Ferric Phosphate Final RR 1107 Part a COM 802 09 M RB

Part A COM 802 09 M RB Registration Report – Central Zone National Assessment Country – Germany Page 1 of 21

REGISTRATION REPORT Part A

Risk Management

Product code: COM 802 09 M RB Active Substance: 12.5 g/kg Ferric phosphate

COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT

Applicant: COMPO GmbH & Co.KG Date: 06/12/12

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 06/12/2012 Part A COM 802 09 M RB Registration Report –Central Zone National Assessment Country – Germany Page 2 of 21

Table of Contents

PART A – Risk Management 4

1 Details of the application 4

1.1 Application background 4

1.2 Approval 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 5

2.2.1 Classification and labelling under Directive 99/45/EC 5

2.2.2 R and S phrases under Regulation (EU) No 547/2011 6

2.2.3 Other phrases 6

2.3 Product uses 7

3 Risk management 11

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 11

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 11

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) 12

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.2) 12

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.4.2.1) 12

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4.2.3) 12

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.4.2.2) 12

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3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 13

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point IIIA 9 14

3.1.6 Ecotoxicology (Part B, Section 6, Point IIIA 10) 16

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points IIIA 10.1 and IIIA 10.3) 16

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point IIIA 10.2) 16

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points IIIA 10.4 and IIIA 10.5) 17

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point IIIA 10.6) 17

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point IIIA 10.6.7, Part B Section 6, Point 6.2.4) 17

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point IIIA 10.7) 18

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point IIIA 10.8) 18

3.1.6.8 Implications for labelling resulting from ecotoxicological assessment: 18

3.1.7 Efficacy (Part B, Section 7, Point 8) 19

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 20

Appendix 1 – Copy of the product authorisation 21

Appendix 2 – Copy of the product label (not yet available) 21

Appendix 3 – Letter of Access 21

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 06/12/2012

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PART A – Risk Management This document describes the acceptable use conditions required for the registration of COM 802 09 M RB containing ferric phosphate in Germany. This evaluation is required subsequent to the approval of ferric phosphate.

The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C. The information, data and assessments provided in Registration Report, Parts B includes assessment of data and information relating to COM 802 09 M RB. Otherwise assessments for the safe use of COM 802 09 M RB have been made using endpoints agreed in the EU review of ferric phosphate.

This document describes the specific conditions of use and labelling required for Germany for the registration of COM 802 M RB.

Appendix 1 of this document provides a copy of the final product authorisation in Germany Appendix 2 copy of the approved product label for Germany is not submitted Appendix 3 of this document contains copies of the letters of access to the protected data / third party data that was needed for evaluation of the formulation (not yet submitted).

1 Details of the application

1.1 Application background This application has been submitted by GAB Consulting GmbH on behalf of COMPO GmbH & Co. KG in September 2011.

Applicant details Name: COMPO GmbH & Co. KG Street: Gildenstr. 38 City: 48157 Münster Country: Germany Contact person: Dr. Otto Schweinsberg Telephone No.: +49-(0)251-3277-457 Telefax No.: +49-(0)251-3277-1457 e-mail: [email protected]

The application is for approval of COM 802 09 M RB, a bait (ready to use) formulation containing 12.5 g/kg ferric phosphate for use as a molluscicide in the home and garden sector.

1.2 Approval Ferric phosphate was included on Annex I of Directive 91/414/EEC on 01.11.2001 under Inclusion Directive 2001/87/EC and implemented under Regulation (EU) No 540/2011.

The regulation for ferric phosphate (540/2011/ EC) provides no 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.

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1.3 Regulatory approach This application was submitted in order to allow the first approval of this product in Germany.

1.4 Data protection claims For all data generated by COMPO protection is claimed as indicated in the reference list in each section. The Part C should be kept strongly confidential.

1.5 Letters of Access Not applicable.

2 Details of the authorisation

2.1 Product identity

Product Name COM 802 09 M RB Authorization Number 007517-00 (for re-registration) Function molluscicide Applicant Compo GmbH & Co KG Composition 12.5 g/kg ferric phosphate Formulation type Bait (ready for use) [Code: RB] Packaging Carton with or without inside PE-bag, 100-2500 g Can (PE), 100 – 800 g and Paperboard can, 100 – 1000 g

2.2 Classification and labelling

2.2.1 Classification and labelling under Directive 99/45/EC The following is proposed in accordance with Directive 99/45/EC in combination with the latest classification and labelling guidance under Directive 67/548/EEC (i.e. in the 18th ATP published as Directive 93/21/EEC):

Hazard Symbol: -

Indication of danger: -

Risk Phrases: -

Safety Phrases: SP001 To avoid risks to man and the environment, comply with the instructions for use.

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2.2.2 R and S phrases under Regulation (EU) No 547/2011 Risk Phrases: -

Safety Phrases: –

2.2.3 Other phrases Human health and animal welfare NT658 Keep domestic animals away. NT665 Do not place in piles. SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB010 Keep out of the reach of children. SB011 Keep children away. VH297 Packaging/containers for use in amateur gardening must be provided with a childproof seal.

Ecosystem protection: NW466 The product and its remains and empty containers and packaging must not be dumped in water. 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. Uses: 001, 004, 007, 010, 013

IPM and sustainable use: NB663 : Due to the manner in which authorisation governs application of the product, bees are not endangered. (B3) NN1001 The product is classified as non-harmful for populations of relevant beneficial insects. NN1002 The product is classified as non-harmful for populations of relevant predatory mites and spiders.

For details of the risk assessment regarding “Effects on bees”see Core Assessment, Part B, Section 6, Point IIIA 10.4.

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2.3 Product uses GAP rev. 0, date: 2012-06-27

PPP (product name/code) COM 802 09 M RB Formulation type: RB active substance ferric phosphate Conc. of as : 12.5 g/kg

Applicant: COMPO GmbH & Co.KG professional use Zone(s): central EU non professional use X

Verified by MS: yes

1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number kg product / ha g, kg as/ha Water L/ha e.g. safener/synergist per ha Kind stage of crop & (min. interval (crop destination / I (additionally: a) max. rate per season between min / max purpose of crop) developmental stages of appl. a) max. rate e.g. recommended or mandatory tank applications) the pest or pest group) per appl. mixtures a) per use b) max. total rate per crop/season b) max. total b) per crop/ rate per season crop/season 001 DE Vegetables (NNNVV) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 002 DE Vegetables (NNNVV) G slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha

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broadcasted when first across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 003 DE Vegetables (NNNVV) I slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment 004 DE fresh herbs (NNNKF) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 005 DE fresh herbs (NNNKF) G slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 006 DE fresh herbs (NNNKF) I slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment 007 DE fruit crops (NNNOO) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption

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broadcasted when first b) 4 b) 200 kg/ha b) 2.5 kg/ha across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 008 DE fruit crops (NNNOO) G slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 009 DE fruit crops (NNNOO) I slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment 010 DE ornamentals (NNNZZ) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 011 DE ornamentals (NNNZZ) G slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

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broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment 013 DE potato (SOLTU) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment

4) Conditions / location of use: Outdoor or field use (F), glasshouse application (G) or indoor application (I)

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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: COM 802 09 M RB, a bait (ready to use) contains a minimum of 12.5 g/kg Ferric phosphate. The product appears as solid flowable granules with a light-bluish green colour and a characteristic odour (like corn). No self ignition temperature was observed up to the maximum test temperature of 409 °C, according to the testing guideline for auto-flammability. It has no explosive or oxidizing properties in the sense of the European Commission Regulation (EC) No. 440/2008, Method A.14 or A.17. The pH of COM 802 09 M RB is around 7.5. According to the accelerated storage stability COM 802 09 M RB is expected to be stable in its original container at least for 2 years. Its technical properties indicate that no particular problems are expected, when used as recommended.

Implications for labelling: None

Compliance with FAO specifications: There is no FAO specification for ferric phosphate. The product COM 802 09 M RB complies with the general requirements according to the FAO/WHO Manual (2010).

Compliance with FAO guidelines: -

Compatibility of mixtures: No tank mixes are applied for.

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 COM 802 09 M RB 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) The analytical ICP method presented for the determination of the active ingredient Ferric phosphate in Formulation COM 802 09 M RB was successfully validated according to SANCO/3030/99 rev. 4 criteria. The method is acceptable.

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 30 July 2012

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3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) The EU review concluded that no harmful effects on human or animal health and no unacceptable effects on the environment will arise from the usage of ferric phosphate as a molluscicide. Thus no residues have to be monitored and no analytical methods are required.

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) If the product is used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected.

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.2) Acute toxicity studies for COM 802 09 M RB were not evaluated as part of the EU review of ferric phosphate. Relevant data were provided and are considered adequate.

COM 802 09 M RB, containing 12.5 g/kg ferric phosphate, has a low toxicity with respect to acute oral and dermal toxicity. It is not irritating to the rabbit eye and skin. There are no indications of skin sensitisation to guinea pigs. Due to the data presented no specific classification and labelling requirements are necessary.

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.4.2.1) Operator exposure to COM 802 09 M RB was not evaluated as part of the EU review of ferric phosphate. Sufficient data and assessments have been provided and are considered to be adequate. No relevant dermal absorption is assumed.

The risk assessment according to the German model has shown that the estimated exposure towards ferric phosphate in COM 802 09 M RB does not exceed the systemic AOEL for operators. No specific PPE is necessary.

Since exposure estimations indicated that the acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of operator exposure was not necessary and was therefore not performed.

If the product is used properly and according to the intended conditions of use, adverse health effects for operators will not be expected.

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4.2.3) Bystander exposure and adult resident exposure is considered to be negligible for granular plant protection products (no drift, no volatility). Exposure assessment of soil ingestion by children who may enter treated areas soon after application of the product does not exceed the systemic AOEL.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.4.2.2) Worker re-entry exposure is considered to be negligible for granular plant protection products. In addition, no relevant dermal absorption is assumed. Therefore, worker exposure estimation was not necessary and was not performed.

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

Hazard symbol(s): None Indication(s) of danger: None Risk phrases: None Safety phrases: None Labelling texts and restrictions: To avoid risks to man and the environment, comply with the instructions for use.

According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the following classification for toxicological hazards of the preparation according to GHS would be proposed:

Classification and labelling according to Regulation (EC) No 1272/2008

Hazard class(es), categories: None Signal word: None Hazard statement(s): None Labelling texts and restrictions: To avoid risks to man and the environment, comply with the instructions for use. 97 percent of the mixture consist of ingredients of unknown inhalation toxicity.

Safety phrases for instructions for use

Safety instructions (codes according to BVL a) Justification b) NT658 Keep domestic animals away. 2 NT665 Do not place in piles. 2 SB001 Avoid any unnecessary contact with the product. Misuse can lead to health 1 damage. SB010 Keep out of the reach of children. 2 SB011 Keep children away. 2 VH297 Packaging/containers for use in amateur gardening must be provided with a 2 childproof seal. a) http://www.bvl.bund.de/SharedDocs/Downloads/04_Pflanzenschutzmittel/eAntrag-Codelisten- EN.pdf?__blob=publicationFile&v=6 b) Justification: 1 Mandatory for plant protection products 2 With regard to preventive health protection and good agricultural practice

3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) Ferric phosphate occurs naturally in soil. Ferric and phosphate ions are plant nutrients and thus are also common constituents in plants. The use of ferric phosphate as a plant protection product is not expected to generate any residues of practical significance as compared to the natural background concentration in the environment. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005, neither a residue definition nor MRLs were established.

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Thus estimation of consumer risk assessment is not necessary. The chronic and short-term intake of ferric phosphate residues resulting from pesticide uses is unlikely to present a public health concern.

The pre-harvest interval (PHI) is covered by the conditions of use (F). The setting of a pre-harvest interval (PHI) is without any relevance (N, for ornamentals).

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

No new studies are presented; all data were reviewed in the EU review for ferric phosphate. Appropriate endpoints from the EU review were used to calculate PECs for ferric phosphate for the intended use patterns. Ferric phosphate is considered to be a stable, non-volatile salt which is practically insoluble in water. Both, ferric and phosphate ions are naturally occurring in soil. Iron phosphates occurring in soils are e. g. strengite (FePO 4 · 2 H 2O, stable in acidic soils) and vivianite (Fe 3(PO 4)2 · 8 H 2O, stable under anaerobic conditions). Iron occurs in a wide variety of minerals and is the fourth most abundant element in the lithosphere. In soils under aerobic conditions iron is present mostly in form of insoluble Fe(III) oxides (e. g. goethite, haematite, ferrihydrite); The fate and transport of Fe(II) and Fe(III) salts in the environment is dominated by three major processes: (1) the pH-redox potential dependent oxidation of Fe(II) to Fe(III); (2) the formation of insoluble oxides and hydroxides that are also well known components of soils; (3) the distinct surface chemistry of the oxides and hydroxides of iron that control the adsorption of anions, cations and organic material or the adsorption of iron species onto the surfaces of mineral and organic components of soils, contributing to the aggregation of soil particles into larger units. The primary source of phosphorous in soils, which is present as orthophosphate anion, is the mineral apatite (Ca 5(PO 4)3OH). In soils there are several mechanisms of immobilisation of the phosphate anion: sorption to inorganic soil components (e. g. Fe(III) oxides), precipitation as low soluble Ca-, Al- or Fe- phosphates and chemical binding to humic substances. Thus most of the total phosphorus is part of the soil solids. Only about 0.1 % of the phosphorus content is dissolved in the soil solution where concentrations of 0.001 – 0.1 mg/L (non fertilised soils) and 0.1 – 5 mg/L (fertilised soils) occur. There are natural mechanisms whereby soil microorganisms and plant rootlets, aided by carbon dioxide and other root exudates, will transform the insoluble ferric phosphate into forms that are usable by plants. Iron is a plant micronutrient and phosphorous is a macronutrient, both of which are essential to plant growth and development. The insolubility of ferric phosphate ensures that breakdown is a slow process. Although the solubility of ferric phosphate increases with water temperature, at normal soil temperatures it is practically insoluble (1.86× 10 -12 g/L, calculated, pH 7, 25°C). The end use product is not intended for use in an aquatic environment, but it should be noted that ferric phosphate’s insolubility in water combined with its ready adsorption to the soil renders it immobile. As a consequence it is unlikely that the Ferric phosphate would migrate from the area of application into aquatic systems. In addition, ferric phosphate is a highly stable compound that does not break down in sunlight and is a non-volatile solid which would not be mobile in the air.

3.1.5.1 Predicted Environmental Concentration in Soil (PEC soil ) (Part B, Section 5, Points IIIA 9.4)

A detailed description of PEC SOIL calculations, modelling inputs and results for Germany is given in the Core Assessment, Part B, Section 5, Chapter 5.5 and in the National Addendum, Part B Section 5, Chapter 5.2.

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For German exposure assessment, the applied soil depth is based on experimental data 1 (Fent, 1999). Generally, for active substances with a K f,oc < 500 a soil depth of 2.5 cm is used whereas for active substances with a K f,oc > 500 a soil depth of 1 cm is applied.

The initial PEC soil calculations according to the FOCUS guidance were performed with ESCAPE 2.0 considering an even distribution of the compound within a soil layer of 1 cm depth and a bulk density of 1.5 g/cm³. The standard soil depth of 1 cm was considered for ferric phosphate due to substance properties – considered to be immobile, indicating a strong potential of adsorption to soil.

The short-term and long-term actual concentrations (PEC soil,actual ) and the time weighted average concentrations (PEC soil,twa ) for the active substance ferric phosphate were not calculated because no reliable DT 50 value in soil could be obtained for the active substance ferric phosphate. Therefore, considering multiple applications, as a worst-case scenario it is assumed that COM 802 09 M RB is applied in one cumulative application of 200 kg/ha (corresponding to 2.5 kg/ha ferric phosphate) to vegetables, fresh herbs, fruits, ornamentals and potatoes. However, it can be realistically concluded that this cumulative application does not reflect the conditions of use since e. g. ingestion by slugs takes place between applications.

The initial PEC SOIL value for the formulation after single and multiple applications are 333.33 -1 -1 mg kg and 1333.33 mg kg respectively. The initial PEC SOIL for ferric phosphate in the upper 1 cm soil layer after single and multiple applications are 4.167 and 16.667 mg kg -1, respectively.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PEC GW ) (Part B, Section 5, Point IIIA 9.6)

The calculation of predicted environmental concentrations in ground water (PEC GW ) of ferric phosphate was not performed and was not considered to be required.

The active substance ferric phosphate is a stable, non-volatile inorganic salt which is practically insoluble in water. Due to the insolubility and strong adsorption on soil, it is practically immobile in soil. In soil ferric phosphate is transformed into iron and phosphate which are both naturally constituents of soil occurring in concentrations of 0.2 – 5 % and 0.01 – 0.2 % (expressed as P), respectively. Therefore risk to groundwater contamination resulting from ferric phosphate application according to the GAP table is not expected.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PEC SW ) (Part B, Section 5, Points IIIA 9.7)

The calculation of predicted environmental concentrations in surface water (PEC SW ) of ferric phosphate was not performed and was not considered to be required.

The active substance ferric phosphate is a stable, non-volatile inorganic salt which is practically insoluble in water. COM 802 09 M RB is considered to be spread across cultivated areas as a ready to use bait and a contamination of surface water via spray drift can therefore be excluded.

1 Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999

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The possible entry route into adjacent water bodies is considered to be via run-off of soil particles containing the active substance after heavy rain events. The maximum environmental concentration which will be expected in the water phase will correspond to the water solubility of ferric phosphate. The insoluble portion remaining in the sediment will add to the natural content of iron and phosphate in the sediment.

3.1.5.4 Predicted Environmental Concentration in Air (PEC Air ) (Part B, Section 5, Point IIIA 9.9)

PEC air is currently not defined for German risk assessment and is not relevant, due to the proposed use pattern.

Implications for labelling resulting from environmental fate assessment :

None.

3.1.6 Ecotoxicology (Part B, Section 6, Point IIIA 10) COM 802 09 M RB was not the representative formulation considered in the EU review process as part of Annex I inclusion and has not been previously evaluated in other Member States according to the Uniform Principles. Therefore additional studies on the effects of the formulation on non-target organisms were submitted and evaluated.

Only information relevant for the prescription of national labelling and environmental restrictions are mentioned in the following chapters. Details of ecotoxicological studies and risk assessment are described in the Core Assessment and the National Addendum Germany, Part B, Section 6, respectively.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points IIIA 10.1 and IIIA 10.3) There is no unacceptable risk for terrestrial vertebrates. No further risk mitigation measures are required for the intended use pattern.

For details of the risk assessment see Core Assessment, Part B, Section 6, Chapter 6.2 (Point IIIA 10.1) and Chapter 6.3 (Point IIIA 10.3), respectively.

3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point IIIA 10.2) There is no unacceptable risk for aquatic species. No further risk mitigation measures are required for the intended use pattern. For the field uses labelling with a reference to the prohibition of application of plant protection products in or in the immediate vicinity of surface waters stipulated by law (§ 12 Pflanzenschutzgesetz) is required (NW642-1).

For details of the risk assessment see Core Assessement, Part B, Section 6, Chapter 6.4 (Point IIIA 10.2).

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Part A COM 802 09 M RB Registration Report –Central Zone National Assessment Country – Germany Page 17 of 21

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points IIIA 10.4 and IIIA 10.5)

Bees All hazard quotients for oral and contact exposure are well below the trigger of 50, indicating that the formulation poses no risk to bees. However, bees will not be exposed by the recommended uses of COM 802 09 M RB as a bait formulation.

NB663 : Due to the manner in which authorisation governs application of the product, bees are not endangered. (B3)

For details of the risk assessment see Core Assessment, Part B, Section 6, Point IIIA 10.4.

Other arthropods (beneficials) COM 802 09 M RB is classified in general as harmless for populations of relevant beneficial insect species.

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

NN1002 The product is classified as non-harmful for populations of relevant predatory mites and spiders.

Other non-target arthropods (environment) There is no unacceptable risk for other non-target arthropods. No further risk mitigation measures are required for the intended use pattern.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point IIIA 10.5 and IIIA 10.6. and National Addendum Germany, Section 6, Point IIIA 10.5. and IIIA 10.6, respectively.

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point IIIA 10.6) There is no unacceptable risk for earthworms and other soil macro-organisms. No further risk mitigation measures are required for the intended use pattern.

For details of the risks assessment see Core Assessment, Part B, Section 6, Point IIIA 10.6, Part B Section 6 and National Addendum Germany, Section 6, Point IIIA 10.6 respectively.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point IIIA 10.6.7, Part B Section 6, Point 6.2.4)

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 06/12/2012

Part A COM 802 09 M RB Registration Report –Central Zone National Assessment Country – Germany Page 18 of 21

There is no unacceptable risk for earthworms and other soil macro- and micro-organisms. No further risk mitigation measures are required for the intended use pattern.

There is no indication of any unacceptable adverse effects on soil macro-organisms relevant for the maintenance of soil quality. Studies on effects of ferric phosphate on organic matter breakdown are not deemed to be required.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point IIIA 10.6 and IIIA 10.7).

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point IIIA 10.7) There is no unacceptable risk for soil non-target micro-organisms. No further risk mitigation measures are required for the intended use pattern.

There is no indication of any unacceptable adverse effects on soil micro-organisms relevant for the maintenance of soil quality. Studies on effects of ferric phosphate on soil microbial activity are not deemed to be required.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point IIIA 10.7.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point IIIA 10.8) There is no unacceptable risk for other non-target organisms (flora and fauna), especially non- target plants. No further risk mitigation measures are required for the intended use pattern.

For details of the risk assessment see Core Assessment, Part B, Section 6, Point 10.8.

3.1.6.8 Implications for labelling resulting from ecotoxicological assessment: Classification and labelling of the formulation COM 802 09 M RB for the intended use pattern are summarised in the following Table.

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 06/12/2012

Part A COM 802 09 M RB Registration Report –Central Zone National Assessment Country – Germany Page 19 of 21

Table 3.1.5.4.8-1 Classification and labelling of the formulation “COM 802 09 M RB“ Ferric phosphate (12.5 g/kg)

LC 50 (96 h, Oncorhynchus mykiss ) > 100 mg product/L Relevant toxicity data EC 50 (48 h, Daphnia magna ) > 100 mg product/L

EC 50 (72 h, Algae – Scenedesmus subspicatus ) > 100 mg product/L Classification & Labelling according directives 67/548/EEC, 78/631/EEC and 1999/45/EEC

Danger Symbol none

Risk Phrases none

C&L according Regulation (EC) No. 1272/2008

Danger Symbol none

Hazard Statements none

Other phrases

NW466 The product and its remains and empty containers and packaging must not be dumped in water. 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. Uses: 001, 004, 007, 010, 013

3.1.7 Efficacy (Part B, Section 7, Point 8) All the data regarding the efficacy of the product have been submitted. These data together with further expert knowledge demonstrate that COM 802 09 M RB fulfils all criteria for the authorization of preparations described in Commission Regulation (EU) No 546/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. If the product is deposited directly on plant surfaces like leaves or flowers during application, it might cause colored spots which would be an undesirable effect in ornamental plants and vegetables. This problem was not addressed in the submitted data, but could be avoided by distributing the granules on the soil between the plants. Based on several years of practical use of ferric phosphate it is not expected to have any impact on the processing procedure or on the yield of treated plants and plant products No phytotoxicity effects, effects on animals or adverse effects on the site of application were observed.

3.2 Conclusions

The EU review concluded that no harmful effects on human or animal health and no unacceptable effects on the environment will arise from the usage of ferric phosphate as a molluscicide. Thus no residues have to be monitored and no analytical methods are required.

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 06/12/2012

Part A COM 802 09 M RB Registration Report –Central Zone National Assessment Country – Germany Page 20 of 21

As the product is a bait distributed on the soil surface, the effect is restricted to slugs feeding above soil surface and to damage on aerial plant parts. An adequate protection of subterranean plant parts like roots, bulbs, rhizomes or tubers was not evaluated in any of the submitted trials and cannot be extrapolated from the submitted data. An acceptable protection of subterranean plant parts from slug damage is unlikely. Therefore in the intended uses on vegetables and ornamentals for Germany the information is given that the product is only for protection of emergence and protection against leaf consumption by slugs.

The applicant has to specify in the use instructions that the uses on balconies and terraces are meant to be restricted to potted plants and not for the sealed area in general. It is unclear how the dosing of the product has to be conducted in containers of potted plants on terraces and balconies. This has to be clarified in the use instructions, for example by giving the number of granules of the product / area for small areas like plant pots.

Bees will not be exposed by the recommended uses of COM 802 09 M RB as a bait formulation.

Harmful effects on ground water consequent to the intended uses of the product “COM 802 09 M RB” have not to be apprehended. Specific additional risk mitigation measures to prevent unacceptable effects on non-target organisms are not required.

No adverse health effects for operators and bystanders will be expected, worker re-entry exposure is considered to be negligible.

An authorisation can be granted for all uses.

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

The following information is required in order to obtain (a prolongation of) the authorisation:

AnnexIII Data point

KIIIA1 2.7.5 A study showing a shelf life of two years is requested. The interim report (1 year storage) is finalised but not submitted. The final report will be finished in May 2013 and must be submitted for evaluation.

…

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 06/12/2012

Part A COM 802 09 M RB Registration Report –Central Zone National Assessment Country – Germany Page 21 of 21

Appendix 1 – Copy of the product authorisation See below

Appendix 2 – Copy of the product label (not yet available) • 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 drawn by the competent authority. The final version of the label is not available, because the layout is the sole responsibility of the applicant and will not be checked again.

Appendix 3 – Letter of Access • No letter of access necessary.

Applicant COMPO GmbH & Co. KG Applicant Document ID dRR Part A Date 06/12/2012

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Birgit Schreiber Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referentin Mit Zustellungsurkunde TELEFON +49 (0)531 299-3612 TELEFAX +49 (0)531 299-3002 E-MAIL [email protected] Compo GmbH & Co. KG INTERNET www.bvl.bund.de Gildenstraße 38 48157 Münster IHR ZEICHEN IHRE NACHRICHT VOM

AKTENZEICHEN 200.22100.007517-00/00.61131 (bitte bei Antwort angeben)

DATUM 8. Februar 2013

ZV1 007517-00/00 COM 802 09 M RB Zulassungsverfahren für Pflanzenschutzmittel Bescheid

Das oben genannte Pflanzenschutzmittel

mit dem Wirkstoff: 12,5 g/kg Eisen-III-phosphat

Zulassungsnummer: 007517-00

Versuchsbezeichnung: COM-80209-M-0-RB

Antrag vom: 16. September 2011

wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzen- schutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen:

Zulassungsende 0 .

1 Die Zulassung endet am 31. Dezember 2016. V _ 0 0 2 _ 7 3 4 2 _ 5 0 _ O F _ L V B

Dienstsitz Braunschweig Abt. Pflanzenschutzmittel Dienststelle Berlin Referatsgr. Untersuchungen Bundesallee 50, Geb. 247 Messeweg 11/12 Mauerstraße 39-42 Diedersdorfer Weg 1 38116 Braunschweig 38104 Braunschweig 10117 Berlin 12277 Berlin Tel: +49 (0)531 21497-0 Tel: +49 (0)531 299-5 Tel: +49 (0)30 18444-000 Tel: +49 (0)30 18412-0 Fax: +49 (0)531 21497-299 Fax: +49 (0)531 299-3002 Fax: +49 (0)30 18444-89999 Fax: +49 (0)30 18412-2955 SEITE 2 VON 32

Festgesetzte Anwendungsgebiete bzw. Anwendungen

Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1):

Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 007517-00/00-004, Nacktschnecken frische Kräuter 007517-00/00-005, 007517-00/00-006 007517-00/00-001, Nacktschnecken Gemüsekulturen 007517-00/00-002, 007517-00/00-003 007517-00/00-013 Nacktschnecken Kartoffel 007517-00/00-007, Nacktschnecken Obstkulturen 007517-00/00-008, 007517-00/00-009 007517-00/00-010, Nacktschnecken Zierpflanzen 007517-00/00-011, 007517-00/00-012

Festgesetzte Anwendungsbestimmungen

Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281) festgesetzt: - keine -

Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.

Verpackungen

Gemäß § 36 Abs. 1 S. 2 Nr. 1 und 2 PflSchG sind für das Pflanzenschutzmittel die nachfol- gend näher beschriebenen Verpackungen in Verbindung mit den in Anlage 1 für den Haus- und Kleingartenbereich aufgeführten Anwendungen für die Anwendung durch nichtberufliche Anwender zugelassen:

Verpackungs- Verpackungs- Anzahl Inhalt art material von bis von bis Einheit 0 . 1 V _ 0 0

2 Beutel Kunststoff 1 100,00 2500,00 g _ 7 3 4 2 _ 5

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Verpackungs- Verpackungs- Anzahl Inhalt art material von bis von bis Einheit Dose Pappe, Karton 1 100,00 1000,00 g Schachtel Pappe, Karton 1 100,00 2500,00 g

Die Verpackungen für den nichtberuflichen Anwender sind wie folgt zu kennzeichnen: Anwendung durch nichtberufliche Anwender zulässig.

Auflagen

Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden: Kennzeichnungsauflagen: (NT658) Haustiere fernhalten.

(NT665) Nicht in Häufchen auslegen.

(NW466) Mittel und dessen Reste sowie entleerte Behälter und Packungen nicht in Gewässer gelan- gen lassen.

(SB001) Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschä- den führen.

(SB010) Für Kinder unzugänglich aufbewahren.

(SB011) Kinder fernhalten.

Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.

Sonstige Auflagen: (VH297) 0 . 1 V _

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Vorbehalt

Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.

Angaben zur Einstufung und Kennzeichnung gemäß § 4 Gefahrstoffverordnung

Gefahrenhinweise (R-Sätze): - keine -

Sicherheitshinweise (S-Sätze): - keine -

Zur Vermeidung von Risiken für Mensch und Umwelt ist die Gebrauchsanleitung einzuhalten.

Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG) Nr. 1272/2008

Signalwort: - keine -

Gefahrenpiktogramme: - keine -

Gefahrenhinweise (H-Sätze): (EUH 401) Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.

Sicherheitshinweise (P-Sätze): - keine -

Abgelehnte Anwendungsgebiete bzw. Anwendungen

Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine - 0 . 1 V _ 0 0 2 _ 7 3 4 2 _ 5 0 _ O F _ L V B SEITE 5 VON 32

Hinweise

Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden: (NB663) Aufgrund der durch die Zulassung festgelegten Anwendungen des Mittels werden Bienen nicht gefährdet (B3).

(NN1001) Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft.

(NN1002) Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen eingestuft.

Weitere Hinweise und Bemerkungen Zur Etikettierung: Auf dem Etikett ist zusätzlich zum Wirkstoffgehalt anzugeben: "Enthält ca. 1 g/L Kaliumsorbat als Konservierungsmittel"

Gemäß Verordnung (EG) Nr. 1272/2008 ist das Gemisch mit folgendem Hinweis zu kennzeichnen: 97 % des Gemisches bestehen aus einem oder mehreren Bestandteilen von unbekannter inhalativer Toxizität.

Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben, soweit sie noch nicht erfüllt sind.

Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulas- sungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen.

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Rechtsbehelfsbelehrung

Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur Niederschrift einzulegen.

Mit freundlichen Grüßen im Auftrag

gez. Dr. Hans-Gerd Nolting Abteilungsleiter

Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.

Anlage 0 . 1 V _ 0 0 2 _ 7 3 4 2 _ 5 0 _ O F _ L V B SEITE 7 VON 32

Anlage 1 zugelassene Anwendung: 007517-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Gemüsekulturen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Haus- und Kleingartenbereich: Freiland - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m²

- Erläuterungen: 0 . 1

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2.2 Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstenge- wässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorge- gebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.

2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Freiland: Gemüsekul- turen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-002 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Gemüsekulturen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Haus- und Kleingartenbereich: Gewächshaus - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m²

- Erläuterungen: 0 . 1

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2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Gewächshaus: Gemü- sekulturen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-003 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Gemüsekulturen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Gemüsebau Anwendungsbereich: Haus- und Kleingartenbereich: Terrassen und Bal- kone - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m² 0 .

1 - Erläuterungen: V _ 0 0 2 _ 7

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2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Terrassen und Bal- kone: Gemüsekulturen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-004 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: frische Kräuter Verwendungszweck:

- Erläuterungen: 0 . 1

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2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Freiland: frische Kräu- ter Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-005 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: frische Kräuter Verwendungszweck:

- Erläuterungen: 0 . 1

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2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Gewächshaus: frische Kräuter Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-006 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: frische Kräuter Verwendungszweck:

1 - Erläuterungen: V _ 0 0 2 _ 7

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2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Terrassen und Bal- kone: frische Kräuter Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

3 Anwendungsbezogene Anwendungsbestimmungen - keine - 0 . 1 V _ 0 0 2 _ 7 3 4 2 _ 5 0 _ O F _ L V B SEITE 19 VON 32

Anlage 1 zugelassene Anwendung: 007517-00/00-007 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Obstkulturen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Obstbau Anwendungsbereich: Haus- und Kleingartenbereich: Freiland - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m²

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2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Freiland: Obstkulturen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-008 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Obstkulturen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Obstbau Anwendungsbereich: Haus- und Kleingartenbereich: Gewächshaus - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m²

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2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Gewächshaus: Obst- kulturen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-009 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Obstkulturen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Obstbau Anwendungsbereich: Haus- und Kleingartenbereich: Terrassen und Bal- kone - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m² 0 .

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2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Terrassen und Bal- kone: Obstkulturen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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Anlage 1 zugelassene Anwendung: 007517-00/00-010 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Zierpflanzen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Haus- und Kleingartenbereich: Freiland - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m²

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2.3 Wartezeiten (N) Haus- und Kleingartenbereich: Freiland: Zierpflanzen Die Festsetzung einer Wartezeit ist ohne Bedeutung.

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Anlage 1 zugelassene Anwendung: 007517-00/00-011 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Zierpflanzen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Haus- und Kleingartenbereich: Gewächshaus - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m²

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2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten (N) Haus- und Kleingartenbereich: Gewächshaus: Zier- pflanzen Die Festsetzung einer Wartezeit ist ohne Bedeutung.

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Anlage 1 zugelassene Anwendung: 007517-00/00-012 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Zierpflanzen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Haus- und Kleingartenbereich: Terrassen und Bal- kone - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m² 0 .

1 - Erläuterungen: V _ 0 0 2 _ 7

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2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten (N) Haus- und Kleingartenbereich: Terrassen und Bal- kone: Zierpflanzen Die Festsetzung einer Wartezeit ist ohne Bedeutung.

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Anlage 1 zugelassene Anwendung: 007517-00/00-013 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Nacktschnecken Pflanzen/-erzeugnisse/Objekte: Kartoffel Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Ackerbau Anwendungsbereich: Haus- und Kleingartenbereich: Freiland - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Ja Erläuterung zum Schadorganismus: Stadium des Schadorganismus: Larven und Adulte - Erläuterungen: Erläuterung zur Kultur: Stadium der Kultur: - Erläuterungen: Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 4 - für die Kultur bzw. je Jahr: 4 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: streuen - Erläuterungen: Köderverfahren / gleichmäßig über den Bestand / zwischen die Kulturpflanzen Aufwand: - 5 g/m²

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2.3 Wartezeiten (F) Haus- und Kleingartenbereich: Freiland: Kartoffel Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

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REGISTRATION REPORT Part B Section 1: Identity, physical and chemical properties, other information

Detailed summary of the risk assessment

Product code: COM 802 09 M RB

Active Substance: Ferric phosphate 12.5 g/kg

Central Zone

Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Compo GmbH&Co. KG

Date: 06 December 2012

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 2 of 47

Table of Contents

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT...... 7

IIIA 1.1 Applicant...... 7

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s) ...... 7

IIIA 1.2.1 Manufacturer(s) of the preparation ...... 7

IIIA 1.2.2 Manufacturer(s) of the active substance(s)...... 7

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s)...... 7

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation...... 7

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation...... 8

IIIA 1.4.1 Content of active substance and formulants...... 8

IIIA 1.4.2 Certified limits of each component...... 9

IIIA 1.4.3 Common names and code numbers for the active substance(s)...... 9

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function...... 9

IIIA 1.4.5 Formulation process...... 10

IIIA 1.4.5.1 Description of formulation process...... 10

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern...... 10

IIIA 1.5 Type of Preparation and Code...... 10

IIIA 1.6 Function...... 10

IIIA 1.7 Other/Special Studies...... 10

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT ...... 11

IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15...... 20

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 3 of 47

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT ...... 20

IIIA 3.1 Field of Use...... 20

IIIA 3.2 Nature of the Effects on Harmful Organisms...... 20

IIIA 3.3 Details of Intended Use ...... 20

IIIA 3.3.1 Details of existing and intended uses ...... 20

IIIA 3.3.2 Details of harmful organisms against which protection is afforded...... 20

IIIA 3.3.3 Effects achieved ...... 20

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) ...... 21

IIIA 3.5 Concentration of the Active Substance in the Material Used ...... 21

IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent ...... 21

IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection...... 21

IIIA 3.7.1 Maximum number of applications and their timings ...... 21

IIIA 3.7.2 Growth stages of crops or plants to be protected...... 21

IIIA 3.7.3 Development stages of the harmful organism concerned ...... 21

IIIA 3.7.4 Duration of protection afforded by each application...... 21

IIIA 3.7.5 Duration of protection afforded by the maximum number of applications ...... 21

IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops ...... 21

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops...... 21

IIIA 3.8.2 Limitations on choice of succeeding crops ...... 21

IIIA 3.8.3 Description of damage to rotational crops...... 21

IIIA 3.9 Proposed Instructions for Use as Printed on Labels...... 22

IIIA 3.10 Other/Special Studies...... 22

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 4 of 47

IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT ...... 23

IIIA 4.1 Packaging and Compatibility with the Preparation ...... 23

IIIA 4.1.1 Description and specification of the packaging ...... 23

IIIA 4.1.2 Suitability of the packaging and closures...... 26

IIIA 4.1.3 Resistance of the packaging material to its contents...... 27

IIIA 4.2 Procedures for Cleaning Application Equipment...... 27

IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing...... 27

IIIA 4.2.2 Effectiveness of the cleaning procedures...... 27

IIIA 4.2.3 Re-entry periods to Protect Man, Livestock and the Environment ...... 27

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks...... 27

IIIA 4.4.1 Warehouse storage ...... 27

IIIA 4.4.2 User level storage...... 27

IIIA 4.4.3 Transport ...... 28

IIIA 4.4.4 Fire...... 28

IIIA 4.4.5 Nature of protective clothing proposed...... 28

IIIA 4.4.6 Characteristics of protective clothing proposed...... 28

IIIA 4.4.7 Suitability and effectiveness of protective clothing and equipment ...... 28

IIIA 4.4.8 Procedures to minimise the generation of waste ...... 28

IIIA 4.4.9 Combustion products likely to be generated in the event of fire ...... 28

IIIA 4.5.1 Containment of spillages...... 28

IIIA 4.5.2 Decontamination of areas, vehicles and buildings...... 28

IIIA 4.5.3 Disposal of damaged packaging, adsorbents and other materials...... 29

IIIA 4.5.4 Protection of emergency workers and bystanders ...... 29

IIIA 4.5.5 First aid measures ...... 29

IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage...... 29

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 5 of 47

IIIA 4.6.1 Details of proposed procedures for small quantities...... 29

IIIA 4.6.2 Evaluation of products of neutralization (small quantities)...... 29

IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste ...... 29

IIIA 4.6.4 Details of proposed procedures for large quantities ...... 30

IIIA 4.6.5 Evaluation of products of neutralization (large quantities) ...... 30

IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste...... 30

IIIA 4.7 Pyrolytic Behaviour of the Active Substance...... 30

IIIA 4.8 Disposal Procedures for the Plant Protection Product...... 30

IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging...... 30

IIIA 4.8.2 Methods other than controlled incineration for disposal ...... 30

IIIA 4.9 Other/Special Studies...... 30

IIIA 11 FURTHER INFORMATION...... 30

IIIA 11.1 Information of Authorisations in Other Countries...... 30

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries...... 30

IIIA 11.3 Justified Proposals for Classification and Labelling...... 30

IIIA 11.4 Proposals for Risk and Safety Phrases...... 31

IIIA 11.5 Proposed Label ...... 31

IIIA 11.6 Specimens of Proposed Packaging...... 31

Appendix 1: List of data used in support of the evaluation ...... 32

Appendix 2: Critical Uses – justification and GAP tables...... 39

Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics:...... 47

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 6 of 47

Introduction This document summarises the information related to the identity, the physical and chemical properties, the data on application, further information and the classification for the product COM 802 09 M RB containing the active substance ferric phosphate which was approved according to Regulation (EC) No 1107/2009. This product was not the representative formulation. The product has not been previously evaluated according to Uniform Principles.

