl-14C-CGA- 321915 by the batch equilibrium method Novartis Crop Protection AG, Basel, Switzerland Not Known, 003-21 GLP, not published Syngenta File No CGA321915/0001 KIIIA1 2010 Cyprodinil - A Leaching Y SYN 9.6.1 / Assessment for Parent N N Y 01 and Metabolites CGA249287, CGA321915 and CGA275535 Using the FOCUS-PEARL 3.3.3 and FOCUS-PELMO 3.3.2 Groundwater Scenarios Following Application to Pome and Stone Fruit, Soft Fruit and Vines Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.568 GLP, not published Syngenta File No CGA219417_11420
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 140 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010a Cyprodinil - A Leaching Y SYN 9.6.1 / Assessment for Parent N N Y 02 and Metabolites CGA249287, CGA321915 and CGA275535 Using the FOCUS-PEARL 3.3.3 and FOCUS-PELMO 3.3.2 Groundwater Scenarios Following Application to Leafy Vegetables, Fruiting Vegetables and Strawberries Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.569 Not GLP, not published Syngenta File No CGA219417_11421
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Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 141 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010b Cyprodinil - A Leaching Y SYN 9.6.1 / Assessment for Parent N N Y 03 and Metabolites CGA249287, CGA321915 and CGA275535 Using the FOCUS-PEARL 3.3.3 and FOCUS-PELMO 3.3.2 Groundwater Scenarios Following Application to Bulb Vegetables, Root Vegetables, Legumes and Tobacco Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.570 Not GLP, not published Syngenta File No CGA219417_11422
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010c Cyprodinil : A European Y SYN 9.7.1 / Fate Assessment for N N Y 01 & Parent and Soil KIIIA1 Metabolites CGA249287, 9.8.1 / CGA275535 and 01 CGA321915 using the FOCUS Surface Water Model at Steps 1 & 2 following use in Vines and Pome/Stone Fruit Crops. Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.553 Not GLP, not published Syngenta File No CGA219417_11411
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 142 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010d Cyprodinil : A European Y SYN 9.7.1 / Fate Assessment for N N Y 02 & Parent and Soil KIIIA1 Metabolites CGA249287, 9.8.1 / CGA275535 and 02 CGA321915 using the FOCUS Surface Water Model at Steps 1 & 2 following use in Fruiting Vegetables and Leafy Vegetables. Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.554 Not GLP, not published Syngenta File No CGA219417_11412
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010e Cyprodinil : A European Y SYN 9.7.1 / Fate Assessment for N N Y 03 & Parent and Soil KIIIA1 Metabolites CGA249287, 9.8.1 / CGA275535 and 03 CGA321915 using the FOCUS Surface Water Model at Steps 1 & 2 following use in Bulb Vegetables, Root Vegetables, Legumes and Tobacco. Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.555 Not GLP, not published Syngenta File No CGA219417_11413
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 143 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010f Cyprodinil : A Fate Y SYN 9.7.1 / Assessment using the N N Y 04 FOCUS Surface Water Scenarios at Steps 3 and 4 for Predicting Environmental Concentrations Following Applications to Vines and Pome/Stone Fruits. Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.556 Not GLP, not published Syngenta File No CGA219417_11414
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010g Cyprodinil : A Fate Y SYN 9.7.1 / Assessment using the N N Y 05 FOCUS Surface Water Scenarios at Steps 3 and 4 for Predicting Environmental Concentrations Following Applications to Fruiting Vegetables and Leafy Vegetables Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.557 Not GLP, not published Syngenta File No CGA219417_11415
