Toelatingsnummer 13316 N

Sluxx  

 

13316 N

 

 

 

 

 

 

 

 

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

1 WEDERZIJDSE ERKENNING

 

Gelet op de aanvraag d.d. 9 oktober 2008 (20080837 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,

 

Sluxx

 

gelet op artikel 36, Wet gewasbeschermingsmiddelen en biociden,

 

BESLUIT HET COLLEGE als volgt:

 

1.1  Toelating

1.      Het middel Sluxx is toegelaten voor de in bijlage I genoemde toepassingen onder nummer 13316 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 oktober 2011.

 

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

29,7 g/kg

 

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.

 

  1. 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:

 

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

 

  1. 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 wederzijdse erkenning van een toelating in Denemarken. In Denemarken is het middel onder de naam Ferrox toegelaten; in Nederland wordt een aanvraag ingediend onder de naam Sluxx (13316 N) Sluxx is een middel op basis van de werkzame stof ijzer(III)fosfaat. Het middel wordt aangevraagd als gewasbeschermingsmiddel voor professioneel gebruik ter bestrijding van naaktslakken.

 

2.1 Informatie met betrekking tot de stof

De werkzame stof ijzer(III)fosfaat is per 1-11-2001 geplaatst op Annex I van gewasbeschermingsrichtlijn 91/414/EEG.

 

2.2 Karakterisering van het middel

Sluxx 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.

 

In Nederland zijn middelen op basis van ijzer(III)fosfaat zowel voor particulier als voor professioneel gebruik toegelaten voor de bestrijding van naaktslakken (zie o.a. Smart Bayt).

 

2.3 Voorgeschiedenis

In Denemarken is Ferrox, waarnaar Sluxx verwijst, sinds 28 januari 2008 toegelaten (Reg-No.364-33). De aanvraag is op 10 oktober 2008 ontvangen; op 15 december 2008 zijn de verschuldigde aanvraagkosten ontvangen. Bij brief d.d. 2 december 2009 is de aanvraag in behandeling genomen.

 

 

3  RISICOBEOORDELINGEN

Het gebruikte toetsingskader voor de beoordeling van deze aanvraag is weergegeven in de RGB (Hoofdstuk 2); te weten de werkinstructies RGB (voor toxicologie en milieu) en in de Regeling houdende nadere regels omtrent gewasbeschermingsmiddelen en biociden (RGB) aangeduide (delen van de) toepasselijke versie van de HTB ( in dit geval versie 1.0)

 

3.1    Inleiding

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 voor de Nederlandse situatie specifieke aspecten toetst het Ctgb zelf.

 

De aanvraag betreft een verzoek tot wederzijdse erkenning van de toelating in Denemarken van het gewasbeschermingsmiddel Sluxx. 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).

 

3.2  Risico voor de mens

De volgende aspecten worden nationaal getoetst:

·          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 – 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 in Hoofdstuk 7, Ecotoxicology, in Bijlage II bij dit besluit.

 

3.4  Eindconclusie

Bij gebruik volgens het Wettelijk Gebruiksvoorschrift/Gebruiksaanwijzing is het middel Sluxx 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, 2 april 2010

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. 2 april 2010 tot toelating van het middel Sluxx, toelatingnummer 13316 N

 

 

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

 

Toegestaan is uitsluitend het gebruik als middel ter bestrijding van naaktslakken.

 

Dit middel is uitsluitend bestemd voor professioneel gebruik.

 

B.

GEBRUIKSAANWIJZING

 

Algemeen

 

Sluxx is een middel op basis van de werkzame stof ijzer(III)fosfaat. 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.

 

De ondergronds, verborgen levende slakken (zoals de kielslak) worden niet bestreden. Schade aan een aardappelgewas tengevolge van deze kielslak wordt niet voorkomen.

 

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 (bij herbehandeling een minimum interval van 7 dagen aanhouden).

Dosering: 7 kg/ha of 0,7 gram per m².

