Toelatingsnummer 13507 N

NEU 1280 M  

 

13507 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 WEDERZIJDSE ERKENNING

 

Gelet op de aanvraag d.d. 7 oktober 2010 (20100949 WERG) van

 

W. NEUDORFF GMBH KG

AN DER MUHLE 3

31860 EMMERTHAL

DUITSLAND

 

tot verkrijging van een wederzijdse erkenning van de toelating in Denemarken van het middel op basis van de werkzame stof ijzer(III)fosfaat,

 

NEU 1280 M

 

gelet op artikel 36, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Toelating

1.                Het middel NEU 1280 M is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 13507 N met ingang van datum dezes. Voor de gronden van dit besluit wordt verwezen naar bijlage II bij dit besluit.

2.                De toelating geldt tot 31 december 2015.

 

1.2  Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

 

1.3  Gebruik

Het middel mag slechts worden gebruikt met inachtneming van hetgeen in bijlage I onder A bij dit besluit is voorgeschreven.

 


1.4 Classificatie en etikettering

 

Gelet op artikel 29, eerste lid, sub d, Wet gewasbeschermingsmiddelen en biociden,

 

 

 

 

1)                De aanduidingen, welke ingevolge artikelen 9.2.3.1 en 9.2.3.2 van de Wet milieubeheer en artikelen 14, 15a, 15b, 15c en 15e van de Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten op de verpakking moeten worden vermeld, worden hierbij vastgesteld als volgt:

 

aard van het preparaat: Lokmiddel in korrelvorm

 

werkzame stof:

gehalte:

ijzer(III)fosfaat

2,97 %

 

letterlijk en zonder enige aanvulling:

 

andere zeer giftige, giftige, bijtende of schadelijke stof(fen):  

-

 

gevaarsymbool:

aanduiding:

 

 

Specifieke vermeldingen:

 

DPD01            -Volg de gebruiksaanwijzing om gevaar voor mens en milieu te voorkomen.

 

2)                Behalve de onder 1. bedoelde en de overige bij de Wet Milieugevaarlijke Stoffen en Nadere regels verpakking en aanduiding milieugevaarlijke stoffen en preparaten voorge­schreven aanduidingen en vermeldingen moeten op de verpakking voorkomen:

 

a.      letterlijk en zonder enige aanvulling:
het wettelijk gebruiksvoorschrift
De tekst van het wettelijk gebruiksvoorschrift is opgenomen in Bijlage I, onder A.

 

b.      Hetzij letterlijk, hetzij naar zakelijke inhoud:
de gebruiksaanwijzing
De tekst van de gebruiksaanwijzing is opgenomen in Bijlage I, onder B.
De tekst mag worden aangevuld met technische aanwijzingen voor een goede bestrijding mits deze niet met die tekst in strijd zijn
.

 

 - 

 

2 DETAILS VAN DE AANVRAAG

 

Het betreft een aanvraag tot verkrijging van een toelating van het middel NEU 1280 M
(13507 N), een middel op basis van de werkzame stof ijzer(III)fosfaat. Het middel wordt aangevraagd  als gewasbeschermingsmiddel voor professioneel gebruik ter bestrijding van naaktslakken.

 

 

 

 

2.2 Informatie met betrekking tot de stof

Er zijn in Nederland reeds andere middelen op basis van de werkzame stof ijzer(III)fosfaat toegelaten.

 

De werkzame stof ijzer(III)fosfaat is een nieuwe werkzame stof, geplaatst op Annex I van gewasbeschermingsrichtlijn 91/414/EG per 1 november 2001 (2001/87/EG).

 

De stof is goedgekeurd krachtens Verordening (EG) No 1107/2009

(Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011, No. 22).

 

2.3 Karakterisering van het middel

NEU 1280 M is een middel op basis van de werkzame stof ijzer(III)fosfaat. De componenten van de werkzame stof zijn ijzer en fosfaat, die van nature voorkomen in de bodem.

 

De korrels zijn attractief voor naaktslakken. De werkzame stof ijzer(III)fosfaat werkt op de maag; na opname van de korrels stoppen de slakken met het vreten van gewassen. De vraatstop gaat niet gepaard met een sterke slijmvorming. De slakken trekken zich terug in hun schuilplaats en gaan na korte tijd dood.

 

2.4 Voorgeschiedenis

De aanvraag is op 22 oktober 2010 ontvangen; op 17 december 2010 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 26 april 2011 is de aanvraag in behandeling genomen.

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is de Handleiding toelating bestrijdingsmiddelen (HTB) versie 1.0.

 

3.1  Inleiding

De onderhavige aanvraag betreft een verzoek tot wederzijdse erkenning van de toelating in Denemarken van het gewasbeschermingsmiddel Derrex. Gezien de aard van de wederzijdse erkenning wordt ervan uitgegaan dat de beoordeling door Denemarken is uitgevoerd conform de Uniforme Beginselen (annex VI bij richtlijn 91/414/EEG).