The review report for Ferric phosphate (SANCO/3035/99 – 08/03/2002) is considered to provide the relevant review information or a reference to where such information can be found.

The following table provides the EU endpoints to be used in the evaluation.

Agreed EU End-points

End-Point Ferric phosphate (2001/87/EC, Reg. 540/2011))

Purity of active substance Min 990 g/kg

The Annex I Inclusion Directive for Ferric phosphate (2001/87/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation:

Appendix 1 of this document contains the list of references included in this document for support of the evaluation.

Appendix 2 of this document is the table of intended uses for COM 802 09 M RB.

Information on the detailed composition of COM 802 09 M RB can be found in the confidential dossier of this submission (Registration Report - Part C).

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 7 of 47

IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT

IIIA 1.1 Applicant Name: COMPO GmbH & Co. KG Address: Gildenstr. 38 48157 Münster Germany

Person to contact Name: Dr. Otto Schweinsberg Phone: +49 251-3277-457 Fax: +49 251-3277-1457 E-mail: [email protected]

IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s)

IIIA 1.2.1 Manufacturer(s) of the preparation

Confidential information - data provided separately (Part C).

IIIA 1.2.2 Manufacturer(s) of the active substance(s)

Confidential information - data provided separately (Part C).

IIIA 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s)

Ferric phosphate anhydrous: minimum 786 g/kg (equivalent to Annex I inclusion: 990 g/kg ferric phosphate tetrahydrate equals 670 g/kg ferric phosphate anhydrous)

Further information/justification is provided in Part C.

IIIA 1.3 Trade Names and Manufacturer’s Code Numbers for the Preparation

Trade name: COM 802 09 M RB

Company code number: COM 802 09 M RB

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 8 of 47

IIIA 1.4 Detailed Quantitative and Qualitative Information on the Composition of the Preparation

IIIA 1.4.1 Content of active substance and formulants

The formulation was not the representative formulation. Pure active substance Ferric phosphate as 1 15.5 g/kg Ferric orthophosphate dihydrate (FePO 4 · 2H 2O) Ferric phosphate as 2 12.5 g/kg Ferric orthophosphate anhydrous (FePO 4)

limits according to FAO/WHO manual (2010):

Ferric orthophosphate dihydrate (FePO 4 · 2H 2O) 11.63 – 19.38 g/kg

Ferric orthophosphate anhydrous (FePO 4) 9.38 – 15.63 g/kg

Technical active substance:

Ferric phosphate as

Ferric orthophosphate anhydrous (FePO 4) 12.8 g/kg at minimum purity (calculated) Ferric phosphate as

Ferric orthophosphate dihydrate (FePO 4 · 2H 2O) 15.9 g/kg at minimum purity (97,4 %) Ferric phosphate as

Ferric orthophosphate tetrahydrate (FePO 4 · 4H2O) 19.0 g/kg at minimum purity (calculated)

Further information on the active substances and on the certified limits of formulants is considered confidential and is provided separately (Part C).

1 Expressed as dihydrate as specified in the MSDS of the active substance 2 Expressed as anhydrous as determined in the five-batch analysis

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 9 of 47

IIIA 1.4.2 Certified limits of each component

This is not an EC data requirement/ not required by regulation (EU) 2011/545.

IIIA 1.4.3 Common names and code numbers for the active substance(s)

Table 1.4.3-1: Details on the active substance Ferric phosphate SUBSTANCE (Trade Ferric phosphate name) Chemical name: Ferric phosphate IUPAC Ferric phosphate CAS Ferric phosphate ISO common name Ferric phosphate Ferric orthophosphate tetrahydrate Synonymes Ferric orthophosphate dihydrate CAS No. 10045-86-0 CIPAC 629 EINECS No 233-149-7 Annex I Index# Not allocated

FePO 4

Molecular formula FePO 4 · 2 H 2O

FePO 4 · 4 H 2O

Structural formula

150.82 g/mol, anhydrous Molecular mass [g/mol] 186,86 g/mol, dihydrate 222.9 g/mol, tetrahydrate Function Active substance

IIIA 1.4.4 Co-formulant details: identity, structure, codes, trade name, specification and function.

CONFIDENTIAL information - data provided separately (Part C).

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment – Germany Page 10 of 47

IIIA 1.4.5 Formulation process

IIIA 1.4.5.1 Description of formulation process

This is not an EC data requirement/ not required regulation (EU) 2011/545.

IIIA 1.4.5.2 Discussion of the formation of impurities of toxicological concern

Ferric phosphate does not contain any impurities of toxicological or ecotoxicological concern.

IIIA 1.5 Type of Preparation and Code Type: Bait (ready for use) [Code: RB]

IIIA 1.6 Function

The product will be used as molluscicide

IIIA 1.7 Other/Special Studies

None.

Applicant: Compo Evaluator: DE Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Core Assessment Central Zone Germany Page 11 of 47

IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT The product COM 802 09 M RB was not the representative formulation. All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of solid flowable granules with a light-bluish green colour and a characteristic odour (like corn). It is not explosive and has no oxidising properties. No self ignition temperature was observed up to the maximum test temperature of 409 °C, according to the testing guideline for auto-flammability. In aqueous solution, it has a pH value around 7.5. The accelerated storage stability data indicate a shelf life of at least 2 years at ambient temperature. Its technical characteristics are acceptable for a ready-to-use bait formulation.

Tabelle 1: Summary of the physical, chemical and technical properties of the plant protection product

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

Colour, odour and Visual assessment and COM 802 09 M RB COM 802 09 M RB is a solid Y Schieck, S. (2011a) Acceptable physical state organoleptic formulation with a light-bluish (IIIA 2.1) determination Batch No. 07/097 green colour and a characteristic odour. Ferric phosphate nominal conc.: 1.25 % w/w After storage (54 °C, 14 d): (Nominal: 0.463% Iron) no change

Explosive properties EEC A.14 COM 802 09 M RB The test item has no explosive Y Dornhagen, D. Acceptable (IIIA 2.2.1) Batch No. 07/097 properties. (2011a) not explosive

Oxidizing properties EEC A.17 COM 802 09 M RB The test item has no oxidizing Y Dornhagen, D. Acceptable properties. (2011b)

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Core Assessment Central Zone Germany Page 12 of 47

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

(IIIA 2.2.2) Batch No. 07/097 not oxidising Flash point - - Not required, because test item is - - Acceptable (IIIA 2.3.1) not a liquid.

Flammability EEC A.10 COM 802 09 M RB The test item is not a highly Y Dornhagen, D. Acceptable (IIIA 2.3.2) Batch No. 07/097 flammable solid in the sense of the (2011c) not highly flammable European Commission Regulation (EC) No. 440/2008, Method A.10 and the UN Recommendations on the Transport of Dangerous Good, Manual of Tests and Criteria Part III, UN Test N. 1.

Auto-flammability EEC A.16 COM 802 09 M RB No auto-ignition up to a temperature Y Dornhagen, D. Acceptable (IIIA 2.3.3) Batch No. 07/097 of 409 °C. (2011d)

Acidity or alkalinity CIPAC MT 191 COM 802 09 M RB Y Schieck, S. (2011a) Acceptable and pH Batch No. 07/097 The free acidity and alkalinity was (IIIA 2.4.1) not determined, because pH was > 4 and < 10 pH of a 1% aqueous CIPAC MT 75.3 COM 802 09 M RB 7.45 (in deionised water) Y Schieck, S. (2011a) Acceptable dilution, emulsion or Batch No. 07/097 dispersion (IIIA 2.4.2) After storage (54 °C, 14 d): 6.6 (PE) and 6.7 (without PE)

Kinematic viscosity - - Not required, because COM 802 09 - - Acceptable (IIIA 2.5.1) M RB is not a liquid preparation.

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Core Assessment Central Zone Germany Page 13 of 47

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

Dynamic viscosity - - Not required. - - Acceptable (IIIA 2.5.2) Surface tension - - Not required. - - (IIIA 2.5.3)

Relative density - - Not required, because COM 802 09 - - Acceptable (IIIA 2.6.1) M RB is not a liquid preparation.

Bulk or tap density EEC A.3 COM 802 09 M RB Pour density: 0.769 g/mL Y Schieck, S. (2011b) Acceptable (IIIA 2.6.2) CIPAC MT 186 Batch No. 07/097 Tap density: 0.798 g/mL

Carton with PE-inside bag (1 kg) Storage Stability after CIPAC MT 46.3 Y Schiek, S. (2011a) Acceptable. 14 days at 54º C Init.: (Fe): 0.4699 %, (Ferric (IIIA 2.7.1) phosphate): 1.2687 % Formulation is stable End: (Fe): 0.4869 % (Ferric in carton with and phosphate): 1.3146 % without inner PE bag.

No significant change of content (active ingredient) was determined (+3,62 %).

No significant change of physical or chemical properties.

Carton without PE-inside bag (1 kg):

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Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

Init.: (Fe): 0.4771 %, (Ferric phosphate): 1.2882 % End: (Fe): 0.4785 % (Ferric phosphate): 1.2920 %

No significant change of content (active ingredient) was determined (+0.29 %).

No significant change of physical or chemical properties.

Stability after storage - - Not required, because the - - Acceptable for other periods preparation is not heat sensitive. and/or temperatures (see Point IIIA 2.7.1) (IIIA 2.7.2) Minimum content - - Not required, because the content of - - Acceptable after heat stability the active substance in the testing preparation did not decrease by (IIIA 2.7.3) more than 5 % in heat stability testing. (see Point IIIA 2.7.1) Effect of low - - Not required, because the - - Acceptable temperatures on formulation COM 802 09 M RB is a stability bait (ready for use) (IIIA 2.7.4)

Ambient temperature - - A shelf life study is on-going. - - Not acceptable. shelf life Please refer to the accelerated An interim report (IIIA 2.7.5) storage stability presented under after 12 month

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Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N Point IIIA 2.7.1. storage is finalised, results are not available. The final report will be finalised in March 2013 and must be submitted for evaluation.

Shelf life in months - - Please refer to 2.7.5 - - Still open, but based (if less than 2 years) on the results of (IIIA 2.7.6) accelerated storage and the composition of the formulation a shelf life of at least two years can be expected.

Wettability - - Not required, because the - - Acceptable (IIIA 2.8.1) formulation COM 802 09 M RB is bait (ready to use). Persistence of - - Not required, because the - - Acceptable foaming formulation COM 802 09 M RB is (IIIA 2.8.2) bait (ready to use). Suspensibility - - Not required, because the - - Acceptable (IIIA 2.8.3.1) formulation COM 802 09 M RB is bait (ready to use). Spontaneity of - - Not required, because the - - Acceptable dispersion formulation COM 802 09 M RB is bait (ready to use).

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Core Assessment Central Zone Germany Page 16 of 47

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

(IIIA 2.8.3.2)

Dilution stability - - Not required, because the - - Acceptable (IIIA 2.8.4) formulation COM 802 09 M RB is bait (ready to use).

Dry sieve test Dry sieve analysis of COM 802 09 M RB The particle size distribution of Y Schieck, S. (2011a) Acceptable (IIIA 2.8.5.1) water dispersible Batch No. 07/097 water dispersible granules is granules specified by the range of two sieves ≥ ≤ ( 90 % and 10 %) CIPAC MT 170 Here: 3350 µm sieve – 2000 µm sieve Fraction: > 3350 µm: 0.72 % > 2000 and < 3350 µm: 98.21 % 98.93 % of the mass of the granules are in the range of the two sieves. A percentage below 4 % (0.44 %) passes a 250 µm sieve and a percentage below 1 % (0.35 % passes a 125 µm sieve. After storage (54 °C, 14 d): no significant change Wet sieve test - - Not required, because the - - Acceptable (IIIA 2.8.5.2) formulation COM 802 09 M RB is a bait (ready to use).

Particle size see KIIIA 2.8.5.1 Acceptable. distribution

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Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N (IIIA 2.8.6.1)

Dust and apparent COM 802 09 M RB Y Schieck, S. (2011a) Acceptable Nominal size range of Apparent 0.756 density of granular granules Batch No. 07/097 density pesticide formulation (IIIA 2.8.6.2) (CIPAC MT 58) > 850 µm 98.51% < 850 > 710 µm 0.08% < 710 > 500 µm 0.18% < 500 > 425 µm 0.32% < 425 > 355 µm 0.22% < 355 > 250 µm 0.16% < 250 > 150 µm 0.18% < 150 µm 0.30% < 150 µm (incl. 0.36% Loss during sieving)

Loss during 0.06% sieving

Dust content CIPAC MT 171 COM 802 09 M RB Mean collected dust: 1.3 mg Y Schieck, S. (2011a) Acceptable (IIIA 2.8.6.3) Batch No. 07/097 After storage (54 °C, 14 d): 1.3 mg (PE), 0.5 mg (without PE)

nearly dust free

Particle size of dust Please refer to dust - Please refer to dust content - Acceptable (IIIA 2.8.6.4) content (Point IIIA (Point IIIA 2.8.6.3) Attrition is low. 2.8.6.3) Friability and attrition CIPAC MT 178 COM 802 09 M RB attrition resistance: 99.71% Y Schieck, S. (2011a) Acceptable

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Core Assessment Central Zone Germany Page 18 of 47

Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

(IIIA 2.8.6.5) Batch No. 07/097 After storage (54 °C, 14 d): 99.86 % (PE); 99.96 (without PE)

Emulsifiability Not required, because the Acceptable (IIIA 2.8.7.1) formulation COM 802 09 M RB is bait (ready to use).

Dispersibility Not required, because the Acceptable (IIIA 2.8.7.1) formulation COM 802 09 M RB is bait (ready to use).

Flowability CIPAC MT 172 COM 802 09 M RB Residue: 0 % Y Schieck, S. (2011a) Acceptable (IIIA 2.8.8.1) Batch No. 07/097 The formulation flowed through the sieve spontaneously. No stacking could be observed. After storage (54 °C, 14 d): 0.0 % (with and without PE) Pourability (including Not required, because the Acceptable rinsed residue) formulation COM 802 09 M RB is (IIIA 2.8.8.2) bait (ready to use). Not required, because the Dustability following Acceptable formulation COM 802 09 M RB is accelerated storage bait (ready to use). (IIIA 2.8.8.3)

Physical The determination of the physical Acceptable compatibility of tank compatibility of tank mixes is not mixes required because COM 802 09 M (IIIA 2.9.1) RB is not intended for use in tank mixes.

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Test or study & Method used / Test material purity Findings GLP Reference Acceptability / Annex point deviations and specification comments Y/N

Chemical The determination of the chemical Acceptable compatibility of tank compatibility of tank mixes is not mixes required because COM 802 09 M (IIIA 2.9.2) RB is not intended for use in tank mixes. Adhesion to seeds COM 802 09 M RB is not intended Acceptable (IIIA 2.10.1) to be used for seed treatment. Distribution to seed COM 802 09 M RB is not intended Acceptable (IIIA 2.10.2) to be used for seed treatment.

Miscibility Not required by regulation (EU) Acceptable. (IIIA 2.11) 2011/545.

Dielectric breakdown Not required by regulation (EU) Acceptable. (IIIA 2.12) 2011/545.

Corrosion Not required by regulation (EU) Acceptable. characteristics 2011/545. (IIIA 2.13)

Container material Not required by regulation (EU) Acceptable. (IIIA 2.14) 2011/545.

Other/special studies Not required by regulation (EU) Acceptable. (IIIA 2.15) 2011/545.

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IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15 COM 802 09 M RB, a bait (ready to use) contains a minimum of 12.5 g/kg Ferric phosphate. The product appears as solid flowable granules with a light-bluish green colour and a characteristic odour (like corn). No self ignition temperature was observed up to the maximum test temperature of 409 °C, according to the testing guideline for auto-flammability. It has no explosive or oxidizing properties in the sense of the European Commission Regulation (EC) No. 440/2008, Method A.14 or A.17. The pH of COM 802 09 M RB is around 7.5. According to the accelerated storage stability COM 802 09 M RB is expected to be stable in its original container at least for 2 years. Its technical properties indicate that no particular problems are expected, when used as recommended.

Experimental testing of the product's physico-chemical and technical characteristics :

See Appendix 3.

Implications for labelling :

No labelling necessary due to physical or chemical properties described above.

IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT

IIIA 3.1 Field of Use

Vegetable - , fruit – and ornamental growing and agriculture.

IIIA 3.2 Nature of the Effects on Harmful Organisms

Ferric phosphate is an inorganic compound that is known to induce pathologic changes to the digestive system of snails and slugs on a cellular base. Calcium metabolism seems to be affected.

IIIA 3.3 Details of Intended Use

IIIA 3.3.1 Details of existing and intended uses

In Germany, COM 802 09 M RB will be mainly used in vegetables, fresh herbs, fruit crops, ornamentals and potatos as field or glasshouse application.

IIIA 3.3.2 Details of harmful organisms against which protection is afforded

The main target pests belong to the genera Deroceras (family Agriolimacidae ) and Arion (family Arionidae ). These are Deroceras reticulatum , D. agreste , D. sturanyi (family Agriolimacidae ) and Arion lusitanicus , A. vulgaris , A. hortensis , A. distinctus , A. rufus and A. ater . Due to the polyphagous nature of slugs with low host plant specificity, these pests cause similar damage in a wide varie-ty of different crops under different growing conditions in field and greenhouse.

IIIA 3.3.3 Effects achieved

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Not relevant here.

IIIA 3.4 Proposed Application Rates (Active Substance and Preparation)

General application rate is 50 kg/ha (625 g/ha of Ferric phosphate) for maximal 4 times.

IIIA 3.5 Concentration of the Active Substance in the Material Used

The product COM 802 09 M RB contains 12.5 g/kg Ferric phosphate.

IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent

COM 802 09 M RB is used as bait treatment. It is spread, uniformly broad-casted across cultivated area, only between plants.

IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection

IIIA 3.7.1 Maximum number of applications and their timings

COM 802 09 M RB can be used in maximum 4 times at the beginning of infestation, when first symptoms or pest organisms occur.

IIIA 3.7.2 Growth stages of crops or plants to be protected

Threr are no special growth stages affected, but especially early growth stages of plants are highly endangered.

IIIA 3.7.3 Development stages of the harmful organism concerned

As bait treatment implies consumption only adult slugs are effected.

IIIA 3.7.4 Duration of protection afforded by each application

Not relevant here.

IIIA 3.7.5 Duration of protection afforded by the maximum number of applications

Not relevant here.

IIIA 3.8 Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops

IIIA 3.8.1 Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops

Not relevant here.

IIIA 3.8.2 Limitations on choice of succeeding crops

The formulated product is a bait that is not taken up by the plants. Ferric phosphate it is not expected to have any impact on the processing procedure.

IIIA 3.8.3 Description of damage to rotational crops

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See IIIA 3.8.2

IIIA 3.9 Proposed Instructions for Use as Printed on Labels

Please refer to Registration Report – Part A, Appendix 2 for Germany. IIIA 3.10 Other/Special Studies

This is not an EC data requirement/ not required by Directive 91/414/EEC.

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IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT

IIIA 4.1 Packaging and Compatibility with the Preparation

Packaging Summary

The packagings are resistant to leakage and appropriate for storage and transport of this kind of product. Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport and handling, resistance to and compatibility with the contents of the packaging, have been submitted and is considered to be acceptable.

IIIA 4.1.1 Description and specification of the packaging Packaging is available with and without childproof locked closures.

Table 4.1.1: PACKAGING DECLARATION BY COUNTRY: No. Kind of Packaging/ Dosing device Closure Size of Country Material packaging

1. Fibreboard box Dosing spoon, PE-bag with 100 – 2500 g All countries with separate PE- dosing pyramid and without 5000 g All countries except AT, bag, with and zip DE, BE without zip- („Box with PE- bag“) 2. Fibreboard box Dosing spoon, - 100 – 2500 g All countries except BE (“Box”) dosing pyramid 5000 g All countries except AT, DE, BE 3. Boîte Plastique With and without Screw cap 100 – 800 g All countries (PE) special dosing device 4. PE-can Screw cap as dosing Screw cap 500 – 1200 g BE only („Can Brenez“) device (10 g flat up to the brim) 5. Paperboard Can Dosing spoon, - 100 – 1000 g All countries except in dosing pyramid BE

Packaging specification of item no. 1 and 2 according to table 4.1.1

Packaging: Carton fibreboard box (148605 CSK 300 BIB 302) Type of closure: reclosable lid construction with tear-off seal Dimension: Height: 165 mm Width: 37.5 mm Length: 115 mm Composite material: coated duplex board, type GD 2, 230 g/m² corrugated board, N-flute,110 g/m² fibreboard type TL brown, 125 g/m² Capacity: Not indicated

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Manufacturer of carton: Not indicated

Packaging: Carton fibreboard box (143041 CSK 250 BIB 325) Type of closure: - Height: 240 mm Width: 64 mm Length: 143 mm composite material: coated duplex board, type GD 2, 230 g/m² corrugated board, E-flute, 125 g/m² fibreboard type KL brown, 115 g/m² Capacity: Not indicated Manufacturer of carton: Not indicated

Packaging: Separate PE-bag (148606 CSK 300) only to be used inside fibreboard box Flat foil made of LDPE, transparent With or without zip Width of role: 300 mm (± 1 mm) Width of rapport: 230 mm Thickness of Material: 70µm Plastic core 76 mm: Capacity: Not indicated Manufacturer of PE-bags: Not indicated

Packaging: Separate PE-bag (145803 CSK 250) only to be used inside fibreboard box. Flat foil made of LDPE, transparent With or without zip Width of role: 370 mm (± 1 mm) Width of rapport: 170 mm Thickness of Material: 70µm Plastic core 76 mm: Capacity: Not indicated Manufacturer of PE-bags: Not indicated

Dosing pyramid Height: 124 mm Width: 170.6 mm Capacity: (60 × 60 × 124) /3 = mm 3 Manufacturer of cans: AJS Verpackung

Dosing spoon Material: Not indicated Capacity: 5 g product for 1 m 2 General Tolerances: ± 0.5 Clearance: 5° Manufacturer of spoon: RBL Plastique

Packaging specification of material no. 3 according to table 4.1.1:

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 25 of 47

Packaging: Boite Plastique COMPO BSD 500 mL With and without special dosing device. PEHD Type of closure: Screw cap Height: 134 mm Width: 63.5 mm Length: 142.5 mm Weight: 63 g Size of opening: 44 mm Capacity: 500 mL Manufacturer of cans: Alpla

Packaging: Boite Plastique COMPO BAD 500 mL With and without special dosing device. PEHD Type of closure: Screw cap Height: 134 mm Width: 63.5 mm Length: 144 mm Weight: 63 g Size of opening: 44 mm Capacity: 500 mL Manufacturer of cans: Alpla

Packaging: Boite Plastique COMPO BAD 1000 mL With and without special dosing device. PEHD Type of closure: Screw cap Height: 205 mm Width: 64 mm Length: 144 mm Weight: 86 g Size of opening: 44 mm Capacity: 1000 mL Manufacturer of cans: Alpla

Packaging: Boite Plastique COMPO BSD 1000 mL With and without special dosing device. PEHD Type of closure: Screw cap Height: 205 mm Width: 64 mm Length: 144 mm Weight: 86 g Size of opening: 44 mm Capacity: 1000 mL Manufacturer of cans: Alpla

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 26 of 47

Packaging specification of material no. 4 according to table 4.1.1:

Packaging: Paperback-Can

Height: 185 mm Diameter: 63 mm Thickness of wall: 1 mm Core with three layers: Aluminium foil to the outside PVC-free protective coating (PET-coat: 2-3 g/m 2) Aluminum foil: 7 µm Glue (Polyvinylacetate), 2 g/m 2 Aluminium, foil laminated to brown kraft paper. 40 g/m 2 Top of tin: Diameter 63mm, with white lower part made from polystyrol and white outer turntable made of polystyrol and 7 stray holes (4 mm) Bottom of tin: Diameter 63 mm, Tinplate, uncoated 7 Stray holes: à 4 mm Manufacturer of cans: Schmitt GmbH & Co. KG

Packaging specification of material no. 5 according to table 4.1.1:

Packaging: PE-Can Brenez PEHD Type of closure: Screw cap Height: 201 mm Width: 67 mm Length: 119 mm Weight: 62 g Size of opening: 38.5 mm Capacity: 1000 mL Manufacturer of cans: Societe des Plastiques Brenez, Astra Plastiques

Packaging: PP-Press and turn screw cap with child proof opening CRC 42/JO-C Sealing: Alkozell,PELD foam Height: 17.4 mm Height over all: 22.75 mm Diameter: 48.6 mm Weight: 5.75 g Manufacturer of cans: Baxter Injection

IIIA 4.1.2 Suitability of the packaging and closures The above mentioned packaging and closures are suitable for containing, handling and transport of the formulation COM 802 09 M RB as indicated by the results of the accelerated storage at 54 °C for 14 days. Furthermore the specified packaging and closures are in use for similar product since many years without any kind of problems.

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IIIA 4.1.3 Resistance of the packaging material to its contents COM 802 09 M RB does not contain any strong acidic or alkaline components and also its other physical and chemical properties do not give reason to expect particular problems. It was physically and chemically stable when stored at 54 °C for 2 weeks in its original packaging (Carton with or without PE-inside bag). No damage or leakage was observed. There was no visible damage or deterioration of the packaging. The accelerated storage test carried out according to CIPAC Method MT 46.3 demonstrated sufficient strength and leak proof of the packaging and resistance to normal handling and transport. There were no signs that the quality of the material has changed. For detailed information, please refer to KIIIA 2.7.1/01.

IIIA 4.2 Procedures for Cleaning Application Equipment

IIIA 4.2.1 Procedures for cleaning application equipment and protective clothing The product is a ready to use bait. It is applied directly from its original container consistent with label directions. It does not require equipment for mixing or loading prior to application. No special cleaning procedure for application equipment and protective clothing needs to be recommended.

IIIA 4.2.2 Effectiveness of the cleaning procedures Please refer to Point IIIA 4.2.1.

IIIA 4.2.3 Re-entry periods to Protect Man, Livestock and the Environment

See Part B.7

IIIA 4.4 Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks Please refer to KIIIA 1.4.4/01 for a copy of the material safety data sheet. IIIA 4.4.1 Warehouse storage Keep only in the original container. Observe general hygienic measures when working with chemicals. Technical measures and storage conditions: Keep in a cool place. Keep away from food, drink and animal feeding stuffs. Packaging materials: HDPE, PP, cardboard, fibreboard Hints on storage assembly: German storage class: 11 Further information on storage conditions: Storage period: Max. 2 years, Storage temperature: -5 to 35°C.

IIIA 4.4.2 User level storage Please refer to Point IIIA 4.4.1.

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 28 of 47

IIIA 4.4.3 Transport Not a dangerous good in the meaning of ADR/RID, ADNR, IMDG-Code, ICAO/IATA-DGR.

IIIA 4.4.4 Fire

Recommended extinguishers: Water spray jet, carbon dioxide (CO 2), foam, dry chemical Extinguishers NOT to be used for safety reasons: Water full jet Protection of fire fighters: Wear self-contained breathing apparatus and chemical protective clothing Hazardous decomposition products: Evolution of toxic vapours / gases during combustion. (CO, CO 2)

IIIA 4.4.5 Nature of protective clothing proposed No special protective clothing is required if used according to product instructions.

IIIA 4.4.6 Characteristics of protective clothing proposed Please refer to Point IIIA 4.4.5.

IIIA 4.4.7 Suitability and effectiveness of protective clothing and equipment Please refer to Point IIIA 4.4.5.

IIIA 4.4.8 Procedures to minimise the generation of waste Observe national and local requirements. Do not dispose into drains or sewage systems. Incineration is an applicable way of disposal. Empty, cleaned containers should be taken for local recycling or waste disposal.

IIIA 4.4.9 Combustion products likely to be generated in the event of fire

Evolution of toxic vapours / gases during combustion (CO, CO 2).

IIIA 4.5.1 Containment of spillages Do not let to enter into surface water or sanitary sewer system. Sweep or suck off granules and dispose of in a container.

IIIA 4.5.2 Decontamination of areas, vehicles and buildings Please refer to Point IIIA 4.5.1.

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IIIA 4.5.3 Disposal of damaged packaging, adsorbents and other materials Observe national and local requirements. Do not dispose into drains or sewage systems. Incineration is an applicable way of disposal.

IIIA 4.5.4 Protection of emergency workers and bystanders Wear protecting gloves, clothes and goggles for skin and eye protection in case of accidental release. Respiratory protection : None required if local exhaust available. Hand protection : Chemical resistant protective gloves (EN 374). Preventing skin protection by skin protection ointment. The selection of suitable depends upon the material, and also upon the quality of the gloves. The degree of protection will vary from manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material cannot be calculated in advance and has therefore to be checked prior to the application. Suitable materials: Nitrile rubber - 0.4 mm thickness Butyl rubber (butyl) - 0.7 mm coating thickness chloroprene rubber (CR) - 0.5 mm coating thickness polyvinylchloride (PVC) - 0.7 mm coating thickness. Eye protection : Tightly fitting safety goggles (splash goggles) (EN 166). Hygiene measures : General industrial hygiene practice.

IIIA 4.5.5 First aid measures General information : If you feel unwell, seek medical attention and show the label when possible. In case of inhalation : Product is granular, so unlikely to be inhaled. In case of skin contact : Wash thoroughly with soap and plenty of water. In case of eye contact : Rinse immediately with clean water for at least 15 minutes; obtain medical advice if redness or soreness persists. In case of ingestion : Rinse mouth immediately and drink plenty of water. Do not induce vomiting. In case of suspected poisoning seek medical advice. Self-protection of the first aider : Avoid direct skin and eye contact with the product. Information to physician : • Symptoms: No special symptoms known. • Hazards: No hazards expected. • Treatment: Treat symptomatically.

IIIA 4.6 Neutralisation Procedure for Use in the Event of Accidental Spillage

IIIA 4.6.1 Details of proposed procedures for small quantities COM 802 09 M RB is neither acidic nor alkaline. Neutralization procedures are therefore not applicable.

IIIA 4.6.2 Evaluation of products of neutralization (small quantities) Not applicable. Neutralization not recommended. See Point IIIA 4.6.1.

IIIA 4.6.3 Procedures for disposal of small quantities of neutralized waste

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Not applicable. Neutralization not recommended. See Point IIIA 4.6.1.

IIIA 4.6.4 Details of proposed procedures for large quantities Not applicable. Neutralization not recommended. See Point IIIA 4.6.1.

IIIA 4.6.5 Evaluation of products of neutralization (large quantities) Not applicable. Neutralization not recommended. See Point IIIA 4.6.1.

IIIA 4.6.6 Procedures for disposal of large quantities of neutralized waste Not applicable. Neutralization not recommended. See Point IIIA 4.6.1.

IIIA 4.7 Pyrolytic Behaviour of the Active Substance Not applicable. Ferric phosphate is not a halogen compound and COM 802 09 M RB is a preparation with halogen content below 60%.

IIIA 4.8 Disposal Procedures for the Plant Protection Product

IIIA 4.8.1 Detailed instructions for safe disposal of product and its packaging Observe national and local legal requirements. Empty containers should be taken for local recycling or waste disposal.

IIIA 4.8.2 Methods other than controlled incineration for disposal No other methods are currently available.

IIIA 4.9 Other/Special Studies Not applicable, since no EU data requirement.

IIIA 11 FURTHER INFORMATION

IIIA 11.1 Information of Authorisations in Other Countries

Please refer to Registration Report – Part B Section 7.

IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries

MRLs set at European Level are stated in the Regulation (EC) No 396/2005 (see: EU Pesticides database, as published, Internet: http://ec.europa.eu/sanco_pesticides/public/index.cfm).

IIIA 11.3 Justified Proposals for Classification and Labelling

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 31 of 47

Physico - chemical properties

Table 11.3-1 Physico-chemical properties

Study Type Findings Reference

(triggered risk phrase)

Explosivity Not explosive

Oxidizing properties Not oxidizing

Flammability not highly flammable

Content of not relevant hydrocarbon

Viscosity (dynamic) not relevant

Surface tension not relevant

Toxicology

Please refer to Registration Report - Part A.

Ecotoxicology/Environment

Please refer to Registration Report - Part A.

IIIA 11.4 Proposals for Risk and Safety Phrases

Please refer to Registration Report - Part A.

IIIA 11.5 Proposed Label

Please refer to Registration Report – Part A.

IIIA 11.6 Specimens of Proposed Packaging

Specimens of the packaging were provided and found to be acceptable.

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

Annex Author Year Title Data Owner point protection Source (where different from company) claimed Yes/No Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

KIIIA 2.1/01 COM 802 09 M RB (CARTON WITH PE- Schieck, S. 2011a yes COM INSIDE BAG) ACCELERATED KIIIA 2.4.1 STORAGE TEST (54°C / 2 WEEKS) Intertek Food Services GmbH, Linden, KIIIA 2.4.2 Germany COMPO GmbH & Co. KG, Münster, KIIIA1 2.7.1/01 Germany Report-no. 60607 KIIIA 2.8.5.1 GLP: yes KIIIA1 2.8.6 Published: no

KIIIA1 2.8.6.2

KIIIA1 2.8.6.3

KIIIA1 2.8.6.4

KIIIA1 2.8.6.5

KIIIA1 2.8.8.1 KIIIA 2.2.1/01 Dornhagen, 2011a EXPLOSIVE PROPERTIES A.14. yes COM D. Siemens AG, Prozess-Sicherheit, Frankfurt am Main, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. 20110008.02, 20110008_02 GLP: yes Published: no KIIIA 2.2.2/01 Dornhagen, 2011b OXIDIZING PROPERTIES OF SOLIDS yes COM D. A.17. Siemens AG, Prozess-Sicherheit, Frankfurt am Main, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. 20110008_04 GLP: yes

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Annex Author Year Title Data Owner point protection Source (where different from company) claimed Yes/No Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Published: no KIIIA 2.3.2/01 Dornhagen, 2011c FLAMMABILITY A.10. yes COM D. Siemens AG, Prozess-Sicherheit, Frankfurt am Main, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. 20110008_01 GLP: yes Published: no KIIIA 2.3.3/01 Dornhagen, 2011d AUTO FLAMMABILITY (SOLIDS - yes COM D. DETERMINATION OF RELATIVE SELF-IGNITION TEMPERATURE) A.16. Siemens AG, Prozess-Sicherheit, Frankfurt am Main, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. 20110008.03, 20110008_03 GLP: yes Published: no KIIIA 2.6.2/01 Schieck, S. 2011b COM 802 09 M RB - DETERMINATION yes COM OF BULK DENSITY Intertek Food Services GmbH, Linden, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. 60609 GLP: yes Published: no KIIIA 2.7.1/02 Schieck, S. 2011c COM 802 09 M RB (CARTON yes COM WITHOUT PE-INSIDE BAG) ACELERATED STORAGE TEST (54°C / 2 WEEKS)" Intertek Food Services GmbH, Linden, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. 60608 GLP: yes Published: no KIIIA 4.1/01 Anonymous 2011d MATERIALSPEZIFIKATION yes COM FALTSCHACHTELN

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 34 of 47

Annex Author Year Title Data Owner point protection Source (where different from company) claimed Yes/No Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/02 Anonymous 2007a STANZE FS 115 X 37,5 X 165 MM yes COM AV20298 Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. 20000-20499 GLP/GEP: no Published: no KIIIA 4.1/03 Anonymous 1900a STANZE FS 142 X 64 X 240 MM yes COM MD111891-B4-01 WELLE Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. n/a GLP/GEP: no Published: no KIIIA 4.1/04 Anonymous 1900b FORMAT PAPPE 300G yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/05 Anonymous 2011e FOLIEN FÜR INNENBEUTEL yes COM FALTSCHACHTELN Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/06 Anonymous 1900c STANDBOGEN FOLIENBEUTEL yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 35 of 47

Annex Author Year Title Data Owner point protection Source (where different from company) claimed Yes/No Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/07 Anonymous 1900d DOSING PYRAMID, COMPO yes COM 60X60X124 Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. MO1042 GLP/GEP: no Published: no KIIIA 4.1/08 Anonymous 1900e DOSING SPOON yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. P00236P-A GLP/GEP: no Published: no KIIIA 4.1/09 Schacherma 1999a COMPO BSD 500 ML yes COM yr Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. 9023100300 GLP/GEP: no Published: no KIIIA 4.1/10 Schacherma 1999b COMPO BAD 500 ML yes COM yr Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. 9030170400 GLP/GEP: no Published: no KIIIA 4.1/11 Schacherma 1999c COMPO BAD 1000 ML yes COM yr Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. 9023110400 GLP/GEP: no Published: no KIIIA 4.1/12 Anonymous 1900f SPECIFICATION DU PRODUIT, yes COM COMPO BAD 1000 ML Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 36 of 47

Annex Author Year Title Data Owner point protection Source (where different from company) claimed Yes/No Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. Mat.-Spez BAD10 GLP/GEP: no Published: no KIIIA 4.1/13 Anonymous 1900g SPECIFICATION DU PRODUIT, yes COM COMPO BSD 500 ML Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. Mat.-Spez BSD05 GLP/GEP: no Published: no KIIIA 4.1/14 Schacherma 1999d COMPO BSD 1000 ML yes COM yr Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. 9023120300 GLP/GEP: no Published: no KIIIA 4.1/15 Anonymous 1900 h SPECIFICATION DU PRODUIT, yes COM COMPO BSD 1000 ML Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. Mat.-Spez BSD10 GLP/GEP: no Published: no KIIIA 4.1/16 Schacherma 1995 COMPO VERSCHLUSS yes COM yr Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. 90505603000 GLP/GEP: no Published: no KIIIA 4.1/17 Baums, 2011 PAPPWICKELDOSE STREUER yes COM A.H. SPEZIFIKATION Supplier COMPO GmbH & Co. KG, Münster, Germany

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 37 of 47

Annex Author Year Title Data Owner point protection Source (where different from company) claimed Yes/No Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/18 Baums, H. 2008 PAPPWICKELDOSE yes COM WEIßBLECHBODEN MATSPEZ + SKIZZE Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/19 Baums, H. 2011a MATERIALSPEZIFIKATION: yes SGC KOMBIDOSEN J.M. Schmidt GmbH & Co. KG, Bad Neuenahr-Ahrweiler, Germany J.M. Schmidt GmbH & Co. KG Report-no. not stated GLP/GEP: no Published: no KIIIA 4.1/20 Baums, H. 2011b MATERIAL-SPECIFIKATION: yes SGC COMPOSITE CANS J.M. Schmidt GmbH & Co. KG, Bad Neuenahr-Ahrweiler, Germany J.M. Schmidt GmbH & Co. KG Report-no. not stated GLP/GEP: no Published: no KIIIA 4.1/21 Anonymous 2010g TOR 1L A VIS BAGUE 40 yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/22 Anonymous 2006a CAN BRENEZ TOR 1 LITRE yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no

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Annex Author Year Title Data Owner point protection Source (where different from company) claimed Yes/No Company, Report No.

