Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 1 of 47
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1.
BESLUIT
Op 19 mei 2014 is van
BASF Nederland B.V.
Groningensingel 1
6835 EA ARNHEM
een aanvraag tot toelating ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te
noemen: de Verordening) voor het gewasbeschermingsmiddel
Delan Pro
op basis van de werkzame stoffen dithianon en kaliumfosfonaten. Nederland is in deze een betrokken
lidstaat, als bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is Oostenrijk.
HET COLLEGE IS VOORNEMENS OM TE BESLUITEN 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.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N


Page 2 of 47
Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.
De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de
voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in paragraaf 2.2
van deel A van het registratierapport.
1.4
Aflever- en opgebruiktermijn (respijtperiode)
Niet van toepassing. Het betreft een nieuwe toelating.
2.
WETTELIJKE GRONDSLAG
Besluit
artikel 28 en artikel 36, derde lid, Verordening (EG) 1107/2009
Classificatie en etikettering
artikel 31 en artikel 65 van de Verordening (EG) 1107/2009
Gebruikt toetsingskader
Bgb en Rgb d.d. 16 december 2011, Evaluation Manual Zonaal, GD
Birds & Mammals 2012 en GD Dermal Absorption 2012
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.
Zienswijzenprocedure
Ingevolge artikel 2:3 Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en
biociden Ctgb 2007 geldt dat dit ontwerpbesluit gedurende twee weken ter inzage wordt gelegd op het
Ctgb; hiervan wordt mededeling gedaan in de Staatscourant. Het ontwerpbesluit wordt gedurende deze
periode tevens op de website van het Ctgb geplaatst. Belanghebbenden kunnen gedurende de ter
inzagenlegging schriftelijk bij het Ctgb aangeven dat zij een zienswijze zullen indienen; de zienswijze
dient schriftelijk binnen twee weken na de inzagenperiode te worden ingediend.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 3 of 47
Ede, 5 februari 2016
HET COLLEGE VOOR DE TOELATING VAN
GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,
Ir. J.F. de Leeuw
Voorzitter
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 4 of 47
BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
2.1 Aanvraaginformatie
Aanvraagnummer:
Type aanvraag:
Middelnaam:
Verzenddatum aanvraag:
Formele registratiedatum: *
Datum in behandeling name:
Datum compliance check:
20131038 NLTG
Nederland is in deze een betrokken lidstaat, als bedoeld
in artikel 36, tweede lid; de beoordelend lidstaat is
Oostenrijk
Delan Pro
11 juli 2013
21 mei 2014
13 oktober 2015
n.v.t.
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2.2 Stofinformatie
Aangezien Delan Pro een voor Nederland nieuwe werkzame stof bevat (zie hieronder,
kaliumfosfonaten), is de zienswijzenprocedure zoals bedoeld in artikel 2:3 Besluit bestuursreglement
regeling toelating gewasbeschermingsmiddelen en biociden Ctgb 2007 van toepassing.
Werkzame stof
dithianon
kaliumfosfonaten
Gehalte
125 g/L
561 g/L

De stof dithianon is per 1 juni 2011 geplaatst op Annex I van Richtlijn 91/414/EEG (2001/41/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.

De stof kaliumfosfonaten is per 1 oktober 2013 goedgekeurd volgens Verordening (EU)
1107/2009 (Uitvoeringsverordening (EU) 369/2013 d.d. 22 april 2013). De goedkeuring van deze
werkzame stof expireert op 30 september 2023.
2.3 Toelatingsinformatie
Toelatingsnummer:
Expiratiedatum:
Afgeleide parallel of origineel:
Biocide, gewasbeschermingsmiddel of toevoegingsstof:
Gebruikers:
15023 N
31 mei 2022
n.v.t.
Gewasbeschermingsmiddel
Professioneel
2.4 Verpakkingsinformatie
Aard van het preparaat:
Suspensie concentraat
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 5 of 47
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel Delan Pro
Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
dithianon
Pictogram
GHS07
GHS08
GHS09
Signaalwoord
WAARSCHUWING
Gevarenaanduidingen
H317 Kan een allergische huidreactie veroorzaken.
H319 Veroorzaakt ernstige oogirritatie.
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.
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.
Aanvullende
EUH401
Volg de gebruiksaanwijzing om gevaar voor de menselijke
etiketelementen
gezondheid en het milieu te voorkomen.
Kinderveilige sluiting verplicht
Nee
Voelbare gevaarsaanduiding verplicht
Nee
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 6 of 47
REGISTRATION REPORT
Part A
Risk Management
Product code:
Delan Pro (BAS 643 01 F)
Active Substances: Dithianon
125 g/L
Potassium phosphonates 561 g/L
[= 375 g/L Phosphonic
(= Phosphorous) acid equivalents]
Central Zone
Zonal Rapporteur Member State: Austria
NATIONAL ADDENDUM - Netherlands
Applicant: BASF
Applicant:
BASF
Date:
January 2016
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
15023 N
Registration Report – Central Zone
Page 7 of 47
Table of Contents
1
Details of the application ...................................................................................... 9
2
Details of the authorisation................................................................................. 11
3
Risk management ................................................................................................ 15
3.3
Further information to permit a decision to be made or to support a
review of the conditions and restrictions associated with the
authorisation ........................................................................................................ 35
Appendix 1
Copy of the product label ................................................................................... 36
Appendix 2 - Reference List ....................................................................................................... 37
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
15023 N
PART A
Registration Report – Central Zone
Page 8 of 47
Risk Management
This document describes the acceptable use conditions required for the national registration of
Delan Pro (BAS 643 01 F) containing 125 g/L dithianon and 561 g/L potassium phosphonates (=
375 g/L phosphonic (=phosphorous) acid equivalents) in pome fruits.
The risk assessment conclusions are based on the information, data and assessments provided in
Registration Report, Part B Sections 1-8 and Part C of the core assessment and where
appropriate in the national addenda for The Netherlands. The information, data and assessments
provided in Registration Report, Parts B includes assessment of further data or information as
required at national registration by the EU review. It also includes assessment of data and
information relating to Delan Pro where that data has not been considered in the EU review.
Otherwise assessments for the safe use of Delan Pro have been made using endpoints agreed in
the EU review of dithianon and potassium phosphonates.
This document describes the specific conditions of use and labelling required for the national
registration of Delan Pro.
Appendix 1 of this document is a copy of the proposed product label.
Appendix 2 of this document contains the reference list.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
1
Page 9 of 47
Details of the application
1.1
Application background
This application was submitted by BASF represented by the following affiliate:
BASF Nederland B.V.
Groningensingel 1
6835 EA Arnhem
The application was submitted for Delan Pro, a SC (Suspension concentrate) containing 125 g/L
dithianon and 561 g/L potassium phosphonates (= 375 g/L phosphonic (=phosphorous) acid
equivalents) for use as a fungicide in pome fruit.
1.2
Annex I inclusion
DITHIANON
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 authorization.
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 finalized 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
Furthermore the Annex I Inclusion Directive for dithianon (2011/41/EU) demands that Member
States concerned shall request the submission of information as regards:

the storage stability and the nature of residues in processed products;

the aquatic and groundwater exposure assessment for phthalic acid;
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N

Page 10 of 47
the risk assessment for aquatic organisms with respect to phthalic acid, phthalaldehyde
and 1,2 benzenedimethanol.
This information has been sent to the RMS, being Greece and all MS, as confirmatory data on
May 30, 2013.
POTASSIUM PHOSPHONATES
Potassium phosphonates was included into Annex I of Regulation 540/2011 by Commission
implementing Regulation (EU) No 369/2013 published on 23rd April 2013 (entry into force 01
October 2013) and approved according Regulation (EC) No 1107/2009.
The Annex I Inclusion Directive for potassium phosphonates 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 authorization.
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation
(EC) No 1107/2009, the conclusions of the review report on potassium phosphonates, and in
particular Appendices I and II thereof, as finalized in the Standing Committee on the Food Chain
and Animal Health on 15 March 2013 shall be taken into account.
In this overall assessment Member States shall pay particular attention to the:


the risk to birds and mammals
the risk of eutrophication of surface water, if the substance is applied in regions or under
conditions favoring a quick oxidation of the active substance in surface water
These concerns for potassium phosphonates have been addressed in the submission.
1.3
Regulatory approach
To obtain approval of the product Delan Pro using Annex I agreed end-points.
This application was submitted in order to allow the first approval of Delan Pro in The
Netherlands in accordance with the above.
1.4
Data protection claims
Data protection is claimed for studies submitted with this application. For details on data
protection claims, please refer to Appendix 1 of each section in the Registration Report.
1.5
Letters of Access
Where third party data have been used information is given in the dossier.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
2
2.1
Page 11 of 47
Details of the authorisation
Product identity
Product Name
Authorization Number
(for re-registration)
Function
Applicant
Composition
Formulation type
Delan Pro (BAS 643 01 F)
not applicable
Fungicide
BASF (see chapter 1.1)
125 g/L dithianon
561 g/L potassium phosphonates (= 375 g/L
phosphonic (=phosphorous) acid equivalents)
Suspension concentrate [Code: SC]
Packaging:
0.15 litre bottle:
material:
shape/size:
opening:
closure:
seal:
HDPE
cylindrical / approx. 63 mm diameter x 92 mm
42 mm inner diameter
polyethylene screw cap
HF-seal
0.25 litre bottle:
material:
shape/size:
opening:
closure:
seal:
HDPE
cylindrical / approx. 63 mm diameter x 126 mm
42 mm inner diameter
polyethylene screw cap
HF-seal
0.5 litre bottle:
material:
shape/size:
opening:
closure:
seal:
HDPE
cylindrical / approx. 69 mm diameter x 185.5 mm
42 mm inner diameter
polyethylene screw cap
HF-seal
1 litre bottle:
material:
shape/size:
opening:
closure:
seal:
HDPE
cylindrical / approx. 88.5 mm diameter x 234 mm
42 mm inner diameter
Polypropylene/Polyethylene screw cap
Induction sealed
1 litre eco-bottle:
material:
shape/size:
opening:
closure:
seal:
HDPE
cylindrical / approx. 88.5 mm diameter x 234 mm
54 mm inner diameter
Polypropylene/Polyethylene screw cap
gasket
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
15023 N
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
Page 12 of 47
3 litre container:
material:
shape/size:
opening:
closure:
seal:
HDPE
rectangular / approx. 190 mm x 140 mm x 241 mm
54mm inner diameter
polypropylene screw cap
Induction sealed
5 litre container
material:
shape/size:
opening:
closure:
seal:
HDPE
rectangular / approx. 190 mm x 140 mm x 313 mm
54 mm inner diameter
polypropylene screw cap
HF-seal
5 litre eco-container material:
shape/size:
opening:
closure:
seal:
HDPE
rectangular / approx. 185 mm x 136 mm x 313 mm
54 mm inner diameter
polypropylene screw cap
gasket
10 litre container
material:
shape/size:
opening:
closure:
seal:
HDPE
rectangular / approx. 230 mm x 165 mm x 375 mm
54 mm inner diameter
polypropylene screw cap
Induction sealed
10 litre eco-container material:
shape/size:
opening:
closure:
seal:
HDPE
rectangular / approx. 230 mm x 187 mm x 358 mm
54 mm inner diameter
polypropylene screw cap
Gasket
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
2.2
Page 13 of 47
Classification and labelling
2.2.1 Classification and labelling according to Reg (EC) 1272/2008
The identity of all substances in the mixture that contribute to the classification of the
mixture *:
dithianon
Pictogram:
GHS07
Signal word:
Warning
GHS08
GHS09
H-statements:
H317
May cause an allergic skin reaction.