 

Voor de beoordeling van de aspecten fysische en chemische eigenschappen, analysemethoden, werkzaamheid en delen van de aspecten risico voor de mens en risico voor het milieu refereert het Ctgb aan het toelatingsbesluit in Denemarken. Op een aantal hieronder weergegeven voor de Nederlandse situatie specifieke punten, toetst het Ctgb zelf inhoudelijk.

 

3.2  Risico voor de mens

De volgende aspecten worden nationaal ingevuld:

·          Arbeidsomstandigheden - nationale modellen en arbeidshygiënische strategie

·          Volksgezondheid - de criteria voor residuen in volggewassen

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen directe of indirecte schadelijke uitwerking heeft op de gezondheid van de mens. De beoordeling van het risico voor de toepasser staat beschreven in Hoofdstuk 4 Mammalian Toxicology, van Bijlage II bij dit besluit.

De beoordeling van het risico voor de volksgezondheid met betrekking tot residuen in volggewassen staat beschreven in Hoofdstuk 5, Residues van bijlage II behorende bij dit besluit.

 

3.3  Risico voor het milieu

De volgende aspecten worden nationaal ingevuld:

·          90–percentiel – de bodem, het grondwater, het oppervlaktewater en het sediment, en innamepunten van drinkwater uit oppervlaktewater

·          Uitspoeling naar grondwater

·          Persistentie – MTR

·          Waterorganismen, vogels, zoogdieren, niet-doelwitplanten, niet-doelwitarthropoden en oppervlaktewater bestemd voor de bereiding van drinkwater – drift

·          RWZI

Het middel voldoet aan de voorwaarde dat het, rekening houdend met alle normale omstandigheden waaronder het middel kan worden gebruikt en de gevolgen van het gebruik, geen voor het milieu onaanvaardbaar effect heeft, waarbij in het bijzonder rekening wordt gehouden met de volgende aspecten:

-          de plaats waar het middel in het milieu terechtkomt en wordt verspreid, met name voor wat betreft besmetting van het water, waaronder drinkwater en grondwater,

-          de gevolgen voor niet-doelsoorten.

(artikel 28, eerste lid, sub b, onderdeel 4 en 5, Wet gewasbeschermingsmiddelen en biociden).

De beoordeling van het risico voor het milieu staat beschreven in Hoofdstuk 6, Environmental Fate and Behaviour, en Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

 

3.4  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel
NEU 1280 M op basis van de werkzame stof ijzer(III)fosfaat voldoende werkzaam en heeft het geen schadelijke uitwerking op de gezondheid van de mens en het milieu (artikel 28, Wet gewasbeschermingsmiddelen en biociden).

 

 

 

Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 119, eerste lid, Wet gewasbeschermingsmiddelen en biociden en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 217, 6700 AE WAGENINGEN. Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.

 

 

Wageningen, 7 oktober 2011

 

 

HET COLLEGE VOOR DE TOELATING VAN  GEWASBESCHERMINGSMIDDELEN EN  BIOCIDEN,





dr. D. K. J. Tommel

voorzitter

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE I bij het besluit d.d. 7 oktober 2011 tot toelating van het middel NEU 1280 M, toelatingnummer 13507 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Algemeen

 

NEU 1280 M is een middel op basis van de werkzame stof ferri fosfaat (ijzer(III)fosfaat) voor toepassing in open lucht en onder glas. De korrels zijn attractief voor naaktslakken. Onmiddellijk na opname van de korrels stoppen de slakken met vreten. De optredende vraatstop gaat niet gepaard met een sterke slijmvorming. De slakken trekken zich terug in hun schuilplaats en gaan na korte tijd dood. In gewassen waarbij de slakken zich continu op het gewas bevinden kunnen slakkenkorrels onvoldoende werken en is een vroegtijdige behandeling nodig.

 

Dit middel is uitsluitend bestemd voor professioneel gebruik

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

 

NEU 1280 M is een middel op basis van de werkzame stof ferri fosfaat (ijzer(III)fosfaat) voor toepassing in open lucht en onder glas. De korrels zijn attractief voor naaktslakken. Onmiddellijk na opname van de korrels stoppen de slakken met vreten. De optredende vraatstop gaat niet gepaard met een sterke slijmvorming. De slakken trekken zich terug in hun schuilplaats en gaan na korte tijd dood. In gewassen waarbij de slakken zich continu op het gewas bevinden kunnen slakkenkorrels onvoldoende werken en is een vroegtijdige behandeling nodig.

Toepassingen

 

Ter bestrijding van naaktslakken.

Een behandeling uitvoeren zodra slakken of slakkenvraat worden waargenomen. Het middel bij voorkeur uitstrooien in de avonduren met de hand of een granulaatstrooier/kunstmest-strooier.

De behandeling herhalen als alle korrels zijn weggevreten én er nog steeds slakken worden waargenomen.

Dosering: 7 kg middel per ha of 0.7 gram middel per m².



