registration report part a risk management active

Part A National Assessment - Federal Republic of Germany

UKS150C 008047-00/00

Registration Report –Central Zone of 28

Applicant (Scott Celaflor GmbH) Evaluator Germany Date 10/10/2016

REGISTRATION REPORT

Part A

Risk Management

Product code: UKS150C

Active Substance: 163 g/kg iron (II) sulfate

COUNTRY: Germany

Central Zone

Zonal Rapporteur Member State: United Kingdom

NATIONAL ASSESSMENT

Applicant: Scotts Celaflor GmbH

Date: 10/10/2016


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Table of Contents

PART A – Risk Management 4

1 Details of the application 4

1.1 Application background 4

1.2 Annex I inclusion 4

1.3 Regulatory approach 5

1.4 Data protection claims 5

1.5 Letters of Access 5

2 Details of the authorisation 5

2.1 Product identity 5

2.2 Classification and labelling 6

2.2.1 Classification and labelling under Directive 99/45/EC 6

2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 6

2.2.3 Standard phrases under Regulation (EC) No 547/2011 7

2.3 Other phrases notified under Regulation (EC) No 547/2011 7

2.3.1 Restrictions linked to the PPP 7

2.3.2 Specific restrictions linked to the intended uses 8

2.4 Product uses 9

3 Risk management 10

3.1 Reasoned statement of the overall conclusions taken in accordance

with the Uniform Principles 10

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 10

3.1.2 Methods of analysis (Part B, Section 2, Point 5) 11

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 11

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 11

3.1.3 Mammalian Toxicology 11

3.1.3.1 Acute Toxicity 12

3.1.3.2 Operator Exposure 12

3.1.3.3 Bystander Exposure 12

3.1.3.4 Worker Exposure 12

3.1.4 Residues and Consumer Exposure 13

3.1.4.1 Residues 13

3.1.4.2 Consumer exposure 13

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 13


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3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil)

(Part B, Section 5, Points 9.4 and 9.5) 13

3.1.5.2 Predicted Environmental Concentration in Ground Water

(PECGW) (Part B, Section 5, Point 9.6) 13

3.1.5.3 Predicted Environmental Concentration in Surface Water

(PECSW) (Part B, Section 5, Points 9.7 and 9.8) 14

3.1.5.4 Predicted Environmental Concentration in Air (PECAir)

(Part B, Section 5, Point 9.9) 14

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 15

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 15

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 15

3.1.6.3 Effects on Bees and Other Arthropod Species

(Part B, Section 6, Points 10.4 and 10.5) 16

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms

(Part B, Section 6, Point 10.6) 16

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 16

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 16

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

(Flora and Fauna) (Part B, Section 6, Point 10.8) 17

3.1.7 Efficacy (Part B, Section 7, Point 8) 17

3.2 Conclusions 17

3.3 Further information to permit a decision to be made or to support

a review of the conditions and restrictions associated with the authorisation 18

Appendix 1 – Copy of the product authorisation 19

Appendix 2 – Copy of the product label 27

Appendix 3 – Letter of Access 28


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PART A – Risk Management

This document describes the acceptable use conditions required for the registration of UKS150C

containing iron (II) sulfate in Germany. This evaluation is required subsequent to the inclusion of iron (II)

sulfate on Annex 1.

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

UKS150C Registration Report, Part B Sections 1-7 and Part C from UK and where appropriate the

addendum for Germany. The information, data and assessments provided in Registration Report, Parts B

includes assessment of further data or information as required at national registration by the EU review. It

also includes assessment of data and information relating to UKS150Cwhere that data has not been

considered in the EU review. Otherwise assessments for the safe use of UKS150C have been made using

endpoints agreed in the EU review of iron (II) sulfate.

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

registration of UKS150C.

Appendix 1 of this document provides a copy of the final product authorisation in Germany.

Appendix 2: The submitted draft product label has been checked by the competent authority. The

applicant is requested to amend the product label in accordance with the decisions made by the competent

authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive

91/414/EEC.

Appendix 3

Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

1 Details of the application

1.1 Application background

This application was submitted by Scotts Celaflor GmbH on 12 September 2013.

The application was for approval of UKS150C, a GR formulation containing 163 g/kg iron )II) sulfate for

use as a moss killer to control moss in lawns (home and garden use) and in managed turf (professional

use). The product combines herbicide and fertilizer.

1.2 Annex I inclusion

Iron (II) sulfate was included on Annex I of Directive 91/414/EEC on 1 September 2009 under Inclusion

Directive 2008/127/EC.

The Annex I Inclusion Directive for iron (II) sulfate (2008/127/EC) and Regulation (EU) No. 637/2012

of 13. July 2012 provides specific provisions under Part B which need to be considered by the applicant

in the preparation of their submission and by the MS prior to granting an authorisation.

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

iron (II) sulfate, (SANCO/2616/2008)and in particular Appendices I and II thereof, as finalised in the


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Standing Committee on the Food Chain and Animal Health on 28 October 2008, shall be taken into

account. In this overall assessment:

Member States shall pay particular attention to the:

• risk for operator

• risk to children/residents playing on treated turf

• risk to surface and to aquatic organisms

On the basis of the proposed and supported uses (as listed in Appendix II), no particular issues have been

identified as requiring particular and short term attention from all Member States, in the framework of

any authorisations to be granted, varied or withdrawn.

These concerns were all addressed in the submission.

1.3 Regulatory approach

To obtain approval the product UKS150C must meet the conditions of Annex I inclusion and be

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

Uniform Principles, using Annex I agreed end-points.

This application was submitted in order to allow the first approval of this product/use in Germany in

accordance with the above.

1.4 Data protection claims

Where studies are owned by Scotts, data protection is claimed under Article 13 of Directive 91/414/EEC.

The identities of these studies have been clearly indicated in Part B.

1.5 Letters of Access

Scotts refers to the Annexe II data owned by EISTF for iron sulfate. Appropriate letter of access is

provided.

2 Details of the authorisation

2.1 Product identity

Product Name UKS150C

Authorization Number

(for registration)

008047-00/00

Function Herbicide

Applicant Scotts Celaflor GmbH

Composition 163 g/kg iron (II) sulfate

Formulation type granules (generic, with defined size) [Code: GR]


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Packaging Non professional users:

- Cardboard carton with polyethene coated liner or

polythene bag holding 0.175 kg to 8.4 kg of

product,

- Paper sack with polyethylene coated outer and

inner holding 8.4 kg to 17.5 kg of product,

- Low density polyethylene bag holding 8.4 kg to

17.5 kg of product,

- Paperboard/polyethylene multilayer box containing

1 to 10 kg of product,

- High density polyethylene container with

applicator holding 250 g to 5 kg of product,

- The SNAP spreader: a pre filled cartridge (bag in

white opaque Linear LDPE) applied through a

specifically engineered rotary type spreader base

(250 – 5000 g).

Professional users:

- LDPE sack (heat sealed on-line) containing up to

25 kg of product,

- PE/woven polypropylene bulk bag (twist tied)

containing up to 1000 kg of product.

2.2 Classification and labelling

2.2.1 Classification and labelling under Directive 99/45/EC

Not proposed.

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

The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:


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Hazard classes and categories:

Eye irrit. 2

Hazard pictograms:

GHS07 exclamation mark

GHS09 environment

Signal word:

Warning

Hazard statements:

H319 Causes serious eye irritation.

H411 Toxic to aquatic life with long lasting effects.

Precautionary statemtents:

P101 If medical advice is needed, have product container or label at hand.

P102 Keep out of reach of children.

P280 Wear protective gloves/protective clothing/eye protection/face protection.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact

lenses, if present and easy to do. Continue rinsing.

P337+P313 If eye irritation persists: Get medical advice/attention.

Special rule for labelling of PPP:

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

Further labelling statements under Regulation (EC) No 1272/2008:

23 percent of the mixture consist of ingredients of unknown inhalation toxicity.

2.2.3 Standard phrases under Regulation (EC) No 547/2011

None

2.3 Other phrases notified under Regulation (EC) No 547/2011

2.3.1 Restrictions linked to the PPP

The authorization of the PPP is linked to the following conditions (mandatory labelling):

Human health protection

SB001 Avoid any unnecessary contact with the product. Misuse can lead to health

damage.

SE126 Wear eye protection when applying/handling the product.

SS201 Wear working clothes (at least long-sleeved shirt and long trousers) and gloves

when applying/handling the product.

SS703 Wear sturdy shoes (e.g. rubber boots) when applying/handling the product.