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 144 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010h Cyprodinil : A Fate Y SYN 9.7.1 / Assessment using the N N Y 06 FOCUS Surface Water Scenarios at Steps 3 and 4 for Predicting Environmental Concentrations Following Applications to Bulb Vegetables, Root Vegetables, Legumes and Tobacco Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.558 Not GLP, not published Syngenta File No CGA219417_11416
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 145 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished
KIIIA1 2010 Cyprodinil - A Surface Y SYN N N Y 9.7.1 / Water Assessment Using 01 the TOXSWA GUI Version 1.0 and the National Guidelines for The Netherlands Following Application to Vines, Soft Fruit and Apples Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.561 Not GLP, not published Syngenta File No CGA219417_11417
THIS IS CONFIDENTIAL INFORMATION KIIIA1 2010a Cyprodinil - A Surface Y SYN 9.7.1 / Water Assessment Using N N Y 02 the TOXSWA GUI Version 1.0 and the National Guidelines for The Netherlands Following Application to Fruiting and Leafy Vegetables Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.562 Not GLP, not published Syngenta File No CGA219417_11418
THIS IS CONFIDENTIAL INFORMATION
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 146 of 159
Annex Year Title Data Owner Included in Data Study used protection (SYN = EU protection Y/N point Source (where different claimed Syngent submission/ granted from company) Y/N a review Y/N Company, Report No. ) Y/N GLP or GEP status (where relevant) Published or Unpublished KIIIA1 2010b Cyprodinil - A Surface Y SYN 9.7.1 / Water Assessment Using N N Y 03 the TOXSWA GUI Version 1.0 and the National Guidelines for The Netherlands Following Application to Legumes, Root and Bulb Vegetables Syngenta - Jealott’s Hill, Bracknell, United Kingdom Cambridge Environmental Assessments, United Kingdom, CEA.563 Not GLP, not published Syngenta File No CGA219417_11419
THIS IS CONFIDENTIAL INFORMATION
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 2010 A9219B GAP FINAL N SYN N N Y 10 / 01 PI0001858 Syngenta Crop Protection AG, Basel, Switzerland, Not GLP, not published Syngenta File No A9219B_11487 2008 Y SYN Y N Y Generic monitoring of birds in vegetable fields in Great Britain Syngenta Study No T011651-06
To be checked and confirmed by syngenta.
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 147 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 1994 Report on the acute toxicity Y SYN Y N y 10.2.2.1 test of CGA 173506 + CGA / 01 219417 62.5 WG (A-9219 B) to Rainbow Trout (Oncorhynchus mykiss) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Basel, Oekotoxikologie, Basel, Switzerland, 943501 GLP, not published Syngenta File No CGA173506/0469 KIIIA1 1994a Report on the acute toxicity Y SYN Y N Y 10.2.2.1 test of CGA 173506 + CGA / 02 219417 62.5 WG (A-9219 B) to Rainbow Trout (Oncorhynchus mykiss) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Basel, Oekotoxikologie, Basel, Switzerland, 943550 GLP, not published Syngenta File No CGA173506/0504 KIIIA1 1994b Report on the acute toxicity Y SYN Y N Y 10.2.2.1 test of CGA 173506 + CGA / 03 219417 62.5 WG (A-9219 B) to Bluegill (Lepomis macrochirus) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Basel, Oekotoxikologie, Basel, Switzerland, 943502 GLP, not published Syngenta File No CGA173506/0468 KIIIA1 1994 Report on the acute toxicity Y SYN Y N Y 10.2.2.2 test of CGA 173506 + CGA / 01 219417 62.5 WG (A-9219 B) on Daphnia (Daphnia magna Straus 1820) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Basel, Oekotoxikologie, Basel, Switzerland, 943503 GLP, not published Syngenta File No CGA173506/0471