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II RISKMANAGEMENT bij het besluit d.d. 7 oktober 2011 tot toelating van het middel NEU 1280 M, toelatingnummer 13507 N

 

 

BIJLAGE II   RISKMANAGEMENT

 

 

 

Contents

                                                                                                                                              Page

1.    Identity of the plant protection product 3

2.    Physical and chemical properties. 4

3.    Methods of analysis. 4

4.    Mammalian toxicology. 4

5.    Residues. 7

6.    Environmental fate and behaviour. 7

7.    Ecotoxicology. 13

8.    Efficacy. 18

9.    Conclusion. 18

10.  Classification and labelling. 19

Appendix 1      Table of authorised uses. 1

Appendix 2      Reference list 1

 


1.                  Identity of the plant protection product

 

1.1       Applicant

Neudorff

An der Mühle 3

31860 Emmertal

 

1.2       Identity of the active substance

Common name

Ferric phosphate

Name in Dutch

IJzer(III)fosfaat

Chemical name

Ferric phosphate

CAS no

10045-86-0

EC no

233-149-7

 

The active substance was included on November, 1st 2001 in Annex I of Directive 91/414/EEC.

 

1.3       Identity of the plant protection product

Name

NEU 1280 M

Formulation type

GB, Granulair Bait

Content active substance

29.7 g/kg pure active substance

 

For the assessment of the formulation and its proposed use we refer to the member state of the original authorisation (Denmark) .

 

1.4       Function

Molluscicide.

 

1.5       Uses applied for

See GAP (Appendix I).

 

1.6       Background to the application

It concerns an application for mutual recognition, based on the authorisation for Derrex in Denmark (Nr 364-39).

 

1.7       Packaging details

Material:

FFS-PE hose, white pigmented and plain

Capacity:

5, 10, 20  and 25 kg

Type of closure and size of opening:

welded, width is 365 mm with a side gusset of 120 mm

Other information

-

 

1.7.2    Detailed instructions for safe disposal

See MSDS (no particular recommendations).

 

 


2.                  Physical and chemical properties

 

For the assessment of the physical and chemical properties of NEU 1280 we refer to the member state of the original authorisation (Denmark).

 

 

3.                  Methods of analysis

 

For the assessment of the methods of analysis required for NEU 1280 we refer to the member state of the original authorisation (Denmark).

 

3.4       Physical-chemical classification and labelling

 

Proposal for the classification and labelling of the formulation concerning physical chemical properties

 

Professional use

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

S phrases

-

-

Special provisions:
DPD-phrases

-

-

Child-resistant fastening obligatory?

not applicable.

Tactile warning of danger obligatory?

not applicable

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

Proposed shelf life of the formulation: 2 years (shelf life study to be submitted)

 

 

4.                  Mammalian toxicology

 

 

4.1       Toxicity of the formulated product (IIIA 7.1)

For the evaluation of the toxicity of the formulated product NEU 1280 M, we refer to the member state of the original authorisation (Denmark).

 

4.2       Dermal absorption (IIIA 7.3)

Denmark concluded that dermal absorption is insignificant.

 

(“No studies have been carried out on dermal absorption, since dermal absorption can be excluded due to the low solubility of ferric phosphate in water as well as in lipids. This is acceptable, since it is deemed that the dermal absorption of ferric phosphate is insignificant“).

 

Since this application is a request for mutual recognition this conclusion is also applicable for this risk assessment.

 

4.3       Available toxicological data relating to non-active substances (IIIA 7.4)

For toxicological data relating to non-active substances we refer to the registration report written by Denmark.

 

4.4       Exposure/risk assessments (Dutch specific aspect)

 

Overview of the intended uses

An application (request for mutual recognition) has been submitted for the authorisation of the plant protection product NEU 1280 M, a molluscicide based on the active substance ferric phosphate.

 

NEU 1280M is a Granular Bait (GB) ready to use formulation and contains 29,7 g/Kg ferric phosphate.

 

The formulation NEU 1280M is applied by manual or mechanical downward spreading. The formulation is applied 1-4 times during the pest infestation period January to December with a maximum dose of 0.21 kg as/ ha.

 

4.4.1    Operator exposure/risk

As the formulation consists of solid, non-dust forming granules which are hardly soluble in water and fats, no relevant dermal absorption to ferric phosphate and inhalatory risk are expected. Taking into account the low toxicity of ferric phosphate, no risk is expected for the unprotected operator.

 

This is in line with the Danish risk assessment.

 

 (“As the granulate does not dust, the Danish Environmental Protection Agency assesses, however, that there is no significant exposure during distribution, and that the application therefore can be accepted”).

 

4.4.2    Bystander exposure/risk

The bystander exposure is only a fraction of the operator exposure. As no risk is expected for the operator, no exposure risk is expected for the bystander.

 

4.4.3    Worker exposure/risk

Not applicable.

 

4.4.4    Re-entry

See 4.4.3 Worker exposure/risk.

 

Overall conclusion of the exposure/risk assessments  of operator, bystander, and worker

The product complies with the Uniform Principles.