 

 



HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

 

BIJLAGE II RISKMANAGEMENT

bij het besluit d.d. 2 april 2010 tot toelating van het middel Sluxx, toelatingnummer 13316 N

 

 

Contents                                                                  Page

 

 

1.   Identity of the plant protection product        2

 

2.   Physical and chemical properties                  2

 

3.   Methods of analysis                                         3

 

4.   Mammalian toxicology                                      3

 

5.   Residues                                                            6

 

6.   Environmental fate and behaviour                6

 

7.   Ecotoxicology                                                    14

 

8.   Efficacy                                                               19

 

9.   Conclusion                                                        20

 

10. Classification and labelling                             20

 


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 in Annex I of Directive 91/414/EEC on 1 November 2001.

 

1.3       Identity of the plant protection product

Name

Sluxx

Formulation type

GB, Granulair Bait

Content active substance

29.7 g/kg pure active substance

 

1.4       Function

Molluscicide

 

1.5       Uses applied for

See GAP-table (Appendix 1)

 

1.6              Background to the application

It concerns an application for mutual recognition, based on an authorisation in Denmark (Ferrox, Reg.No 364-33). Ctgb evaluated the Dutch specific aspects only.

 

1.7       Packaging details

 

1.7.1    Packaging description

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 application form and MSDS (no particular recommendations)

 

 

2.                 Physical and chemical properties

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

 

3.4       Physical-chemical classification and labelling

 

Proposal for the classification of the ferric phosphate (symbols and R phrases)
(EU classification) concerning physical chemical properties

 

Symbol(s):

-

Indication(s) of danger: -

 

Risk phrase(s)

-

-

 

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

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?

n.a.

Tactile warning of danger obligatory?

n.a.

 

Explanation:

Hazard symbol:

-

Risk phrases:

-

Safety phrases:

-

Other:

-

 

4.                 Mammalian toxicology

 

4.1       Toxicity of the formulated product (IIIA 7.1)

For the evaluation of the toxicity of the formulated product Sluxx, 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 (III) phosphate in water as well as in lipids. This is acceptable, since it is deemed that the dermal absorption of ferric (III) 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 the evaluation of the toxicity of the formulated product Sluxx, we refer to the member state of the original authorisation (Denmark).

 


4.4       Exposure/risk assessments (Dutch specific aspect)

 

Overview of the intended uses

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

 

The formulation NEU 1181M is applied by manual or mechanical downward spreading. The formulation is applied 1-4 times during the pest infestation period March-November with a maximum dose of 7 kg formulation / 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 to ferric phosphate as a result of the application of Sluxx 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 Sluxx 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 Sluxx.

 


4.5       Appropriate mammalian toxicology and operator exposure endpoints 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

Sluxx 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 of the active ingredient (symbols and R phrases)
(EU classification)

 

Symbol:

-

Indication of danger: -

 

Risk phrases

-

-

 

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 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.

 

5.2       Maximum Residue Levels

Ferric phosphate is included in Annex IV to Regulation 396/2005 (regulation 149/2008), which lists active substances for which no maximum residue levels (MRLs) are required. No MRLs are necessary.

 

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 Ferrox. For the Dutch specific aspects is elaborated upon a previous assessment (unprotected data).

 

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

 

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 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 phosphate 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.

 

MPCsoil

Within the context of the authorisation of the molluscicide Sluxx, with ferric phosphate as active substance, Ctgb has to address the potential risks for the soil ecosystem resulting from long-term exposure to iron. Since iron does not degradate, an MPC should be derived, however, recognising the specific nature of iron, being an essential micro-nutrient, Ctgb requested to explore the possibility to derive a Maximum Permissible Addition (MPA) for iron, and to consider background concentrations of iron and levels of essentiality.

 

In RIVM report 11753a00 the possibility to derive an MPA for soil for ferric phosphate was explored. Parts of this report are included below, but data to which the applicant has no access are deleted. Since the conclusion is based on mainly public literature and background concentrations, the conclusion on the MPC is the same.