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 148 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 1994a Report on the growth Y SYN Y N Y 10.2.2.3 inhibition test of CGA 173506 / 01 + CGA 219417 62.5 WG (A- 9219 B) to Green Algae (Scenedesmus subspicatus) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Basel, Oekotoxikologie, Basel, Switzerland, 943504 GLP, not published Syngenta File No CGA173506/0470 KIIIA1 1995 Toxicity of CGD 20450 F to Y SYN Y N Y 10.2.2.3 scenedesmus subspicatus in / 02 an algal growth inhibition test Novartis Crop Protection AG, Basel, Switzerland RCC Umweltchemie GmbH & Co. KG, Rossdorf, Germany, 500401 GLP, not published Syngenta File No CGA173506/0807 KIIIA1 2001 A 96-Hour Static Growth Y SYN Y N Y 10.2.2.3 Inhibition Test of CGA- / 03 173506/CGA-219417 WG 62.5 (A9219B) to the Green Alga, Selenastrum capricornutum Syngenta Crop Protection AG, Basel, Switzerland Wildlife International Ltd., Easton MD, USA, 528A-111, 2003739 GLP, not published Syngenta File No CGA173506/5449 KIIIA1 2005 Statement regarding the Y SYN Y N Y 10.2.3 / proposed NOEAEC endpoint 01 from the microcosm study (Kennedy & Reed, 1995) and the uncertainty factor proposed during EPCO review Syngenta Crop Protection AG, Basel, Switzerland, ERA11959 Not GLP, not published Syngenta File No CGA219417/1418
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 149 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 2007 Cyprodinil (CGA219417) 300 Y SYN N Y Y 10.2.3 / g/L EC formulation A14325E - 02 Effects on aquatic organisms in an outdoor microcosm Syngenta Crop Protection AG, Basel, Switzerland Syngenta - Jealott’s Hill International, Bracknell, Berkshire, United Kingdom, T008777-05-REG 2034035 GLP, not published Syngenta File No CGA219417/1683 KIIIA1 1996 Toxicity of CGD 20450 F to Y SYN Y N Y 10.2.5.1 rainbow trout (oncorhynchus / 01 mykiss) in a prolonged flow- through-test (21 days) Novartis Crop Protection AG, Basel, Switzerland RCC Umweltchemie GmbH & Co. KG, Rossdorf, Germany, 500405 GLP, not published Syngenta File No CGA173506/0809 KIIIA1 1995a Influence of CGD 20450 F on Y SYN Y N Y 10.2.6.1 survival and reproduction of / 01 daphnia magna in a semistatic test (22 days) Novartis Crop Protection AG, Basel, Switzerland RCC Umweltchemie GmbH & Co. KG, Rossdorf, Germany, 500403 GLP, not published Syngenta File No CGA173506/0808 KIIIA1 1998 Toxicity test of CGA 173506 / Y SYN Y N Y 10.2.6.2 CGA 219417 WG 62.5 (A- / 01 9219 B) on Sediment- Dwelling Chironomus riparius (syn. Chironomus thummi) under static conditions Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection AG, Basel, Switzerland, 983810 GLP, not published Syngenta File No CGA173506/1230
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 150 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 1994 CGA 173506 + CGA 219417 Y SYN Y N Y 10.3.2.1 WG 62.5 (A-9219 B) - Acute / 01 oral toxicity in the rat. Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Stein, Switzerland, 933182 GLP, not published Syngenta File No CGA173506/0453 KIIA1 1994 Testing toxicity to Honeybee - Y SYN Y N Y 10.4.2.1 Apis mellifera L. (laboratory) / 01 according to EPPO Guideline No. 170 CGA 173506 + CGA 219417 WG 62.5 (A-9219 B) Novartis Crop Protection AG, Basel, Switzerland BioChem GmbH, Cunnersdorf, Germany, 94 10 48 012 GLP, not published Syngenta File No CGA173506/0494 KIIA1 1995 Testing toxicity to Honeybee - Y SYN Y N Y 10.4.2.1 Apis mellifera L. (laboratory) / 02 CGD 20450 F Novartis Crop Protection AG, Basel, Switzerland BioChem GmbH, Cunnersdorf, Germany, 95 10 48 017 GLP, not published Syngenta File No CGA173506/0805 KIIA1 1995 Laboratory testing for toxicity Y SYN Y N Y 10.4.2.1 (acute contact and oral LD50) / 03 of CGD 20450 F to the honey bees, (apis mellifera L.) (hymenoptera, apidae) Novartis Crop Protection AG, Basel, Switzerland IBACON GmbH, Rossdorf, Germany, 570036 GLP, not published Syngenta File No CGA173506/0811