 

Operator exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected operator after dermal and respiratory exposure ferric phosphate as a result of the application of NEU 1280M in edible and non edible crops.

 

Bystander exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected bystander due to exposure to ferric phosphate during application of NEU 1280M  in edible and non edible crops.

 

Worker exposure

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the unprotected worker after dermal and respiratory exposure during re-entry activities in edible and non edible crops due to exposure to ferric phosphate after application of NEU 1280M.

 

4.5       Appropriate mammalian toxicology and operator exposure end-points relating to
the product and approved uses

See List of Endpoints.

 

4.6       Data requirements

Based on this evaluation, no additional data requirements are identified.

 

4.7       Combination toxicology

NEU 1280M contains only one active substance and it is not described that it should be used in combination with other formulations.

 

4.8       Mammalian toxicology classification and labelling

 

Proposal for the classification and labelling of the formulation concerning health (Dutch specific aspect)

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 labelling of the preparation is proposed:

 

Professional users

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

-

-

 

 

 

Special provisions:
DPD-phrases

-

-

Plant protection products phrase:
DPD-phrase

DPD01

To avoid risk for man and the environment, comply with the instructions for use

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 


5.                  Residues

 

For the aspect ‘Residues’, and risk for consumers we refer to the member state of the original authorisation (Denmark), except for the sub aspect ‘residues in succeeding crops’.

 

5.1       Summary of residue data

 

5.1.6    Residues in succeeding crops (Dutch specific aspect)

No relevant (toxic) residues of iron or phosphate are to be expected in plants after soil application of ferric phosphate. In addition, iron and particularly phosphate are used as fertilizers. Therefore, additional relevant residues from the application of iron phosphate for the control of slugs will not occur in succeeding crops.

 

Conclusion

Based on the assessment for residues, no risk for the consumer due to the exposure to ferric phosphate is currently expected.

 

5.2.1        Data requirements

None

 

 

6.                  Environmental fate and behaviour

 

The underlying risk assessment is based on the final List of Endpoints for ferric phosphate and on the Danish authorisation for Derrex. For the Dutch specific aspects data from previous assessment is used:

 

The new active substance ferric phosphate is listed on Annex I of Guideline 91/414/EC since 1st November 2001 (Commission Directive 2001/87/EC of 12 October 2001). The LoEP dates 15th May 2001.

 

List of Endpoints Fate/behaviour 

 

Fate and behaviour in the environment

 

Fate and behaviour in soil

Definition of the Residues

 

Residues relevant to the environment

None.

 

Route of degradation

 

Aerobic:

 

Mineralization after 100 days:

Not applicable.

Non-extractable residues after 100 days:

Not applicable.

Relevant metabolites above 10 % of applied active substance: name and/or code
% of applied rate (range and maximum)

Not applicable.

 

 

Supplemental studies

 

Anaerobic:

Not applicable.

 

 

Soil photolysis:

Not applicable.

 

 

Remarks:

None.

 

Rate of degradation

 

Laboratory studies

 

DT50lab (20 °C, aerobic):

Not applicable.

DT90lab (20 °C, aerobic):

Not applicable.

DT50lab (10 °C, aerobic):

Not applicable.

DT50lab (20 °C, anaerobic):

Not applicable.

 

 

Field studies (country or region)

 

DT50f from soil dissipation studies:

Not applicable.

DT90f from soil dissipation studies:

Not applicable.

Soil accumulation studies:

Not applicable.

Soil residue studies:

Not applicable.

 

 

Remarks:

e.g. effect of soil pH on degradation rate

None.

 


Adsorption/desorption

 

Kf / Koc:

Kd

pH dependence:

Not applicable.

 

 

Mobility

 

Laboratory studies:

 

Column leaching:

Not applicable.

Aged residue leaching:

Not applicable.

 

 

Field studies:

 

Lysimeter/Field leaching studies:

Not applicable.

 

 

Remarks:

None.

 

Fate and behaviour in water

Abiotic degradation

 

Hydrolytic degradation:

Not applicable.

Relevant metabolites:

Not applicable.

Photolytic degradation:

Not applicable.

Relevant metabolites:

Not applicable.

 

 

Biological degradation

 

Readily biodegradable:

Not applicable.

Water/sediment study:

DT50 water:
DT90 water:
DT50 whole system:
DT90 whole system:

Distribution in water / sediment systems
(active substance)

Distribution in water / sediment systems
(metabolites)

Not applicable.

Accumulation in water and/or sediment:

Not applicable.

 

 

 

Degradation in the saturated zone

Not applicable.

 

 

Remarks:

None.

 

Fate and behaviour in air

Volatility

 

Vapour pressure:

Non-volatile.

Henry's law constant:

Not applicable.

 

 

Photolytic degradation

 

Direct photolysis in air:

Not applicable.

Photochemical oxidative degradation in air

DT50:

Not applicable.

Volatilisation:

Not applicable.

 

 

Remarks:

None.