H319
Causes serious eye irritation.
H351
Suspected of causing cancer.
H410
Very toxic to aquatic life with long lasting
effects.
P-statements:
P261
Avoid breathing
dust/fume/gas/mist/vapours/spray.
P280
Wear protective gloves/protective clothing/eye
protection/face protection.
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 EUH401
To avoid risks to human health and the
information:
environment, comply with the instructions for
use.
SP1
Do not contaminate water with the product or
its container.
Child-resistant fastening obligatory?
n.a.
Tactile warning of danger obligatory?
n.a.
Explanation:
Pictogram:
H-statements:
H319 was assigned based on a study with the formulation.
H317 and H351 were assigned based on classification of
a.s. dithianon.
P-statements:
P280 was assigned based on H351. Other P-statements
proposed by the applicant. Proposal accepted.
Other:
* according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
2.3
Product uses
1
UseNo.
Page 14 of 47
2
Member
state(s)
3
4
Crop
and/ F
or situation
G
or
I
5
Pests or Group of pests
controlled
6
7
8
10
Application
Method
Kind
11
12
Application rate per treatment
/ Timing / Growth Number
/
stage of crop & (min. Interval
season
between
applications)
L product kg as/ha
/ ha
Water
a) max. rate per L/ha
a)
max. appl.
rate
per
min / max
b) max. total rate
appl.
per season
13
Remarks:
PHI
(days) a) max. no. of applications per crop and
season
b) Maximum product rate per season
c) additional remarks
b)
max
total rate
per season
1
NL
Pomes
F
Venturia spp.
spraying
BBCH 53–81
(February October)
6
(5 days)
a) 2,5
b) 15.0
a)
Dithianon
0,313 kg / ha
+
Potassium
phosphonates
1.403 kg /ha
b)
Dithianon 1.875
kg/ha
+
Potassium
phosphonates
8.415 kg/ha
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
200-1500
14
35
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
3
3.1
Page 15 of 47
Risk management
Reasoned statement of the overall conclusions taken in accordance with the Uniform
Principles
3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4)
The plant protection product Delan Pro is a suspension concentrate (SC). All studies have been
performed in accordance with the current requirements, the critical GAP and the results are
deemed to be acceptable.
The preparation is a brown liquid with a faint sourish odour. It is not explosive, has no oxidising
properties. It has a self ignition temperature of 341°C. In a 1% aqueous solution, it has a pH
value around 5.3 it has a neat pH of 5.0.
The plant protection product was found to be stable after accelerated storage for eight weeks at
40 °C, at low temperature for one week and for 2 years at 20 °C in HDPE bottles. The product
showed good physical and chemical stability with properties unchanged significantly from initial
measurements.
The investigations of the physical and chemical properties have shown that Delan Pro meets the
general requirements for a SC-formulation according to the FAO specifications. This indicates
that no particular problems are to be expected if the preparation is used and stored as
recommended.
Implications for labeling: None
Compatibility of mixtures: A complete report regarding physical and chemical compatibility of
the tank mixes with Nimrod EC, Topas EC, Bardos Neu, Chorus, Luna Experience, Dursban 75
WG, Reldan 22, Insegar WP, Teppeki WG and Calypso SC has been submitted which has
demonstrated compatibility. These tank mixes can therefore be mentioned on the product label
for Delan Pro.
3.1.2 Methods of analysis (Part B, Section 2, Point 5)
3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)
The methods included in the core dossier are considered adequate.
3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)
Analytical methods developed for determination of dithianon and phosphonic acid (potassium
phosphonates) residues in the environmental matrices soil, water and air were already EU
reviewed and considered adequate.
The method for determination of phosphonic acid in water and soil requires derivatisation using
diazomethane. Development of a new method using LC-MS/MS did not provide sufficient
sensitiveness. Considering diazomethane can usually be replaced by less hazardous materials,
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 16 of 47
like trisilyldiazomethane, and the use for monitoring of phosphonic acid in the environment is
limited as it cannot be traced back to the use of dithianon, the available methods can be accepted.
The methods for surface water for both dithianon and phosphonic acid comply with the Dutch
national requirement for an LOQ of 0.1 µg/L.
3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)
3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1)
Acute toxicity studies for Delan Pro were not evaluated as part of the EU review of dithianon
and potassium phosphonates.
Acute toxicological data obtained with Delan Pro
Parameter
[Reference]
Acute Oral Toxicity
Species
Acute dermal LD50
Rat
Acute inhalation
toxicity to rats
Rat
Rat
Result
mg/kg or mg/m3 or effect
LD50 oral, rat > 2000 mg/kg bw
(females)
LD50 dermal, rat > 2000 mg/kg bw
(females/males)
Classification
None
None
None
Skin irritation
Rabbit
> 4.790 (both sexes)
> 4.790 (males)
> 4.790 (females)
Not irritating to skin
Eye irritation
Rabbit
Irritating to eyes
Eye irrit 2, H319
Skin sensitisation
None
Delan Pro contains more than 1%
(w/w) of dithianon (H317)
Skin Sens 1, H317
None
Delan Pro containing 125 g/L dithianon and 561 g/L potassium phosphonate (= 375 g/L
phosphorous acid equivalent) has a low toxicity in respect to acute oral, inhalation and dermal
toxicity and is not irritating to the rabbit skin. It has been found to be irritating to the rabbit eye
requiring classification and is classified as a skin sensitiser based on the content of the active
ingredient dithianon, which is a known skin sensitiser.
3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3)
Operator exposure to Delan Pro was not evaluated as part of the EU review of dithianon and
potassium phosphonates for this submitted rate/crop. Operator exposure was assessed against the
AOEL agreed in the EU review (0.0135 mg/kg bw/day for dithianon and 5.0 mg/kg bw/day for
potassium phosphonates). For dithianon, a dermal absorption value of 0.07% and 0.79% for the
concentrate and spray dilution was used. And for potassium phosphonates, a dermal absorption
of 5% and 8%, respectively.
According to the model calculations by zRMS Austria, it can be concluded that the risk for the
operator using Delan Pro on pome fruits for tractor-mounted mechanical application is
acceptable without the use of personal protective equipment. The estimated exposure with the
German model without PPE is 29% and 3% of the AOEL for dithianon and potassium
phosphonates, respectively. For handheld application, the risk for the operator using Delan Pro
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Date: January 2016
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Page 17 of 47
on pome fruits is also acceptable according to the German model without the use of personal
protective equipment during application. For this manual application, the estimated exposure is
27% and 6% of the AOEL for dithianon and potassium phosphonates, respectively.
When taking into account any possible additive effects of combined exposure to dithianon and
potassium phosphonates, the highest combined exposure amounts to 27% + 6% = 33% of the
AOEL. As this combined exposure is below the AOEL, no undue risk for the operator is
expected when Delan Pro is applied on pome fruits by tractor mounted application or by handheld devices without the use of PPE.
3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4)
Bystander and resident exposure to Delan Pro was not evaluated as part of the EU review of
dithianon and potassium phosphonates.
The estimated work-related bystander exposure is below the EU-AOEL for dithianon and
potassium phosphonates according to the EUROPOEM II model calculations provided in the
core by zRMS AT (22% and < 1% of the EU-AOEL, respectively).
According to the German model (Martin et al, 2008) provided in the Core, there is no undue risk
to nearby non-work related bystanders and residents after accidental short-term exposure to
Delan Pro. According to these model calculations the highest estimated exposure was 5% and
<1% of the EU-AOEL for dithianon and potassium phosphonates, respectively.
In addition to the German model, also the UK model is calculated by the Netherlands. This
method calculates the total bystander exposure for adults, and separately the respiratory and
dermal/oral route for resident children. In the tables below the estimated internal exposure values
from this method are compared with the systemic AEL. Only the exposure for the tractormounted mechanical application scenario is calculated, as this is considered the worst case
scenario.
Table 3.1.3.3-1 Internal bystander and resident exposure to dithianon and risk assessment for the
application of Delan Pro
Route
Estimated internal
Systemic
% AOEL c
a
exposure (mg /day)
AEL
(mg/day)b
Bystander exposure during application in representative uses according to the UK method
Adult
Total
0.0458
0.81
6%
Resident exposure during application in representative uses according to the UK method
Child
a
b
c
Respiratory
0.0083
0.20
4%
Dermal+Oral
0.0096
0.20
5%
External exposure was estimated according to the UK method. Internal exposure was calculated with:
 biological availability via the respiratory route: 100% (worst case)
 biological availability via the dermal route: 0.79% (see 7.6)
 biological availability via the oral route: 45% (see List of EndPoints)
From the systemic AOEL of 0.0135 mg/kg bw/day a specific AEL is derived assuming a body weight of 15 kg for children
and of 60 kg for adults.
The % AOEL is calculated by dividing the internal exposure by the systemic AOEL and multiplying this by 100%.