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 151 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIA1 1995 Assessment of side effects of Y SYN Y N Y 10.4.2.1 CGD 20450 F to the honey / 04 bee, apis mellifera L. in the laboratory Novartis Crop Protection AG, Basel, Switzerland GAB Biotechnologie GmbH, Niefern, Germany, 95023/01- BLEU GLP, not published Syngenta File No CGA173506/0810 KIIIA1 1999 Acute toxicity of CGA 173506 Y SYN Y N Y 10.5.1 / / CGA 219417 WG 62,5 (A- 01 9219 B) to the predaceous mite Typhlodromus pyri Scheuten (Acari: phytoseiidae) Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection AG, Basel, Switzerland, 983963 GLP, not published Syngenta File No CGA173506/5120 KIIIA1 2001 CGA 173506 and CGA Y SYN Y N Y 10.5.1 / 219417: a rate-response 02 laboratory test to evaluate the effects of a 250 + 375 g/kg WG formulation (A-9219 B) on the predatory mite, Typhlodromus pyri Syngenta Crop Protection AG, Basel, Switzerland Mambo-Tox. Ltd., Southampton, United Kingdom, SYN-01-33 GLP, not published Syngenta File No CGA173506/5417 KIIIA1 1998 Acute toxicity of CGA 173506 Y SYN Y N Y 10.5.1 / / CGA 219417 WG 62.5 (A- 03 9219 B) to the parasitic wasp Aphidius rhopalosiphi (Hymenoptera: Aphidiidae) Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection AG, Basel, Switzerland, 973512 GLP, not published Syngenta File No CGA173506/1046
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 152 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 2001 CGA 173506 and CGA Y SYN Y N Y 10.5.1 / 219417: a rate-response 04 laboratory test to evaluate the effects of a 250 + 375 g/kg WG formulation (A-9219 B) on the parasitic wasp, Aphidius rhopalosiphi Syngenta Crop Protection AG, Basel, Switzerland Mambo-Tox. Ltd., Southampton, United Kingdom, SYN-01-32 GLP, not published Syngenta File No CGA173506/5418 KIIIA1 1994 Acute toxicity test of SWITCH Y SYN Y N Y 10.5.1 / WG 62,5 (A-9219 B) on the 05 Ground Beetle (Poecilus cupreus) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Basel, Switzerland, 94-020-LB94-PC GLP, not published Syngenta File No CGA173506/0540 KIIIA1 1999a Acute toxicity test of CGA Y SYN Y N Y 10.5.1 / 173506 / CGA 219417, WG 06 62.5 (A-9219 B) to the predatory ground beetle Poecilus cupreus L. (Coleoptera: carabidae) Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection AG, Basel, Switzerland, 983962 GLP, not published Syngenta File No CGA173506/5104 KIIIA1 2000 Evaluation of the effects of Y SYN Y N Y 10.5.1 / pesticides on the rove beetle 07 Aleochara bilineata in the laboratory Novartis Crop Protection AG, Basel, Switzerland Huntingdon Research Centre, Cambridgeshire, United Kingdom, NVR 050/002379 GLP, not published Syngenta File No CGA173506/5325
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 153 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 1994a Acute toxicity of SWITCH WG Y SYN Y N Y 10.5.2 / 62,5 (A-9219 B) on the 01 predaceous mite Typhlodromus pyri Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Basel, Oekotoxikologie, Basel, Switzerland, 94-032-LB94-TP GLP, not published Syngenta File No CGA173506/0541 KIIIA1 1999 Residual effect of 2 Y SYN Y N Y 10.5.2 / applications of Switch 62.5 02 WG (A-9219 B) on the life history of the parasitic wasp Aphidius rhopalosiphi (Destefani-Perez) determined in an extended laboratory test on grape Novartis Crop Protection AG, Basel, Switzerland MITOX Consultants, Amsterdam, Netherlands, NO18ARE GLP, not published Syngenta File No CGA173506/5090 KIIIA1 2001 CGA 219417 + CGA 173506 Y SYN Y N Y 10.5.2 / WG (A 9219 B): An Extended 03 Laboratory Study to Evaluate the Duration of Effects on the Predaceous Mite Amblyseius cucumeris Oudemans (Acari: Phytoseiidae) on Sweet Pepper Leaves Syngenta Crop Protection AG, Basel, Switzerland MITOX Consultants, Amsterdam, Netherlands, N050ACE GLP, not published Syngenta File No CGA173506/5403