 


6.1       Fate and behaviour in soil

 

6.1.1    Persistence in soil (Dutch specific aspect)

The higher tier risk assessment on persistence in soil is a Dutch national specific aspect. For the current application for mutual recognition this means that if for the evaluation of the product a higher tier risk assessment is necessary for persistence, the Danish risk assessment cannot be used for mutual recognition and a national risk assessment has to be performed.

 

Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion persistence. If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPC-INS[1] method. Currently this method equals the method described in the Technical Guidance Document (TGD). Additional guidance is presented in RIVM[2]-report 601782001/2007[3].

 

For the current application this means the following:

 

Active substance ferric phosphate

There are no  DT50 values available for ferric phosphate. As it is a stable non-volatile inorganic compound no biological degradation occurs. It dissociates in soil into iron(III) and phosphate ions, which both occur naturally in soil. Iron is present in soil a large variety of minerals. In aerobic soils iron is mostly present as Fe(III)oxides (e.g. goethite, haematite, ferrihydrite) Examples of ferric phosphates present in soil are strengite and vivianite). The bio-availability  of iron in soil is determined by pH, redox potential and the presence of complexating agents. Uptake of iron by plants occurs as Fe(II). The most important source of phosphate in soil is the mineral apatite. In soil there are several mechanisms to immobilise phosphate. Adsorption to inorganic compounds, precipitation as Ca-,Al- and Fe-phosphates and chemical binding to the humic fraction.

 

Background concentrations

Iron is present in all soils, being a constituent of several (clay) minerals such as chlorites, smectites, vermiculites, tourmaline, and staurolite. Other forms of soil iron include iron oxides and – hydroxides (Fe2O3; Fe-OOH), iron sulphides (FeS2, pyrite; FeS; Fe3S4) and iron phosphates (Fe3(PO4)28H2O; Fe(PO4)2H2O). Iron concentrations in soil are about 0.2 ‑ 5% dw. Additionally, iron and, in particular, phosphate are applied in considerable amounts to agricultural soils in fertilisers.

 

Concentrations of iron in subsoil and topsoil in the Netherlands are presented by Van der Veer (2006), based on 358 sample locations all over the country. For a range of different soil types, median levels of iron range from 0.24 – 2.70% dw (2400 – 27000 mg/kg) in topsoils at 0-20 cm depth and from 0.16 to 3.39% dw (1600 – 33900 mg/kg) in subsoils. Individual measurements range from <0.001 to 6.37% dw in topsoils (<10 – 63700 mg/kg) and from 0.002 to 9.05% dw in subsoils (20 – 90500 mg/kg). Highest concentrations occur in peat and clay soils, lowest levels are found in sandy soils.

 

In a study into background concentrations of metals in the Netherlands, median iron levels of 8882 and 6765 mg/kg dw were determined for topsoil (0-10 cm) and subsoil (0.5-1.0 m), respectively. Maximum levels are 28811 and 27866 mg/kg dw, respectively, 90th percentiles 22864 and 20137 mg/kg dw.

 

It should be noted that in both studies, all kinds of locations were sampled, including arable land and grassland, and forest and nature areas. The definition of “natural background” in terms of the choice of land use types to be included in the dataset is at present under discussion.

 

Risk assessment

A comparison between the natural abundance and the amount added by application of NEU 1280M is given below:

Iron and phosphate ions naturally occur in soil in concentrations ranging between 0.2 – 5% for ‘Fe’ and 0.01 – 0.2% for ‘P’. These amounts are 500 to 500,000 times higher than the amounts added by the application of NEU 1280M. Therefore the addition to the background levels is considered acceptable and no accumulation as a result of the application of NEU 1280M is expected. In this way, the standards for persistence as laid down in the RGB are met.

 

PECsoil

Regarding the fact that the addition to the background levels of iron an phosphate as a result of the application of NEU 1280M is negligible, no PECsoil is calculated. The exposure assessment can be done based on the background levels.

 

These exposure concentrations are examined against ecotoxicological threshold values in section 7.5.2.

 

6.1.2    Leaching to shallow groundwater (Dutch specific aspect)

Leaching to shallow ground water is a Dutch specific aspect. For the current application for mutual recognition this means that the Danish risk assessment for leaching to ground water cannot be used for mutual recognition and a national risk assessment has to be performed.

 

Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater. No specific data on the leaching potential of ferric phosphate have been provided. Regarding the fact that the active substance is practically insoluble in water and the fact that both iron and phosphate ions are abundant in soil in concentrations far higher than those resulting from the application of NEU 1280M, no risk of leaching of ferric phosphate is expected as a result of the application of NEU 1280M.

 

Monitoring data

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

 

Conclusions

The proposed application of the product comply with the requirements laid down in the RGB concerning persistence in soil and leaching to groundwater.

 

6.2       Fate and behaviour in water

 

6.2.1    Rate and route of degradation in surface water (Dutch specific aspect)

Since the Netherlands has its own national drift values, the exposure concentrations of the active substance ferric phosphate in surface water have been estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percen­tage depends on the use.

