HET COLLEGE VOOR DE TOELATING VAN ...

10001 N

Delan DF, 20130779 NLTHG

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT Op 27 mei 2013 is van

BASF Nederland B.V. Postbus 1019 6801 MC ARNHEM

een aanvraag ontvangen tot Vrijwillig zonale herregistratie met Nederland als betrokken lidstaat als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel

Delan DF op basis van de werkzame stof dithianon. Nederland is in deze een betrokken lidstaat, als bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is Oostenrijk HET COLLEGE BESLUIT tot toelating van bovenstaand middel. Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel van dit besluit. 1.1 Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.2 Gebruik Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I. 1.3 Classificatie en etikettering Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden vermeld: De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder

“verpakkingsinformatie” in bijlage I. Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel

A van het registratierapport, Appendix I. Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

10001 N


De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2 van deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Bij de herregistratie wordt het etiket voor deze toelating op diverse manieren aangepast en daarom wordt de w-codering verhoogd van W.11 naar W.12. Het etiket wordt omgezet van een WGGA naar een WG format, waarbij het maximum aantal toepassingen per jaar expliciet wordt gelimiteerd. Er vervallen toepassingen in bessen, wijndruif, rozen en tulp af, omdat deze

niet zijn aangevraagd bij de herregistratie. Het voorschrift voor het gebruik van een lagere dosering voor percelen grenzend aan oppervlaktewater vervalt, maar er worden zwaardere driftbeperkende maatregelen voorgeschreven ter bescherming van het aquatisch milieu. Omdat de aanpassingen in het etiket significant zijn en mede verband houden met het beperken van risico’s, worden beperkte respijttermijnen vastgesteld voor het oude etiket met W-codering W.11. Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op de verpakking te worden aangebracht. De te hanteren w-coderingen en aflever- en opgebruiktermijnen voor oude verpakkingen staan vermeld onder “toelatingsinformatie” in bijlage I. 2. WETTELIJKE GRONDSLAG

Besluit Artikel 80, vijfde lid juncto artikel 128 Wgb (oud)

Classificatie en etikettering artikel 31 en artikel 65 van de Verordening (EG) 1107/2009

Gebruikt toetsingskader Rgb d.d. 13 juni 2011 en Evaluation Manual 1.1

3. BEOORDELINGEN

3.1 Fysische en chemische eigenschappen De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar geacht.

3.2 Analysemethoden De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd gebruik.

3.3 Risico voor de mens Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het werkzaam is.

Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het registration report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel bekendmaken delen A en B van het Registration Report.

10001 N


Bezwaarmogelijkheid Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

Ede, 1 juli 2016

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN, Ir. J.F. de Leeuw Voorzitter

10001 N


BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 2.1 Aanvraaginformatie Aanvraagnummer: 20130779 NLTHG Type aanvraag: Vrijwillig zonale aanvraag tot herregistratie van

gewasbeschermingsmiddeltoelating met Nederland als betrokken lidstaat

Middelnaam: Delan DF Verzenddatum aanvraag: 23 mei 2013 Formele registratiedatum: * 31 mei 2013 Datum in behandeling name: Datum compliance check: 18 november 2011 * Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan. 2.2 Stofinformatie Werkzame stof Gehalte

dithianon 70% De stof is per 1 juni 2011 geplaatst op Annex I van Richtlijn 91/414/EEG (Directive 2011/41/EU d.d. 11 April 2011) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd) De goedkeuring van deze werkzame stof expireert op 31 mei 2021. 2.3 Toelatingsinformatie Toelatingsnummer: 10001 N Expiratiedatum: 1 juli 2026 Afgeleide parallel of origineel: n.v.t. Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel Gebruikers: Professioneel W-coderingen en aflever- en opgebruiktermijnen: W-codering professioneel gebruik: 12 Vorige w-codering professioneel gebruik: 11 Aflevertermijn professioneel gebruik: 1 oktober 2016 Opgebruiktermijn professioneel gebruik: 1 januari 2017 2.4 Verpakkingsinformatie Aard van het preparaat: Wateroplosbaar granulaat

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:097:0038:0041:EN:PDF

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

10001 N


HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Delan DF Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: dithianon Pictogram GHS05

GHS06 GHS08 GHS09

Signaalwoord GEVAAR

Gevarenaanduidingen H301 Giftig bij inslikken. H317 Kan een allergische huidreactie veroorzaken. H318 Veroorzaakt ernstig oogletsel H351 Verdacht van het veroorzaken van kanker. H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen.

Voorzorgsmaatregelen P261 Inademing van stof/rook/gas/nevel/damp/spuitnevel vermijden. P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen. P301 + P310 NA INSLIKKEN: Onmiddellijk een ANTIGIFCENTRUM/arts/... raadplegen. P302 + P352 BIJ CONTACT MET DE HUID: Met veel water/... wassen. P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen. P308 + P313 Na (mogelijke) blootstelling: een arts raadplegen. P333 + P313 Bij huidirritatie of uitslag: een arts raadplegen. P391 Gelekte/gemorste stof opruimen. P501 Inhoud/verpakking afvoeren naar .... SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt. SPo 2 Was alle beschermende kleding na gebruik.

Aanvullende etiketelementen

EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee

Part A National Addendum - Netherlands

Delan DF

Registration Report – Central Zone Page 1 of 80


Bijlage III; dRR part A

REGISTRATION REPORT Part A

Risk Management

Product name: Delan DF

Product Code: (BAS 216 03 F)

Active Substance: Dithianon 700 g/kg

Central Zone Zonal Rapporteur Member State: Austria

NATIONAL ADDENDUM – The Netherlands

Applicant: BASF

Date: June 2016

Registration type: Reregistration


Delan DF



Table of Contents

PART A Risk Management 4 1 Details of the application 5 1.1 Application background 5 1.2 Annex I inclusion 6 1.3 Regulatory approach 6 1.4 Data protection claims 6 1.5 Letters of Access 6 2 Details of the authorization 6 2.1 Product identity 6 2.2 Classification and labelling 8 2.2.1 Classification and labelling under Directive 99/45/EC 8 2.2.2 Other phrases 9 2.3 Product uses 10 3 Risk management 11 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 11 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 11 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 12 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 12 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 12 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 13 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 13 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 13 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 14 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 14 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 14 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 14 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 15 3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 16 3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) 16 3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 17 3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) 18 3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) 23 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 24 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 24 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 24 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 25


Delan DF



3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) 25 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 25 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 26 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 26 3.1.7 Efficacy (Part B, Section 7, Point 8) 26 3.2 Conclusions 27 3.3 Substances of concern for national monitoring 27 3.4 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorization 27 Appendix 1 Copy of the product label 28


Delan DF



PART A Risk Management

This document describes the acceptable use conditions required for the national re-registration of Delan DF containing Dithianon 700 g/kg in the Netherlands. 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 in the national addendum. The information, data and assessments provided in Registration Report, Parts B includes 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 Delan DF where that data has not been considered in the EU review. Otherwise assessments for the safe use of Delan DF have been made using endpoints agreed in the EU review of Dithianon. This document describes the specific conditions of use and labeling required for the national registration of Delan DF. Appendix 1 of this document is a copy of the approved product label. Appendix 2 of this document is a list of data submitted in support of the evaluation


Delan DF



Details of the application Application background This application was submitted by, represented by the following affiliate:

BASF Nederland B.V. Groningensingel 1 6835 EA Arnhem Netherlands

The application was submitted for the approval of Delan DF, a WG formulation containing 700 g/kg dithianon for use as a fungicide in pome fruits and cherries. Annex I inclusion Dithianon was included into Annex I of Directive 91/414 by commission directive 2011/41/EU of 11 April 2011 (entry into force 01 June 2011) and approved according to Commission Implementing Regulation (EU) No 540/2011 under the current regime Regulation (EC) No 1107/2009. The Annex I Inclusion Directive for dithianon 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. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dithianon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account. In this overall assessment Member States shall pay particular attention to the:

protection of aquatic organisms; conditions of use shall include risk mitigation measures, where appropriate

operator safety; conditions of use shall include the application of adequate personal protective equipment, where appropriate

long-term risks to birds; conditions of use shall include risk mitigation measures, where appropriate

These concerns for dithianon have been addressed in the submission.


Delan DF



Regulatory approach

To obtain approval, Delan DF must meet the conditions of the Approval for the active substance and must be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, considering EU agreed end-points and additional data where appropriate.

Data protection claims

Data protection is claimed for studies submitted with this application. For details on data protection claims, please refer to Appendix 3.

Letters of Access

No data protected studies of third parties were included in this dossier. Therefore, no letter of access was necessary.

Details of the authorisation

Product identity

Product Name Trade name: Delan DF

Development code: BAS 216 03 F

Authorization Number (for re-registration)

10001 N

Function Fungicide

Applicant BASF (see chapter 1.1)

Composition Dithianon 700 g/kg

Formulation type Water dispersible granules [Code: WG]


Delan DF



Packaging 0.02 kg bag material: self-opening paper/ polyethylene bag

size: 150 mm(L) x 110 mm(W) x 20 mm(H)

seal: heat-sealing

0.05-0.1 kg bag material: self-opening paper/ polyethylene bag


seal: heat-sealing

0.5 kg bag material: groove fold polyethylene bag w/o barrier (FFS)

size: 120mm(L) x 70 mm(W) x 350 mm(H)

seal: heat-sealing

0.5 kg container material: HDPE

shape/size: cylindrical / approx. 88.5 mm diameter x 234 mm

opening: 42 mm inner diameter

closure: Polypropylene/Polyethylene screw cap

1 kg bag: material: groove fold polyethylene bag w/o barrier (FFS)

size: 120mm(L) x 70 mm(W) x 350 mm(H)

seal: heat-sealing

1 kg bag: material: self-opening square bottom paper/ polyethylene bag


seal: heat-sealing

2.5 kg bag: material: groove fold polyethylene bag w/o barrier (FFS)


seal: heat-sealing

5 kg bag: material: groove fold polyethylene bag w/o barrier (FFS)


seal: heat -sealing

2 kg container material: HDPE

shape/size: rectangular / approx. 214 mm x 130 mm x 234 mm

opening: 54mm inner diameter

closure: polypropylene screw cap

seal: HF-seal

2 kg eco-container material: HDPE

shape/size: rectangular / approx. 185 mm x 136 mm x 313 mm

opening: 54mm inner diameter

closure: polypropylene screw cap

seal: gasket


Delan DF



Classification and labelling

Classification and labelling according to Reg. (EC) 1272/2008

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed:

The identity of all substances in the mixture that contribute to the classification of the mixture *:

Dithianon Pictogram: GHS05 Signal word: danger GHS06 GHS08 GHS09 H-statements: H301 Toxic if swallowed. H317 May cause an allergic skin reaction. H318 Causes serious eye damage. H351 Suspected of causing cancer. H410 Very toxic to aquatic life. P-statements: P261 Avoid breathing dust/fume/gas/mist/

vapours/spray. P280 Wear protective gloves/protective

clothing/eye protection/face protection. P301 + P310 IF SWALLOWED: Immediately call a

POISON CENTER/doctor/... P302 + P352 IF ON SKIN: Wash with plenty of water/... P305 + P351 +

P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P308 + P313 IF exposed or concerned: Get medical advice/attention.