Table 3.1.3.3-2 Internal bystander and resident exposure to potassium phosphonates and risk
assessment for the application of Delan Pro
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Systemic
% AOEL c
AEL
(mg/day)b
Bystander exposure during application in representative uses according to the UK method
Adult
Route
Estimated internal
exposure a (mg /day)
Total
2.0776
300.00
< 1%
Resident exposure during application in representative uses according to the UK method
Child
a
b
c
Respiratory
0.0083
75.00
< 1%
Dermal+Oral
0.1869
75.00
< 1%
External exposure was estimated according to the UK method. Internal exposure was calculated with:
 biological availability via the respiratory route: 100% (worst case)
 biological availability via the dermal route: 8% (see 7.6)
 biological availability via the oral route: 100% (see List of EndPoints)
From the systemic AOEL of 5 mg/kg bw/day a specific AEL is derived assuming a body weight of 15 kg for children, and
of 60 kg for adults.
The % AOEL is calculated by dividing the internal exposure by the systemic AOEL and multiplying this by 100%.
The estimated bystander and resident exposure is below the EU-AOEL for both dithianon and
potassium phosphonates. Also, when taking into account any possible additive effects of
combined exposure to dithianon and potassium phosphonates, the highest combined %AOEL
amounts to 6% + <1% = 6%. Based on these calculations, the bystander and resident exposure
of children and adults living next to a field treated with Delan Pro is considered to be safe. This
conclusion is also valid for the simultaneous exposure to dithianon and potassium phosphonates.
3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5)
Worker exposure to Delan Pro was not evaluated as part of the EU review of dithianon and
potassium phosphonates. According the German re-entry model provided in the Core, it is
concluded that there is no unacceptable risk anticipated for the worker wearing adequate work
clothing (excluding PPE), when re-entering crops treated with Delan Pro in pome fruits. The
estimated exposure is 66% and 24% of the AOEL for dithianon and potassium phosphonates,
respectively. The model calculations with the EUROPOEM II model provided in the Core, show
similar results (49% and 18% of the AOEL, respectively). The above conclusion also applies for
the combined exposure to dithianon and potassium phosphonates. In addition, based on exposure
study data generated for dithianon, the re-entry worker exposure was estimated at 3% of the
AOEL when wearing adequate work clothing, but no PPE. As a standard rule, crops should not
be re-entered before spray deposits on leaf surfaces have completely dried.
3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8)
3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7)
Dithianon
For the uses proposed for dithianon in the product Delan Pro on pomes, all relevant residue data
and assessments are available in the Part B, section 4. Part of the studies evaluated within this
application are studies required as confirmatory data after the peer review of the active substance
dithianon (EFSA Journal 2010; 8(11):1904.
A new storage stability study was submitted and evaluated. It was concluded that dithianon is
stable in water matrices for 2 years in frozen conditions. Metabolite Reg. No. 4110904, which is
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formed under processed conditions was shown to be stable in high water content matrices for 2
years, however this metabolite was not stable in high acid content matrices (< 7 days).
Eight supervised residue trials in apples have been evaluated and accepted. Residues were in
range: 0.17- 0.52 mg/kg (STMR: 0.32 mg/kg, HR: 0.52 mg/kg).
A new hydrolysis studies and balance processing studies in apples were evaluated within this
application, with a transfer factor for apple juice 0.04.
The MRLs for dithianon are published in Annex III of Regulation (EC) No 396/2005. The
current EU-MRL for dithianon in pomes is 3 mg/kg and based on the trials the intended uses are
covered by the MRL.
Potassium phosphonates
For the uses proposed for potassium phosphonates in the product Delan Pro on pomes, all
relevant residue data and assessments are available in the Part B, section 4.
Eight supervised residue trials with potassium phosphonates in apples have been evaluated and
accepted. Residues calculated as phosphonic acid and its salts expressed as phosponic acid were
in range: 6.50- 20 mg/kg (STMR: 16.07 mg/kg, HR: 20 mg/kg). Residues calculated as fosetylAl (sum of fosetyl plus phosphorus acid and their salts, expressed as fosety) were in range: 8.726.8 mg/kg (STMR: 21.5 mg/kg, HR: 26.8 mg/kg).
EU MRLs for phosphonic acid are not established in Regulation (EC) No 396/2005. Residues of
phosphonic acid are covered by the residue definition of the active substance fosetyl-Al, which is
the sum of fosetyl and phosphonic acid and its salts, expressed as fosetyl. EU MRLs for fosetyl
are published in Annex III of Regulation (EC) No 396/2005. The current EU-MRL for fosetyl in
pomes is 75 mg/kg and based on the trials the intended uses are covered by the MRL.
3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10)
For the consumer risk assessment calculations zRMS Austria included only uses requested
within this application (pome fruits). This is not in line with the agreed methodology: a chronic
risk calculations is based on all existing uses (Guidance document on draft registration report
format). Therefore, for this application for active substance dithianon chronic and acute risk
assessment were calculated by the Netherlands and for potassium phosphonates the most recent
risk assessment was used calculated by EFSA during Article 12 review of existing MRLs for
fosetyl (see below).
TMDI / NEDI calculations

Dithianon:
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA
PRIMo model rev.2 containing all available Member States diets and the EU-MRLs. The
maximum TMDI is 506.7% of ADI for German child. The TMDI is 103% and 320.2% of the
ADI for the Dutch general population and Dutch children ages 1-6, respectively.
Refinement of assessment for chronic exposure through diet
A refinement of the risk assessment was performed for pome fruits (STMR of 0.32 mg/kg) and
for grapes (STMR 1.01 mg/kg, peer review). The theoretical daily intake was reduced to 140%
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of ADI in German child population, 124% of ADI in Dutch children population and 50.1% of the
ADI for Dutch general population. Main contributors of long-term intake were apples and
oranges. No additional residue data is available for further refinement of the chronic exposure of
dithianon through diet. After a consultation with a Member State Germany a following approach
was applied:
Further information for refinement purposes was drawn from a metabolism study of dithianon in
oranges. According to the reported results of this study only about 1% of the applied
radioactivity (RA) was found having penetrated into the consumed part of the fruit (pulp) at 28
and 121 DALA. The radioactivity consisted in the pulp of polar degradation products only.
About 85-90% of the RA were found on the peel and 10-15% in the peel. Therefore, residues in
consumable part of the fruit are considered negligible.
Additionally, Germany considered use of a German dietary intake models (VELS, NVS II). This
models provide information on the portion of apples and pears which are anticipated to be
consumed raw, and which portion anticipated to be consumed after processing into juice. As
there is data available on the processing factor for juice production, this information was fed into
a further refinement step. Based on available data on proportion of daily consumption of raw
apple and juice in the Netherlands and in Germany, it is shown that Dutch children consumption
habits are similar to German children.
When considering both pieces of information on two of the main contributors of long-term
dietary intake, no long-term risk was found to persist for German child population and based on
the arguments mentioned above no risk for the Dutch children is expected.

Potassium phosphonates:
Risk assessment for chronic exposure through diet
A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA
PRIMo rev. 2.0 during the most recent Article 12 Review for active substance fosetyl (residue
definition for risk assessement: phosphonic acid, EFSA Journal 2012;10(11):2961), containing
all available Member State diets. In this EFSA Reasoned Opinion ADI value of 3.9 mg/kg
bw/day was used (EFSA, 2005). However, in the peer review for the active substance potassium
phosphonates (EFSA Journal 2012; 10(12): 2963) new, lower ADI was set for phosphonate,
expressed as phosphonic acid: 2.25 mg/kg bw/day. For this application the TMDI calculation,
performed in the EFSA RO (EFSA Journal 2012;10(11):2961) are updated with the new ADI
value.
The maximum TMDI is 11.9% of the ADI for German child. The TMDI is 4.6% and 9.7% of
the ADI for the Dutch general population and Dutch children ages 1-6, respectively.
Based on the assessment for residues, no risk for the consumer due to the exposure to potassium
phosphonates is currently expected.
NESTI calculations
Acute dietary risk assessments were conducted for the use of product Delan Pro in pome fruits.

Dithianon:
Risk assessment for acute exposure through diet
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Evaluator: Ctgb, NL
Date: January 2016
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A calculation of the Estimated Short Term Intake (ESTI) was carried out using EFSA PRIMo
rev. 2.0 and the previously mentioned EU-MRLs for pome fruits.. The highest percentage of the
ESTI is 244.9% of the ARfD for apple and 227.7% for pears for the UK infant and German
population, respectively. For apple juice calculated ESTI was 127.4% for German population.
Refinement of the risk assessment for acute exposure
A refinement of the risk assessment for apple and pear was done by calculation using the HR for
pome fruits of 0.52 mg/kg and HR-P of 0.0208 mg/kg (0.52*0.04 TF) instead of the MRL. The
highest percentage of the ESTI is 42.5% of the ARfD for apple and 39.5% for pears for the UK
infant and German population, respectively. For apple juice calculated ESTI is 16.4% of ARfD.

Potassium phosphonates:
As no ARfD was derived for potassium phosphonates, a risk assessment for acute exposure was
not performed.
3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)
The environmental fate and behaviour of the active substances dithianon and potassium
phosphonates (expressed as phosphonic acid equivalents) and their main metabolites were
assessed in the context of Annex I inclusion process according to Council Directive 91/414/EEC
and the results of the peer review are summed up in the Review Reports (SANCO/10040/06 –
rev. 3; SANCO/10349/2011 final – 11/March/2011 in combination with EFSA Peer Review,
EFSA Journal 2010;8 (11): 1904; for dithianon and EFSA Journal 2012;10 (12): 2963 in
combination with Draft assessment report (DAR) of potassium phosphite, April 2005; for
phosphonic acid (potassium phosphonates)).
The product Delan Pro, containing the active substances dithianon and potassium phosphonates,
is scheduled for six spray applications to pome fruit with an application rate of 313 g a.s. ha-1
(dithianon) and 938 g a.s. ha-1 (phosphonic acid).
Appropriate endpoints for PEC calculations were derived from the study data in accordance with
the conclusions from the EU review and national requirements. A summary of the PEC
calculations is given hereafter.
3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points
9.4 and 9.5)
Calculations were carried out in accordance with national requirements for exposure assessment.
Calculations of PEC in soil were conducted in the context of a risk envelope approach,
considering an application scenario with a worst case application rate over the entire application
window in the corresponding GAP (6 x 313 g ha-1 of dithianon and 938 g ha-1 phosphonic acid).
Dithianon and its metabolite
The maximum PECsoil of dithianon after sixfold application to pome fruit was 1.007 mg kg-1.
Applicant: BASF
Evaluator: Ctgb, NL
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For the major metabolite of dithianon in soil, phthalic acid, maximum PECsoil after sixfold
application to pomefruit was 0.019 mg kg-1.