Integrated pest management (IPM)/sustainable use


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NB663 Due to the manner in which authorisation governs application of the product, bees

are not endangered.(B3)

Ecosystem protection

NW 467 The product and its remains, empty containers and packaging and rinsing fluids

must not be dumped in water. This also applies to indirect entry via the urban or

agrarian drainage system and to rain-water and sewage canals.

The authorization of the PPP is linked to the following conditions (voluntary labelling):


NN1001 The product is classified as non-harmful for populations of relevant beneficial insects.

NN1002 The product is classified as not harmful for populations of relevant beneficial predatory

mites and spiders.

2.3.2 Specific restrictions linked to the intended uses

Some of the authorised uses are linked to the following conditions (mandatory labelling):

See 2.4 (Product uses)


WH9161 The instructions for use must include a summary of weeds which can be controlled well,

less well and insufficiently by the product, as well as a list of species and/or varieties

showing which crops are tolerant of the intended application rate and which are not.

WW742 The product has no sustainable effect in perennial weeds.

Ecosystem protection

NW642-1 The product may not be applied in or in the immediate vicinity of surface or coastal waters.

Irrespective of this, the minimum buffer zone from surface waters stipulated by state law

must be observed. Violations may be punished by fines of up to 50 000 EUR.


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2.4 Product uses

Reg.-No.: 008047-00/00 GAP rev.1, date: 2014-12-09

PPP (product name/code): UKS150C Active substance: Iron-II-sulfate

Formulation Type: GR Conc. of a.s.: 182 g/kg

Applicant: Scotts Celaflor GmbH Zone(s): central/EU

Professional use: Yes

Non-professional use: Yes Verified by MS: yes

1 2 3 4 5 6 7 8 9 10 11 12 13

Use-No.

Member state(s)

Crop and/ or situation (crop destination / purpose of crop)

F G or I

Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group)

Application Application rate PHI (days)

Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures

Method / Kind

Timing / Growth stage of crop & season

Max. number (min. interval between applications)

a) per use

b) per crop/ season

kg, L product / ha

a) max. rate per appl.

b) max. total rate per crop/season

g, kg a.s./ha



Water L/ha min / max

001 DE lawn (NNNZW)

F mosses (MMMMM) spreading During growing season, spring and autumn, not in seeding year

a) 1

b) 2

(90 days)

a) 35 g/m²

b) 70 g/m²

a) 63.70 kg/ha b) 127.40 kg/ha

-/ - Professional and amateur gardening, WH9161,

WW742,

NW642-1


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3 Risk management

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

Uniform Principles

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

Overall Summary:

UKS 150C is a GR formulation containing 18.2 % w/w ferrous sulphate monohydrate (16.3 % ferrous

sulphate, 6 % iron). The PPP was not the representative formulation considered for annex 1 inclusion

(approval) of the active substance.

The sample consisted of free-flowing granules which were not uniform in colour. The granules were

mainly brown and light brown with occasional light blue and cream. The granules ranged in size from

1 mm to 2 mm in diameter. They had a free flowing consistency, with no sign of clumping, caking or

compaction. No strong odour was noted. The formulation is not explosive, flammable or oxidising.

The physical and chemical and storage stability data were generated on a different formulation to the one

for which authorisation is being sought. However, as outlined in section C of the RR the data can be

extrapolated to UKS 150C.

The formulation is categorised as nearly dust free and based on the particle size data >1 % of particles do

not have a diameter of less than 50 µm. Hence no further consideration is required. The attrition

resistance of the particles was acceptable.

The flowability of the formulation was poor. It does not meet the requirements of all the material passing

through the sieve with a maximum 5 liftings. The poor flowability raises the following concerns:

• It may not be possible to apply the PPP through the standard operating equipment satisfactorily.

• The granules during storage under pressure (which would be encountered for the flexible packs)

may not maintain their integrity and the physical and chemical properties could potentially be

adversely affected.

To address these issues the applicant provided interim ambient storage data for 1 year of storage. The PPP

was stored under pressure. The physical and chemical properties determined were acceptable and indicate

that storage under pressure will have no impact on the PPP.

However, these interim storage stability data do not address the issue of the satisfactory application of the

PPP through the standard operating equipment. Such equipment subjects the granules to high

temperatures and pressures during application as experienced in the flowability test. Ambient storage

under pressure does not address this issue. It may be the case that the use of the standard application

equipment is not relevant to this PPP. But the applicant has not addresses this use. Authorisation is

therefore subject to the operator exposure assessment considering this issue.

It should be noted that in the interim study provided for ambient storage the active content was not

determined prior to and after storage. This is not an issue in the context of the use of this study in this


UKS150C 008047-00/00



assessment. However, the lack of data may be an issue if the study is required to fully support the ambient

storage of a PPP.

There was an acceptable retention of the physical and chemical properties of the PPP following

accelerated storage. Interim ambient storage data indicate that the formulation will be stable for 12

months when stored in the flexible packaging for 12 months.

Data must be provided showing satisfactory chemical and physical properties for the product and their

retention after ambient storage in the commercial packaging for two years.

Implications for labelling: none

Compliance with FAO guidelines:

The product UKS150 C complies with the general requirements according to the FAO/WHO manual

(2010).

Compatibility of mixtures:

No mixtures are recommended for UKS 150 C.

Nature and characteristics of the packaging:

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

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

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

Nature and characteristics of the protective clothing and equipment:

Information regarding the required protective clothing and equipment for the safe handling of UKS150C

has been provided and is considered to be acceptable.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2)

A fully validated ICP-OES method of analysis is available for the determination of iron in the PPP.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8)

Analytical methods for the monitoring of iron-(II)-sulfate residues in food of plant and animal origin, soil

and air are not required due to the nature of the compound and the intended use. During the EU peer

review, a data gap has been identified for an analytical method for iron in water with a LOQ of 0.2 mg/L.

This data gap can be addressed in the context of the next renewal of the approval of iron-(II)-sulfate

according to Reg. (EC) No 1107/2009. A method for body fluids and tissues is not required as the active

substance is not classified as toxic or very toxic.

3.1.3 Mammalian Toxicology

If used properly and according to the intended conditions of use, adverse health effects for operators,

workers, bystanders and residents will not be expected.

As a result of the German assessment no additional evaluation is regarded necessary to cover the national

situation. For further details please refer to the registration report of the zonal RMS UK.


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3.1.3.1 Acute Toxicity

Please refer to the registration report of the zonal RMS UK.

3.1.3.2 Operator Exposure


3.1.3.3 Bystander Exposure


3.1.3.4 Worker Exposure


Implications for labelling resulting from operator, worker, bystander assessments:

See 2.2 and 2.3.


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3.1.4 Residues and Consumer Exposure

3.1.4.1 Residues

Not relevant. UKS 150C is only intended to be used in non crop area (lawn).

3.1.4.2 Consumer exposure

Not relevant. UKS 150C is only intended to be used in non crop area (lawn).

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

A full exposure assessment for the plant protection product UKS150C in its intended uses on lawn is

documented in detail in the core assessment of the plant protection product UKS150C dated from May

2013 performed by UK.

The following chapters summarise specific exposure assessment for soil and surface water and the

specific risk assessment for groundwater for the authorization of UKS150Cin Germany according to its

intended use on lawn (Use No. 00-001).

Metabolites

No new study on the fate and behaviour of Iron sulfate or UKS150C has been performed. Hence no

potentially new metabolites need to be considered for environmental risk assessment.

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points

9.4 and 9.5)

For the intended use of the plant protection product UKS150C on lawn according to use No 00-001

PECsoil was calculated for the active substance Iron sulfate considering a soil depth of 2.5 cm. As a

worst-case scenario it is assumed that UKS150C is applied in one cumulative application of 114.1 kg Iron

sulfate/ha (equals 42 kg/ha iron and 72.1 kg/ha sulfate).

Compared to the natural content of iron and sulfate the additions are very small and consequently, no

unreasonable effects are expected from the use of FeSO4, even if repeated applications over multiple

years were to be assumed.

Details are given in Part B National Addendum-Germany, Section 5, chapter 5.5.

The results for PEC soil for the active substance and the metabolites were used for the eco-toxicological

risk assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B,

Section 5, Point 9.6)

For plant protection products that are applied as granules only exposure of surface water by run off is

considered. Furthermore, degradation of the active substance between application and runoff event is not

applicable. The exposure of dust drift is not considered in that case because of the simple application

equipment (hand spreading or rotary/wheeled spreader) of the granule formulation for non professional

use.