 

 


Data sources

 

Ecotoxicity data

For the derivation of the MPA for iron, data from the EU-assessment of ferric phosphate were used. Additionally, an on-line literature search was performed via SCOPUS, available via http://www.scopus.com/ and TOXLINE. Because iron is such a common element, and essential for the functioning of organisms, the search profile that is normally used for MPC-derivation resulted in too many hits. It was therefore decided to narrow down the search and focus specifically on soil organisms commonly used for ecotoxicity experiments, i.e. earthworms, nematodes, enchytraeids, springtails and plants. In addition, information on iron deficiency and/or toxicity to plants was retrieved from the internet by using Google with the search strings “iron deficiency plants”, “iron toxicity plants” and “iron tolerance plants”.

 

Human toxicology

 

Human toxicological threshold limits and carcinogenicity

No risk phrases are assigned to iron or ferric phosphate with respect to human toxicology. An ADI is not available. For iron, the DAR gives a provisional maximum TDI of 0.8 mg/kg bw.

 

Ecotoxicological effect data for iron

 

Earthworms

Fischer and Molnár (1997) studied the effect of FeCl3 on Eisenia fetida in a peaty soil/manure mixture. Effects on reproduction were found at an exposure level of 180 mM/kg. From the description, it is not clear whether this should be read as 180 mmol/kg (equivalent to 10000 mg Fe/kg), or that a 180 mmol/L solution was added to the soil. It should further be noted that the authors conclude that the effect on reproduction is most likely due to the elevated salinity rather than to toxicity of iron. This is supported by the fact that for a range of other chloride salts effects were found at similar molarities.

 

Langan and Shaw (2006) observed that growth and activity of juvenile Lumbricus terrestris was decreased upon surface application of Sluggo® pellets (1% iron phosphate) in an artificial burrow system. At an exposure rate of165 pellets/m2, significantly less apple leaves and pellets were removed from the surface during the exposure period of 33 days as compared to the treatment with control pellets, and body weight gain was lower than in the control. It is considered likely that this effect is mainly due to direct toxicity of the slug pellets to earthworms after ingestion, rather than to a long-term effect of iron itself. In this way, the result may be considered to assess the potential risks of Sluxx for earthworms, but not for the derivation of an MPA for iron.

 

Several literature references were retrieved that deal with the effects of metals on earthworms. These studies, however, focus on heavy metal polluted sites, in which iron is present as part of a mixture of other metals such as cadmium, zinc, lead and copper.

Abdul Rida (1996) studied the effects of metal contaminated soils on the earthworm Lumbricus terrestris. Total iron content of the soils was between 28495 and 47518 mg/kg, other metals present were cadmium (1.6-32.3 mg/kg), copper (61-150 mg/kg), lead (52-1419 mg/kg) and zinc (85-1296 mg/kg). No correlation was found between iron content and biomass or relative weight gain, while significant correlations were present for cadmium, zinc and lead.

Nahmani et al. (2007) concluded that other factors earthworm life cycle parameters may be impacted by several metals in combination with soil characteristics. They did not found a correlation between iron content of the soils or soil solution and cocoon production of Eisenia fetida. Soil iron content showed a (weak) correlation with body weight (r2 0.48). There was a linear correlation between internal iron concentrations and earthworm survival and cocoon production, but regression coefficients were low (r2 0.35 and 0.48).

In a study on the abundance of earthworms along heavy metal pollution gradients in Finland, Lukkari et al. (2004) did not find a significant correlation between total or soil extractable iron content and earthworm biomass and abundance. Significant correlations were observed for copper, lead and zinc.

 

Plants

The majority of information on effects of iron on plants is related to deficiency rather than to toxicity. Because iron is normally found in abundant quantities in most soils, low iron availability or mobility due to environmental and soil conditions rather than a low iron content in the soil is most often the cause of iron deficiency problems in plants.