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 154 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 1995 Acute toxicity test of SWITCH Y SYN Y N Y 10.5.2 / WG 62.5 (A-9219 B) on the 04 aphid predator Orius insidiosus (SAY) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Basel, Oekotoxikologie, Basel, Switzerland, 94-065 LB94-OI GLP, not published Syngenta File No CGA219417/0438 KIIIA1 2002 Toxicity of CGA 173506 + Y SYN Y N Y 10.5.2 / CGA 219417 WG 62.5 (A 05 9219 B) to the Rove Beetle Aleochara bilineata (Coleoptera: Staphylinidae) under Extended Laboratory Conditions Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection AG, Basel, Switzerland, 2003528 GLP, not published Syngenta File No CGA173506/5451 KIIIA1 2000 Toxicity of CGA 173506 / Y SYN Y N Y 10.5.3 / CGA 219417 WG 62.5 (A 01 9219 B) to Aphidius rhopalosiphi (Hymenoptera: Aphidiidae) under semi-field conditions Novartis Crop Protection AG, Basel, Switzerland Syngenta Crop Protection AG, Basel, Switzerland, 2003526 GLP, not published Syngenta File No CGA173506/5324 KIIIA1 1998 CGA 173506 / CGA 219417 Y SYN Y N Y 10.5.3 / WG 62.5 (A-9219 B) semi- 02 field toxicitiy test with the predator, orius insidiosus (Heteroptera: anthocoridae) Novartis Crop Protection AG, Basel, Switzerland Springborn Smithers Laboratories (Europe) AG, Horn, Switzerland, 97-217- 1047 GLP, not published Syngenta File No CGA173506/1126
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 155 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 1999 CGA 173506 / CGA 219417 Y SYN Y N Y 10.5.3 / WG 62.5 (A-9219 B): semi- 03 field toxicitiy test with the seven-spotted lady beetle, Coccinella septempunctata L. (Coleoptera: coccinellidae) Novartis Crop Protection AG, Basel, Switzerland Springborn Smithers Laboratories (Europe) AG, Horn, Switzerland, 97-215- 1047 GLP, not published Syngenta File No CGA173506/1290 KIIIA1 1999 Evaluating effects of Switch Y SYN Y N Y 10.5.4 / 62.5 WG (A-9219 B) 01 applications on the predatory mite fauna (Acari: Phytoseiidae) in the field (grapevines, Sth France) Novartis Crop Protection AG, Basel, Switzerland MITOX Consultants, Amsterdam, Netherlands, NO15AFF GLP, not published Syngenta File No CGA173506/5067 KIIIA1 2000 Evaluating effects of Switch Y SYN Y N Y 10.5.4 / 62.5 WG (A-9219 B) 02 applications on the predatory mite fauna (Acari: Phytoseiidae) in the field (grapevines, Sth Germany) Novartis Crop Protection AG, Basel, Switzerland MITOX Consultants, Amsterdam, Netherlands, NO14AFF GLP, not published Syngenta File No CGA173506/5153
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 156 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 2001 Toxicity of CGA 173506 / Y SYN Y N Y 10.5.4 / CGA 219417 WG 62.5 (A 03 9219 B) to predatory mites (Acari: Phytoseiidae) under field conditions Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection AG, Basel, Switzerland, 2003674 GLP, not published Syngenta File No CGA173506/5355 KIIIA1 1995 Acute effects on earthworm Y SYN Y N Y 10.6.2 / eisenia fetida (savigny) of 01 CGD 20450 F Novartis Crop Protection AG, Basel, Switzerland Dr. U. Noack, Laboratorium für angewandte Biologie, Sarstedt, Germany, 950127CG GLP, not published Syngenta File No CGA173506/0812 KIIIA1 1996 Acute toxicity test of CGA Y SYN Y N Y 10.6.2 / 173506 / CGA 219417 (A- 02 9219 B) to earthworm (Eisenia foetida) Novartis Crop Protection AG, Basel, Switzerland Ciba-Geigy Ltd., Basel, Switzerland, 953608 GLP, not published Syngenta File No CGA173506/0705 KIIIA1 1998a Chronic toxicity test of CGA Y SYN Y N Y 10.6.3 / 173506 / CGA 219417 WG 01 62.5 (A-9219 B) to the earthworm (Eisenia foetida) Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection AG, Basel, Switzerland, 973585 GLP, not published Syngenta File No CGA173506/1196
