HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van...

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14507 N Solofol, 20146224 ZWTG HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN 1. BESLUIT Op 23 december 2014 is van Belchim Crop Protection N.V./S.A. Technologielaan 7 B-1840 LONDERZEEL Belgium Aanvraag tot wijziging van gewasbeschermingsmiddeltoelating met Nederland als zonaal rapporteur ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel Solofol op basis van de werkzame stof folpet. HET COLLEGE BESLUIT tot toelating van bovenstaand middel. Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel van dit besluit. 1.1 Samenstelling, vorm en verpakking De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend. 1.2 Gebruik Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I. 1.3 Classificatie en etikettering Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden vermeld: De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie” in bijlage I. Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I. Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

Transcript of HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van...

Page 1: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

14507 N

Solofol, 20146224 ZWTG

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT

Op 23 december 2014 is van

Belchim Crop Protection N.V./S.A.

Technologielaan 7

B-1840 LONDERZEEL

Belgium

Aanvraag tot wijziging van gewasbeschermingsmiddeltoelating met Nederland als zonaal rapporteur

ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening)

voor het gewasbeschermingsmiddel

Solofol

op basis van de werkzame stof folpet.

HET COLLEGE BESLUIT tot toelating van bovenstaand middel.

Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel

van dit besluit.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als

waarvoor de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en

zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende

aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden

vermeld:

� De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder

“verpakkingsinformatie” in bijlage I.

� Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel

A van het registratierapport, Appendix I.

� Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

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14507 N

Solofol, 20146224 ZWTG

� De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de

voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2

van deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op

de verpakking te worden aangebracht. De te hanteren w-coderingen en aflever- en

opgebruiktermijnen voor oude verpakkingen staan vermeld onder “toelatingsinformatie” in bijlage I.

2. WETTELIJKE GRONDSLAG

Besluit artikel 28 Verordening (EG) Nr. 1107/2009

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

Gebruikt toetsingskader Conform Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual

Zonaal 2.0.

3. BEOORDELINGEN

3.1 Fysische en chemische eigenschappen

De aard en de hoeveelheid van de werkzame stoffen en de in humaan-toxicologisch en

ecotoxicologisch opzicht belangrijke onzuiverheden in de werkzame stof en de hulpstoffen zijn

bepaald. De identiteit van het middel is vastgesteld. De fysische en chemische eigenschappen van het

middel zijn vastgesteld en voor juist gebruik en adequate opslag van het middel aanvaardbaar

geacht.

3.2 Analysemethoden

De geleverde analysemethoden voldoen aan de vereisten om de residuen te kunnen bepalen die

vanuit humaan-toxicologisch en ecotoxicologisch oogpunt van belang zijn, volgend uit geoorloofd

gebruik.

3.3 Risico voor de mens

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor de mens verwacht.

3.4 Risico voor het milieu

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften geen

onaanvaardbaar risico voor het milieu verwacht.

3.5 Werkzaamheid

Van het middel wordt voor de toegelaten toepassingen volgens de voorschriften verwacht dat het

werkzaam is.

Voor nadere onderbouwing van de beoordelingen verwijzen wij u naar deel A en B van het

registration report als toegevoegd aan de bijlagen van dit besluit overeenkomstig Besluit beleidsregel

bekendmaken delen A en B van het Registration Report.

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14507 N

Solofol, 20146224 ZWTG

Bezwaarmogelijkheid

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de

Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes

weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College

voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.

Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift

opengesteld.

Ede, 1 juni 2018

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN,

Ir. J.F. de Leeuw

Voorzitter

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Solofol, 20146224 ZWTG

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20146224 ZWTG

Type aanvraag: Aanvraag tot wijziging van

gewasbeschermingsmiddeltoelating met Nederland als

zonaal rapporteur

Middelnaam: Solofol

Verzenddatum aanvraag: 18 december 2014

Formele registratiedatum: * 7 januari 2015

* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.

2.2 Stofinformatie

Werkzame stof Gehalte

folpet 80 %

• De stof is per 1 oktober 2007 geplaatst op Annex I van Richtlijn 91/414/EEG ((2007/5/EC d.d.

7 februari 2007)) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011

goedgekeurd) De goedkeuring van deze werkzame stof expireert op 31-07-2018.

2.3 Toelatingsinformatie

Toelatingsnummer: 14507 N

Expiratiedatum: 1 augustus 2024

Afgeleide parallel of origineel: Wijziging Middel

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel

Gebruikers: Professioneel

W-coderingen en aflever- en opgebruiktermijnen:

� W-codering professioneel gebruik: W2

� Vorige w-codering professioneel gebruik: W1

� Aflevertermijn professioneel gebruik: nvt

� Opgebruiktermijn professioneel gebruik: nvt

2.4 Verpakkingsinformatie

Aard van het preparaat:

Water dispergeerbaar granulaat

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14507 N

Solofol, 20146224 ZWTG

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel Solofol

Professioneel gebruik

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:

folpet

methylnaftaleensulfonaat \ formaldehyde condensaat, natriumzout

Pictogram GHS05

GHS07

GHS08

GHS09

Signaalwoord Gevaar

Gevarenaanduidingen H317 Kan een allergische huidreactie veroorzaken.

H318 Veroorzaakt ernstig oogletsel

H332 Schadelijk bij inademing.

H351 Verdacht van het veroorzaken van kanker.

H410 Zeer giftig voor in het water levende organismen, met langdurige

gevolgen.

Voorzorgsmaatregelen SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water

verontreinigt.

P201 Alvorens te gebruiken de speciale aanwijzingen raadplegen.

P273 Voorkom lozing in het milieu.

P280 Beschermende handschoenen/beschermende

kleding/oogbescherming/gelaatsbescherming dragen.

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.

P391 Gelekte/gemorste stof opruimen.

P501 Inhoud/verpakking afvoeren naar ....

Aanvullende

etiketelementen

EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke

gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Nee

Voelbare gevaarsaanduiding verplicht Nee

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Part A National Assessment Country – The Netherlands

Solofol

Registration Report – Central Zone Page 6 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018

REGISTRATION REPORT

Part A

Risk Management

Product code: Solofol (BCP324F)

Active Substance: 800 g/kg

COUNTRY: The Netherlands

Central Zone

Zonal Rapporteur Member State: The Netherlands

NATIONAL ASSESSMENT

Applicant: Belchim Crop Protection NV/SA

Date: May 2018

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Part A National Assessment Country – The Netherlands

Solofol

Registration Report – Central Zone Page 7 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Table of Contents

PART A – Risk Management 9

1 Details of the application 9

1.1 Application background 9

1.2 Annex I inclusion 10

1.3 Regulatory approach 10

1.4 Data protection claims 10

1.5 Letters of Access 11

2 Details of the authorisation 11

2.1 Product identity 11

2.2 Classification and labelling 11

2.2.1 Classification and labelling under Regulation (EC) No. 1272/2008 11

2.2.3 Other phrases for Regulation (EC) 1272/2008 12

2.3 Product uses 13

3 Risk management 16

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

Principles 16

3.1.1 Physical and chemical properties 16

3.1.2 Methods of analysis 17

3.1.2.1 Analytical method for the formulation 17

3.1.2.2 Analytical methods for residues 17

3.1.3 Mammalian Toxicology 17

3.1.3.1 Acute Toxicity 18

3.1.3.2 Operator Exposure 18

3.1.3.3 Bystander Exposure 19

3.1.3.4 Worker Exposure 19

3.1.4 Residues and Consumer Exposure 19

3.1.4.1 Residues 19

3.1.4.2 Consumer exposure 19

3.1.5 Environmental fate and behaviour 20

3.1.6 Ecotoxicology 24

3.1.6.1 Effects on Terrestrial Vertebrates 24

3.1.6.2 Effects on Aquatic Species 26

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Part A National Assessment Country – The Netherlands

Solofol

Registration Report – Central Zone Page 8 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

3.1.6.3 Effects on Bees and Other Arthropod Species 27

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms 27

3.1.6.5 Effects on organic matter breakdown 28

3.1.6.6 Effects on Soil Non-target Micro-organisms 28

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna)

28

3.2 Conclusions 31

3.2 Additional information 31

Appendix 1 – Copy of the product authorisation 32

Appendix 2 – Copy of the product label 33

Wettelijk Gebruiksvoorschrift 33

Appendix 3 – Letter of Access 35

Appendix 4: List of data submitted in support of the evaluation 36

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Part A National Assessment Country – The Netherlands

Solofol

Registration Report – Central Zone Page 9 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018

PART A – Risk Management

1 Details of the application

This document describes the specific conditions of use and labelling required for the registration of the

plant protection product Solofol containing the active substance folpet which was included into Annex I

of Directive 91/414 (Commission Directive 2007/5/EC of 07 February 2007) and under Regulation

1107/2009/EC (Commission Regulation n° 540/2011 of 25 May 2011).

Where appropriate this document refers to the conclusions of the EU review of the active substance

folpet. This will be where:

• the active substance data is relied upon in the risk assessment of the formulation; or when

• the EU review concluded that additional data/information should be considered at national re-

registration.

Ctgb from The Netherlands received application for Solofol (BCP324F) on 24 December 2010. After

evaluation of the application the product was approved on 1 August 2014 with Approval nr.: 14507 N.

The risk assessment conclusions are based on the information, data and assessments provided in

Registration Report, Part B Sections 1-8 and Part C and where appropriate the addendum 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 re-registration/registration by the EU

review. It also includes assessment of data and information relating to Solofol where that data has not

been considered in the EU review.

Appendix 1 of this document provides a copy of the final product authorisation The Netherlands.

Appendix 2 of this document is a copy of the approved product label for The Netherlands.

Appendix 3 of this document contains copies of the letters of access to the protected data / third party data

that was needed for evaluation of the formulation.

Table 2.3 of this document is the table of intended uses for Solofol.

1.1 Application background

This application was submitted by Belchim Crop Protection nv/sa on December 2014.

The application was for approval of Solofol, a WG containing 800 g/kg folpet for use as a fungicide for

use on vines and on flower bulbs.

Company: Belchim Crop Protection N.V./S.A.

Address: Technologielaan 7

B-1840 Londerzeel

Belgium

Telephone: +32 52 30 09 06

Fax: +32 52 30 11 35

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Part A National Assessment Country – The Netherlands

Solofol

Registration Report – Central Zone Page 10 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

1.2 Annex I inclusion

Folpet was included into Annex I of Directive 91/414 (Commission Directive 2007/5/EC of 07 February

2007) and under Regulation 1107/2009/EC (Commission Regulation n° 540/2011 of 25 May 2011).