GLP or GEP status (where relevant)

Published or Unpublished

Published: no KIIIA 4.1/23 Anonymous 2006b COL CLIQ 42, PLAN yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/24 Némoz, Y. 2004 CRC 42 SÉCURITÉ ENFANT JOINTE yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/25 Vescovi, J. 2006 FICHE TECHNIQUE CLIQ 42 JOINTE yes COM Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. not applicable GLP/GEP: no Published: no KIIIA 4.1/26 Anonymous 2007b PRODUCT SPECIFICATION 801, LD- yes COM PE, ALKOZELL Supplier COMPO GmbH & Co. KG, Münster, Germany Report-no. SP 801-e GLP/GEP: no Published: no

Applicant Compo Evaluator Date: 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Core Assessment Central Zone Germany Page 39 of 47

Appendix 2: Critical Uses – justification and GAP tables GAP rev. 0, date: 2012-06-27

PPP (product name/code) COM 802 09 M RB Formulation type: RB active substance ferric phosphate Conc. of as : 12.5 g/kg

Applicant: COMPO GmbH & Co.KG professional use Zone(s): central EU non professional use X

Verified by MS: yes

1 2 3 4 5 6 7 8 10 11 12 13 14 Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or Method / Timing / Growth Max. number kg product / ha g, kg as/ha Water L/ha e.g. safener/synergist per ha Kind stage of crop & (min. interval (crop destination / I (additionally: a) max. rate per season between min / max purpose of crop) developmental stages of appl. a) max. rate e.g. recommended or mandatory tank applications) the pest or pest group) per appl. mixtures a) per use b) max. total rate per crop/season b) max. total rate per b) per crop/ crop/season season 001 DE Vegetables (NNNVV) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment

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002 DE Vegetables (NNNVV) G slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 003 DE Vegetables (NNNVV) I slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment 004 DE fresh herbs (NNNKF) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment

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006 DE fresh herbs (NNNKF) I slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment 007 DE fruit crops (NNNOO) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 008 DE fruit crops (NNNOO) G slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment

009 DE fruit crops (NNNOO) I slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment

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010 DE ornamentals (NNNZZ) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment 012 DE ornamentals (NNNZZ) I slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first on terraces and balconies treatment only across symptoms/harmful in plant container of potted plants cultivated organisms become area, only visible between plants, bait treatment 013 DE potato (SOLTU) F slugs (MOLLNS) spreading, at beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha not protection of emerging plants and uniformly infestation and/or applicable reduction of leaf consumption b) 4 b) 200 kg/ha b) 2.5 kg/ha broadcasted when first

across symptoms/harmful cultivated organisms become area, only visible between plants, bait treatment

Applicant Compo Evaluator Date 06/12/2012 Part B – Section 1 COM 802 09 M RB Registration Report – Central Zone Core Assessment Germany Page 43 of 47

General remarks/explanations: The GAP-Sheet should indicate if the displayed information was provided by the applicant OR was revised by the zRMS (due to the product label and Annex III data). The zRMS has to verify the presented information and to ask (the applicant) for clarification of missing details (e.g. BBCH stages, EC-codes of crops). All abbreviations in the GAP-Sheet used must be explained. Use separate worksheet for each product. Make use of existing standards like EPPO and BBCH. Product: Please indicate the specific variant of the active substance if relevant. If additional components have to be added to the applied product (tankmixtures), all relevant information must be provided in the column remarks. As the product usually will be determined either for professional or non professional use, this information should be given here. Otherwise to be indicated in column 4 of the GAP-sheet (conditions / location of use). Formulation: Type: e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) Refer to: ° GCPF Codes - GIFAP Technical Monograph No 2, (1989), 6 th Edition – Revised May 2008 – Catalogue of pesticide formulation types and international coding system. ° Technical Monograph n°2, 6th Edition - Revised May 2008 - Catalogue of pesticide formulation types and international coding system (CropLife International) 1) .

Conc. of as: g/kg or g/L In case the plant protection product contains more than one active substance the amount applied for each active substance occurs in the same order as the substances are mentioned in the heading. Safener/Synergist: Since safeners and synergists are in scope of REG 1107/2009, information about safeners/synergists should be included in the GAP table as well. Zone(s): All relevant zone(s) should be indicated. For interzonal uses (e.g. greenhouse, seed treatment, etc.) “EU” should be chosen. Explanations to the particular columns: No.: Numeration would be important when references are necessary e. g. to the dossier or to the authorisation certificate.

1) http://www.croplife.org/files/documentspublished/1/en-us/PUB-TM/4147_PUB-TM_2008_05_01_Technical_Monograph_2_-_Revised_May_2008.pdf

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Member state(s): For a better general view of the valid uses for the particular zones/MS it would be helpful to mention both (the zone as well as the MS) in the column. However, to keep the table clearly arranged it seems dispensable to cite the zone; each MS is distinctly allocated to one zone; moreover the zone(s) are cited in the head of the table. Desirably MS are put in order accordant to the zone they belong. Crop and/or situation: The common name(s) of the crop and the EC (EPPO)-Codes or at least the scientific name(s) [EU and Codex classifications (both)] should be used; where relevant, the situation should be described (e.g. fumigation of a structure). In case of crop groups all single crops belonging to that group should be mentioned, (either in the respective table element or – in case of a very extensive crop group - at least in a footnote). If it is not possible to mention all single crops belonging to a crop group (e.g. for horticulture), it should be referred to appropriate crop lists (e.g. EPPO, residue (codex). It would be desirable to have a “joint list” of crop groups for the zones. Exceptions of specific crops/products/objects or groups of these and restrictions to certain uses (e.g. only for seed production, fodder) must be indicated. This column should also include when indicated information concerning “crop destination or purpose of crop” and which part of plants will be used / processed (e. g. for medicinal crops roots or leaves or seeds). Conditions / location of use: Outdoor or field use (F), glasshouse application (G) or indoor application (I) “Glasshouse” indicates that the respective trials are acceptable for all zones. As results achieved in compartments without controlled conditions (temperature, light exposure), e.g. simple plastic tunnels [for those GAPs field trials have to be conducted in the respective zone the use is applied for], are not considered to be applicable for use in other zones the kind of glasshouse should be clearly indicated. [Remark: Greenhouse definitions are at the moment under evaluation]. Conditions include also information concerning the substrate (natural soil, artificial substrate). Pests or Group of pests controlled: Scientific names and EPPO-Codes of target pests/diseases/ weeds or when relevant the common names of the pest groups (e.g. biting and suckling insects, soil born insects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at the moment of application must be named. If necessary – in case of pest groups - exceptions (e.g. sucking insects excluding scale insects) should be indicated. In some cases, the set of pests concerned for a given crop may vary in different parts of the EU region (where appropriate the pests should be specified individually). If the product is used as growth regulator the target organism is the specific crop, whose development should be influenced; the aim could also be e.g. an empty room for treatment. Application details: Method / Kind: Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench, drilling, high precision drilling (with or without pneumatic systems). Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant - type of equipment used (e.g. ultra low volume equipment (ULVA) or low volume equipment (LVA)) should be indicated if relevant.

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Timing of Application / Growth stage of crop & season: Time(s), period, first and last treatment, e.g. autumn or spring pre- or post-emergence, at sufficient pest density or begin of infection, including restrictions (e.g. not during flowering). Growth stage of crop (BBCH-code, …) – period, first and last treatment. Since the BBCH-codes are accomplished in the individual member states at different time periods the month(s) of application should be indicated in addition. BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3-8263-3152-4 It seems sensible to constrain specifications in this column only to the crop, - information concerning the pest should be dealt in column “pest or group of Pests controlled”. In certain circumstances it might be helpful to give information about the expected rate of interception related to the BBCH codes. In many minor crops no BBCH/interception rate scenarios have been specified so far. This could also simplify grouping for the envelope approach. Number of applications and interval between applications a) Maximum number of applications per growing season used for the named crop/pest combination possible under practical conditions of use. b) The proposed maximum number in the crop including applications on all pests/targets on the same crop in a growing season should be given. It should be clearly indicated whether the displayed number of applications is per season, per crop cycle or per pest generation. Minimum interval (in days) between applications of the same product. The figure for the interval between the applications is to be set in brackets. Application rate: Application rate of the product per ha: a) (Maximum) product rate per treatment (usually kg or L product / ha). For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms or pallox (= big box used for storage potatoes, fruits, roots). b) Maximum product rate per growing season (especially if limited) or per crop cycle should be cited. Especially in three dimensional crops other dose expressions (kg/l per 10.000 m² leaf wall area or kg/l per ha per meter crown (canopy) height) should be given additionally. For seed treatment also the load of product (l/g, kg) per kg, 100 kg or unit treated seed should be stated beside the application rate per hectare. The number of seeds per (seed) unit is to be given. The maximum seed drilling rate (=number of seed sown/maximum seed volume) per row and ha should be indicated. Information concerning the sowing method (precision drilling, …) would be advantageous. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products (please note, additional EPPO-guidelines may be developed). Application rate of the active substance per ha: a) (Maximum) as rate per treatment (usually kg active substance / ha). For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms or pallox (= big box used for storage potatoes, fruits, roots).

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b) Maximum as rate per growing season (especially if limited) or per crop cycle should be cited. The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg active substance / ha). In case the plant protection product contains more than one active substance the amount applied for each active substance occurs in the same order as the substances are mentioned in the heading. Water L/ha: It should be clearly indicated if a stated water volume range depends upon the developmental stage of the crop (low volume – early crops stage, high volume – late crop stage) which causes a consistent concentration of the spray solution, or if a water volume range indicates different spray solution concentrations. In the last mentioned case extremely low water volumes (indicating high concentrated spray solutions) need to be covered within selectivity trials. If water volume range depends on application equipments (e.g. ULVA or LVA) it should be mentioned under “application: method/kind”. PHI (days) – minimum pre harvest interval: PHI - minimum pre-harvest interval For some crop situations a specific PHI may not be relevant. If so an explanation (e. g. the PHI is covered by the time remaining between application and harvest.) should be given in the remarks column (e.g. crop harvest at maturity or specific growth stages). Remarks: Remarks may include: amount of safener/synergist per ha or extent of use/economic importance/restrictions, e.g. limiting the number of uses per crop and season, if several target pests/diseases are controlled with the same product. If additional components (other ppp or adjuvant) should be used with the applied product (tankmixtures), all relevant information must be provided in the column remarks. In addition, it should be mentioned as well those mixtures are recommended or mandatory. Additional recommendations: For the description of uses of a PPP the following EPPO Standards should be considered: • EPPO Standard PP 1/240 “Harmonized basic information for databases on plant protection products” • EPPO Standard PP1/ 248 “Harmonized classification and coding of the uses of plant protection products“ Whereas EPPO Standard PP1/ 248 gives more general information on possible description of uses, EPPO Standard PP 1/240 especially gives an overview of all points necessary to fully understand a use. Ad EPPO-Guidelines, see: http://archives.eppo.org/EPPOStandards/efficacy.htm Use EPPO extrapolation tables, see http://www.eppo.org/PPPRODUCTS/extrapolation/tables.htm EPPO Plant Protection Thesaurus: http://eppt.eppo.org/

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Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics:

The following physical, chemical and technical properties of the plant protection product were experimentally tested: colour, pH, pour and tap density, storage stability at high temperatures (14 d at 54 °C), content of dust/fines, attrition and flowability.

No significant deviations from the data submitted by the applicant were detected. After accelerated storage a weight loss of 7.2 % was detected (applicant: 0.9 % with PE inner bag and 4.5 % without PE inner bag)

The formulation complies with the chemical, physical and technical criteria which are stated for this type of formulation in the FAO/WHO manual (2010).

Applicant Compo Evaluator Date: 12/2012 COM 802 09 M RB – ZV1 007517-00/00 Part B – Section 2 - Core Assessment

REGISTRATION REPORT Part B

Section 2 Analytical Methods Detailed summary of the risk assessment

Product code: COM 802 09 M RB Active Substance: 12.5 g/kg Ferric Phosphate

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: COMPO GmbH & Co. KG Date: 06 December 2012

Page 1 / 8 COM 802 09 M RB – ZV1 007517-00/00 Part B – Section 2 - Core Assessment

Table of Contents

IIIA 5 METHODS OF ANALYSIS 3 IIIA 5.1 Analytical Standards and Samples 3 IIIA 5.1.1 Samples of the preparation 3 IIIA 5.1.2 Analytical standards for the pure active substance 3 IIIA 5.1.3 Samples of the active substance as manufactured 4 IIIA 5.1.4 Analytical standards for relevant metabolites and all other components 4 IIIA 5.1.4 Samples of reference substances for relevant impurities 4 IIIA 5.2 Methods for the Analysis of the Plant Protection Product 4 IIIA 5.2.1 Description of the analytical methods for the determination of the active substance in the plant protection product 4 IIIA 5.2.2 For preparations containing more than one active substance, description of method for determining each in the presence of the other 5 IIIA 5.2.3 Applicability of existing CIPAC methods 5 IIIA 5.2.4 Description of analytical methods for the determination of relevant impurities 6 IIIA 5.2.5 Description of analytical methods for the determination of formulants 6 IIIA 5.3 Description of Analytical Methods for the Determination of Residues 6 IIIA 5.3.1 Evaluation of the active substance ferric phosphate 6 IIIA 5.3.1.1 Overview of residue definitions and levels for which compliance is required 6 IIIA 5.3.1.2 Description of Analytical Methods for the Determination of Residues of Ferric phosphate in Plant Matrices (OECD KIII A 5.3.1) 7 IIIA 5.3.1.3 Description of Analytical Methods for the Determination of Residues of Ferric phosphate in Animal Matrices (OECD KIII A 5.3.1) 7 IIIA 5.3.1.4 Description of Methods for the Analysis of Ferric phosphate in Soil (OECD KIII A 5.4) 8 IIIA 5.3.1.5 Description of Methods for the Analysis of Ferric phosphate in Water (OECD KIII A 5.6) 8 IIIA 5.3.1.6 Description of Methods for the Analysis of ferric phosphate in Air (OECD KIII A 5.7) 8 IIIA 5.3.1.7 Description of Methods for the Analysis of Ferric phosphate in Body Fluids and Tissues (OECD KIII A 5.8) 8 IIIA 5.3.1.8 Other Studies/Information 8 IIIA 5.4 Conclusion on the availability of analytical methods for the determination of residues 8

APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION 8

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METHODS OF ANALYSIS

IIIA 5 METHODS OF ANALYSIS This document summarises the information related to the analytical methods for the product COM 802 09 M RB containing the active substance ferric phosphate which was approved according to Regulation (EC) No 1107/2009.

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

Note : this Part B document only reviews data (Annex II or Annex III) and additional information that has not previously been considered within the EU review process, as part of the Annex I inclusion decision. New annex II data must only be included if they are considered essential for the evaluation and in this case a full study summary must be provided. In the case where the formulation has been previously evaluated, at European level, detailed summaries have not been provided.

The product was not already evaluated as the ‘representative formulation’ during the Annex I inclusion. The product has not been previously evaluated by other Member States according to Uniform Principles.

The review report for Ferric phosphate (SANCO/3035/99 – 08/03/2002) is considered to provide the relevant review information or a reference to where such information can be found.

The Annex I Inclusion Directive for Ferric phosphate (2001/87/EC) provides no 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 active substance Ferric phosphate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29/06/2001 shall be taken into account. On the basis of the proposed and supported uses, 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.

Appendix 1 of this document contains the list of references included in this document for support of the evaluation. Information on the detailed composition of COM 802 09 M RB can be found in the confidential dossier of this submission (Registration Report - Part C).

IIIA 5.1 Analytical Standards and Samples

IIIA 5.1.1 Samples of the preparation A sample of the preparation was provided by the applicant but no analysis of the contents of the active substances was performed.

IIIA 5.1.2 Analytical standards for the pure active substance Analytical standard of ferric phosphate was not provided because this was not requested.

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IIIA 5.1.3 Samples of the active substance as manufactured No samples were provided because this was not requested.

IIIA 5.1.4 Analytical standards for relevant metabolites and all other components included in the residue definition Samples will be provided upon request.

IIIA 5.1.4 Samples of reference substances for relevant impurities No samples were provided because there was no request. Ferric phosphate does not contain any impurity of toxicological or ecotoxicological concern.

IIIA 5.2 Methods for the Analysis of the Plant Protection Product

An analytical method for determination of Ferric phosphate, impurities and relevance of CIPAC methods in COM 802 09 M RB were not evaluated as part of the EU review of Ferric phosphate. Therefore all relevant data are provided as followed and are considered adequate.

IIIA 5.2.1 Description of the analytical methods for the determination of the active substance in the plant protection product

Report: Schieck, S. (2011):

Title: COM 802 09 M RB: Validation of Analytical Method: Determination of Iron in formulation COM 802 09 M RB by ICP Document No: 60522 Intertek Food Services GmbH, Linden, Germany – published: (Dates of work: study completed on 07 February 2011). Guidelines: SANCO/3030/99, rev.4. GLP Yes

Method description After dividing the complete material (contained in cartons) into 8 parts, one sub-sample (1/8 of the original sample) was grinded and homogenised (via mixing). This was done both for the formulation and blank formulation. Afterwards, approximately 1 g of each sample was weighed and 21 mL HCl and 7 mL

HNO 3 were added. Two to three drops of 1-octanol were added and the sample was boiled under reflux for two hours. The sample was left to cool at room temperature then water was filled up to 100 mL and the sample was filtered. Finally, the sample was diluted 1:10 with aqua regia (1:4) and analysed by ICP.

ICP parameters

ICP Apparatus: ICP 7300 DV, Rodgau, Germany (Series no: 077C9031801) Detection Wavelength: 238.204 nm Method of measurement: 3-fold, the mean value was calculated by the instrument Delay time: 25 s High voltage: 1300 V Nebulizer: Neb 0.55 L/min Plasma 15 L/min AUX 0.2 L/min

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Observation direction: Radial Resolution of spectrometer: High

Method validation The analytical method was used for the determination of Ferric phosphate in the formulation COM 802 09 M RB measured in terms of iron content. The method, based on ICP, was validated with regard to specificity, linearity, precision and accuracy for a concentration range of 0.8 mg Fe/L – 8 mg Fe/L (0.08% - 0.8% Fe in the formulation).

Table containing the validation of the method (formulation COM 802 09 M RB ) Analyte Linearity Accuracy Repeatability n Specificity/Inteferences n = 6 n = 3 = 5 Mean [%] [% RSD] Ferric 0.8 to 8 mg Fe/L 96.64 2.30 The mean signal intensity of the formulation phosphate r2 = 0.999688 was 8492, while the blank formulation showed a One mean signal intensity of 96 (1 % of the intensity measurement of the sample formulation). This complies with was rejected the requirement that interference from impurities based on should not be more than 3 % of the total peak Nalimov Test. area measured for the target analyte.

Summary The method for the quantitative analysis of Ferric phosphate (active ingredient in COM 802 09 M RB ) has been validated. The parameters specificity, linearity, precision (repeatability) and accuracy were checked. Typical spectra and calibration curves are presented in the report.

Conclusion: The analytical ICP method presented for the determination of the active ingredient Ferric phosphate in Formulation COM 802 09 M RB was successfully validated according to SANCO/3030/99 rev.4 criteria. The method is acceptable.

IIIA 5.2.2 For preparations containing more than one active substance, description of method for determining each in the presence of the other

Not required, because the formulation contains only one active substance. Please refer to method provided under point IIIA 5.2.1.

IIIA 5.2.3 Applicability of existing CIPAC methods There is no CIPAC method available for the determination of Ferric phosphate.

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IIIA 5.2.4 Description of analytical methods for the determination of relevant impurities According to the SANCO report ( SANCO/3035/99 – 08/03/2002 ) and the Commission Directive 2001/87/EC , no manufacturing impurities of toxicological or ecotoxicological concern are present in the technical active substance Ferric phosphate. For further information, please, refer to CONFIDENTIAL data provided separately (Part C).

IIIA 5.2.5 Description of analytical methods for the determination of formulants No formulants with toxicological or ecotoxicological relevant compounds are present in the formulation. Therefore, no analytical methods for the determination of formulants are necessary.

IIIA 5.3 Description of Analytical Methods for the Determination of Residues

IIIA 5.3.1 Evaluation of the active substance ferric phosphate The conclusion regarding the peer review of the analytical methods for residues of ferric phosphate is summarized in SANCO/3055/99-final.

Table IIIA 5.3-1: Information on the active substance ferric phosphate

Name of component of residue definiton Structural formula substance code IUPAC name formula

Ferric phosphate 3- FePO 4 O Fe 3+ O P O O

IIIA 5.3.1.1 Overview of residue definitions and levels for which compliance is required Compared to the residue definition proposed in the Draft Assessment Report (incl. its addenda) the current legal residue definition is identical.

Table IIIA 5.3-2: Relevant residue definitions

Matrix Relevant residue Reference Remarks plant material not defined Regulation (EC) 839/2008 annex IV foodstuff of animal origin not defined Regulation (EC) 839/2008 annex IV soil ecotoxicology not defined Review report (SANCO/3055/99) water ecotoxicology not defined Review report (SANCO/3055/99) human toxicology not required ubiquitous compound air not required not classified T/T+/Xi/Xn, vapor pressure <10 -5 Pa

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body fluids/tissue not required not classified as T / T+

Table IIIA 5.3-3: Levels for which compliance is required

Matrix MRL Reference for MRL/level Remarks Plant, high water content MRLs do not exist Regulation (EC) No 839/2008 annex IV Plant, acidic commodities MRLs do not exist Regulation (EC) No 839/2008 annex IV Plant, dry commodities MRLs do not exist Regulation (EC) No 839/2008 annex IV Plant, high oil content MRLs do not exist Regulation (EC) No 839/2008 annex IV Plant, difficult matrices (hops, MRLs do not exist Regulation (EC) No 839/2008 annex spices, tea) IV meat MRLs do not exist Regulation (EC) No 839/2008 annex IV milk MRLs do not exist Regulation (EC) No 839/2008 annex IV eggs MRLs do not exist Regulation (EC) No 839/2008 annex IV fat MRLs do not exist Regulation (EC) No 839/2008 annex IV liver, kidney MRLs do not exist Regulation (EC) No 839/2008 annex IV soil not required Review report (SANCO/3055/99) drinking water 0.1 µg/l general limit for drinking water surface water not required Review report (SANCO/3055/99) air not required not classified T/T+/Xi/Xn, vapor pressure <10 -5 Pa tissue (meat or liver) not required not classified as T / T+ blood not required not classified as T / T+

IIIA 5.3.1.2 Description of Analytical Methods for the Determination of Residues of Ferric phosphate in Plant Matrices (OECD KIII A 5.3.1) Based on EU Conclusions (SANCO/3035/99) no harmful effects on human or animal health will arise from the usage of ferric phosphate as a molluscicide, thus no residues have to be monitored in crops and no analytical methods are required. IIIA 5.3.1.3 Description of Analytical Methods for the Determination of Residues of Ferric phosphate in Animal Matrices (OECD KIII A 5.3.1) Based on EU Conclusions (SANCO/3035/99) no harmful effects on human or animal health will arise from the usage of ferric phosphate as a molluscicide, thus no residues have to be monitored foodstuff of animal origin and no analytical methods are required.

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IIIA 5.3.1.4 Description of Methods for the Analysis of Ferric phosphate in Soil (OECD KIII A 5.4) Based on EU Conclusions (SANCO/3035/99) no harmful effects on human or animal health will arise from the usage of ferric phosphate as a molluscicide, thus no residues have to be monitored in soil. As a consequence, no analytical methods are proposed. IIIA 5.3.1.5 Description of Methods for the Analysis of Ferric phosphate in Water (OECD KIII A 5.6) Based on EU Conclusions (SANCO/3035/99) no harmful effects on human or animal health will arise from the usage of ferric phosphate as a molluscicide, thus no residues have to be monitored in water. As a consequence, no analytical methods are proposed. IIIA 5.3.1.6 Description of Methods for the Analysis of ferric phosphate in Air (OECD KIII A 5.7) The vapor pressure of ferric phosphate is <10 -5 Pa and the substance is not classified as T/T+/Xi/Xn, thus no residues have to be monitored in air. As a consequence, no analytical methods are proposed.

IIIA 5.3.1.7 Description of Methods for the Analysis of Ferric phosphate in Body Fluids and Tissues (OECD KIII A 5.8) Methods for the determination of residues in body fluids and tissues are not required since the active substance is not classified as toxic or highly toxic. IIIA 5.3.1.8 Other Studies/Information No other studies were provided. There are no additional European requirements for formulated products.

IIIA 5.4 Conclusion on the availability of analytical methods for the determination of residues

Analytical methods for residues are not required. Consequently, data gaps do not exist.

Appendix 1 List of data submitted in support of the evaluation For chapter 5.3 no data were submitted in support of the evaluation and none are required.

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REGISTRATION REPORT Part B

Section 3: Mammalian Toxicology Detailed summary of the risk assessment

Product code: COM 802 09 M RB Active Substance: 12.5 g/kg Ferric Phosphate

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: COMPO GmbH & Co. KG Date: 06/12/2012

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Table of Contents

IIIA 7 Mammalian Toxicology ...... 3 IIIA 7.1 Toxicological Evaluation of Active Substance...... 3 IIIA 7.1.1 Ferric sulphate ...... 3 IIIA 7.2 Toxicological Evaluation of Pesticide...... 3 IIIA 7.3 Dermal Absorption ...... 5 IIIA 7.4 Safety Assessment of Pesticide Application...... 5 IIIA 7.4.1 Selection of critical use(s) and justification...... 5 IIIA 7.4.2 Evaluation of the Active Substance Ferric Phosphate...... 7 IIIA 7.4.2.1 Operator exposure and risk assessment ...... 7 IIIA 7.4.2.2 Worker exposure and risk assessment ...... 7 IIIA 7.4.2.3 Bystander and resident exposure and risk assessment...... 8 IIIA 7.4.3 Conclusion of Exposure Estimation and Risk Assessment ...... 8 IIIA 7.5 Justified Proposals for Classification and Labelling and Safety Instructions...... 8 Appendix 1 List of Data Submitted in Support of the Evaluation...... 10 Appendix 2 Detailed Evaluation of the Studies Relied upon...... 11 A 2.1 Acute Oral Toxicity...... 11 A 2.2 Acute Percutaneous (Dermal) Toxicity ...... 12 A 2.3 Acute Inhalation Toxicity...... 13 A 2.4 Skin Irritation...... 13 A 2.5 Eye Irritation...... 14 A 2.6 Skin Sensitisation ...... 15 A 2.7 Supplementary Studies for Combinations of Plant Protection Products ...... 17 A 2.8 Short-Term Toxicity Studies ...... 17 A 2.9 Data on Formulants ...... 17 A 2.9.1 Material safety data sheet for each formulant...... 17 A 2.9.2 Available toxicological data for each formulant...... 17 A 2.10 Studies on Dermal Absorption...... 17 Appendix 3 Exposure Calculations ...... 18 A 3.1 Exposure Calculations for Ferric Phosphate...... 18 A 3.1.1 Operator exposure calculations...... 18 A 3.1.2 Resident (children) exposure calculations ...... 19

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IIIA 7 Mammalian Toxicology

IIIA 7.1 Toxicological Evaluation of Active Substance

IIIA 7.1.1 Ferric sulphate

Table IIIA 7.1-1: General information on ferric phosphate

Common Name Ferric phosphate CAS-No. 10045-86-0

Table IIIA 7.1-2: Agreed EU endpoints

Value Reference

ADI (provisional maximum 0.8 mg/kg bw/d SANCO/3035/99-final (2002-03-08) tolerable daily intake; iron)

ADI (MTDI, maximum tolerable 70 mg/kg bw/d SANCO/3035/99-final (2002-03-08) daily intake; phosphate) AOEL systemic 0.8 Fe mg/kg bw/d SANCO/3035/99-final (2002-03-08) ARfD (acute reference dose) n.n. SANCO/3035/99-final (2002-03-08)

Table IIIA 7.1-3: Classification and proposed labelling for ferric phosphate

with regard to toxicological data Regulation (EC) No 1272/2008 (Table 3.2): (according to the criteria in Dir. 67/548/EEC) no classification necessary Proposal BfR: none additional with regard to toxicological data Regulation (EC) No 1272/2008 (Table 3.1): (according to the criteria in Reg. 1272/2008) no classification necessary Proposal BfR: none additional

IIIA 7.2 Toxicological Evaluation of Pesticide

Table IIIA 7.2-1: General information on COM 802 09 M RB Product name COM 802 09 M RB Formulation type RB (bait, ready for use) Active substance(s) (incl. content) Ferric phosphate (iron(III)orthophosphate, 12.5 g/kg) Category Molluscicide Statement as to whether the product was already No evaluated as the ‘representative formulation’ during the Annex I inclusion or has been previously evaluated in an other MS according to Uniform Principles

Information on the detailed composition of COM 802 09 M RB can be found in the confidential dossier of this submission (Registration Report - Part C).

A summary of the toxicological evaluation for COM 802 09 M RB is given in Table IIIA 7.2-2. Full summaries of studies on the product COM 802 09 M RB are presented in Appendix 2.

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Table IIIA 7.2-2: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for COM 802 09 M RB

Type of test, species Result Acceptability Classification Classification Reference (Guideline) (acc. to the (acc. to the criteria in Dir. criteria in Reg. 67/548/EEC) 1272/2008)

LD 50 oral, rat > 5000 mg/kg Yes None None Haferkorn, J. (OECD 423) bw/day (2011)

LD 50 dermal, rat > 5000 mg/kg Yes None None Haferkorn, J. (OECD 402) bw/day (2011)

LC 50 inhalation, rat Not submitted, not necessary (active substance: non-volatile, no significant proportion (> 1 % on a weight basis) of particles of diameter < 50 µm) Skin irritation, rabbit Non-irritant Yes None None Leuschner, J. (OECD 404) (2011) Eye irritation, rabbit Non-irritant Yes None None Leuschner, J. (OECD 405) (2011) Skin sensitisation, Non-sensitising Yes None None Haferkorn, J. guinea pig (2011) (OECD 406, M&K) Supplementary studies No data – not for combinations of required plant protection products

Table IIIA 7.2-3: Additional relevant toxicological information

Type of test, species Substance Classification of the Reference Classification of COM 802 (Guideline) (Concentration substance 09 M RB in product, (acc. to the criteria in (acc. to the criteria in Dir. % w/w) Dir. 67/548/EEC and/or 67/548/EEC, in Dir. in Reg. 1272/2008) 1999/45/EC and/or in Reg. 1272/2008)

Short-term toxicity No data – not studies required Toxicological data on None active substance(s) (not tested with the preparation) Toxicological data on None non-active substance(s) (not tested with the preparation) Further relevant No data – not toxicological required information

An overview on the classification and labelling of the preparation is given in paragraph IIIA 7.5.

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IIIA 7.3 Dermal Absorption

In the Review report for ferric phosphate (SANCO/3035/99-final, 08.03.2002; ASB2008-7514), dermal absorption of the ferric or phosphate ions is considered to be negligible. Therefore no dermal absorption study was conducted with the plant protection product COM 802 09 M RB.

The very conservative approach of applicant to consider a dermal absorption of 10% in exposure and risk assessments was neglected by ZRMS.

IIIA 7.4 Safety Assessment of Pesticide Application

Table IIIA 7.4-1: Product information and toxicological reference values used for safety assessment of pesticide application Product name COM 802 09 M RB Formulation type RB (bait, ready for use) Active substance(s) (incl. content) Ferric phosphate (iron(III)orthophosphate, 12.5 g/kg) Category Molluscicide Container size(s), short description Boxes, bags, bottles and cans, 100 – 5000 g Statement as to whether the product was already No evaluated as the ‘representative formulation’ during the Annex I inclusion AOEL systemic 0.8 mg Fe/kg bw/d Oral absorption 100 % Inhalative absorption 100 %

Dermal absorption No relevant dermal absorption of FePO 4 is expected (extremely low solubility in water and lipids)

IIIA 7.4.1 Selection of critical use(s) and justification The critical GAPs used for the safety assessment of pesticide application are presented in Table IIIA 7.4-2.

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Table IIIA 7.4-2: Critical uses according to Art. 51 VO 1107/2009 (worst case) for safety assessment of pesticide application

Crop and/ Member Product F Pests or PHI Remarks: or situation State name G Group of (days) or or pests Formulation Application Application rate per treatment Country I controlled

(a) (b) (c) (l) (m) Type Conc. method growth numb interval kg/ha water l/ha g as/ha of as kind stage & season er between Product (j) min appli- min max min (d-f) (i) (f-h) max cations min max max (k) (min)

Vegetables, Central COM F slugs RB 12.5 g/kg Spreading, Start at 1 - 4 1 day 50 n.a. 625 n.a. Protection of fresh herbs, zone 802 09 ferric uniformly beginning of (231 g emerging fruit crops, M RB Phosphate broadcasted infestation / iron/ha) plants and ornamentals, (Anhydrite) across cultivated when first reduction of potatoes area, only symptoms / leaf between plants, pests consumption, bait treatment organisms home and occur allotment garden area uses Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (i) g/kg or g/l situation should be described ( e.g. fumigation of a structure) (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds season at time of application (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (k) The minimum and maximum number of application possible under practical (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 conditions of use must be provided (f) All abbreviations used must be explained (l) PHI - minimum pre-harvest interval (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (m) Remarks may include: Extent of use/economic importance/restrictions (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

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IIIA 7.4.2 Evaluation of the Active Substance Ferric Phosphate

IIIA 7.4.2.1 Operator exposure and risk assessment

Estimation of operator exposure and risk assessment

Table IIIA 7.4-3: Exposure models for intended uses

Critical use(s) Vegetables, fresh herbs, fruit crops, ornamentals, potatoes (max. 4 x 50 kg COM 802 09 M RB/ha) Model(s) Health and Safety Executive (HSE, UK), The Applicant Guide: Completing An Application Overview For Operator And Consumer Exposure - Granular formulations (GR), EXPOSURE TO GRANULAR FORMULATIONS: HAND-HELD EQUIPMENT (available on http://www.pesticides.gov.uk/applicant_guide.asp?id=1246), (The proposed model for amateur uses by the notifier based on indoor applications (application in a kitchen or in a living room) are not adequate for larger scale outdoor applications.) and German model (available on http://www.bfr.bund.de/cm/343/anwendersicherheit_deutsches_modell_v1.xls) [Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products (Uniform Principles for Operator Protection), Mitteilungen aus der Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277, 1992]

Table IIIA 7.4-4: Estimated operator exposure towards ferric phosphate Total absorbed % of systemic Model data Level of PPE dose (mg/kg/day) 1) AOEL Applications of granular formulations (home and allotment gardens) using hand held machinery Application rate: 0.231 kg Fe/ha HSE model for granular formulations and German model no PPE 0.000077 0.01 Body weight: 70 kg 1) based on inhalation exposure only (no relevant dermal absorption)

For the detailed calculations it is referred to Appendix 3.

Measurement of operator exposure and risk assessment Since the exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of operator exposure was not necessary and was therefore not performed.

IIIA 7.4.2.2 Worker exposure and risk assessment

Estimation of worker exposure and risk assessment Worker re-entry exposure is considered to be negligible for granular plant protection products. In addition, no relevant dermal absorption is assumed. Therefore, worker exposure estimation was not necessary and was not performed.

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Measurement of worker exposure and risk assessment Since dermal exposure of workers is assumed to be negligible under conditions of intended uses, a study to provide measurements of worker exposure was not necessary and was therefore not performed.

IIIA 7.4.2.3 Bystander and resident exposure and risk assessment

Estimation of bystander and resident exposure and risk assessment Bystander exposure and adult resident exposure is considered to be negligible for granular plant protection products (no drift, no volatility). However, for applied granules there is a potential risk of ingestion by children who may enter treated areas soon after application of the product.

Resident exposure (children)

As a ‘worst case’ scenario (PICA) children ingesting 10 g soil per day are considered. Furthermore, as a conservative estimate oral bioavailability of 100 % is assumed.

Systemic exposure was estimated to be 0.95 µg iron/kg bw/day for children ingesting 10 g soil per day corresponding to 0.12 % of the AOEL for iron.

Measurement of bystander and resident exposure and risk assessment Since the exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) would not be exceeded under conditions of intended uses, a study to provide measurements of bystander and/or resident exposure was not necessary and was therefore not performed.

IIIA 7.4.3 Conclusion of Exposure Estimation and Risk Assessment The risk assessment according to the HSE model and the German model has shown that the estimated exposure towards ferric phosphate in COM 802 09 M RB does not exceed the systemic AOEL for operators, workers, bystanders and residents. No specific PPE is necessary for operators or for workers.

If the product is used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected.

IIIA 7.5 Justified Proposals for Classification and Labelling and Safety Instructions

Justified proposals for classification and labelling

In accordance with Directives 67/548/EEC and 1999/45/EC the following classification and labelling with regard to toxicological data is proposed for the preparation:

Table IIIA 7.5-1: Classification and labelling according to Directives 67/548/EEC and 1999/45/EC

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Table IIIA 7.5-2: Classification and labelling according to Regulation (EC) No 1272/2008

Safety instructions

Table IIIA 7.5-3: Safety phrases for instructions for use

Particular regulations for packages in the home and allotment garden area:

Maximal allowed quantity: Approval for the home and allotment garden area applies only for positive evaluated containers up to 2.5 kg.

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Appendix 1 List of Data Submitted in Support of the Evaluation

Table A 1: List of data submitted in support of the evaluation Annex point/ Author(s) Year Title Data Owner How reference No Source (where different from protection considered in company) claimed dRR Report-No. Study-Status / GLP or GEP status (where relevant), Usage * Published or not Authority registration No KIIIA 7.1.1 xxxxxxxxx, 2011 ACUTE ORAL TOXICITY yes COM 1 STUDY OF COM 802 09 M RB IN RATS Report-no. 26841 ASB2011-13370 KIIIA 7.1.2 xxxxxxxxx, 2011 ACUTE DERMAL TOXICITY yes COM 1 STUDY OF COM 802 09 M RB IN CD RATS Report-no. 26842 ASB2011-13371 KIIIA 7.1.4 xxxxxxxxx, 2011 ACUTE DERMAL yes COM 1 IRRITATION/CORROSION TEST (PATCH TEST) OF COM 802 09 M RB IN RABBITS Report-no. 26843 ASB2011-13372 KIIIA 7.1.5 xxxxxxxxx, 2011 ACUTE EYE yes COM 1 IRRITATION/CORROSION TEST OF COM 802 09 M RB IN RABBITS Report-no. 26844 ASB2011-13373 KIIIA 7.1.6 xxxxxxxxx, 2011 EXAMINATION OF COM 802 yes COM 1 09 M RB IN THE SKIN SENSITISATION TEST IN GUINEA PIGS ACCORDING TO MAGNUSSON AND KLIGMAN (MAXIMISATION TEST) Report-no. 26779 ASB2011-13374 * 1 accepted (study valid and considered for evaluation)

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Appendix 2 Detailed Evaluation of the Studies Relied upon

A 2.1 Acute Oral Toxicity

Reference: KIIIA 7.1.1 Report ACUTE ORAL TOXICITY STUDY OF COM 802 09 M RB IN RATS, xxxxxxxxx, (2011), Document No. 26841, ASB2011-13370 Guideline(s): OECD No. 423, EC method B1 tris (2004/73/EC) Deviations: No GLP: Yes Acceptability: Yes

Materials and methods The acute oral toxicity of COM 802 09 M RB (Batch No. 07/097, light blue-white solid granules, purity ferric orthophosphate: 1.3 %, total iron: 0.482 %) was tested in 6 female rats (CD/Crl:CD (SD) at a dose level of 5000 mg/kg bw according to the acute toxic class method.