Phosphonic acid
The maximum PECsoil for phosphonic acid was estimated to 3.591 mg kg-1 and occurred after the
last application of Delan Pro. The overall accumulation PEC in soil (PECsoil,accu) was estimated
to 5.080 mg kg-1 (PECsoil plateau + PIEC)
These exposure concentrations are examined against ecotoxicological threshold values in section
3.1.6.
3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,
Section 5, Point 9.6)
Calculations for dithianon and its metabolite and for phosphonic acid were based on guidance of
the FOCUS groundwater workgroup (2000, 2009, 2012). The simulations were performed
assuming spring application scenarios with the model FOCUS-PEARL 4.4.4 for all relevant
FOCUS groundwater scenarios available for the selected FOCUSgw crops.
In the context of a risk envelope approach, the highest application rate over the entire application
window in the corresponding GAP (6 x 313 g ha-1 of dithianon and 6 x 938 g ha-1 phosphonic
acid) was assumed.
Dithianon and its metabolite
The PECgw of the active substance and its soil metabolite phthalic acid in the relevant scenarios
and for all models were < 0.001 µg L-1. It is taken into consideration that the autumn scenario
(application in November) has not been evaluated and that it could lead to a higher PECgw.
However, it is assumed that this would not exceed the threshold of 0.01 µg/L.
Phosphonic acid
The PECgw of phosphonic acid ranged from 0.001 to 5.426 µg L-1 in all standard scenarios
following application of Delan Pro to pomefruit. All PECgw values were far below the drinking
water limit for phosphonic acid of 3000 µg/L, according to an estimation following WHO
guidelines for drinking water.
It can be concluded that the leaching of unacceptable amounts of dithianon and its metabolite
phthalic acid and of phosphonic acid after application of Delan Pro to pomes remains below the
trigger values indicated in the respective guidance documents.
Monitoring data groundwater
There are no data available regarding the presence of the substances dithianon and phosphonic
acid in groundwater.
Applicant: BASF
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3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section
5, Points 9.7 and 9.8)
PECsw and PECsed in the 'edge-of-field ditch' were calculated with the surface water model
TOXSWA (version 1.2) and the Dutch standard scenarios for spring and autumn application. The
model TOXSWA considers only the entry path ‘spray drift’. The Dutch calculations assume
16.6% drift from spray application to orchards (early scenario) and 8.6% drift from spray
application to orchards (late scenario) which implies no reduction by drift reducing nozzles.
Furthermore, drift mitigation measures applying spray drift reducing technology, partly in
connection with a buffer zone, was taken into account and calculated for the surface water
relevant schemes.
The maximum PECsw and TWAsw for 4, 21 and 28 days were derived directly from TOXSWA.
Table 3.1.5.3-1. Overview of surface water and sediment concentrations for active
substances dithianon and phosphonic acid in the edge-of-field ditch following spring and
autumn application in Pomes
Substance
Rate
a.s.
[kg/ha]
Freq. Interval
Drift
[%]
PIECsw
[g/L] *
dithianon
0.313
6
5
2.5
1.3
1.3
0.36
0.8
0.41
1.085
1.051
3.829
1.931
0.5036
0.491
1.99
0.5634
0.5454
0.5341
0.139
0.1355
1.222
0.3456
0.3346
0.5734
0.1493
0.1455
phosphonic
acid***
0.938
6
5
2.5
62.62
-
49.2
-
43.02
-
1.3
1.3
0.36
0.8
0.41
32.55
20.00
-
5.864
1.619
1.739
25.58
3.580
0.991
1.064
22.37
13.74
-
3.680
1.019
1.094
Spring autumn
*
PECsw-TWA21d
[g/L] *
spring autumn
15.71
-
PECsw-TWA28d
[g/L] *
spring autumn
PECsed [mg/kg
sed]**
spring/autumn
0.278
0.136
0.149
0.040
0.094
0.043
12.00
1.375
6.375
0.404
3.975
0.433
calculated according to TOXSWA
**calculated as (PECsed in g/m3 / 80 kg/m3)*1000 (conversion of g/kg to mg/kg)
*** For phosphonic acid, the PECsw was calculated with the low Kom value and the PECsed was calculated with the high Kom
value.
Table 3.1.5.3-2. Overview of surface water concentrations for the metabolites of active
substances dithianon and phosphonic acid
Substance
Rate parent
[kg/ha]
Freq.
Inter-val
Drift
[%]
PIECsw
[g/L] *
Spring
autumn
phthalic acid
0.313
6
5
24.820
1,2-benzenedimethanol
0.313
6
5
phthalaldehyde
0.313
6
5
16.6
8.6
16.6
8.6
2.51
1.31
1.32
0.362
0.83
0.413
Applicant: BASF
PECsed
[µg/kg]
n.a.
2.785
7.769
1.277
0.3043
0.099
0.158
0.027
0.100
0.263
Evaluator: Ctgb, NL
Date: January 2016
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Registration Report – Central Zone
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Page 24 of 47
Substance
Rate parent
[kg/ha]
Freq.
Inter-val
Drift
[%]
CL 1017911
0.313
6
5
2.51
1.31
1.32
0.362
0.83
0.413
2.51
1.31
1.32
0.362
0.83
0.413
phosphate
0.938
6
1
5
PIECsw
[g/L] *
Spring
autumn
PECsed
[µg/kg]
n.a.
7.986
1.182
4.152
0.327
2.555
0.646
73.890
6.892
38.410
1.909
23.640
2.172
1.130
0.129
0.599
0.038
0.375
0.043
Tunnel sprayer
Venturi nozzles + one-sided spraying of the last tree row (ventilator low before May 1st)
3
Wanner equipment with reflection shield and venturi nozzles (Lechler ID 90-015C)
2
The results for PEC surface water and PEC sediment for the active substance and its metabolites
were used for the ecotoxicological risk assessment.
Monitoring data surface water
The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is
used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess
whether the observed concentrations exceed threshold values.
Dithianon
In the Pesticide Atlas, surface water concentrations are compared to the authorisation threshold
value of 0.97 µg/L (HC5 fish, acute, correction factor 20, 07-09-2012) and to the indicative/ad
hoc Maximum Permissible Concentration (MPC).
For dithianon, an indicative/ad hoc MPC value is available (RIVM Letter report 6017160161,
2008). This value (0.097 µg/L) is identical to the value presented as AA-EQS (JG-MKN) in the
Pesticide Atlas. Therefore, if threshold exceedings are correlated to the proposed use, this may
have consequences for the authorisation.
Phosphonic acid
There are no data available in the Pesticide Atlas regarding the presence of phosphonic acid in
surface water. The active substance (or potassium phosphonates) was not observed in surface
water (data of 2009 to 2013).
As there are no exceedings of thresholds, the monitoring data have no consequences for the
proposed uses of the product.
1
http://www.rivm.nl/bibliotheek/rapporten/601716016.pdf
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Date: January 2016
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Drinking water criterion
Substances are categorized 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 pre-registration 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.
o 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.
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.
Phosphonic acid
Phosphonic acid can be considered a new substance on the Dutch market. Therefore a preregistration model was performed in order to calculate predicted environmental concentrations at
nine drinking water abstraction points in The Netherlands.
The edge-of-field peak concentrations of the FOCUS Surface Water Scenario D3
(PECFOCUS_NL,D3) that forms the basis of the calculations was 227.599 g L-1 of the parent
compound for the pome fruits scenario considering multiple application. For the single
application PECFOCUS_NL,D3 was 84.309 µg L-1 for the early application. In order to calculate
PECTier1 only the maximum values of PECFOCUS_NL,D3 for single and multiple application were
considered. The maximum PEC values at drinking water abstraction points (PECtier1) of
phosphonic acid are summarized in Table 9.7.1-15.
Table 3.1.5.3-3. Predicted Environmental Concentrations of phosphonic acid at Drinking
Water Abstraction Points
Abstraction Point
De Punt
Andijk
Nieuwegein
Heel
Amsterdam-Rijnkanaal
Applicant: BASF
PECtier1 (g L-1)
Single application
0.002
<0.001
0.068
0.002
0.051
Multiple application
0.006
0.001
0.184
0.006
0.138
Evaluator: Ctgb, NL
Date: January 2016
Part A
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Registration Report – Central Zone
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Brakel
Petrusplaat
Twentekanaal
Scheelhoek
Page 26 of 47
0.025
0.025
0.002
0.028
0.068
0.066
0.005
0.076
The edge-of-field concentrations consist of concentrations in the FOCUS D3 ditch caused by
spray drift deposition calculated using Dutch drift values. Predicted concentrations of
phosphonic acid for each of the nine abstraction points in the Netherlands ranged from
<0.001 µg L1 to 0.184 µg L-1. For the two abstraction points Amsterdam-Rijnkanaal and
Nieuwegein the Drinking Water Standard was above the threshold value of 0.1 µg L-1.
Nevertheless this value accounts for organic pesticides and therefore does not apply to
phosphonic acid. A drinking water limit value of 3000 µg L-1 was proposed in the WHO
guideline [WHO (2013) Guidelines for Drinking-water Quality, 4th edition. Recommendations,
World Health Organization, Geneva], using 20% of the phosphonic acid ADI (accepted daily
intake), an infant body weight of 5 kg and a daily water consumption value of 0.75 L. The
calculated PECTier1 in all scenarios were orders of magnitude below the limit value for
phosphonic acid in drinking water. Therefore, it can be concluded that the use of phosphonic
acid is not likely to pose an unacceptable risk to drinking water abstraction points in The
Netherlands if the active substance is used in compliance with label recommendations.
3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point
9.9)
Dithanon
The vapour pressure of dithianon is considered to be a very low with 2.71 x 10-9 Pa at 20 C,
leading to very low concentrations of dithianon in the vapour phase of the atmosphere. Any
dithianon that may potentially reach the atmosphere would be rapidly degraded by hydroxyl
radicals. Therefore, no significant concentrations are expected in the atmosphere.
Phosphonic acid
Phosphonic acid is a non-volatile salt. Therefore, no significant concentrations are expected in
the atmosphere.
3.1.6 Ecotoxicology (Part B, Section 6, Point 10)
3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)
Effects on Birds
The risk assessment for birds is carried out following the latest guidance document by EFSA
(Anonymous 2009: Guidance Document on risk assessment for Birds & Mammals on request
from EFSA. EFSA Journal 2009; 7(12):1438. European Food Safety Authority), hereafter cited
as EFSA/2009/1438.