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 157 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 2001 Effects of CGA 173506 (250 Y SYN Y N Y 10.6.3 / G/L) + CGA 219417 (375 02 G/L) 62.5 WG (A-9219 B) on Reproduction and Growth of Earthworms Eisenia fetida (Savigny 1826) in Artificial Soil Syngenta Crop Protection AG, Basel, Switzerland IBACON GmbH, Rossdorf, Germany, 8171022 GLP, not published Syngenta File No CGA173506/5404 KIIIA1 2006 CGA173506/CGA219417 WG Y SYN N Y Y 10.6.3 / (25/37.5) (A9219B): Sublethal 03 toxicity to the earthworm Eisenia fetida artificial soil with 5 % peat Syngenta Crop Protection AG, Basel, Switzerland BioChem agrar, Gerichshain, Germany, 06 10 48 027 T004964-05 GLP, not published Syngenta File No CGA173506/6813 KIIIA1 2001 A Chronic Toxicity and Y SYN N N N 10.6.3 / Reproduction Test Exposing 04 Eisenia Fetida to CGA 219417 75 WG (A-8779 A) in OECD Artificial Soil Syngenta Crop Protection AG, Basel, Switzerland Springborn Smithers Laboratories (Europe) AG, Horn, Switzerland, 1047.094.631 GLP, not published Syngenta File No CGA219417/1029 KIIIA1 2004 CGA173506/CGA219417: Y SYN Y Y Y 10.6.6 / Toxicity of a SWITCH WG 01 62.5 formulation (A9219B) on the reproduction of the collembolans Folsomia candida Syngenta Crop Protection AG, Basel, Switzerland BioChem agrar, Gerichshain, Germany, 04 10 48 031 2033707 GLP, not published Syngenta File No CGA173506/5934
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 158 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 2005 Fludioxonil (CGA173506) / Y SYN N Y Y 10.6.7 / Cyprodinil (CGA219417) WG 01 62.5 (A9219B): Effects on the decomposition of organic straw in litter bags by soil macro and micro organisms in the field Syngenta Crop Protection AG, Basel, Switzerland CEMAS, North Ascot, United Kingdom, CEMR-2267 2033674 GLP, not published Syngenta File No CGA173506/6176 KIIIA1 2009 Cyprodinil 300 g/L formulation Y SYN N Y Y 10.6.7 / (A14325E): Effects on the 02 Decomposition of Organic Matter in the Field Syngenta - Jealott’s Hill, Bracknell, United Kingdom Eurofins - GAB, Niefern Öschelbronn, Germany, S0800969, T012668-05 GLP, not published Syngenta File No A14325E_10029 KIIIA1 1995 Effects on the activity of soil Y SYN Y N Y 10.7.1 / microflora CGD 20450 F 01 Novartis Crop Protection AG, Basel, Switzerland BioChem GmbH, Cunnersdorf, Germany, 95 1049 007 GLP, not published Syngenta File No CGA173506/0806 KIIIA1 2000 Herbicide profiling test to Y SYN Y N Y 10.8.1.2 evaluate the phytotoxicity of / 01 CGA173506 / CGA 219417 62.5 WG (A-9219 B) to terrestrial non-target higher plants Novartis Crop Protection AG, Basel, Switzerland Novartis Crop Protection AG, Basel, Switzerland, SMQ 99002 Not GLP, not published Syngenta File No CGA173506/5160
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013 Part A A9219B Registration Report National Addenda – Netherlands Central zone Page 159 of 159
Annex Year Title Data Owner Included in Data Studies point Source (where different from protection EU protection relied company) claimed SYN = submission/ granted upon Company, Report No. Y/N Syngenta review GLP or GEP status (where y/n Y/N relevant) Y/N Published or Unpublished KIIIA1 2002 Growth Inhibition Test of CGA Y SYN Y N Y 10.8.2.1 173506/CGA 219417, WG / 01 62.5 (A 9219 B) to the Duckweed Lemna gibba G3 under Static Conditions Syngenta Crop Protection AG, Basel, Switzerland Syngenta Crop Protection AG, Basel, Switzerland, 2003738 GLP, not published Syngenta File No CGA173506/5458
Document Evaluator CTGB, The Netherlands Author: S Ellis Date: August 2013