The exposure concentrations of the active substance ferric phosphate in surface water have not been estimated for the various proposed uses due to the application (granulate no drift expected), because it is assumed that for this application technique there is no exposure of surface water.

 


Monitoring data

The Pesticide Atlas on internet (www.pesticidesatlas.nl, www.bestrijdingsmiddelenatlas.nl) is used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the observed concentrations exceed threshold values. Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters. In the Pesticide Atlas, these monitoring data are processed into a graphic format accessible on-line and aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards. Recently, the new version 2.0 was released. This new version of the Pesticide Atlas does not contain the land use correlation analysis needed to draw relevant conclusions for the authorisation procedure. Instead a link to the land use analysis performed in version 1.0 is made, in which the analysis is made on the basis of data aggregation based on grid cells of either 5 x 5 km or 1 x 1 km.

 

Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation threshold and the MPC (ad-hoc or according to INS) threshold. For examination against the drinking water criterion, another database (VEWIN) is used, since the drinking water criterion is only examined at drinking water abstraction points. For the assessment of the proposed applications regarding the drinking water criterion, see next section.

 

There are no data available regarding the presence of the substance ferric phosphate in surface water. Phosphate is naturally occurring in surface waters. Besides that there is a large anthropogenic contribution with the application of fertilizers as the major source. Measured concentrations range from 0.2 – 0.8 mg/L (CIW/CUWVO Landelijke Watersysteemrapportage 1996). Iron is also a naturally occurring substance in surface water. For instance, RIWA measured a concentration of 0.24 – 1.6 mg/L in Rhine water at Lobith (RIWA Jaarrapport 2008).

 

Drinking water criterion (Dutch specific aspect)

Assessment of the drinking water criterion is a Dutch specific aspect.

 

It follows from the decision of the Court of Appeal on Trade and Industry of 19 August 2005 (Awb 04/37 (General Administrative Law Act)) that when considering an application, the Ctgb should, on the basis of the scientific and technical knowledge and taking into account the data submitted with the application, also judge the application according to the drinking water criterion ‘surface water intended for drinking water production’. The assessment methodology followed is developed by the WG implementation drinking water criterion and outlined in Alterra report 1635[4].

 

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 preregistration calculation is performed.

-          For existing substances, the assessment is based on monitoring data of VEWIN (drinking water board).

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

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

 

Ferric phosphate has been on the Dutch market for > 3 years (authorised since 15/08/1991). 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 as laid down in the RGB are met.

 

Conclusion drinking water criterion

All proposed applications of the product NEU 1280M comply with the RGB.

 

6.3       Fate and behaviour in air

 

Route and rate of degradation in air

Assessment of fate and behaviour in air is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Denmark).

 

6.4       Appropriate fate and behaviour end-points relating to the product and approved uses

See List of End-points.

 

6.5       Data requirements

None

 

The following restriction sentences were proposed by the applicant:

None

 

Based on the current assessment, the following has to be stated in the GAP/legal instructions for use:

None

 

6.6       Overall conclusions fate and behaviour

It can be concluded that:

1.      the active substance ferric phosphate meets the standards for per­sis­tence in soil as laid down in the RGB.

2.      the proposed application of the active substance ferric phosphate meets the standards for leaching to the shallow groundwater as laid down in the RGB.

3.      the proposed application of the product comply with the RGB with regard to the standards for surface water destined for the production of drinking water.

 

 

7.                  Ecotoxicology

 

For the current application of mutual recognition of NEU 1280 M, risk assessment is done in accordance with Chapter 2 of the RGB.

 

The underlying risk assessment is based on the final list of endpoints for ferric phosphate (15 May 2001; from final review report presented at ec.europa.eu/food/plant/protection/evaluation/newactive/list1-05_en.pdf) and on the Danish authorisation for the product Derrex.

 


List of Endpoints Ecotoxicology

 

Terrestrial Vertebrates

Acute toxicity to mammals:

LD50 >5000 mg/kg bw (formulation Ferramol Schneckenkorn)

Acute toxicity to birds:

LD50 >2000 mg/kg bw (formulation Ferramol Schneckenkorn)

Dietary toxicity to birds:

No data provided.
Not required.

Reproductive toxicity to birds:

No data provided.
Not required.

Short term oral toxicity to mammals:

52 mg FePO4 per day (18 month, children)

 

Aquatic Organisms

Acute toxicity fish:

LC50 >100 mg/L, NOEC > 100 mg/L (96 h; Oncorhynchus mykiss)

Long term toxicity fish:

Not required.

Bioaccumulation fish:

Not relevant.

Acute toxicity invertebrate:

EC50 > 100 mg/L, NOEC > 100 mg/L (48 h; Daphnia magna)

Chronic toxicity invertebrate:

Not required.

Acute toxicity algae:

EC50>100 mg/L, NOEC > 100 mg/L (72 h; Scenedesmus subspicatus)

Chronic toxicity sediment dwelling organism:

Not required.

 

Honeybees

Acute oral toxicity:

Not required.