In (soil) solution, iron (II) is rapidly oxidised into iron (III) forming insoluble oxide/hydroxide species.

The identical reaction occurs in aerated, natural surface waters leads to the rapid formation of the

insoluble ferric form of iron. Thus, iron in surface water exists primarily in the insoluble ferric form,

either as settled or suspended sediment, and will be unavailable to aquatic organisms. Therefore, the


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predicted environmental concentrations in surface water were only calculated for the possible

bioavailable compounds Fe2+ and SO42- in the annex 1 assessment of Iron sulfate which covers the

intended uses of UKS150C on lawn.

The expected levels of iron and sulfate in surface water due to the intended use of the formulation

UKS150C on lawn will not significantly influence the natural background concentration of iron and

sulfate found in the aqueous environment.

Details are given in Part B, National Addendum-Germany, Section 5, chapter 5.6.

The results for PEC surface water for the active substance and its metabolites were used for the eco-

toxicological risk assessment.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section

5, Points 9.7 and 9.8)

For plant protection products that are applied as granules only exposure of surface water by run off is

considered. Furthermore, degradation of the active substance between application and runoff event is not

applicable. The exposure of dust drift is not considered in that case because of the simple application

equipment (hand spreading or rotary/wheeled spreader) of the granule formulation for non professional

use.


The identical reaction occurs in aerated, natural surface waters and leads to the rapid formation of the





intended uses of UKS150C on lawn.

The expected levels of iron and sulfate in surface water due to the intended use of the formulation

UKS150C on lawn will not significantly influence the natural background concentration of iron and

sulfate found in the aqueous environment.

Details are given in Part B, National Addendum-Germany, Section5, chapter 5.6.

The results for PEC surface water for the active substance and its metabolites were used for the eco-

toxicological risk assessment.

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

9.9)

The fate and behaviour in air of iron sulfate was evaluated during the Annex I Inclusion. No additional

studies have been performed. It is not anticipated that iron or sulfate will readily partition into the air

compartment under normal environmental conditions.

The vapour pressure at 20 °C of iron sulfate is < 10-5 Pa. Hence it is regarded as non-volatile. Therefore

aerial transport and exposure of surface water by the active substance due to deposition following

volatilization does not need to be considered.

Implications for labelling resulting from environmental fate assessment: (Phrase Rxx should

be added to the label)

none


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3.1.6 Ecotoxicology (Part B, Section 6, Point 10)

A full risk assessment according to Uniform Principles for the plant protection product UKS150C in its

intended uses lawn is documented in detail in the core assessment of the plant protection product

UKS150C dated from May 2013 performed by UK. The intended use of UKS150C in Germany is

generally covered by the uses evaluated in the course of the core assessment by UK.

The authorization in UK is not linked with any risk mitigation measures regarding effects on non-target

organisms (see Part A, National Assessment – UK, May 2013).

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

mitigation measures for the authorization of UKS150C in Germany according to its intended use on lawn

(use No. 00-001).

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

The risk assessment for effects on birds and other terrestrial vertebrates was carried out according to the

European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals on

request from EFSA (EFSA Journal 2009; 7(12): 1438).

Birds

According to the assessment scheme for granular formulations of the EFSA guidance document on risk

assessment for birds and mammals birds may be exposed to granules in different ways:

- By ingestion of granules as a source of food

- By ingestion of granules as grit

- By ingestion of granules when eating food contaminated with soil

- By consuming food contaminated with residues of the granules

Tier 1 toxicity/exposure ratios (TER) for acute and long-term exposure of birds to UKS150C for all

scenarios resulted in TER values above the trigger so that refined assessments were not necessary. A low

risk from dietary exposure was concluded after calculation of the tier 1 assessments.

Furthermore an acceptable risk for birds for exposure via contaminated drinking water can be concluded.

For details see core assessment, Part B, section 6.

Terrestrial vertebrates (other than birds)

According to the assessment scheme for granular formulations of the EFSA guidance document on risk

assessment for birds and mammals vertebrates other than birds may be exposed to granules in different

ways:

- By ingestion of granules as a source of food

- By ingestion of granules when eating food contaminated with soil

- By consuming food contaminated with residues of the granules

The risk to mammals was assessed and discussed for these scenarios according to the EFSA guidance

document on risk assessment for birds and mammals (EFSA, 2009) as specified above. In case of

UKS150C the possible uptake of granules when eating food contaminated with soil Tier 1

toxicity/exposure ratios (TER) for acute and long-term exposure of birds to UKS150C for this scenario

resulted in TER values above the trigger.

Furthermore an acceptable risk for mammals for exposure through contaminated drinking water was

concluded.

For details see core assessment, Part B, section 6.

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


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Results of aquatic risk assessment for the intended for uses of UKS150C on lawn based on FOCUS

Surface Water PEC values is presented in the core assessment, Part B, Section 6, chapter 6.4.

Predicted environmental concentrations in surface water were only calculated for the possible


intended uses of UKS150C on lawn. The expected levels of iron and sulfate in surface water due to the

intended use of the formulation UKS150C on lawn will not significantly influence the natural background

concentration of iron and sulfate found in the aqueous environment.

However, the application of PPP in the immediate vicinity of surface or coastal waters is not permitted in

Germany, minimum buffer zones stipulated by state law must be observed and no additional entries as

those according to the evaluated use pattern and good agricultural practice are acceptable. The conditions

of use NW468 and NW642-1 are assigned.

For details see Part B, National Addendum-Germany, Section 6, chapters 6.4.4.

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

10.5)

Bees

No endpoints are available for the active substance iron sulfate as the exposure of bees is unlikely for a

granular application. The DAR concludes that the risk for bees is acceptable and low.

Due to the manner in which authorisation governs application of the product, bees are not endangered.

Other non-target arthropods

The applicant has submitted data on the effect of UKS150C on non-target arthropods (namely Aleochara

bilineata and Poecilius cupreus; ER50 and LR50 > 665 kg/ha, respectively). Due to the lack of effects in

the ecotoxicological studies and with respect to the natural background levels of ferric and sulphate (see

Part B, National Addendum section 5, chapter 5.5), a quantitative risk assessment for non-target

arthropods is for that reason not conducted in this national addendum.

For details please refer to the core assessment Part B, section 6, chapter 6.6.

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

10.6)





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

Since no risk was identified for soil fauna, soil micro-organisms and non-target arthropods from the use

of UKS150C on lawn, data on the effects on organic matter breakdown (litterbag) is not required.


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






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

Fauna) (Part B, Section 6, Point 10.8)

Non-Target Plants

Exposure of non-target terrestrial plants in non-target off-field areas to UKS150C due to spray from field

application is not considered because UKS150C as a granule formulation is applied by spreading. The

exposure of dust drift is not considered in that case because of the simple application equipment (hand

spreading or rotary/wheeled spreader) of the granule formulation for non professional use.


Implications for labelling resulting from ecotoxicological assessment:

NW467 The product and its remains, empty containers and packaging and rinsing fluids must not

be dumped in water. This also applies to indirect entry via the urban or agrarian drainage

system and to rain-water and sewage canals.

NW642-1 The product may not be applied in or in the immediate vicinity of surface or coastal

waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by

state law must be observed. Violations may be punished by fines of up to 50 000 EUR.

H411 Toxic to the aquatic environment with long lasting effects Aquatic Chronic 2

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

The use of UKS150C is intended for the control of mosses (MMMMM). For some mosses only a few or

no efficacy results have been submitted, so certain moss species may show different sensitivity. This

should be addressed by a label warning. The instructions for use must include a summary of weeds which

can be controlled well, less well and insufficiently by the product, as well as a list of species and/or

varieties showing which crops are tolerant of the intended application rate and which are not. This also

addresses DE’s concerns that safe species of turf are not named in the RR.

Because assessments in the following year are missing, although perennial crops and pest are concerned,

it must be addressed by a label warning that the product has no sustainable effect in perennial weeds.

No adverse effects on beneficial organisms were noted when visual observations were made within the

efficacy and selectivity field trial sites.

On the basis of the results of laboratory studies, UKS150C can be classified as not harmful for the soil-

dwelling insects Poecilus cupreus and Aleochara bilineata.

3.2 Conclusions

With respect to physical, chemical and technical properties of the formulation an authorisation can be

granted.

Concerning analytical methods (formulation) an authorisation can be granted.

Regarding analytical methods for residues an authorisation can be granted.

With respect to efficacy/IPM and sustainable use incl. safety for honey bees an authorisation can be

granted.