P333 + P313 If skin irritation or rash occurs: Get medical advice/attention.

P391 Collect spillage. P501 Dispose of contents/container to … Supplemental Hazard information:

SPo2 Wash all protective clothing after use.

SP1 Do not contaminate water with the product or its container.

EUH401 To avoid risks to human health and the environment, comply with the instructions for use.

Child-resistant fastening obligatory? n.a.


Delan DF



Tactile warning of danger obligatory? n.a.

Explanation:

Pictogram: GHS07 is not assigned as GHS06 is applicable. H-statements: H301 and H318 were assigned based on studies with the

formulation. H317 and H351 were assigned based on classification of dithianon (as proposed in the EFSA conclusion 2010).

P-statements: P280 and P301+P310 were assigned based on classification with H317/H351 and H301, respectively. P280 and P305+P351+P338 are assigned based on classification with H318. The other P-statements were proposed by the applicant. Proposal accepted.

Other: SPo2 is applicable as H301 is assigned.

* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

Other phrases

The following restriction sentences should be placed on the label: Om in het water levende organismen te beschermen is toepassing in de teelt van pitvruchten en kers in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan wanneer: Vóór 1 mei gebruik gemaakt wordt van:

Wannerspuit met reflectieschermen en venturidoppen (minimaal 90% driftreducerend) (Lechler ID 90-015C,) met inachtneming van een teeltvrije zone van tenminste 3 meter, of

een KWH k1500-3R2 VLOS 3-rijenspuit met variabele luchtondersteuning en minimaal 90% driftreducerende spuitdoppen en ventilatorstand "laag" in de eerste 20 meter grenzend aan het oppervlaktewater met inachtneming van een teeltvrije zone van tenminste 3 meter.

Vanaf 1 mei gebruik gemaakt wordt van:

een tunnelspuit met inachtneming van een teeltvrije zone van tenminste 3 meter, of

Venturidoppen (minimaal 90% driftreducerend) in de eerste 20 meter grenzend aan het oppervlaktewater in combinatie met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel en ventilatorstand“laag“ of "hoog", met inachtneming van een teeltvrije zone van tenminste 3 meter, of

een Wannerspuit met reflectieschermen en venturidoppen (minimaal 90% driftreducerend) (Lechler ID 90-015C,) met inachtneming van een teeltvrije zone van tenminste 3 meter, of



Delan DF



Product uses

Table 2.3: Authorized uses; Delan DF – Dithianon 700 g/kg

1 2 3 4 5 6 7 8 10 11 12 13 14

Use-No.

Member state(s)

Crop and/ or situation

F G or I

Pests or Group of pests controlled

Application Application rate per treatment PHI (days)

Remarks:

a) max. no. of applications per crop and season

b) Maximum product rate per season

c) additional remarks

Method / Kind

Timing / Growth stage of crop & season

Number / (min. Interval between applications)

kg product / ha

kg as/ha Water L/ha min / max

1 NL Pomes F Venturia inaequalis, Venturia pirina

Spray BBCH 53-79

February- October

6

(5 days)

0.425 0.298 150-300 42 NL addendum: 6 x 0.425 or 6 x 0.525 kg/ha Lower rate used in orchards under lower disease pressure.

0.525 0.368

Minor uses.

2 NL Cherries F Wilsonomyces carpophilum, Blumeriella hiemalis Venturia cerasii, Gnomonia erythrostoma,

Spray BBCH 61-85

April- August

3

(7 days)

0.75 0.525 200-1500 21 After harvest use: treatment of trees without fruits, but still with foliage.

BBCH 91-95

(after harvest)

September- December

1

(7 days)

n.a.


Delan DF



Risk management

Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles

Physical and chemical properties (Part B, Section 1, Points 2 and 4)

Overall Summary: The plant protection product Delan DF is a water dispersible granule containing 700 g/kg of dithianon. All studies have been performed in accordance with the current requirements, the critical GAP and the results are deemed to be acceptable. The product is a dark brown free flowing granule. It is not explosive, has no oxidising properties. It is neither flammable nor self-heating. In aqueous solution, a 1% solution has a pH value around 4.0. The plant protection product was found to be stable after accelerated storage for two weeks at 54°C. The product showed good physical and chemical stability with properties unchanged significantly from initial measurements. After storage for up to 2 years at 20 and 30°C in HDPE container the preparation showed good physical and chemical stability with properties unchanged significantly from initial measurements. The shelf life study of the former formulation BAS 216 80 F indicated the stability of the product also in paper/PE and paper/Alu/PE packaging material. The investigations of the physical and chemical properties have shown that Delan DF meets the general requirements for a WG-formulation according to the FAO specifications. This indicates that no particular problems are to be expected if the preparation is used as recommended.


Delan DF



Compliance with FAO specifications: The product Delan DF complies with FAO specifications. Compatibility of mixtures: A complete report regarding physical and chemical compatibility of the tank mixes with Delan DF and height other plant protection products has been submitted which has demonstrated compatibility. These tank mixes can therefore be mentioned on the product label for Delan DF. No mixing is proposed, therefore use of antifoam agents does not have to be recommended. Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable. Methods of analysis (Part B, Section 2, Point 5) Analytical method for the formulation (Part B, Section 2, Point 5.2) Delan DF was the representative formulation in the EU review of dithianon. Analytical methods for determination of dithianon, its impurities and relevance of CIPAC methods in Delan DF were evaluated as part of the EU review. All data are considered adequate. Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) The analytical methods for the determination of dithianon in foodstuffs of plant origin were evaluated in the framework of the peer review of Directive 91/414/EEC (Greece, 2008). Dithianon residues in commodities of plant origin can be determined by LC/MS-MS with an LOQ of 0.01 mg/kg. The analysis of the supervised field trials from 2009 to 2011 and studies on the nature of residues in processed commodities occurred with BASF method No. L0152/01, which is, with the exception of minor modifications, identical to SOP-PA.0281. The further developments of SOP-PA.0281 have been performed to include the degradation product Reg. No. 4110904 (CL 1017911), known from the hydrolysis study at exaggerated temperatures in buffer solutions, in the analytical method. The method is based on LC/MS-MS and has for dithianon and Reg. No. 4110904 a limit of quantification of 0.01 mg/kg. With this elaborated method further information can be obtained on the presence/absence of Reg. No. 4110904 on RAC and processed products. Thus, BASF method No. L0152/01 is included in this draft registration report.


Delan DF



The analytical methods for the determination of dithianon in foodstuffs of animal origin were evaluated in the framework of the peer review of Directive 91/414/EEC (Greece, 2008). Dithianon residues in commodities of animal origin can be determined by LC/MS-MS with an LOQ of 0.01 mg/kg for cow liver, kidney, fat and milk. Beyond that, dithianon residues in commodities of animal origin can be determined by HPLC-ECD or LC/MS with an LOQ of 0.01 mg/kg in bovine muscle, bovine fat, bovine whole milk and chicken egg. Analytical methods developed for determination of dithianon residues in the environmental matrices soil, water and air were already EU reviewed and considered adequate. The analytical method for the determination of residues in surface water meets the Dutch national requirement (LOQ≤0.1 µg/L)

Mammalian Toxicology (Part B, Section 3, Point 7)

Acute Toxicity (Part B, Section 3, Point 7.1)

Delan DF was a representative formulation in the EU review of dithianon. The acute toxicity studies for the Delan DF were evaluated during the review and were considered adequate. Delan DF containing 700 g dithianon/kg has a moderate toxicity in respect to acute oral route of application and low dermal toxicity. The granular formulation is not inhalable and does not meet the criteria for performance of an acute inhalation study according to regulation 545/2011. Delan DF is not irritating to the rabbit skin. It has been found to cause severe eye damage and is classified as a skin sensitizer based on the high content of the active ingredient dithianon, which is a known skin sensitizer. Table 3.1.3.1-1: Acute toxicological data obtained with Delan DF

Parameter [Reference]

Species

Result mg/kg or mg/m

3 or effect

Classification

Acute Oral Toxicity

Rat LD50 oral, rat = 273 mg/kg bw (females) H301

Acute Dermal Toxicity

Rat LD50 dermal, rat >4000 mg/kg bw None

Acute Inhalation Toxicity

- Not inhalable, no test required None

Skin irritation

Rabbit Not irritating to skin None

Eye Irritation

Rabbit Severely eye irritant H318

Skin sensitization, Buehler Test

Guinea pig

Not a skin sensitizer None based on the study but self-classified with

Skin Sens 1, H317 based on the positive results of M&K Test with dithianon


Delan DF



Operator Exposure (Part B, Section 3, Point 7.3)

According to the model calculations, it can be concluded that the risk for the operator using Delan DF on pome fruits and cherries is acceptable without the use of PPE for mechanical application (50% of the NL-AOEL) and with the use of gloves during application for hand-held application (99% of the NL-AOEL). Given the eye damaging and skin sensitizing potential of Delan DF impermeable gloves and eye/face protection should be worn when handling the concentrate. Gloves should also be used for the maintenance of the sprayer during application.

Bystander Exposure (Part B, Section 3, Point 7.4)

Non-work related bystander and resident exposure was modeled according to the German and UK model. Professional bystander exposure was estimated using the EUROPOEM model. Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander, nor for nearby non-work related bystanders and residents, due to exposure to dithianon during application of Delan DF in pome fruits and cherries (the highest estimated exposure is 64% of the AOEL).

Worker Exposure (Part B, Section 3, Point 7.5)

It is concluded that there is no unacceptable risk anticipated for the worker with the use of PPE, when re-entering crops treated with Delan DF (the estimated exposure is 15% of the NL-AOEL). As a standard rule, treated crops should not be re-entered before spray deposits on leaf surfaces have completely dried.