The Annex I Inclusion Directive for folpet (2007/5/EC) provides specific provisions under Part B which

need to be considered by the applicant in the preparation of their submission and by the MS prior to

granting an authorisation

1.3 Regulatory approach

To obtain re-approval/approval the product Solofol must meet the conditions of Annex I inclusion and be

supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to

Uniform Principles, using Annex I agreed end-points.

Ctgb from the Netherlands received application for Solofol (BCP324F) on 24 December 2010. After

evaluation of the application the product was approved on 1 August 2014 with Approval nr.: 14507 N.

The SANCO report for folpet (SANCO/10032/2006 – rev. 5 of 11 July 2008) is considered to provide the

relevant review information or a reference to where such information can be found. The following table

provides the EU endpoints to be used in the evaluation.

EU End-points

End-Point Active Substance

EU agreed endpoints

(SANCO/10032/2006 – rev. 5)

Endpoints used a

Purity of active substance Minimum 940 g/kg Minimum 960 g/kg

Identity of relevant

impurities in the active

substance as manufactured

Perchloromethyl mercaptan: max. 3.5 g/kg

Carbon tetrachloride max. 4 g/kg

< 1 g/kg

< 1 g/kg a Data based on new manufacturing sources for technical folpet of the applicant. Details on the composition including

confirmation of the technical equivalence by the designated member state France are provided in Part C.

This application was submitted in order to allow the registration of the product in The Netherlands in

accordance with the above.

1.4 Data protection claims

Where protection for data is being claimed for information supporting the registration of Solofol

(BCP324F), it is indicated in the reference lists in Appendix 1 of the Registration report, Part B, Sections

1-8 and Part C.

Information on the detailed composition of Solofol can be found in the confidential dossier of this

submission (Registration Report - Part C).

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Part A National Assessment Country – The Netherlands

Solofol

Registration Report – Central Zone Page 11 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

1.5 Letters of Access

Letter of access by ADAMA Makhteshim Ltd. for studies IIIA 8.3.1/03 (R-27558) and IIIA 8.3.1/04 (R

27930) on magnitude of residue of folpet and its metabolite phthalimide in table grapes.

2 Details of the authorisation

2.1 Product identity

Product Name Code name: BCP324F /Folpet 80WG - Marketing name : Solofol

Authorization Number (for re-

registration)

To be assigned

Function Fungicide

Applicant Belchim Crop Protection N.V./S.A.

Composition 800 g/kg folpet

Formulation type Water dispersible granules [Code: WG]

Packaging Bags comprising of PET/LDPE: 125 g.

Bag comprising of three layers of film (triplex), formed by an external

layer of polyamide bi-oriented, a middle layer of aluminum and an

internal layer of polyethylene: 1 kg and 5 kg

Bags comprising of brown kraft 70 + LDPE 15 + ALU FOIL 19-7 My +

LDPE 35: 10 kg

2.2 Classification and labelling

2.2.1 Classification and labelling under Regulation (EC) No. 1272/2008

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the

co-formulants, the method of application and the risk assessment for the operator, as mentioned above,

the following labeling of the preparation is proposed:

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

Folpet, condensation of product of sodium methyl naphthalene and formaldehyde

Pictogram: GHS05 Signal word: danger

GHS07

GHS08

GHS09

H-statements: H317 May cause an allergic skin reaction

H318 Causes serious eye damage.

H332 Harmful if inhaled.

H351 Suspected of causing cancer.

H410 Very toxic to aquatic life with long lasting effects.

P-statements: P201 Obtain special instructions before use.

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Part A National Assessment Country – The Netherlands

Solofol

Registration Report – Central Zone Page 12 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

P273 Avoid release to the environment.

P280 Wear protective gloves/protective clothing/eye

protection/face protection.

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.

P391 Collect spillage.

P501 Dispose of contents/container to…

Supplemental Hazard

information:

EUH401 To avoid risks to human health and the

environment, comply with the instructions for use.

SP-statement: 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: H317 and H351 are assigned based on the classification of

folpet. H318 and H332 are assigned based on calculation rules.

P-statements: P280 is assigned based on H317, H318, and H351

classification. P305+P351+P338 is assigned based on H318

classification. Other P-statements were proposed by the

applicant and accepted.

Other: -

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

2.2.3 Other phrases for Regulation (EC) 1272/2008

-

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 13 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018

2.3 Product uses

PPP (product name/code) Solofol/BCP 324 F

Active substance 1 folpet

Active substance 2 n.a.

Safener /

Synergist /

Formulation type: WG

Conc. of as 1: 800 g/kg

Conc. of as 2: n.a.

Conc. of safener: /

Conc. of synergist: /

Applicant: Belchim Crop Protection NV/SA

Zone(s): Central Zone

professional use

non professional use

Verified by MS:

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

Use-

No.

Member

state(s)

Crop and/

or

situation

(crop

destination

/ purpose

of crop)

F

G

or

I

Pests or

Group of

pests

controlled

(additionally:

developmental

stages of the

pest or pest

group)

Application Application rate

PHI

(days)

Remarks:

e.g. safener/synergist per

ha

e.g. recommended or

mandatory tank mixtures

Method /

Kind

Timing /

Growth

stage of

crop &

season

Max.

number

(min.

interval

between

applications)

a) per use

b) per season

kg product / ha

a) max. rate

per appl.

b) max. total

rate per season

kg as/ha

a) max. rate per

appl.

b) max. total rate

per crop/season

Water

L/ha

min /

max

Existing use in NL, not evaluated in this dossier

1 NL Wine grape

(VITVI,

Vitis

vinifera)

F Downy

mildew

(PLASVI,

Plasmopara

viticola)

Airblast

sprayer;

foliar

application

BBCH 12 –

BBCH 83

(spring –

summer)

(April –

September)

a) 10

(7 days)

b) 10

(7 days)

a) 1.8 kg/ha

b) 18.0kg/ha

a) 1.44 kg

b) 14.4 kg

1000 /

1200

28

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 14 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

New uses

9 NL Flower

bulbs and

flower

corms

(GLASS,

Gladiolus

spp.)

I/F FUSASP,

Fusarium spp.

bulb dip BBCH 00

(Before

planting)

(January –

December)

a) 1

(n.a.)

a) 1.8 kg/ha

b) 1.8 kg/ha

a) 1.44 kg

b) 1.44 kg

- - Dose rate of 0.5% product.

Bulb dip water uptake

360 L/ha

10 NL Flower

bulbs and

flower

corms

(CROSS,

Crocussus

spp.)

I/F FUSASP,

Fusarium spp.

bulb dip BBCH 00

(Before

planting)

(January –

December)

a) 1

(n.a.)

a) 2.43 kg/ha

b) 2.43 kg/ha

a) 1.944 kg

b) 1.944 kg

- - Dose rate of 0.5% product.

Bulb dip water uptake

487.5 L/ha

11 NL Flower

bulbs and

flower

corms

(IRISS, Iris

spp.)

I/F FUSASP,

Fusarium spp.

bulb dip BBCH 00

(Before

planting)

(January –

December)

a) 1

(n.a.)

a) 2.45 kg/ha

b) 2.45 kg/ha

a) 1.96 kg

b) 1.96 kg

- - Dose rate of 0.5% product.

Bulb dip water uptake

490 L/ha

12 NL Flower

bulbs and

flower

corms

(TULSS,

Tulipa

spp.)

I/F FUSASP,

Fusarium spp.

bulb dip BBCH 00

(Before

planting)

(January –

December)

a) 1

(n.a.)

a) 3.25 kg/ha

b) 3.25 kg/ha

a) 2.6 kg

b) 2.6 kg

- - Dose rate of 0.5% product.

Bulb dip water uptake

650 L/ha

13 NL Flower

bulbs and

flower

corms

(NARSS,

Narcissus

I/F FUSASP,

Fusarium spp.

bulb dip BBCH 00

(Before

planting)

(January –

December)

a) 1

(n.a.)

a) 3.25 kg/ha

b) 3.25 kg/ha

a) 2.6 kg

b) 2.6 kg

- - Dose rate of 0.5% product.

Bulb dip water uptake

650 L/ha for miniature

bubs

(m.u.v. grofbollige narcis)

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 15 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

spp.)

14 NL Flower

bulbs and

flower

corms

(LILSS,

Lilium

spp.)

I/F FUSASP,

Fusarium spp.

bulb dip BBCH 00

(Before

planting)

(January –

December)

a) 1

(n.a.)

a) 3.5 kg/ha

b) 3.5 kg/ha

a) 2.8 kg

b) 2.8 kg

- - Dose rate of 0.5% product.

Bulb dip water uptake

700 L/ha

15 NL Flower

bulbs and

flower

corms

(HYASS,

Hyacinthus

spp.)

I/F FUSASP,

Fusarium spp.

bulb dip BBCH 00

(Before

planting)

(January –

December)

a) 1

(n.a.)

a) 3.575 kg/ha

b) 3.575 kg/ha

a) 2.86 kg

b) 2.86 kg

- - Dose rate of 0.5% product.

Bulb dip water uptake

715 L/ha

16 NL Flower

bulbs and

flower

corms

(NNNZJ,

all species)

F BOTRSP,

Botrytis spp.

foliar

spray

BBCH

12-39 91

(March-

September)

a) 2 10#

(7 days)

b) 2 10#

(7 days)

a) 1.0 kg/ha

1.5

b) 2.0 kg/ha

10-15

a) 0.80 kg

1.2

b) 1.60 kg

8-12

150 /

400

- # Before BBCH 40, only

2applications with the

lowest dose are allowed.

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Part A National Assessment Country – The Netherlands

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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018

3 Risk management

3.1 Reasoned statement of the overall conclusions taken in accordance with the

Uniform Principles

3.1.1 Physical and chemical properties The product Solofol is a water dispersible granular formulation (WG). The in–use concentrations are

0.10 - 1.0 %. All studies have been performed in accordance with the current requirements, the critical

GAP and the results are deemed to be acceptable. The appearance of the product is that of brown

granules, with no characteristic odour. It is not explosive and has no oxidising properties. It has a self

ignition temperature of > 400°C. In a 1% aqueous dilution, it has a pH value of around 8.8 to 9.8. The

stability data indicate a shelf life of at least 2 years at ambient temperature. Its technical characteristics

are acceptable for a WG formulation.