Dietary risk assessment
Under the conservative assumptions of a tier 1 assessment all TER values for dithianon and
phosphonic acid exceed the trigger set by Commission regulation (EU) 546/2011 for
acceptability of effects with the exception of the TERLT values for the small insectivorous bird
“tit” scenario for dithianon, which are below the trigger and need to be refined.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
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Registration Report – Central Zone
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Page 27 of 47
Refinement point 1: Identification of focal bird species including ecological data (PT and
FIR/bw)
Refinement point 2: Residue decline in arthropods
Refinement point 3: Deposition factor for food items in orchards
Refinement point 4: Moving time window approach for calculation of TERLT for the
insectivorous bird “tit”
Taking these factors into account the refined reproductive assessments for dithianon result in
TERLT values exceeding the trigger of 5 set by Commission regulation (EU) 546/2011 for
acceptability of effects.
Food chain behaviour (secondary poisoning) and bioaccumulation
Only for dithianon the log Pow is greater than 3 and a secondary poisoning risk assessment is
triggered. Based on the tier 1 assessment all TER values for the risk assessments for earthwormand fish-eating birds for dithianon exceed the trigger of 5 set by Commission regulation (EU)
546/2011 for acceptability of effects for secondary poisoning. The bioaccumulation potential of
dithianon and phosphonic acid was considered as low in the EU review and therefore further
evaluation on biomagnification is not necessary. It can therefore be concluded that the
application of Delan Pro does not raise concerns regarding food chain behaviour (secondary
poisoning) or biomagnification.
Drinking water risk assessment
Following EFSA/2009/1438, the puddle scenario is the one relevant for orchards. Since the ratio
of the effective application rate to the relevant toxicity endpoints is below the value of 3000 and
50 for dithianon and phosphonic acid, respectively, conducting a quantitative risk assessment for
the proposed use pattern of Delan Pro is not necessary. In conclusion the proposed use pattern of
Delan Pro does not pose a risk to birds via uptake of contaminated drinking water.
Combined effects for formulations containing more than one active substance
In conclusion, even under the conservative assumptions of the tier 1 acute dietary risk
assessment all TER values, from the risk assessment addressing the combined effects of
simultaneous exposure to more than one active substance, exceed the trigger set by Commission
regulation (EU) 546/2011 for acceptability of effects. This indicates a low acute risk for birds
from the use of Delan Pro in orchards.
Following the refinements of the long-term risk for the small insectivorous bird “tit”, it can be
concluded that the proposed use pattern of Delan Pro does not pose a risk to birds from
combined effects of the active substances.
Overall conclusion
It can be concluded that the application of Delan Pro in orchards according to good
agricultural practice will not adversely affect birds under natural conditions.
Effects on Terrestrial Vertebrates Other Than Birds
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
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Registration Report – Central Zone
15023 N
Page 28 of 47
The risk assessment for mammals is carried out following the latest guidance document by
EFSA (Anonymous 2009: Guidance Document on Risk Assessment for Birds & Mammals on
request from EFSA. EFSA Journal 2009; 7(12):1438. European Food Safety Authority),
hereafter cited as EFSA/2009/1438.
Dietary risk assessment
Under the conservative assumptions of a tier 1 assessment, all TERA and the TERLT values for
dithianon and phosphonic acid exceed the trigger values as set by Commission regulation (EU)
546/2011 for acceptability of effects. Only for the small herbivorous mammal “vole” and the
frugivorous mammal "dormouse" scenario the TERLT values for dithianon are below the trigger
and need to be refined.
Refinement point 1:
Refinement point 2:
Refinement point 3:
Refinement point 4:
Initial RUD values for dithianon and potassium phosphonate
Foliar DT50 of dithianon in young wheat and pea plants
Use of deposition factor (DF) according to FOCUS groundwater
guidance
Moving time window approach for calculation of TERLT for the
small herbivorous mammal “vole”
Regarding the frugivorous mammal "dormouse", the refined reproductive assessments for
dithianon and potassium phosphonates result in TERLT values exceeding the trigger of 5 set by
Commission regulation (EU) 546/2011 for acceptability of effects. Regarding the small
herbivorous mammal “vole”, TERLT of 4.56 was calculated for dithianon, which is below the
trigger of 5. However, the uncertainity analysis available from the core dossier has demonstrated
a safe risk at comparable TERLT of 4.6. Therefore, reproductive risk to the small herbivorous
mammal “vole” has been concluded.
Food chain behaviour (secondary poisoning) and bioaccumulation
Since the active substance phosphonic acid is an anorganic acid, no log Pow is determinable and
no potential risk of secondary poisoning is expected. Based on the tier 1 assessment all TER
values for the risk assessments for dithianon for earthworm- and fish-eating mammals exceed the
trigger of 5 set by Commission regulation (EU) 546/2011 for acceptability of effects for
secondary poisoning. The bioaccumulation potential of dithianon and phosphonic acid was
considered as low in the respective EU reviews and therefore further evaluation on
biomagnification is not necessary. It can therefore be concluded that the application of Delan Pro
does not raise concerns regarding food chain behaviour (secondary poisoning) or
biomagnification.
Drinking water risk assessment
Following EFSA/2009/1438, the puddle scenario is the one relevant for mammals. Since the
ratio of the effective application rate to the relevant toxicity endpoints is below the trigger values
for dithianon and for phosphonic acid, conducting a quantitative risk assessment for the proposed
use pattern of Delan Pro is not necessary. In conclusion the proposed use pattern of Delan Pro
does not pose a risk to mammals via uptake of contaminated drinking water.
Combined effects for formulations containing more than one active substance
Combined effects were assessed according to EFSA/2009/1438. All TER values from the acute
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
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15023 N
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Page 29 of 47
dietary risk assessment for the virtual compound, addressing the combined effects of
simultaneous exposure to two active substances according to EFSA/2009/1438, exceed the
trigger set by Commission regulation (EU) 546/2011 for acceptability of effects. This leads to
conclude on an overall low and acceptable risk from combined effects of Delan Pro to mammals.
The combined risk assessment for the small herbivorous mammal "vole" results in a long-term
TERmix value of 3.07, which is below the trigger value of 5. However, an uncertainity analysis
has been performed and a safe long-term risk from the combined effects of the active substances
has been concluded.
Overall conclusion
It can be concluded that the application of Delan Pro in pome fruit orchards according to
good agricultural practice will not adversely affect mammals under natural conditions.
3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)
All acute and chronic TER values for the active substance phosphonic acid exceed the
Commission regulation (EU) 546/2011 trigger values based on standard worst-case assumptions,
indicating low risk to aquatic organisms following applications of Delan Pro in pomefruit close
to water bodies.
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 and aquatic insects 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. Based on a refined
but still conservative risk assessment - using the RAC of 2.44 µg a.s./L as proposed by the EFSA
Conclusion for dithianon and considering new data - certain technical drift mitigation measures
(such as venturi nozzles for the first 20 m plus one-sided spraying of the last tree row when
ventilator was low (early application) or off (late application) or Wanner equipment with
reflection shield and venture nozzles) would be required for applications of Delan Pro in pome
fruit.
The calculated TER values for the metabolites phthalaldehyde and CL 1017911exceed the
required trigger values, if certain technical drift mitigation measures (such as tunnel sprayers,
venturi nozzles for the first 20 m plus one-sided spraying of the last tree row when ventilator was
low (early application) or off (late application) or Wanner equipment with reflection shield and
venture nozzles) are considered. The TER values for the metabolites phthalic acid and 1,2benzenedimethanol exceed the Commission regulation (EU) 546/2011 trigger values based on
standard worst-case assumptions for all proposed uses, indicating low ecotoxicological relevance
of these metabolites.
The results obtained in the studies with the formulated product Delan Pro indicate that the
formulation does not cause (unexpected) increased toxicity compared to the active substances.
Furthermore, the studies performed with the formulated product Delan Pro reflect the toxicity of
dithianon whereas phosphonic acid has no significant contribution to the observed toxicity of the
product. In line with the recommendations given in the EFSA Aquatic Guidance Document
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
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15023 N
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Page 30 of 47
(EFSA, 2013) and Appendix C of the NL Evaluation Manual for the Authorisation of Plant
protection products and Biocides, the risk assessments presented for the active substances
therefore also cover the risk to aquatic organisms following the proposed uses of Delan Pro and
no additional TER calculations were performed for the formulated product.
Furthermore, due to the absence of indications for interactions of the active substances, which
was demonstrated in the short-term studies and the different physico-chemical properties of the
active substances, in case of Delan Pro, long-term combination exposure to the active substances
does not occur. Chronic exposure is thus sufficiently addressed in the risk assessment for the
active substances.
Overall Conclusion
The fungicidal product Delan Pro shows toxicity to aquatic organisms and contamination
of aquatic ecosystems must be avoided. Based on the standard risk assessments for the
active substances and the dithianon metabolites, no safe use could be demonstrated for
applications close to surface waters due to the toxicity of the active substance dithianon.
However, a range of additional and higher tier studies have been performed with dithianon
and a refined risk assessment is provided. Based on a refined but still conservative risk
assessment using the RAC of 2.44 µg a.s./L as proposed by the EFSA Conclusion for
dithianon and considering new data - it can be demonstrated that there is no unacceptable
risk to aquatic ecosystems if certain technical drift mitigation measures (such as venturi
nozzles for the first 20 m plus one-sided spraying of the last tree row when ventilator was
low (early application) or off (late application) or Wanner equipment with reflection shield
and venture nozzles are considered for applications of Delan Pro in pomefruit.
On the WG the following restriction sentence should be included:
Om in het water levende organismen te beschermen is toepassing in de teelt van pitvruchten in
percelen die grenzen aan oppervlaktewater uitsluitend toegestaan wanneer gebruik gemaakt
wordt van:
een Wannerspuit met reflectieschermen en venturidoppen (minimaal 90% driftreducerend)
(Lechler ID 90-015C) met inachtneming van een teeltvrije zone van tenminste 3 meter, of
wanneer voor 1 mei gebruik wordt gemaakt van:
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", met inachtneming van een teeltvrije zone van
tenminste 3 meter, of
wanneer vanaf 1 mei gebruik wordt gemaakt van:
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 met inachtneming van een teeltvrije zone van tenminste 3 meter.
3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and
10.5)
Bees
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
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15023 N
Registration Report – Central Zone
Page 31 of 47
The calculated HQs for acute oral and acute contact exposure of honeybees to dithianon,
phosphonic acid and Delan Pro are considerably below the Commission Regulation (EU)
546/2011 trigger value of 50. The summed up HQcombitox values for the active substances of
Delan Pro were also clearly below the trigger value of 50, indicating an acceptable risk as
proposed in the Dutch Evaluation Manual 1.0 (2013); Appendix C: Combination toxicity.