Following an overnight fast three female rats were given a single dose of the test material by gavage at a dose level of 5000 mg COM 802 09 M RB /kg bw suspended in sesame oil (10 mL/kg bw). A second group received the same dose of 5000 mg/kg bw.

Mortality and overt signs of toxicity were checked immediately and 5, 15, 30 and 60 min after treatment, then 3, 6 and 24 hours after dosing and subsequently once daily until day 14. Body weights were recorded before dosing, and after seven and fourteen days post dosing. On day 15 all animals were sacrificed and subjected to gross necropsy.

Results and discussions

Table A 2: Results of acute oral toxicity study in rats of COM 802 09 M RB

1) Dose Toxicological results Duration of signs Time of death LD 50 (mg/kg bw) (mg/kg bw) (14 days)

female rats 5000 0 / 0 / 6 -- -- > 5000 1) Number of animals that died/number of animals with clinical signs/number of animals used

Table A 3: Summary of findings of acute oral toxicity study in rats of COM 802 09 M RB

Mortality: No Clinical signs: No Body weight: Not reduced Macroscopic No apparent abnormalities in any of the animals examination:

Conclusion

Under the experimental conditions, the oral LD 50 of COM 802 09 M RB is greater than 5000 mg/kg bw in

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COM 802 09 M RB – ZV1 007517-00/00 Part B – Section 3 - Core Assessment rats. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

Comments of zRMS: Acceptable (no deviations from above mentioned test guideline), used for evaluation, applicant’s description slightly modified by the zRMS

A 2.2 Acute Percutaneous (Dermal) Toxicity

Reference: KIIIA 7.1.2 Report ACUTE DERMAL TOXICITY STUDY OF COM 802 09 M RB IN CD RATS, xxxxxxxxx, (2011), Document No. 26842, ASB2011-13371 Guideline(s): OECD No. 402, EC method B.3 (92/69/EEC) Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

In an acute dermal toxicity study, a group of Sprague-Dawley derived rats (CD/Crl:CD (SD), 5/sex, was exposed to undiluted COM 802 09 M RB (Batch No. 07/097, light blue-white solid granules, purity ferric orthophosphate: 1.3 %, total iron: 0.482 %) by dermal administration.

On the day prior to dosing, each animal’s back and flanks were clipped free of hair without causing injury. The undiluted substance was administered as a single semi-occluded dermal application to an area of shorn skin (approximately 10 % of the total body surface area). A dose of 5000 mg/kg bw suspended in sesame oil was applied. After an exposure period of 24 h, the dressing was taken off. No residual test item had to be removed.

The animals were observed for mortality and overt signs of toxicity immediately and 5, 15, 30 and 60 min, 3, 6 and 24 h after dosing, on the day of treatment and subsequently once daily for the 14-day study period. Specific attention was paid to evident signs of skin irritation, e.g. formation of erythema or oedema. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. On day 15 all animals were sacrificed and subjected to gross necropsy.

Results and discussions

Table A 4: Results of acute dermal toxicity study in rats of COM 802 09 M RB

1) Dose Toxicological results Duration of signs Time of death LD 50 (mg/kg bw) (mg/kg bw) (14 days)

male rats 5000 0 / 0 / 5 -- -- > 5000 female rats 5000 0 / 0 / 5 -- -- > 5000 1) Number of animals that died/number of animals with clinical signs/number of animals used

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Table A 5: Summary of findings of acute dermal toxicity study in rats of COM 802 09 M RB

Mortality: No Clinical signs: No Body weight: Not reduced Macroscopic No apparent abnormalities in any of the animals examination:

Conclusion

Under the experimental conditions, the dermal LD 50 of COM 802 09 M RB is greater than 5000 mg/kg bw in rats. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

Comments of zRMS: Acceptable (no deviations from above mentioned test guideline), used for evaluation, applicant’s description slightly modified by the zRMS

A 2.3 Acute Inhalation Toxicity

An inhalation toxicity study was not submitted because the active substance is non-volatile, the product is formulated as solid granules, which do not produce dust. The granules have no respirable size (dust of granular pesticide formulation: 0.46 % < 150 µm acc. to CIPAC MT 58).

Comments of zRMS: Justification for waiving of the study is acceptable

A 2.4 Skin Irritation

Reference: KIIIA 7.1.4 Report ACUTE DERMAL IRRITATION/CORROSION TEST (PATCH TEST) OF COM 802 09 M RB IN RABBITS, xxxxxxxxx, (2011), Document No. 26843, ASB2011-13372 Guideline(s): OECD Guideline 404 (2002), EC Directive 2004/73/EC method B.4 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods In a dermal irritation study, 3 male New Zealand White rabbits were exposed dermally to 0.5 g of neat COM 802 09 M RB (Batch No. 07/097, light blue-white solid granules, purity ferric orthophosphate: 1.3 %, total iron: 0.482 %) per animal.

One day before dosing, the fur was removed from the dorsal area of the trunk of each animal using veterinary clippers. The test material was applied as a single dermal administration to 3 male albino rabbits to a small area (approx. 6 cm²). Initially, one animal was treated 24 h in advance of the others

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(initial test). As there was no evidence of corrosive or severe irritant effects two additional confirmatory animals were treated. The substance was covered with a gauze patch and held in place by non-irritating tape. Access to the patch, inhalation or ingestion of test item by the animals was prevented. Observations were made 1, 24, 48 and 72 hours following administration.

Results and discussions

Table A 6: Skin irritation of COM 802 09 M RB

Animal Scores after treatment Mean scores Reversible

No. 1 h 24 h 48 h 72 h (24-72 h) [day] 1 Erythema 0 0 0 0 0 -- Oedema 0 0 0 0 0 2 Erythema 0 0 0 0 0 -- Oedema 0 0 0 0 0 3 Erythema 0 0 0 0 0 -- Oedema 0 0 0 0 0

Clinical signs: No

Conclusion Under the experimental conditions, COM 802 09 M RB is not a skin irritant. Thus, no classification is required according to the classification criteria of Council Directive 67/548/EEC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

Comments of zRMS: Acceptable (no deviations from above mentioned test guideline), used for evaluation, applicant’s description slightly modified by the zRMS

A 2.5 Eye Irritation

Reference: KIIIA 7.1.5 Report ACUTE EYE IRRITATION/CORROSION TEST OF COM 802 09 M RB IN RABBITS, xxxxxxxxx, (2011), Document No. 26844, ASB2011-13373 Guideline(s): OECD Guideline 405 (1992), EC Directive 2004/73/EC method B.5 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods In an eye irritation study 100 mg of COM 802 09 M RB (Batch No. 07/097, light blue-white solid granules, purity ferric orthophosphate: 1.3 %, total iron: 0.482 %) were instilled into the conjunctival sac of one eye of three male New Zealand White rabbits. The eyelids were then gently held together for one second before releasing. The left eye remained untreated and served as the reference control. The test was performed initially using one animal. As no corrosive effects were noted, two animals were employed one day later.

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One hour after treatment, eyes were rinsed with 20 mL 0.9 % aqueous NaCl solution based on the conjunctival redness. Fluorescein measurements were performed at 24-h post treatment. Observations were made 1, 24, 48 and 72 hours after instillation of the test substance.

Results and discussions

Table IIIA 7: Eye irritation of COM 802 09 M RB Corneal Conjunctivae Animal no. Time Iris opacity Redness 1) Chemosis Secretion 1 h 0 0 1 0 0 24 h 0 0 1 0 0 1 48 h 0 0 0 0 0 72 h 0 0 0 0 0 Mean score (24 - 72 h) 0 0 0.33 0 0 1 h 0 0 1 0 0 24 h 0 0 1 0 0 2 48 h 0 0 0 0 0 72 h 0 0 0 0 0 Mean score (24 - 72 h) 0 0 0.33 0 0 1 h 0 0 1 0 0 24 h 0 0 1 0 0 3 48 h 0 0 0 0 0 72 h 0 0 0 0 0 Mean score (24 - 72 h) 0 0 0.33 0 0 1) Scores ranging from 0-3

Clinical signs: No

Conclusion Under the experimental conditions, COM 802 09 M RB was not irritating to rabbit eyes. Thus, no classification is required according to the requirements specified by Directive 67/548/EC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

Comments of zRMS: Acceptable (no deviations from above mentioned test guideline), used for evaluation, applicant’s description slightly modified by the zRMS

A 2.6 Skin Sensitisation

Reference: KIIIA 7.1.6 Report EXAMINATION OF COM 802 09 M RB IN THE SKIN SENSITISATION TEST IN GUINEA PIGS ACCORDING TO MAGNUSSON AND KLIGMAN (MAXIMISATION TEST), author, (2011), Document No. 26779, ASB2011-13374 Guideline(s): OECD Guideline 406 and EC method B.6 (96/54/EC) Deviations: No GLP: Yes Acceptability: Yes

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Materials and methods Skin sensitisation properties of COM 802 09 M RB (Batch No. 07/097, light blue-white solid granules, purity ferric orthophosphate: 1.3 %, total iron: 0.482 %) prepared in sesame oil were investigated in 10 male Dunkin Hartley guinea pigs using the Magnusson and Kligman maximisation method. A vehicle control group of 5 animals was run concurrently.

The treatment regime involved induction of sensitisation by intracutaneous injection on day 1, pre- treatment with 0.5 mL sodium lauryl sulphate in order to induce a local irritation on day 6, topical induction on day 8 (occlusive for 48 hours) and challenge by topical application on day 22 (occlusive dressing for 24 hours).

The following test concentrations were selected based on a preliminary test: intracutaneous injection of 10 % suspension of COM 802 09 M RB in sesame oil for primary induction on day 1, 50 % suspension of COM 802 09 M RB in sesame oil for topical application on day 8; 0.5 % suspension of the test compound in sesame oil (left flank) for challenge by topical application on day 22.

The skin reaction results of the first induction exposure were evaluated 24 and 48 hours after instillation. Skin evaluation after the second induction exposure was performed at 48 and 72 hours after begin of exposure. The challenge area was cleaned 21 hours after patch removal. The challenge sites were examined for erythema or swelling of the skin 48 and 72 hours after challenge application (24 and 48 hours after patch removal). During the study period the animals were observed daily for mortality and clinical signs. Individual body weights were recorded prior to dosing (day 1) and upon study termination and analysed statistically using Student`s t-test.

Results and discussions

Table A 8: Results of skin sensitisation study of COM 802 09 M RB

Test Substance Group 1) 24 hours 48 hours after challenge COM 802 09 M RB 0 / 10 0 / 10 Test Vehicle Control Group 0 / 5 0 / 5 Positive control ( α-hexyl cinnamic 20 / 20 20 / 20 aldehyde) 1) Number of animals with positive dermal response / number of animals in dose group

Clinical signs: No

Conclusion Under the experimental conditions, COM 802 09 M RB is not a skin sensitiser. Thus, no classification is required according to the requirements specified by Directive 67/548/EC and subsequent regulations as well as according to Regulation (EC) No. 1272/2008.

Comments of zRMS: Since all scores of the 10 treated animals were 0 after challenge, no further animals have to be tested.

Acceptable (no deviations from above mentioned test guideline), used for evaluation, applicant’s description slightly modified by the zRMS

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A 2.7 Supplementary Studies for Combinations of Plant Protection Products Supplementary studies are not required because COM 802 09 M RB is not intended to be registered in combination with other plant protection products. Therefore, no specific studies on such combinations were conducted.

A 2.8 Short-Term Toxicity Studies This is not an EC data requirement / not required by Regulation (EC) No 1107/2009.

A 2.9 Data on Formulants

A 2.9.1 Material safety data sheet for each formulant Material safety data sheets of the formulants can be found in the confidential dossier of this submission (Registration Report - Part C).

A 2.9.2 Available toxicological data for each formulant Available toxicological data for each formulant can be found in the confidential dossier of this submission (Registration Report - Part C).

A 2.10 Studies on Dermal Absorption Dermal absorption of the ferric or phosphate ions is considered to be negligible. Therefore no dermal absorption study was conducted with the plant protection product COM 802 09 M RB.

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Appendix 3 Exposure Calculations

A 3.1 Exposure Calculations for Ferric Phosphate

A 3.1.1 Operator exposure calculations

Table A 9: Estimation of operator exposure towards ferric phosphate using the HSE model and the German model Input parameters considered for the estimation of operator exposure Formulation type: RB Application rate (AR): 0.231 kg Fe /ha Area treated per day (A): 0.05 ha Dermal absorption (DA): 0 % (no relevant dermal absorption) Inhalation absorption (IA): 100 % Body weight (BW): 70 kg/person AOEL 0.8 mg Fe/kg bw/d Application technique: Application using hand held machinery Dermal (D): 93.8523 mg/person/kg a.s. Inhalation (I): 0.4677 mg/person/kg a.s.

Operator exposure towards ferric phosphate Without PPE Operators: Systemic dermal exposure after application in vegetables, herbs, fruits, ornamentals, potatoes Dermal exposure 1) SDE O = (D x AR x A x 100 x DA) / BW (93.8523 x 0.231 x 0.05 x 100 x 0%) / 70 External dermal exposure 108.399383 mg/person External dermal exposure 1.548563 mg/kg bw/d Systemic dermal exposure 0 mg/kg bw/d

Total systemic dermal exposure: SDE O Total external dermal exposure 108.399383 mg/person Total external dermal exposure 1.548563 mg/kg bw/d Total systemic dermal exposure 0 mg/kg bw/d Operators: Systemic inhalation exposure after application in vegetables, herbs, fruits, ornamentals, potatoes Inhalation exposure

SIE O = (I x AR x A x IA) / BW (0.4677 x 0.231 x 0.05 x 100%) / 70 External inhalation exposure 0.005402 mg/person External inhalation exposure 0.000077 mg/kg bw/d Systemic inhalation exposure 0.000077 mg/kg bw/d

Total systemic inhalation exposure: SIE O Total external inhalation exposure 0.005402 mg/person Total external inhalation exposure 0.000077 mg/kg bw/d Total systemic inhalation exposure 0.000077 mg/kg bw/d

Total systemic exposure: SE O = SDE O + SIE O Total systemic exposure 0.005402 mg/person Total systemic exposure 0.000077 mg/kg bw/d % of AOEL 0.01 % 1) measured values are with PPE (gloves and workwear according to model conditions), dermal exp. without PPE according to model conditions is calculated 'with PPE x 100' (i.e. assuming a penetration factor of 1 %, ‘worst case’)

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A 3.1.2 Resident (children) exposure calculations

Exposure assessment - Children (granule applications) (‘worst case’ PICA children) Active substance Iron Concentration of a.i. in the product 4.62 g/kg Application rate product 50 kg/ha Application rate a.i. 231 g/ha Application rate a.i. 2.31 µg/cm² Soil density 1.5 g/cm³ Concentration of a.i. in soil 1.54 µg/g soil

Average daily soil ingestion rate 10 g soil/day Oral exposure 15.4 µg/day Body weight 16.15 kg Exposure 0.95 µg/kg bw/day AOEL 0.8 mg/kg bw/day Proportion of AOEL 0.12 %

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REGISTRATION REPORT Part B

Section 4: Metabolism and Residues Detailed summary of the risk assessment

Product code: COM 802 09 M RB Active Substance: 12.5 g/kg Ferric Phosphate

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: COMPO GmbH & Co. KG Date: 06/12/2012

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Table of Contents

IIIA 8 METABOLISM AND RESIDUES DATA...... 4 IIIA 8.1 Evaluation of the active substances ...... 4 IIIA 8.1.1 Ferric phosphate ...... 4 IIIA 8.1.1.1 Storage stability...... 4 IIIA 8.1.1.2 Metabolism in plants and plant residue definition(s)...... 4 IIIA 8.1.1.3 Metabolism in livestock and animal residue definition(s)...... 5 IIIA 8.1.1.4 Residues in rotational crops...... 5 IIIA 8.1.1.5 Residues in livestock ...... 5 IIIA 8.2 Evaluation of the intended use(s) ...... 5 IIIA 8.2.1 Selection of critical use and justification...... 5 IIIA 8.2.2 Vegetables ...... 9 IIIA 8.2.2.1 Residues in primary crops ...... 9 IIIA 8.2.2.2 Distribution of the residue in peel/pulp ...... 9 IIIA 8.2.2.3 Residues in processed commodities ...... 9 IIIA 8.2.2.4 Proposed pre-harvest intervals, withholding periods...... 9 IIIA 8.2.3 Fresh herbs...... 9 IIIA 8.2.3.1 Residues in primary crops ...... 9 IIIA 8.2.3.2 Distribution of the residue in peel/pulp ...... 9 IIIA 8.2.3.3 Residues in processed commodities ...... 9 IIIA 8.2.3.4 Proposed pre-harvest intervals, withholding periods...... 9 IIIA 8.2.4 Fruits...... 9 IIIA 8.2.4.1 Residues in primary crops ...... 9 IIIA 8.2.4.2 Distribution of the residue in peel/pulp ...... 9 IIIA 8.2.4.3 Residues in processed commodities ...... 9 IIIA 8.2.4.4 Proposed pre-harvest intervals, withholding periods...... 10 IIIA 8.2.5 Ornamentals...... 10 IIIA 8.2.5.1 Residues in primary crops ...... 10 IIIA 8.2.5.2 Proposed pre-harvest intervals, withholding periods...... 10 IIIA 8.2.6 Potatoes...... 10 IIIA 8.2.6.1 Residues in primary crops ...... 10 IIIA 8.2.6.2 Distribution of the residue in peel/pulp ...... 10 IIIA 8.2.6.3 Residues in processed commodities ...... 10 IIIA 8.2.6.4 Proposed pre-harvest intervals, withholding periods...... 10

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IIIA 8.3 Consumer intake and risk assessment...... 10 IIIA 8.4 Proposed maximum residue levels (MRLs) ...... 11 IIIA 8.5 Conclusion...... 11 Appendix 1 List of data submitted in support of the evaluation ...... 11 Appendix 2 Detailed evaluation of the additional studies relied upon...... 12 Appendix 3 Pesticide Residue Intake Model (PRIMo) ...... 12

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IIIA 8 METABOLISM AND RESIDUES DATA

IIIA 8.1 Evaluation of the active substances

IIIA 8.1.1 Ferric phosphate

Table IIIA 8.1-1: Identity of the active substance

Structural formula 3- 3- O O 3+ 3+ Fe O P O Fe O P O x 4 H 2O O O

Common Name Ferric phosphate CAS number 10045-86-0

IIIA 8.1.1.1 Storage stability No studies are available and none required (see also DAR, ASB2010-10535 ). IIIA 8.1.1.2 Metabolism in plants and plant residue definition(s) No studies are available and none are required. This is briefly explained in the following table (see also DAR, ASB2010-10535 ).

Table IIIA 8.1-2: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, 6.6.2 and 6.7.1)

Plant groups covered No studies available and none required. Ferric phosphate occurs naturally in soil. Ferric and phosphate ions are plant nutrients and thus are also common constituents in plants. The uses of ferric phosphate as a pesticide are not expected to generate any residues of practical significance as compared to the natural background concentration in the environment. Rotational crops No studies available and none required. Metabolism in rotational crops similar to metabolism Not applicable in primary crops? (yes/no) Distribution of the residue in peel/ pulp Not applicable Processed commodities (nature of residue) No studies available and none required. Residue pattern in raw and processed commodities Not applicable similar? (yes/no) Plant residue definition for monitoring Not required. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005, neither a residue definition nor MRLs were established. Plant residue definition for risk assessment Not required Conversion factor(s) (monitoring to risk assessment) Not applicable

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IIIA 8.1.1.3 Metabolism in livestock and animal residue definition(s) No studies are available and none are required. This is briefly explained in the following table (see also DAR, ASB2010-10535 ).

Table IIIA 8.1-3: Metabolism in livestock (Annex IIA, point 6.2.2 to 6.2.5 and 6.7.1)

Animals covered No studies available and none required. The uses of ferric phosphate as a pesticide are not expected to generate any residues of practical significance in feed as compared to the natural background concentration. Time needed to reach a plateau concentration in milk Not applicable and eggs Animal residue definition for monitoring Not required. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005, neither a residue definition nor MRLs were established. Animal residue definition for risk assessment Not required Conversion factor(s) (monitoring to risk assessment) Not applicable Metabolism in rat and ruminant similar (yes/no) Not applicable Fat soluble residue: (yes/no) Not applicable (ferric phosphate is practically insoluble)

IIIA 8.1.1.4 Residues in rotational crops No studies are available and none are required. This is briefly explained in the following table (see also DAR, ASB2010-10535 ).

Table IIIA 8.1-4: Residues in rotational crops (Annex IIA, point 6.6.3)

Field studies No studies available and none required. No significant change of natural background levels expected consequent to uses as a pesticide.

IIIA 8.1.1.5 Residues in livestock Residues of ferric phosphate in commodities of animal origin were not assessed, since the active substance occurs naturally in soils and its constituents iron and phosphate are essential plant nutrients. The uses of ferric phosphate as a pesticide are not expected to generate any residues of practical significance in feed as compared to the natural background concentration. Therefore no feeding studies are required.

IIIA 8.2 Evaluation of the intended use(s)

IIIA 8.2.1 Selection of critical use and justification The critical GAP used for consumer intake and risk assessment is presented in Table IIIA 8.2-1. It has been selected from the individual GAPs in the Central zone for vegetables, fresh herbs, fruits, ornamentals and potatoes.

Note: the PHI of 1 day for food crops has been proposed during the peer review. It is not yet confirmed by the competent authority of zRMS (in Germany: (BVL).

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Table IIIA 8.2-1: Critical Use (worst case) used for consumer intake and risk assessment

Application Application rate Pests or Group of pests Remarks: Crop and/ F controlled Max. number or situation kg as/ha G (min. interval kg product / ha e.g. safener/synergist per ha Use- Member Timing / Growth PHI or (additionally: Method / between a) max. rate Water No. state(s) (crop destination / stage of crop & a) max. rate (days) I developmental stages of Kind applications) per appl. L/ha e.g. recommended or purpose of crop) season per appl. (i) the pest or pest group) a) per use b) max. total mandatory tank mixtures b) max. total (b) (d-f) b) per crop/ rate per min / max (a) (g) rate per (c) season crop/season (j) crop/season (h) 1 Central Vegetables F Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible 2 Central Vegetables G, I Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible 3 Central Vegetables F Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment: zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 terrace and balcony when first symptoms/harmful organisms become visible 4 Central Fresh herbs F Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible 5 Central Fresh herbs G, I Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible

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Application Application rate Pests or Group of pests Remarks: Crop and/ F controlled Max. number or situation kg as/ha G (min. interval kg product / ha e.g. safener/synergist per ha Use- Member Timing / Growth PHI or (additionally: Method / between a) max. rate Water No. state(s) (crop destination / stage of crop & a) max. rate (days) I developmental stages of Kind applications) per appl. L/ha e.g. recommended or purpose of crop) season per appl. (i) the pest or pest group) a) per use b) max. total mandatory tank mixtures b) max. total (b) (d-f) b) per crop/ rate per min / max (a) (g) rate per (c) season crop/season (j) crop/season (h) 6 Central Fresh herbs F Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment: zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 terrace and balcony when first symptoms/harmful organisms become visible 7 Central Fruit crops F Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible 8 Central Fruit crops G, I Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible 9 Central Fruit crops F Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. F home garden and allotment: zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 terrace and balcony when first symptoms/harmful organisms become visible 10 Central Ornamentals F Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. N home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible 11 Central Ornamentals G, I Slugs (larvae and adults) Spreading At beginning of a) 4 (1 day) a) 50 a) 0.625 n.a. N home garden and allotment zone infestation and/or b) 4 (1 day) b) 200 b) 2.5 when first symptoms/harmful organisms become visible

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Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, the use situation should be described ( e.g. fumigation of a structure) Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) at time of application (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (h) The minimum and maximum number of application possible under practical (d) All abbreviations used must be explained conditions of use must be provided (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, (i) PHI - minimum pre-harvest interval drench (j) Remarks may include: Extent of use/economic importance/restrictions (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

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IIIA 8.2.2 Vegetables

IIIA 8.2.2.1 Residues in primary crops Ferric phosphate occurs naturally in soils and its constituents, iron and phosphate, are essential plant nutrients. The intended uses are therefore not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005 a residue definition is not required and MRLs were not established. Analytical methods for enforcement are therefore not necessary. IIIA 8.2.2.2 Distribution of the residue in peel/pulp Not relevant. IIIA 8.2.2.3 Residues in processed commodities No data. IIIA 8.2.2.4 Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 1 day is proposed. It has to be confirmed by the competent authority of zRMS (in Germany: (BVL).

IIIA 8.2.3 Fresh herbs

IIIA 8.2.3.1 Residues in primary crops Ferric phosphate occurs naturally in soils and its constituents, iron and phosphate, are essential plant nutrients. The intended uses are therefore not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005 a residue definition is not required and MRLs were not established. Analytical methods for enforcement are therefore not necessary. IIIA 8.2.3.2 Distribution of the residue in peel/pulp Not relevant. IIIA 8.2.3.3 Residues in processed commodities No data. IIIA 8.2.3.4 Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 1 day is proposed. It has to be confirmed by the competent authority of zRMS (in Germany: (BVL).

IIIA 8.2.4 Fruits

IIIA 8.2.4.1 Residues in primary crops Ferric phosphate occurs naturally in soils and its constituents, iron and phosphate, are essential plant nutrients. The intended uses are therefore not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005 a residue definition is not required and MRLs were not established. Analytical methods for enforcement are therefore not necessary. IIIA 8.2.4.2 Distribution of the residue in peel/pulp No data. IIIA 8.2.4.3 Residues in processed commodities No data.

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IIIA 8.2.4.4 Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 1 day is proposed. It has to be confirmed by the competent authority of zRMS (in Germany: (BVL).

IIIA 8.2.5 Ornamentals

IIIA 8.2.5.1 Residues in primary crops The intended uses are not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary. IIIA 8.2.5.2 Proposed pre-harvest intervals, withholding periods Setting of a pre-harvest interval (PHI) is not applicable (N).

IIIA 8.2.6 Potatoes

IIIA 8.2.6.1 Residues in primary crops Ferric phosphate occurs naturally in soils and its constituents, iron and phosphate, are essential plant nutrients. The intended uses are therefore not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005 a residue definition is not required and MRLs were not established. Analytical methods for enforcement are therefore not necessary. IIIA 8.2.6.2 Distribution of the residue in peel/pulp No data. IIIA 8.2.6.3 Residues in processed commodities No data. IIIA 8.2.6.4 Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 1 day is proposed. It has to be confirmed by the competent authority of zRMS (in Germany: (BVL).

IIIA 8.3 Consumer intake and risk assessment

The envisaged uses are not relevant in terms of consumer health protection. Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005 a residue definition is not required and MRLs were not established. Thus estimation of consumer risk assessment is not necessary.

Table IIIA 8.3-1: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)

ADI JECFA has 1982 allocated a MTDI (maximum tolerable daily intake) for man: 70 mg/kg bw/d. For iron, JECFA has 1983 allocated a provisional maximum tolerable daily intake (PMTDI) for man: 0.8 mg/kg bw/d. TMDI (% ADI) according to EFSA PRIMo Not required, no MRLs established NTMDI (% ADI) according to NVS II model Not required, no MRLs established ARfD Not allocated IESTI (EFSA PRIMo) (% ARfD) Not required NESTI (NVS II model) (% ARfD) Not required Factors included in IESTI and NESTI Not applicable

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IIIA 8.4 Proposed maximum residue levels (MRLs)

Since ferric phosphate is listed in Annex IV of Regulation (EC) No 396/2005, no MRLs are required.

IIIA 8.5 Conclusion

The intended uses are not relevant in terms of consumer health protection. MRLs are not required.

The chronic and the short-term intake of ferric phosphate residues resulting from pesticide uses are unlikely to present a public health concern.

As far as consumer health protection is concerned, Germany/BfR agrees with the authorization of the intended uses.

Appendix 1 List of data submitted in support of the evaluation Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered in Authority registration No claimed dRR * Germany 1999 Iron-III-phosphate (ferric Add orthophosphate) (Monograph)

ASB2010-10535 OECD: KIIA 5, Anon. 1995 Iron: Nutritional and physiological N OECD: KIIA 5.1, significance OECD: KIIA 5.4, OECD: KIIA 5.5.1, BVL-2186119, BVL-2186123, BVL- OECD: KIIA 5.6 2186232, BVL-2186235, BVL- 2186241, RIP9801276 OECD: KIIA 5, Brady, N. C. 1974 Ferric Phosphate: The nature and N OECD: KIIA 5.11 properties of soils

BVL-2186281, BVL-2186293, RIP9801270 OECD: KIIA 5.1, Friberg, L.; Nordberg, G. 1986 Handbook on the toxicology of metals. N OECD: KIIA 5.5.1 F.; Vouk, V. B.; Kessler, E. Second edition. Volume II: Specific metals. Chapter 13: Iron Page: 276-293 BVL-2186376, BVL-2186377, TOX1999-370 OECD: KIIA 5.11 Anon. 1982 Evaluation of certain food additives and N contaminants, Twenty-sixth report (TRS 683) Report series 683 BVL-2186268, RIP9801271 OECD: KIIA 5.11 Anon. 1983 Evaluation of certain food additives and N contaminants, Twenty-seventh report (TRS 696) Report series 696 BVL-2186276, RIP9801273 OECD: MIIA Sec 4 Beck, C. 2011 Eisen-III-phosphat: Residues in or on N treated products, food and feed - Tier 2, IIA-6 MII / Sec. 4 BVL-2182535, ASB2011-13329 OECD: MIIIA1 Anon. 2011 Eisen-III-phosphat / COM 802 09 M N Sec 4 RB: Residues in or on treated products, food and feed - Tier 2, IIIA-8; Registration report Part B Section 4 Metabolism and Residues MIII / Sec. 4 BVL-2182452, BVL-2182787, ASB2011-13335 * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation

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Appendix 2 Detailed evaluation of the additional studies relied upon No data were submitted in support of the evaluation and none are required.

Appendix 3 Pesticide Residue Intake Model (PRIMo) Not applicable, no calculation required.

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REGISTRATION REPORT Part B

Section 5 Environmental Fate Detailed summary of the risk assessment

Product code: COM 802 09 M RB Active Substance(s): Ferric phosphate 12.5 g/kg

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: COMPO GmbH & Co. KG Date: 06/12/2012

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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 FERRIC PHOSPHATE ...... 4 5.3.1 Identity, further information of Ferric phosphate...... 4 5.3.2 Physical and chemical properties of Ferric phosphate ...... 4 5.3.3 Metabolites of Ferric phosphate...... 5 5.4 SUMMARY ON INPUTPARAMETER FOR ENVIRONMENTAL EXPOSURE ASSESSMENT...... 5 5.4.1 Rate and route of degradation in soil...... 6 5.4.2 Adsorption/desorption...... 6 5.4.3 Rate of degradation in water ...... 6 5.4.4 Rate of degradation in air ...... 7 5.5 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4)...... 7 5.6 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7)...... 7 5.7 ESTIMATION OF CONCENTRATIONS IN GROUNDWATER (KIIIA1 9.6)...... 8 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ...... 9 APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON...... 10 KIIA 7 FATE AND BEHAVIOUR IN THE ENVIRONMENT ...... 10 KIIIA1 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT ...... 10

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Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) This document comprises the risk assessment for groundwater and the exposure assessment of surface water and soil for the plant protection product COM 802 09 M RB containing the active substance Ferric phosphate in its intended uses in vegetables, fresh herbs, fruits, ornamentals and potatoes according to Part B, Section 1, Appendix 2. National Addenda are included containing country specific assessments for some annex points.

5.1 General Information on the formulation

Table 5.1-1: General information on the formulation COM 802 09 M RB

Code COM 802 09 M RB plant protection product COM 802 09 M RB applicant COMPO GmbH & Co. KG date of application September 2011 Formulation type RB (ready for use bait) (WP, EC, SC, …; density) active substance Ferric phosphate -/- -/- Concentration of as 12.5 g/kg -/- -/-

5.2 Proposed use pattern

The critical GAP used for exposure assessment is presented inTable 5.2-1. It has been selected from the individual GAPs in the zentral zone for vegetables, fresh herbs, fruits, ornamentals, potatoes. A list of all intended uses within the zentral zone is given in Part B, Section 1, Appendix 2. Table 5.2-1: Critical use pattern of COM 802 09 M RB

Group/ Crop/growth Application Number of applications, Application rate, Soil effective use No stage method Drift Minimum application cumulative application rate scenario interval, application (g as/ha) (g as/ha) time, interception A/ Vegetables Spreading, 1-4 x, 1 d; --; -- COM 802 09 M COM 802 09 M 00-001 Fresh herbs uniformly RB: 4 x 50000 = RB: 4 x 50000 = 00-003 Fruits (soft broadcasted 200000 200000 00-004 fruit, tree nuts, across Ferric phosphate: Ferric phosphate: 00-006 pome fruit, cultivated 4 x 625 = 2500 4 x 625 = 2500 00-007 stone fruit) area, only 00-009 Ornamentals between 00-010 Potatoes plants, bait 00-012 treatment. 00-013 Outdoor or field use (F)

Start at beginning of infestation.

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B/ Vegetables Spreading, 1-4 x, 1 d; --; -- COM 802 09 M COM 802 09 M 00-002 Fresh herbs uniformly RB: 4 x 50000 = RB: 4 x 50000 = 00-005 Fruits (soft broadcasted 200000 200000 00-008 fruit, tree nuts, across Ferric phosphate: Ferric phosphate: 00-011 pome fruit, cultivated 4 x 625 = 2500 4 x 625 = 2500 stone fruit) area, only Ornamentals between plants, bait glasshouse treatment. application (G) or indoor application (I)

Start at beginning of infestation.

5.3 Information on the active substances Ferric phosphate

5.3.1 Identity, further information of Ferric phosphate Table 5.3-1: Identity, further information on Ferric phosphate

Active substance (ISO common name) Ferric phosphate IUPAC Ferric phosphate Function (e.g. fungicide) Molluscicide Status under Reg. (EC) No 1107/2009 approved 2001/87/EC (OJ L 276, 19.10.2001, p.17-20) Date of approval 01/11/2001 10/11/2010 (Extension) Conditions of approval Only uses as a molluscicide may be authorised. Confirmatory data -/- RMS Germany Minimum purity of the active substance Min. 990 g/kg as manufactured (g/kg)

Molecular formula FePO 4 · 4 H 2O Molecular mass 222.9 g/mol (150.82 g/mol anhydrous) Structural formula

5.3.2 Physical and chemical properties of Ferric phosphate Physical and chemical properties of Ferric phosphate as agreed at EU level (see SANCO/3035/99-final – 08/03/2002) and considered relevant for the exposure assessment are listed in Table 5.3-2.

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Table 5.3-2: EU agreed physical chemical properties of Ferric phosphate relevant for exposure assessment

Value Reference Vapour pressure (Pa) Non-volatile ( at 25°C) SANCO/3035/99-final – 08/03/2002 Henry’s law constant (Pa × m³ × mol -1) Not applicable Solubility in water (mg/L) 1.86 × 10 -12 (calculated, 25°C, pH 7) With decreasing pH the solubility increases.

Partition co-efficient, log K OW Not applicable (practically insoluble in water) Dissociation constant, pKa Not applicable (practically insoluble in water) Not applicable (practically Photolytic stability insoluble in water) Not applicable (practically Hydrolytic stability insoluble in water)

5.3.3 Metabolites of Ferric phosphate No studies on the fate and behaviour of Ferric phosphate were performed. Apart from ferric and phosphate ions there are no degradation products of the active substance. Both ferric and phosphate ions are natural constituents of soils.

5.4 Summary on Inputparameter for environmental exposure assessment

As it is possible to extrapolate from data provided for the active substances, no further data is provided on the preparation. The fate and behaviour of Ferric phosphate was evaluated during the Annex I inclusion. No studies have been performed and were not required. Ferric phosphate is considered to be a stable, non-volatile salt which is practically insoluble in water. Both, ferric and phosphate ions are naturally occurring in soil. Iron phosphates occurring in soils are e.g. strengite (FePO 4 · 2 H 2O, stable in acidic soils) and vivianite (Fe 3(PO 4)2 · 8 H 2O, stable under anaerobic conditions). Iron occurs in a wide variety of minerals and is the fourth most abundant element in the lithosphere. In soils under aerobic conditions iron is present mostly in form of insoluble Fe(III) oxides (e.g. foethite, haematite, ferrihydrite); The fate and transport of Fe(II) and Fe(III) salts in the environment is dominated by three major processes: (1) the pH-redox potential dependent oxidation of Fe(II) to Fe(III); (2) the formation of insoluble oxides and hydroxides that are also well known components of soils; (3) the distinct surface chemistry of the oxides and hydroxides of iron that control the adsorption of anions, cations and organic material or the adsorption of iron species onto the surfaces of mineral and organic components of soils, contributing to the aggregation of soil particles into larger units. The primary source of phosphorous in soils, which is present as orthophosphate anion, is the mineral apatite (Ca 5(PO 4)3OH). In soils there are several mechanisms of immobilisation of the phosphate anion: sorption to inorganic soil components (e.g. Fe(III) oxides), precipitation as low soluble Ca-, Al- or Fe-phosphates and chemical bonding to humic substances. Thus most of the total phosphorus is part of the soil solids. Only about 0.1% of the phosphorus content is dissolved in the soil solution where concentrations of 0.001 – 0.1 mg/L (non fertilised soils) and 0.1 – 5 mg/L (fertilised soils) occur.

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There are natural mechanisms whereby soil microorganisms and plant rootlets, aided by carbon dioxide and other root exudates, will transform the insoluble Ferric phosphate into forms that are usable by plants. Iron is a plant micronutrient and phosphorous is a macronutrient, both of which are essential to plant growth and development. The insolubility of Ferric phosphate ensures that breakdown is a slow process. Although the solubility of Ferric phosphate increases with water temperature, at normal soil temperatures it is practically insoluble (1.86× 10 -12 g/L, calculated, pH 7, 25°C). The end use product is not intended for use in an aquatic environment, but it should be noted that Ferric phosphate’s insolubility in water combined with its ready adsorption to the soil renders it immobile. As a consequence it is unlikely that the Ferric phosphate would migrate from the area of application into aquatic systems. In addition, Ferric phosphate is a highly stable compound that does not break down in sunlight and is a non-volatile solid which would not be mobile in the air.

5.4.1 Rate and route of degradation in soil As it is possible to extrapolate from data provided for the active substances, no further data are provided on the preparation. The degradation of Ferric phosphate was evaluated during the Annex I inclusion. No studies were provided for Ferric phosphate and were not required. For further information please refer to 5.4.

5.4.2 Adsorption/desorption As it is possible to extrapolate from data provided for the active substances, no further data are provided on the preparation. The mobility of Ferric phosphate was evaluated during the Annex I inclusion. No studies on adsorption/desorption of Ferric phosphate have been performed and were not required. Due to the fact that substance is practically insoluble in water and both iron and phosphate ions are naturally occurring substances. Additionally, iron and, in particular, phosphate are applied in considerable amounts to agricultural soils in fertilisers. Therefore, it is impossible to distinguish between amounts occurring naturally in soils form those added with the slug bait. For further information please refer to 5.4.

5.4.3 Rate of degradation in water No new water/sediment study has been submitted. The fate and behavior of Ferric phosphate in water was evaluated during the Annex I inclusion. No studies on degradation of Ferric phosphate in water have been performed and were not required. The active substance is an inorganic salt with a very low solubility in water (1.86 x 10 -12 g/l). Both ferric and phosphate ions are naturally occurring components of terrestric and aquatic ecosystems serving as essential nutrients in animal and plant physiology. Due to the properties of the active substance and the kind of application a significant contamination of water bodies resulting from application of ferric phosphate according to the GAP is not expected.

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5.4.4 Rate of degradation in air The active substance Ferric phosphate is a non-volatile inorganic salt. Therefore, no unacceptable amounts of Ferric phosphate are to be expected in air due to volatilisation or in aquatic or terrestrial environments.