Implications for labelling: There are not clear implications for labelling

Compliance with FAO specifications:

Yes, the product Solofol complies with FAO specifications.

Compatibility of mixtures:

Not applicable. No specific tank mixtures or mixing recommendations are proposed on the label.

Nature and characteristics of the packaging:

Information with regard to type, dimensions, capacity, size of opening, type of closure, strength,

leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents

of the packaging, have been submitted, evaluated and is considered to be acceptable. Solofol is intended

to be commercialised in five commercial packs: 1 kg bags, a case containing 10 of the 1 kg bags, a 1 kg

box, a 5 kg 3-ply bag and a 10 kg multi layer bag.

Nature and characteristics of the protective clothing and equipment:

Information regarding the required protective clothing and equipment for the safe handling of Solofol has

been provided and is considered to be acceptable (IIIA 4.2.1).

Implications for labelling:

Hazard Pictogram:

GHS07, GHS08, GHS09

Signal word: Warning

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Part A National Assessment Country – The Netherlands

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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

3.1.2 Methods of analysis

Folpet is determined in formulated Solofol via HPLC with UV detection. The method was fully validated

with respect to specificity, linearity, repeatability and accuracy. A CIPAC method is not available for

folpet formulated as a water dispersible granule. However, CIPAC methods exist for folpet technical,

dustable powders and wettable powders and during the EU review were considered to be applicable for

WG formulations.

3.1.2.1 Analytical method for the formulation

There are no impurities within the preparation that are of toxicological, ecotoxicological or environmental

concern. The toxicological relevant impurities in technical folpet of the reference specification (i.e.

carbon tetrachloride and perchloromethyl mercaptan) are well below 0.1% in the material from the

manufacturing sources for Solofol and are significantly below the limit values (0.35% for

perchloromethyl mercaptan and 0.4% for carbon tetrachloride) set for the inclusion of folpet in Annex I of

Council Directive 91/414/EEC (for details on the composition of the technical active substance in Solofol

please refer to the confidential part C of this dossier). Since these impurities cannot be formed upon

storage of the technical active substance or the manufacturing and storage of the formulated product, no

analytical method is needed for their determination in Solofol.

Analytical methods for determination of folpet, impurities and relevance of CIPAC methods in Solofol

were not evaluated as part of the EU review of folpet. Therefore all relevant data are provided and are

considered adequate.

A CIPAC method is not available for folpet formulated as a water dispersible granule. However, the

existing CIPAC methods for folpet technical (CIPAC 1B, 75/TC/M), dustable powders (CIPAC 1B,

75/DP/M) and wettable powders (CIPAC 1B, 75/WP/M) are considered to be applicable (EU endpoint

list).

3.1.2.2 Analytical methods for residues

The applicant supports the use of Solofol in vines and flower bulbs. The EU Annex II dossier contains

several crop residue methods in these segments. However, the majority of crop residue methods did not

consider the quantification of phthalimide which, at the time of Annex I decision, was considered a

relevant degradation product in plants.

Additional data on methods/validation in crops, soil, sediment, water, air, body fluid & tissues for folpet

have been provided for the original application for Solofol and considered adequate.

All analytical methods are active substance data and were provided in the EU review of the active

substance folpet and were considered adequate.

The analytical method for the determination of residues in surface water meets the Dutch national

requirement (LOQ<0.1 µg/L)

3.1.3 Mammalian Toxicology

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Part A National Assessment Country – The Netherlands

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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

3.1.3.1 Acute Toxicity

The following tests were performed on Solofol: acute LD50 oral (rat), acute LD50 dermal (rat), skin

irritation (rabbit) and eye irritation (rabbit). An inhalation toxicity study was not performed. The

calculation method has been used instead. A skin sensitisation test was not performed as the active

substance is already classified for its sensitising effects. The eye irritation test did not comply with OECD

405 and has therefore not been used for the classification of Solofol. The calculation method has been

used instead.

Table 3.1.3-1: Summary of Acute toxicological data of Solofol

Parameter

[Reference]

Species Result

mg/kg or mg/m3 or effect

Classification according

to CLP Reg (EC) No

1272/2008

Acute oral toxicity

Rat

LD50 > 2000 unclassified

Acute dermal

toxicity

Rat

LD50 > 2000 unclassified

Acute inhalation

toxicity Based on the calculation method, H332 is required. H332 (“Harmful if inhaled)

Skin irritation

Rabbit

Not irritating unclassified

Eye irritation

Based on the calculation method, H318 is required.

H318 (“Causes serious eye

damage”)

Skin sensitization n.a. Sensitizer1 H317 “May cause an

allergic skin reaction” 1 Classification based on data of the active substance

Solofol containing 800 g/kg folpet, has a low toxicity in respect to acute oral and dermal toxicity and in

not irritating to the rabbit skin. It has been found to be a skin sensitizer, based on skin sensitising

properties of the active substance. Based on the calculation method, H318 (Causes serious eye damage)

and H332 (Harmful if inhaled) is required for classification and labelling of the product.

Acute toxicity studies for Solofol were not evaluated as part of the EU review of the active substance

folpet. Therefore, all relevant data are provided here and are considered adequate.

3.1.3.2 Operator Exposure

The model estimations were based on the following data:

Endpoint Folpet

Endpoints used in risk assessment

Dermal penetration Concentrate: 0.3%

Spray dilution (3.2 g/L): 2%

Spray dilution (1.5 g/L): 4%

AOEL 0.1 mg/kg bw/day

In the Netherlands, only flower bulb dipping and foliar spray in flower bulbs (field) has been applied for.

According to the model calculations, it can be concluded that the risk for the operator using Solofol for

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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

mechanical outdoor spraying on flower bulbs and for automated indoor dipping of flower bulbs is

acceptable without the use of PPE (23% and 29% of the AOEL, respectively).

Given the eye irritating and sensitising potential of Solofol impermeable gloves and eye/face protection

should be worn when handling the concentrate.

3.1.3.3 Bystander Exposure

It is concluded that there is no undue risk to any, work related bystander, non-work related bystander or

resident (adult or child) after exposure to Solofol. The exposure is estimated to be less than 3.1% of the

AOEL for all relevant NL-GAP uses.

3.1.3.4 Worker Exposure

Based on the Dutch national assessment for re-entry activities in flower bulbs after foliar application and

in flower bulb planting (for putting the treated bulbs manually upright), the worker exposure does not

exceed the EU-AOEL without the use of PPE. The exposure is estimated to be 41% of the AOEL for the

foliar application in flower bulbs and 98% of the AOEL for flower bulb planting.

3.1.4 Residues and Consumer Exposure

3.1.4.1 Residues

The metabolism and residue data of folpet have been evaluated by EFSA during the peer review (EFSA

Scientific Report (2009) 297, 1-80) and review of the existing MRLs of folpet (EFSA Journal 2014;

12(5):3700). In the peer review and MRL review residue definition for monitoring and risk assessment is

defined as sum of folpet and phthalimide.

Additional supervised residue trials with folpet in pasture, grapes and grape’s processed commodities,

nature of folpet resides in hydrolytic conditions have been submitted for this application. The studies have

been evaluated by Ctgb and also summary of the studies is available in this application.

Eight trials in wine grapes in Northern Europe are available. Four trials have been evaluated in the DAR

and four trials are evaluated in this application. Total residues of folpet (sum of folpet and phthalimide,

expressed as folpet) were 0.43-3.5 mg/kg. The intended use in wine grapes is covered by the current EU-

MRL (20 mg/kg).

Six residue trials with folpet in table grapes in Northern Europe are provided, that have been previously

evaluated in EFSA Journal 2013;11(9):3384. Total residues of folpet (sum of folpet and phthalimide,

expressed as folpet) were 0.19 – 0.73 mg/kg. Table grapes are minor crop in Northern Europe, hence six

trials is considered acceptable. The intended use in table grapes is covered by the current EU-MRL of 6

mg/kg.

Based on the submitted study on nature of folpet residues in processing simulation, it was concluded that

folpet is hydrotically unstable. Depending on hydrolysis conditions degradation via phthalimide to

phthalamic acid, phthalic acid and 2-cyanobenzoic acid was observed. One balance and three follow up

studies in grapes have been submitted for this application. Transfer factors for processing into wine, juice

and dry raisins have been calculated.

3.1.4.2 Consumer exposure

A calculation of the Theoretical Maximum Daily Intake (TMDI) was carried out using EFSA PRIMo rev.

2.0, containing all available Member State diets. This calculation was updated with the median residue

values (STMR) derived from the residue trials conducted on the crops under consideration in this

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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

application. This calculation covers the requested use in wine grapes and table grapes. No long term risk

for the consumers has been identified (highest TMDI was 7.4% of the ADI for FR general population).

A calculation of the International Estimated Short Term Intake (IESTI) was carried out using EFSA

PRIMo rev. 2.0, including uses requested within this application. The percentage of the IESTI is 13.6 %

of the ARfD for wine grapes for UK infant and 23.9 % of the ARfD for table grapes for German child.

The risk assessments show that folpet residues from the intended uses in wine grapes and table grapes do

not represent an acute risk to consumers.

Based on the different calculations made to estimate the risk for consumers through diet and other means

it can be concluded that the use of product Solofol does not lead to an unacceptable risk for consumers for

the requested use in wine grapes and table grapes.

3.1.5 Environmental fate and behaviour

The calculations of predicted environmental concentrations in soil, groundwater, surface water, sediment

and air presented in the core assessment were performed in consideration of the risk envelope GAP use

covering all other intended GAP uses for which authorisation is sought in the EU central zone.

A comparison of the GAP uses supported in with the envelope uses of the core assessment is provided in

the Table 3.1.5-01.

Table 3.1.5-01

Critical use patterns of Folpet for each crop supported in the C-EU (flower bulbs only intended for The Netherlands)

Use given in GAP sheet Supported risk envelope for the

C-EU

GAP

use

no.*

Crop Application

method

App. rate per

treatment (g

a.s./ha)

No.

of

app.

Interval

(days)

App. rate per

treatment (g

a.s./ha)

No.

of

app.

Interval

(days)

1 Vine (VITVI,

Vitisvinifera)

Airblast

sprayer; foliar

application

1500 10 7

1500 10 7 4 1500 5 7

6

Flower bulbs

(GLASS,

Gladiolus

spp.)