Therefore, low risk to honeybees is expected from application of Delan Pro according to the
proposed uses.
The proposed uses of Delan Pro according to good agricultural practice present a low risk
to honeybees and will not adversely affect honeybees or honeybee colonies.
Other non-target arthropods
The calculated hazard quotient of the first tier risk assessment indicated no in-field risk for
Typhlodromus pyri and Aphidius rhopalosiphi. Furthermore a risk assessment based on Tier II
studies with T. pyri and C. carnea is presented. Low in-field risk was indicated for C. carnea and
low off-field risk was indicated for C. carnea and T. pyri. However, based on the ER50 value of
T. pyri a potential in-field risk cannot be excluded based on this study. Therefore, an aged
residue study with T. pyri for a higher tier risk assessment was carried out. Based on these
results, no in-field risk for T. pyri is expected already at DAT 0. In addition, three field studies
were carried out, which are presented as additional information to the risk assessment. The field
studies were conducted in vineyards in Southern France and Northern Italy. In each study, Delan
Pro was applied with an application rate of 4 x 4.0 L/ha. The findings indicate no unacceptable
effects on natural mite populations.
The off-field exposure is calculated based on the spray drift rates as given in the CTGB
Evaluation Manual for the Authorization of Plant Protection Products and Biocides.
The calculated hazard quotient of the first tier and the second tier risk assessment indicated no
off-field risk. In addition, three field studies were carried out, which are presented as additional
information to the risk assessment. Overall, it can be concluded that Delan Pro poses no risk or
unacceptable effects to non-target arthropods in off-field areas. For the in-field risk assessment,
please refer to the core assessment.
Taking into account all available data and considering drift rates according to the CTGB
Evaluation Manual, it can be concluded that low risk for non-target arthropods is expected
from the use of Delan Pro in in-field and off-field habitats.
3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point
10.6)
Earthworms and other soil non-target macro-organisms
The acute TER values were above the trigger value of 10, indicting low acute risk for
earthworms arising from dithianon and phosphonic acid as contained in Delan Pro when applied
according to the proposed use pattern. The TER values of combination toxicity for acute and
chronic exposure to earthworms were above the trigger value of 1 as proposed by Regulation
(EC) No 1107/2009, version 1.0 (2013); Appendix C: Combination toxicity. Therefore, no acute
and chronic risk for earthworms arising from a combination toxicity of dithianon and phosphonic
acid is expected after application of Delan Pro according to the proposed use pattern.
The long-term TER values were above the trigger value of 5, indicting low long-term risk for
earthworms arising from Delan Pro when applied according to the proposed use pattern.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
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Registration Report – Central Zone
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Page 32 of 47
Furthermore, the TER value of combination toxicity was above the trigger value of 1 as
proposed by Regulation (EC) No 1107/2009, version 1.0 (2013); Appendix C: Combination
toxicity. Therefore, no chornic risk for earthworms arising from a combination toxicity of
dithianon and phosphonic acid is expected after application of Delan Pro according to the
proposed use pattern.
The long-term TER value was above the trigger value of 5, indicating that Delan Pro poses no
long-term risk to Folsomia candida.
The theoretical assessment of combination tox assuming additive toxicity was not performed
because specific product data is available. The theoretical calculation assumes concentration
addition as a worst case, conservative assumption. This is acceptable if no product data are
available. However, the interaction of the mixture partners is not always reflecting concentration
addition, in many cases independent action is observed. Therefore the data for the product is
considered more appropriate for the risk assessment because it reflects exposure under realistic
conditions and includes all potential mixture effects.
It is concluded that the proposed use of Delan Pro will not pose any unacceptable effects to
populations of earthworms or other soil macro-organisms.
3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6)
According to Commission Regulation (EU) No 283/2013, studies on organic matter breakdown
are not required.
3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7)
Delan Pro had no significant effect on soil micro-organisms at 73.23 mg/kg dry soil,
corresponding to 6.67 mg dithianon/kg dry soil and 20 mg phosphonic acid/kg dry soil. This
corresponds to 26.67 mg a.s./kg dry soil based on the sum of the active substances. It is more
than 4 times higher than the maximum PECsoil of 6.087 mg/kg dry soil based on the sum of
active substances. This supports the conclusion that under field conditions, the use of Delan Pro
at the proposed rates poses no unacceptable risk to non-target soil micro-organisms.
It is concluded that the proposed use of Delan Pro will not pose an unacceptable risk to
non-target soil micro-organisms, if applied according to the recommended use pattern.
3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and
Fauna) (Part B, Section 6, Point 10.8)
Non-Target Plants
The risk assessment on non-target plants for the Netherlands is conducted according to the ctgb
Evaluation Manual for the Authorisation of Plant protection products and Biocides [Zorn et al.
2010: Evaluation Manual for the Authorisation of Plant protection products and Biocides, NL
part, Chapter 7 Ecotoxicology: terrestrial; non targets. ctgb board for the Authorisation of Plant
protection products and Biocides]. This is done, as drift rates to be considered for off-field
exposure of non-target plants differ from drift rates given in the Terrestrial Guidance Document
[Anonymous (2002b). Guidance Document on terrestrial ecotoxicology under council directive
91/414/EEC. SANCO/10329/2002. 17 October 2002]. However, in this case acceptable risk to
non-target plants is demonstrated already in the Tier I risk assessment presented in the zonal core
assessment (less than 50 % effect on all tested species is seen at the foreseen maximum single
application rate). However, the risk assessment for non-target plants based on the spray drift
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
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Registration Report – Central Zone
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Page 33 of 47
rates given in the Ctgb Manual is provided here as additional information.
The TER values for the vegetative vigor test conducted under worst-case greenhouse conditions
are below the trigger value of 5. However, after a careful inspection of data, it has been
concluded that it is unlikely that the product will, at the proposed application rate, induce more
than 50% effects on non-target plants.
Populations of terrestrial non-target higher plants are not at risk following application of
Delan Pro to the proposed uses and good agricultural practice.
Other non-target species (Flora and Fauna)
Tests on other non-target species are not required.
3.1.7 Efficacy (Part B, Section 7, Point 8)
All the data regarding the efficacy of the product have been submitted. These data demonstrate
that Delan Pro fulfills all criteria for the authorization of preparations described in Directive
97/57/EC (Uniform Principles, Regulation (EU) No 546/2011, formerly Annex VI to Directive
91/414/EEC).
Minimum effective dose
In apple 17 trials from Germany, France, Belgium and Denmark were carried out to evaluate the
minimum effective dose for control of Venturia inaequalis. Delan Pro was applied at the full
(100 % of GAP rate), a reduced (60 % of GAP rate) and an exaggerated (120 % of GAP rate)
dose rate. For both trial sets characterized by either high or low LWA, a positive dose response
could be demonstrated. Differences between the target dose and the lower dose were generally
greater than those observed between the target dose and the higher dose rate.
In pear 4 trials from Belgium were carried out to evaluate the minimum effective dose for
control of Venturia pyrina. Delan Pro was applied at the full (100 % of GAP rate), a reduced (60
% of GAP rate) and an exaggerated (120 % of GAP rate) dose rate. A clear dose response to
increasing amounts of the test product was not shown in general. However, a trend was shown in
regard of fruit scab control.
Efficacy
In apple 31 efficacy trials were provided to justify the efficacy of BAS 642 01F against Venturia
inaequalis. Trials were conducted from 2011 to 2013 and were carried out in Belgium (6),
Germany (10), Denmark (3), France (6), The Netherlands (2) and the United Kingdom (4).
Delan Pro showed mean control values > 80 % for disease incidence and > 90 % for disease
severity on leaves.
Assessments for disease incidence and severity on fruits showed values more inhomogeneous
than those found for leaf control. Delan Pro showed mean control values > 69 % for disease
incidence and > 78 % for disease severity.
In all trials except 4, Delan Pro performed better (numerically) or equal to the reference product.
Differences were partly shown to be significant.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
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Page 34 of 47
In pear 5 efficacy trials were provided to justify the efficacy of BAS 642 01F against Venturia
pyrina. Thereof one trial was assessed for fruit scab only. Trials were conducted in 2012 and
2013 and were carried out in Belgium (4) and the United Kingdom (1).
Delan Pro showed a mean control value of 84 % for disease incidence and 88 % for disease
severity on leaves and a mean control value of 80 % for disease incidence and 84 % for disease
severity on fruits.
Delan Pro performed similar than the reference product in regard of scab control on leaves. In
contrast, results assessed on fruits showed a better performance of the test product. Differences
were not shown to be significant.
Based on the efficacy trials in apple and pear against Venturia inaequalis and Venturia pyrina
and expert judgement extrapolation is possible from control of venturia spp. in apple and pear, to
control of Venturia spp. in other pome fruits.
The proposed dose rate of max. 2.5 L/ha is considered justified for control of Venturia spp. in
pome fruits.
Yield
Based on the assessment of quality parameters such as leaf aspects, bronzing, fruit colour, size
and fruit firmness as well as sugar content Delan Pro is expected to have no negative impact on
the quality of yield when applied to pome fruits at the proposed dose of 2.5 L/ha.
Any risk may possibly derive from an increase of skin russeting which was shown on one pear
variety. However, the extent of increase was shown to attaine 3.5 % and was limited to max. 10
% of the fruit surface. The impact on fruit quality is deemed negligible.
Based on the trials, it can be concluded that Delan Pro is not expected to negatively impact
organoleptic quality in pome fruit processing.
However, effects of Delan Pro on transformation processes (crucial for making cider) cannot be
excluded. As no fermentation studies were submitted to the ZRMS, effects on fermentation
cannot be excluded. Therefore the following sentence has to be placed on the label:
Het effect op de fermentatie is niet beoordeeld.
Based on the trials, it can be concluded that Delan Pro is not expected to impair quantity of yield
in pome fruits.
Adverse effects
Delan Pro was demonstrated to be safe in at least 14 common European apple varieties.
The test product was also demonstrated to be safe in three pear varieties including Conference,
the most common and important European variety.
Adverse effects on parts of plants used for propagation purposes are considered unlikely to occur
after the application of Delan Pro.
Delan Pro is intended to be applied on a perennial crop. Therefore, an impact on succeeding
crops is deemed unlikely.