UKS150C 008047-00/00



With respect to toxicology, residues and consumer protection an authorisation can be granted.

With respect to fate and ecotoxicology assessment, an authorisation can be granted. Considering an

application in accordance with the evaluated use pattern and good agricultural practice as well as strict

observance of the conditions of use no harmful effects on groundwater or adverse effects on the

ecosystem are to be apprehended.

An authorisation can be granted.

3.3 Further information to permit a decision to be made or to support a review of the

conditions and restrictions associated with the authorisation

No further information is required.


UKS150C 008047-00/00



Appendix 1 – Copy of the product authorisation


UKS150C 008047-00/00




UKS150C 008047-00/00



Appendix 2 – Copy of the product label

Appendix 2: The submitted draft product label has been checked by the competent authority. The

applicant is requested to amend the product label in accordance with the decisions made by the competent

authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive

91/414/EEC.


UKS150C 008047-00/00



Appendix 3 – Letter of Access

Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

Part B – Section 5

National Addendum– Germany

UKS150C Registration Report

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zRMS: UK

Page 1 of 11

Scotts Celaflor GmbH Evaluator: Germany (UBA)

Date: August 2016

REGISTRATION REPORT

Part B

Section 5 Environmental Fate

Detailed summary of the risk assessment


Active Substance: Iron sulfate 163 g/kg

Central Zone

Zonal Rapporteur Member State: UK

NATIONAL ADDENDUM – Germany


Date: August 2016




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Page 2 of 11


Date: August 2016

Table of Contents TABLE OF CONTENTS ....................................................................................................................................... 2

SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ........................................ 3

5.1 GENERAL INFORMATION ON THE FORMULATION .................................................................................... 3

5.2 PROPOSED USE PATTERN ........................................................................................................................ 3

5.3 INFORMATION ON THE ACTIVE SUBSTANCES ........................................................................................... 4

5.3.1 Iron sulfate ........................................................................................................................................ 4

5.4 SUMMARY ON INPUT PARAMETERS FOR ENVIRONMENTAL EXPOSURE ASSESSMENT ............................... 4

5.4.1 Rate of degradation in soil................................................................................................................. 4

5.4.2 Adsorption/desorption ....................................................................................................................... 4

5.4.3 Rate of degradation in water/sediment .............................................................................................. 5

5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4) ........................................................................ 5

5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7) ............................ 6

5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition .......................... 6

5.6.2 PECSW after exposure by surface run-off and drainage ..................................................................... 6

5.7 RISK ASSESSMENT FOR GROUNDWATER (KIIIA1 9.6) ............................................................................. 7

APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ............................ 9

APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON .............................................. 10

APPENDIX 3 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL 08.12.2014) .... 11




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Date: August 2016

Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT

(KIIIA 9)

The exposure assessment of the plant protection product UKS150C in its intended uses on lawn is

documented in detail in the core assessment of the plant protection product UKS150C dated from May

2013 performed by UK.

This document comprises the risk assessment for groundwater and the exposure assessment of surface

water and soil for authorization of the plant protection product UKS150C in Germany according to uses

listed in Appendix 3.

Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document.

PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary

(see National addendum Germany, part B, section 6 and part A).

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation UKS150C

Code ZV3 008047-00/00

Plant protection product UKS150C

Applicant Scotts Celaflor GmbH

Date of application 12.09.2013

Formulation type

(WP, EC, SC, …; density)

GR

Active substances (as) Iron sulfate

Concentration of as (g/kg) 163

Data pool/task force European Iron Sulfate Task Force

Letter of access/cross reference European Iron Sulfate Task Force; Rakem

existing authorisations in DE none

5.2 Proposed use pattern

The intended uses in Germany classified according the soil effective application rate (cumulative,

assuming no degradation in soil) are presented in Table 5.2-1. Full details of the proposed uses that will

be assessed is included in Appendix 3.

The intended use in Germany (use No. 00-001) is covered by the core assessment performed by UK.




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Date: August 2016

Table 5.2-1: Classification of intended uses in Germany for UKS150C

Group/

use No*

Crop/growth

stage

Application

method

Drift scenario

Number of applications,

Minimum application

interval, application

time, interception

Application rate,

cumulative

(g as/ha)

Soil effective

application rate

(g as/ha)

A/

00-001

Lawn

(home and

garden use)

strewing 2

(90 days)

Spring/autumn

application

(during vegeation period)

50 % **

Iron sulfate,

2 x 57.05 kg a.s./ha

Iron sulfate,

2 x 57.05 kg

a.s./ha

* For administrative purposes, each intended use of a plant protection product in Germany is assigned with an individual use

number from the German Federal Office of Consumer Protection and Food Safety (BVL). A complete list of the

individual GAPs in Germany together with their assigned use numbers is given in Appendix 3 of this Addendum.

** The notifier suggest a crop interception of 76.2 % based on the study by Staffa, C. (2012, study code: 783-001, AS232,

BVL code 2704826). Whereas the zRMS stated that according to the higher single use rate featured in the annex 1

assessment member states should further assess the impact of the proposed product uses if they consider a crop

interception of less than 25 % for granular applications to established grasses (please refer to the reviewer’s comments

in the core assessment, section 5, chapter IIIA1 9.4.1). However, the approach of the study by Staffa is reasonable

unfortunately the amendements of the report regerading the prelimary study on the fixing of the granules and some raw

data are not available. The lawn tested in the study was well established. Considering the use of the formulation as non

professional it is questionable whether this is always the situation for the intended use of the formulation. Therefore the

evaluation in the national addendum is based on a crop interception of 50 %.

5.3 Information on the active substances

5.3.1 Iron sulfate

Iron sulfate is an inorganic salt that dissociates in the soil solution to iron- and sulfate-ions. Both iron

and sulfate-ions are naturally occurring components of terrestrial ecosystems. Please refer to EFSA

Journal 2012;10(1):2521.

5.4 Summary on input parameters for environmental exposure assessment

5.4.1 Rate of degradation in soil

Not applicable. Please refer to EFSA Journal 2012;10(1):2521.

5.4.2 Adsorption/desorption

Iron sulfate is an inorganic salt that dissociates in the soil solution to iron- and sulfate-ions. Both iron

and sulfate-ions are naturally occurring components of terrestrial ecosystems.. Sulfate is mobile in soils

and readily leached (Kf 2.6 – 21.1). Sorption increases with decreasing pH. Above pH 6 all sulfate is

found in solution. Under typical aerobic environmental conditions (pH 5 – pH 9), the highly soluble Fe

(II) salts will be rapidly oxidised to less soluble Fe (III) oxides and hydroxides. Due to the low solubility

of the oxide/hydroxide forms, the concentration of dissolved Fe in the soil solution is rather low (< 0.01

- 0.5 mg/L). Please refer to EFSA Journal 2012;10(1):2521.




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Date: August 2016

5.4.3 Rate of degradation in water/sediment

Not applicable. Iron sulfate is an inorganic salt with high solubility in water. When dissolved in water,

it readily dissociates to iron- and sulfate ions. Please refer to EFSA Journal 2012;10(1):2521.

5.5 Estimation of concentrations in soil (KIIIA1 9.4)

Results of PECsoil calculation for UKS150C according to EU assessment considering 5 cm soil depth

and an interception value of 75 % are given in the core assessment (May 2013), part B, section 5, Table

9.4.1-1. However, zRMS didn’t accept the proposed interception value of 75 % but considers the annex

1 assessment to be protective of the proposed uses (please refer to EFSA Journal 2012;10(1):2521).

For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler,

Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittel-

wirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben

FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a KFoc < 500 a soil depth of

2.5 cm is applied whereas for active substances with a KFoc > 500 a soil depth of 1 cm is applied. As soil

bulk density 1.5 g cm-3 is assumed. The standard soil depth of 2.5 cm was considered for Iron sulfate.

Additional PECsoil,act was calculated for the formulation UKS150C for a soil depth of 2.5 cm. The short-

term and long-term actual concentrations (PECsoil,actual) and the time weighted average concentrations

(PECsoil,twa) for the active substance Iron sulfate were not calculated because no degradation is assumed

for the active substance Iron sulfate.

PEC soil calculation is based on two applications of 350 kg UKS 150C/ha corresponding to 57.05 kg/ha

Iron sulfate (equals 21 kg/ha iron and 36.05 kg/ha sulfate) with a minimum interval of 90 days are

proposed. As a worst-case scenario it is assumed that UKS150C is applied in one cumulative application

of 114.1 kg Iron sulfate/ha (equals 42 kg/ha iron and 72.1 kg/ha sulfate). However, it can be realistically

concluded that this cumulative application does not reflect the conditions of use since e.g. decay of the

granular and dissolution in water takes place between applications.