Bulb dip

1440

1 - 2860 1 -

7 Flower bulbs

(CROSS,

Crocussus

spp.)

1944

8 1960

9

Flower bulbs

(TULSS,

Tulipa spp.)

2600

10

Flower bulbs

(NARSS,

Narcissus

spp.)

2600

11

Flower bulbs

(LILSS,

Lilium spp.)

2800

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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Table 3.1.5-01

Critical use patterns of Folpet for each crop supported in the C-EU (flower bulbs only intended for The Netherlands)

Use given in GAP sheet Supported risk envelope for the

C-EU

GAP

use

no.*

Crop Application

method

App. rate per

treatment (g

a.s./ha)

No.

of

app.

Interval

(days)

App. rate per

treatment (g

a.s./ha)

No.

of

app.

Interval

(days)

12

Flower bulbs

(HYASS,

Hyacinthus

spp.)

2860

13

Flower bulbs

(NNNZJ, all

species)

foliar spray

800+800+1200

+1200+1200

+1200+1200

+1200+1200

+1200

10 7

800+800+1200

+1200+1200

+1200+1200

+1200+1200

+1200

10 7

*: Please refer to GAP table listed in core assessment for the detailed GAP table.

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil)

All PEC calculations in the core dossier have been performed assuming a soil bulk density of 1.5 g/cm³

and an equal distribution of the product in the top 5 cm (spray application) or 10 cm (planting after

dipping). The bulbs are almost completely and equally distributed over the topsoil and they are covered

with 5 cm soil. Therefore a soil layer of 10 cm (5 cm cover soil + 5 cm soil below) is used for PECsoil

calculations. It was assumed that the degradation of the active substance in soil follows a simple first

order kinetic with a worst-case DT50 value of 10 days. In vines grapes (use no. 1) interception rates of

50% for 1st and 2nd application, 60% for 3rd to 10th application were used. No interception needs to be

taken account for calculating PECs for flower bulb in use no. 6 to 12 as method of application was bulb

dip. In use no. 13, interception of 10% for first two applications, and 40% for 3rd to 10th application were

used.

Active Substance

Initial and time weighted PECs values of folpet for application to vines, and flower bulb are provided in

the core dossier. Initial PECs values of 1.324, 1.907, 1.419 and 1.907 mg/kg were obtained for vines,

flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar

application), respectively.

Relevant Metabolites

Phthalimide, phthalic acid and phthalamic acid are major soil metabolites of folpet. These soil metabolites

of folpet appear shortly after application.

Initial and time weighted PECs values of metabolites for application to vines, and flower bulb are

provided in the core dossier.

Initial PECs values of 1.367, 0.615, 1.607 and 1.717 mg/kg were obtained for phthalimide for vines,

flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar

application), respectively.

Initial PECs values of 0.124, 0.179, 0.131 and 0.179 mg/kg were obtained for phthalic acid for vines,

flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar

application) respectively.

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Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Initial PECs values of 0.092, 0.175, 0.088 and 0.175 mg/kg were obtained for phthalamic acid for vines,

flower bulbs (dipping application), flower bulb (foliar application) and flower bulb (dipping + foliar

application) respectively.

Results can be used for the ecotoxicological assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECgw)

PECgw for the active substance folpet and its metabolites were presented in the core assessment (points

IIIA 9.6 to 9.6.1) in consideration of the worst case GAP use that cover all intended uses in the zone.

A conservative transformation scheme, i.e. complete sequential conversion from folpet to Phthalimide to

Phthalamic acid to Phthalic acid and finally to CO2 and non-extractable residues was used for the

leaching assessment.

The FOCUS PEARL Kremsmünster scenario, which is relevant to the conditions in the Netherlands,

shows acceptable PECgw of <0.001 µg/L for all assessed crop simulations (use 1 for vines, use 15 and 16

-separately and combined- for dip and foliar treatment of flower bulbs respectively). .

Thus, use of Solofol is not likely to cause a risk for leaching to groundwater.

Monitoring data groundwater

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

Regarding the presence of metabolites no monitoring data are available.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECsw)

An assessment was carried out to estimate the PECsw after application of Solofol (800 g/kg folpet) to

vines and flower bulbs. The PEC of folpet in surface water (PECsw and PECsed) has been assessed with the

Dutch TOXSWA 1.2 model and Dutch specific drift figures and the DT50 water/sediment values

established in the EU review.

The GAP uses supported in the Netherlands with the envelope uses of the core assessment is provided in

Table 3.5.1. As the Dutch surface water model only accounts for emission via spray drift, no assessment

is done for the flower bulb dip treatment.

The applicant proposed mitigation measures to reduce the level of spray drift for both the use in vines as well as the foliar use in flower bulbs.

The maximum PECsw of 2.568 µg/L and a maximum PECsed of 0.0016 mg/kg were obtained for folpet

after application in vines in the standard spring scenario, thereby assuming a mitigation of Venturi nozzle

(90 % drift reduction) + one sided spraying last three row and reduced air fan setting.

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The maximum PECsw of 2.854 µg/L and a maximum PECsed of 0.0019 mg/kg were obtained for folpet

after application in flower bulbs in the standard spring scenario, thereby assuming a 75% drift reducing

mitigation.

Results can be used for the ecotoxicological assessment.

Monitoring data surface water

Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold

and environmental quality standards.

The active substance folpet was observed in the surface water (most recent data from 2014). Several

locations show an exceedance of the ad hoc MPC threshold. Therefore it is assessed whether there is a

correlation between the observed exceedances and land use types. The correlation analysis as included in

the Pesticide Atlas uses a progressive three-year period to assess whether there is a relation. The last three

available years, in this case 2012-2014 are used to establish the relation.

The observed exceedance of the water quality standard ad hoc MPC threshold is not significantly

correlated to any proposed use.

Therefore, no consequences can be drawn from the observed exceedance.

The surface water metabolite phtalimide (NL translation ftalimide) was observed in the surface water

(most recent data from 2014). As there is no exceedance of thresholds, the monitoring data have no

consequences for the proposed uses of the product.

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).

If for an existing substance based on monitoring data no problems are expected by VEWIN, Ctgb follows

this VEWIN assessment.

If for an existing substance based on monitoring data a potential problem is identified by VEWIN, Ctgb

assesses whether the 90th percentile of the monitoring data meet the drinking water criterion at each

individual drinking water abstraction point.

Folpet has been on the Dutch market for > 3 years (authorised since 12-05-1993). This period is

sufficiently large to consider the market share to be established. 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 are met.

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3.1.5.4 Predicted Environmental Concentration in Air (PECAir)

The behaviour of the active substance and its metabolites in air has been considered in the EFSA

conclusion. It was concluded that volatilisation from freshly treated soils is not a relevant factor for the

transport into the air.

Concentrations of folpet in the air are expected to be negligible, due to its low volatility and short

persistence in the atmosphere.

3.1.6 Ecotoxicology

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the

active substance folpet, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 29.09.2006 (Standing Committee took note of the

change of the ARfD on 11 July 2008) shall be taken into account. In this overall assessment Member

States must pay particular attention to the:

- the protection of birds, mammals, aquatic and soil organisms. Conditions of authorisation should

include risk mitigation measures

These concerns have been addressed within the current submission.

The ecotoxicological properties and risk assessment of the active substance folpet and its main

metabolites were evaluated in this document. The risk assessments were based on exposure values

estimated for the active substance, its metabolites or the formulated product.

The following chapters summarise specific risk assessment for non-target organisms and hence risk

mitigation measures for the authorisation of BCP324F (Solofol, folpet 800WG) according to its intended

use in vines and flower bulbs (only The Netherlands).

Where specific national requirements were not considered or covered in the core assessment and a

national assessment is needed, calculations were done on the basis of the worst-case application scenario

for Solofol in the Netherlands. This concerns the following point(s):

- Effects on aquatic organisms:

The risk assessment for aquatic and sediment-dwelling organisms was performed on the basis of

member state specific PECsw calculations using the modelling program TOXSWA 1.2

- Effects on arthropods other than bees:

The risk assessment for terrestrial non-target arthropods was performed on the basis of member

state specific PERoff-field calculations using national spray drift scenarios

3.1.6.1 Effects on Terrestrial Vertebrates

Effects on birds:

Folpet is of low toxicity to birds in acute and reproduction studies. The main metabolites of folpet in

plants are phthalic acid, phthalamic acid and phthalimide. The risk assessment on folpet is also valid for

these metabolites.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 25 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

The acute toxicity exposure values based on the screening data are above 10, thus indicating a low acute

risk to birds from the proposed uses (since February 2018) of SOLOFOL in Flower bulbs and flower

corms and grape vines.

The risk of birds to be exposed to contaminated drinking water through residual spray liquid from pools

in leaf whorls is considered negligible for the uses in question. However, birds may drink water from

puddles formed on the soil surface after a rainfall event or irrigation follows the application to a crop or

bare soil, and the risk from this exposure must be investigated. The risk assessment shows that the worst

case TER value for the use of SOLOFOL exceeds the trigger level of 10, thus indicating a negligible

acute risk for birds drinking from field puddles formed after the application of SOLOFOL in vineyards

and Flower bulbs and flower corms. The corresponding reproductive TER value exceeds the trigger value

of 5. It is therefore concluded that the reproductive risk is negligible for birds drinking from field puddles.

For the birds a low long-term risk from the use of SOLOFOL in Flower bulbs and flower corms was

found in Tier one. For the use of SOLOFOL in vineyards, a low risk is predicted in tier 1 for small

granivorous and omnivorous birds. The TER value for small insectivorous birds is below 5 and should

require a refined risk assessment. However if rounded to one digit it will be already five and because it is

in the first Tier only a small refinement will be needed and therefore won’t be taken into account but is

reckoned to be save.

Given the low potential for bioaccumulation of folpet in fish in combination with the fast degradation in

the environment, and the very low potential for accumulation in the pharmacokinetic studies in mammals

(EU endpoint list), the risk of secondary poisoning at multiple levels in the terrestrial vertebrate food

chain is very low and further studies are not required.

Effects on Terrestrial Vertebrates Other Than Birds:

Folpet is of low toxicity in acute, short-term and reproduction studies. The main metabolites of folpet in

plants are phthalic acid, phthalamic acid and phthalimide. These metabolites were also found in

metabolism studies in rats and show no risk to accumulate in animal tissues. Hence, the risk assessment

on folpet also takes into account the presence of these metabolites.