5.5 Estimation of concentrations in soil (KIIIA1 9.4)

COM 802 09 M RB is a molluscuide containing the active substance Ferric phosphate (12.5 g/kg). It is considered to be applied as ready-to-use bait against slugs in vegetables, fresh herbs, fruits, ornamentals and potatoes. It is considered to be used for protection of emerging plants outdoors or indoors and greenhouses (only in field for potatoes) at up to four application of 50 kg product/ha (equivalent to 625 g Ferric phosphate/ha) and with minimum of one day between applications. The product is considered to be spread, uniformly across cultivated area only between plants, bait treatment. Therefore, the application is directly to the soil surface, with plant interception of 0% taken into account. PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation kinetics. A soil bulk density of 1.5 g cm -3, a soil depth of 5 cm were assumed. The initial PECsoil calculations were performed with ESCAPE 2.0. The short-term and long-term actual concentrations (PECsoil, actual) and the time weighted average concentrations (PECsoil, twa) for the active substance Ferric phosphate were not calculated because no reliable DT 50 value in soil could be obtained for the active substance Ferric phosphate. Therefore, considering multiple applications, as a worst-case scenario it is assumed that COM 802 09 M RB is applied in one cumulative application of 200 kg/ha (corresponding to 2.5 kg/ha Ferric phosphate) to vegetables, fresh herbs, fruits, ornamentals and potatoes. However, it can be realistically concluded that this cumulative application does not reflect the conditions of use since e.g. ingestion by slugs takes place between applications.

Table 5.5-1: Results of PECsoil calculation (soil bulk density 1.5 g/cm -3, soil depth 5 cm)

plant protection product: COM 802 09 M RB (12.5 g/kg Ferric phosphate) use: Vegetables, fresh herbs, ornamentals, fruits, potatoes Number of applications/intervall 4 / 1 day application rate: 50 kg/ha, corresponding to 0.625 kg as/ha crop interception: None, application to soil surface active soil relevant Single Appl. cumulative substance/preparati application rate PEC act PEC act on (kg/ha) (mg/kg) (mg/kg) COM 802 09 M RB 4 x 50 66.667 266.667 Ferric phosphate 4 x 0.625 0.833 3.333

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

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bait and a contamination of surface water via spray drift can therefore be excluded. The possible entry route into adjacent water bodies is considered to be via runoff of soil particles containing the active substance after heavy rain events. The maximum environmental concentration which will be expected in the water phase will correspond to the water solubility of ferric phosphate. The insoluble portion remaining in the sediment will add to the natural content of iron and phosphate in the sediment.

5.7 Estimation of concentrations in groundwater (KIIIA1 9.6)

The calculation of Predicted Environmental concentrations in ground water (PEC GW ) of Ferric phosphate was not performed and was not considered to be required. Active substance Ferric phosphate is a stable, non-volatile inorganic salt which is practically insoluble in water. Due to the insolubility and strong adsorption on soil, it is practically immobile in soil. In soil Ferric phosphate is transformed into iron and phosphate which are both naturally constituents of soil occurring in concentrations of 0.2 – 5% and 0.01 – 0.2% (expressed as P), respectively. Therefore risk to groundwater contamination resulting from Ferric phosphate application according to the GAP table is not expected.

Consequences for authorisation: None

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

* 1) accepted (study valid and considered for evaluation) 2) not accepted (study not valid and not considered for evaluation) 3) not considered (study not relevant for evaluation) 4) not submitted but necessary (study not submitted by applicant but necessary for evaluation) 5) supplemental (additional information, alone not sufficient to fulfil a data requirement, considered for evaluation)

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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). Present the authority's evaluation of the study in a box below each individual study.

KIIA 7 Fate and Behaviour in the Environment No new studies were submitted.

KIIIA1 9 Fate and Behaviour in the Environment No new studies were submitted.

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REGISTRATION REPORT Part B

Section 5 Environmental Fate Detailed summary of the risk assessment

Product code: COM 802 09 M RB Active Substance(s): Ferric phosphate 12.5 g/kg

Central Zone Zonal Rapporteur Member State: Germany

National Addendum - Germany

Applicant: COMPO GmbH & Co. KG Date: May 2012, revised October 2012

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Table of Contents TABLE OF CONTENTS...... 2 SEC 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) ...... 3 5.1 PROPOSED USE PATTERN ...... 3 5.2 ESTIMATION OF CONCENTRATIONS IN SOIL (KIIIA1 9.4)...... 4 5.3 ESTIMATION OF CONCENTRATIONS IN SURFACE WATER AND SEDIMENT (KIIIA1 9.7)...... 5 5.4 ESTIMATION OF CONCENTRATIONS IN GROUNDWATER (KIIIA1 9.6)...... 6 APPENDIX 1 LIST OF DATA SUBMITTED IN SUPPORT OF THE EVALUATION ...... 7 APPENDIX 2 DETAILED EVALUATION OF STUDIES RELIED UPON...... 8 KIIA 7 FATE AND BEHAVIOUR IN THE ENVIRONMENT ...... 8 KIIIA1 9 FATE AND BEHAVIOUR IN THE ENVIRONMENT ...... 8

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Sec 5 FATE AND BEHAVIOUR IN THE ENVIRONMENT (KIIIA 9) The exposure assessment of the plant protection product COM 802 09 M RB in its intended uses in vegetables, fresh herbs, fruits, ornamentals and potatoes within the Central Zone is described in detail in the core assessment of the plant protection product COM 802 09 M RB dated from the 25/04/2012 performed by Germany. This document contains the specific exposure assessment regarding PECsoil, PECgw and PECsw for authorisation of the plant protection product COM 802 09 M RB in Germany according to its intended uses in vegetables, fresh herbs, fruits, ornamentals and potatoes based on the data and results presented in the core assessment of the plant protection product COM 802 09 M RB. Only concentrations of the active substances in COM 802 09 M RB in soil were predicted following the proposed use pattern. The predicted environmental concentrations (PEC values) in surface water, sediment and groundwater along with the long-term concentrations based on results obtained for the active substances contained in the formulation were not calculated and are not considered to be required basing on active substance data. The impact of formulants is limited to short-term effects such as formation of stable spray dispersions or to facilitate uptake by target organisms, while their influence on long-term processes, such as degradation and distribution is negligible. Therefore, for the purposes of this risk assessment it is assumed that formulants do not influence the fate and behaviour of an active substance in the environment and are not considered further. Properties considered relevant in assessing the fate of active substance are presented in the core assessment of COM 802 09 M RB, Part B, Section 5 for Central Zone.

Regarding PEC gw relevant risk mitigation measures, if necessary, are documented in this document. PEC soil , PEC sw are used for risk assessment to derive specific risk mitigation measures if necessary (see Part B section 6 and Part A).

5.1 Proposed use pattern

COM 802 09 M RB is a molluscicide against slugs formulated as a ready to use bait containing the active substance Ferric phosphate (12.5 g/kg). It is intended to be applied to various crops (vegetables, fresh herbs, fruits, ornamentals and potatoes) up to four times starting at beginning of infestation or when first symptoms/pests organisms occur with application rate of 50 kg product/ha (equivalent to 625 g Ferric phosphate/ha). The applications are considered to be done on the field, indoor or in greenhouses for vegetables, fresh herbs, fruits and ornamentals and on the field for potatoes. The critical GAP used for exposure assessment is presented in Table 5.1-1. It has been selected from the individual GAPs in the zentral zone for vegetables, fresh herbs, fruits, ornamentals, potatoes. A list of all intended uses within the zentral zone is given in Part B, Section 1, Appendix 2.

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Table 5.1-1: Critical use pattern of COM 802 09 M RB

Start at beginning of infestation. B/ Vegetables Spreading, 1-4 x, 1 d; --; -- COM 802 09 M COM 802 09 M 00-002 Fresh herbs uniformly RB: 4 x 50000 = RB: 4 x 50000 = 00-005 Fruits (soft broadcasted 200000 200000 00-008 fruit, tree nuts, across Ferric phosphate: Ferric phosphate: 00-011 pome fruit, cultivated 4 x 625 = 2500 4 x 625 = 2500 stone fruit) area, only Ornamentals between plants, bait glasshouse treatment. application (G) or indoor application (I)

Start at beginning of infestation.

5.2 Estimation of concentrations in soil (KIIIA1 9.4)

Results of PEC soil calculations for Ferric phosphate according to EU assessment considering 5 cm soil depth are given in Table 5.6-2 of Part B, Section 5 of the core assessment.

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For german exposure assessment, the applied soil depth is based on experimental data 1 (Fent, 1999). Generally, for active substances with a K f,oc < 500 a soil depth of 2.5 cm is used whereas for active substances with a K f,oc > 500 a soil depth of 1 cm is applied.

The initial PEC soil calculations according to the FOCUS guidance were performed with ESCAPE 2.0 considering an even distribution of the compound within a soil layer of 1 cm depth and a bulk density of 1.5 g/cm³. The standard soil depth of 1 cm was considered for Ferric phosphate due to substance properties – considered to be immobile, indicating a strong potential of adsorption to soil.

The short-term and long-term actual concentrations (PEC soil,actual ) and the time weighted average concentrations (PEC soil,twa ) for the active substance Ferric phosphate were not calculated because no reliable DT 50 value in soil could be obtained for the active substance Ferric phosphate. Therefore, considering multiple applications, as a worst-case scenario it is assumed that COM 802 09 M RB is applied in one cumulative application of 200 kg/ha (corresponding to 2.5 kg/ha Ferric phosphate) to vegetables, fresh herbs, fruits, ornamentals and potatoes. However, it can be realistically concluded that this cumulative application does not reflect the conditions of use since e.g. ingestion by slugs takes place between applications.

The summary of PEC soil calculations is presented below in Table 5.2-1. -3 Table 5.2-1: Results of PEC soil calculation (soil bulk density 1.5 g/cm , soil depth 1 cm)

plant protection product: COM 802 09 M RB (12.5 g/kg Ferric phosphate) use: Vegetables, fresh herbs, ornamentals, fruits, potatoes Number of applications/intervall 4 / 1 day application rate: 50 kg/ha, corresponding to 0.625 kg as/ha crop interception: None, application to soil surface active soil relevant Single Appl. cumulative substance/preparati application rate PEC act PEC act on (kg/ha) (mg/kg) (mg/kg) COM 802 09 M RB 4 x 50 333.33 1333.33 Ferric phosphate 4 x 0.625 4.167 16.667

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

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5.4 Estimation of concentrations in groundwater (KIIIA1 9.6)

Consequences for authorisation: None

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

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KIIA 7 Fate and Behaviour in the Environment No studies were submitted.

KIIIA1 9 Fate and Behaviour in the Environment No studies were submitted.

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REGISTRATION REPORT Part B

Section 6: Ecotoxicological Studies Detailed summary of the risk assessment

Product code COM 802 09 M RB

Active Substance Ferric phosphate 12.5 g/L

Member State: Germany Central Zone

CORE ASSESSMENT

Applicant COMPO GmbH & Co. KG

Date May 2012, revised October2012

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

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Table of Contents 6.1 PROPOSED USE PATTERNS ...... 3 6.2 EFFECTS ON BIRDS (IIIA1 10.2) ...... 5 6.2.1 Overview...... 5 6.2.2 Toxicity exposure ratios for birds (IIIA 10.2.1)...... 7 6.2.3 Drinking water exposure...... 8 6.2.4 Details on formulation type in proportion per item...... 8 6.2.5 Effects of secondary poisoning (IIIA1 10.1.9)...... 8 6.3 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (IIIA1 10.3) ...... 9 6.3.1 Overview and summary ...... 9 6.3.2 Toxicity exposure ratios (IIIA1 10.3.1) ...... 10 6.3.3 Drinking water exposure...... 10 6.3.4 Details on formulation type in proportion per item (IIIA 10.3.2) ...... 10 6.3.5 Effects of secondary poisoning (IIIA1 10.3.2.3)...... 10 6.3.6 Supervised cage or field trials (IIIA 10.3.3)...... 10 6.4 EFFECTS ON AQUATIC ORGANISMS (IIIA1 10.2)...... 11 6.4.1 Overview and summary ...... 11 6.4.2 Toxicity exposure ratios (IIIA1 10.2.1) ...... 13 6.4.3 Risk from metabolites...... 14 6.5 EFFECTS ON BEES (IIIA 10.4) ...... 14 6.6 EFFECTS ON ARTHROPODS OTHER THAN BEES (IIIA 10.5)...... 15 6.6.2 Risk Assessment for Arthropods other than Bees...... 17 6.6.3 Using artificial substrates...... 17 6.6.4 Extended laboratory studies (IIIA 10.5.2)...... 17 6.7 EFFECTS ON EARTHWORMS AND OTHER SOIL NON -TARGET MACRO -ORGANISMS (IIIA 10.6) ...... 18 6.7.2 Toxicity exposure ratios for earthworms, TERA and TERLT (IIIA 10.6.1)...... 20 6.7.3 Acute toxicity (IIIA 10.6.2) ...... 21 6.7.4 Sublethal effects (IIIA 10.6.3) ...... 21 6.7.5 Field tests (IIIA 10.6.4)...... 21 6.7.6 Residue content of earthworms (IIIA 10.6.5) ...... 22 6.7.7 Effects on other non-target macro-organisms (IIIA 10.6.6)...... 22 6.7.8 Effects on organic matter breakdown (IIIA 10.6.7)...... 23 6.8 EFFECTS ON SOIL MICROBIAL ACTIVITY (IIIA 10.7) ...... 23 6.9 EFFECTS ON NON -TARGET PLANTS (IIIA 10.8) ...... 23 6.9.1 Terrestrial plants (IIIA 10.8.1)...... 23 6.9.2 Effects on non-target aquatic plants (IIIA 10.8.2) ...... 23 6.10 OTHER NON -TARGET SPECIES (F LORA AND FAUNA ) (IIIA 10.9)...... 23 6.11 SUMMARY AND EVALUATION OF POINTS 9 AND 10.1-10.10 ...... 24 6.11.1 Predicted distribution and fate in the environment and time courses involved (IIIA 10.11.1) ...... 24 6.11.2 Non-target species at risk and extent of potential exposure (IIIA1 10.11.2)...... 24 6.11.3 Short and long term risks for non-target species, populations, communities and processes (IIIA 10.11.3)...... 24 6.11.4 Risk of fish kills and fatalities in large vertebrates or terrestrial predators (IIIA 10.11.4)...... 26 6.11.5 Precautions necessary to avoid/minimise environmental contamination and to protect non-target species (IIIA 10.11.5) ...... 26 A2-1 ACTIVE SUBSTANCE ...... 30 A2-2 FORMULATION ...... 31 IIIA 10.1 Effects on birds ...... 31 IIIA 10.2 Effects on aquatic organisms...... 32 IIIA 10.4 Effects on bees ...... 35 IIIA 10.5 Effects on arthropods other than bees ...... 36 IIIA 10.6 Effects on earthworms and other makro soil-organisms ...... 38

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Sec 6 ECOTOXICOLOGICAL STUDIES

This document reviews the ecotoxicological studies for the product COM 802 09 M RB containing the active substance Ferric phosphate, which is included in Annex I of Regulation (EC) 1107/2009 as set out in Commission Directive 2001/87/EC (OJ L 276, 19.10.2001, p.17-20). A full risk assessment according to Uniform Principles is provided which predicts acceptable environmental risks for the product if applied according to the proposed uses. Addenda are included containing country specific assessments for some annex points. In those cases this document should be read in conjunction with the relevant addenda. Where appropriate, this document refers to the conclusions of the EFSA, especially when data on the active substance is relied upon in the risk assessment of the formulation. Each section will begin with a table providing the EU endpoints used in this evaluation. Note: this Part B document only reviews data (Annex II or Annex III) and additional information that has not previously been considered within the EU review process, as part of the Annex I inclusion decision. New Annex II data must only be included if they are considered essential for the evaluation and in this case a full study summary must be provided.

COM 802 09 M RB was not the representative formulation considered in the EU review process as part of Annex I inclusion and has not been previously evaluated in other Member States according to the Uniform Principles. The SANCO report for Ferric phosphate (SANCO/3035/99 - Final, 8 March 2002) is considered to provide the relevant review information or a reference to where such information can be found. The Annex I Inclusion Directive for Ferric phosphate (2001/87/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation: For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the active substance Ferric phosphate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 June 2001 shall be taken into account. On the basis of the proposed and supported uses, 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.

Appendix 1 of this document contains the list of references included in this document for support of the evaluation. Appendix 2 of this document is the table of intended uses for COM 802 09 M RB. Information on the detailed composition of COM 802 09 M RB can be found in the confidential dossier of this submission (Registration Report - Part C).

6.1 Proposed use patterns

Introduction

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This section of the submission summarises the ecotoxicological effects of the formulation COM 802 09 M RB and evaluates the potential risk to various representatives of terrestrial, aquatic and soil organisms. Full details or the proposed use pattern that will be assessed are shown in Appendix 2 of this document and summarized in the table below. The critical GAP used for exposure assessment is presented in Table 6.1-1. It has been selected from the individual GAPs in the zentral zone for vegetables, fresh herbs, fruits, ornamentals, potatoes. A list of all intended uses within the zentral zone is given in Part B, Section 1, Appendix 2. Table 6.1-1: Critical use pattern of COM 802 09 M RB

Start at beginning of infestation.

Consideration of metabolites Ferric phosphate does not require conversion to a metabolite or degradation product to exert its intended effect. Therefore, information relative to the formation of active metabolites and degradation products are not relevant. Apart from ferric and phosphate ions there are no degradation products of the active substance. Both ferric and phosphate ions are natural constituents of soils.

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6.2 Effects on birds (IIIA1 10.2)

6.2.1 Overview Effects on birds for the product COM 802 09 M RB were not evaluated as part of the EU review of the active substance Ferric phosphate. Additional data is considered essential and thus an acute bird study (limit test) with COM 802 09 M RB was conducted. Avian acute oral, short-term dietary and long-term reproduction studies have not been carried out with Ferric phosphate. SANCO/10329/2002 1 indicates that, in the case of granules birds are clearly exposed to the formulation. Thus, the relevant toxicity endpoint for the acute assessment should be based on the endpoint of the formulation. Full details of the avian toxicity study with the product COM 802 09 M RB is provided in appendix 2 of this document. In terms of granular formulations, the risk assessment is usually carried out according to the European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals (EFSA Journal 2009; 7(12): 1438), taking into account specific exposure scenarios. Accordingly, birds and mammals may be exposed to granules in the following ways: a) Birds and mammals may ingest granules as a source of food. b) Birds may ingest granules as grit. c) Birds may mistake granules for small seed. d) Birds and mammals may ingest granules when they eat food contaminated with soil. e) Birds and mammals may consume food contaminated with residues resulting from granular applications. However, since iron and phosphate are naturally occurring non-toxic substances and common in the metabolism of birds and mammals, and taking into account the use of ferric phosphate as a nutrient and dietary supplement in foods, a qualitative risk assessment for COM 802 09 M RB based on a weight of evidence approach is provided here and is considered more adequate.

6.2.1.1 Toxicity The endpoint considered in the qualitative risk assessment for birds is indicated in the following table. Table 6.2-1: Summary of avian toxicity endpoints for COM 802 09 M RB

Species Test substance Timescale Endpoint Reference ICS- (test type) Toxicity Author No. (mg/kg Bw) code

Japanese quail COM 802 09 M RB 1 d LD 50 > 2000 mg/kg bw XXXXXX 77609 acute 2011 LPT 26444

In the avian acute oral toxicity study with the formulation COM 802 09 M RB no signs of toxicity were noted at the highest dose tested. Therefore, no specific LD 50 value could be determined in the reported studies (please refer to appendix 2 for further details). No short-term dietary studies and long- term reproduction studies have been carried out.

1 SANCO/10329/2002 rev 2 final 17 October 2002 Draft Working document Guidance Document on Terrestrial Ecotoxicology under Council Directive 91/414/EEC

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6.2.1.2 Risk assessment As mentioned above, the risk assessment for granular formulations is usually performed in a quantitative way (e.g. toxicity/exposure-ratios), bearing in mind the difficulty of assessing the exposure of birds to granules as noted in the EFSA Guidance Document on birds and mammals (EFSA, 2009). However, in this specific case it was deemed more appropriate to consider a weight-of evidence approach in the risk assessment for birds and mammals for the following reasons: • Ferric phosphate occurs naturally in soils. Consequently, the activity of ferric phosphate in the environment is well known • No signs of toxicity of the end-use product COM 802 09 M RB were noted in birds and mammals at the highest doses tested • The active substance is practically insoluble in water and organic solvents and will only be absorbed to a limited degree and thus is only partly bioavailable • Bioaccumulation can be excluded • Ferric phosphate is being used as a nutrient and dietary supplement in foods • Ferric phosphate may already be present in the food sources of the living organisms in the environment • Iron and phosphate ions are an inherent part of plant and animal metabolism The acute oral toxicity study in Japanese quails did not reveal any signs of toxicity after a single oral administration of 2000 mg of COM 802 09 M RB/kg b.w. Similarly, no signs of toxicity were noted in rats at the highest tested dose of 5000 mg of COM 802 09 M RB/kg bw. However, it is reasonable to assume that considerable higher doses will not have any detrimental impacts on birds and mammals. According to Firman (1993) 2 up to 80 mg Fe/kg diet are recommended for the breeding of chicken and turkey. It was also stated by Firman (1993) that several foods show a higher iron content than the formulation COM 802 09 M RB e.g. soy bean and wheat germ with 86 mg/kg and 94 mg/kg, respectively. A phosphorous content of 0.25%-0.6% is recommended by Firman (1993) for the breeding of chicken and turkey. The phosphorous content of COM 802 09 M RB is 0.26%, which lies in the recommended range. Ramsey et al. (1954) 3 and Planas et al. (1961) 4 showed that the iron metabolism in birds and mammals is similar. They also observed that female bird elevated their serum iron level during egg laying. This was regarded as a response to compensate for the loss caused by the transfer of iron to the eggs. This shows that birds are able to partly regulate their iron concentration in the serum and that they can handle increased iron levels. In terms of the use pattern it should be noted that COM 802 09 M RB is applied in garden rather than on agricultural fields. Therefore it can be assumed that the likelihood that a bird will spent its entire foraging time in the treated area is low.

2 Firman (1993): Nutrient requirements of chicken and turkeys. In: Nutrient Requirements of Poultry. 8th edition. National Academy Press: Washington 3 Ramsey et al. (1954): Iron metabolism in the laying hen. Biochem. J. 58 : 313-317 4 Planas et al. (1961): Serum iron and its transport mechanism in the fowl. Nature 189 : 668-669

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6.2.1.3 Overall conclusion

Although a quantitative risk assessment for birds and mammals was not provided here, the use of COM 802 09 M RB is not likely to be of consequence for populations of birds and mammals. In the acute toxicity studies for bird and mammals no toxicity was noted at the highest concentrations tested in any instance. Taking into account the available information on toxicity of COM 802 09 M and the feeding recommendations on Ferric phosphate, the risk of COM 802 09 M RB for birds can be considered negligible. Prolonged exposure of avian species to slug pellets is considered negligible.

The log P OW of Ferric phosphate cannot be estimated since Ferric phosphate is practically insoluble in water. However, a risk of bioaccumulation is not expected based on the natural occurrence of Ferric phosphate in the environment and the function as dietary supplement in food sources. According to the Review Report (2002) 5 Ferric phosphate when used as a slug pellet should be regarded as safe for birds, considering that there had been no effects at all up to 2000 mg product/kg bw in bobwhite quail. Therefore, the use of COM 802 09 M RB according to GAP is not considered to have any adverse effects on birds and risk is acceptable.

6.2.2 Toxicity exposure ratios for birds (IIIA 10.2.1)

6.2.2.1 Acute toxicity exposure ratios (TER A) (IIIA1 10.1.1) No TER calculations performed (for further details see above)

6.2.2.2 Short-term toxicity exposure ratios (TER ST ) (IIIA1 10.1.2)

There is no requirement for the calculation of TER ST for birds according to the EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438).

6.2.2.3 Long-term toxicity exposure ratio (TER LT ) (IIIA1 10.1.3) Ferric phosphate can be regarded as safe for birds and mammals due to the natural occurrence of Ferric phosphate in the environment, the occurrence of Ferric phosphate in avian and mammal feed items and the general toxicological properties e.g. Ferric phosphate iron is rather insoluble and will be absorbed to a lower degree. It must also be considered that there had been no acute effects at all up to 2000 mg product/kg bw and 5000 mg product/kg in Japanese quails and rats, respectively. As a matter of fact COM 802 09 M RB is applied when slug infestation occurs. Only when the applied product is eaten up by slugs, a second application should be made. Thus, accumulation of the product in the environment and in birds is not relevant. Furthermore, the uptake of slug baits by birds and mammals may be reduced due to the blue colour. Consequently, prolonged exposure of avian and mammalian species to slug pellets is negligible.

5 Review report Ferric phosphate. SANCO/3035/99-final. 8 March 2002

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6.2.3 Drinking water exposure No assessment necessary (for further details see 6.2.1.2)

6.2.4 Details on formulation type in proportion per item

6.2.4.1 Baits: Concentration of active substance in bait in mg/kg (IIIA1 10.1.3) COM 802 09 M RB is formulated as granular bait and contains 12500 mg Ferric phosphate/kg.

6.2.4.2 Pellets, granules, prills or treated seed (IIIA1 10.1.4) Please refer to chapter 6.2.4.1.

6.2.4.3 Amount of active substance in or on each item (IIIA1 10.1.4) According to COMPO GmbH & Co. KG baits have a weight of 0.357 mg. With a content of 12.5 g a.s./kg, this amounts to 0.0045 mg a.s./bait.

6.2.4.4 Proportion of active substance LD50 per 100 items and per gram of items (IIIA1 10.1.4.2)

Bird species LD 50 (mg a.s./kg bw) Proportion for the a.s. in Proportion for the a.s. per 100 baits (%) a gram of baits (%) b Japanese quail >25 0.018 50 a (mg a.s./bait) × 100/LD 50 b (g a.s./kg product) × 100/LD 50

6.2.4.5 Size and shape of pellet, granule or prill (IIIA1 10.1.5) COM 802 09 M RB is a granular bait, in a cylindrical shape with a particle size of 2000– 3350 µm (ca. 98%).

6.2.5 Effects of secondary poisoning (IIIA1 10.1.9) 6 According to EFSA 2009 , substances with a log P OW greater than 3 have potential for bioaccumulation and should be assessed for the risk of bioaccumulation in terrestrial food chains and uptake through contaminated water.

The log P OW of Ferric phosphate cannot be estimated since Ferric phosphate is practically insoluble in water. However, a risk of bioaccumulation is not expected based on the natural occurrence of Ferric phosphate in the environment and the function as dietary supplement in food sources. According to the Review Report (2002) Ferric phosphate when used as a slug pellet should be regarded as safe for birds, considering that no signs of toxicity were revealed up to 2000 mg product/kg bw in Japanese quail. Considering the above mentioned arguments, effects of secondary poisoning can be excluded and are not further assessed.

6 European Food Safety Authority; Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA. EFSA Journal 2009; 7(12): 1438. [139 pp.].

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6.3 Effects on Terrestrial Vertebrates Other Than Birds (IIIA1 10.3)

6.3.1 Overview and summary

6.3.1.1 Toxicity The endpoints considered in the risk assessment for mammals are indicated in the following table: Table 6.3-1: Toxicity of COM 802 09 M RB to mammals

Species Test substance Timescale Endpoint Reference ICS- (test type) Toxicity Author No. (mg/kg Bw) code

rat COM 802 09 M 1 d LD 50 > 5000 mg/kg bw XXXXXXX 78638 RB (acute oral toxicity) 2011 26841

In the mammalian acute oral toxicity study with the formulation COM 802 09 M RB no signs of toxicity were noted at the highest dose tested. Therefore, no specific LD 50 value could be determined (please refer to the mammalian toxicology section for further details).

6.3.1.2 Overall conclusion In view of the natural occurrence of ferric phosphate and lacking toxicity of the compound for terrestrial vertebrates, no quantitative risk assessment was deemed necessary (for further details see chapter 6.2.1.2). It can be concluded that the endpoints obtained from avian and mammalian toxicity studies and the publicly available information on iron salts indicate no risk to mammals from exposure to COM 802 09 M RB according to GAP. As such it is considered that safe use is adequately determined in this assessment without the need for any calculations of toxicity/exposure ratios. It should also be noted that the DAR for Ferric phosphate considered this use to be generally safe for mammals. Overall it can be concluded that Ferric phosphate is practically non-toxic to terrestrial vertebrates and the acute and long-term risk after use of COM 802 09 M RB as a slug pellet according to Good Agricultural Practice is considered non-existent.

Drinking water risk assessment Drinking water assessments are not required as the ratio of effective treatment rate to toxicological endpoint does not exceed the trigger.

Food chain behaviour

An assessment of the risk from secondary poisoning is not required due to log P OW values below the trigger.

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6.3.2 Toxicity exposure ratios (IIIA1 10.3.1)

6.3.2.1 Acute toxicity exposure ratios (TER A) (IIIA1 10.3.1.1) No TER calculations performed (for further details see above)

6.3.2.2 Long-term toxicity exposure ratio (TER LT ) (IIIA1 10.3.1.3) Please refer to chapter 6.2.2.2

6.3.3 Drinking water exposure No assessment necessary (for further details see 6.3.1.2)

6.3.4 Details on formulation type in proportion per item (IIIA 10.3.2)

6.3.4.1 Acute oral toxicity of the preparation (IIIA 10.3.2.1) Not required (for further information see 6.3.1.2)

6.3.4.2 Acceptance of bait, granules or treated seeds by terrestrial vertebrates (palatibility test (IIIA1 10.3.2.2) Not required (for further information see 6.3.1.2)

6.3.5 Effects of secondary poisoning (IIIA1 10.3.2.3) The EFSA birds and mammals guidance document (EFSA Journal 2009; 7(12): 1438) states that a log Kow ≥3 is used to indicate that there might be a potential for bioaccumulation (see Section 5.6 Bioaccumulation and food chain behaviour). The log K ow of Ferric phosphate cannot be estimated since Ferric phosphate is practically insoluble in water. However, a risk of bioaccumulation is not expected based on the natural occurrence of Ferric phosphate in the environment and the function as dietary supplement in food sources. According to the Review Report (2002) Ferric phosphate when used as a slug pellet should be regarded as safe for mammals, considering that no signs of toxicity were revealed up to 5000 mg product/kg bw in rats.

6.3.6 Supervised cage or field trials (IIIA 10.3.3) Supervised cage/field trials with the formulation were not performed, since low risk to mammals indicates that further studies are not required.

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6.4 Effects on Aquatic Organisms (IIIA1 10.2)

6.4.1 Overview and summary The applicant provides static limit tests on the risk of aquatic organisms from use of the granular bait formulation COM 802 09 M RB. The limit tests were conducted with a suspension of 100 mg/L of the formulation. All tests resulted in EC/LC 50 values > 100 mg prod./L. More detailed study summaries of the studies performed with the formulated product COM 802 09 M RB are presented under Appendix 2.

The calculation of Predicted Environmental concentrations in surface water (PEC SW ) of Ferric phosphate was not performed and was not considered to be required. Active substance Ferric phosphate is a stable, non-volatile inorganic salt which is practically insoluble in water (1.86 x 10 -12 mg/L). In soil COM 802 09 M RB is considered to be spread across cultivated area as a ready to use bait and a contamination of surface water via spray drift can therefore be excluded. The possible entry route into adjacent water bodies is considered to be via runoff of soil particles containing the active substance after heavy rain events. The maximum environmental concentration which will be expected in the water phase will correspond to the water solubility of ferric phosphate. The insoluble portion remaining in the sediment will add to the natural content of iron and phosphate in the sediment. It is expected that COM 802 09 M RB will not pose any concern for aquatic organisms based on the low toxicity, insolubility and immobility of Ferric phosphate in soil. Both, ferric and phosphate ions are naturally occurring in soil. Iron phosphates occurring in soils are e.g. strengite (FePO 4 · 2 H 2O, stable in acidic soils) and vivianite (Fe 3(PO 4)2 · 8 H 2O, stable under anaerobic conditions). Iron occurs in a wide variety of minerals and is the fourth most abundant element in the lithosphere. In soils under aerobic conditions iron is present mostly in form of insoluble Fe(III) oxides (e.g. foethite, haematite, ferrihydrite). According to the Review Report (2002) 7 the type of formulation in connection with method of application of COM 802 09 M RB and the application rate of 625 g a.s./ha leads to a low toxicity to aquatic organisms.

6.4.1.1 Toxicity The endpoints employed in the risk assessment for aquatic organisms are indicated in the following Tables. Table 6.4-1: Ecotoxicological endpoints of Ferric phosphate (EU agreed endpoints) and COM 802 09 M RB to aquatic species

Species Test substance Timescale Endpoint Reference ICS-No. (test type) Toxicity Author (mg/L) code Fish, acute toxicity EU agreed endpoint (SANCO/3035/99-final)

Oncorhynchus Ferric 4 d (static) LC 50 > 100 mg XXXXXXX -- mykiss phosphate a.s./L 1997 97241/01- NOEC ≥ 100 mg AAOm

7 European Food Safety Authority; Guidance Document on Risk Assessment for Birds & Mammals on request from EFSA. EFSA Journal 2009; 7(12): 1438. [139 pp.].

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Species Test substance Timescale Endpoint Reference ICS-No. (test type) Toxicity Author (mg/L) code a.s./L New study with formulation

Oncorhynchus COM 802 09 M 4 d (static) LC 50 > 100 mg XXXXXXX 77610 mykiss RB prod./L 2011 FAR14144 NOEC ≥ 100 mg a.s./L Invertebrates, acute toxicity EU agreed endpoint (SANCO/3035/99-final)

Daphnia magna Ferric 4 d (static) EC 50 > 100 mg Heintze, A., -- phosphate a.s./L 1997 97241/01- NOEC ≥ 100 mg AADm a.s./L Immobilisation New study with formulation

Daphnia magna COM 802 09 M 2 d (static) EC 50 > 100 mg Noack, M. 77611 RB prod./L 2011 DA14144 NOEC ≥ 100 mg a.s./L Immobilisation Algae EU agreed endpoint (SANCO/3035/99-final)

Scenedesmus Ferric phosphate 3 d (static) ErC50 > 100 mg Dengler, D., -- subspicatus a.s./L 1997 97241/01-AASs New study with formulation

Pseudokirchneriell COM 802 09 M 3 d (static) ErC50 > 100 mg Scheerbaum, D. 77612 a subcapitata RB prod./L 2011 EyC50 > 100 mg SPO14144 prod./L

6.4.1.2 Exposure Please refer to 6.4.1.

6.4.1.3 Overall conclusions Please refer to 6.4.1.

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6.4.2 Toxicity exposure ratios (IIIA1 10.2.1)

6.4.2.1 TER A for fish The acute toxicity of Ferric phosphate and the formulation COM 802 09 M RB to fish has been studied with the results summarised above in Table 6.4-1. The calculation of Predicted Environmental

Concentrations in surface water (PEC SW ) of Ferric phosphate was not performed and was not considered to be required. Active substance Ferric phosphate is a stable, non-volatile inorganic salt which is practically insoluble in water. The risk to surface water contamination resulting from Ferric phosphate application according to the GAP table is not expected. Therefore the TER A value is expected to be above the trigger value of 100.

6.4.2.2 TER LT for fish No chronic studies were conducted with the formulation COM 802 09 M RB or Ferric phosphate. No risk from Ferric phosphate is expected for aquatic organisms, since Ferric phosphate is nearly insoluble. Thus the long-term risk assessment for fish can be waived.

6.4.2.3 TER A for Daphnia The acute toxicity of Ferric phosphate and the formulation COM 802 09 M RB to daphnids has been studied with the results summarised above in Table 6.4-1. The calculation of Predicted Environmental

6.4.2.4 TER LT for Daphnia No chronic studies were conducted with the formulation COM 802 09 M RB or Ferric phosphate. No risk from Ferric phosphate is expected for aquatic organisms, since Ferric phosphate is nearly insoluble. Thus the long-term risk assessment for daphnids can be waived.

6.4.2.5 TER A for aquatic insect Not required since COM 802 09 M RB is not intended to be used directly on surface waters. In addition, according to Guidance Document on Aquatic Ecotoxicology SANCO/3268/2001 rev. 4 (final), Chapter 2.3.2, Daphnia acute toxicity data are suitably representative for aquatic insects and other invertebrates.

6.4.2.6 TER LT for aquatic insect Please refer to chapter 6.4.2.5 above.

6.4.2.7 TER A for aquatic crustacean Please refer to chapter 6.4.2.5 above.

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6.4.2.8 TER LT for aquatic crustacean Please refer to chapter 6.4.2.5 above.

6.4.2.9 TER A for aquatic gastropod mollusc Please refer to chapter 6.4.2.5 above.

6.4.2.10 TER LT for aquatic gastropod mollusc Please refer to chapter 6.4.2.5 above.

6.4.2.11 TER LT for algae The acute toxicity of Ferric phosphate and the formulation COM 802 09 M RB to algae has been studied with the results summarised above in Table 6.4-1. The calculation of Predicted Environmental

6.4.2.12 TER for aquatic plants No study on higher aquatic plants ( Lemna gibba ) was conducted with COM 802 09 M RB, since this formulation is not a herbicide. In addition, COM 802 09 M RB is not intended to be used directly on surface waters.

6.4.3 Risk from metabolites There are no relevant metabolites occurring in surface water or sediment from the active ingredient Ferric phosphate.

6.5 Effects on Bees (IIIA 10.4)

Toxicity Concerning effects on bees no data are available from the Review Report on ferric phosphate (SANCO/3035/99-final. 8 March 2002). Nevertheless, an acute oral and contact study on COM 802 09 M RB was provided in support of the assessment.

Table 6.5-1: Toxicity to bees of COM 802 09 M RB Value Substance Endpoint Reference (µg/bee) COM 802 09 M 48 h oral LD 50 > 5030 (prod.) Bruhnke, C. 2011 RB 48 h contact LD 50 > 3620 (prod.) Refer to KIIIA 10.4.2.1/01

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Hazard quotients for bees Hazard quotients for oral contact exposure according to EPPO (2003) Environmental risk assessment scheme for plant protection products (Chapter 10: Honeybees (PP 3/10(2)). Bulletin OEPP/EPPO Bulletin 33: 141-145) were calculated as follows: Hazard Quotient = max. application rate [g test substance/ha] / LD50 [ µg test substance/ha]

Table 6.5-2: Oral and contact HQ for honeybees exposed to COM 802 09 M RB Exposure Endpoint Max. application Hazard HQ assessment Test substance route (µg prod./bee) rate (g prod./ha) quotient trigger COM 802 09 M oral > 5030 50000 < 10 50 RB contact > 3620 50000 < 14 50

Conclusion All hazard quotients for oral and contact exposure are well below the trigger of 50, indicating that the formulation poses no risk to bees. However, bees will not be exposed by the recommended uses of COM 802 09 M RB as a bait formulation.