The calculated PECsoil used for German risk assessment for Iron sulfate as well as for the formulation

UKS150C are summarized in Table 5.5-1 and Table 5.5-2.

Table 5.5-1: Results of PECsoil calculation for the intended use on lawn (00-001) used for

German risk assessment

plant protection product: UKS150C

use: 00-001

Number of applications/intervall 2 x / 90 days

application rate: Single application: 350 kg/ha → Iron sulfate: 57.05 kg/ha

cumulative application: 700 kg/ha → Iron sulfate: 114.1 kg/ha

crop interception: 50 %

active substance/

formulation

soil relevant

application rate

(g/ha)

soil depthact

(cm)

PECact

(mg/kg)

tillage

depth (cm)

PECbkgd

(mg/kg)

PECaccu =

PECact +

PECbkgd

(mg/kg)

UKS150C 350 000 2.5 933.3 -- -- --

Iron sulfate 57 050 2.5 152.1 -- -- --

Fe 21 000 2.5 56.0 -- -- --




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Date: August 2016

SO42- 36 050 2.5 96.1 -- -- --

Table 5.5-2: Concentration of iron and sulfate in soil after two applications (cumulative

calculation) in comparison to the natural occurance of iron and sulfate in soil

Substance PECact

(mg/kg)

PECact

(% by mass)

Natural occurance

in soil

(% by mass)

Iron 56.0 0.0056 Iron: 0.2 to 5

Sulfate 96.1 (=32.0 as sulphur) 0.0096 (= 0.0032 as sulphur) Sulphur: 0.02 to 2

The natural environmental concentrations of iron and sulfate in soil range from 2,000 to 50,000 mg/kg

(= 0.2 to 5 % iron) and from 600 to 60,000 mg/kg (= 0.02 – 2 % sulphur), respectively. Following two

applications of 57.05 kg FeSO4/ha (≡ 2 x 21.0 kg Fe2+ and 2 x 36.05 kg SO42-), the increase in the levels

of iron and sulfate in soil will be 56.0 and 96.1 mg/kg, respectively. The maximum levels applied

correspond to a soil iron concentration of ca. 0.0056 % compared to a natural iron content in soil of ca.

0.2 to 5% (by mass). A part of the added iron will be absorbed by plant tissue as nutrient and be removed

from the area by regular mowing. Compared to the natural content of iron and sulfate the additions are

very small and consequently, no unreasonable effects are expected from the use of FeSO4, even if

repeated applications over multiple years were to be assumed.

5.6 Estimation of concentrations in surface water and sediment (KIIIA1 9.7)


The identical reaction occurs in aerated, natural surface waters leads to the rapid formation of the




bioavailable compounds Fe2+ and SO42-.

5.6.1 PECSW after exposure by spraydrift and volatilization with subsequent

deposition

The formulation UKS150C is intended to be used against moss on lawn in home garden (non

professional use). The formulation is applied by spreading hence no direct exposure of aquatic organism

by the formulation UKS150C due to spray drift occurs.

The exposure of dust drift is not considered in that case because of the simple application equipment

(hand spreading or rotary/wheeled spreader) of the granule formulation for non-professional use.

5.6.2 PECSW after exposure by surface run-off and drainage

The annex 1 representative use of Iron sulfate features two applications of 71.4 k/ha Iron sulfate with

an application interval of 40 days and 40 % crop interception. The resulting cumulative amount of

85.68 kg/ha Iron sulfate reaching the soil covers the intended uses of UKS150C on lawn (57.05 kg/ha

Iron sulfate).

The annex I PECsw calculations of Fe2+ and SO42- using FOCUS Surface Water and considering runoff

and drainage only are resulting in initial predicted environmental concentrations of iron and sulfate in




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Page 7 of 11


Date: August 2016

surface water at Step 2 to be 0.164 mg/L and 8.88 mg/L, respectively, (refer to EFSA Journal

2012;10(1):2521).

The expected levels of iron and sulfate in surface water following application of ferrous sulfate are

below the EU regulatory thresholds for iron and sulfate in drinking water of 0.2 and 250 mg/L,

respectively (Council Directive 998/83/EC). Furthermore, according to the Water Framework Directive

(Directive 2000/60/EC) average annual concentrations in surface water up to 75 mg/L and 0,7 mg/L for

sulfate and iron, repectively, are not opposed to the good ecological status of water bodies. While natural

background concentrations of sulfate in surface water are up to 25 mg/L but not specified for iron

(LAWA, 2015).

However, it can be realistically concluded that the assumption of cumulative applications do not reflect

the conditions of use. Taking into account that the instability of ferrous ions under aerobic conditions,

leads to the formation of the insoluble ferric form of iron in aerated, natural surface waters most of the

iron in surface water will be unavailable to aquatic organisms.

Overall, for the active substance iron sulphate the exposure of surface water due to the intended use of

the formul1ation UKS150C on lawn will not significantly influence the natural background

concentration of iron and sulfate found in the aqueous environment.

5.7 Risk assessment for groundwater (KIIIA1 9.6)

Results of the PECgw calculation of Iron sulfate for the intended uses of UKS150C on lawn according

to EU assessment using FOCUS PELMO/PEARL are given in the core assessment by zRMS UK (May

2013), part B, section 5, chapter IIIA 9.6.

For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct

leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and

drainage of the active substance into an adjacent ditch with subsequent bank filtration into the

groundwater.

For the active substance iron sulfate the exposure of groundwater due to the use of the formulation

UKS150C can be neglected considering the natural background concentration of iron (refer to chapter

5.5).

Consequences for authorization:

The authorization of the plant protection product UKS150C is linked with following labeling:

none

1 LAWA (2015): http://www.wasserblick.net/servlet/is/142684/RaKon%20B%20-%20Arbeitspapier-

II_Stand_09012015.pdf?command=downloadContent&filename=RaKon%20B%20-%20Arbeitspapier-

II_Stand_09012015.pdf




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Page 9 of 11


Date: August 2016

Appendix 1 List of data submitted in support of the evaluation

No additional data for national assessment submitted.




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zRMS: UK

Page 10 of 11


Date: August 2016

Appendix 2 Detailed evaluation of studies relied upon

Report only studies, which have not previously been evaluated within a peer reviewed process at EU

level (Annex I inclusion of active substance).

none



UKS150C Tstst Registration Report

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zRMS: UK

Page 11 of 11


Date

Appendix 3 Table of Intended Uses in Germany (according to BVL 08.12.2014)

PPP (product name/code) UKS150C

active substance Iron sulfate

Formulation type: GR

Conc. of as: 163 g/kg (183 g/kg as monohydrate)

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

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination /

purpose of crop)

F

G

or

I

Pests or Group of pests

controlled

(additionally:

developmental stages of

the pest or pest group)

Application Application rate PHI

(days)

Remarks:

e.g. safener/synergist per ha

e.g. recommended or mandatory tank

mixtures

Method /

Kind

Timing / Growth

stage of crop &

season

Max. number

(min. interval

between

applications)

a) per use

b) per crop/

season

kg, L product /

ha

a) max. rate per

appl.

b) max. total rate

per crop/season

g, kg as/ha

a) max. rate

per appl.

b) max. total

rate per

crop/season

Water L/ha

min / max

00-

001

DE Home Garden Lawn

Treatment

F Moss Spreader/

hand

application

Spring/autumn

application

(during vegeation

period)

a) 2

b) 2

a) 350 kg/ha

(equivalent to

57.05 kg a.s./ha)

a) 57.05 kg

a.s./ha

b) 114.1 kg/ha

NA


National Addendum – DE

UKS150C

Draft Registration Report

Central Zone

Page 1 of 11

Applicant: Scotts Celaflor GmbH Evaluator: zRMS DE

Date: November 2016

DRAFT REGISTRATION REPORT

Part B

Section 6: Ecotoxicological studies

Detailed summary of the risk assessment


Active Substance: Iron sulfate 163 g/kg

Central Zone

Zonal Rapporteur Member State: Germany

NATIONAL ADDENDUM


Date: August 2016



UKS150C


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Page 2 of 11


Date: November 2016

Table of Contents

SEC 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)............................................................ 3

6.1 PROPOSED USE PATTERN AND CONSIDERED METABOLITES .............................................................. 4

6.1.1 Grouping of intended uses for risk assessment ...................................................................... 4