Acute contact toxicity:

Not required.

 

Other arthropod species

Test species

% Effect

Aphidius rhopalosiphi

0 % mortality, 52.2 % parasitisation
[adults; 1 kg as/ha; Ferramol Schneckenkorn (10 g as/kg)]

Typhlodromus pyri

6.6 % mortality, 0 % fertility
[life cycle; 1 kg as/ha; Ferramol Schneckenkorn (10 g as/kg)]

Aleochara bilineata

5.5 % parasitisation
[life cycle; 1 kg as/ha; Ferramol Schneckenkorn (10 g as/kg)]

Poecilus cupreus

3.3 % mortality, 16.25 % food uptake
[adults; 1 kg as/ha; Ferramol Schneckenkorn (10 g as/kg)]

 

Earthworms

Acute toxicity:

LC50 > 10 mg as/kg soil

LC50 > 1000 mg Ferramol Schneckenkorn/kg soil

Reproductive toxicity:

NOEC reproduction Eisenia fetida 5 g/m2 Ferramol Schneckenkorn

NOEC weight Lumbricus terrestris 50 g/m2 Ferramol Schneckenkorn

 

Soil micro-organisms

Nitrogen mineralisation:

Not required.

Carbon mineralisation:

Not required.

 

7.1              Effects on birds (Dutch specific aspect)

The risk assessment for birds from exposure via sprayed natural food and secondary poisoning via earthworms is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorisation (Denmark).

 

The risk assessment for birds via surface water (drinking water and secondary poisoning via fish) is a Dutch specific aspect, since surface water concentrations are calculated based on national drift values. However, for this application technique it is assumed that there is no exposure of surface water. Therefore, the risk via drinking water and secondary poisoning is acceptable.

 

Conclusions birds

The application for mutual recognition of the product complies with the RGB for exposure of birds via surface water and secondary poisoning.

 

7.2       Effects on aquatic organisms (Dutch specific aspect)

Since the Netherlands have their own national drift values, the exposure concentrations in surface water are normally based on these drift values (see PECsw in section 6.2). However, for this application technique it is assumed that there is no exposure of surface water. Therefore, the risk to aquatic and sediment organisms and for bioconcentration is acceptable.

 

Conclusions aquatic organisms

The proposed applications meet the standards for aquatic organisms.

 

7.3       Effects on terrestrial vertebrates other than birds (Dutch specific aspect)

The risk assessment for mammals via natural food and secondary poisoning via earthworms is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorisation (Denmark).

 

The risk assessment for mammals via surface water (drinking water and secondary poisoning via fish) is a Dutch specific aspect, since surface water concentrations are calculated based on national drift values. However, for this application technique it is assumed that there is no exposure of surface water. Therefore, the risk via drinking water and secondary poisoning is acceptable.

 

Conclusions mammals

The application for mutual recognition of the product complies with the RGB for exposure of mammals via surface water and secondary poisoning.

 

 

7.4       Effects on bees

The risk assessment for bees is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Denmark).

 

7.5       Effects on any other organisms (see annex IIIA 10.5-10.8)

 

7.5.1    Effects on non-target arthropods (Dutch specific aspect)

In-field

The in-field risk assessment for non-target arthropods in accordance with ESCORT2 is not based on drift values and is therefore not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorisation (Denmark).

 

Off-field (Dutch specific aspect)

For the off-field risk assessment on non-target arthropods in accordance with ESCORT2, drift values are used to estimate the off-crop risk for the two standard species A. rhopalosiphi and T. pyri. Since the Netherlands have their own national drift values, the off-field risk assessment is a national specific aspect.

 

However, the product is applied as a granule only in the in-field area. Therefore no exposure off-field is to be expected. Since there is no exposure, the standards for non-target arthropods as laid down in the RGB are met. 

 

7.5.2    Earthworms

The risk assessment for earthworms is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Denmark).

 

7.5.3    Effects on soil micro-organisms

The risk assessment for soil micro-organisms is not a Dutch specific aspect. For the risk assessment we refer to the member state of the original authorization (Denmark).

 

7.5.4    Effects on activated sludge (Dutch specific aspect)

The risk assessment for activated sludge is a Dutch specific aspect. However, for the proposed uses no exposure of activated sludge is expected. Therefore, the proposed applications comply with the standards for activated sludge as laid down in the RGB.

 

7.5.5    Effects on non target-plants (Dutch specific aspect)

According to the Terrestrial guidance document (Sanco/10329/2002) spray drift is considered to be the key exposure route for non-target plants in the off-field area. Since the Netherlands have their own national drift values, the risk assessment for non-target plants is a national specific aspect. However, the product is applied as a granule only in the in-field area. Therefore no exposure off-field is to be expected. Since there is no exposure, the standards for non-target plants as laid down in the RGB are met. 

 

Conclusions any other organisms

The proposed application of the product complies with the RGB for the aspects activated sludge, non-target arthropods (off-field) and terrestrial non-target plants.