6.6 Effects on Arthropods Other Than Bees (IIIA 10.5)

6.6.1.1 Toxicity Effects of COM 802 09 M RB on arthropods other than bees were not evaluated as part of the EU review of Ferric phosphate. Therefore, all relevant data and assessments are provided here and are considered adequate. Additionally studies with the formulation COM 802 09 M RB on non-target arthropods were conducted. Studies with foliage dwelling arthropods were not conducted due to the lack of exposure. As a result of the intrinsic properties no higher sensitivity of T. pyri and A. rhopalosiphi is expected in comparison to the soil dwelling organisms Poecilus and Aleochara , with whom studies were conducted. The critical endpoints employed in the risk assessment for non-target arthropods are indicated in the tables below. Table 6.6-1: EU Endpoints for Ferric phosphate: Toxicity to arthropods other than bees EU agreed endpoints Endpoints used in risk Test substance Test species SANCO/3035/99-final assessment (8 March 2002) Laboratory studies Ferramol Aphidius Mortality: 0% No Schneckenkorn rhopalosiphi Parasitisation: 52.2% Ferramol Mortality: 6.6% Typhlodromus pyri No Schneckenkorn Effect on fertility: 0% Ferramol Aleochara Parasitisation: 5.5% No Schneckenkorn bilineata Ferramol Mortality: 3.3% Poecilus cupreus No Schneckenkorn Effect on food uptake: 16.25% Extended laboratory studies No data provided

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Table 6.6-2: Toxicity of COM 802 09 M RB to arthropods other than bees

Test item Species Timescale Endpoint Reference ICS-No. Endpoints (test type) Toxicity Author used in risk (g/ha) code assessment

COM 802 09 Aleochara 70 d ER 50 : > 100 kg/ha Bruhnke, Ch. 77615 Yes M RB bilineata laboratory parasite rate 2011 IKR14144

COM 802 09 Poecilus 14 d LR 50 : > 100 kg/ha Bruhnke, Ch. 77620 Yes M RB cupreus laboratory mortality 2011 ER50 : > 100 kg/ha ILA14144 feeding rate

6.6.1.2 Exposure In field Non-target arthropods inhabiting the crop can be exposed to residues from COM 802 09 M RB through contact with residues on plants and soil or in food items. The formulation COM 802 09 M RB is applied maximally four times at an application rate of 50 kg/ha. As a worst-case assumption, the maximum in-field exposure (Predicted Environmental Rate, PER) to arthropods is therefore 50 kg formulation/ha, assuming 0% crop interception. The in-field exposure (predicted environmental rate, PER) is calculated according to ESCORT 2 using the following equation: = × PER in − field Application rate (g a.s./ha) MAF Where: MAF is a generic multiple application factor, which is used to take into account the potential build-up of applied substances between applications based on the application interval, DT 50 value and number of applications. Default foliar and soil MAF values following multiple applications are given in the ESCORT 2 Guidance Document. COM 802 09 M RB may be applied up to four times a season at a maximum application rate of 50 kg prod./ha. According to the table of intended uses the application is proposed as bait granules. It has to be considered that only one application rate will reach non-target arthropods, since the following applications are only planned, when the bait has been eaten up by the slugs and there is still slug infestation. Thus, no accumulation of the product is assumed and the MAF factor is not considered in the present risk assessment for the non-target arthropods. Off-field COM 802 09 M RB is a ready-to-use bait to be strewed on the soil surface. Since the product is not sprayed drift does not happen when applied. Thus, no exposure of the off-field is assumed and it is not considered in the present risk assessment for the non-target arthropods.

6.6.1.3 Overall Conclusion The maximum tested rate in the studies is above the in-field exposure (application rate) and the results show clearly that the effects are < 50% for mortality and reproduction. It can be concluded that the risk to non-target soil dwelling arthropods after application of COM 802 09 M RB at the recommended application rates is acceptable. Therefore, a potential risk can be excluded and further considerations regarding exposure of COM 802 09 M RB are not required. The risk assessment is considered below.

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6.6.2 Risk Assessment for Arthropods other than Bees

6.6.2.1 In-field The risk to terrestrial arthropods after use of COM 802 09 M RB according to the GAP table was determined considering the recommendations of the ESCORT 2 (2000)8 and SANCO/10329/2002. The potential risk of COM 802 09 M RB to in-field non-target arthropods was assessed by calculation of the hazard quotient (HQ = exposure/toxicity) with the predicted environmental rate (PER) and the lowest lethal rate (LR 50 ) values according to the formula:

-In field PER In field HQ = LR 50

The resulting HQ in-field values for the standard species are presented in the following table. The HQ trigger is 2. Table 6.6-3: Tier 1 in-field HQs for non-target arthropods

Species ER 50 [kg PER [kg In-field HQ Trigger value product/ha] product/ha] Aleochara bilineata > 100 50 < 0.5 2 Poecilus cupreus > 100 50 < 0.5 2

The in-field HQ values for exposure to maximum residues for the representative species Aleochara bilineata and Poecilus cupreus are less than the ESCORT 2 trigger value of 2. Thus, the results indicate that COM 802 09 M RB poses low risk to in-field non-target arthropods following application according to the proposed use patterns.

6.6.2.2 Off field COM 802 09 M RB is a ready-to-use bait to be strewed on the soil surface. Since the product is not sprayed drift does not happen when applied. Thus, no exposure of the off-field is assumed and it is not considered in the present risk assessment for the non-target arthropods.

6.6.3 Using artificial substrates Please refer to chapter 6.6.4.

6.6.4 Extended laboratory studies (IIIA 10.5.2) Please refer to appendix 2 of this document.

8 Escort 2 (2000): Guidance document on regulatory testing and risk assessment procedures for plant protection products with non-target arthropods. From the ESCORT 2 workshop.

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6.7 Effects on Earthworms and Other Soil Non-target Macro-organisms (IIIA 10.6)

6.7.1.1 Toxicity Effects on earthworms and other soil non-target macro-organisms for COM 802 09 M RB were not evaluated as part of the EU review of Ferric phosphate. Therefore, all relevant study data for this risk assessment are provided here and are considered valid and acceptable by the zRMS. Additional data is considered essential and thus acute and sublethal studies with COM 802 09 M RB were conducted. Risk assessments for COM 802 09 M RB with the proposed use pattern are provided here and are considered adequate.

Table 6.7-1: EU Endpoints for Ferric phosphate: Toxicity to earthworms

EU agreed endpoints Endpoints used in risk Test substance Test species SANCO/3035/99-final assessment (8 March 2002) Acute toxicity Ferramol Eisenia fetida LD > 1000 mg product/kg soil No Schneckenkorn 50 Sublethal toxicity Ferramol Eisenia fetida NOEC = 0.5 kg a.s./ha No Schneckenkorn

Table 6.7-2: Studies on earthworms with the end-use product COM 802 09 M RB

Test item Species Timescale Endpoint Reference ICS-No. Endpoints (test type) Toxicity Author used in risk (g/ha) code assessment

COM 802 09 Eisenia 14 d LC 50 > 1000 mg Krome, K. 77621 Yes M RB 1) fetida product/kg soil dry 2011 weight RRA14144 COM 802 09 Eisenia 56 d NOEC ≥ 500 kg Krome, K. 77622 Yes M RB 2) fetida product/ha 2011 RBN14144 1) test item (granules) mixed into the artificial soil 2) test item (granules) applied onto the soil surface

6.7.1.2 Exposure For PEC calculations reference is made to the environmental fate section (Part B, Section 5) of this submission. The resulting maximum PEC soil values are presented in the Table 6.7-3 below. Calculations considered the maximum application rate of 50 kg COM 802 09 M RB /ha and assumed an even distribution of the substances in the top 5 cm horizon with a soil bulk density of 1.5 g/mL. The PEC for the acute risk assessment was based on a single application of 50 kg prod./ha, converted to 66.67 mg prod./kg soil d.w. assuming a soil depth of 5 cm and a bulk density of soil of 1.5 g/cm 3, which is equivalent to 0.833 mg a.s./kg d.w. The short-term and long-term actual concentrations

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(PECsoil, actual) and the time weighted average concentrations (PEC soil, twa ) for the active substance Ferric phosphate were not calculated because no reliable DT 50 value in soil could be obtained for the active substance Ferric phosphate. Therefore, considering multiple applications, as a worst-case scenario it is assumed that COM 802 09 M RB is applied in one cumulative application of 200 kg/ha (corresponding to 2.5 kg/ha Ferric phosphate) to vegetables, fresh herbs, fruits, ornamentals and potatoes. However, it can be realistically concluded that this cumulative application does not reflect the conditions of use since additional applications are only sensible, when the product has been eaten up by the slugs and if there is still infestation.

Table 6.7-3: Maximum PEC S for COM 802 09 M RB, Ferric phosphate, Iron and phosphate after single and multiple application of COM 802 09 M RB

Substance Maximum instantaneous PEC S (mg/kg) Single application Multiple Application COM 802 09 M RB 66.667 266.667 Ferric phosphate 0.833 3.333 Fe 3+ 0.309 1.23 3- PO 4 0.524 2.10

Furthermore iron is present in all soils, being a constituent of several minerals. The EU review of 3+ 3- Ferric phosphate stated natural concentrations of Fe -Ions and PO 4 Ions commonly found in soils between 2000 and 50000 mg/kg and between 100 and 2000 mg/kg soil, respectively. Thus the amount of iron added to the soil after application of the product is negligible in comparison to the quantities which naturally exist in soils. Additionally, iron and in particular, phosphate are applied in considerable amounts to agricultural soils in fertilisers. The additional predicted environmental concentrations following single and multiple application are compared to concentrations due to ubiquitous occurrence and application as fertilizer stated in the EU review of Ferric phosphate in the following table: Table 6.7-4: Comparison of the natural occurance of iron and phosphate with single and multiple applications of COM 802 09 M RB 3+ 3- Scenario Active Substance Fe PO 4 additional PEC following 0.833 0.309 0.524 single application additional PEC following 3.33 1.23 2.10 multiple application Concentration naturally -- 2000 - 50000 100 – 2000 occuring in soils additional PEC following -- ≥ 8.7 ≥ 8.7 single application

6.7.1.3 Overall conclusion The acute TER value for earthworms is above the Annex VI acute trigger value of 10, indicating that COM 802 09 M RB does not pose an acute risk when applied according to the proposed use rate. The long-term TER value for earthworms is above the Annex VI acute trigger value of 5, indicating that COM 802 09 M RB poses no long-term risk when applied according to the proposed use rate. Considering the cumulative application rate in soil, the acceptability criteria TER ≥ 5 for long-term effects after multiple application of COM 802 09 M RB, according to Annex VI to Regulation (EC) 1107/2009, uniform principles, point 2.5.2.5 is not reached.

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Taking into account the extreme worst case character of the multiple application scenario, the ubiquitous occurrence of iron and phosphate in soils and the low toxicity of ferric phosphate to earthworms, it can be concluded, that COM 802 09 M RB poses low risk to earthworms following application according to the proposed use patterns.

The TER value for the predatory soil mite Hypoaspis aculeifer is below the Annex VI trigger value of 5, indicating that COM 802 09 M RB may pose a risk to when applied according to the proposed use rate. However, neither an acute LR 50 nor a true NOER could be determined due to lacking effects at the limit test rate. Thus the calculated TER value overestimates the effect of COM 802 09 M RB on Hypoaspis aculeifer . The realistic TER value would be considerably higher if an LR 50 would have been determined. A study on Folsomia-species was not performed, since no risk was detected for Hypoaspis aculeifer . Furthermore, accumulation of applications is not relevant under field conditions, since additional applications are only sensible, when the product has been eaten up by the slugs and if there is still infestation. Furthermore iron is present in all soils, being a constituent of several minerals.

6.7.2 Toxicity exposure ratios for earthworms, TERA and TERLT (IIIA 10.6.1)

6.7.2.1 Acute risk The potential acute risk of COM 802 09 M RB and the active substance Ferric phosphate was assessed by comparing the maximum instantaneous PECsoil with the 14-day LC 50 value to generate acute TER values. The peat content in the effect study with the formulation was 10%. However, no correction for the study with the formulation was performed since the logK OW of Ferric phosphate cannot be defined due to the insolubility of Ferric phosphate in water.

The TER A was calculated as follows:

LC 50 (mg/kg) TER A = PEC soil (mg/kg)

The resulting TER A values are shown in the following Table, considering the highest initial PEC in soil: Table 6.7-5: Acute TER values for earthworms following applications of COM 802 09 M RB.

Test substance Maximum initial Timescale LC 50 TER PEC (mg/kg) (mg/kg) COM 802 09 M RB 66.667 (single 14 d > 1000 > 14.99 application) TERs shown in bold fall below the relevant trigger.

Based on the worst case scenario, the acceptability criteria TER ≥ 10 for acute effects after single application of COM 802 09 M RB, according to Annex VI to Regulation (EC) 1107/2009, uniform principles, point 2.5.2.5 is reached.

6.7.2.2 Long-term risk For COM 802 09 M RB a study on the reproduction of earthworms was submitted and the long term risk of COM 802 09 M RB and the active substance Ferric phosphate is assessed. However, since the item was applied onto the soil surface as granules in the respective study and given the low solubility

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Part B – Section 6 COM 802 09 M RB Registration Report Core Assessment Germany – Central Zone Page 21 of 45 of the granular formulation, it was deemed more appropriate to calculate toxicity/exposure ratios with respect to application rates expressed in kg product/ha. NOEC (kg product/ha) TER LT = PEC soil (kg product/ha)

The resulting TER lt values are shown in the following Table, considering the highest initial PEC in soil: Table 6.7-6: Long-term TER values for earthworms following single or multiple applications of COM 802 09 M RB

Test substance Maximum initial Timescale NOEC TER PEC (kg/ha) (kg/ha) COM 802 09 M RB 50 (single 56 d ≥500 ≥10 application) COM 802 09 M RB 200 (multiple 56 d ≥500 ≥2.5 application) TERs shown in bold are below the relevant Annex VI trigger of 5

Based on the worst case scenario, the acceptability criteria TER ≥ 5 for long term effects after single application of COM 802 09 M RB, according to Regulation (EC) 1107/2009, Annex VI, uniform principles, point 2.5.2.5 is reached for the formulation COM 802 09 M RB. Considering the cumulative application rate in soil, the acceptability criteria TER ≥ 5 for long term effects after multiple application of COM 802 09 M RB, according to Annex VI to Regulation (EC) 1107/2009, uniform principles, point 2.5.2.5 is not reached. Taking into account the extreme worst case character of the multiple application exposure scenario (refer to chapter 6.7.1.2), the ubiquitous occurrence of iron and phosphate in soils and the low toxicity of ferric phosphate to earthworms, it can be concluded, that COM 802 09 M RB poses low risk to earthworms following application according to the proposed use patterns.

6.7.3 Acute toxicity (IIIA 10.6.2) Please refer to appendix 2 of this document.

6.7.4 Sublethal effects (IIIA 10.6.3) Please refer to appendix 2 of this document.

6.7.5 Field tests (IIIA 10.6.4) Based on the considerations presented in chapter 6.7.2.1 and 6.7.2.2 no field test on earthworms is regarded necessary.

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6.7.6 Residue content of earthworms (IIIA 10.6.5) According to EFSA 2009, substances with a log POW greater than 3 have potential for bioaccumulation and should be assessed for the risk of accumulation in aquatic non-target organisms. The log POW of Ferric phosphate cannot be estimated since Ferric phosphate is practically insoluble in water. However a risk of bioaccumulation is not expected based on the natural occurrence of Ferric phosphate in the environment and the function as dietary supplement in food sources. Furthermore accumulation of the applied amounts is unlikely since earthworms are only exposed to one application rate and multiple applications are only planned, when the bait has been eaten up by the slugs and there is still slug infestation. Considering the above mentioned arguments accumulation in earthworms can be excluded and is not further assessed.

6.7.7 Effects on other non-target macro-organisms (IIIA 10.6.6) In this special case of exposure where surface active species might be endangered a study on the effects on other non-target macro-organisms is required. Thus a study on the non-target macro- organism Hypoaspis aculeifer was conducted and a risk assessment is presented below. A study on Folsomia -species was not performed since no risk was detected for Hypoaspis aculeifer . Furthermore, accumulation of multiple applications is unlikely under field conditions since additional applications are only sensible when the product has been eaten up by the slugs and if there is still infestation. Furthermore, iron is present in all soils, being a constituent of several minerals. Additionally, the EU 3+ 3- review of Ferric phosphate stated natural concentrations of Fe -Ions and PO 4 Ions commonly found in soils between 2000 and 50000 mg/kg and between 100 and 2000 mg/kg soil, respectively. Thus the amount of iron added to the soil after application of the product is negligible in comparison to the quantities which naturally exist in soils. Iron and in particular phosphate is also applied in considerable amounts to agricultural soils in fertilisers. The toxicity endpoints and worst-case initial PECsoil estimates for the relevant substances are summarized above (see Point 10.6) and the risk assessments are provided in the following Table:

Table 6.7-7: Long-term TER values for non-target soil macro-organisms

Test substance NOER Maximum TER [kg product/ha] instantaneous PEC soil [kg/ha] COM 802 09 M RB ≥100 50 ≥2

The TER value is below the Annex VI trigger value of 5, indicating that COM 802 09 M RB may pose a risk to Hypoaspis aculeifer when applied according to the proposed use rate. An acute LR50 value could not be determined due to lacking mortality. Furthermore, no significant effect on the reproduction rate was noted at the treatment rate of 100 kg/ha. Thus, the calculated TER value of 2 clearly overestimates the effect of COM 802 09 M RB on Hypoaspis aculeifer . The realistic TER value would be considerably higher if a true NOER value would have been determined.

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6.7.8 Effects on organic matter breakdown (IIIA 10.6.7) With respect to the high naturally occurring amounts of Ferric phosphate in soil and the fact that Ferric phosphate is hardly soluble in water no studies on effects of Ferric phosphate on organic matter breakdown are required.

6.8 Effects on Soil Microbial Activity (IIIA 10.7)

With respect to the high naturally occurring amounts of Ferric phosphate in soil and the fact that Ferric phosphate is hardly soluble in water no studies on effects of Ferric phosphate on soil microbial activity are required.

6.9 Effects on Non-Target Plants (IIIA 10.8)

6.9.1 Terrestrial plants (IIIA 10.8.1) With respect to the high naturally occurring amounts of Ferric phosphate in soil and the fact that Ferric phosphate is hardly soluble in water. There are natural mechanisms whereby soil microorganisms and plant rootlets, aided by carbon dioxide and other root exudates, will transform the insoluble Ferric phosphate into forms that are usable by plants. Iron is a plant micronutrient and phosphorous is a macronutrient, both of which are essential to plant growth and development. Therefore, no studies on effects of Ferric phosphate terrestrial pants are required.

6.9.2 Effects on non-target aquatic plants (IIIA 10.8.2) No studies on effects of Ferric phosphate on non-target aquatic plants are required, since COM 802 09 M RB is not intended as growth regulator or herbicide.

6.10 Other Non-Target Species (Flora and Fauna) (IIIA 10.9)

Not relevant.

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6.11 Summary and Evaluation of Points 9 and 10.1-10.10

6.11.1 Predicted distribution and fate in the environment and time courses involved (IIIA 10.11.1) The predicted distribution and fate of COM 802 09 M RB in the environment is described in Part B, Section 5.

6.11.2 Non-target species at risk and extent of potential exposure (IIIA1 10.11.2) Please refer to chapter 6.11.3

6.11.3 Short and long term risks for non-target species, populations, communities and processes (IIIA 10.11.3) Birds and mammals Although a quantitative risk assessment for birds and mammals was not performed, it has been considered that safe use is adequately determined in the present assessment based on a weight-of- evidence approach. The endpoints obtained from avian and mammalian toxicity studies and the publicly available information on iron salts did not reveal or give any indication of risks to birds and mammals from exposure to COM 802 09 M RB slug pellets. Prolonged exposure of avian and mammalian species to slug pellets is considered negligible.

The log P OW of Ferric phosphate cannot be estimated since Ferric phosphate is practically insoluble in water. However a risk of bioaccumulation is not expected based on the natural occurrence of Ferric phosphate in the environment and the function as dietary supplement in food sources. According to the Review Report (2002) 9 Ferric phosphate when used as a slug pellet should be regarded as safe for birds and mammals, considering that there had been no effects at all up to 2000 mg product/kg bw and 5000 mg product/kg bw in bobwhite quails and rats, respectively. Therefore, the use of COM 802 09 M RB according to GAP is not considered to have any adverse effects on birds and mammals and risk is acceptable.

Aquatic Organisms The applicant provides static limit tests on the risk of aquatic organisms from use of the granular bait formulation COM 802 09 M RB. The limit tests were conducted with a suspension of 100 mg/L of the formulation. All tests resulted in EC/LC 50 values > 100 mg prod./L. More detailed study summaries of the studies performed with the formulated product COM 802 09 M RB are presented under Appendix 2.

9 Review report Ferric phosphate. SANCO/3035/99-final. 8 March 2002

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It is expected that COM 802 09 M RB will not pose any concern for aquatic organisms based on the low toxicity, insolubility and immobility of Ferric phosphate in soil. Both, ferric and phosphate ions are naturally occurring in soil. Iron phosphates occurring in soils are e.g. strengite (FePO 4 · 2 H 2O, stable in acidic soils) and vivianite (Fe 3(PO 4)2 · 8 H 2O, stable under anaerobic conditions). Iron occurs in a wide variety of minerals and is the fourth most abundant element in the lithosphere. In soils under aerobic conditions iron is present mostly in form of insoluble Fe(III) oxides (e.g. foethite, haematite, ferrihydrite).

Arthropods other than bees The maximum tested rate in the study is above the in-field exposure (application rate) and the results show clearly that the effects are < 50% for mortality and reproduction. It can be concluded that the risk to non-target soil dwelling arthropods after application of COM 802 09 M RB at the recommended application rates is acceptable. Therefore, a potential risk can be excluded and further considerations regarding exposure of COM 802 09 M RB are not required.

Earthworms and other soil non-target marco-organisms The acute TER value for earthworms is above the Annex VI acute trigger value of 10, indicating that COM 802 09 M RB does not pose an acute risk when applied according to the proposed use rate. The long-term TER value for earthworms is above the Annex VI acute trigger value of 5, indicating that COM 802 09 M RB poses no long-term risk when applied according to the proposed use rate. Considering the cumulative concentration in soil, the acceptability criteria TER ≥ 5 for long-term effects after multiple application of COM 802 09 M RB, according to Annex VI to Regulation (EC) 1107/2009, uniform principles, point 2.5.2.5 is not reached. Taking into account the extreme worst case character of the multiple application scenario, the ubiquitous occurrence of iron and phosphate in soils and the low toxicity of ferric phosphate to earthworms, it can be concluded, that COM 802 09 M RB poses low risk to earthworms following application according to the proposed use patterns. The TER value is below the Annex VI trigger value of 5, indicating that COM 802 09 M RB may pose a risk to Hypoaspis aculeifer when applied according to the proposed use rate. An acute LD 50 value could not be determined due to the low mortality. The detected value is actually a No Observed Effect Rate (NOER). Thus the calculated TER value overestimates the effect of COM 802 09 M RB on Hypoaspis aculeifer . The realistic TER value would be considerably higher if an LD 50 would have been determined.

Organic matter breakdown/ Soil microbial activity With respect to the high naturally occurring amounts of Ferric phosphate in soil and the fact that Ferric phosphate is hardly soluble in water no studies on effects of Ferric phosphate on organic matter breakdown are required.

Non-target plants With respect to the high naturally occurring amounts of Ferric phosphate in soil and the fact that Ferric phosphate is hardly soluble in water. There are natural mechanisms whereby soil microorganisms and plant rootlets, aided by carbon dioxide and other root exudates, will transform the insoluble Ferric phosphate into forms that are usable by plants. Iron is a plant micronutrient and phosphorous is a macronutrient, both of which are essential to plant growth and development. Therefore, no studies on effects of Ferric phosphate terrestrial pants are required.

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6.11.4 Risk of fish kills and fatalities in large vertebrates or terrestrial predators (IIIA 10.11.4) In view of the generally low acute and chronic toxicity of COM 802 09 M RB and its active substance to vertebrates (i.e. fish, birds and mammals), the likelihood of fish kills or fatalities in large vertebrates or terrestrial vertebrates occurring is considered to be negligible.

6.11.5 Precautions necessary to avoid/minimise environmental contamination and to protect non-target species (IIIA 10.11.5) No special precautions are necessary to avoid or minimize contamination of the environment with regard to non-target species.

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Appendix 1 List of data submitted in support of the evaluation

Table A1: List of data submitted in support of the evaluation

Annex Author(s) Year Title Data Owner How considered point/referenc Source (where different from protection in dRR e No company) claimed Study- Report-No. Status/Usage* GLP or GEP status (where relevant), Published or not Authority registration No KIIIA XXXXXX 2011 AVIAN ACUTE ORAL yes COM 1) 10.1.6/01 TOXICITY STUDY OF COM 802 09 M RB IN JAPANESE QUAIL LPT Lab. of Pharm. and Tox. GmbH & Co. KG, Hamburg, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. 26444 GLP: yes Published: no KIIIA XXXXXX 2011a COM 802 09 M RB, FISH yes COM 1) 10.2.2.1/01 (RAINBOW TROUT), ACUTE TOXICITY TEST, STATIC, 96 H DR.U.NOACK- LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. FAR14144 GLP: yes Published: no KIIIA Noack, M. 2011 COM 802 09 M RB: ACUTE yes COM 1) 10.2.2.2/01 IMMOBILIZATION TEST TO DAPHNIA MAGNA , LIMIT-TEST, STATIC, 48 H DR.U.NOACK- LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. DAI14144 GLP: yes Published: no KIIIA Scheerbau 2011b COM 802 09 M RB, ALGA, yes COM 1) 10.2.2.3/01 m, D. GROWTH INHIBITION TEST WITH PSEUDOKIRCHNERIELLA SUBCAPITATA , 72 HOURS DR.U.NOACK-

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LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. SPO14144 GLP: yes Published: no KIIIA Bruhnke, 2011a COM 802 09 M RB - ACUTE yes COM 1) 10.4.2.1/01 C. EFFECTS ON THE HONEYBEE APIS MELLIFERA (HYMENOPTERA, APIDAE) DR.U.NOACK- LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. IBA14144 GLP: yes Published: no KIIIA Bruhnke, 2011b COM 802 09 M RB, yes COM 1) 10.5.2/01 C. EFFECTS OF PLANT PROTECTION PRODUCTS ON THE ROVE BEETLE ALEOCHARA BILINEATA , LABORATORY TEST DR.U.NOACK- LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. IKR14144 GLP: yes Published: no KIIIA Bruhnke, 2011c COM 802 09 M RB, yes COM 1) 10.5.2/02 C. ASSESSMENT OF SIDE EFFECTS ON THE GROUND BEETLE, POECILUS CUPREUS L. (COLEOPTERA, CARABIDAE), LABORATORY TEST DR.U.NOACK- LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. ILA14144 GLP: yes Published: no KIIIA Krome, K. 2011a COM 802 09 M RB, yes COM 1) 10.6.2/01 EARTHWORM ( EISENIA FETIDA ), ACUTE TOXICITY TEST IN ARTIFICIAL SOIL DR.U.NOACK- LABORATORIEN, Sarstedt,

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Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. RRA14144 GLP: yes Published: no KIIIA Krome, K. 2011b COM 802 09 M RB, yes COM 1) 10.6.3/01 EARTHWORM ( EISENIA FETIDA ), EFFECTS ON REPRODUCTION DR.U.NOACK- LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. RBN14144 GLP: yes Published: no KIIIA Bruhnke, 2011d COM 802 09 M RB, yes COM 1) 10.6.6/01 C. PREDATORY MITE REPRODUCTION TEST IN SOIL ( HYPOASPIS ACULEIFER ) DR.U.NOACK- LABORATORIEN, Sarstedt, Germany COMPO GmbH & Co. KG, Münster, Germany Report-no. IHL14144 GLP: yes Published: no

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Appendix 2 Detailed evaluation of studies relied upon

A2-1 Active substance Not relevant. No new Annex II data was provided after annex I inclusion.

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A2-2 Formulation

IIIA 10.1 Effects on birds IIIA 10.1.6 Acute oral toxicity of the preparation to the more sensitive of the species identified in tests with the active substance Report: KIIIA 10.1.6/01, XXXXXX 2011 Title: Avian acute oral toxicity study of COM 802 09 M RB in Japanese Quail Report No: 26444 Guidelines: OECD Guideline 223 GLP Yes

Materials and methods COM 802 09 M RB was administered at 2000 mg/kg body weight to 10 male birds (in mature plumage, 6 weeks old at start of treatment). The limit test design consists of dosing 5 animals simultaneously at the limit dose in addition to sham-dosing the control birds. The birds were given a single oral dose of the test item (administration volume: 5 mL/kg body weight) into the crop. Birds are observed continuously during the first two hours after dosing for regurgitation and onset of clinical signs, at least three times on the day of dosing, and at least twice daily throughout the observation period. Observations are made for signs of intoxication and remission, abnormal behaviour, mortality and time of death and are continued until clinical symptoms and mortality cease. Body weight is determined just before dosing and then at 3, 7 and 14 days after dosing and, if the observation period is extended, at termination. Food consumption was recorded daily until day 3, then for the intervals 3 – 7 days and 7 – 14 days post dosing. All surviving animals are sacrificed, dissected and inspected macroscopically to help identify incidental mortalities and obvious symptoms of toxicity. All gross pathological changes are recorded. Results and discussions A single oral administration of 2000 mg COM 802 09 M RB /kg b.w. to birds (Japanese quail) revealed no signs of toxicity. No animal died prematurely during the test period. If no mortality occurs, it can be concluded at the 95% confidence level, that the LD 50 is above the limit test. There were no test item related differences in food consumption and body weight compared to control. No signs of abnormalities were noted at necropsy. Normal body weight development was observed for all animals during the course of the study. Conclusion Under the present test conditions, a single oral administration of 2000 mg COM 802 09 M RB/kg b.w. to birds did not reveal any signs of toxicity. Study Comments: The study is acceptable. IIIA 10.1.6/01

Agreed endpoint/s: LD50 > 2000 mg product/kg b.w. IIIA 10.1.6/01

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IIIA 10.2 Effects on aquatic organisms IIIA 10.2.2 Acute toxicity (aquatic) of the preparation IIIA 10.2.2.1 Fish acute toxicity LC50, freshwater, cold-water species Report: KIIIA 10.2.2.1/01, XXXXXXX, 2011a Title: COM 802 09 M RB Fish Rainbow Trout, Acute Toxicity Test, Static, 96-h Report No: FAR-14144 Guidelines: OECD Guideline 203 for Testing of Chemicals (1992) GLP Yes

Materials and methods The acute toxicity of the test item COM 802 09 M RB to fish (Rainbow trout) was determined. A static limit test was conducted with a suspension of 100 mg/L of the test item. Duration of the test was 96 h. 7 test organisms each were exposed to the limit concentration and the control. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits. The validity criteria of the guideline were fulfilled. The concentration of the ferric orthophosphate was determined via spectrophotometric analysis at test start and test end. The measured Iron (III) concentration was below the limit of quantification of the tube test (0.02 mg Fe/L) at test start and at test end. The LC 50 value for 96 h was greater than 100 mg/L (based on nominal concentrations of the test item). Results and discussions The test item showed turbidity and precipitation throughout exposure. The cumulative mortality at each time of observation is shown in the following table: Cumulative mortality [%] in the test vessels (mean measured concentrations)

Concentration Test duration [h] [mg/L] 3 24 48 72 96 100 0 0 0 0 0 Control 0 0 0 0 0

Symptoms of toxicity (behaviour) are given in the following table: Observations in the test vessels (n = 7)

Nominal test item Effect a Test duration [h] concentration [mg/L] 3 24 48 72 96 100 (1) 7/7 7/7 7/7 7/7 7/7 Control (1) 7/7 7/7 7/7 7/7 7/7 aThe number in brackets corresponds to the following observation: (1) = normal behaviour

Conclusion

The NOEC (0-96 h) is laid down as the nominal test item concentration of 100 mg/L. The LC 50 (0-96 h) is above the limit test concentration of 100 mg COM 802 09 M RB/L.

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Study Comments: The study is acceptable. IIIA 10.2.2.1/01

Agreed endpoint/s: LC 50 (96 h) > 100 mg product/L IIIA 10.2.2.1

IIIA 10.2.2.2 Acute toxicity (24 & 48 h) for Daphnia preferably Daphnia magna Report: KIIIA 10.2.2.2/01, Noack, M., 2011 Title: COM 802 09 M RB. Acute immobilization test to Daphnia magna , Limit- Test, Static, 48 h Report No: DAI14144 Guidelines: OECD Guideline 202 for Testing of Chemicals (2004) GLP Yes

Materials and methods In the acute immobilization test to Daphnia magna the effects of the suspension of the test item COM 802 09 M RB with a nominal concentration of 100 mg/L were determined in a limit test. The limit test was conducted under static conditions over a period of 48 h. Twenty daphnids were exposed to the limit concentration and the control. The limit concentration and the control were analytically verified in the fresh media (0 h) and old media (48 h) by determination of the iron (III) content with a tube test via spectrophotometry. The measured concentration of iron (III) in the limit concentration were below the limit of quantification of the tube test (0.02 mg Fe/L) in the fresh media at test start (0 h) and in the old media at test end (48 h). Water quality parameters (pH-value and dissolved oxygen concentration), measured in the fresh (0 h) an old media (48 h), were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled. At the limit concentration of 100 mg/L (nominal) of the test item COM 802 09 M RB, no effect was observed on Daphnia magna. The EC 50 (48 h) was determined to be > 100 mg/L. Results and discussions The percentage immobility, determined in all test and control groups after 24 h and 48 h under static conditions, is presented in the following table: Observations in the test vessels

Nominal IMMOBILIZATION [%] Test Item 24 h 48 h Concentration Replicates Replicates [mg/L] 1. 2. MV 1. 2. MV 100.0 0 0 0 0 0 0 Control 0 0 0 0 0 0

There was no effect observed in the limit concentration and in the control group. The suspension of the test item was turbid and slightly green to blue coloured. After 24 h white sediment was observed, the test item suspension was visually clear. The measured concentrations of iron (III) in the limit concentration were below the limit of quantification of the tube test (0.02 mg Fe/L) in

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the fresh media at test start (0 h) and in the old media at test end (48 h). The EC 50 -value of the reference item, 1.46 mg/L, is within the recommended range of 0.6 – 2.1 mg/L. Conclusion At the limit concentration of 100 mg/L (nominal) of the test item COM 802 09 M RB, no effect was observed on Daphnia magna. Thus, the EC 50 is above the maximum test item rate of 100 mg/L. Study Comments: The study is acceptable. IIIA 10.2.2.2/01

Agreed endpoint/s: EC 50 > 100 mg product/L IIIA 10.2.2.2

IIIA 10.2.2.3 Effects on algal growth and growth rate Report: KIIIA1 10.2.2.3/01, Scheerbaum, D., 2011b Title: COM 802 09 M RB. Alga, Growth Inhibition Test with Pseudokirchneriella subcapitata , 72 hours Report No: SPO14144 Guidelines: OECD Guideline No. 201 for Testing of Chemicals (2006) GLP Yes

Materials and methods The toxicity of COM 802 09 M RB to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined. The aim of the study was to assess the effects on growth rate and yield production over a period of 72 hours. The study was conducted under static conditions with an initial cell density of about 1 × 104 cells/mL. A limit concentration of 100 mg/L was tested. Six replicates were tested for the limit concentration and the control. Environmental conditions were determined to be within the acceptable limits. The concentration of the active ingredient was determined via spectrophotometric analysis at test start and test end. The measured Iron (III) concentration was below the limit of quantification of the tube test (0.02 mg Fe/L) at test start and at test end. The NOEC for inhibition of specific growth rate and yield after 72 h were 100 and < 100 mg/L, respectively. Inhibition of yield was < 20%. All effect levels are given based on nominal concentrations of COM 802 09 M RB. The EC 50 (0-72 h) for growth inhibition and yield inhibition is above the limit test item concentration of 100 mg COM 802 09 M RB/L. Results and discussions The percentage immobility, determined in all test and control groups after 24 h and 48 h under static conditions, is presented in the following table:

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Observations in the test vessels

Nominal test item Growth rate Rate related inhibition Inhibition of Yield concentration [d -1] [%] [%] [mg/L] 100 (+) 1.79 a 2.96 (+) 15.1 Control 1.85 - - a = biologically not significant (+) = statistically significant differences of growth rates and yield compared to control values Conclusion The NOEC for inhibition of specific growth rate and yield after 72 h were 100 and < 100 mg/L, respectively. Inhibition of yield was < 20%. The EC50 (0-72 h) for growth inhibition and yield inhibition is above the limit test item concentration of 100 mg COM 802 09 M RB/L. Study Comments: The study is acceptable. IIIA 10.2.2.3/01

Agreed endpoint/s: ErC50 > 100 mg product/L IIIA 10.2.2.3 EyC50 > 100 mg product/L

IIIA 10.4 Effects on bees IIIA 10.4.2 Acute toxicity of the preparation to bees Report: KIIIA 10.4.2.1/01, Bruhnke, C. 2011a Title: COM 802 09 M RB. Acute effects on the Honeybee Apsis mellifera (Hymenoptera, Apidae) Report No: ILB14144 Guidelines: OECD 213/214 (1998) GLP Yes

Materials and methods In oral and contact mode a limit-test with the nominal test item ( COM 802 09 M RB, Batch 07/092 ) dose 99.6 µg a.i./bee (oral) and 44 µg a.i./bee (contact), respectively was conducted. 5 replicates per control and test item (oral mode) and 3 replicates for the reference item were tested, each with 10 bees. In contact mode, for the test item treatment 10 replicates each with 5 bees were used. In oral mode 50% aqueous sucrose solution were used as control, in the contact mode acetone and demineralised water. Danadim Progress (0.046, 0.1, 0.22, 0.46 µg Dimethoate/bee – nominal doses in oral and contact mode) was used as a reference item. The test item uptake was determined after 2-6 hours by weight (oral application). Mortality and abnormal behaviour was determined after 4, 24 and 48 h. No statistical calculations were performed. Results and discussions A summary of the acute toxicity of COM 802 09 M RB to honey bees is given in the table below.

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Observations in the test vessels

Test substance COM 802 09 M RB Species Apis mellifera Exposure oral a contact 24 h > 64.1 >46.2 LD [µg a.s./bee] 50 48 h > 64.1 >46.2

* 24 h > 5.03 > 3.62 LD 50 [mg prod./bee] 48 h > 5.03 > 3.62 a = LD 50 -value based on actual test item dose

Conclusion Under laboratory test conditions, COM 802 09 M RB had no significant effects on vitality and behaviour of the honey bee Apis mellifera . In oral and contact mode the LD 50 -values of the test item, based on actual doses were determined to be oral LD 50 (24 and 48 h) > 64.1 µg a.s./be (> 5.03 mg product/bee) and contact LD 50 (24 and 48 h) > 46.2 µg a.s./bee (> 3.62 mg product/bee). Study Comments: The study is acceptable. IIIA 10.4.2.1/01 Agreed endpoint/s: LD 50 (oral 48 h) > 64.1 µg a.s./bee IIIA 10.4.2.1/01 LD 50 (contact 48 h) > 46.2 µg a.s./bee

IIIA 10.5 Effects on arthropods other than bees IIIA 10.5.2 Effects on non-target terrestrial arthropods in extended laboratory tests Report: KIIIA 10.5.2/01, Bruhnke, C. 2011b Title: COM 802 09 M RB. Effects of plant protection products on the rove beetle Aleochara bilineata , laboratory test Report No: IKR14144 Guidelines: Grimm et al. (2000) GLP Yes

Materials and methods The effects of COM 802 09 M RB at a limit rate of 100 kg/ha on the rove beetle Aleochara bilineata was measured in the laboratory via contact on quartz sand, compared to a water treated control (400 L/ha) and to a reference item (Dimethoate, 426 g/L at 1.1 and 2.2 L/ha). Application took place once at the beginning of the study onto the test medium without food and test organisms. The control and reference item was applied as spray, the test item as granules onto the soil surface. After application beetles were introduced and were fed approximately one hour later. On day 7, 14 and 21 the hatched beetle larvae got approximately 500 individual pupae of Delia antiqua per replicate to parasitize them. The pupae were mixed with the test medium so that the pupae were distributed homogeneously in the soil and covered with substrate. The test medium was re-moistened with demineralised water at least two times a week (including day 7, 14 and 21)

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to avoid a water loss of more than 25% within 7 days. The amount of evaporated water was determined by weighing the test vessels on day 0, on the days of moistening and on day 28. On day 28 the number of beetles which survived the first test period was documented. From day 35 onwards the hatching rate of the beetles was recorded on each working day up to the test end. Results and discussions No adverse effect of the test item COM 802 09 M RB (100 kg/ha) on the vitality and reproduction rate of Aleochara bilineata could be observed. For details on mortality and parasitisation efficiency see the following table: Toxicity of COM 802 09 M RB to Aleochara bilineata , laboratory study

Parasitation Adult Mortality Mean Number of Rate(compared to [%] ± SD hatched Beetles ± SD control) [%] Control 20.0 ± 5.00 862 ± 46.1 - COM 802 09 M RB 10.0 ± 9.13 902 ± 16.5 105 [100 kg /ha] Danadim Progress

[L/ha] 1.1 50.0 ± 14.7 617 ± 90.7 71.6 2.2 88.0 ± 7.50 59.5 ± 38.5 6.90 SD = Standard deviation Conclusion No adverse effect of the test item COM 802 09 M RB (100 kg/ha) on the vitality and reproduction rate of Aleochara bilineata could be observed.