The acute toxicity exposure ratio values based on the screening data are below 10, thus triggering the

first-tier risk assessment. Under the first-tier assumptions, the acute TER-values were all above the trigger

value of 10, indicating a low acute risk to mammals from the proposed uses of SOLOFOL in Flower

bulbs and flower corms and grape vines.

The TERLT value based on the screening data is less than five, therefore the first-tier risk assessment was

conducted for long term as well. The TER values for long-term exposure in the first-tier risk assessment

are above the trigger level of five for mammals in the Flower bulbs and flower corms and in the vineyard

scenario except for small herbivorous mammal (BBCH >40)

At the next tier a refinement is applied on DT50, a DT50 of 4.3 in grasses is applied instead of default of

10. As a result the TER value for long-term exposure in the Step 2 risk assessment is above the trigger

level of five indicating acceptable long-term risk to small herbivorous mammals.

The acute and reproductive exposure risk from contaminated drinking water can be limited to scenarios

with field puddles. The worst case TER value for the use of SOLOFOL exceeds the trigger level of 10.

The corresponding reproductive TER value exceeds the trigger value of 5. It is therefore concluded that

the acute and reproductive risk is negligible for mammals drinking from field puddles formed after the

application of SOLOFOL in vineyards and flower bulb fields.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 26 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Given the low toxicity to mammals and the low potential for bioaccumulation of folpet in fish and

earthworms in combination with the fast degradation in the environment, and the very low potential for

accumulation in the pharmacokinetic studies in mammals (EU endpoint list), the risk of secondary

poisoning at multiple levels in the terrestrial vertebrate food chain is very low and further studies are not

required.

3.1.6.2 Effects on Aquatic Species

No acceptable risk is indicated for all GAP uses supported in the Netherlands. The long-term TER for

aquatic invertebrates is considerably below the trigger value of 10, even with drift reduction measures.

Hence, a further refinement of the long-term risk to aquatic invertebrates is required.

Toxicity data on fish, Daphnia and algae indicate that the metabolites which were considered potentially

of concern in aquatic systems show less toxicity compared to the parent folpet. Concurrently, relevant

PECsw values for these metabolites do not exceed the predicted concentrations calculated for the parent

folpet. Thus, either way (from both the toxicity and exposure point of view), it is reasonably concluded

that the risk for aquatic organisms arising from these metabolites is covered by the parent folpet and

consequently, separate TER calculations for this metabolite are not considered to be required.

Core assessment:

For the exposure and risk assessment based on FOCUS SWASH PECsw calculations, the risk envelope

GAP use in vineyards was considered as worst-case application scenario.

An acceptable acute risk for fish is indicated using a species sensitivity distribution refinement. An

acceptable acute risk for fish is indicated at Step-3 for R1 Pond scenario, at Step-4 considering a no spray

zone of 10-m for D6 Ditch, and at Step-4 considering a vegetated filter strip and no spray zone of 10-m

forR3 Stream scenario. For R1, R2 and R4 stream scenario an acceptable acute risk for fish is indicated at

Step-4 considering a vegetated filter strip and no spray zone of 20-m.

An acceptable chronic risk for fish is indicated at Step-3 for R1 Pond scenario, at Step-4 considering a no

spray zone of 10-m for D6 Ditch, and at Step-4 considering a vegetated filter strip of 20-m for R3 Stream,

at Step-4 considering a no spray zone of 20-m for R2 stream scenarios.

For R1 and R4 stream scenario an acceptable acute risk for fish is indicated considering a 2-d PECsw,twa

value at Step-4/20-m vegetated filter strip and no spray zone.

On this account the acute risk for fish is considered acceptable with a 20 m no spray zone for drainage

scenarios and 20 m vegetated filter strip and no spray zone in runoff scenarios at this zonal level

evaluation.

An acceptable acute risk for daphnia is indicated at Step-3 for R1 Pond scenario, at Step-4 considering a

no spray zone of 10-m for D6 Ditch and considering a vegetated filter strip and no spray zone of 10-m R3

Stream scenario and at Step-4 considering a vegetated filter strip and no spray zone of 20-m for R1 and

R2, Stream scenarios.

For R4 stream scenario an unacceptable acute risk for daphnia is indicated at Step-4 considering a

vegetated filter strip and no spray zone of 20-m. However the R4 stream scenario is only relevant for

Hungary and Ireland, while the maximum proposed application rate of BCP324F used in current

assessment is recommended for the Netherlands, Slovenia, Romania, and Slovakia, only. On this account

the acute risk for daphnia is considered acceptable with a 20 m no spray zone for drainage scenarios and

20 m vegetated filter strip and no spray zone in runoff scenarios at this zonal level evaluation.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 27 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Based on an NOEC of 320 µg a.s./L, an acceptable chronic risk for Daphnia is indicated at Step-3, except

for R4 stream with flower bulps. However, it should be noted that the use in flower bulbs is specific for

The Netherlands and only presented here for completeness.

Based on a EC of > 10000 µg a.s./L, an acceptable risk for algae is indicated at Step-1 without the need of

any risk mitigation measures.

NL assessment:

The entry route spray drift was considered to be of potential relevance for loading of surface water and

sediment following spray application of BCP324F. For this route of exposure, the predicted

environmental concentrations in surface water and sediment were calculated using the modelling program

TOXSWA 1.2.

Considering the Tier-1 TER calculations an acceptable risk is indicated for all GAP uses supported in the

Netherlands provided the following restrictions:

• “Om in het water levende organismen te beschermen is de toepassing van het middel in de teelt van

bloembollen en bloemknollen op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan

indien gebruik wordt gemaakt van minimaal 75% drift reducerende spuitdoppen.”

In February 2018, the GAB was revised for the use in Wine grapes (not relevant for NL) as was the use in

flower bulbs (field spray). These revised uses represent a less conservative use pattern compared to the

use pattern assessed in the Fate assessment. Therefore, the fate risk assessment is considered appropriate

for the proposed uses and not altered. In some cases, this revised GAP may lead to less strict mitigation

measures compared to those proposed in the fate core assessment. However in the common practice in the

Netherlands a restriction that is needed is already provided through the activities decree.

Further, the risk arising from bioaccumulation of the active substance folpet is considered to be low.

3.1.6.3 Effects on Bees and Other Arthropod Species

The acute risks to honeybees for the formulated product, expressed as the active substance, were assessed

using the maximum single field use rate and the LD50 values to calculate hazard quotients. All hazard

quotients (HQ) are considerably less than 50, indicating that folpet and Solofol applied at the maximum

use rate in vines poses low risk to bees. As folpet does not pose an unacceptable risk to honey-bees,

further tests were not necessary for larval toxicity, long residual effects, disorienting effects, tunnels tests

were not necessary.

Other Arthropods:

The first level of risk assessment is based on Hazard Quotients (HQ) for two standard species, Aphidius

rhopalosiphi and Typhlodromus pyri. These species are generally the most sensitive tested in laboratory

studies and assessment of risk to these species therefore covers assessment of risk to other species. The

HQ values are all below the trigger value of 2, as recommended by ESCORT 2, indicating no risk to non-

target arthropods within the field.

Further higher tier test data was available and a risk assessment was performed by using a trigger value of

50% effect on lethal or sub-lethal endpoints in extended laboratory studies. For the Tier-2 data available

for non-target arthropods, the endpoints on reproduction were compared to the in-field PER values.

Results were all below the trigger value of 50% indicating no unacceptable effects on reproduction.

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms

Effects on earthworms:

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 28 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

The worst-case TERA values are all above the relevant trigger value of 10 indicating an acceptable acute

risk for earthworms. The TERLT values for flower bulbs (bulb dipping) is below the relevant trigger value

of 5 when using the NOEC derived from study conducted on folpet technical. However, the TERLT values

was above the trigger of 5 when toxicity endpoint (NOAEC = 15.34 mg as/kg soil) is taken from the

study conducted with the formulated product Solofol, indicating an acceptable chronic risk for

earthworms. Therefore, it can be concluded that when folpet is used in the preparation BCP 324 F there

will be low risk to earthworms following the recommended uses of BCP 324 F.

The toxicity of the major soil metabolites phthalimide, phthalic acid and phthalamic acid was not tested

with earthworms but since they are formed rapidly by hydrolysis it is assumed that the metabolites were

present in the tests with folpet and hence the risk is covered by the risk assessment for folpet (EFSA,

2009a).

Effects on other non-target soil macro-organisms:

The DT90 values of folpet under field conditions are far below 365 days (DT50 = 4.3 days). Furthermore,

as there are no unacceptable risks associated with the use of the active substance or the formulated

product to soil macrofauna, non-target arthropods and soil microflora, additional tests on other soil

macro-organisms have not been conducted and no studies are deemed necessary.

3.1.6.5 Effects on organic matter breakdown

The active substance is rapidly dissipated in soil and therefore is not expected to have any significant

effects on organic matter breakdown. Therefore no studies have been conducted and no studies are

deemed necessary.

3.1.6.6 Effects on Soil Non-target Micro-organisms

For the acute toxicity study on soil microflora, reference is made to the non-protected report from 1995

cited in the European dossier under IIA 8.5/01.

The effects of folpet, and its quickly formed main soil metabolites, on the activity of soil-microflora

(nitrogen transformation / soil nitrification /; carbon mineralization / soil respiration, dehydrogenase

activity) were investigated in laboratory studies measuring short-term respiration and nitrification. Since

the formulated product does not contain any co-formulants which give raise to adverse effects on soil

microorganisms, a study with the formulated product is not considered necessary.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and

Fauna)

Toxicity tests on non-target plants have been carried out with Solofol on seven different species: Zea

mays, Lolium perenne, Triticum aestivum, Cucumis sativus, Beta vulgaris, Lycopersicon esculentum, and

Brassica napus. No significant inhibitory effects (exceeding 50 %) on shoot height and biomass

production of overall 7 species could be observed. In consideration of these results, the ER50 of this test

system is determinable at 1600 g a.s./ha that covers the maximum single application rate of 1500 g a.s./ha

intended for the use in vineyard.

The effects of Solofol, a.s. content 78.0%, to vegetative vigour of 3 monocotyledon and 4 dicotyledon

terrestrial plant species were determined in glass house conditions over 21 days. ER50 values have been

calculated using final foliar fresh weight data for each species. No symptoms of visual injury or plant

mortality were recorded in any treatment of any species. ER50 values based on final fresh weights for all

species are greater than the highest rate tested of 3.2 kg a.s./ha.