Residues and Consumer Exposure (Part B, Section 4, Point 8)

Residues (Part B, Section 4, Points 8.3 and 8.7)

This application for authorization is based on the metabolism and residue studies of dithianon that have been evaluated by the Greek Rapporteur Member State in the context of the Annex I re-inclusion procedure, and has been peer reviewed by EFSA (EFSA Journal 2010;8(11):1904). Confirmatory data were set regarding the storage stability of dithianon incurred residues in pome fruit and grape wine, and the nature of residues in processed products under standard hydrolytic conditions. These studies were submitted in the form of confirmatory data to the responsible authority in Greece (RMS). In parallel, the confirmatory studies were submitted in the framework of the present dossier. The ZRMS has used the evaluation of RMS Greece in the current dossier, since the peer review by EFSA and other MSs was not finalized yet. Currently, the evaluation of EFSA has been finished and is about to be published. Therefore, for the application for authorization in the Netherlands, both the evaluation of the confirmatory data by the ZRMS as well as the evaluation of EFSA has been taken into account. Additional storage stability studies were performed as part of the confirmatory data package. The results of these newly submitted storage stability studies show that dithianon is stable in commodities with high water content for the time period of 2 years. Metabolite Reg. No.


Delan DF



4110904 also remains stable up to 2 years of frozen storage in commodities with high water content. Since pome fruit and cherries belong to the group of commodities with high water content, these storage stability studies are sufficient for the current application for authorization. GAP compliant residue trials have been submitted for the intended use on pome fruits and cherries. The harmonised EU MRLs for dithianon on pome fruits of 3 mg/kg and cherries (2 mg/kg) will not be exceeded when the product is applied according to the recommendations. An additional hydrolysis study was performed within the confirmatory data package, including the characterisation of the degradation products formed. The hydrolysis experiment with dithianon was performed with apple juice. According to the study results, after pasteurization parent dithianon was identified at around 50% of total applied radioactivity (TAR). Metabolite Reg. No. 4110904 was identified slightly below 10% TAR and all other degradation products were below 5% TAR. After baking, boiling or brewing, metabolites Reg. No. 4110904 and Reg. No. 31062 were identified at >5% and <10% TAR. All other degradation products were below 5% TAR. After sterilization, metabolite Reg. No. 4107273 was identified at >10% TAR. Metabolite Reg. No. 4110904 was identified at >5% and <10% TAR after sterilisation. Metabolite Reg. No. 31062 was identified at around 10% TAR after sterilization. All other degradation products and the parent compound were identified below 5% TAR. Balance studies on processed apple and cherry commodities have been submitted, in which only parent dithianon and metabolite Reg. No. 4110904 were determined. Transfer factors from raw agricultural commodities to processed commodities were proposed for dithianon and metabolite Reg. No. 4110904. In EFSA’s evaluation of the processing data, data gaps were set for the magnitude of residues of the metabolites Reg. No. 4107273, Reg. No. 31062, Reg. No. 4005234 (phthalic acid) and Reg. No. 4110933, which were identified as well in the hydrolysis study. Actual studies addressing the data gaps are not available within the current dossier. Nevertheless, based on plausible assumptions, the ZRMS concluded that these metabolites are not relevant for inclusion in the residue definition. The conclusions from the ZRMS are considered sufficient for the current dossier.

Consumer exposure (Part B, Section 4, Point 8.10)

Assessment of the potential chronic and acute dietary consumer risk due to exposure to residues of dithianon was performed using the EFSA model for chronic and acute risk assessment - rev. 2_0 (Model PRIMo). The EFSA model was used since it considers all the different diets in the EU and all consumer groups. Based on the existing EU MRLs for dithianon the TMDI is representing >500 % of the ADI. However, the ZRMS only considered uses registered in Austria as input values for the risk assessment. According to the agreed methodology, all registered uses should be included in the calculation of the consumer risk. Therefore, the consumer risk assessment has been updated in part A, taking into account all possible uses of dithianon. STMRs of the requested uses within


Delan DF



this application have been used as input. Furthermore, the STMR for grapes has been used from the peer review. In addition, from a metabolism study with dithianon on citrus fruits, it can be concluded that only 1% of the residue will be find in the pulp. Consequently, the MRLs for citrus are multiplied with a processing factor for peeling. When considering these refinements, it can be concluded that there is no long term risk for consumers. No acute risk can be expected from the consumption of pome fruits and cherries after application of the formulation Delan DF according to the cGAP applied for. Based on the different calculations made to estimate the risk for consumers through diet and other means it can be concluded that the use of the product Delan DF does not lead to an unacceptable risk for consumers when applied according to the recommendations.

Environmental fate and behaviour (Part B, Section 5, Point 9)

The environmental fate and behaviour of the active substance dithianon and its metabolites was assessed in the context of Annex I inclusion. The results of the peer review are summed up in the Review Report for dithianon (SANCO/10349/2011 final – 11/March/2011). All environmental fate studies performed with the active substance or its metabolites are adequate to support the proposed use of the formulated product Delan DF. Thus, no extra studies with the product were conducted. Based on new data provided in this submission and on data reviewed in the EU review, appropriate endpoints for PEC calculations were derived in accordance with the conclusions from the EU review and national requirements.

Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5)

PECs of the active substance dithianon with its metabolite phthalic acid in soil cover the uses of Delan DF in pome fruits. Calculations of PEC in soil were conducted in the context of a risk envelope approach, considering the worst-case application scenario (3 x 525 g ha-1, followed by 3 x 350 g ha-1 (sixfold)), worst-case crop interception of 50% for all applications and a minimum interval of 5 days between the applications. The worst-case GAP that is used in the core assessment covers the use in the Netherlands.

Table -1: Maximum PECsoil for dithianon with its metabolite phthalic acid

Pome fruit PECsoil,max

[mg kg-1

]

Dithianon 1.368

Phthalic acid 0.032


Delan DF



Calculations were carried out in accordance with national requirements for exposure assessment and under consideration of substance-specific endpoints. The results are considered acceptable for subsequent ecotoxicological assessments.

Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)

The PEC of dithianon with its metabolite phthalic acid in ground water have been assessed with standard FOCUS groundwater scenarios and the FOCUS models FOCUS PEARL 4.4.4. The calculations were based on DT50 and Koc values established in the EU review or agreed in the assessment based on new data provided (i.e. DT50 / KOC of 10.5 days / 3627 mL g-1 (dithianon) and 1 day / 18.8 mL g-1 (phthalic acid). The predicted environmental concentrations (PECgw) at 1m depth for dithianon with its metabolite phthalic acid following 20 years use were calculated. The worst-case GAP that is used in the core assessment covers the use in the Netherlands.

Table -2: Worst-case application scenarios for application of dithianon in Delan DF considered for PECgw calculations

Crops in GAP Pome fruits

FOCUSgw crop Apples (PEARL)

Application time [BBCH code] 53

Max. number of applications 6 (3 and 3)

Min. application interval [d] 5

Max. application rate [g a.s. ha-1

] 3 x 525 and

3 x 350

Interception [%] 50

Soil load [g a.s. ha-1

] 3 x 262.5 and

3 x 175

Total yearly soil load [g a.s. ha-1

] 1312.5

* Covering the uses of pome fruits and stone fruits in the GAP in the context of a risk envelope approach

The PECgw was less than 0.001 g/L in the Kremsmunster scenario. According to these modelling results, the active substance and its metabolite phthalic acid are not expected to leach into groundwater at concentrations greater than 0.001 μg L-1 when the product Delan DF is used according to GAP.

Monitoring data groundwater

There are no data available regarding the presence of the substance dithianon in groundwater.


Delan DF



Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)

The calculations for PEC of dithianon and its metabolites in surface water (PECsw) and sediment (PECsed) were calculated with TOXSWA 1.2 for autumn and spring application according to the Dutch recommendations on the surface water assessment. Since spray drift is the only entry path in the Dutch surface water assessment, formation of metabolites in soil is not considered in the PECsw and PECsed calculations. An overview of the worst-case application scenario is given in the following table. Table 3.1.5.3-1: Standard worst case scenario of dithianon in Delan DF to pome and stone fruits in the Netherlands

Crops in GAP Pome fruits Pome fruits Cherries

Scenario name Pome fruit, early / late

Pome fruit, early / late

Stone fruit, early / late

Situation according to guidelines Fruit crops without

/ with leaves Fruit crops without

/ with leaves Fruit crops without

/ with leaves

Drift value [%] 17 / 7 % 17 / 7 % 17 / 7 %

Application time [BBCH code] 53-79

(early / late) 53-79

(early / late)

61-85 / 91-95

(early / late) / (late)

Max. number of applications 6 6 3+1

Min. application interval [d] 5 5 7 (21 day PHI)

Max. application rate [g a.s. ha-1] 6 x 368 6 x 298* 4 x 525**

* for dithianon and metabolite phthalaldehyde the use rate of 6 x 298 g a.s. ha-1 for orchards bordering surface water was calculated

** for the spring scenario, three early applications and one late application is applicable.

The spray drift percentage depends on the use. The default Dutch calculations assume 17% drift from spray application to orchards (early scenario, before May 1st) and 7% drift from spray application to orchards (late scenario, from May 1st) which implies standard reduction of 50% by drift reducing nozzles (Evaluation manual 1.1, 20111). For pomes the spring scenario was used for the early applications and the autumn scenario was used for the late applications. For cherries, the early application occurs in April (BBCH 61) when petals have developed, but leafs have not. The latter post-harvest application occurs when leafs have developed. Therefore the high drift value is applicable for BBCH 61-85 and the low drift value is applicable for BBCH 91-95. Therefore the spring scenario is consecutively modelled with three applications with high drift and one application with low drift. The autumn scenario is modelled with four late applications (low drift). See table 3.1.5.3-2 for the drift per application timing.. The applicant suggests the use of drift mitigation measures by applying spray drift reducing technology, partly in connection with a buffer zone. These measures are taken into account and are calculated for the surface water relevant schemes.

1 http://ctgb.nl/gewasbescherming/toetsingskader/evaluation-manual


Delan DF



The following drift mitigation measures were considered as options for reduction of drift values: Table 3.1.5.3-2: Drift mitigations as proposed by the applicant Use # Drift mitigation

measures [EN] Drift mitigation measures [NL] Corresponding drift (%)

(Early application

Late application

Pome/ cherry

- No mitigation Geen mitigerende maatregelen 17.0 7.0

Pome/ cherry

1 Tunnel sprayer Tunnelspuit 2.5 1.0

Pome/ cherry

2 Venturi nozzle + one-sided spraying of the last tree row

when ventilator high

Venturidoppen (minimaal 90% driftreducerend) in de eerste 20 meter grenzend aan het oppervlaktewater in combinatie met éénzijdige bespuiting laatste bomenrij in de richting van het perceel

en ventilatorstand "hoog".

- 0.8

when ventilator low

en ventilatorstand "laag".

2.4 0.3

when ventilator off

en ventilatorstand "uit".