Study Comments: The study is acceptable. IIIA 10.5.1/01 Agreed endpoint/s: NOEC = 100 kg product/ha IIIA 10.5.1

Report: KIIIA 10.5.2/02, Bruhnke, C. 2011c Title: COM 802 09 M RB. Assessment of side effects on the ground beetle, Poecilus cupreus L. (Coleoptera, Carabidae), Laboratory Test Report No: ILA14144 Guidelines: Heimbach U. et al. (2000) GLP Yes

Materials and methods The effects of COM 802 09 M RB on the ground beetle, Poecilus cupreus L. , was evaluated at a limit rate of 100 kg/ha over a test period of 14 days. Also included in this test was a water-treated control and a toxic reference treatment of Dimethoate/426 g/L, applied at a rate of 200 and 400 g

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a.s./ha. The test and reference item and control were tested with six replicates, each with 3 females and 3 males. The moisture content of the soil was guaranteed by adding the evaporated water (a. demin) on day 0, 2 (if necessary), 4, 7, 10/11. A water loss of > 50% was avoided. Only dead beetles which were visible on the soil surface were considered. The parameters mortality, damage of the beetles and abnormal behaviour of the organisms during the exposure period were recorded on day: 0 (2 h and if effects occur, ca. further 2 hours after application), 1, 2, 4, 7, 10 or 11 and 14. Mortality of each treatment group was recorded for each sex separately. The parameter feeding rate was determined on day 1, 2, 4, 7, 10/11, and 14 of the test. Results and discussions After 14 days no mortality was observed in the COM 802 09 M RB treatment group and in the water treated control. The mean feeding rate (consumed pupae/living beetle and day) was 0.36 in the test item group and in the control. For details see the table below: Effects on ground beetles ( Poecilus cupreus ) exposed to COM 802 09 M RB Mortality Corrected Mean feeding rate mortality (consumed pupae/living [%] ± SD [%] beetle and day ± SD Control 2.78 ± 6.82 - 0.36 ± 0.00 COM 802 09 M RB 0.0 ± 0.0 -2.86 0.36 ± 0.00 100 kg a.s./ha Reference item 400 g a.s./ha 77.8 ± 22.8 77.2 0.38 ± 0.10 800 g a.s./ha 100 ± 0.00 100 ± 0.00 0.49 ± 0.03 SD = Standard deviation Conclusion No mortality, no effects on feeding activity and no abnormal behaviour of the ground dwelling predator Poecilus cupreus were observed after exposure up to an application rate of 100 kg product/ha on quartz sand.

Study Comments: The study is acceptable. IIIA 10.5.2/02 Agreed endpoint/s: NOEC = 100 kg product/ha IIIA 10.5.2

IIIA 10.6 Effects on earthworms and other makro soil-organisms IIIA 10.6.2 Acute toxicity to earthworms Report: KIIIA 10.6.2/01, Krome, K. 2011a Title: COM 802 09 M RB Earthworm Eisenia fetida using in Artificial Soil Report No: RRA14144

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Guidelines: OECD 207 (1984); ISO 11268-1 (1997) GLP Yes

Materials and methods The effects of COM 802 09 M RB on earthworm species Eisenia fetida was determined in a laboratory acute toxicity test using artificial soil (10% peat). The main test was performed with concentrations of 62.5, 125, 250, 500 and 1000 mg product/kg soil dry weight. Adult earthworms were exposed for 14 days to the test substrate at a temperature of 20±2°C in the dark. The test item was weighed out as granules for each test item concentration and was given to the artificial soil. Demineralised water was added to the artificial soil to adjust the humidity of the artificial soil to a moisture of 40 - 60% of the maximum water holding capacity. Subsequently, the test medium was thoroughly mixed to ensure a homogenous distribution and about 555 g soil dry weight was filled into each test vessel. The maximum water holding capacity, the moisture content and the pH-value of the soil was determined prior to the adaptation of the earthworms. At start and end of the test, pH-value and moisture content of the test medium was analysed in the treatments and control using mixed samples of all four replicates. The live weight of the earthworms was determined individually at the day of application (day 0) and at day 14. Mortality, behaviour and morphological changes of the earthworms were recorded 7 and 14 days after application. Results and discussions After 14 days of exposure to COM 802 09 M RB no evident mortality (< 10%) of adult earthworms was observed in the control and at all test item concentrations. The earthworm biomass was statistically significantly increased compared to the control at 1000 mg/kg soil dry weight. Earthworms in the control and at all test item concentrations showed no changes in behaviour or pathological symptoms after 7 and 14 days of exposure to COM 802 09 M RB.

Earthworm mortalities and weight after exposure to COM 802 09 M RB and the control group

COM 802 09 M RB Mean mortality 7 days Mean mortality 14 days [mg/kg soil dry weight] [%] [%] Control 0 0 62.5 2.5 2.5 125 0 0 250 0 0 500 0 0 1000 0 0

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Live weight of the earthworms

Mean live weight Test item Test start Test end Test end [mg/kg soil dry Growth weight] MV±SD MV±SD CV Significance [%] [g/worm] [g/worm] [%] Control 0.459 ± 0.055 0.468 ± 0.060 12.8 2 – 62.5 0.460 ± 0.049 0.465 ± 0.044 9.46 1 No 125 0.461 ±0.057 0.471 ± 0.057 12.1 2 No 250 0.460 ± 0.056 0.478 ± 0.052 10.9 4 No 500 0.461 ± 0.053 0.478 ± 0.047 9.83 1 No 1000 0.460 ± 0.056 0.505 ± 0.057 11.3 10 Yes* MV) Mean value *) statistically significant increase compared to the control, ANOVA (P < 0.05), Dunnett´s Test CV) Coefficient of variation SD) Standard deviation Conclusion After 14 days of exposure to COM 802 09 M RB no evident mortality (< 10%) of adult earthworms was observed in the control and at all test item concentrations. Also, no evident pathological symptoms or changes in the behaviour of the earthworms were observed at 62.5, 125, 250, 500 and 1000 mg/kg soil dry weight after 14 days of exposure. The earthworm biomass was statistically significantly increased compared to the control at 1000 mg/kg soil dry weight. Consequently, the concentration with No Observed Effects (NOEC) of the test item with respect to earthworm mortality, biomass as well as pathological symptoms and behaviour is determined to be at 500 mg/kg soil dry weight after 14 days of exposure.

Study Comments: The study is acceptable. IIIA 10.6.2/01 The peat content in the effect study with the formulation was 10%. However, no correction for the study with the formulation was performed since the logK OW of Ferric phosphate cannot be defined due to the insolubility of Ferric phosphate in water.

Agreed endpoint/s: LC 50 (14 d) > 1000 mg product/kg soil d.w. IIIA 10.6.2

IIIA 10.6.3 Sublethal effects on earthworms Report: KIIIA 10.6.3/01, Krome, K. 2011b Title: COM 802 09 M RB Earthworm (Eisenia fetida), Effects on reproduction Report No: RBN14144 Guidelines: OECD 222 (2004); ISO 11268-2: 1998 (E); BBA Guideline (1994) GLP Yes

Materials and methods

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Effects of the test item COM 802 09 M RB and the blank formulation of the test item COM 802 10 M RB on mortality, biomass and the reproductive potential of the earthworm species Eisenia fetida were determined. The study was conducted under static conditions over 8 weeks with the concentrations of 31.25, 62.5, 125, 250 and 500 kg/ha for the test item as well as for the blank formulation of the test item. The test item and the blank formulation were directly weighed for each replicate and applied onto the soil surface as granules. The artificial soil used contained 10% peat. Additionally an untreated control was set up. 80 test organisms were inserted into 8 control replicates and 40 test organisms were divided into 4 replicates for each treatment (10 earthworms per replicate). At experimental starting and experimental completion, pH-value and moisture content of the test medium was determined in every treatment and control from pooled samples of all replicates. The water content of each test vessel was checked weekly by weighing. The weight loss was replenished with the appropriate amount of demineralised water. The body weight of the adult earthworms was individually determined at day 0 and at day 28. After the first four weeks the adult earthworms were removed and subsequently mortality and morphological changes were recorded. After further four weeks, the number of offspring hatched from the cocoons was counted. Results and discussions No mortality of adult earthworms was observed in the control as well as at all treatments of the test item COM 802 09 M RB and the blank formulation COM 802 10 M RB after 28 days of exposure. Compared to the control the reproduction of the earthworms did not statistically significantly differ at all treatments with the test item as well as with the blank formulation. No pathological symptoms or changes in the behaviour of the earthworms were observed in the control as well as at all treatments of the test item COM 802 09 M RB and the blank formulation COM 802 10 M RB after 28 days of exposure. The body weights of the adult earthworms increased throughout the first 28 days at all treatments of the test item COM 802 09 M RB as well as of the blank formulation COM 802 10 M RB without any statistically significant differences compared to the control.

Earthworm mortalities, weight and reproduction after 28 days of exposure to COM 802 09 M RB and the control group

COM 802 09 M RB Mortality 28 days Mean weight Reproduction [%] of [kg product/ha] [%] * [% of initial] ± SD control Control 0 51.8 ± 8.26 - 31.25 0 55.8 ± 7.09 154 62.5 0 58.4 ± 2.17 129 125 0 63.2 ± 9.60 138 250 0 61.7 ± 12.2 122 500 0 65.9 ± 5.94 118 SD = standard deviation Conclusion The No Observed Effect Rate (NOER) for COM 802 10 M RB and COM 802 10 M RB with respect to mortality, body weight and reproduction of Eisenia fetida after 8 weeks of exposure in artificial soil was determined to be at 500 kg/ha.

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Study Comments: The study is acceptable. IIIA 10.6.3/01 Agreed endpoint/s: NOER = 500 kg prod./ha IIIA 10.6.3

IIIA 10.6.6 Effects of other soil non-target macro-organisms Report: KIIIA 10.6.6/01, Bruhnke, C. 2011d Title: COM 802 09 M RB. Predatory Mite Reproduction Test in Soil ( Hypoaspis aculeifer ) Report No: IHL14144 Guidelines: OECD 226 (October 2008) GLP Yes

Materials and methods The test was conducted to determine the effects of COM 802 09 M RB in soil on vitality and reproduction of the soil mite species Hypoaspis aculeifer . Adult females were exposed a limit test item rate of 100 kg/ha. Demineralised water was used as control and boric acid was used as reference item and tested in a separate study. Application of the test item was carried out once at experimental starting. 10 adult females were introduced per replicate. One additional replicate per each treatment was used for the determination of the pH-value and the water content on day 0 and day 14. The mites were introduced into the test vessels within 2 hours after application of 100 kg/ha test item. The test was ended after 14 days. From day 14 to 16 the mites (adults and juveniles) were extracted from the soil by heat/light extraction and the number of surviving females and the number of juveniles per replicate were counted on day 16/17. The soil moisture and maximum water holding capacity was determined prior to experimental starting. From day 0 to 14 the temperature was recorded with a thermohygrograph. At test start and test end, pH-value and moisture content of the test medium was determined in additional containers for the test item concentration and control. Three times a week the soil moisture was determined by weighing of the test vessels and the soil was re-moistened, if necessary. From day 14 to 16 the temperature in the soil were measured by a data logger. Results and discussions Effects of COM 802 09 M RB are summarized in the table below: Mortality and reproductive capacity of the mites Corrected Coefficient of Inhibition of Mortality Mean number [kg product/ha] mortality variation reproduction [%] ±SD of juveniles [%] [%] [%] Control 10.0 ± 10.5 - 161 21.1 - 100 11.0 ± 11.0 1.11 159 8.93 1.24 SD = Standard Deviation

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Conclusion Under laboratory test conditions COM 802 09 M RB had no significant effects on the survival and on the reproduction rate of the adult predatory mite Hypoaspis aculeifer at an application rate of 100 kg/ha.

Study Comments: The study is acceptable. IIIA 10.6.6/01

Agreed endpoint/s: LR 50 > 100 kg prod./ha IIIA 10.6.6

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Appendix 3 Risk envelope rationale for Ecotoxicological risk assessment Not required.

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Appendix 4 Relevance of the metabolites in groundwater Apart from ferric and phosphate ions there are no degradation products of the active substance. Both ferric and phosphate ions are natural constituents in environmental compartments. Based on (1) a lack of biological activity of the metabolites, (2) the overall lack of genotoxic potential with these metabolites, and (3) the lack of toxicological properties of the parent active ingredient that would require classification and labelling as toxic or very toxic, a reproductive toxin, or a carcinogen, the metabolites can be considered as not relevant.

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REGISTRATION REPORT Part B

Section 6: Ecotoxicological Studies Detailed summary of the risk assessment

Product code COM 802 09 M RB

Active Substance Ferric phosphate 12.5 g/L

Member State: Germany Central Zone

National Addendum - Germany

Applicant COMPO GmbH & Co. KG

Date May 2012, revised October 2012

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Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 2 of 10

Table of Contents 6.1 EFFECTS ON BIRDS (IIIA1 10.2) ...... 3 6.2 EFFECTS ON TERRESTRIAL VERTEBRATES OTHER THAN BIRDS (IIIA1 10.3) ...... 3 6.3 EFFECTS ON AQUATIC ORGANISMS (IIIA1 10.2)...... 3 6.4 EFFECTS ON BEES (IIIA 10.4) ...... 3 6.5 EFFECTS ON ARTHROPODS OTHER THAN BEES (IIIA 10.5)...... 3 6.6 EFFECTS ON EARTHWORMS AND OTHER SOIL NON -TARGET MACRO -ORGANISMS (IIIA 10.6) ...... 3 6.6.2 Toxicity exposure ratios for earthworms, TERA and TERLT (IIIA 10.6.1)...... 5 6.6.3 Effects on other non-target macro-organisms (IIIA 10.6.6)...... 5 6.6.4 Effects on organic matter breakdown (IIIA 10.6.7)...... 6 6.7 EFFECTS ON SOIL MICROBIAL ACTIVITY (IIIA 10.7) ...... 6 6.8 EFFECTS ON NON -TARGET PLANTS (IIIA 10.8) ...... 6 6.9 SUMMARY AND EVALUATION OF POINTS 9 AND 10.1-10.10 ...... 7 6.9.1 Predicted distribution and fate in the environment and time courses involved (IIIA 10.11.1) ...... 7 6.9.2 Non-target species at risk and extent of potential exposure (IIIA1 10.11.2)...... 7 6.9.3 Short and long term risks for non-target species, populations, communities and processes (IIIA 10.11.3)...... 7 6.9.4 Risk of fish kills and fatalities in large vertebrates or terrestrial predators (IIIA 10.11.4)...... 8 6.9.5 Precautions necessary to avoid/minimise environmental contamination and to protect non-target species (IIIA 10.11.5) ...... 8

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 3 of 10

Sec 6 ECOTOXICOLOGICAL STUDIES Please refer to the core assessment for the central zone.

6.1 Effects on birds (IIIA1 10.2)

Please refer to the core assessment.

6.2 Effects on Terrestrial Vertebrates Other Than Birds (IIIA1 10.3)

Please refer to the core assessment.

6.3 Effects on Aquatic Organisms (IIIA1 10.2)

Please refer to the core assessment.

6.4 Effects on Bees (IIIA 10.4)

Please refer to the core assessment.

6.5 Effects on Arthropods Other Than Bees (IIIA 10.5)

COM 802 09 M RB is a ready-to-use bait to be strewed on the soil surface. Since the product is not sprayed drift does not happen when applied. Thus, no exposure of the off-field is assumed and it is not considered in the present risk assessment for the non-target arthropods.

6.6 Effects on Earthworms and Other Soil Non-target Macro-organisms (IIIA 10.6) 6.6.1.1 Toxicity Please refer to the core assessment.

6.6.1.2 Exposure For german exposure assessment, the applied soil depth is based on experimental data 1 (Fent, 1999). Generally, for active substances with a K f,oc < 500 a soil depth of 2.5 cm is used whereas for active substances with a K f,oc > 500 a soil depth of 1 cm is applied. For PEC calculations reference is made to the environmental fate section (Part B, Section 5) of this submission. The resulting maximum PEC soil values are presented in the Table 6.6-1 below. Calculations considered the maximum application rate of 50 kg COM 802 09 M RB /ha and assumed an even distribution of the substances in the top 1 cm horizon with a soil bulk density of 1.5 g/mL. The

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 4 of 10 standard soil depth of 1 cm was considered for Ferric phosphate due to substance properties – considered to be immobile, indicating a strong potential of adsorption to soil. The PEC for the acute risk assessment was based on a single application of 50 kg prod./ha, converted to 333.3 mg prod./kg soil d.w. assuming a soil depth of 1 cm and a bulk density of soil of 1.5 g/cm 3, which is equivalent to 4.2 mg a.s./kg d.w. The short-term and long-term actual concentrations (PECsoil, actual) and the time weighted average concentrations (PEC soil, twa ) for the active substance Ferric phosphate were not calculated because no reliable DT 50 value in soil could be obtained for the active substance Ferric phosphate. Therefore, considering multiple applications, as a worst-case scenario it is assumed that COM 802 09 M RB is applied in one cumulative application of 200 kg/ha (corresponding to 2.5 kg/ha Ferric phosphate) to vegetables, fresh herbs, fruits, ornamentals and potatoes. However, it can be realistically concluded that this cumulative application does not reflect the conditions of use since additional applications are only sensible, when the product has been eaten up by the slugs and if there is still infestation.

Table 6.6-1: Maximum PEC S for COM 802 09 M RB, Ferric phosphate, Iron and phosphate after single and multiple application of COM 802 09 M RB

Substance Maximum instantaneous PEC S (mg/kg) Single application Multiple Application COM 802 09 M RB 333.33 1333.33 Ferric phosphate 4.167 16.667 Fe 3+ 1.55 6.15 3- PO 4 2.62 10.5

Furthermore iron is present in all soils, being a constituent of several minerals. The EU review of 3+ 3- Ferric phosphate stated natural concentrations of Fe -Ions and PO 4 Ions commonly found in soils between 2000 and 50000 mg/kg and between 100 and 2000 mg/kg soil, respectively. Thus the amount of iron added to the soil after application of the product is negligible in comparison to the quantities which naturally exist in soils. Additionally, iron and in particular, phosphate are applied in considerable amounts to agricultural soils in fertilisers. The additional predicted environmental concentrations following single and multiple application are compared to concentrations due to ubiquitous occurrence and application as fertiliser stated in the EU review of Ferric phosphate in the following table: Table 6.6-2: Comparison of the natural occurance of iron and phosphate with single and multiple applications of COM 802 09 M RB 3+ 3- Scenario Active Substance Fe PO 4 additional PEC following 4.17 1.55 2.62 single application additional PEC following 16.67 6.15 10.5 multiple application Concentration naturally -- 2000 - 50000 100 – 2000 occuring in soils additional PEC following -- ≥ 8.7 ≥ 8.7 fertiliser application

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 5 of 10

6.6.1.3 Overall conclusion Considering an even distribution of the substance in the top 1 cm horizon, the acceptability criteria TER ≥ 10 for acute effects after single application of COM 802 09 M RB, according to Annex VI to Regulation (EC) 1107/2009, uniform principles, point 2.5.2.5 is not reached. Taking into account the extreme worst case character of the exposure scenario (even distribution of the substance in the top 1 cm horizon, cumulative concentration), the ubiquitous occurrence of iron and phosphate in soils and the low toxicity of ferric phosphate to earthworms (limit tests), it can be concluded, that COM 802 09 M RB poses low risk to earthworms following application according to the proposed use patterns. Regarding the long-term risk to earthworm and other Soil Non-target Macro-organisms please refer to the core assessment.

6.6.2 Toxicity exposure ratios for earthworms, TERA and TERLT (IIIA 10.6.1) 6.6.2.1 Acute risk The potential acute risk of COM 802 09 M RB and the active substance Ferric phophate was assessed by comparing the maximum instantaneous PECsoil with the 14-day LC 50 value to generate acute TER values. The peat content in the effect study with the formulation was 10%. However, no correction for the study with the formulation was performed since the logK OW of Ferric phosphate cannot be defined due to the insolubility of Ferric phosphate in water.

The TER A was calculated as follows:

LC 50 (mg/kg) TER A = PEC soil (mg/kg)

The resulting TER A values are shown in the following Table, considering the highest initial PEC in soil: Table 6.6-3: Acute TER values for earthworms following applications of COM 802 09 M RB.

Test substance Maximum initial Timescale LC 50 TER PEC (mg/kg) (mg/kg) COM 802 09 M RB 333.33 (single 14 d > 1000 > 3 application) TERs shown in bold fall below the relevant trigger.

6.6.2.2 Long-term risk Please refer to the core assessment.

6.6.3 Effects on other non-target macro-organisms (IIIA 10.6.6) Please refer to the core assessment.

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 6 of 10

6.6.4 Effects on organic matter breakdown (IIIA 10.6.7) Please refer to the core assessment.

6.7 Effects on Soil Microbial Activity (IIIA 10.7)

Please refer to the core assessment.

6.8 Effects on Non-Target Plants (IIIA 10.8)

Please refer to the core assessment.

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 7 of 10

6.9 Summary and Evaluation of Points 9 and 10.1-10.10

6.9.1 Predicted distribution and fate in the environment and time courses involved (IIIA 10.11.1) Please refer to the core assessment.

6.9.2 Non-target species at risk and extent of potential exposure (IIIA1 10.11.2) Please refer to the core assessment.

6.9.3 Short and long term risks for non-target species, populations, communities and processes (IIIA 10.11.3) Birds and mammals Please refer to the core assessment.

Aquatic Organisms Please refer to the core assessment.

Arthropods other than bees Please refer to the core assessment.

Earthworms and other soil non-target marco-organisms Considering an even distribution of the substance in the top 1 cm horizon, the acceptability criteria TER ≥ 10 for acute effects after single application of COM 802 09 M RB, according to Annex VI to Regulation (EC) 1107/2009, uniform principles, point 2.5.2.5 is not reached. Taking into account the extreme worst case character of the exposure scenario (even distribution of the substance in the top 1 cm horizon, cumulative concentration), the ubiquitous occurrence of iron and phosphate in soils and the low toxicity of ferric phosphate to earthworms (limit tests), it can be concluded, that COM 802 09 M RB poses low risk to earthworms following application according to the proposed use patterns. Regarding the long-term risk to earthworm and other Soil Non-target Macro-organisms please refer to the core assessment.

Organic matter breakdown/ Soil microbial activity Please refer to the core assessment.

Non-target plants Please refer to the core assessment.

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 8 of 10

6.9.4 Risk of fish kills and fatalities in large vertebrates or terrestrial predators (IIIA 10.11.4) Please refer to the core assessment.

6.9.5 Precautions necessary to avoid/minimise environmental contamination and to protect non-target species (IIIA 10.11.5) No special precautions are necessary to avoid or minimize contamination of the environment with regard to non-target species.

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 COM 802 09 M RB Registration Report National Addendum - Germany Central Zone Page 9 of 10

Appendix 1 List of data submitted in support of the evaluation Please refer to the core assessment.

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 6 GF-2463 Registration Report – Core Assessment Germany-Central Zone

Page 10 of 10

Appendix 2 Detailed evaluation of studies relied upon Please refer to the core assessment.

Applicant: COMPO GmbH & Co. KG Evaluator: ZRMS Germany

Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 1 of 36

REGISTRATION REPORT Part B Section 7: Efficacy Data and Information Detailed Summary

Product Code: COM 802 09 M RB Reg. No.: ZV1 007517-00/00 Active Substance: 12.5 g/kg Ferric phosphate

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Compo GmbH & Co KG Date: 2011-08-28

Evaluator: Julius Kühn-Institut Date: 2012-10-17

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 2 of 36

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 substances (Uptake and mode of action) ...... 3 Information on crops and pests ...... 3 Information on the intended uses (2012-10-16) ...... 4 IIIA1 6.1 Efficacy data...... 7 IIIA1 6.1.1 Preliminary range-finding tests ...... 8 IIIA1 6.1.2 Minimum effective dose tests ...... 9 IIIA1 6.1.3 Efficacy tests ...... 10 IIIA1 6.1.4 Effects on yield and quality ...... 15 IIIA1 6.1.4.1 Impact on the quality of plants and plant products ...... 15 IIIA1 6.1.4.2 Effects on the processing procedure ...... 15 IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products ...... 15 IIIA1 6.2 Adverse effects ...... 15 IIIA1 6.2.1 Phytotoxicity to host crop...... 15 IIIA1 6.2.2 Adverse effects on health of host animals ...... 16 IIIA1 6.2.3 Adverse effects on site of application ...... 16 IIIA1 6.2.4 Adverse effects on beneficial organisms (other than bees) ...... 16 IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes ...... 19 IIIA1 6.2.6 Impact on succeeding crops ...... 20 IIIA1 6.2.7 Impact on other plants including adjacent crops ...... 20 IIIA1 6.2.8 Possible development of resistance or cross-resistance ...... 20 IIIA1 6.3 Economics ...... 20 IIIA1 6.4 Benefits ...... 20 IIIA1 6.4.1 Survey of alternative pest control measures ...... 20 IIIA1 6.4.2 Compatibility with current management practices including IPM...... 20 IIIA1 6.4.3 Contribution to risk reduction ...... 20 IIIA1 6.5 Other/special studies ...... 20 IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 ...... 20 IIIA1 6.7 List of test facilities including the corresponding certificates ...... 21 Appendix 1: List of data submitted in support of the evaluation ...... 22 Appendix 2: GAP tables ...... 31

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 3 of 36

IIIA1 6 Efficacy Data and Information on the Plant Protection Product

General information This document summarises the information related to the efficacy of the molluscicide COM 802 09 M RB containing the active substance ferric phosphate (12.5 g/kg) for slug control in vegetables, potatoes, ornamentals and fruit (non–professional use). Ferric phosphate is included in Annex I of Directive 91/414/EEC. Germany is the zRMS and belongs according to Regulation EC No 1107/2009 to the central registration zone (zone B). According to the EPPO standard PP1/241 (zones of comparable climate in the EPPO region) Germany is part of the maritime climatic zone. The dossier is submitted in parallel to the following cMS of the central registration zone: United Kingdom, Belgium, the Netherlands, Luxembourg, Czech Republic, Poland and Austria. United Kingdom, Belgium, the Netherlands, Luxembourg, Czech Republic and Austria belong to the maritime climatic zone, while Poland is part of the north-east climatic zone according to EPPO.

Recent registration situation/history of the PPP The active substance is registered in Germany and in countries of zone B in different molluscicidal products. Comparable molluscicidal products with this active substance are registered in Germany and other EU-Countries for slug control in different crops. The test product COM 802 09 M RB is not registered in any country of the EU yet.

Information on the active substances (Uptake and mode of action) Mode of action The mollusc bait COM 802 09 M RB is based on the active substance ferric phosphate. Ferric phosphate interferes with the calcium metabolism, resulting in a disturbance of the fluid house- hold of snails and slugs and therefore disrupting feeding and mucus production. Ferric phosphate is an inorganic compound that is known to induce pathologic changes to the digestive system of snails and slugs on a cellular base. Calcium metabolism seems to be affected. Slugs stop feeding quickly and die after 3-6 days at places not always noticeable. Ferric phosphate is a natural compound occurring in soils and its breaks down to phosphate and iron, which are a mineral source that can be taken up by plants. Resistance risk of the active substance Ferric phosphate does not belong to a specific MOA group. It is an inorganic compound that is known to induce pathologic changes to the digestive system of snails and slugs on a cellular base. Calcium metabolism seems to be affected. Slugs stop feeding quickly and die soon. There is no knowledge of any resistance having developed and such a development seems unlikely Field of use Different snails and slugs of different genera attacking all types of cultivated plants are affected. Slugs attacking roots in the soil will not be attracted and affected if granules are applied on soil surface. Similarly snails inhabiting the crop canopy of e.g. trees and bushes will not be exposed and may damage fruit. Crop damages are not expected due to the active, but depending on the way of application coloured spots due to the Iron might affect the quality of certain plants.

Information on crops and pests According to EPPO 1/95(3) and 1/96(3) the main target pests belong to the genera Deroceras (family Agriolimacidae) and Arion (family Arionidae). The applicant gives detailed information on the biology of several species which are claimed to cause damage in agriculture and horticulture. These are Deroceras reticulatum, D. agreste, D. sturanyi (family Agriolimacidae) and Arion lusitanicus, A. vulgaris, A. hortensis, A. distinctus, A. rufus and A. ater. Due to the polyphagous

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 4 of 36 nature of slugs with low host plant specificity, these pests cause similar damage in a wide variety of different crops under different growing conditions in field and greenhouse.

With using both genera Deroceras spp. and Arion spp. in the trials, the applicant has covered a suitably broad range of pest slugs. The majority of trials have been performed with Arion spp. which can be considered as the more important genus in small house gardens or allotments. Deroceras spp. are better known as slug pests in open fields in agricultural crops. In several of the efficacy trials individual species are mentioned, but for the Arion spp. in some cases only the genus is given. For trials with Deroceras spp. two species, Deroceras reticulatum and Deroceras agreste, are mentioned. Due to the difficulties in taxonomy and identification of slug species and some still unsolved issues in Arion taxonomy, it seems advisable not to concentrate on individual species, but to test both the different genera Arion and Deroceras in efficacy evaluation trials.

Information on the intended uses (2012-10-16)

Use No. 007517-00/00-001 Area of application vegetable growing Crop(s)/object(s) vegetables (NNNVV) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: outdoors Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment Spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-002 Area of application Vegetable growing Crop(s)/object(s) vegetables (NNNVV) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae und Adult Area of use Amateur gardening: greenhouse Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-003 Area of application Vegetable growing Crop(s)/object(s) vegetables (NNNVV) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: balconies and patios Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-004 Area of application Vegetable growing Crop(s)/object(s) fresh herbs (NNNKF)

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 5 of 36

Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: outdoors Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-005 Area of application Vegetable growing Crop(s)/object(s) fresh herbs (NNNKF) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: greenhouse Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-006 Area of application Vegetable growing Crop(s)/object(s) fresh herbs (NNNKF) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: balconies and patios Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-007 Area of application Fruit growing Crop(s)/object(s) fruit crops (NNNOO) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: outdoors Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-008 Area of application Fruit growing Crop(s)/object(s) fruit crops (NNNOO) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: greenhouse Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 6 of 36

------Use No. 007517-00/00-009 Area of application Fruit growing Crop(s)/object(s) fruit crops (NNNOO) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: balconies and patios Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-010 Area of application Ornamental growing Crop(s)/object(s) ornamentals (NNNZZ) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: outdoors Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-011 Area of application Ornamental growing Crop(s)/object(s) ornamentals (NNNZZ) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: greenhouse Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-012 Area of application Ornamental growing Crop(s)/object(s) ornamentals (NNNZZ) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: balconies and patios Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------Use No. 007517-00/00-013 Area of application Agriculture (field crops) Crop(s)/object(s) potato (SOLTU) Pest(s)/target(s)/aim(s) slugs (MOLLNS) Pest stage(s) (BBCH) Larvae and Adult Area of use Amateur gardening: outdoors Time of treatment At beginning of infestation and/or when first symptoms/harmful organisms become visible Max. number of treatments for the use 4 Max. number of treatments per crop or 4 season Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 7 of 36

Application technique/type of treatment spreading Notes on application technique between plants / evenly in the crop / baiting method Dose rate(s) in amount of water to be 5 g/m² used ------

IIIA1 6.1 Efficacy data This Registration Report is based on the results of 25 trials with the test product and 4 preliminary range finding tests with a slightly different formulation. 18 trials were conducted in the years 2010 and 2011 by official and private testing facilities in Germany, the United Kingdom, Austria and the Czech Republic (maritime climatic zone as defined in EPPO PP1/241, central registration zone). In addition 5 trials are available from Poland (north-east climatic zone as defined in EPPO PP1/241, Central registration zone) and 2 trials are available from Northern France (maritime climatic zone as defined in EPPO PP1/241, southern registration zone). 4 additional trials performed in Germany in 2009 were preliminary range-finding tests carried out with a different formulation, but 6 of the trials from 2010 are testing both formulations and can serve as bridging trials. All trials were carried out to GEP standards and followed general and appropriate EPPO standards, in particular EPPO standard PP 1/95(3). The submitted 25 trials were conducted in different countries and regions under different climatic conditions and soil types and they were fairly evenly distributed over a time period ranging from May to November. The majority of the trials were caged plot trials in the field, with slugs artificially introduced into the system, but 8 field trials from 4 countries (United Kingdom, Germany, Czech Republic and Poland) were performed with the natural population at sites of high slug pressure. 4 of these trials were performed at sites with a population of Arion spp. and 4 at sites with Deroceras spp. The conduction of trials using the natural slug population is important, as the population structure of natural slug populations differs from the population structure in caged plot trials in the field. In the caged plot trials only a certain part of the natural population is used, as only those slugs will be sampled for the trial that are active and have a certain size. In EPPO standards 1/95 (3) and 1/96 (3) it is stated that small barriered plots, or laboratory studies into which slugs are introduced, may be used to provide useful additional information, but should not be seen as a replacement for field effectiveness studies. Both standards state that for such studies the slugs, preferably adult and of the same species, should be collected from field sites and introduced uniformly into the plots. Several days should elapse before test treatments are applied to the plots. Suitable food plants should be presented to slugs during this acclimatization period but should be replaced with undamaged plants immediately prior to the application of treatments. It is not always clear if all these requirements were fulfilled. In the caged plots a defined number of slugs (13-70 individuals per plot, depending on trial design and plot size) have been introduced. In most cases 20-25 slugs were used. Subsequently still living slugs as well as dead slugs were counted and crop damages due to slugs were assessed. If the slugs were given time for acclimatisation is not always clear from the trial reports. 5 assessments were performed in the majority of trials: 2-3 days after treatment, 4-6 days after treatment, 7-8 days after treatment, 9-11 days after treatment and 14-16 days after treatment. In some sites, where due to slug damage complete plants were missing the numbers of still living plants were counted at the end of the observation period. The product was measured by individual plot and applied by hand “broadcast to the soil surface” between the crop plants. All trials presented were conducted with a single application. The reference products were applied the same way as the test item. Reference products were “Fer- ramol Schneckenkorn” or “Bayer Garten Schneckenkorn Biomol” with the same active substance ferric phosphate at their registered rates of 5 g product/m². At some sites the product granules disappeared within a week time or less. Despite the advice to re-apply in such situations, no further application was performed in these trials in order to have the same application rate in every trial. Such trials showed less efficacy in the late assessments. Evaluation of effectiveness was based on the assessments of percent damage on leaves or plants in treated plots. In most field trials the percentage of damage on leaves was assessed,

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 8 of 36 but in some cases different types of assessment were performed. In oil seed rape trials the number of plants still living was the parameter assessed. In strawberry trials the number of damaged fruits was evaluated. Additionally the number of dead or alive slugs found in the treatments was assessed. The efficacy was calculated according to Abbott. For statistical evaluation an analysis of variance followed by a mean separation test (Student Newmans Keuls, 95 % significance level) was applied on the raw data without any transforma- tion by the applicant.

Table 6.1-1: Efficacy trials per country, type and year EPPO Sum Sum Sum Country / code 2009 2010 2011 zone Open field Caged plots total Germany / DE maritime 41) 11 (3) 2 3 142) 17 Czech Republic / CZ maritime 1 (1) 1 0 1 United Kingdom / UK maritime 2 (2) 2 0 2 Austria / AT maritime 2 0 2 2 Poland / PL north-east 5 (2) 2 3 5 France (North) / FR maritime 2 0 2 2

Total 8 21 29 1) Preliminary range finding trials with different formulation 2) 2 greenhouse trials with caged plots in DE in 2010, all other caged plot trials in the field () Open Field Trials with natural population

IIIA1 6.1.1 Preliminary range-finding tests Range finding tests were not performed with the finally selected formulation COM 802 09 M RB but with a formulation coded COM 802 05 M RB. This formulation contains 10 g/kg FePO4 (Ferric phosphate) instead of the 12.5 g/kg Ferric phosphate in COM 802 09 M RB. It was tested in field trials with caged plots in Germany in 4 trial sites. Plot size was between 1.3 – 4.6 m². The plots were artificially infested with 13 - 40 slugs (Arion spp.), depending on plot size. In order to justify extrapolation generated from data with the previous formulation coded COM 802 05 M RB, the applicant mentions a further set of 8 trials performed with caged plots in Germany. Data from only 6 caged plot trials are given in text and tables. In these 6 trials this formulation has been compared to the finally selected formulation COM 802 09 M RB containing 12.5 g/kg FePO4 (Ferric phosphate). Therefore these 6 trials can be considered as bridging trials. 5 of these 6 trials were performed with Arion sp. and one of the trials was performed with a Deroceras sp. In the 4 range-finding tests and the 6 bridging trials mentioned under this chapter the crop used was lettuce. All trials were applied once by hand, with the product distributed on the soil between the plants. 5 assessments were conducted during the trials, at 2 days after application (2DAA), 5 DAA, 6-7 DAA, 9-10 DAA and 14 DAA. Some trials were not evaluated at all assessments. Parameters evaluated were the percentage of damage on plants or leaves and the number of live slugs observed in the treatments. All trials were performed in Germany under GEP and following EPPO standard PP 1/95(3). Slug numbers and damages in the trials were highly variable. For example, crop damage in the control treatment ranged from about 10 % to nearly 85 % damage 14 days after the application (14 DAA). The results of the preliminary trials indicate a lower efficacy of the preliminary test

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 9 of 36 product COM 802 05 M RB compared to the reference product Ferramol Schneckenkorn at several dates. The efficiency in the reduction of live slugs increases from 46 % at 2 days after application (2 DAA) continuously to 88 % at 14 DAA in the preliminary test product COM 802 05 M RB. At the same time, for the reference product the efficiency in reduction of slugs increases continuously from about 85 % at 2 days after application (2 DAA) up to 100 % at 14 DAA. The leaf area damaged by slugs in the untreated control increased from about 27 % 2 DAA to about 55 % 6-7 DAA and stayed at that level until the last assessment 14 DAA. Concerning the reduction of slugs, the efficiency decreases slightly from 89 % to about 84 % in the treatment with the preliminary test product COM 802 05 M RB. In the reference product treatment the efficiency is clearly above 95 % at most dates except for the assessment 2 DAA, where the efficiency reaches only about 84 %. In direct comparison (6 bridging trials) of the preliminary test product COM 802 05 M RB to the new formulation COM 802 09 M RB, the latter demonstrated in average a higher efficacy at several dates. For the preliminary test product COM 802 05 M RB the efficacy in slug reduction increases from an efficiency of 35 % at 2 days after application (2 DAA) to about 63 % at 14 DAA. At the same time the efficiency in reduction of leaf area damaged by slugs is highest in the beginning at 2 DAA (about 65 %) and only 35 % at 14 DAA. Similar tendencies are shown by the formulation COM 802 09 M RB. But these results for COM 802 09 M RB indicate a higher efficacy than for the preliminary test product COM 802 05 M RB. COM 802 09 M RB reaches about 40 % efficacy against slugs 2DAA increasing to about 75 % efficacy 14 DAA. Concerning the reduction of leaf damage the efficacy is also highest in the beginning with 93 %, decreasing to 58 % 14 DAA. According to the applicant, due to the better results the formulation COM 802 09 M RB was chosen for further development and testing.