Iron deficiency is associated with a.o. high soil pH, free calcium carbonate and low organic matter. High levels of P, NO3-N, Zn, Mo and/or Mn may inhibit Fe-uptake. Some of the crop species that are susceptible to iron-deficiency are alfalfa, barley, beans (white), beets, broccoli, Brussels sprouts, cabbage, cauliflower, celery, grass, oats, rye, spinach, strawberry, and tomato.

 

The interaction with other trace elements may also result in iron toxicity. Some iron-rich, low pH, low manganese soils create an environment in which an interaction between the iron and manganese in the soil reduces manganese uptake by plants. The symptoms observed on the plants are of manganese deficiency, but the low plant uptake of manganese is caused by excessive available iron in the soil. Zinc deficiency can also lead to increased uptake of iron, to the point of toxicity.

 

There is some information on direct toxicity of iron to plants. Rice is one of the crop species for which iron toxicity is extensively described. Optimum levels for rice are reported as 100-150 mg/kg, toxicity may occur at levels >300-500 mg/kg. Critical levels of iron in solution vary widely, reported values range from 10 to 1000 mg Fe/L, suggesting that iron toxicity is not related to external iron levels alone.

Iron toxicity in rice tends to occur on waterlogged soils, and can be attributed to excess uptake of Fe2+ after reduction of insoluble Fe3+-oxides, enhanced Fe2+ uptake due to deficiency in other elements (P, Ca, Mg or K), continuous supply of excess iron via groundwater or application of sewage with high iron-contents. The combination of high iron content in groundwater and formation of Fe2+ was also considered as the main cause of iron toxicity in the helophyte Glyceria fluitans (L.) after restoration of the hydrology in a eutrophic wetland.

In contrast to this, Batty and Younger (2003) point out that there are a number of wetland plants that are able to withstand high iron concentrations. This has been attributed to the oxidation of soluble ferrous iron to insoluble ferric iron in the rhizosphere. The formation of iron oxyhydroxide deposits on the roots of wetland plants may reduce the amount of iron entering the plant tissues and thus provide a mechanism of avoidance of toxicity. Such iron oxide deposits may in turn adsorb nutrients such as phosphate, reducing their uptake into plant tissues and potentially resulting in nutrient deficiency. It is therefore suggested that the observed decreased growth of rice at elevated iron concentrations may be due to nutrient deficiency rather than to toxicity. This is supported by observations that rice cultivars from sites toxic in iron are deficient in phosphate, zinc and potassium in their leaves. A decreased concentration of phosphate in shoots at increasing iron levels was observed in studies on wetland species.

Although each of the above mentioned mechanisms may play a role in the effects of iron on plant growth, the interactions are rather complicated. In an experiment in which the helophytic grass Phragmites australis (common reed) was exposed to increasing concentrations of iron in nutrient solution, Batty and Younger (2003) showed that concentrations higher than 1 mg Fe/L had a significant effect on the growth of common reed and on both iron and phosphate concentrations associated with roots. However, neither direct toxicity nor phosphate deficiency could explain the reduction in growth.

 

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.

 

Possibility to derive the MPAsoil

It is most likely that possible observed effects on soil organisms are not caused by specific iron toxicity, but are rather due to osmotic stress resulting from increased salinity. This is supported by the additional information on earthworms as presented in Section 1.4.2.1, which does not point at any effects of iron on earthworms. Also for plants, the available information does not indicate that iron in general should be considered as a potential risk for plants. The cases where toxicity is observed are related to specific situations that are not applicable to the normal agricultural practice in the Netherlands.

 

Based on the data presented here, derivation of an MPAsoil for iron is not considered possible. Given the fact that the background concentrations in the Netherlands are in the range of 1600 to 30000 mg/kg, it is questionable whether the use of this plant protection product will significantly contribute to the iron content of agricultural soils.

 

Conclusion

Based on the available data, it is not considered possible, nor scientifically justified to derive an MPAsoil for iron.

 

Risk assessment

A comparison between the natural abundance and the amount added by application of Sluxx 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 Sluxx. Therefore the addition to the background levels is considered acceptable and no accumulation as a result of the application of Sluxx 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 Fe and phosphate as a result of the application of Sluxx 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)

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 Sluxx, no risk of leaching of ferric phosphate is expected as result of the application of Sluxx.