1.2 -

Pome/ cherry

3 Wanner equipment with reflection shield and venturi nozzles (Lechler ID 90-015C)

Wannerspuit met reflectieschermen en venturidoppen (minimaal 90% driftreducerend) (Lechler ID 90-015C)

0.98

0.21

Pome/ cherry

4* KWH k1500-3R2 VLOS 3-row sprayer with variable air support system and 90% drift reducing nozzles

KWH k1500-3R2 VLOS 3-rijenspuit met variabele luchtondersteuning en minimaal 90% driftreducerende spuitdoppen in de eerste 20 meter grenzend aan het oppervlaktewater

0.70 0.43

Cherry 5 6 meter crop-free zone

standaardspuit met een 6 meter teeltvrije zone

6.7 2.7

Cherry 6 Sensor-controlled spraying

sensor gestuurde spuit.

13.6 3.4

* The drift percentages that correspond to this mitigation are described in Evaluation Manual 2.0 (Ctgb, 2014).

These drift percentages were used to calculate mitigation-specific loading rates for TOXSWA GUI. The maximum PECsw and PEC_TWAsw of dithianon and its metabolites are summarised in the following tables.


Delan DF



Table 3.1.5.3-2. Overview of surface water concentrations for active substance dithianon in the edge-of-field ditch following spring and autumn application in Pomes and cherries non-adjacent to surface water Substance Rate a.s.

[kg/ha] Freq. Inter-

val Drift [%]

PIECsw

[g/L]

PECsw-TWA-21d

[g/L]

PECsw-TWA-28d

[g/L]

Spring autumn spring autumn spring autumn

dithianon 0.368 6 5 17 30.66 - 8.6 - 7.22 -

7 - 12.24 - 3.185 - 2.625

2.51 4.503 - 1.258 - 1.057 -

11 - 1.746 - 0.4528 - 0.3733

dithianon 0.525 3+1 7(+21) 17* 42.63 - 8.19 - 6.206 -

7 - 17.46 - 4.571 - 4.46

2.51* 6.258 1.198 0.9084 -

11 - 2.491 - 0.6502 - 0.6339 1

Tunnel sprayer * for the spring scenario, three early applications and one late (post harvest) application take place


Delan DF



Table 3.1.5.3-3: Overview of surface water concentrations for dithianon metabolites phthalic acid, phthalaldehyde, CL 1017911 and 1,2-benzenedimethanol for application in pome fruit non-adjacent to surface water

Pome fruit non adjacent to surface water, 6 applications

Appl. scheme Drift value [%]

PIECsw

[µg/L] Drift value [%]

PIECsw

[µg/L]

phthalic acid 1,2-

benzenedimethanol

phthalaldehyde

CL 1017911

early 17 29.870 9.361 17 2.241 63.890

late 7 2.666 1.203 7 0.6245 7.483

early n.a.

2.51*

0.357 9.391

late 11 0.089 1.069

late 1.22

0.071 0.855

Stone fruit non adjacent to surface water, 3+1 applications*

Appl. scheme Drift value [%]

PIECsw

[µg/L] Drift value [%]

PIECsw

[µg/L]

phthalic acid 1,2-

benzenedimethanol

phthalaldehyde

CL 1017911

early 17 23.34 8.255 17 2.697 55.05

late 7 3.787 1.71 7 0.8886 10.65

early n.a.

2.51*

0.3964 8.095

late 11 0.127 1.521

late 1.22 0.152 1.825

1 Tunnel sprayer

2 Venturi nozzle

* for the spring scenario, three early applications and one late (post harvest) application take place

n.a. not available

The PEC values for the other mitigations are covered by the presented mitigations (Tunnel sprayer and Venturi nozzle) as presented in table 3.1.5.3-2 and 3.1.5.3-3. PEC values for applications adjacent to surface water are covered by the application in pomes fruit, not adjacent to surface water (i.e. the higher application rate).

The results for PEC surface water for the active substance and its metabolites were used for the ecotoxicological risk assessment.


Delan DF



Monitoring data surface water

Pesticide Atlas Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold and environmental quality standards (MKN in Dutch, data source http://www.rivm.nl/rvs/Normen). These environmental quality standards consist either of the harmonised WFD thresholds derived according to the Fraunhofer methodology2 (AA-EQS and MAC-EQS) or of an MPC value (which is usually derived on the basis of outdated guidance). When EQS values according to the Water Framework Directive are available, the MPC value is not used further in the analysis of monitoring data for the purpose of the registration. Dithianon The active substance dithianon was observed in the surface water (most recent data from 2013). In Table 3.1.5.3-4 observed concentrations in surface water are presented. The authorisation threshold equals 0.97 µg a.s./L [HC5 fish, correction factor 20, 07-09-2012]. The relevant environmental quality standards for this substance are AA-EQS (JG-MKN) and MAC-EQS (MAC-MKN) and equal 0.097 µg/L [02-06-2010] respectively 0.36 µg/L [02-06-2010]. Table 3.1.5.3-4 Monitoring data in Dutch surface water in dithianon (from

www.pesticidesatlas.nl, version 3)

Total no of locations (2014)

n > authorisation threshold

n > EQS

MAC-EQS AA-EQS MPC (ad-

hoc/indicative) 59* 0 0 0 n.r. * the number of observations at each location varies between 1 and 30, total number of measurements is 320 in 2014. n.r. not relevant

As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed uses of the product PEC values of surface water intended for drinking water production From the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) it follows that when considering an application, the Dutch competent Authority should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion ‘surface water intended for drinking water production’. The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 1635.

2 P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework

of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision 2007’.

RIVM report 601782001.


Delan DF



Substances are categorised as new substances on the Dutch market (less than 3 years authorisation) or existing substances on the Dutch market (authorised for more than 3 years).

- For new substances, a preregistration calculation is performed. - For existing substances, the assessment is based on monitoring data of VEWIN (drinking

water board).

o If for an existing substance based on monitoring data no problems are expected by VEWIN, CTGB follows this VEWIN assessment.

If for an existing substance based on monitoring data a potential problem is identified by VEWIN, CTGB assesses whether the 90th percentile of the monitoring data meet the drinking water criterion at each individual drinking water abstraction point.

Risk for drinking water from surface water by dithianon Dithianon has been on the Dutch market for > 3 years (first authorised in 1988). This period is sufficiently large to consider the market share to be established. Dithianon is not included in the list of substances of concern generated by VEWIN. From the general scientific knowledge collected by the CTGB about the product and its active substance, the CTGB concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The CTGB does under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the RGB are met. The worst case use of dithianon in Delan DF (6 x 368 g a.s./ha) is covered by the use of the registered product DELAN WG. For dithianon exceeding the drinking water criterion, at the intake point of surface water for drinking water, is not expected. It is concluded that the proposed use of Delan DF will not give an unacceptable risk for drinking water from surface water.

Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9)

Dithianon has a low volatilisation potential. Dithianon shows a very low vapour pressure (2.71 x 10-9 Pa at 20°C), and the calculated tropospheric half-life is < 6.3 hours (Atkinson model (v. 1.89)). Implications for labelling resulting from environmental fate assessment: Directive 99/45/EC (as amended):

None

Directive 2003/82/EC (Annex IV and V):

None


Delan DF



Other:

None

Ecotoxicology (Part B, Section 6, Point 10)

Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

Effects on birds Under the conservative assumptions of a tier 1 assessment all TERA values and the two TERLT exceed the trigger. The TERLT value from the small insectivorous bird “tit” scenario is below the trigger and needed to be refined to obtain a safe risk: identification of focal bird species including ecological data (PT and PD values and FIR/b.w. calculations), residues of dithianon in arthropods and deposition factor for food items in orchards. The application of Delan DF does not raise concerns regarding food chain behaviour (secondary poisoning), biomagnification or uptake of contaminated drinking water by birds. Effects on terrestrial vertebrates other than birds Under the conservative assumptions of the tier 1 acute dietary risk assessment and reproductive risk assessment the TERA and the TERLT values for two scenarios for dithianon exceed the trigger For the small herbivorous mammal “vole” and the frugivorous mammal “dormouse” scenarios the TERLT values for dithianon are below the trigger. Based on residue data in fruits and foliar residue decline data these scenarios were refined and exceed the trigger and the risk is low and acceptable. The application of Delan DF does not raise concerns regarding food chain behaviour (secondary poisoning), biomagnification or uptake of contaminated drinking water by mammals.

Effects on Aquatic Species (Part B, Section 6, Point 10.2)

The active substance dithianon is of high toxicity to aquatic organisms, particularly to fish. The acute and long-term TER values for fish, aquatic invertebrates, aquatic insects and algae do not meet the required trigger values based on standard worst-case assumptions. However, a range of additional and higher tier studies has been conducted for dithianon, including both a large number of tests with different fish species, the simulation of multiple applications under laboratory conditions (worst-case scenarios) and a mesocosm study. This allows a complex evaluation of the potential risk to aquatic ecosystems and fish in particular. The TER values for the metabolites phthalic acid and 1,2-benzenedimethanol exceed the trigger values indicating a low ecotoxicological relevance of these metabolites. In addition, the metabolites phthalaldehyde and CL 1017911 exceed the required trigger value based on standard worst-case assumptions following application in stone fruits. As a result, drift mitigation measures are required to obtain a safe risk for the proposed uses of Delan DF in pome and stone fruits.


Delan DF



The results obtained with the formulated product Delan DF (tested with the minor change formulation BAS 216 80 F) show, based on the content of the active substance within the formulation, a slightly higher toxicity to algae and Daphnia compared to the studies performed with the active substance (please refer to the core dossier). The toxicity to fish is in the same range for the formulated product as expected from the toxicity of the active substance. Since the most sensitive species shows comparable toxicity, the risk assessment for the active substance covers the risk assessment for the formulation as well.

Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

Bees The calculated HQs for acute oral and acute contact exposure of honeybees to dithianon and the formulated product Delan DF are below the Commission Regulation (EU) 546/2011 trigger value of 50. The proposed uses of Delan DF according to good agricultural practice present low risk to bees and will not adversely affect bees or bee colonies. Other non-target arthropods The calculated hazard quotients of the first tier risk assessment indicate no in- and off-field risk for Typhlodromus pyri and Aphidius rhopalosiphi. Nevertheless, a worst-case laboratory study was carried out with Chrysoperla carnea and Paradosa spec. as well as an extended laboratory studies and and aged residue design study with Aphidius rhopalosiphi. For all species, low in-field and off-field risk following application of Delan DF was indicated.

Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6)

Earthworms All acute TER values exceed the Commission Regulation (EU) 546/2011 trigger value of 10, indicating low acute risk to earthworms following application of Delan DF according to the proposed use rates. The long-term TER values calculated for dithianon were above the trigger but for Delan DF below the trigger. Therefore, a field study with Delan DF was carried out. No unacceptable effects on earthworm communities were observed at application rates higher than the intended use of Delan DF Therefore, it can be concluded that the use of Delan DF will be of low risk to natural earthworm communities. The dithianon metabolite phthalic acid occurred to some extent (16%) in the soil during photolysis under aerobic conditions. However, due to its short half-life the occurrence is transient and thus of low ecotoxicological relevance. Furthermore, based on literature data of phthalic acid on aquatic organisms and a QSAR a low risk of phthalic acid on soil organisms can be concluded. Moreover, the chronic risk for earthworms from phthalic acid is covered by the 56-d reproduction test (dithianon) and the field study with Delan DF (70% dithianon). Therefore, it can be concluded that the metabolite phthalic acid will be of low risk to natural earthworm communities. Effects on other soil non-target macro-organisms Tests on other soil non-target macro-organisms are not required.

Effects on organic matter breakdown (Part B, Section 6, Point 10.6)

Tests on organic matter breakdown are not required.


Delan DF



Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)

Delan DF had no significant effect on soil micro-organisms at more than 13 times higher than the maximum PECsoil. This supports the conclusion that under field conditions, the use of Delan DF at the proposed rates poses no unacceptable risk to non-target soil micro-organisms. The dithianon metabolite phthalic acid occurred to some extent (16%) in the soil during photolysis under aerobic conditions. Taking the predicted low acute toxicity to earthworms into perspective, a low risk of phthalic acid on soil organisms can be concluded.

Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)

Non-Target Plants The TER values for the vegetative vigor test and the seedling emergence test conducted under worst-case greenhouse conditions with Delan DF were above the trigger value of 5 for all tested plant species indicating no unacceptable risk for non-target plants. Overall conclusion: In conclusion, populations of terrestrial non-target plants in off-crop areas are not at risk following application of Delan DF to the proposed use and good agricultural practice, provided that drift mitigation is applied.

Other non-target species (Flora and Fauna) Tests on other non-target species are not required.

Efficacy

The ZRMS of this dossier is Austria. Austria concludes that the use in pomefruits can be granted, however this evaluation does not completely cover the requested use in the Netherlands Therefore a national addendum was submitted and evaluated. The National Addendum concerns the intended use of 0.425 kg/ha Delan DF in apple and pear in the Netherlands. This lower dose rate was claimed for use in orchards that border on water surfaces, or in orchards with a lower infection pressure. In order to do so, data from 23 efficacy trials in apple in the EPPO Maritime Climatic Zone were submitted and summarized. It must be stressed that the dose rate of 0.425-0.525 kg/ha is required because of restrictions imposed by aspects other than efficacy, if no such restrictions apply a dose rate of 0,75 kg/ha would be considered the minimum effective dose, as is concluded in the core. However since restrictions apply, the efficacy of dose rates of 0.425- 0.525 kg/ha has been evaluated. The number of trials as well as the disease pressure in the 20 trials was sufficient. In the effectiveness trials, 7-15 applications with the claimed dose rate of 0.425 kg/ha Delan DF showed significant control of apple scab on leaves and fruits. The control of 0.425 kg/ha Delan DF was always significant higher compared to the untreated control and generally comparable to (or sometimes better) the control given by the reference products based on dithianon, kresoxim-methyl, pyrimethanil, trifloxystrobin and pyraclostrobin/dithianon.


Delan DF



Overall, it can be concluded that 0.425 kg/ha Delan has proven its effectiveness in controlling Venturia inaequalis in apple on both leaves and fruit. Even in cases of moderate leaf infection, high levels of apple

scab control were found on fruits. In line with the core assesment it has to be concluded that under higher disease pressure, higher rates are needed. It can be concluded that a dose rate range can be claimed of 0.425-0.525 kg/ha, depending on disease pressure. Based on expert judgement and according to the extrapolation document “Possibilities for extrapolation of efficacy and crop safety of crop protection products” (CTB, May 2004), effectiveness data obtained for scab control in apple can be extrapolated to scab control (Venturia pirina) in pear and other pomes. In addition in the core assessment, it is concluded by the zRMS that the cMS have to ask for further data when cherry is a major crop in their country. For the authorization in the Netherlands, cherry is a minor crop and for this reason efficacy data is not evaluated.

Resistance management Dithianon has been authorised for considerable time and is a broad spectrum preventative fungicide. It is a multisite inhibitor, which makes resistance development less likely. It is concluded that while Venturia spp. are high risk pathogens for development of resistance, no resistance development against dithianon has been observed in the past 40 years. The total number of six applications is found to be acceptable for the Netherlands, a full spray program will typically have significantly more than 6 applications against Venturia spp. Therefore the product will have to be alternated with other products in practice. No additional resistance management is required.

Conclusions

An authorisation can be granted.

3.3 Substances of concern for national monitoring

No further information is required.

3.4 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation

None.


Delan DF



Appendix 1 Copy of the product label

Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als schimmelbestrijdingsmiddel door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden

Toepassings- gebied

Type toepassing Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen of uiterst gewasstadium waarop toegepast mag worden

Pitvruchten Voor oogst behandeling

Schurft 1 0,425 – 0,525 kg/ha*

6 5 dagen 42 dagen

*Dosering afhankelijk van ziektedruk 1 Venturia inaequalis; Venturia pirina;

Het gebruik in de teelt van kers is beoordeeld conform de “vereenvoudigde uitbreidingsprocedure”. Er is voor deze toepassing geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in dit toepassingsgebied valt onder verantwoordelijkheid van de gebruiker.

Toepassings- gebied

Type toepassing Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen of uiterst gewasstadium waarop toegepast mag worden

Kers Voor oogst behandeling

Hagelschotziekte 2 Bladvalziekte 3 Schurft 4

Bladverbruining 5

0,75 kg/ha 3 7 dagen

21 dagen

Na oogst behandeling

1 -


Delan DF



2 Thyrostroma carpophilum;

3 Blumeriella hiemalis;

4 Venturia cerasi;

5 Gnomonia erythrostoma

Toepassingsvoorwaarden In pitvruchten Delan DF toepassen in 150-300 liter water per ha. In kers Delan DF toepassen in 200-1500 liter water per ha. Om in het water levende organismen te beschermen is toepassing in de teelt van pitvruchten en kers in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan wanneer:

Vóór 1 mei gebruik gemaakt wordt van:

Wannerspuit met reflectieschermen en venturidoppen (minimaal 90% driftreducerend) (Lechler ID 90-015C,) met inachtneming van een teeltvrije zone van tenminste 3 meter, of


Vanaf 1 mei gebruik gemaakt wordt van:

een tunnelspuit met inachtneming van een teeltvrije zone van tenminste 3 meter, of

Venturidoppen (minimaal 90% driftreducerend) in de eerste 20 meter grenzend aan het oppervlaktewater in combinatie met éénzijdige bespuiting van de laatste bomenrij in de richting van het perceel en ventilatorstand“laag“ of "hoog", met inachtneming van een teeltvrije zone van tenminste 3 meter, of

een Wannerspuit met reflectieschermen en venturidoppen (minimaal 90% driftreducerend) (Lechler ID 90-015C,) met inachtneming van een teeltvrije zone van tenminste 3 meter, of


Delan DF





Delan DF



Appendix 2 List of data submitted in support of the evaluation Physical and chemical properties

Annex point

Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished

Data protection claimed Yes/No

Data protection granted

Yes/No

Relied on

Yes/No

Owner

KIIIA 2.2.1/1

2013 a

Evaluation of physical and chemical properties according to Directive 94/37/EC (Regulation (EC) No 440/2008) BASF AG, Ludwigshafen/Rhein, Germany Fed.Rep. 2013/1002661 Yes Unpublished

Yes Y Y BASF

KIIIA 2.2.2/1

2013 a


Yes Y Y BASF

KIIIA 2.3.2/1

2013 a


Yes Y Y BASF

KIIIA 2.3.3/1

2013 a


Yes Y Y BASF


Delan DF



Annex point




Yes/No

Relied on

Yes/No

Owner

KIIIA 2.8.6.1/1

2005 a

Report amendment no. 1 to Dithianon 700 g/kg WG: chemical and physical stability of formula reference Delan DF when stored in commercial HDPE packs BASF AG Agrarzentrum Limburgerhof, Limburgerhof, Germany Fed.Rep. 2005/1016477 Yes Unpublished

Yes Y Y BASF

KIIIA 2.9.1/1

2013 a

Physical and Chemical Compatibity in Aqueous Tank Mixtures of Delan DF BASF SE Agricultural Center Limburgerhof, Limburgerhof, Germany Fed.Rep. 2013/1068042 No Unpublished

Yes Y Y BASF

KIIIA 2.9.2/1

2013 a

Physical and Chemical Compatibity in Aqueous Tank Mixtures of Delan DF BASF SE Agricultural Center Limburgerhof, Limburgerhof, Germany Fed.Rep. 2013/1068042 No Unpublished

Yes Y Y BASF

KIIIA 4.1.2/1

2004 a

EU performance tests of Delan DF (Standard-PE-Bottle, 1 L, Spec.-No. 775 5107) BASF AG, Ludwigshafen/Rhein, Germany Fed.Rep. 2004/1000701 No, not subject to GLP regulations Unpublished

Yes Y Y BASF

KIIIA 4.1.2/2

2008 a

Delan DF, EU Performance Test (FFS bag, 0.5 Kg) BASF AG, Ludwigshafen/Rhein, Germany Fed.Rep. 2007/1038857 No Unpublished

Yes Y Y BASF


Delan DF



Annex point




Yes/No

Relied on

Yes/No

Owner

KIIIA 4.1.3/1

2004 a

Dithianon 700 g/kg WG - chemical and physical stability of formula Delan DF when stored in commercial HDPE packs - 156 week final report - BASF AG Agrarzentrum Limburgerhof, Limburgerhof, Germany Fed.Rep. 2004/1027371 Yes Unpublished

Yes Y Y BASF

KIIIA 4.1.3/2

2005 a

Report amendment no. 1 to Dithianon 700 g/kg WG: chemical and physical stability of formula reference Delan DF when stored in commercial HDPE packs BASF AG Agrarzentrum Limburgerhof, Limburgerhof, Germany Fed.Rep. 2005/1016477 Yes Unpublished

Yes Y Y BASF

KIIIA 4.2.2/1

2013 a

Delan DF: Effectiveness of procedures for cleaning application equipment and protective clothing BASF SE Agricultural Center Limburgerhof, Limburgerhof, Germany Fed.Rep. 2013/1167008 No, not subject to GLP regulations Unpublished

Yes Y Y BASF

Methods of analysis

Annex point

Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) PublishedorUnpublished



Yes/No

Relied on

Yes/No

Owner


Delan DF



Annex point




Yes/No

Relied on

Yes/No

Owner

KIIIA 5.6/1

2010 a

Amended report - Method validation of BASF analytical method D0701: Method for determination of BAS 216 F (Dithianon) in surface and drinking water using LC/MS/MS ADPEN Laboratories Inc., Jacksonville FL, United States of America 2010/7003537 Yes Unpublished