Provided that Delan Pro is applied in accordance to good agricultural practice the risk to other
plants including adjacent crops to become damaged is deemed unlikely.
Possible development of resistance
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
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Registration Report – Central Zone
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Page 35 of 47
It may be concluded that the combined risk for development of resistance of Venturia inaequalis
and Venturia pyrina towards both phosphonic acid and dithianon is estimated as low. However
resistance management strategies to avoid any adaptation are recommended by the applicant.
In order to avoid resistance development the following resistance management strategies were
drafted:
•
The use of a fungicide mixture combining two active ingredients.
•
Restriction of the number of applications (6 x) as described in the label.
•
Label recommendation for preventive applications only.
For use of Delan Pro against Venturia inaequalis and Venturia pyrina in apples and pears drafted
measures are considered appropriate.
However, the current resistance risk analysis does not fully comply with EPPO demands
(standard PP1/213(3)) as current sensitivity data of Venturia inaequalis to phosphonic acid have
not been provided. Respective data of the high risk pathogen Venturia inaequalis may be
recommended on national level.
The following resistance management sentence has to be placed on the label:
Resistentiemanagement
Dit middel bevat de werkzame stoffen dithianon en potassium fosfonaat. Dithianon behoort tot
de Quinonen. De Frac code is M9. Kalium fosfonaat behoort tot de fosfonaten. De Frac code is
33. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van
resistentiemanagement dient u de adviezen die gegeven worden in de
voorlichtingsboodschappen, op te volgen.
3.2
Conclusions
The assessment conducted for Delan Pro was in accordance with the Uniform Principles and
demonstrates an acceptable risk to human health and the environment. An authorisation can
therefore be granted.
3.3 Further information to permit a decision to be made or to support a review of the
conditions and restrictions associated with the authorisation
No further information is required.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
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Appendix 1
Registration Report – Central Zone
Page 36 of 47
Copy of the product label
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.
Toepassin
gsgebied
Te
Dosering
bestrijden (middel)
organisme per
toepassing
Pitvruchten Schurft1
1
2,5 liter/ha
Maximaal
aantal
toepassingen
per 12
maanden
6
Minimum
Veiligheidstermijn
interval
in dagen
tussen
toepassingen
in dagen
5 dagen
35 dagen
Schurft (Venturia spp)
Toepassingsvoorwaarden
Toepassen in pitvruchten vanaf BBCH 53, het openen van de knoppen (uitbotten) waarbij de
bloemen nog omhuld zijn door de groene blaadjes.
Om in het water levende organismen te beschermen is toepassing in de teelt van pitvruchten in
percelen die grenzen aan oppervlaktewater uitsluitend toegestaan wanneer gebruik wordt
gemaakt van
 een Wannerspuit met reflectieschermen en venturidoppen (minimaal 90%
driftreducerend) (Lechler ID 90-015C) met inachtneming van een teeltvrije zone van
tenminste 3 meter, of
 Voor 1 mei:
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", met inachtneming van een teeltvrije
zone van tenminste 3 meter
 Vanaf 1 mei:
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 met inachtneming van een teeltvrije zone van tenminste 3 meter.
Het effect op de fermentatie is niet beoordeeld.
Resistentiemanagement
Dit middel bevat de werkzame stoffen dithianon en kalium fosfonaat. Dithianon behoort tot de
Quinonen. De Frac code is M9. Kalium fosfonaat behoort tot de fosfonaten. De Frac code is 33.
Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van
resistentiemanagement
dient
u
de
adviezen
die
gegeven
worden
in
de
voorlichtingsboodschappen op te volgen.
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 37 of 47
Appendix 2 - Reference List
Identity, physical-chemical properties and analytical methods
Annex
point
Year
KIIIA
2.1/1,
2.4.2/1,
2.5.2/1,
2.5.3/1,
2.6.1/1,
2.7.1/1,
2.7.2/1,
2.7.4/1,
2.8.2/1,
2.8.3.1/1
,
2.8.3.2/1
,
2.8.5.2/1
,
2.8.6.1/1
,
2.8.8.2/1
, 4.1.3/1
KIIIA
2.2.1/1,
2.2.2/1,
2.3.1/1,
2.3.3/1
2013 a
KIIIA
2.7.5/1
2011 a
2013 a
Applicant: BASF
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Physical and chemical properties of
formula BAS 643 01 F including low
temperature and accelerated storage
stability in commercial packs
BASF SE, Limburgerhof, Germany
Fed.Rep.
2012/1236759
Yes
Unpublished
Data
protection
claimed
Yes/No
Data
protection
granted
Yes/No
Relied
on
Yes/No
Owner
Yes
Yes
Yes
BASF
Evaluation of physical and chemical
properties according to Directive
94/37/EC (Regulation (EC) No
440/2008)
BASF SE, Ludwigshafen/Rhein,
Germany Fed.Rep.
2012/1147165
Yes
Unpublished
Dithianon / calcium
hydrogenphosphonate monohydrate
12.5 / 50.3 % WG - chemical and
physical stability of formula 643 00 F
when stored at 23°C for 2 years in
commercial packs
BASF SE, Limburgerhof, Germany
Fed.Rep.
2011/1221833
Yes
Unpublished
Yes
Yes
Yes
BASF
Yes
Yes
Yes
BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 38 of 47
Annex
point
Year
KIIIA
2.9.1/1,
2.9.2/1
2014 a
KIIIA
4.1.2/1
2012 a
KIIIA
4.2.1/1,
4.2.2/1
2013 a
KIIIA
5.2.2/3
2012 a
KIIIA
5.6/1
2010 a
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Physical and chemical compatibility
in aqueous tank mixtures of BAS 643
01 F
BASF SE, Limburgerhof, Germany
Fed.Rep.
2014/1092447
no
Unpublished
EU-Performance-Test of BAS 643 01
F, packaging made of HDPE
BASF SE, Ludwigshafen/Rhein,
Germany Fed.Rep.
2012/1104912
No, not subject to GLP regulations
Unpublished
BAS 643 01 F: Effectiveness of
procedures for cleaning application
equipment and protective clothing
BASF SE Agricultural Center
Limburgerhof, Limburgerhof,
Germany Fed.Rep.
2013/1140560
No, not subject to GLP regulations
Unpublished
Validation of the analytical method
for the determination of phosphonic
acid in BAS 643 01 F
BASF SE - GMC Competence Center
Analytics, Ludwigshafen, Germany
Fed.Rep.
2012/1141325
Yes
Unpublished
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
Data
protection
claimed
Yes/No
Data
protection
granted
Yes/No
Relied
on
Yes/No
Owner
Yes
Yes
Yes
BASF
Yes
Yes
Yes
BASF
Yes
Yes
Yes
BASF
Yes
Yes
Yes
BASF
Yes
Yes
Yes
BASF
Human toxicology
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 39 of 47
Annex
point
Year
KIIIA
7.1.1/1
2012 a
KIIIA
7.1.2/1
2012 b
KIIIA
7.1.3/1
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
BAS 643 01 F - Acute oral toxicity
study in rats
2012/1016092
Yes
Unpublished
Data
protection
claimed
Yes/No
Data
protection
granted
Yes/No
Relied on
Yes/No
Owner
Y
Y
Y
BASF
BAS 643 01 F - Acute dermal
toxicity study in rats
2012/1016093
Yes
Unpublished
Y
Y
Y
BASF
2012 a
BAS 643 QB F - Acute inhalation
toxicity study in Wistar rats - 4-hour
liquid aerosol exposure (head-nose
only)
2011/1270062
Yes
Unpublished
Y
Y
Y
BASF
KIIIA
7.1.4/1
2012 c
BAS 643 01 F: Acute dermal
irritation / corrosion in rabbits
2012/1016095
Yes
Unpublished
Y
Y
Y
BASF
KIIIA
7.1.5/1
2012 d
BAS 643 01 F - Acute eye irritation
in rabbits
2012/1016094
Yes
Unpublished
Y
Y
Y
BASF
KIIIA
7.3.3/1
2003 a
Determination of dermal and
inhalation operator exposure for
application of Polyram DF with air
assisted sprayers in grapes
BASF
AG
Agrarzentrum
Limburgerhof,
Limburgerhof,
Germany Fed.Rep.
2002/1011839
yes
Unpublished
Y
Y
Y
BASF
KIIIA
7.5.4/1
2011 a
Determination of worker exposure
(passive dosimetry) associated to
typical crop maintenance activities in
apple orchards following treatment
with BAS 216 03 F in the United
Kingdom and Germany, 2010
BASF SE, Limburgerhof, Germany
Fed.Rep.
2011/1122477
yes
Unpublished
Y
Y
Y
BASF
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 40 of 47
Annex
point
Year
KIIIA
7.6.2/1
2013 a
KIIIA
7.6.2/2
2014 a
KIIIA
7.7.1/1
2012 a
KIIIA
7.11/1
2012 a
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
14C-BAS 216 F in BAS 643 01 F Study of penetration through human
skin in vitro
BASF SE, Ludwigshafen/Rhein,
Germany Fed.Rep.
2013/1096093
Yes
Unpublished
Data
protection
claimed
Yes/No
Data
protection
granted
Yes/No
Relied on
Yes/No
Owner
Y
Y
Y
BASF
BAS 181 02 S in BAS 643 01 F Study of penetration through human
skin in vitro
BASF SE, Ludwigshafen/Rhein,
Germany Fed.Rep.
2014/1037974
yes
Unpublished
Determination of dislodgeable foliar
residues of Dithianon (BAS 216 F)
resulting from an application regimen
of BAS 216 03 F in apples, 2010
BASF SE, Limburgerhof, Germany
Fed.Rep.
2012/1081844
yes
Unpublished
Y
Y
Y
BASF
Y
Y
Y
BASF
BAS 643 01 F - Concentration
control analysis in deionized water
BASF SE, Ludwigshafen/Rhein,
Germany Fed.Rep.
2012/1302194
Yes
Unpublished
Y
Y
Y
BASF
Residues
Annex
point
Year
Applicant: BASF
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
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 41 of 47
Annex
point
Year
KIIIA
8.1.1/2
2013
b
KIIIA
8.3.1/1
2013
a
KIIIA
8.3.1/2
2014
a
KIIIA
8.3.1/9
2013 a
KIIIA
8.5.1/1
2013 a
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
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
Study on the residue behaviour of
BAS 216 F (Dithianon) and
Phosphoric Acid in pome fruits after
application of BAS 643 01 F under
field condition in United Kingdom,
The Netherlands, Southern France,
Greece, Italy, Spain and Germany,
2012
Agro-Check Dr. Teresiak & Erdmann
GbR, Lentzke, Germany Fed.Rep.