 

Monitoring data

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

 

Conclusions

The proposed applications 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)

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 (hand scattering of the product pellets to garden and small field plots) because it is assumed that for this application technique there is no exposure of surface water.

 

Monitoring data

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).

 

Drinking water criterion

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’. No mathematical model for this aspect is available. This means that any data that is available cannot be adequately taken into account. It is therefore not possible to arrive at a scientifically well-founded assessment according to this criterion. The Ctgb has not been given the instruments for testing surface water from which drinking water is produced according to the drinking water criterion. In order to comply with the Court’s decision, however - from which it can be concluded that the Ctgb should make an effort to give an opinion on this point – and as provisional measure, to avoid a situation where no authorisation at all can be granted during the development of a model generation of the data necessary, the Ctgb has investigated whether the product under consideration and the active substance could give cause for concern about the drinking water criterion.

 

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

Conclusion risk assessment according to HTB 1.0: all proposed applications of the product Sluxx 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 current application for mutual recognition this means that the Danish risk assessment should be used. At present there is no framework to assess fate and behaviour in air of plant protection products.

 

6.4       Appropriate fate and behaviour endpoints relating to the product and approved uses

See List of Endpoints.

 

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. All proposed applications of the active substance ferric phosphate meet the standards for leaching to the shallow groundwater as laid down in the RGB.
  3. According to HTB 1.0, the proposed applications of the product comply with the RGB with regard to the standards for surface water destined for the production of drinking water.

 

 

7.                 Ecotoxicology

The underlying risk assessment is based on the final list of endpoints for ferric phosphate (15 May 2001) and on the Danish authorisation for Ferrox.

 

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 via sprayed food (via natural food and secondary poisoning via earthworms) is not a Dutch specific criterion. For the current application for mutual recognition this means that the Danish risk assessment should be used.

 

The risk assessment for birds via surface water (drinking water and secondary poisoning via fish) is a Dutch specific criterion, since surface water concentrations are calculated based on national drift values. However, no exposure to surface water is expected for the proposed uses.

 

Drinking water

The risk from exposure through drinking surface water is calculated for a small bird with body weight 10 g and a DWI (daily water intake) of 2.7 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). 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 since it is assumed that there is no exposure of surface water.

In the first instance, the acute risk of drinking water (TER) is calculated according the formula (LD50 * bw) / (PIEC*DWI). Since PIEC is negligible, TER ³ 10. Therefore the risk is acceptable. 

 

7.1.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish. Since it is assumed that there is no exposure of surface water, the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

 

Conclusions birds

The application for mutual recognition of the product complies with the RGB.

 

7.2       Effects on aquatic organisms (Dutch specific aspect)

 

7.2.1    Aquatic organisms

Since the Netherlands has its own national drift values, the exposure concentrations of the active substance ferric phosphate in surface water have been estimated based on these drift values (see PECsw in section 6.2).

 

The risk for aquatic organisms is assessed by comparing toxicity values with surface water exposure concentrations from section 6.2. Risk assessment is based on toxicity-exposure ratio’s (TERs). Since it is assumed that there is no exposure of surface water, no further assessment is deemed necessary.

 

7.2.2    Risk assessment for bioconcentration

Since it is assumed that there is no exposure of surface water, no further assessment is deemed necessary.

 

7.2.3    Risk assessment for sediment organisms

Since it is assumed that there is no exposure of surface water and aquatic sediment, no further assessment is deemed necessary.


Conclusions aquatic organisms

The proposed applications meet the standards for aquatic organisms in both the edge-of-field ditch as well as the WFD-water body.

 

7.3       Effects on terrestrial vertebrates other than birds

The risk assessment for mammals via sprayed food is not a Dutch specific criterion. For the current application for mutual recognition this means that the Danish risk assessment should be used.