On this account, an acceptable risk for terrestrial non-target plants exposed to applications of BCP 324 F

is indicated.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 29 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

3.1.7 Efficacy (Part B, Section 7, Point 8):

BCP324F (Solofol) is currently registered in NL for the control of Plasmopara viticola in wine grape. It

concerns a new application in this crop in other member states. For the Netherlands authorisation is now

also sought for table grape (unprotected), and for flower bulbs and flower corms, either by dipping

(Fusarium spp.) or by spraying in the field (Botrytis spp.).

Grape Plasmopara viticola

For the Netherlands, the current use in wine grape against Plasmopara viticola can be reregistered, as it

remains unchanged from the current authorization, and because there have been no relevant resistance

issues. As the use is limited to a spray volume of 1000-1200 liter water per ha, the following sentence is

written on the label:

In de teelt van wijndruif het middel toepassen in 1000 tot 1200 liter water per ha.

The use in table grapes is a new use. For determination of efficacy of Solofol in table grapes in the

Maritime EPPO Zone only 4 trials are available. In the trials disease pressure was sufficient for reliable

assessments. Use of Solofol against Plasmopara viticola in wine grape is currently authorized in the

Netherlands at a dose rate of 1.8 kg/ha.

Unprotected cultivation of table grapes in the Netherlands does not occur according to available

information; cultivars for table grapes are grown under protected conditions in our climate. Therefore the

applicant decided to withdrawn this use for The Netherlands

Flower bulbs and corms, Fusarium spp.

For control of Fusarium spp in flower bulbs, Solofol is claimed as a dip application at a dose rate of

0.5%. For dose justification Solofol was tested in 8 tulip and 3 gladiolus trials at 0.25, 0.5, 1 and 2%. A

clear dose response was not found in most trials. In one gladiolus trial and two tulip trials with a medium

to high infection pressure, a dose response is found. A dose of 1% seems to be the optimum dose rate. But

as the efficacy results between the 0.5% and 1% do not differ that much, a dose 0.5% can be seen as the

minimum effective dose.

For efficacy, based on the results of 9 tulip trials and 3 in gladiolus trials it can be concluded that,

compared to the untreated, bulb treatment with Solofol results in a significant effective control of

Fusarium oxysporum. Level of control is generally comparable to the reference products based on

prochloraz or captan. Extrapolation is possible to Fusarium spp. in all flower bulbs (field grown).

Flower bulbs and corms, Botrytis

For control of Botrytis in flower bulbs and corms, Solofol is claimed as a spray application at a dose rate

of 1.5 kg/ha. However, due to risk to birds at early application (before BBCH 40); Solofol can only be

applied 2 times at a maximum dose rate of 1.0 kg/ha before BBCH 40. After BBCH 40, the proposed

label rate for Solofol is 1.5 kg/ha.

In a total of 9 relevant efficacy trials against Botrytis sp., BCP 324F was tested at dose rates of 1, 1.5 and

2 kg/ha. The trials were conducted in tulip (2), lily (5) and gladiolus (2). Though generally no clear dose

related effect was observed, a tendency towards higher and more prolonged control of Botrytis was

observed in tulip and lily for higher dose rates of Solofol. In these crops the higher rate of 1.5 kg/ha

achieved a more effective control of Botrytis sp. as compared to the rate of 1.0 kg/ha. Higher

effectiveness was observed at a dose rate of 2 kg/ha as compared to the dose rate of 1.5 kg/ha in 2 trials in

lily. The dose rate is found to be sufficiently justified.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 30 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Compared to the reference product, at the claimed dose rate BCF324 performed significantly better than

the mancozeb based product in lily and tulip, but under high disease pressure in gladiolus, somewhat

worse. Overall it compared favourably to the reference.

According to the extrapolation document “Possibilities for extrapolation of efficacy and crop safety of

crop protection products” (CTGB, 2013) extrapolation is possible from Botrytis tulipae in tulip, Botrytis

elliptica in lily and Botrytis gladiolorum in gladiolus to Botrytis spp. in all flower bulbs.

The amount of data presented is low, however efficacy in the trials was good and consistent, only in one

trial (out of four) in tulip efficacy was low. Folpet based products have been on the market for several

decades, also for applications in flower bulbs, based on expert judgement the small data package is found

to be acceptable.

It is concluded the product Solofol sufficiently controls Botrytis sp. in flower bulbs when applied in the

original intended GAP (up to 10 applications of 1.0 to 1.5 kg/ha applied between BBCH 12 and 91).

However, the applicant provided an adjusted GAP during the commenting phase to comply with the risk

envelope for birds and mammals. Compared to the initial GAP, the adjusted GAP is restricted by

reducing the maximum number of applications from 10 to 2 in flower bulbs and flower corn as well as by

restricting the maximal dose rate to 1.0 kg/ha as well as by shortening the application timing period

(which was initial from BBCH 12 to 91 and is now proposed from BBCH 12 to 39).

The proposed restrictions were re-evaluated regarding the efficacy on Botrytis spp. in flower bulbs and

flower corns which led to the conclusion that (single) applications of 1.0 kg/ha BCP324F do give a

sufficient contribution to the control of Botrytis spp. in flower bulbs and flower corns.

However, considering that BCP324 F has a preventative mode of action and that trials were set up to

demonstrate the efficacy of BCP324 F over the complete course of a growing season, it is strongly

assumed that efficacy on Botrytis spp. significantly decreases when BCP324F is applied with the

proposed restrictions. This assumption appears to be a logic consequence due to the fact that no

applications are allowed anymore towards the end of the growth season (after BBCH 39) and due to the

reduced dose rate and number of applications in a single growth season.

As subsequence of the assumed lower efficacy due to the restrictions in the adjusted GAP the following

sentence will be placed on the Dutch label to ensure complete control of Botrytis spp. over the course of a

season.

Yield

Yield was assessed in a total of 28 relevant trials in flower bulbs conducted in the Netherlands in the

period between 2008 and 2013. No adverse effect on the bulb grading was found.

Phytotoxicity

With the exception of some minor phytotoxic symptoms in lily after foliar application, no negative effects

to the crop were observed after application with Solofol. Based on the presented data and the wide

experience with the use of products containing folpet in flower bulbs, it is concluded that Solofol does not

cause unacceptable effects to the crop of flower bulbs and flower corms.

In de teelt van bloembollen en bloemknollen is het maximale aantal toepassingen 2. Dit kan onvoldoende zijn voor een volledige bestrijding van Grauwe schimmel. Het wordt daarom aangeraden het middel af te wisselen met toegelaten middelen op basis van andere actieve stoffen.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 31 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Other adverse effects

The product did not cause significant phytotoxicity. In addition, products based on folpet have already

been authorized for usage in flower bulbs and grapevine for a considerable time all over Europe.

Experience shows that adverse effects on parts of plants used for propagating purposes, succeeding crops

and adjacent crops are not expected.

Resistance management

Folpet is classified by the Fungicide Resistance Action Committee (FRAC) in ‘multi-site contact activity’

mode of action with FRAC code M4 and it belongs therefore to low risk group without any signs of

resistance developing to the fungicides. Some of the claimed pathogens have a high risk for development

of resistance but based on the mode of action of the product, it is concluded that the resistance risk for this

product is found to be acceptable.

3.2 Conclusions

The product Solofol, is a WG solo formulation containing folpet as the active substance at 800 g/kg. Its

planned uses are for vines by foliar spray and for flower bulbs by bulb dipping and foliar spray in The

Netherlands.

For the Netherlands: Based on the data provided an authorization can be granted for flower bulbs by bulb

dipping and for the use in flower bulbs by foliar spray in The Netherlands. The specific risk management

measures outlined should be applied.

3.2 Additional information

None.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 32 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Appendix 1 – Copy of the product authorisation

Product authorization will be inserted after finalization of the RR

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 33 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb May 2018

Appendix 2 – Copy of the product label

Wettelijk Gebruiksvoorschrift

Toegestaan is uitsluitend het professionele gebruik als schimmelbestrijdingsmiddel in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden.

Toepassingsgebied Type toepassing Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per teeltcyclus

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen

Wijndruif (onbedekte teelt)

Gewasbehandeling Valse meeldauw1

1,8 kg/ha 10 7 28

Gladiool (onbedekte teelt)

Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)

1 - -

Krokus (onbedekte teelt)

Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)

1 - -

Iris (onbedekte teelt)

Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)

1 - -

Tulp (onbedekte teelt)

Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)

1 - -

Narcis m.u.v. grofbollige narcis (onbedekte teelt)

Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)

1 - -

Lelie (onbedekte teelt)

Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)

1 - -

Hyacint (onbedekte teelt)

Dompelbehandeling Fusarium2 0,5% (0,5 kg per 100L water)

1 - -

Bloembollen en bloemknollen

Gewasbehandeling Grauwe schimmel3

1,0 kg/ha 2 7 -

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 34 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Toepassingsgebied Type toepassing Te bestrijden organisme

Dosering (middel) per toepassing

Maximaal aantal toepassingen per teeltcyclus

Minimum interval tussen toepassingen in dagen

Veiligheidstermijn in dagen

(onbedekte teelt) 1 Valse meeldauw (Plasmopara viticola) 2 Fusarium (Fusarium spp.) 3 Grauwe schimmel (Botrytis spp.) Toepassingsvoorwaarden In de teelt van wijndruif het middel toepassen in 1000 tot 1200 liter water per ha. Om in het water levende organismen te beschermen is toepassing in de teelt van druiven op percelen die grenzen aan oppervlaktewater uitsluitend toegestaan wanneer in de eerste 20 meter grenzend aan het oppervlaktewater het middel verspoten wordt met een Venturidop met ventilatorstand laag, waarbij de laatste gewasrij éénzijdig in de richting van het perceel bespoten dient te worden, in combinatie met een teeltvrije zone van 4,5 meter (gemeten vanaf het midden van de laatste gewasrij tot aan de insteek van de sloot). Om de zoogdieren te beschermen is toepassing in de teelt van bloembollen en bloemknollen uitsluitend toegestaan voordat een bodembedekking van maximaal 25% is bereikt. In de teelt van bloembollen en bloemknollen is het maximale aantal toepassingen 2. Dit kan onvoldoende zijn voor een volledige bestrijding van Grauwe schimmel. Het wordt daarom aangeraden het middel af te wisselen met toegelaten middelen op basis van andere actieve stoffen.