 

 

7.6       Appropriate ecotoxicological end-points relating to the product and approved uses

See List of End-points.

 

7.7       Data requirements

-

 

7.8       Classification and Labelling

 

Proposal for the classification and labelling of the formulation concerning the environment (Dutch specific aspect)

Based on the profile of the substance, the provided toxicology of the preparation and the  characteristics of the co-formulants, the following labeling of the preparation is proposed:

 

Symbol:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

-

-

 

-

-

Special provisions
(DPD-phrases) :

-

-

 

 

 

 

 

 

Based on the current assessment, the following has to be stated in the legal instructions for use:

-

 

7.9       Overall conclusions regarding the environment

It can be concluded that:

1.      for the risk assessment for birds via natural food and secondary poisoning via earthworms, Ctgb refers to the member state of the original authorisation (Denmark).

2.      all proposed applications of the active substance ferric phosphate meet the standards for birds (exposure via surface water; secondary poisoning via fish) as laid down in the RGB.

3.      all proposed applications of the active substance ferric phosphate meet the standards for aquatic organisms as laid down in the RGB.

4.      the active substance ferric phosphate meets the standards for bioconcentration as laid down in the RGB.

5.      for the risk assessment for mammals via natural food and secondary poisoning via earthworms, Ctgb refers to the member state of the original authorisation (Denmark)

6.      all proposed applications of the active substance ferric phosphate meet the standards for mammals (exposure via surface water; secondary poisoning via fish) as laid down in the RGB.

7.      for the risk assessment for bees, Ctgb refers to the member state of the original authorisation (Denmark).

8.      for the risk assessment for non-target arthropods in-field, Ctgb refers to the member state of the original authorisation (Denmark).

9.      all proposed applications of the active substance ferric phosphate meet the standards for non-target arthropods (off-field) as laid down in the RGB.

10.  for the risk assessment for earthworms, Ctgb refers to the member state of the original authorisation (Denmark).

11.  for the risk assessment for soil micro-organisms, Ctgb refers to the member state of the original authorisation (Denmark)

12.  all proposed applications of the active substance ferric phosphate meet the standards for activated sludge as laid down in the RGB.

13.  all proposed applications of the active substance ferric phosphate meet the standards for non-target plants as laid down in the RGB

 

 


8.                  Efficacy

 

The product is authorised in Denmark for the use in agriculture and horticulture, in the cultivation of vegetables and ornamental plants, outdoors and in greenhouses. Climatological and environmental circumstances relevant for the aspect efficacy in the claimed uses in The Netherlands are comparable to those in Denmark. The cultivation method in claimed uses is similar in both countries and there are no country-specific situations for the use of NEU 1280 as a product for the control of pest slugs.

 

8.1       Efficacy evaluation

For the evaluation of the aspect ‘Efficacy’ we refer to the evaluation of the member state of the original authorisation (Denmark).

 

8.2       Harmful effects

For the evaluation of the aspect ‘Harmful effects’ we refer to the evaluation of the member state of the original authorisation (Denmark).

 

8.3       Resistance

For the evaluation of the aspect ‘Resistance’ we refer to the evaluation of the member state of the original authorisation (Denmark).

 

 

8.4       For vertebrate control agents: impact on target vertebrates

Because no vertebrates are controlled, this point is not relevant.

 

8.5       Any other relevant data / information

None.

 

 

9.                  Conclusion

 

The authorisation of the product is based on mutual recognition of the authorisation in Denmark of the product  Derrex. For the evaluation is referred to the original authorisation, as Denmark has adopted the Uniform Principles.

 

The evaluation of the Dutch specific aspects is in accordance with the Uniform Principles laid down in appendix VI of Directive 91/414/EEC. The evaluation has been carried out on basis of a dossier that meets the criteria of appendix III of the Directive. 

 

The product is considered to comply with the Uniform Principles. 

 

 


10.             Classification and labelling

 

Proposal for the classification and labelling of the formulation

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 assessments, the following labelling of the preparation is proposed:

 

Substances, present in the formulation, which should be mentioned on the label by their chemical name (other very toxic, toxic, corrosive or harmful substances):

-

Symbol:

-

Indication of danger:

-

R phrases

-

-

 

 

 

S phrases

-

-

 

 

 

Special provisions:
DPD-phrases

-

-

Plant protection products phrase:
DPD-phrase

DPD01

To avoid risk for man and the environment, comply with the instructions for use

Child-resistant fastening obligatory?

n/a

Tactile warning of danger obligatory?

n/a


Appendix 1  Table of authorised uses

 

Ferric phosphate

 

Appendix 2    Reference list

-

 

 



[1] INS: international and national quality standards for substances in the Netherlands.

[2] RIVM: National institute of public health and the environment.

[3] 601782001/2007: P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision 2007’.

[4] Adriaanse et al. (2008). Development of an assessment methodology to evaluate agricultural use ofplant

protection products for drinking water production from surface waters - A proposal for the registration procedure

in the Netherlands. Alterra-Report 1635