6.1.2 Consideration of metabolites .................................................................................................. 4

6.2 EFFECTS ON BIRDS (MIIIA 10.1, KPC 10.1, KPC 10.1.1) ................................................................. 5

6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (MIIIA 10.3, KPC 10.1, KPC

10.1.2) ...................................................................................................................................................... 5

6.4 EFFECTS ON OTHER TERRESTRIAL VERTEBRATE WILDLIFE (REPTILES AND AMPHIBIANS) (KPC

10.1.3) ...................................................................................................................................................... 5

6.5 EFFECTS ON AQUATIC ORGANISMS (MIIIA 10.2, KPC 10.2, KPC 10.2.1) ........................................ 5

6.5.1 Overview ................................................................................................................................ 5

6.5.2 Toxicity .................................................................................................................................. 5

6.5.3 Justification for new endpoints .............................................................................................. 6

6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1) ............................................. 6

6.5.5 Overall conclusions ................................................................................................................ 6

6.6 EFFECTS ON BEES (MIIIA 10.4, KPC 10.3.1) .................................................................................... 6

6.7 EFFECTS ON ARTHROPODS OTHER THAN BEES (MIIIA 10.5, KPC 10.3.2) ....................................... 7

6.8 EFFECTS ON NON-TARGET SOIL MESO- AND MACROFAUNA (MIIIA 10.6, KPC 10.4, KPC 10.4.1,

KPC 10.4.2) .............................................................................................................................................. 7


6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna, TERA and

TERLT (MIIIA 10.6.1) ............................................................................................................ 7

6.8.3 Higher tier risk assessment ..................................................................................................... 9


6.9 EFFECTS ON SOIL MICROBIAL ACTIVITY (MIIIA 10.7, KPC 10.5) .................................................... 9


6.9.2 Risk assessment ...................................................................................................................... 9


6.10 EFFECTS ON NON-TARGET PLANTS (MIIIA 10.8, KPC 10.6) ............................................................ 9

6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1) .......................................................... 9

6.10.2 Toxicity ................................................................................................................................ 10

6.10.3 Justification for new endpoints ............................................................................................ 10

6.10.4 Risk assessment .................................................................................................................... 10

6.10.5 Conclusion............................................................................................................................ 10

APPENDIX 1 TABLE OF INTENDED USES IN GERMANY (ACCORDING TO BVL

08.12.2014) 11



UKS150C


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Date: November 2016

Sec 6 ECOTOXICOLOGICAL STUDIES (MIIIA 10)

A full risk assessment according to Uniform Principles for the plant protection product UKS150C in its

intended uses in lawn is documented in detail in the core assessment of the plant protection product

UKS150C dated from May 2013 performed by zRMS UK.

This document comprises specific risk assessment for some annex points for authorization of the plant

protection product UKS150C in Germany according to the uses listed in Appendix 2.

General information on the formulation UKS150C can be found in Table 5.1-1of Section 5 of the National

addendum Germany (April 2013).



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6.1 Proposed use pattern and considered metabolites

6.1.1 Grouping of intended uses for risk assessment

Full details of the proposed use pattern of the formulation UKS150C that will be assessed are presented in

Appendix 1 and summarized in the table below. The intended use (use no. 00-001) in Germany are covered

by the core assessment performed by zRMS UK.

Table 6.1-1: Critical use pattern of UKS150C

Group/use No. * Crop/growth

stage/interception

Application method/drift

scenario

Application rate,

cumulative (g a.s./ha)

A/

00-001

Lawn

(home and garden use)

Spring/autumn application

(during vegeation period)

50 % **

Strewing;

2 applications

(90 days)

2 x 57.05 kg a.s./ha

* For administrative purposes, each intended use of a plant protection product in Germany is assigned with an individual use

number from the German Federal Office of Consumer Protection and Food Safety (BVL). A complete list of the individual

GAPs in Germany together with their assigned use numbers is given in Appendix 3 of this Addendum.

** The notifier suggest a crop interception of 76.2 % based on the study by Staffa, C. (2012, study code: 783-001, AS232, BVL

code 2704826). Whereas the zRMS stated that according to the higher single use rate featured in the annex 1 assessment

member states should further assess the impact of the proposed product uses if they consider a crop interception of less than

25 % for granular applications to established grasses (please refer to the reviewer’s comments in the core assessment,

section 5, chapter IIIA1 9.4.1). However, the approach of the study by Staffa is reasonable unfortunately the amendements

of the report regerading the prelimary study on the fixing of the granules and some raw data are not available. The lawn

tested in the study was well established. Considering the use of the formulation as non professional it is questionable

whether this is always the situation for the intended use of the formulation. Therefore the evaluation in the national

addendum is based on a crop interception of 50 %.

6.1.2 Consideration of metabolites

Please refer to the core assessment.



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6.2 Effects on birds (MIIIA 10.1, KPC 10.1, KPC 10.1.1)



none

6.3 Effects on Terrestrial Vertebrates Other Than Birds (MIIIA 10.3, KPC 10.1,

KPC 10.1.2)



none

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KPC

10.1.3)



none

6.5 Effects on aquatic organisms (MIIIA 10.2, KPC 10.2, KPC 10.2.1)

6.5.1 Overview

Results of aquatic risk assessment for the intended for uses of UKS150C in lawn based on FOCUS Surface

Water PEC values is presented in the Core assessment, Part B, Section 6.

For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i)

spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to

allow risk mitigation measures separately for each entry route. Hence, aquatic risk assessment differs from

those in the core assessment.

The risk assessment for aquatic organism for authorization of UKS150C is outlined in the following chap-

ters.

6.5.2 Toxicity




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Date: November 2016

6.5.3 Justification for new endpoints


6.5.4 Toxicity to exposure ratios for aquatic species (MIIIA 10.2.1)

The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with

the recommendations of the “Guidance on tiered risk assessment for plant protection products for aquatic

organisms in edge-of-field surface waters” (EFSA Journal 2013;11(7):3290).

6.5.4.1 TER values for the entry into surface water via spraydrift and deposition

following volatilization

Not relevant (for further details, see Part B section 5, chapter 5.6.1.)

6.5.4.2 TER values for the entry into surface water via run-off and drainage

It was not deemed necessary to calculate TER values for the entry into surface water via run-off and drain-

age for the following reasons:

In could be shown that the intended use of the formulation UKS150C on lawn will not significantly influ-

ence the natural background concentration of iron and sulfate found in the aqueous environment. For further

details, please refer to Part B, National Addendum section 5, chapter 5.6.2.

6.5.4.3 Consideration of Metabolites


6.5.5 Overall conclusions

The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of

UKS150C in lawn according to the label.


For the authorization of the plant protection product UKS150C following labeling and conditions of use

are mandatory:

Required Labelling

none

6.6 Effects on bees (MIIIA 10.4, KPC 10.3.1)

No endpoints are available for the active substance iron sulfate as the exposure of bees is unlikely for a

granular application. The DAR concludes that the risk for bees is acceptable and low.

Due to the manner in which authorisation governs application of the product, bees are not endangered.

For details please refer to the core assessment.



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Date: November 2016


none

6.7 Effects on arthropods other than bees (MIIIA 10.5, KPC 10.3.2)

The applicant has submitted data on the effect of UKS150C on non-target arthropods (namely Aleochara

bilineata and Poecilius cupreus; ER50 and LR50 > 665 kg/ha, respectively). Due to the lack of effects in

the ecotoxicological studies and with respect to the natural background levels of ferric and sulphate (see

Part B, National Addendum section 5, chapter 5.5), a quantitative risk assessment for non-target arthropods

is for that reason not conducted in this national addendum.



None

6.8 Effects on non-target soil meso- and macrofauna (MIIIA 10.6, KPC 10.4, KPC

10.4.1, KPC 10.4.2)




6.8.2 Toxicity exposure ratios for earthworms and other soil macro- and mesofauna,

TERA and TERLT (MIIIA 10.6.1)

The evaluation of the risk for earthworms and other soil macro-organisms was performed in accordance

with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the

Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the

environmental fate section (Part B, Section 5) of this submission. The resulting maximum PECsoil values

for the active substances iron sulfate and the major soil degradation products are presented in the table

below.

For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Ku-

biak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirk-

stoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ

360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is

applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As soil bulk density

1.5 g cm-3is assumed.