Yes Y Y BASF

Mammalian Toxicology

Metabolism and residues

Annex point


Data protection

claimed Yes/No


Yes/No

Relied on

Yes/No

Owner

KIIIA 7.6.2/1

2008 c

14C-BAS 216 F in Delan DF: Study of penetration through human skin in vitro 2008/1063737 Yes Unpublished

N N Y BASF


Delan DF



Annex point



Data protection granted Yes/No

Study relied on Yes/No

Owner

KIIIA 8.1.1/1

2013 a

Investigation of the storage stability of incurred BAS 216 F residues (Dithianon) in apples BASF SE, Limburgerhof, Germany Fed.Rep. 2013/1061838 Yes Unpublished

No No Yes BASF

KIIIA 8.1.1/2

2013 b

Investigation of the storage stability of BAS 216 F metabolite Reg.No.4110904 in plant matrices BASF SE, Limburgerhof, Germany Fed.Rep. 2013/1061837 Yes Unpublished

Yes Yes

Yes BASF

KIIIA 8.3.1/1

2011 a

Delan DF: Determination of residues of Dithianon in apples (RAC fruit) following six treatments with Delan DF (700 g/kg Dithianon) under open field conditions in Northern and Southern Europe in 2010 Harlan Laboratories Ltd., Itingen, Switzerland 2011/1150054 Yes Unpublished

Yes Yes Yes BASF

KIIIA 8.3.1/2

2011 b

Delan DF: Determination of residues of Dithianon in apples (RAC fruit) following four to six treatments with Delan DF (700 g/kg Dithianon) under open field conditions in Northern and Southern Europe in 2010 Harlan Laboratories Ltd., Itingen, Switzerland 2011/1150053 Yes Unpublished

Yes Yes Yes BASF

KIIIA 8.3.1/3

2012 a

Study on the residue behaviour of BAS 216 F in pome fruits after application of Delan DF under field condition in Belgium, The Netherlands, United Kingdom, Southern France, Italy, Greece, Spain and Germany, 2011 Agro-Check Dr. Teresiak & Erdmann GbR, Lentzke, Germany Fed.Rep. 2012/1150991 Yes Unpublished

Yes Yes Yes BASF


Delan DF



Annex point





Owner

KIIIA 8.3.2/1

2011 a

Residue study (decline) with Delan DF applied to sweet and sour cherries in Germany, Northern France, the Netherlands and the UK in 2009 and in Spain, Greece, Southern France and Italy in 2010 Huntingdon Life Sciences Ltd., Eye Suffolk IP23 7PX, United Kingdom 2010/1014785 Yes Unpublished

Yes Yes Yes BASF

KIIIA 8.3.2/2

2012 b

Study on the residue behaviour of Dithianon in cherry (sour and sweet) after application of Delan DF under field condition in The Netherlands, UK, Southern France, Greece, Italy and Germany, 2010 Agro-Check Dr. Teresiak & Erdmann GbR, Lentzke, Germany Fed.Rep. 2011/1050127 Yes Unpublished

Yes Yes Yes BASF

KIIIA 8.3.2/3

2010 a

Residue study (decline) with Delan DF applied to peaches in Germany, Northern France, Southern France, Greece, Italy and Spain in 2009 Huntingdon Life Sciences Ltd., Huntingdon Cambridgeshire PE28 4HS, United Kingdom 2010/1014784 Yes Unpublished

Yes Yes Yes BASF

KIIIA 8.3.2/4

2011 b

Residue study (decline) with Delan DF applied to peaches in Germany, Northern France, Southern France, Greece, Italy and Spain in 2010 Huntingdon Life Sciences Ltd., Eye Suffolk IP23 7PX, United Kingdom 2011/1059017 Yes Unpublished

Yes Yes Yes BASF

KIIIA 8.5.1/1

2013 a

14C-Labelled Dithianon: High temperature hydrolysis in apple juice at 90°C, 100°C and 120°C

PTRL Europe, Ulm, Germany Fed.Rep. 2013/1078029 Yes Unpublished

No No Yes BASF

KIIIA 8.5.3/1

2011 a

Determination of residues of BAS 216 F (Dithianon) in apples and their processed products after four applications of Delan DF in Germany BioChem agrar Labor fuer biologische und chemische Analytik GmbH, Gerichshain, Germany Fed.Rep. 2011/1135917 Yes Unpublished

Yes Yes Yes BASF


Delan DF



Annex point





Owner

KIIIA 8.5.3/2

2010 a

Determination of residues of BAS 216 F (Dithianon) in cherries and their processed products after three applications of Delan DF in Germany BioChem agrar Labor fuer biologische und chemische Analytik GmbH, Gerichshain, Germany Fed.Rep. 2010/1093253 Yes Unpublished

Yes Yes Yes BASF

KIIIA 8.5.3/3

2011 a

Determination of residues of BAS 216 F (Dithianon) in plums and their processed products after three applications of Delan DF in Germany BioChem agrar Labor fuer biologische und chemische Analytik GmbH, Gerichshain, Germany Fed.Rep. 2011/1031148 Yes Unpublished

Yes Yes Yes BASF

Environmental fate and behaviour Annex point



Owner Data protection granted

Y/N

Studies relied on

Y/N

KIIIA 9.1.1/1

2012 a

Rate of degradation of phthalic acid (Reg.No. 4005234), metabolite of Dithianon BASF SE, Limburgerhof, Germany Fed.Rep. 2011/1257594 Yes Unpublished

No BASF Y Y


Delan DF



KIIIA 9.3/1 2011 a

Adsorption of the BAS 216 F metabolite Phthalic acid (Reg.No. 4005234) to five soils BASF SE, Limburgerhof, Germany Fed.Rep. 2011/1142533 Yes Unpublished

No BASF Y Y

Ecotoxicology Core dossier

Annex point Year

Title Source (where different from company) Company. Report No. GLP or GEP status (where relevant) Published or Unpublished

Data protection claimed Y/N

Used for evaluation Y/N

Owner *)

KIIIA 10.1.6 2001 a

Avian acute oral toxicity study with Dithianon 700 g/kg WG (formulation code: SF09321) in the Northern bobwhite (Colinus virginianus) DT-560-123 Yes Unpublished

Y Y BASF

KIIIA 10.2.2.1 2010 a

Dithianon (BAS 216F): A 96-hour static acute toxicity test with the channel catfish (Ictalurus punctatus) 2010/7013083 Yes Unpublished

Y Y BASF

KIIIA 10.2.2.2 2012 a

Reg.No. 120387 (o-Phthalaldehyde; Phthaldialdehyde; metabolite of BAS 216 F) - Daphnia magna - Acute immobilization test Institute of Industrial Organic Chemistry, Pszczyna, Poland 2012/1002444 Yes Unpublished

N N BASF


Delan DF



Annex point Year




Owner *)

KIIIA 10.3.1.3 2012 a

BAS 216 F - Dithianon - Ecologically relevant chronic toxicity endpoint for the wild mammal reproductive risk assessment (Ecotoxicology) BASF SE, Limburgerhof, Germany Fed.Rep. 2012/1159688 No, not subject to GLP regulations Unpublished

Y N BASF

KIIIA 10.3.1.3 2012 a

Generic statement - Relevance of the common vole scenario in orchards 2012/1064674 No, not subject to GLP regulations Unpublished

Y N BASF

KIIIA 10.6.4 2011 a

Field study to evaluate the effects of Delan DF on earthworm populations on a grassland area RIFCon GmbH, Heidelberg, Germany Fed.Rep. 2010/1000042 Yes Unpublished

Y N BASF

KIIIA 10.10.2/01 2006 b

Bird species in modern pome fruit orchards in Germany: Field data for the determination of focal species 2006/1039469 No Unpublished

Y Y BASF

KIIIA 10.10.2/02 2013 a

Dithianon residues on arthropods after spray application in pome fruit orchards in Germany (2012) tier3 solutions GmbH, Leichlingen, Germany Fed.Rep. 2012/1017192 Yes Unpublished

Y Y BASF


Delan DF



Annex point Year




Owner *)

KIIIA 10.10.2/03 2013 a

Dissipation of BAS 216 F (Dithianon) in arthropods sampled from pome fruit orchards in Germany - Calculation of DT50 dissipation times BASF SE, Limburgerhof, Germany Fed.Rep. 2013/1068015 No, not subject to GLP regulations Unpublished

Y Y BASF

KIIIA 10.10.2/04 2013a

Study on the residue behavior of Dithianon (BAS 216 F) on pea (young plants) after the application of Delan DF under field conditions in France (North), Germany, United Kingdom, Italy and Spain, 2012 BASFDocID 2013/1045206

- Y BASF

KIIIA 10.10.2/05 2013a

Study on the residue behaviour of Dithianon (BAS 216 F) on wheat (young plants) after treatment with Delan DF under field conditions in North and South Europe, season 2012 BASFDocID 2013/1045204

- Y BASF

KIIIA 10.10.2/06 2013 a

Dissipation of BAS 216 F - Dithianon on young plants (wheat and peas) - Calculation of DT50 / DT90 dissipation times BASF SE, Limburgerhof, Germany Fed.Rep. 2013/1061843 No, not subject to GLP regulations Unpublished

Y Y BASF

KIIIA 10.10.2/07 2013 b

Dissipation of BAS 216 F - Dithianon on young plants (wheat and peas) - Calculation of DT50 / DT90 dissipation times BASF SE, Limburgerhof, Germany Fed.Rep. 2014/1037481 No, not subject to GLP regulations Unpublished

Y Y BASF

NL addendum


Delan DF



References to chapter 10.2; no data protection applicable. Anonymous (2006) Conclusion on the peer review of folpet. EFSA Scientific Report 2006; 70: 1-78.

Anonymous (2009) Conclusion on the peer review of the pesticide risk assessment of the active substance folpet. Re-issued on 4 June 2009. EFSA Scientific Report 2009; 297: 1-89).

Anonymous (2010) Conclusion regarding the peer review of the pesticide risk assessment of the active substance dithianon. EFSA Journal 2010; 8(11): 1904.

Sepic, E.; Bricelj, M. & Lsekovsek, H. (2003) Toxicity of fluoranthene and its biodegradation metabolites to aquatic organisms. Chemosphere, 52: 1125-1133.