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Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 35 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Appendix 3 – Letter of Access

• Applicant has provided the ZRMS a letter of access to the protected data / third party data that

was needed for evaluation of the formulation.

Page 36: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 36 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Appendix 4: List of data submitted in support of the evaluation

Annex

point

Year Title

Source (where different from

company)

Company, Report No.

GLP or GEP status (where

relevant)

Published or Unpublished

Data

protection

claimed

Y/N

Studie

relied

on

Y/N

Dataprotection

granted

Y/N

Owner

IIIA,

2.8/01

2014 Physical and Chemical

Properties of BCP324F:

Accelerated Storage Stability

up to 2 weeks at 54°C. Report

nr. OZ/14/001/2

GLP: Y

Unpublished

Y Y Y Belchim

Human Toxicology

No new studies submitted.

Residu

Annex

point

Year

Title

Source (where different

from company)

Company, Report No.

GLP or GEP status (where

relevant)

Published or Unpublished

Data

protection

claimed

Y/N

Studie

relied

on

Y/N

Data protection

granted

Y/N

Owner

IIIA

8.1.1/02 2007a

Frozen Storage Stability of

Residues of folpet in Grapes

RAC and Processing

Fractions

Anadiag, France,

Report No. A7067

GLP

Unpublished

Y Y N

Belchim

Crop

Protection

N.V.

IIIA

8.3.1/01

(& IIIA

8.5.3/01)

2007b

Determination of folpet and

phthalimide residues in

grapes (RAC and processed

fractions) following

treatments with Solofol

under field conditions in

Europe

Anadiag, France

Report No. A7008

GLP

Unpublished

Y Y N

Belchim

Crop

Protection

N.V.

Page 37: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 37 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

point

Year

Title

Source (where different

from company)

Company, Report No.

GLP or GEP status (where

relevant)

Published or Unpublished

Data

protection

claimed

Y/N

Studie

relied

on

Y/N

Data protection

granted

Y/N

Owner

IIIA

8.3.1/02 2009

Determination of folpet and

phthalimide residues in

grapes following treatments

with Solofol under field

conditions in Europe in

2009

Anadiag, France

Report No. A9078

GLP

Unpublished

Y Y N

Belchim

Crop

Protection

N.V.

IIIA

8.3.1/03 2011

Magnitude of residue of

folpet and its metabolite

phthalimide in table grape

raw agricultural commodity

after four applications of

Folpan 80 WDG – 4 decline

curve trials – Germany –

2010. Biotek Agriculture.

Study no.: BPL 10/321/VI

(sponsor no.: R-27558)

Y Y N

ADAMA

Makhteshim

Ltd.

IIIA

8.3.1/04 2012

Magnitude of residue of

folpet and its metabolite

phthalimide in table grape

Raw Agricultural

Commodity after four

applications of FOLPAN 80

WDG – 4 trials (4 HS) –

Northern Europe (Hungary)

- 2011. Biotek Agriculture.

Study no.: BPL 11/334/VI

(sponsor no.: R-27930)

Y Y N

ADAMA

Makhteshim

Ltd.

IIIA

8.5.1/01 2007

[14C]-Folpet: Investigation

of the nature of the potential

residue in the product of

industrial processing or

household preparation

Battelle, UK

Report No. OZ/07/007

GLP

Unpublished

Y Y N

Belchim

Crop

Protection

N.V.

Page 38: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 38 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

point

Year

Title

Source (where different

from company)

Company, Report No.

GLP or GEP status (where

relevant)

Published or Unpublished

Data

protection

claimed

Y/N

Studie

relied

on

Y/N

Data protection

granted

Y/N

Owner

IIIA

8.5.3/02 2010

Determination of folpet and

phthalimide residues in

RAC grapes and processed

fractions (must, young wine

and juice) following

treatments with Solofol in

Europe in 2009

Anadiag, France

Report No. A9139

GLP

Unpublished

Y Y N

Belchim

Crop

Protection

N.V.

Page 39: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 39 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Fate and behaviour

Annex

point

Year Title

Source (where different from

company)

Company, Report No.

GLP or GEP status (where

relevant)

Published or Unpublished

Data

protection

claimed

Y/N

Owner data

protection

granted

y/n’

studies

relied on

y/n’

IIIA

9.6/01

2015 Raw data to Predicted

environmental concentrations in

groundwater (PECgw) for folpet

and its metabolites Using FOCUS

PEARL 4.4.4 AND FOCUS

PELMO 5.5.3

related to the Draft Registration

Report Part B Section 5 of

BCP324F for the Central Zone

Report no. (ReSc-15-0007)

GVK Biosciences Private Limited

Not GLP, unpublished

Y BCP N Y

IIIA

9.7/01

2015 Raw data to Predicted

environmental concentrations in

surface water (PECsw) for folpet

and its metabolites Using FOCUS

models

related to the Draft Registration

Report Part B Section 5 of

BCP324F for the Central Zone

Report no. (ReSc-15-0008)

GVK Biosciences Private Limited

Not GLP, unpublished

Y BCP N Y

Page 40: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 40 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Efficacy

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1.3

IIIA1

6.2.1

2012

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg

WG), and BCP330F

(cymoxanil+folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in European

grapevine. Central

zone. 2011.

Martin

Feldversuc

hswesen

F11-

VITVI-03-

DE01

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.3

IIIA1

6.2.1

2012

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg

WG), and BCP330F

(cymoxanil+folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in European

grapevine. Central

zone. 2011.

Martin

Feldversuc

hswesen

F11-

VITVI-03-

DE02

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2012

Evaluation of the

efficacy of BCP324F

(Folpet, 800 g ai/kg,

WG), and BCP330F

(Cymoxanil+Folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in European

grapevine. Central

zone. 2012.

Martin

Feldversuc

hswesen

F12-

VITVI-04-

DE01

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2013

Determination of the

efficacy of BCP324F

and BCP330F on

Plasmopara viticola

in European

grapevine, 1 Site in

Germany 2012

Eurofins

Agroscienc

e Services

GmbH

F12-

VITVI-04-

DE02

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2014

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg,

WG) on Plasmopara

viticola in European

grapevine (moving

moderl). Central zone

(Maritime EPPO

zone). 2013

Martin

Feldversuc

hswesen

F13-

VITVI-

06A-DE01

Y Y Y

Belchim

Crop

Protectio

n NV

Page 41: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 41 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2014

Determination of the

efficacy of BCP324F

on Plasmopara

viticola in European

grapevine,

1 Site in Germany

2013

Eurofins

Agroscienc

e Services

GmbH

F13-

VITVI0-

6A-DE02

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.3

IIIA1

6.2.1

2013

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg

WG), and BCP330F

(cymoxanil+folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in European

grapevine. Central

zone. 2 trials in Czech

Republic, 2012

Eurofins

Agroscienc

e Services

F12-

VITVI-

04A-CZ01

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.3

IIIA1

6.2.1

2013

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg

WG), and BCP330F

(cymoxanil+folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in European

grapevine. Central

zone. 2 trials in Czech

Republic, 2012

Eurofins

Agroscienc

e Services

F12-

VITVI-

04A-CZ02

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.3

IIIA1

6.2.1

2014

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg

WG) on Plasmopara

viticola in European

grapevine

ATC –

Agro Trial

Center

GmbH

F13-

VITVI-

06A-CZ01

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.2.1 2012

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg

WG), and BCP330F

(cymoxanil+folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in European

grapevine. Central

zone. 2012

Governmen

t Office of

Baranya

County

F12-

VITVI-04-

A-HU01

Y Y Y

Belchim

Crop

Protectio

n NV

Page 42: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 42 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2012

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg

WG), and BCP330F

(cymoxanil+folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in European

grapevine. Central

zone. 2012

SynTech

Research

Hungary

F12-

VITVI-04-

A-HU02

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2008

Efficacy of stand

alone Cymoxanil

dose rates against

downy mildew on

vines (artificial

contamination and

misting)

Field

Research

Support

FRS05208 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2009

Evaluation of the

efficacy and

selectivity of

BCP324F at different

dose rates on

Plasmopara viticola

in grapevines.

Martin

Feldversuc

hswesen

F09VITVI

04GE01 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2008

Efficacy of

Cymoxanil and

Folpet against downy

mildew on vines

ANADIAG

APA

EU08107A

L1 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2008

Efficacy of

Cymoxanil and

Folpet against downy

mildew on vines

ANADIAG

APA

EU08107.

SO8HGF.J

G65

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2013

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg,

WG) on Plasmopara

viticola in European

grapevine (fixed

model). Central zone

(South-East EPPO

zone). 2013

Governmen

t Office of

county

Komárom-

Esztergom

F13-

VITVI-

19A-HU01

Y Y Y

Belchim

Crop

Protectio

n NV

Page 43: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 43 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2013

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg,

WG) on Plasmopara

viticola in European

grapevine (fixed

model). Central zone

(South-East EPPO

zone). 2013

SynTech

Research

Hungary

F13-

VITVI-

19A-HU02

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2013

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg,

WG) on Plasmopara

viticola in European

grapevine (fixed

model). Central zone

(South-East EPPO

zone). 2013

GEMERPR

ODUKT

VALICE

OVD

F13-

VITVI-

20A-SK01

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2014

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg,

WG) on Plasmopara

viticola in European

grapevine (fixed

model). Central zone

(South-East EPPO

zone), 2013

Eurofins

Agroscienc

e Services

SRL

F13-

VITVI-

19A-RO01

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2014

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg,

WG) on Plasmopara

viticola in European

grapevine (fixed

model). Central zone

(South-East EPPO

zone), 2013

Eurofins

Agroscienc

e Services

SRL

F13-

VITVI-

19A-RO02

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.3

IIIA1

6.2.1

2014

Registration.

Evaluation of the

efficacy of BCP324F

(folpet, 800 g/l, WP)

and BCP362FC

(folpet 250 g/l, PO3

375 g/l, SC) on

Plasmopara viticola

in European

grapevine. Moving

model based on leaf

wall area. Maritime

EPPO zone, 2014.

Belchim

Crop

Protection

NV

F14VITVI-

06A-DE01 Y Y Y

Belchim

Crop

Protectio

n NV

Page 44: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 44 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1.3

IIIA1

6.2.1

2014

Registration.

Evaluation of the

efficacy of BCP324F

(folpet, 800 g/l, WP)

and BCP362FC

(folpet 250 g/l, PO3

375 g/l, SC) on

Plasmopara viticola

in European

grapevine. Moving

model based on leaf

wall area. Maritime

EPPO zone, 2014.