UKS150C


Central Zone

Page 8 of 11


Date: November 2016

The acute risk for earthworms and other non-target soil macro- and mesofauna resulting from an exposure

to UKS150C/iron sulfate as well as the major soil degradation products of iron sulfate was assessed by

comparing the maximum PECSOIL with the 14-day LC50 value to generate acute TER values. The TERA was

calculated as follows:

The chronic risk for earthworms, other non-target soil macro- and mesofauna and organic matter breack-

down resulting from an exposure to UKS150C/iron sulfate as well as the major soil degradation products

of iron sulfate was assessed by comparing the maximum PECSOIL with the NOEC value to generate chronic

TER values. The TERLT was calculated as follows:

The results of the risk assessment are summarized in the following table.

Table 6.8-1: TER values for earthworms and other soil macro- and mesofauna (Tier-1) for the

use in lawns

Species Test item Time scale Endpoint Max. PECSOIL TER

[mg/kg soil dw] [mg a.s./kg soil dw]

Eisenia fetida Iron sulfate Acute LC50:

4376 mg/kg soil >

LC50 > 3829 mg a.s.

/kg soil

152.1 >25.2

UKS150C

(similar

formulation, UKS

151A)

Chronic NOEC: 2200 mg

product/kg soil

(equivalent to 358.6

mg a.s./kg soil)

152.1 2.36

The chronic TER value shown above fall below the relevant trigger of 5. However, the PEC value was

based on one cumulative application (no degradation is assumed) which is highly unlikely, since e.g. decay

of the granular and dissolution takes place between applications at an interval of 90 days.

Furthermore, as explained in Table 6.8-2 in chapter 5.5 (Part B, National Addendum section 5), the natural

environmental concentrations of iron and sulfate in soil range from 2,000 to 50,000 mg/kg (= 0.2 to 5 %

iron) and from 600 to 60,000 mg/kg (= 0.02 – 2 % sulphur), respectively. Following two applications of

57.05 kg FeSO4/ha (≡ 2 x 21.0 kg Fe2+ and 2 x 36.05 kg SO42-), the increase in the levels of iron and

sulfate in soil will be 56.0 and 96.1 mg/kg, respectively. The maximum levels applied correspond to a soil

iron concentration of ca. 0.0056 % compared to a natural iron content in soil of ca. 0.2 to 5% (by mass). A

part of the added iron will be absorbed by plant tissue as nutrient and be removed from the area by regular

mowing. Compared to the natural content of iron and sulfate the additions are very small and consequently,

(mg/kg) PEC

(mg/kg) LC=TER

soil

50

A

(mg/kg) PEC

(mg/kg) NOEC=TER

soil

LT



UKS150C


Central Zone

Page 9 of 11


Date: November 2016

no unreasonable effects are expected from the use of FeSO4, even if repeated applications over multiple


6.8.3 Higher tier risk assessment

Not relevant.


The results of the assessment indicate an acceptable risk for soil organisms due to the intended use of

UKS150C in lawn according to the label.


none

6.9 Effects on soil microbial activity (MIIIA 10.7, KPC 10.5)




6.9.2 Risk assessment



Based on the predicted concentrations of iron sulfate/UKS150C in soils, the risk to soil microbial processes

following exposure to iron sulfate /UKS150C according to the GAP of the formulation UKS150C is con-

sidered to be acceptable according to commission implementing regulation (EU) No 546/2011, Annex, Part

I C , 2. Specific principles, point 2.5.2.


none

6.10 Effects on non-target plants (MIIIA 10.8, KPC 10.6)

6.10.1 Effects on non-target terrestrial plants (MIIIA 10.8.1)




UKS150C


Central Zone

Page 10 of 11


Date: November 2016

6.10.2 Toxicity




6.10.4 Risk assessment

The risk assessment is based on the “Guidance Document on Terrestrial Ecotoxicology”,

6.10.5 Conclusion

The formulation UKS 150C is in the form of granules and is applied in a targeted manner to lawns and

managed amenity turf. As a result, no exposure of non-target terrestrial plants is anticipated and no study

was carried out.

The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the intended

use of UKS150C in lawn according to the label.


None



UKS150C


Central Zone

Page 11 of 11


Date: November 2016

Appendix 1 Table of Intended Uses in Germany (according to BVL 08.12.2014)

PPP (product name/code) UKS150C

active substance Iron sulfate

Formulation type: GR

Conc. of as 1: 163 g/kg (183 g/kg as monohydrate)

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

Use-

No.

Member

state(s)

Crop and/

or situation

(crop destination / pur-

pose of crop)

F

G

or

I

Pests or Group of pests

controlled

(additionally: developmen-

tal stages of the pest or

pest group)

Application Application rate PHI

(days)

Remarks:

e.g. safener/synergist per ha

e.g. recommended or mandatory tank

mixtures

Method /

Kind

Timing / Growth

stage of crop & sea-

son

Max. number

(min. interval

between appli-

cations)

a) per use

b) per crop/

season

kg, L product /

ha

a) max. rate per

appl.

b) max. total rate

per crop/season

g, kg as/ha

a) max. rate

per appl.

b) max. total

rate per

crop/season

Water L/ha

min / max

00-

001

DE Home Garden Lawn

Treatment

F Moss Spreader/

hand appli-

cation

Spring/autumn ap-

plication

(during vegeation

period)

a) 2

b) 2

a) 350 kg/ha

(equivalent to

57.05 kg a.s./ha)

a) 57.05 kg

a.s./ha

b) 114.1 kg/ha

NA

Part B – Section 7 National Addendum Germany

UKS150C 008047-00/00

Registration Report Central Zone

Page 1 of 9

Julius Kühn-Institut 2015-01-23

REGISTRATION REPORT

Part B

Section 7: Efficacy Data and Information

Detailed Summary

Product Code: UKS150C

Reg. No.: 008047-00/00

Active Substance: 16.3% iron sulphate

Central Zone

Zonal Rapporteur Member State: UK

National Addendum Germany

Applicant: The Scotts Company (UK) Ltd.

Evaluator: Julius Kühn-Institut

Date: 2015-01-23


UKS150C 008047-00/00


Page 2 of 9


Table of Contents

IIIA1 6 Efficacy Data and Information on the Plant Protection Product ............................ 3

General information ............................................................................................. 3

Recent registration situation/history of the PPP ................................................... 3

Information on the active ingredients (Uptake and mode of action) ...................... 3

Information on crops and pests ............................................................................ 3

Information on the intended uses ......................................................................... 3

IIIA1 6.1 Efficacy data ........................................................................................................ 3

IIIA1 6.1.1 Preliminary range-finding tests ............................................................................. 4

IIIA1 6.1.2 Minimum effective dose tests ............................................................................... 4

IIIA1 6.1.3 Efficacy tests........................................................................................................ 4

IIIA1 6.1.4 Effects on yield and quality .................................................................................. 4

IIIA1 6.1.4.1 Impact on the quality of plants and plant products ............................................... 4

IIIA1 6.1.4.2 Effects on the processing procedure .................................................................... 4

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products ...................................... 4

IIIA1 6.2 Adverse effects .................................................................................................... 5

IIIA1 6.2.1 Phytotoxicity to host crop ..................................................................................... 5

IIIA1 6.2.2 Adverse effects on health of host animals ............................................................ 5

IIIA1 6.2.3 Adverse effects on site of application ................................................................... 5

IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) .................................. 5

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ......................... 6

IIIA1 6.2.6 Impact on succeeding crops ................................................................................ 6

IIIA1 6.2.7 Impact on other plants including adjacent crops ................................................... 6

IIIA1 6.2.8 Possible development of resistance or cross-resistance ...................................... 6

IIIA1 6.3 Economics ........................................................................................................... 6

IIIA1 6.4 Benefits ................................................................................................................ 6

IIIA1 6.4.1 Survey of alternative pest control measures ........................................................ 6

IIIA1 6.4.2 Compatibility with current management practices including IPM .......................... 6

IIIA1 6.4.3 Contribution to risk reduction ............................................................................... 7

IIIA1 6.5 Other/special studies ........................................................................................... 7

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5......................... 7

IIIA1 6.7 List of test facilities including the corresponding certificates ................................. 7

Appendix 1: List of data submitted in support of the evaluation ............................................... 8

Appendix 2: GAP table ............................................................................................................ 9


UKS150C 008047-00/00


Page 3 of 9


IIIA1 6 Efficacy Data and Information on the Plant Protection Product

The zRMS UK did not observe DE`s remarks related to Annex point IIIA1 6 (see reporting ta-ble). DE’s view is that all data should be displayed in the RR. The RR should be prepared as a “stand alone” document. Refer to Registration Report and reporting table for further information.

General information

Refer to Registration Report for further information.