Efficacy: Annex point



Owner Study used y/n

Data protection granted y/n

KIIIA 6/1

2013 b

Biological Assessment Dossier - Part K - Section 7: Efficacy data and information - BAS 216 03 F - Central Zone - Zonal Rapporteur Member State: Austria BASF Belgium SA, Waterloo, Belgium 2013/1282545 No Unpublished

Yes BASF y Y

KIIIA 6/1

2013 a

Appendix 8 compilation of tier II summaries - Part 4 Section 7 - Efficacy data and information - National addendum to core BAD - Delan - Central registration zone - The Netherlands BASF Nederland BV, Arnhem, Netherlands 2013/1108146 No Unpublished

Yes BASF Y y

KIIIA 6/2

2013 a

Raw data included trials BAD Delan (BAS 216 03 F) 2013/1113674 Yes Unpublished

Yes BASF y Y


Delan DF



Annex point





KIIIA 6/2 2013 b Biological Assessment Dossier: BAS 216 03 F Core C update (Dithianon 700 g/kg) - Efficacy data and information - Central Zone - Zonal ZRMS: Austria BASF Belgium SA, Waterloo, Belgium 2013/1282545 No Unpublished

Yes BASF y Y

KIIIA 6/3 2013 x Background information on target organisms - Overview literature studies 2013/1294782 No Published

No public y n

KIIIA 6.1.3/1

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV-F-2002-BE-DHJ-C01-BE-BE0-JG2 2013/1112489 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/2

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2002 BE JBJ A 01 BE BE0 JG1 2013/1112490 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/3

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2002 BE SBJ B01 BE BE0 JG2 2013/1112491 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/4

2013 d BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2003 BE BNJ A01 BE BE0 JGG 2013/1112492 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/5

2013 e BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2003 BE SBJ A01 BE BE0 JGB 2013/1112493 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/6

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2004 BE K03 G04 BE BE4 0R5 2013/1112494 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/7

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2009 BE K03 B01 BE BE4 010 2013/1112495 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/8

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2011 BE K10 A 02 BE BE4 009 2013/1112496 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/9

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2012 BE K05 A 01 BE BE4 011 2013/1112497 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/10

2013 d BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2012 BE K05 A 01 BE BE4 017 2013/1112498 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/100

2013 j BAS 216 03 F, apricots peaches and nectarines, efficacy - Apricots peaches nectarines Maritime DE DEV F 2002 ZX D02 A 02.0 DE VTO 453 2013/1113785 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/101

2013 a BAS 216 03 F, apricots peaches and nectarines, efficacy - Apricots peaches nectarines South East DEV F 2006 BG 882 A 01.0 BG BG0 006 2013/1113786 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/102

2013 b BAS 216 03 F, apricots peaches and nectarines, efficacy - Apricots peaches nectarines South East DEV F 2006 BG 882 A01 BGBG0 005 2013/1113787 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/103

2013 ab BAS 216 03 F, apricots peaches and nectarines, efficacy - Apricots peaches nectarines South East DEV F 2007 BG 883 A 01 BG BG0 007 2013/1113788 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/104

2013 c BAS 216 03 F, apricots peaches and nectarines, efficacy - Apricots peaches nectarines South East DEV F 2007 BG 883 A 01 BG BG0 010 2013/1113789 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/105

2013 d BAS 216 03 F, apricots peaches and nectarines, efficacy - Apricots peaches nectarines South East DEV F 2006 BG 882 A 01.0 BG BG0 006 2013/1113790 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/106

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DE DEV F 2011 PL K05 A 01 PL PL6 001 2013/1114281 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/107

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2012 ZX K50 F 02 DE VTO 815 2013/1120887 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/108

2013 b BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime 2013/1120866 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/109

2013 l BAS 216 03 F, pear, efficacy against Venturia inaequalis - Apple North East PL DEV 2011 K10 B02 PL PL6 002 2013/1120872 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/11

2013 e BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2012 BE K10 A 01 BE BE4 002 2013/1112499 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/110

2013 m BAS 216 03 F, pear, efficacy against Venturia inaequalis - Apple North East PL DEV 2012 K30 Z PL PLD 001 2013/1120873 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/111

2013 n BAS 216 03 F, pear, efficacy against Venturia inaequalis - Apple North East PL DEV 2012 K05 A02 PL PL6 001 2013/1120876 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/112

2013 a BAS 216 03 F, apricots, peaches and nectarines, efficacy, South East DEV F 2007 BG 883 A 01 BG BG0 009 2013/1120888 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/113

2013 o BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DE DEV F 2012 PL K30 X 01 PL PLU 001 2013/1120959 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/114

2013 p BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV F 2012 PL K30 Z 01.0 PL PLJ 001 2013/1123482 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/115

2013 q BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV F 2012 PL K05 Z 02.0 PL PLJ 001 2013/1123483 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/116

2013 r BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV F 2012 UK K30 B 02.0 UK UK4 J62 2013/1123484 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/117

2013 r BAS 216 03 F, apple, efficacy against Venturia inaequalis - Maritime East DEV F 2012 PL K30 Z 01.0 PL PLU 001 2013/1123485 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/12

2013 f BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2012 BE K10 A 01 BE BE4 029 2013/1112500 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/13

2013 g BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2012 BE K30 A 1 BE BE4 009 2013/1112501 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/14

2013 h BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2012 BE K30 A BE BE4 018 2013/1112502 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/15

2013 i BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2012 BE K30 B 01 BE BE4 019 2013/1112503 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/16

2013 j BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime CZ DEV F 2011 CZ K10 B01 CZ CZZ F01 2013/1112504 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/17

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2001 326 A01 DE D06 001 2013/1112505 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/18

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2001 ZX 404 A 00 DE VTO 407 2013/1113450 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/19

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2001 ZX 404 A 00 DE VTO 408 2013/1113451 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/20

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2001 ZX 411 00 DE VTO 422 2013/1113453 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/21

2013 d BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2001 ZX 411 00 DE VTO 423 2013/1113454 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/22

2013 e BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2002 ZX 401 A01 DE VTO 406 2013/1113456 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/23

2013 f BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2002 ZX 401 A01 DE VTO 407 2013/1113457 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/24

2013 g BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2003 ZX 408 A01 DE VTO 412 2013/1113458 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/25

2013 k BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2004 EX K01 V04 DE VTO 800 2013/1113459 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/26

2013 l BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2004 EX K01 V04 DE VTO K01 2013/1113460 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/27

2013 m BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2005 EX K 11 V02 DE VTO 819 2013/1113461 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/28

2013 n BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2005 EX K01 W02 DE VTO 803 2013/1113466 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/29

2013 o BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2005 EX K01 W02 DE VTO 804 2013/1113470 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/30

2013 p BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2005 EX K11 V02 DE VTO 818 2013/1113471 Yes Unpublished

Yes BASF y y


Delan DF



Annex point





KIIIA 6.1.3/31

2013 q BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2006 EX K03 V04 DE VTO 803 2013/1113472 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/32

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2006 ZX K50 S 02 DE VTO 817 2013/1113473 Yes Unpublished

Yes BASF y y

KIIIA 6.1.3/33

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2006 ZX K50 S 02 DE VTO 818 2013/1113475 Yes Unpublished

Yes BASF y Y

KIIIA 6.1.3/34

2013 r BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2007 EX K01 W02 DE VTO 803 2013/1113476 Yes Unpublished

Yes BASF Y y

KIIIA 6.1.3/35

2013 s BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2008 DE K03 W 02 DE VTO 807 2013/1113529 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/36

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2008 DE K42 A 02 DE 006 001 2013/1113530 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/37

2013 t BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2008 EX K10 V01 DE VTO 810 2013/1113531 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/38

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2008 EX K42 V02 DE VTO 818 2013/1113532 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/39

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2008 ZX K52 S DE VTO 821 2013/1113533 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/40

2013 u BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2009 EX K03 W01 DE VTO 803 2013/1113534 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/41

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2011 DE K30 A 02 DE DE0 001 2013/1113535 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/42

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2011 DE K30 A 010 DE IHE 001 2013/1113536 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/43

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2011 DE K30 B 02 DE IHE 001 2013/1113537 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/44

2013 v BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2011 EX K10 V DE VTO 816 2013/1113538 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/45

2013 w BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2011 EX K10 W DE VTO 817 2013/1113539 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/46

2013 x BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2011 EX K30 B 01 IHE 001 2013/1113540 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/47

2013 f BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2012 DE K01 DE DE0 FRS 2013/1113541 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/48

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2012 DE K30 B 01 DE IHE 001 2013/1113542 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/49

2013 y BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2012 EX K07 W01 DE VTO 805 2013/1113543 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/50

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2012 ZX K50 F 02 VTO 812 2013/1113544 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/51

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime DE DEV F 2012 ZX K50 F 02 VTO 814 2013/1113545 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/52

2013 z BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime IT DEV F 2012 IT K30 B01 IT IT0 028 2013/1113546 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/53

2013 aa BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime IT DEV F 2012 IT K30 B01 IT IT0 207 2013/1113548 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/54

2013 ab BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime IT DEV F 2012 IT K30 B01 IT IT2 103 2013/1113549 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/55

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2004 UK K02 UK UK1 J02 2013/1113550 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/56

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2008 UK 802 A 02 UK UK4 J47 2013/1113551 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/57

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2008 UK 802 A 02 UK UK4 J48 2013/1113689 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/58

2013 d BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2008 UK 802 A 02 UK UK4 J49 2013/1113691 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/59

2013 e BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2009 UK K03 A 03 UK UK4 J04 2013/1113692 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/60

2013 f BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2009 UK K03 A 03 UK UK4 J05 2013/1113693 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/61

2013 g BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2009 UK K03 A 03 UK UK4 J06 2013/1113696 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/62

2013 h BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2011 UK K30 B 02 UK UK4 J80 2013/1113697 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/63

2013 i BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2012 UK K05 A 04 UK UK5 G99 2013/1113698 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/64

2013 j BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2012 UK K05 A04 UK UK5 G98 2013/1113699 Yes Unpublished

Yes BASF Y

KIIIA 6.1.3/65

2013 p BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2011 PL K05 A 01 PL PL6 001 2013/1113708 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/66

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2011 PL K08 B 01 PL PL6 007 2013/1113709 Yes Unpublished

Yes BASF Y

KIIIA 6.1.3/67

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2011 PL K30 A 01 PL PL6 004 2013/1113710 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/68

2013 d BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2012 PL K10 A0 3 PL PL6 002 2013/1113712 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/69

2013 e BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2012 PL K15 A 01 PL PL6 003 2013/1113713 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/70

2013 f BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2011 PL K05 A 01 PL PL6 001 2013/1113714 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/71

2013 g BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2012 PL K15 X 01 PL PLJ 001 2013/1113724 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/72

2013 h BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2012 PL K30 X 01 0 PL PLJ 001 2013/1113726 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/73

2013 i BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2012 PL K30 X 01 PL PLD 001 2013/1113729 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/74

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East HU DEV F 2004 HU 881 A 01 HU HU1 481 2013/1113730 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/75

2013 ac BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East HU DEV F 2004 HU 881 A 01 HU HU1 481 2013/1113731 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/76