2013/1003731
yes
Unpublished
Study on the residue behavior of
Dithianon (BAS 216 F) and
Phosphorous acid on apples after the
application of BAS 643 01 F under
field conditions in Belgium, France
(North and South), Germany, Greece,
Italy and Spain, 2013
Agrologia SLU, Utrera, Spain
2014/1031598
yes
Data
protection
claimed
Yes/No
Data
protection
granted
Yes/No
Relied on
Yes/No
Owner
Yes
Yes
Yes
BASF
Yes
Yes
Y
BASF
Yes
Yes
Y
BASF
Yes
Yes
Y
BASF
Yes
Yes
Y
BASF
Unpublished
Applicant: BASF
Dithianon (BAS 216 F) - Summary of
residue data and processing factors for
Dithianon metabolite Reg.No. 4110904
BASF SE, Limburgerhof, Germany
Fed.Rep.
2013/1125976
No, not subject to GLP regulations
Unpublished
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
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 42 of 47
Annex
point
Year
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
KIIIA
8.5.3/2
2013 a
Dithianon (BAS 216 F) - Summary of
residue data and processing factors for
Dithianon metabolite Reg.No. 4110904
BASF SE, Limburgerhof, Germany
Fed.Rep.
2013/1125976
No, not subject to GLP regulations
Unpublished
Data
protection
claimed
Yes/No
Yes
Data
protection
granted
Yes/No
Yes
Relied on
Yes/No
Y
Owner
BASF
Environmental fate and behaviour
Annex
point
Year
KIIIA
9.7.1/1
2014 a
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Predicted
environmental
concentrations of BAS 216 H Dithianon and its metabolites in
surface water and sediment
following application of BAS 643
01 F to pome fruits in the
Netherlands
Data
protection
claimed
Yes/No
Owner
Data
protection
granted
Yes/No
Studies
relied on
Yes/No
Yes
BASF
N
Y
Yes
BASF
N
Y
BASF SE, Limburgerhof, Germany
Fed.Rep.
2013/1379497
no
Unpublished
KIIIA
9.7.1/2
2014 b
Predicted
environmental
concentrations of Phosphonic acid
and its metabolite in surface water
and sediment following application
to pome fruits in the Netherlands
BASF SE, Limburgerhof, Germany
Fed.Rep.
2013/1379502
no
Unpublished
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 43 of 47
Annex
point
Year
KIIIA
9.8.1/1
2014 a
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Predicted
environmental
concentrations of BAS 216 H Dithianon and its metabolites in
surface water and sediment
following application of BAS 643
01 F to pome fruits in the
Netherlands
Data
protection
claimed
Yes/No
Owner
Data
protection
granted
Yes/No
Studies
relied on
Yes/No
Yes
BASF
N
Y
Yes
BASF
N
Y
BASF SE, Limburgerhof, Germany
Fed.Rep.
2013/1379497
no
Unpublished
KIIIA
9.8.1/2
2014 c
Predicted
environmental
concentrations of Phosphonic acid
and its metabolite in surface water
and sediment following application
to pome fruits in the Netherlands
BASF SE, Limburgerhof, Germany
Fed.Rep.
2013/1379502
no
Unpublished
Ecotoxicology
Annex
point
Year
KIIIA
2012 a
10.2.2.1/1
Title
Source (where different from
company)
Company, Report No.
GLP or GEP status (where
relevant)
Published or Unpublished
Reg.No. 120387 (oPhthalaldehyde;
Phthaldialdehyde; metabolite of
BAS 216 F) - Acute toxicity for
rainbow trout
2012/1002443
OECD 203 (1992)
GLP - Yes
Data
protection
claimed
Yes/No
Yes
Owner
BASF
Data
protection
granted
Yes/No
Y
Studies
relied on
Yes/No
Y
Efficacy
Applicant: BASF
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 44 of 47
Annex
point
Year
KIIIA 6/1
2014
KIIIA 6/2
2014
KIIIA 6.2.8
2014
KIIIA 6.5
2014
KIIIA 6.7/
01
2010
KIIIA 6.7/
02
2007
KIIIA 6.7/
03
2008
KIIIA 6.7/
04
2012
Applicant: BASF
Title
Source (where different from company)
Company, Report No.
GLP or GEP status (where relevant)
Published or Unpublished
Biological Assessment Dossier - BAS 643
01 F - Core C - ZRMS: Austria - Part K
RIFCon GmbH, Hirschberg, Germany
Fed.Rep.
2014/1036960
no
Unpublished
Delan Pro - BAS 643 01 F – Raw Data
BASF
2014/1109970
no
Unpublished
BAS 643 01 F Resistance Risk Analysis
BASFSE, ARS Limburgerhof, Germany
2014/1010833
Yes
Unpublished
Physical and Chemical Compatimility
in Aqeous Tank Mixtures
BASF SE, ARS Limburgerhof,
Germany Fed. Rep.
2014/1092447
Yes
Unpublished
GEP Certificate:
PC Fruit
(Proefcentrum Fruitteelt v.z.w.)
Sint-Truiden, Belgium
2009/1128165
Yes
Unpublished
GEP Certificate:
BASF Nederland B.V.
Arnhem, The Netherlands
2007/1036981
Yes
Unpublished
GEP Certificate:
Eurofins Agroscience Services Ltd.
- Agrisearch UK Ltd
Melbourne / Derby, United Kingdom
2008/1099917
Yes
Unpublished
No
GEP Certificate:
Eurofins Agroscience Services Ltd.
- Agrisearch UK Ltd.
Melbourne / Derby, United Kingdom
2013/1037925
Yes
Unpublished
Data
protectio
n claimed
Y/N
Owner
Relied
on
Yes/No
BASF
Data
protecti
on
granted
Yes/No
Yes
Yes
Yes
BASF
Yes
Yes
Yes
BASF
Yes
Yes
Yes
BASF
Yes
Yes
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
Yes
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 45 of 47
KIIIA 6.7/
05
2009
KIIIA 6.7/
06
2011
KIIIA 6.7/
07
2013
KIIIA 6.7/
08
2008
KIIIA 6.7/
09
2009
KIIIA 6.7/
10
2012
KIIIA 6.7/
11
2011
KIIIA 6.7/
12
2009
KIIIA 6.7/
13
2010
Applicant: BASF
GEP Certificate:
FAST Ltd.
(Farm Advisory Services Team
Limited)
Faversham / Kent, United Kingdom
2009/1128042
Yes
Unpublished
GEP Certificate:
CAMPDEN Technology Ltd.
Gloucestershire, United Kingdom
2014/1094029
Yes
Unpublished
GEP Certificate:
CAMPDEN Technology Ltd.
Gloucestershire, United Kingdom
2014/1094030
Yes
Unpublished
GEP Certificate:
University of Aarhus (Flakkebjerg)
Slagelse, Denmark
2008/1101736
Yes
Unpublished
GEP Certificate:
BASF Agro SAS
Ecully, France
2009/1124052
Yes
Unpublished
GEP Certificate:
BASF Agro SAS
Ecully, France
2012/1086543
Yes
Unpublished
GEP Certificate:
Promo-Vert
Serres Castet, France
2011/1276942
Yes
Unpublished
GEP Certificate:
BASF SE,VTO Limburgerhof
Limburgerhof, Germany
2009/1049016
Yes
Unpublished
GEP Certificate:
Field Research Support
Wunstorf, Germany
2011/1294035
Yes
Unpublished
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 46 of 47
KIIIA 6.7/
14
2009
KIIIA 6.7/
15
2012
KIIIA 6.7/
16
2010
KIIIA 6.7/
17
2012
KIIIA 6.7/
18
2010
KIIIA 6.7/
19
2012
KIIIA 6.7/
20
2011
KIIIA 6.7/
21
2007
Applicant: BASF
GEP Certificate:
Ingenieurbüro A. Hetterich,
Schwarzach,Germany
2009/1089717
Yes
Unpublished
GEP Certificate:
Gemerprodukt Valice OVD,
Rimavska Sobota, Slovakia
2012/1366004
Yes
Unpublished
GEP Certificate:
Government Office, Agricultural
Office of County (Szabolcs-) SzatmárBereg,
Nyíregyháza, Hungary
2010/1226844
Yes
Unpublished
GEP Certificate:
Government Office, Agricultural
Office of County (Szabolcs-) SzatmárBereg,
Nyíregyháza, Hungary
2012/1366022
Yes
Unpublished
GEP Certificate:
Government Office, Agricultural
Office of County Zala,
Zalaegerszeg, Hungary
2010/1226845
Yes
Unpublished
GEP Certificate:
Government Office, Agricultural
Office of County Zala,
Zalaegerszeg, Hungary
2012/1257675
Yes
Unpublished
GEP Certificate:
SynTech Research Hungary,
Táplánszentkereszt, Hungary
2011/1291596
Yes
Unpublished
GEP Certificate:
Institute of Horticulture,
Kaunas, Lithuania
2007/1068185
Yes
Unpublished
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
Evaluator: Ctgb, NL
Date: January 2016
Part A
National Addendum – Netherlands
Delan Pro / BAS 643 01 F
Registration Report – Central Zone
15023 N
Page 47 of 47
KIIIA 6.7/
22
2011
KIIIA 6.7/
23
2011
KIIIA 6.7/
24
2011
KIIIA 6.7/
25
2010
KIIIA 6.7/
26
2011
KIIIA 6.7/
27
2012
Applicant: BASF
GEP Certificate:
BASF Polska Sp. z o.o.,
Warszawa, Poland
2011/1269204
Yes
Unpublished
GEP Certificate:
BIOTEK Agriculture Polska Sp. z o.o,
Olawa, Poland
2011/1288631
Yes
Unpublished
GEP Certificate:
Instytut Ogrodnictwa,
Skierniewice, Poland
2011/1269207
Yes
Unpublished
GEP Certificate:
University of Life Sciences Poznan,
Poznan, Poland
2010/1226833
Yes
Unpublished
GEP Certificate:
Agro Research International B.V.,
TC Lepelstraat, The Netherlands
2011/1294011
Yes
Unpublished
GEP Certificate:
AGROLAB S.A.,
Sindos Thessaloniki, Greece
2012/1224236
Yes
Unpublished
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
No
BASF
No
No
Evaluator: Ctgb, NL
Date: January 2016