 

The risk assessment for mammals via surface water (drinking water and secondary poisoning via fish) is a Dutch specific criterion, since surface water concentrations are calculated based on national drift values.

 

Drinking water

The risk from exposure through drinking from surface water is calculated for a small mammal with body weight 10 g and a DWI (daily water intake) of 1.57 g/d. Surface water concentrations are calculated using TOXSWA (see paragraph 6.2.1). 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 since it is assumed that there is no exposure of surface water. In the first instance, the acute risk of drinking water is calculated according the formula (LD50 * bw) / (PIEC*DWI). Since PIEC is negligible, TER ³ 10. Therefore the risk is acceptable. 

 

7.3.2    Secondary poisoning

The risk as a result of secondary poisoning is assessed based on bioconcentration in fish. Since it is assumed that there is no exposure of surface water, the potential for bioaccumulation is considered low and no further assessment is deemed necessary.

 

Conclusions mammals

The application for mutual recognition of the product complies with the RGB.

 

7.4       Effects on bees

The risk assessment for bees is not a Dutch specific criterion. For the current application for mutual recognition this means that the Danish risk assessment should be used.

 

Conclusions bees

The application for mutual recognition of the product complies with the RGB.

 

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

 

7.5.1    Effects on non-target arthropods

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 criterion. For the current application for mutual recognition this means that the Danish risk assessment should be used.

 

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 criterion.

 

The product is used in-field and is applied as granules.Therefore no drift 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 criterion. For the current application for mutual recognition this means that the Danish risk assessment should be used.

                                                                                       

7.5.3    Effects on soil micro-organisms

The risk assessment for soil micro-organisms is not a Dutch specific criterion. For the current application for mutual recognition this means that the Danish risk assessment should be used.

 

7.5.4    Effects on activated sludge (Dutch specific aspect)

 

The risk assessment for activated sludge is a Dutch specific criterion.

No EC50 value is available. 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-crop area. Since the Netherlands have their own national drift values, the risk assessment for non-target plants is a national specific criterion.

The product is used in-field and is applied as granules. Therefore no drift 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 application for mutual recognition of the product complies with the RGB for the aspects non-target arthropods, activated sludge and terrestrial non-target plants.

 

7.6       Appropriate ecotoxicological endpoints relating to the product and approved uses

See List of Endpoints.

 

7.7       Data requirements

None.

 

7.8       Classification and Labelling

 

Proposal for the classification and labelling of the active substance ferric(III)phosphate (symbols and R phrases)

Symbol:

-

Indication of danger: -

 

R phrases

-

-

 

Proposal for the classification and labelling of the formulation concerning the environment

 

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 GAP/legal instructions for use:

None.

 

7.9       Overall conclusions regarding the environment

It can be concluded that:

  1. all proposed applications of the active substance ferric phosphate meet the standards for birds as laid down in the RGB.
  2. all proposed applications of the active substance ferric phosphate meet the standards for aquatic organisms as laid down in the RGB.
  3. the active substance ferric phosphate meets the standards for bioconcentration as laid down in the RGB.
  4. all proposed applications of the active substance ferric phosphate meet the standards for mammals as laid down in the RGB.
  5. all proposed applications of the active substance ferric phosphate meet the standards for bees as laid down in the RGB.
  6. all proposed applications of the active substance ferric phosphate meet the standards for non-target arthropods as laid down in the RGB.
  7. all proposed applications of the active substance ferric phosphate meet the standards for activated sludge as laid down in the RGB.
  8. 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 control of pest slugs in fields, vegetables, horticulture and decorative plants, in the open air and in greenhouses. Climatological and environmental circumstances relevant for the aspect efficacy / weed control in the claimed uses in The Netherlands are comparable to those in Denmark. There are no country-specific situations for the use of Sluxx as 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 Sluxx is based on mutual recognition of the authorisation in Denmark of the product Ferrox. 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 apply 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

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

 

Child-resistant fastening obligatory?

Not applicable

Tactile warning of danger obligatory?

Not applicable


Appendix 1  Table of authorised uses

 


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’.