2013 ad BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East HU DEV F 2011 HU K10 B01 HU HU0 ZAL 2013/1113732 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/77

2013 ae BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East HU DEV F 2012 HU K10 X 01 HU HU0 SZA 2013/1113733 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/78

2013 af BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East HU DEV F 2012 HU K10 X 01 HU HU0 ZAL 2013/1113734 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/79

2013 ag BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East HU DEV F 2012 SK K05 X 01 SK SK0 G03 2013/1113735 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/80

2013 ah BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East SK DEV F 2012 SK K05 X 01 SK SK0 G13 2013/1113739 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/81

2013 ai BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple South East SK DEV F 2012 SK K10 X 01 SK SK0 G04 2013/1113749 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/82

2013 g BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 1999 ZX K21 A 01 BE BE0 392 2013/1113700 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/83

2013 q BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2000 BE LAC A 01 BE BE0 BOR 2013/1113701 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/84

2013 r BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2000 BE LAC B 01 BE BE0 BO2 2013/1113702 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/85

2013 s BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2000 ZX K16 A 01 BE BE0 385 2013/1113703 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/86

2013 t BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2001 BE PVC A 01 BE BE0 CON 2013/1113704 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/87

2013 u BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2002 BE DHD A 01 BE BE0 DUR 2013/1113705 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/88

2013 v BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2003 BE DHC A 01 BE BE0 CON 2013/1113706 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/89

2013 w BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2003 BE RHC A 01 BE BE0 CON 2013/1113707 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/90

2013 k BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime UK DEV F 2012 UK K05 PO4 UK UK5 G97 2013/1113711 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/91

2013 h BAS 216 03 F, cherry, efficacy - Cherry maritime BE DEV F 1984 Coccomyces 1 2013/1113740 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/92

2013 i BAS 216 03 F, cherry, efficacy - Cherry maritime BE DEV F 1987 C0C 1 2013/1113741 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/93

2013 j BAS 216 03 F, cherry, efficacy - Cherry maritime BE DEV F 1987 C0C 2 2013/1113742 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/94

2013 k BAS 216 03 F, cherry, efficacy - Cherry South East BG DEV F 2006 BG 848 A01 BG BG0 011 2013/1113744 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/95

2013 l BAS 216 03 F, cherry, efficacy - Cherry South East BG DEV F 2006 BG 884 A01 BG BG0 012 2013/1113745 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.3/96

2013 m BAS 216 03 F, cherry, efficacy - Cherry South East BG DEV F 2006 BG 884 A01 BG BG0 013 2013/1113746 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/97

2013 n BAS 216 03 F, cherry, efficacy - Cherry South East DE DEV F 2012 DE D30 A01 DE DMN 001 2013/1113747 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/98

2013 o BAS 216 03 F, cherry, efficacy - Cherry South East DE DEV F 2012 DE D30 A01 DE IHE 001 2013/1113748 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.3/99

2013 i BAS 216 03 F, apricots peaches and nectarines, efficacy - Apricots peaches nectarines Maritime DE DEV F 2002 ZX D02 A 02.0 DE VTO 452 2013/1113784 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.1/1

2005 a Biological efficacy evaluation of BAS 584 00 F (4.0 and 12.0 WG) against scab, Venturia inaequalis, on apple - Trials 2004 RSF - Services for Industry NPO, Sint-Truiden, Belgium 2005/1042380 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.4.1/2

2005 b Biological efficacy evaluation of BAS 584 00 F (4.0 and 12.0 WG) against scab, Venturia inaequalis, on apple - Trials 2004 RSF - Services for Industry NPO, Sint-Truiden, Belgium 2005/1042381 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.1/3

2006 a Biological efficacy evaluation of Maccani (BAS 584 00 F) against scab, Venturia inaequalis, on apple - Trials 2005 Proefcentrum Fruitteelt vzw, Sint-Truiden, Belgium 2006/1050333 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.1/4

2006 b Biological efficacy evaluation of Maccani (BAS 584 00 F) against scab, Venturia inaequalis, on apple - Trials 2005 Proefcentrum Fruitteelt vzw, Sint-Truiden, Belgium 2006/1050334 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.1/5

2012 a Biological efficacy evaluation of BAS 669 01 F and BAS 669 00 F (Pyrimethanil and Dithianon) against scab, Venturia inaequalis, on apple - Trial 2010 2013/1119933 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.1/6

2013 a Biological efficacy evaluation of BAS 700 04 F (Fluxapyroxad) against scab, Venturia pirina, on pear - Trial 2010 Proefcentrum Fruitteelt vzw, Sint-Truiden, Belgium 2013/1119934 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.4.1/7

2012 a Study on unintentional effects of the fungicide Delan on the apple crop: Laboratory part - Processing Staphyt Sarl, Inchy en Artois, France 2013/1086837 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.2/1

2011 a Study on unintentional effect of the fungicides BAS 700 04 F in apples Agrolab SA, Thessaloniki, Greece 2011/1289532 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.2/2

2011 a Study on unintentional effects of the fungicides BAS 669 01 F and BAS 700 04 F in apples and apple processed after applications under field conditions in Italy, 2011 Astra Innovazione e Sviluppo Srl, Faenza, Italy 2011/1289531 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.2/3

2012 a Study on unintentional effect of the fungicides BAS 700 04 F, BAS 643 01 F, Delan 70 WG and Stroby in apple Agrolab SA, Thessaloniki, Greece 2012/1362364 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.4.2/4

2012 a Study on unintentional effects of the fungicides BAS 700 04 F, BAS 643 01 F, Delan 70WG and Stroby in apples and apple processed after applications under field condition in Italy, 2012 Astra Innovazione e Sviluppo Srl, Faenza, Italy 2012/1338659 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.2/5

2013 a Taint study - Delan 70 WG (Dithianon 70%) on pears - Trial 2012 Proefcentrum Fruitteelt vzw, Sint-Truiden, Belgium 2013/1110175 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.3/1


Yes BASF Y Y

KIIIA 6.1.4.3/2


Yes BASF Y Y

KIIIA 6.1.4.3/3


Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.1.4.3/4

2006 b Biological efficacy evaluation of Maccani (BAS 584 00 F) against scab, Venturia inaequalis, on apple - Trials 2005 Proefcentrum Fruitteelt vzw, Sint-Truiden, Belgium 2006/1050334 Yes Unpublished

Yes BASF Y Y

KIIIA 6.1.4.3/5


Yes BASF Y Y

KIIIA 6.1.4.3/6

2013 b Biological efficacy evaluation of BAS 700 04 F (Fluxapyroxad) against scab, Venturia pirina, on pear - Trial 2010 Proefcentrum Fruitteelt vzw, Sint-Truiden, Belgium 2013/1119934 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/1

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2004 UK K02 UK UK1 J02 2013/1113550 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/2

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2008 UK 802 A 02 UK UK4 J47 2013/1113551 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.2.1/3

2013 l BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2008 UK 802 A 02 UK UK4 J48 2013/1113689 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/4

2013 m BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2008 UK 802 A 02 UK UK4 J49 2013/1113691 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/5

2013 n BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2009 UK K03 A 03 UK UK4 J04 2013/1113692 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/6

2013 o BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2009 UK K03 A 03 UK UK4 J05 2013/1113693 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/7

2013 p BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime UK DEV F 2009 UK K03 A 03 UK UK4 J06 2013/1113696 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.2.1/8

2013 j BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2012 PL K15 X 01 PL PLJ 001 2013/1113724 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/9

2013 k BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple North East DEV 2012 PL K30 X 01 0 PL PLJ 001 2013/1113726 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/10

2013 a BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV-F-2002-BE-DHJ-C01-BE-BE0-JG2 2013/1112489 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/11

2013 b BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2002 BE JBJ A 01 BE BE0 JG1 2013/1112490 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/12

2013 c BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2002 BE SBJ B01 BE BE0 JG2 2013/1112491 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.2.1/13

2013 e BAS 216 03 F, apple, efficacy against Venturia inaequalis - Apple maritime BE DEV F 2003 BE SBJ A01 BE BE0 JGB 2013/1112493 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/14


Yes BASF Y Y

KIIIA 6.2.1/15


Yes BASF Y Y

KIIIA 6.2.1/16


Yes BASF Y Y

KIIIA 6.2.1/17

2013 g BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 1999 ZX K21 A 01 BE BE0 392 2013/1113700 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.2.1/18

2013 r BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2000 BE LAC B 01 BE BE0 BO2 2013/1113702 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/19

2013 x BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2000 ZX K16 A 01 BE BE0 385 2013/1113703 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/20

2013 t BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2001 BE PVC A 01 BE BE0 CON 2013/1113704 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/21

2013 y BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2002 BE DHD A 01 BE BE0 DUR 2013/1113705 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/22

2013 z BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2003 BE DHC A 01 BE BE0 CON 2013/1113706 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.2.1/23

2013 aa BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime BE DEV F 2003 BE RHC A 01 BE BE0 CON 2013/1113707 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/24

2013 q BAS 216 03 F, pear, efficacy against Venturia pirina - Pear maritime UK DEV F 2012 UK K05 PO4 UK UK5 G97 2013/1113711 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.1/25


Yes BASF Y Y

KIIIA 6.2.1/26

2013 b Biological efficacy evaluation of BAS 700 04 F (Fluxapyroxad) against scab, Venturia pirina, on pear - Trial 2010 Proefcentrum Fruitteelt vzw, Sint-Truiden, Belgium 2013/1119934 Yes Unpublished

Yes BASF Y Y

KIIIA 6.2.4/1

2004 a Side effect evaluation of BAS 516 01 F (100 and 200 SE) against the predatory bug, Anthocoris nemoralis (F.), on pear - Trial 2002 RSF - Services for Industry NPO, Sint-Truiden, Belgium 2004/1039474 Yes Unpublished

Yes BASF Y Y


Delan DF



Annex point





KIIIA 6.2.7/1

2001 a Effect of Dithianon 700 g/kg WG formulation at 1.4 and 4.2 kg a.i./ha on seedling emergence and vegetative vigor of seven terrestrial plant species BASF Corp. Agro Research, Princeton NJ, United States of America DT-549-047 No Unpublished

No BASF Y Y

KIIIA 6.2.8/1

2013 h BAS 216 03 F - Resistance risk analysis BASF SE, Limburgerhof, Germany Fed.Rep. 2013/1038927 No Unpublished

Yes BASF Y Y

KIIIA 6.5/1 2013 a Physical and Chemical Compatibity in Aqueous Tank Mixtures of BAS 216 03 F BASF SE Agricultural Center Limburgerhof, Limburgerhof, Germany Fed.Rep. 2013/1068042 No Unpublished

Yes BASF Y Y

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