Recent registration situation/history of the PPP


Information on the active ingredients (Uptake and mode of action)


Information on crops and pests


Information on the intended uses

Date: 2014-12-09 Product: UKS150C Use No. 008047-00/00-001 Field of use Ornamental growing Crop(s)/object(s) lawn (NNNZW) Pest(s)/target(s) mosses (MMMMM) Area of application use in amateur gardening: Outdoors Timing of application During growing season, spring and autumn, not in seeding year Max. number of treat-ments for the use

2

Max. number of treat-ments per crop or sea-son

2

Interval between treat-ments

90 days

Application meth-od/kind of treatment

spreading

Application rate(s) 35 g/m² ---------------------------- ----------------------------

IIIA1 6.1 Efficacy data

The use of UKS150C is intended for the control of mosses (MMMMM). For some mosses only a few or no efficacy results have been submitted, which entails that a reliable evaluation on these moss species is not possible. Therefore, a label warning should be addressed on the label. The instructions for use must include a summary of weeds which can be controlled well, less well and insufficiently by the product, as well as a list of species and/or varieties showing which crops are tolerant of the intended application rate and which are not.


UKS150C 008047-00/00


Page 4 of 9


Mosses are perennial plants, which grow in perennial lawns. For proving long term control, as-sessments in the following year are required. Due to the missing assessments in the following year, an adequate label warning (e.g.: The product has no sustainable effect in perennial weeds.) should be addressed on the label. The zRMS UK did not observe DE`s remarks related to Annex point IIIA1 6.1 (see reporting table). DE’s view is that all used EPPO standards should be specified. Refer to Registration Report and reporting table for further information.

IIIA1 6.1.1 Preliminary range-finding tests


IIIA1 6.1.2 Minimum effective dose tests

The zRMS UK did not observe DE`s remarks related to Annex point IIIA1 6.1.2 (see reporting table). DE’s view is that the evaluation should be based on single moss species instead of groups of mosses (MMMMM). Certain moss species could respond different to the application of UKS150 C and maybe show different sensitivity. Refer to Registration Report and reporting table for further information.

IIIA1 6.1.3 Efficacy tests

The zRMS UK did not observe DE`s remarks related to Annex point IIIA1 6.1.3 (see reporting table). DE’s view is that the evaluation should be based on single moss species instead of groups of moss (MMMMM). Certain moss species could respond different to the application of UKS150C and maybe show different sensitivity. The results of the formulation UKS151A cannot be used for the evaluation of UKS150C. The additional content of MCPA/MCPP could falsify the results in comparison to a sole Fe-product because of missing competition of weeds. Refer to Registration Report and reporting table for further information.

IIIA1 6.1.4 Effects on yield and quality


IIIA1 6.1.4.1 Impact on the quality of plants and plant products


IIIA1 6.1.4.2 Effects on the processing procedure


IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products



UKS150C 008047-00/00


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IIIA1 6.2 Adverse effects


IIIA1 6.2.1 Phytotoxicity to host crop

The zRMS UK did not observe DE`s remarks related to Annex point IIIA1 6.2.1 (see reporting table). DE’s view is that safe species of turf should be named in the RR. Refer to Registration Report and reporting table for further information.

IIIA1 6.2.2 Adverse effects on health of host animals

This is not an EC data requirement.

IIIA1 6.2.3 Adverse effects on site of application


IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees)

The herbicide UKS150C (182 g/kg iron-II-sulfate or 163 g/kg as monohydrate, GR) has been proposed for two treatments per crop and season in lawn with a field rate of 35 g/m² (350 kg/ha). Due to a 90-day gap between the two applications and a half-life for iron sulfate of 1 day, a multiple application factor of 1.0 can be used. No adverse effects on beneficial organisms were noted when visual observations were made within the efficacy and selectivity field trial sites. Appropriate studies on the potential adverse effects on beneficial arthropods were available from Registration Report Part B, Section 6, Annex Point IIIA 10.5 (Effects on Arthropods Other Than Bees), Core Assessment. As tests with the indicator species Typhlodromus pyri and Aphidius rhopalosiphi are not de-manded for granular formulations, the toxicity of the test product has been investigated by carry-ing out laboratory tests with two soil dwelling organisms, the ground beetle Poecilus cupreus and the rove beetle Aleochara bilineata, only. Instead of the test product, the formulation UKS 151A (14-1-5), which contains the same concentration of iron-II-sulfate as UKS150C, but addi-tionally mecoprop-P + MCPA, was applied (Table 6.2.4-1). Only marginal lethal or sublethal effects < 30% occurred in both tests at 1.9fold the single field rate of UKS 151A. UKS150C is not suspected to be more toxic than the tested product containing additional active ingredients. Table 6.2.4-1: Effects of UKS 151A (14-1-5) (182 g/kg iron-II-sulfate + 3 g/kg mecoprop-P + 5 g/kg MCPA) on beneficial organisms in laboratory test on an artificial substrate

Species (Exposed Stage)

Substrate Rate Product [kg/ha]

Corrected Mortality

[%]

Sublethal Effect

[%]

Reference

P. cupreus (A) Quartz sand 665 0 1.4 (F) 2076/024-D2149

A. bilineata (DC) Quartz sand 665 8.6 6.8 (Re) 2076/025-D2149

A = adults, La = larvae, DC = developmental cycle, Re = reproduction, F = feeding rate


UKS150C 008047-00/00


Page 6 of 9


Conclusion

On the basis of the results of laboratory studies, UKS150C can be classified as not harmful for

Poecilus cupreus and Aleochara bilineata. Classification of the effects: Laboratory tests on inert substrates

< 30% = not harmful 30 – 80% = slightly harmful > 80% = harmful

Adverse effects on soil quality indicators (e. g. microorganisms, earthworms) are considered in Section 6 Ecotoxicological Studies in the Registration Report. Refer to Registration Report for further information.

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes


IIIA1 6.2.6 Impact on succeeding crops


IIIA1 6.2.7 Impact on other plants including adjacent crops


IIIA1 6.2.8 Possible development of resistance or cross-resistance


IIIA1 6.3 Economics


IIIA1 6.4 Benefits

The zRMS UK did not observe DE`s remarks related to Annex point IIIA1 6.4 (see reporting table). The reference in the RR is not correct. Council Directive 91/414/EEC is not valid any longer. Refer to Registration Report and reporting table for further information.

IIIA1 6.4.1 Survey of alternative pest control measures


IIIA1 6.4.2 Compatibility with current management practices including IPM



UKS150C 008047-00/00


Page 7 of 9


IIIA1 6.4.3 Contribution to risk reduction


IIIA1 6.5 Other/special studies


IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5


IIIA1 6.7 List of test facilities including the corresponding certificates



UKS150C 008047-00/00


Page 8 of 9


Appendix 1: List of data submitted in support of the evaluation

The evaluation is based on the Registration Report Part A, Part B7, Part B6, the Authorization Certificate of the Reference Member State and the label.


UKS150C 008047-00/00


Page 9 of 9


Appendix 2: GAP table

Reg.-No. 008047-00/00 GAP rev.1, date: 2014-12-09

PPP (product name/code) UKS150C active substance 1 Iron-II-sulfate active substance 2 0 active substance 3 0 active substance 4 0 active substance 5 0

Formulation Type: GR Conc. of a.s. 1: 182 g/kg Conc. of a.s. 2: 0 Conc. of a.s. 3: 0 Conc. of a.s. 4: 0 Conc. of a.s. 5: 0

Applicant: Scotts Celaflor GmbH Zone(s): central/EU

professional use No

non professional use Yes Verified by MS: yes

1 2 3 4 5 6 7 8 9 10 11 12 13

Use-No.

Mem-ber state(s)

Crop and/ or situation (crop destination / purpose of crop)

F G or I

Pests or Group of pests controlled (additionally: devel-opmental stages of the pest or pest group)

Application Application rate PHI (days)

Remarks: e.g. safener/synergist per ha e.g. recommended or mandato-ry tank mixtures

Method / Kind

Timing / Growth stage of crop & sea-son

Max. num-ber (min. interval be-tween appli-cations)

a) per use

b) per crop/ season

kg, L product / ha



g, kg a.s./ha



Water L/ha min / max

001 DE lawn (NNNZW)

F mosses (MMMMM) spread-ing

During growing season, spring and autumn, not in seeding year

(90 days) b) 2

a) 35 g/m² b) 70.00 g/m²

a) 63.70 kg/ha b) 127.40 kg/ha

-/ - Amateur gardening

registration report part a risk management active

Documents