Eurofins

Agroscienc

e Services

GmbH

F14VITVI-

06A-DE02 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.2

IIIA1

6.1.3

IIIA1

6.2.1

2014

Registration.

Evaluation of the

efficacy of BCP324F

(folpet, 800 g ai/kg,

WG) and BCP330F

(cymoxanil+folpet,

40+334 g ai/kg, WG)

on Plasmopara

viticola in european

grapevine (fixed

model). South-East

EPPO zone. 2014.

Governmen

t Office of

Heves

County,

Plant

protection

and soil

conservatio

n

directorate

F14VITVI

09A-HU01 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.4.2 2008

Non intentional effect

on four Belchim

fungicides on wines

processing and

quality of wines

ANADIAG

APA

EU08109A

L1 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.4.2 2008

Non intentional effect

on four Belchim

fungicides on wines

processing and

quality of wines

ANADIAG

APA

EU08109D

R1 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.4.2 2013

Evaluation of efficacy

of different

formulations applied

at different timings on

wine making in

Grapevine. France

2012

SGS Agri

Min

12 REG F

BE AN

002

Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1.4.2 2013

Evaluation of efficacy

of different

formulations applied

at different timings on

wine making in

Grapevine in France

2012

SGS Agri

Min

12 WHG F

BE RS 003 Y Y Y

Belchim

Crop

Protectio

n NV

IIIA1

6.1

IIIA1

6.2

2008 Vuurbestrijdig tulp Innoventis 2008 I

Tulip Y Y Y

Belchim

Crop

Protectio

n NV

Page 45: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 45 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1

IIIA1

6.2

2009 Vuurbestrijdig tulp Innoventis 2009 I

tulip Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2010 Disinfection of flower

bulbs (tulip)

Proeftuin

Zwaagdijk 10024 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2010 Disinfection of flower

bulbs (tulip)

Proeftuin

Zwaagdijk 10025 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2010 Disinfection of flower

bulbs in gladiolus

Proeftuin

Zwaagdijk 10182 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2010

Control of Botrytis

gladiolorum in

gladiolus

Proeftuin

Zwaagdijk 10200 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2010

Control of Botrytis

gladiolorum in

gladiolus

Proeftuin

Zwaagdijk 10201 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2010

Control of Botrytis

gladiolorum in

gladiolus

Proeftuin

Zwaagdijk 10180 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2010

Control of Botrytis

gladiolorum in

gladiolus

Proeftuin

Zwaagdijk 10181 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs (tulip)

Proeftuin

Zwaagdijk 11011 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs (tulip)

Proeftuin

Zwaagdijk 11012 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs (tulip)

Proeftuin

Zwaagdijk 11013 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs (tulip)

Proeftuin

Zwaagdijk 11014 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs (lilium)

Proeftuin

Zwaagdijk 11174 Y Y Y

Belchim

Crop

Protectio

n NV

Page 46: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 46 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs (lilium)

Proeftuin

Zwaagdijk 11175 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs in gladiolus

Proeftuin

Zwaagdijk 11202 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Disinfection of flower

bulbs in gladiolus

Proeftuin

Zwaagdijk 11203 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Control of Botrytis

tulipae in tulip

Proeftuin

Zwaagdijk 11015 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Control of Botrytis

tulipae in tulip

Proeftuin

Zwaagdijk 11016 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Control of Botrytis

tulipae in tulip

Proeftuin

Zwaagdijk 11017 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Control of Botrytis

tulipae in tulip

Proeftuin

Zwaagdijk 11018 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Control of Botrytis

elliptica in Lilium

Proeftuin

Zwaagdijk 11176 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2011 Control of Botrytis

elliptica in Lilium

Proeftuin

Zwaagdijk 11177 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2012 Control of Botrytis

elliptica in Lilium

Proeftuin

Zwaagdijk 12168 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2013 Disinfection of flower

bulbs in Tulip

Proeftuin

Zwaagdijk 13052 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2013 Control of Botrytis

tulipae in Tulip

Proeftuin

Zwaagdijk 13061 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2013 Control of Botrytis

elliptica in Lilium

Proeftuin

Zwaagdijk 13168 Y Y Y

Belchim

Crop

Protectio

n NV

Page 47: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 47 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

Point

Report

Date Title Source

Company

Report

No.

Studies

relied

on

Y/N

Data

protection

claimed

Y/N

Data

protection

granted

Y/N

Owner

IIIA1

6.1

IIIA1

6.2

2013 Control of Botrytis

elliptica in Lilium

Proeftuin

Zwaagdijk 13181 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2015

Efficacy of Solofol

and BCP345F in bulb

dipping tulip

Proeftuin

Zwaagdijk 150025 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2015

Efficacy of Solofol

and BCP345F in bulb

dipping tulip

Proeftuin

Zwaagdijk 150026 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2016

Efficacy of Solofol,

BCP345F, Monarch

and BCP352F in bulb

dipping tulip

Proeftuin

Zwaagdijk 160049 Y Y Y

Belchim

Crop

Protectio

n NV IIIA1

6.1

IIIA1

6.2

2016

Efficacy of Solofol,

BCP345F, Monarch

and BCP352F in bulb

dipping tulip

Proeftuin

Zwaagdijk 160050 Y Y Y

Belchim

Crop

Protectio

n NV

Page 48: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 48 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Ecotox

Annex

point

Year Title

Source (where different from company)

Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Data

Protection

Claimed

Owner data

protection

granted

y/n

studies

relied on

y/n

IIIA

10.1.2 1989

Nahrungsökologie und Raumnutzung einer

subalpinen Population des Hänflings

(Carduelis cannabina) [Feeding ecology

and habitat use in a subalpine population

of linnets].

Der Ornithologische Beobachter 86, pp.

291-305.

GLP not relevant, published.

No Public n y

IIIA

10.1.2 2011

Landscape-moderated biodiversity effects

of agri-environmental management: a

meta-analysis

Proc Biol Sci. Jun 22, 2011; 278(1713):

1894–1902

GLP not relevant, published.

No Public n y

IIIA

10.2.2.1/01 2007a

Acute Toxicity of Folpet 80 WG to

Rainbow Trout (Oncorhynchus mykiss) in

a 96-hour semi-static Test

IBACON GmbH, Germany

Report No33891230, GLP, unpublished.

Yes Sapec

Belchim y y

IIIA

10.2.2.2/01 2007b

Acute toxicity of Folpet 80 WG to

Daphnia magna in a Semi-static 48-hour

Immobilization Test.

IBACON GmbH, Germany

Report No 33892220, GLP, unpublished.

Yes Sapec

Belchim y y

IIIA

10.3.3/01 2010

Small Mammal focal species in vineyards

in southern Europe.

RifCon, Germany

Report No RA-10023, GLP not relevant,

unpublished.

Yes Sapec

Belchim y y

IIIA

10.3.3/02 2011

Determination of initial residues and residue

decline of folpet after one application of Folpet

80 WG in pasture at 3 sites in Northern and Southern Europe 2011 ; Eurofins GmbH report

S11-01405 ; GLP, unpublished;

Yes Sapec

Belchim y y

IIIA

10.4.2/01 2007

Effects of Folpet 80 WG (Acute Contact

and Oral) on Honey Bees (Apis mellifera

L.) in the Laboratory.

IBACON GmbH, Germany

Report No33893035, GLP, unpublished.

Yes Sapec,

Belchim y y

IIIA

10.5.1/01 2007a

Effects of Folpet 80 WG on the Predatory

Mite Typhlodromus pyri in the Laboratory

- Dose Response

IBACON GmbH, Germany

Test. Report No33895063, GLP,

unpublished.

Yes Sapec,

Belchim y y

IIIA

10.5.2/01 2007b

Effects of Folpet 80 WG on the Parasitoid

Aphidius rhopalosiphi, Extended

Laboratory Study - Aged Residue Test.

IBACON GmbH, Germany

Report No 33899003, GLP, unpublished.

Yes Sapec,

Belchim y y

IIIA

10.5.2/02 2007c

Effects of Folpet 80 WG on the Lacewing

Chrysoperla carnea, Extended Laboratory

Study - Dose Response Test.

IBACON GmbH, Germany

Report No33898047, GLP, unpublished.

Yes Sapec,

Belchim y y

Page 49: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 49 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018

Annex

point

Year Title

Source (where different from company)

Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Data

Protection

Claimed

Owner data

protection

granted

y/n

studies

relied on

y/n

IIIA

10.5.2/03 2007d

Effects of Folpet 80 WG on the Ladybird

Beetle Coccinella septempunctata,

Extended Laboratory Study - Dose

Response Test.

IBACON GmbH, Germany

Report No33897012, GLP, unpublished.

Yes Sapec,

Belchim y y

IIIA

10.6.2/01 2009

Acute Toxicity (14 days) of Folpet 80 WG

to the Earthworm Eisenia fetida in

Artificial Soil with 5% Peat.

IBACON GmbH, Germany

Report No51141021, GLP, unpublished.

Yes Sapec

Belchim y y

IIIA

10.6.3/01 2014

Effects of BCP324F on Reproduction and

Growth of Earthworms Eisenia fetida in

Artificial Soil with 5% Peat.

IBACON GmbH, Germany; unpublished

report

Yes Belchim y y

IIIA

10.8/01 2009a

Evaluation of the Phytotoxicity of Folpet

80% WG - Non Target Terrestrial Plant

Vegetative Vigor Test.

Agrochemex Ltd. UK

Report No ACE-08-260, GLP,

unpublished.

Yes Sapec

Belchim y y

IIIA

10.8/02 2009b

Evaluation of the Phytotoxicity of Folpet

80% WG - Non Target Terrestrial Plant

Seedling Emergence and Growth Test.

Agrochemex Ltd., UK

Report No ACE-08-259, GLP,

unpublished.

Yes Sapec

Belchim y y

IIIA

10.10.1/01 2007c

Influence of Folpet technical to Daphnia

magna in a Reproduction Test,

IBACON GmbH, Germany

Report No 33881221, GLP, unpublished

Yes Sapec

Belchim y y

Page 50: HET COLLEGE VOOR DE TOELATING VAN ......Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend

Part A National Assessment Country – The Netherlands

BCP324F Registration Report – Central Zone Page 50 of 50

Applicant Belchim Crop Protection NV/SA Evaluator – NL, Ctgb Date:May 2018