IIIA1 6.1.2 Minimum effective dose tests Intended use: 007517-00/00-001 A total of 14 trials with two reduced dose rates (2.5 g/m² and 3.5 g/m²) of COM 802 09 M RB compared to the target dose rate (5 g/m²) have been performed in the years 2010 and 2011. The trials were conducted in Germany, Austria, Czech Republic, United Kingdom, Northern France and Poland, against Deroceras spp. and Arion spp. populations. All countries mentioned with the exception of Poland belong to the Maritime climatic zone. Poland is part of the North- east climatic zone according to EPPO, but for these studies conditions can be considered comparable to the Maritime climatic zone. The trials were performed on different crops (lettuce -6 trials, French marigolds - 2, strawberries - 2, cabbage - 2, oilseed rape - 1 and spinach - 1) in 2010 and 2011. 3 trials were performed in the open field on Arion spp., 9 with caged plots in the field (2 Deroceras spp., 6 Arion spp., 1 both) and 2 trials with caged plots in the greenhouse (1 Deroceras spp., 1 Arion spp.). 2 different reference products both containing the same active substance Ferric phosphate have been used in these trials. One reference product was “Ferramol Schneckenkorn” (German registration number 024496-00) containing 9.9 g Ferric phosphate/kg. The other reference product was “Bayer Garten Schneckenkorn Biomol” (German registration number 006455-00) containing 16.2 g/kg Ferric phosphate. Both reference products were applied at a rate of 5 g product/m². 5 assessments were conducted during the trials, at 2 days after application (2DAA), 5 DAA, 6-7 DAA, 9-10 DAA and 14 DAA. Parameters evaluated were the percentage of damage on plants or leaves and the number of live slugs observed in the treatments. These results were not sepa- rated after trial type (caged or open field), after slug genus or after time of the year by the applicant. The applicant calculated mean efficiency values based on the displayed treatment means of individual trials for slug numbers and damage. This means the mean efficiency data are biased towards trials in which higher slug numbers are visible. Calculating the mean efficiency from the efficiency given for single trials causes slightly different values, as given below. For the damage produced by the slugs in the 3 COM 802 09 M RB treatments a dose response was visible across the 5 assessment dates between 2 and 14 days after application. The highest percentage of damage was found in the treatment with the lowest application rate of 2.5

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 10 of 36 g/m². The lowest percentage of damage and therefore the highest efficacy was observed in the treatment with the application rate of 5 g/m². For example, 2 DAA the mean efficiency increased from 49 % for the treatment with the lowest application rate of 2.5 g/m² to about 62 % for the treatment with the highest application rate of 5 g/m². The treatment with the application rate of 3.5 g/m² was intermediate with a mean efficiency of 58 %. 14 DAA the efficiency for the treatments was about 45 %, 50 % and 58 % from the treatment with the lowest application rate to the treatment with the highest application rate. The same applies to live slugs observed in the plots. For the number of surviving slugs a dose response was visible after the application of the different rates. Concerning the test product treatments, the highest average number of slugs occurred in the treatment with the lowest application rate of 2.5 g/m². The lowest number average number of slugs occurred in the treatment with an application rate of 5 g/m². 14 days after application the mean efficiency reached 38 % for the treatment with the lowest application rate of 2.5 g/m², and about 51 % for the treatment with the highest application rate of 5 g/m². In both parameters the reference was even slightly more efficient than the recommended rate of COM 802 09 M RB, reaching a mean efficacy of 75 % 2 DAA and 79 % after 14 DAA concerning the plant damage by slugs, and reaching a mean efficacy of 33 % and 66 % at these dates concerning the number of live slugs The variation in results was very high between single trials with some trials showing no effect of different rates of the test product on live slug counts and slug damage, while in other trials high efficacy and a clear dose response was observed for the test product.

Conclusion Slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several different crops. Therefore in this case an overview over a whole series of trials from a range of different crops in different growing conditions is acceptable for evaluation. With 14 minimum effective dose tests a sufficient number of trials were submitted for the countries of the Maritime EPPO Zone and Poland. Throughout the trials, a generally high variability in efficacy occurs. Live animals are difficult to count due to their hidden way of life. Therefore part of the variability can be considered the result of methodical problems with quantifying the efficacy of a product against slugs. Both the lowest damage and the lowest number of live slugs were observed in the treatment with the recommended application rate of 5 g/m². This indicates that the recommended rate is justified.

As slugs are polyphagous pests with very low host plant specificity, they cause similar damage in several very different crops under different growing conditions in field and greenhouse. Therefore the evaluation of minimum effective dose trials is also valid for all following intended uses from intended use 007517-00/00-002 to intended use 007517-00/00-013.

IIIA1 6.1.3 Efficacy tests

Intended use: 007517-00/00-001 17 trials on vegetables were submitted. With 14 trials in lettuce, 2 trials in cabbage and 1 trial in spinach they were focused on one crop. However, slugs are polyphagous pests. Due to their very low host plant specificity, they cause similar damage in several very different crops. This implies that trials on crops other than vegetables could also be considered. Therefore, in the case of this pest, the whole series of efficacy trials conducted on a range of different crops was used for evaluation. Additionally to the vegetable trials mentioned above 3 trials on oilseed rape, 3 trials on French marigolds and 2 trials on strawberries were taken into consideration. With 25 trials a sufficient number of trials was submitted for the countries of the Maritime EPPO Zone and Poland. These trials were conducted in Germany, Austria, Czech Republic, United

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Kingdom, Northern France and Poland against Deroceras spp. and Arion spp. The countries mentioned belong to the Maritime climatic zone, with the exception of Poland. Poland is part of the North-east climatic zone according to EPPO, but for these studies conditions can be considered comparable to the Maritime climatic zone. The trials were performed under different conditions: in the field under open field conditions with natural slug populations (8 trials) as well as with caged plots (15 trials), or in the greenhouse (2 trials). Sizes of caged plots were 4 m² to 4.6 m² in most cases except for 4 trials with lower plot sizes (1 m² to 1.3 m²). The submitted trials were conducted in different countries and regions under different climatic conditions and soil types and they were fairly evenly distributed over a time period ranging from May to November. An application rate of 5 g/m² was used for the test product COM 802 09 M RB containing 12.5 g as/kg. 2 different reference products both containing the same active substance ferric phosphate have been used in these trials. One reference product was “Ferramol Schneckenkorn” (German registration number 024496-00) containing 9.9 g Ferric phosphate/kg. This reference product was used in 14 trials and applied at a rate of 5 g product /m². The other reference product was “Bayer Garten Schneckenkorn Biomol” (German registration number 06455-00) containing 16.2 g/kg Ferric phosphate and applied at a rate of 5 g product/m² as well. This reference product was used in 13 trials. 5 assessments were conducted during the trials, at 2 days after application (2 DAA), 5 DAA, 6-7 DAA, 9-10 DAA and 14 DAA. Parameters evaluated were the percentage of damage on plants or leaves and the number of live slugs observed in the treatments. These results were not sepa- rated after trial type (caged or open field) or after time of the year by the applicant. The efficacy differed markedly between different trials. A generally high variability is considered the result of methodical problems with quantifying the efficacy of a product against slugs. Live slug numbers are difficult to assess due to their hidden mode of life. Therefore also the damages were assessed according to EPPO standards PP 1/95(3) and PP 1/96(3). An acceptable efficacy of the product is therefore sufficiently documented despite sometimes low efficacy and in general variable trial results. The applicant calculated mean efficiency values based on the displayed treatment means of individual trials for slug numbers and damage. This means the mean efficiency data are biased towards trials in which higher slug numbers are visible. Calculating the mean efficiency from the efficiency given for single trials causes slightly different values, as given below. Concerning the percentage of damage produced by slugs on leaves or plants over all trials, the efficiency at 2 DAA reached 60 % in the treatment with COM 802 09 M RB and 69 % in the reference treatment. 14 DAA the efficiency reached approximately 66 % for the test product treatment and 81 % for the reference treatment. Separating between open field trials (7) and trials with caged plots (16) results in a mean efficiency of 55 % for the test product and 63 % for the reference treatment after 2 DAA in the open field trials. 14 DAA in the open field trials a similar efficiency with 83 % for the test product and 85 % for the reference is observed. In the caged plot trials the mean efficacy was lower in the test product treatment with around 60 % both at 2 DAA and 14 DAA, compared to about 71 % and 81 % in the reference treatment. The effects on life slugs were also evaluated. The number of slugs was highly variable between trials ranging from zero in some trials to over 200 in the test product treatment in a single open field trial at 2 DAA. The mean efficiency at 14 DAA reached approximately 56 % in the test product treatment and about 72 % in the reference treatment. The effects on slugs were also evaluated separately for the genera Arion and Deroceras. For the genus Deroceras some open field trials initially had more slugs in the test treatment plots than in the reference plots in the beginning. For both genera the results are variable, but indicate a slightly lower efficacy in the test product treatment compared to the reference product. For the genus Deroceras the efficacy concerning numbers of living slugs 2 days after application (9 trials evaluated) was slightly below 9 % for the test product, whereas for the reference products it was about 10 %. 14 days after application (11 trials evaluated) the respective values were about 71 % for the test product and about 77 % for the reference products. For the genus Arion the efficacy concerning numbers of living slugs 2 days after application (14 trials evaluated) was about 32 % for the test product, whereas for the reference products it was

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 12 of 36 about 31 %. 14 days after application (15 trials evaluated) the respective values were about 60 % for the test product and about 67 % for the reference products. For trials in which the species Arion lusitanicus was explicitly named, the efficacy concerning numbers of living slugs 2 days after application (10 trials evaluated) was about 47 % for the test product, whereas for the reference products it was about 43 %. 14 days after application (10 trials evaluated) the respective values were about 64 % for the test product and about 74 % for the reference products.

Intended use: 007517-00/00-002 Only one greenhouse trial on vegetables (Lettuce, Germany, caged plots) was submitted. Only one further greenhouse trial on ornamentals has been submitted. However, slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops under different growing conditions. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-003 The applicant has specified in his application to the BVL, that the uses on balcony and terrace are meant to be restricted to potted plants and not for the sealed area of balconies and terraces in general. No trials have been submitted on slugs in potted vegetables on balcony and terrace, but slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops in different growing conditions. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-004 No minimum effective dose tests have been submitted on herbs in the field, but slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-005 No minimum effective dose tests have been submitted on herbs in the greenhouse but slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops in field and greenhouse. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-006 The applicant has specified in his application to the BVL, that the uses on balcony and terrace are meant to be restricted to potted plants and not for the sealed area of balconies and terraces in general. No minimum effective dose tests have been submitted on slugs in potted herbs on balcony and terrace, but slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

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Intended use: 007517-00/00-007 One minimum effective dose trial on strawberries in the open field in Czech Republic and one trial on strawberries in caged plots in Poland have been submitted. In both trials the pests were Arion spp. As slugs are polyphagous pests and have very low host plant specificity, they cause similar damage in several very different crops. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-008 No trials on fruit in the greenhouse have been submitted, but slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several cause similar damage in several very different crops under different growing conditions. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-009 The applicant has specified in his application to the BVL, that the uses on balcony and terrace are meant to be restricted to potted plants and not for the sealed area of balconies and terraces in general. No trials on slugs in potted fruit on balcony and terrace have been submitted. But slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-010 One trial with French Marigolds Tagetes patula in caged plots in the field has been performed in Poland and one trial with a Tagetes species in caged plots in the field has been performed in Germany. As slugs are polyphagous pests and have very low host plant specificity, they cause similar damage in several very different crops. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-011 One trial with French Marigolds Tagetes patula in caged plots in the greenhouse has been performed in Germany. As slugs are polyphagous pests and have very low host plant specificity, they cause similar damage in several very different crops in under different growing conditions. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

Intended use: 007517-00/00-012 The applicant has specified in his application to the BVL, that the uses on balcony and terrace are meant to be restricted to potted plants and not for the sealed area of balconies and terraces in general. No tests on slugs in potted ornamental plants on balcony and terrace have been submitted. But slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops and growing conditions. Therefore the submitted trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

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Intended use: 007517-00/00-013 No trials on the efficacy of COM 802 09 M RB on potato are available, but slugs are polyphagous pests and due to their very low host plant specificity, they cause similar damage in several very different crops under different growing conditions. Therefore trials from other crops can also be used for evaluation in this case. For evaluation see intended use 007517-00/00-001.

The described acceptable efficacy is restricted to slug damage on aerial plant parts. An acceptable protection of subterranean plant parts like roots, bulbs, rhizomes or tubers was not evaluated in any of the submitted trials and cannot be extrapolated from the submitted data. Protec- tion of subterranean plant parts from damage cannot be achieved by application of this product.

Conclusion A total of 25 trial results from countries in the “central EU registration zone” were submitted for the registration of COM 802 09 M RB for control of slug damage in vegetables, potatoes, orchards and ornamentals (non–professional use). The application of COM 802 09 M RB at a rate of 5 g/m² provided reductions of crop damage by slugs similar or slightly lower than the results achieved with the reference products registered in Germany.

As the product is a bait distributed on the soil surface, the effect is restricted to slugs feeding above soil surface and to damage on aerial plant parts. An adequate protection of subterranean plant parts like roots, bulbs, rhizomes or tubers was not evaluated in any of the submitted trials and cannot be extrapolated from the submitted data. An acceptable protection of subterranean plant parts from slug damage is unlikely. Therefore in the intended uses on vegetables, potatoes and ornamentals for Germany the information is given that the product is only for protection of emergence and protection against leaf consumption by slugs.

Concerning applications in the greenhouse, which are generally not restricted to one registration zone, the evaluation is considered valid concerning only the zRMS Germany and the cMS of the central registration zone, where the registration was also submitted: United Kingdom, Belgium, the Netherlands, Luxembourg, Czech Republic, Poland and Austria. If further countries, especially in the southern registration zone are involved, slug species and slug problems in greenhouse might be different. Concerning field applications the evaluation is considered valid for the whole of the central registration zone.

The applicant has specified in his application to BVL, that the uses on balcony and terrace are meant to be restricted to potted plants and not for the sealed area of balconies and terraces in general. In the intended uses for terrace and terrace as given by BVL it is not mentioned that the use applies to the plant containers of potted plants only.

The applicant has provided a provisional label with use instructions. The application rate is 5 g product/m². A dosing spoon for 5 g product will be added to the package according to the applicant. Concerning potted plants on balcony and terraces (Intended uses 007517-00/00-003, 007517-00/00-006, 007517-00/00-009 and 007517-00/00-012), the following dosing information is given by the applicant:

Diameter of the pot/number of pellets: Up to 13 cm: 2-3* pellets Up to 17 cm: 4-5* pellets Up to 20 cm: 6-7* pellets Up to 23 cm: 7-9* pellets Up to 26 cm: 9-12* pellets

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 15 of 36

Up to 29 cm: 12-15* pellets Up to 32 cm: 14-18* pellets *The higher amount of pellets is for angled pots

Plants on balconies in flower boxes: 4-8 pellets per plant or per 13-15 cm box lengths.

This dosing information for potted plants is acceptable and has to be added to the use instructions on the label.

IIIA1 6.1.4 Effects on yield and quality

IIIA1 6.1.4.1 Impact on the quality of plants and plant products No results were submitted. The formulated product is a bait that is not taken up by plants. The active substance Ferric phosphate is practically insoluble in water, but solubility increases with decreasing ph. There might be an uptake of breakdown products by the plants, but this would not differ from the way these substances are taken up from natural sources. Based on several years of practical use of Ferric phosphate it is not expected to have any impact on the quality of plants and plant products in general. One exception might occur that could potentially affect the quality of certain plants or plant products. If the product is deposited directly on plant surfaces like leaves or flowers during application, it might cause coloured spots which would be an undesirable effect in ornamental plants and vegetables. This problem is not addressed in the submitted data, but could be avoided by distributing the granules on the soil between the plants.

IIIA1 6.1.4.2 Effects on the processing procedure No results were submitted. The formulated product is a bait that is not taken up by the plants. The active substance Ferric phosphate is practically insoluble in water, but solubility increases with decreasing ph. An uptake of its ionic breakdown products would occur, but this does not differ from the way these substances are taken up from natural sources by the plants. Based on several years of practical use of Ferric phosphate it is not expected to have any impact on the processing procedure.

IIIA1 6.1.4.3 Effects on the yield of treated plants and plant products No results were submitted. No specific yield trials have been conducted or were available for this dossier. No other trials where yield was recorded were available for this dossier. According to EPPO standards 1/95 (3) and 1/96 (3) yield data are not necessarily requested in slug trials. However, based on several years of practical use of Ferric phosphate it is not expected to have any negative impact on the yield of treated plants and plant products.

IIIA1 6.2 Adverse effects

IIIA1 6.2.1 Phytotoxicity to host crop No specific phytotoxicity trials have been submitted. The observations on phytotoxicity made in the 25 efficacy trials do not demonstrate any negative impacts on the treated host crops. In all efficacy trials at each assessment time evaluations for potential phytotoxic effects were performed. No phytotoxic effects were observed at any time in any of these trials. Additionally no phytotoxic effects have been observed in several years of practical use of Ferric phosphate as

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 16 of 36 active substance in other products. The product can therefore be regarded as having no phytotoxic effects if used in the submitted application rate of 5 g/m².

IIIA1 6.2.2 Adverse effects on health of host animals According to the applicant no negative effects on animals were observed in the efficacy trials.

IIIA1 6.2.3 Adverse effects on site of application According to the applicant no adverse effects on the site of application were observed and reported in any efficacy trial.

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

Effects on relevant beneficial organisms

Results from laboratory tests (test medium: quartz sand) with the rove beetle Aleochara bilineata and the carabid beetle Poecilus cupreus were submitted. COM 802 09 M RB was applied as granule onto the soil surface with 100 kg/ha (corresponding to double application rate of COM 802 09 M RB/ha and treatment). At this application rate, no impact of COM 802 09 M RB on the reproduction of the soil-dwelling arthropod Aleochara bilineata as well as on the mortality, food uptake and behaviour of the carabid beetle Poecilus cupreus were observed (References: Bruhnke, C., 2011 = Study-No. IKR14144 + Bruhnke, C., 2011 = Study-No. ILA14144). Therefore, no effects ≥ 25% are expected for populations of Aleochara bilineata and Poecilus cupreus, if COM 802 09 M RB is applied according to the recommended use pattern as bait treatment maximally four times with 5 g/m2.

Conclusion COM 802 09 M RB is classified as not harmful for populations of Aleochara bilineata and Poecilus cupreus.

Effects on soil quality Effects on soil macro-organisms being used as indicators of soil quality Effects on earthworms

Products

Duration, Test product Endpoint Value Dimension Reference organism Acute, 14 d Mortality, Krome, > 1000 [mg/kg] COM 802 09 M Eisenia fetida LD50 2011a RB sublethal, 56 d Reproduction Krome, 500 [kg/ha] Eisenia fetida NOEC 2011b

Exposure

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The PEC for the acute risk assessment was based on a single application of 50 kg prod./ha, converted to 66.64 mg prod./kg soil dw assuming a soil depth of 5 cm and a bulk density of soil 3 of 1.5 g/cm , which is equivalent to 0.833 mg a.s./kg d.s. The cumulative application rate of 200 kg prod./ha was not used, since accumulation of applications is not relevant under field conditions. Additional applications are only sensible, when the product has been eaten up by the slugs and if there is still infestation. Furthermore iron is present in all soils, being a constituent of several minerals. Thus the amount of iron added to the soil after application of the product is negligible in comparison to the quantities which naturally exist in soils. Additionally, iron and in particular, phosphates are applied in considerable amounts to agricultural soils in fertilisers.

Risk assessment (Toxicity exposure ratios, TERA and TERLT)

The potential acute/long-term risk of the parent compound to earthworms was assessed by comparing the maximum instantaneous PECS with the 14-day LC50 / NOEC value to generate the respective TER values:

LC (mg/kg) TER = 50 A PEC (mg/kg) S

NOEC (mg/kg) TER = lt PEC (mg/kg) S

Toxicity/exposure ratios for earthworms arising from the use of COM 802 09 M RB TER Test risk as- Test item Species Endpoint PEC TER type sessment trigger 66.64 mg COM 802 Eisenia fet- LC > 1000 mg Acute 50 prod./kg > 15 10 09 M RB ida prod./kg soil dw soil dw COM 802 Eisenia fet- NOER = 500 kg 50 kg Chronic 10 5 09 M RB ida prod./ha prod./ha

Conclusion The acute TER value is above the Annex VI acute trigger value of 10, indicating that COM 802 09 M RB poses no acute risk to earthworms when applied according to the proposed use rates. The long-term TER value is above the Annex VI acute trigger value of 5, indicating that COM 802 09 M RB poses no long-term risk to earthworms when applied according to the proposed use rates. Field tests Based on the considerations presented above, no field testing with earthworms is regarded necessary. Residue content of earthworms According to EFSA 2009, substances with a log POW greater than 3 have potential for bioaccumulation and should be assessed for the risk of accumulation in aquatic non-target organisms. The log POW of Ferric phosphate cannot be estimated since Ferric phosphate is practically insoluble in water. However a risk of bioaccumulation is not expected based on the natural occurrence of Ferric phosphate in the environment and the function as dietary supplement in food sources.

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Furthermore accumulation of the applied amounts is unlikely since earthworms are only exposed to one application rate and multiple applications are only planned, when the bait has been eaten up by the slugs and there is still slug infestation. Considering the above mentioned arguments accumulation in earthworms can be excluded and is not further assessed.

Effects on other non-target macro-organisms

In this special case of exposure where surface active species might be endangered a study on the effects on other non-target macro-organisms is required. Thus a study on the non-target macro-organism Hypoaspis aculeifer was conducted and the summary and a risk assessment are presented below. A study on Folsomia-species was not performed, since no risk was detected for Hypoaspis aculeifer. Furthermore accumulation of applications is not relevant under field conditions, since additional applications are only sensible, when the product has been eaten up by the slugs and if there is still infestation. Furthermore iron is present in all soils, being a constituent of several minerals. For a range of different soil types, median levels of iron range from 2400-27000 mg/kg in top soils and 1600-33900 mg/kg in sub soils. Thus the amount of iron added to the soil after application of the product is negligible in comparison to the quantities which naturally exist in soils. Additionally, iron and in particular, phosphate is applied in considerable amounts to agricultural soils in fertilisers.

Ecotoxicological endpoints for applied test systems exposed to Products Duration, or- Test item Endpoint Value Dimension Reference ganism sublethal, 14 d Bruhnke, C., COM 802 09 M Reproduction, Hypoaspis > 100 [kg/ha] 2011d RB NOEC aculeifer IHL14144

Under laboratory test conditions COM 802 09 M RB had no significant effects on the survival and on the reproduction rate of the adult predatory mite Hypoaspis aculeifer at an application rate of 100 kg/ha. As the test was designed as a limit test, the LD50 and NOEC are undeter- mined.

Risk assessment (Toxicity exposure ratios, TERA and TERLT)

LC (mg/kg) TER = 50 A PEC (mg/kg) S

NOEC (mg/kg) TER = lt PEC (mg/kg) S

Toxicity/exposure ratios for non-target macro-organisms arising from the use of COM 802 09 M RB TER risk as- Test item Species Test type Endpoint PEC TER sessment trigger

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COM 802 Hypoaspis NOEC > 100 kg 50 kg Laboratory >2 5 09 M RB aculeifer prod./ha prod./ha

Conclusion based on long term effects on other non-target macro-organisms The TER value is below the Annex VI trigger value of 5, indicating that COM 802 09 M RB may pose a risk to Hypoaspis aculeifer when applied according to the proposed use rate. An acute LD50 value could not be determined due to the low mortality. The detected value is actually a No Observed Effect Rate (NOER). Thus the calculated TER value overestimates the effect of COM 802 09 M RB on Hypoaspis aculeifer. The realistic TER value would be considerably higher if an LD50 or NOEC would have been determined.

Effects on organic matter breakdown

Iron is an element occurring in soil. Ferric phosphate is hardly soluble in water. Therefore, no studies on effects of Ferric phosphate on organic matter breakdown are required.

Evaluation

It is concluded that the proposed use of COM 802 09 M RB will not pose an unacceptable risk to populations of earthworms or other soil macro-organisms, when applied according to the recommended use pattern.

Instructions and information: None

Effects on soil quality Effects on soil micro-organisms being used as indicators of soil quality

Effects on soil non-target micro-organisms exposed to COM 802 09 M RB

Risk assessment for soil microflora functions

COM 802 09 M RB contains Fe-III-phosphate (12.5 g/kg). Iron is an element occurring in soil. Ferric phosphate is hardly soluble in water. Therefore, no studies on effects of Ferric phosphate on soil microbial activity are required.

Overall conclusion with respect to effects on soil quality There is no indication of any unacceptable adverse effects on soil macro- or soil micro- organisms relevant for the maintenance of soil quality.

IIIA1 6.2.5 Adverse effects on parts of plant used for propagating purposes No results were submitted. However, based on several years of experience with practical use of Ferric phosphate it is not expected to have any adverse effects on plant parts used for propagating purposes.

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IIIA1 6.2.6 Impact on succeeding crops No results were submitted. No impact on succeeding crops needs to be considered in the evaluation. Already in the efficacy trials, which were conducted with plants from several different families, no phytotoxic effects were observed.

IIIA1 6.2.7 Impact on other plants including adjacent crops No results were submitted. No impact on other plants including adjacent crops needs to be considered in the evaluation. Already in the efficacy trials, which were conducted with plants from several different families, no phytotoxic effects were observed.

IIIA1 6.2.8 Possible development of resistance or cross-resistance Until now no case of resistance development of terrestrial slugs to any molluscicide is known worldwide. Even cases of resistance to molluscicides other than Ferric phosphate seem to be restricted to a few subtropical or tropical species of aquatic and terrestrial snails so far (e.g. Biomphalaria glabrata, Bradybaena similaris). Furthermore the slug species mentioned have in general only 1 generation per year, rarely two generations in a few cases. Therefore terrestrial slugs are not considered to bear an inherent risk for resistance build up against Ferric phosphate.

IIIA1 6.3 Economics This is not an EC data requirement/ not required by Directive 91/414/EEC.

IIIA1 6.4 Benefits This is not an EC data requirement/ not required by Directive 91/414/EEC.

IIIA1 6.4.1 Survey of alternative pest control measures This is not an EC data requirement/ not required by Directive 91/414/EEC.

IIIA1 6.4.2 Compatibility with current management practices including IPM This is not an EC data requirement/ not required by Directive 91/414/EEC.

IIIA1 6.4.3 Contribution to risk reduction This is not an EC data requirement/ not required by Directive 91/414/EEC.

IIIA1 6.5 Other/special studies According to the applicant, a specific rain stability study has been conducted by a GEP contrac- tor to check the stability of the bait granules under heavy rain or wet soil conditions. Under the test conditions in this study COM 802 09 M RB granules were at least as stable or more stable as the registered reference product Ferramol Schneckenkorn used in this test.

IIIA1 6.6 Summary and assessment of data according to points 6.1 to 6.5 A total of 25 trial results from countries in the “central EU registration zone” were submitted for the registration of COM 802 09 M RB for control of slug damage in vegetables, potatoes, orchards and ornamentals (non–professional use). The evaluation of the test product is based on

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 21 of 36 results of trials which were conducted in the years 2010 and 2011 in Germany, the United King- dom, Austria, the Czech Republic, Northern France (maritime climatic zone) and in Poland. Slug occurrence and cropping systems are comparable between Germany and Poland. Therefore the results from Poland can be considered for the assessment. Greenhouse trials are generally not restricted to one registration zone, but only 2 trials from Germany were carried out in the greenhouse. Therefore concerning applications in the greenhouse, the evaluation is considered valid concerning only the zRMS Germany and the cMS of the central registration zone, where the registration was also submitted: United Kingdom, Belgium, the Netherlands, Luxembourg, Czech Republic, Poland and Austria. If further countries, especially in the southern registration zone are involved, slug species and slug problems in greenhouses might be different. The application of COM 802 09 M RB at a rate of 5 g/m² provided reductions of crop damage by slugs similar or slightly lower than the results achieved with the reference products registered in Germany. The application of COM 802 09 M RB at a rate of 5 g/m² provided reductions of slug numbers similar or slightly lower than the results achieved with the reference products registered in Ger- many. This applied to both genera Arion and Deroceras. Ferric phosphate is not considered to cause any phytotoxic effects. No pytotoxicity trials were conducted, but in the efficacy trials conducted with plants from several different families, no phytotoxic effects were observed. Terrestrial slugs are not considered to bear an inherent risk for resistance build up against the active substanceFerric phosphate. COM 802 09 M RB is classified as not harmful for populations of relevant beneficial organisms (Aleochara bilineata and Poecilus cupreus). There is no indication of any unacceptable adverse effects on soil macro- or soil micro-organisms relevant for the maintenance of soil quality.

IIIA1 6.7 List of test facilities including the corresponding certificates

Agrartest Agrartest GmbH Palmbachstraße 37 D 65326 Aarbergen-Panrod, Deutschland Agrostat Sp.z.o.o. Agrostat Sp.z.o.o (Staphyt PL) Ul. Brzozowa 12 61-429 Poznan POLAND Agrostat AGROSTAT GmbH In den Gruben 6 (New: Langenburgerstr. 35) 74572 Blaufelden-Herrentierbach (New: 74572 Blaufelden) Germany ATC ATC - Agro Trial Center GmbH Versuchsstation Gerhaus A-2471 Rohrau Österreich PSA Freising Bayrische Landesanstalt für Bodenkulturen und Pflanzenbau Vöttinger Str. 38 85354 Freising Deutschland I2L Newcastle University Biology Field Station, Close House, Heddon-on-the-Wall, NE15 0HT Newcastle upon Tyne UK

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PSA Berlin Pflanzenschutzamt Berlin Mohriner Allee 137 12347 Berlin Deutschland PSA Bonn Landwirtschaftskammer Rheinland -Pflanzenschutzamt- Siebengebirgsstr. 200 53229 Bonn Deutschland PSA Hannover Landwirtschaftskammer Niedersachsen Pflanzenschutzamt, Sachgebiet 3.7.7 Wunstorfer Str. 9 30453 Hannover PSA Oldenburg Landwirtschaftskammer Weser-Ems IPP-Institut für Pflanzenbau und Pflanzenschutz Sedanstr. 4 26121 Oldenburg Solevi SOLEVI 11 Impasse Gaz des Mulets 38300 RUY France

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

Annex Author Title Year Ref. App.

Point Ref. JKI

MIIIA1 Compo Draft Registration Report - Part B - COM 802 09 2011 Sec 6 M RB - DE -Section 6 - Ecotoxicology -- Core assessment 230093

MIIIA1 Compo Draft Registration Report - Part B - COM 802 09 2011 Sec 7 M RB - DE - Section 7 - Efficacy Data and In- formation - Core assessment 230095

MIIIA1 Compo Draft Registration Report - Part B - COM 802 09 2011 Sec 7 M RB - DE - Section 7 - Efficacy Data and In- formation - National addendum 230096

MIIA Sec Barletta- Document MIIA Sec 6, point 8 2011 - 6 Bergan, A. 230099

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Annex Author Title Year Ref. App.

Point Ref. JKI

MIIA Sec Anony- Document O Part 3 2011 6 mous 230100

MIIIA1 Compo Draft Registration Report - Part B - COM 802 09 2011 Sec 6 M RB - DE -Section 6 - Ecotoxicology -- Core assessment 230103

MIIIA1 Compo Draft Registration Report - Part B - COM 802 09 2011 Sec 6 M RB - DE - Section 6 - Ecotoxicology - National addendum 230105

MIIIA1 Compo Draft Registration Report - Part B - COM 802 09 2011 Sec 7 M RB - DE - Section 7 - Efficacy Data and In- formation - National addendum 230106

MIIIA1 Compo Draft Registration Report - Part B - COM 802 09 2011 Sec 7 M RB - DE - Section 7 - Efficacy Data and In- formation - Core assessment 230107

KIIIA1 Bruhnke, Effects of plant protection products on the rove 2011 IKR14144 10.5.2 Ch. beetle Aleochara bilineata, laboratory test 230110

KIIIA1 Bruhnke, Assessment of side effects on the ground bee- 2011 ILA14144 10.5.2 Ch. tle, Poecilus cupreus L. (Coleoptera, Carabidae), laboratory test 230111

KIIIA1 Krome, K. Earthworm (Eisenia fetida), Acute toxicity test in 2011 RRA1414 10.6.2 artificial soil 4

230112

KIIIA1 Krome, K. Earthworm (Eisenia fetida), Effects on reproduc- 2011 RBN1414 10.6.3 tion 4

230113

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Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Bruhnke, Predatory mite reproduction test in soil 2011 IHL14144 10.6.6 Ch. 230114

KIIIA1 Specta, N. The new COOMPO slug baits against slugs in 2011 6.1.3 ornamentals or vegetables 230121

KIIIA1 Specta, N. Test new COMPO slug baits against slugs in 2011 I-11-S- 6.1.3 ornamental or vegetables 52.-03

230122

KIIIA1 Whaley, Evaluation of new COMPO slug baits against 2011 10/82 6.1.3 C. ; slugs in ornamentals ( Trial two: Winter oil Scriven L. seed rape ) 230123

KIIIA1 Whaley, Evaluation of new COMPO slug baits against 2011 10/ 81 6.1.3 C. ; slugs in ornamentals (Trial one : Lacuta sativa Scriven, L. ) 230124

KIIIA1 Förster , PP1/95 (3) Schnecken in Gemüse , Erdbeeren 2010 S10 COM 6.1.3 K. und Zierpflanzen (künst A.) 01 09

230125

KIIIA1 Ciesla, M. Determination of efficacy and selectivity of COM 2011 S11COM 6.1.3 802 09 M RB against ARIOSP ( Arion sp / Arion _03 ! sp. ) on LACSA ( Lactca sativa ) / Lettuce). Reg- 10024_03 istration purpose. Poland 2011 _2011

230126

KIIIA1 Ciesla, M. Determination of efficacy and selectivity of COM 2011 S11COM 6.1.3 802 09 M RB against ARIOSP (Arion sp. / Arion _03 ! sp. ) on FRAAN ( Fragaria x ananassa ) / Gar- 10024_01 den strawberry ). Registration purpose. Poland _2011 2011 230127

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Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Ciesla, M. Determination of efficacy and selectivity of COM 2011 S11Com_ 6.1.3 802 09 M RB against ARIOSP ( Arion sp. / Arion 03 ! sp. ) on TGPA Tagetes patula ( French marigold 10024_02 ). Registration purpose. Poland 2011. _2011

230128

KIIIA1 Allemoz, Declaration de confirmite aux BPE pour les 2011 S11BSI06 6.1.3 P. etudes de plein champInsecticide trial in cage 3JDA13!F slug COA1169 35

230129

KIIIA1 Allemoz, Declaration de conformite aux BPE pour les 2011 S11BSI06 6.1.3 P. etudes de plein champInsecticide trial in cages 3JDA07! slug FCOA112 335

230130

KIIIA1 Speta, N. Trial report - The new COMPO slug baits 2011 I-11-S- 6.1.3 against slugs 052-02

230131

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S10COM 6.1.3 ornamentals or vegetables Final report _01_07

230132

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S10COM 6.1.3 ornamentals or vegetables Final report _02_10

230133

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S10COM 6.1.3 ornamentals or vegetables Final report _01_06

230134

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Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S11COM 6.1.3 ornamentals or vegetables Final report _01_RR_ 03 (POL)

230135

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S11COM 6.1.3 ornamentals or vegetables Final report _01_RR_ 04 (POL)

230136

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S11COM 6.1.3 ornamentals or vegetables Final report _01_RR_ 01

230137

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S11COM 6.1.3 ornamentals or vegetables Final report _01_RR_ 02

230138

KIIIA1 Wilke, R. Scnecken an Tagetes, FR 2011 S10COM 6.1.3 _01_3

230139

KIIIA1 Wichura, Bekämpfung von Nacktschnecken in Kopfsalat 2010 S10COM 6.1.3 A. _01_01

230140

KIIIA1 Rohr, J. Test new COMPO slug baits against slugs in 2010 S10COM 6.1.3 ornamentals or vegetablesFinal report _03a_16

230141

Julius Kühn-Institut 2012-10-17 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 27 of 36

Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Schneider, Bekämpfung von Schnecken in Gemüse 2010 S10COM 6.1.3 H. _01_05

230142

KIIIA1 Schmidt, I. Determination of efficacy and selectivity of new 2010 S10COM 6.1.3 Compo slug baits against slugs in ornamentals _03a_14 or vegetables. Germany 2010 230143

KIIIA1 Schmidt, I. Determination of efficacy and selectivity of new 2010 S10COM 6.1.3 COMPO slug baits against slugs in ornamentals _03a_13 or vegetables. Germany 2010 230144

KIIIA1 Förster, K. PP 1/95 (3) Schnecken in Gemüse, Erdbeeren 2010 S10COM 6.1.3 und Zierpflanzen (künst. A) _01_04

230145

KIIIA1 März, C. Bekämpfung von Schnecken an Salat 2009 S09COM 6.1.1 _02_05

230146

KIIIA1 Rohr, J. Test new COMPO slug baits against slugs in 2009 S09COM 6.1.1 ornamnets or vegetablesFinal report _02_03

230147

KIIIA1 Schneider, Bekämpfung von Schnecken in Gemüse 2009 S09COM 6.1.3 H. _02_01

230148

KIIIA1 Förster , PP 1/95 (3) Schnecken in Gemüse , Erdbeeren 2009 S09COM 6.1.1 K. und Zierpflanzen (künst. A) _02_02

230149

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Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Specta, N. The new COOMPO slug baits against slugs in 2011 I-11-S- 6.1.2 ornamentals or vegetables 052-01

230150

KIIIA1 Specta, N. Test new COMPO slug baits against slugs in 2011 I-11-S- 6.1.2 ornamental or vegetables 52.-03

230151

KIIIA1 Whaley, Evaluation of new COMPO slug baits against 2011 10/82 6.1.2 C. ; slugs in ornamentals ( Trial two: Winter oil Scriven L. seed rape ) 230152

KIIIA1 Whaley, Evaluation of new COMPO slug baits against 2011 10/ 81 6.1.2 C. ; slugs in ornamentals (Trial one : Lacuta sativa Scriven, L. ) 230153

KIIIA1 Förster , PP1/95 (3) Schnecken in Gemüse , Erdbeeren 2010 S10 COM 6.1.2 K. und Zierpflanzen (künst A.) 01 09

230154

KIIIA1 Ciesla, M. Determination of efficacy and selectivity of COM 2011 S11COM 6.1.2 802 09 M RB against ARIOSP ( Arion sp / Arion _03 ! sp. ) on LACSA ( Lactca sativa ) / Lettuce). Reg- 10024_03 istration purpose. Poland 2011 _2011

230155

KIIIA1 Ciesla, M. Determination of efficacy and selectivity of COM 2011 S11COM 6.1.2 802 09 M RB against ARIOSP (Arion sp. / Arion _03 ! sp. ) on FRAAN ( Fragaria x ananassa ) / Gar- 10024_01 den strawberry ). Registration purpose. Poland _2011 2011 230156

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Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Ciesla, M. Determination of efficacy and selectivity of COM 2011 S11Com_ 6.1.2 802 09 M RB against ARIOSP ( Arion sp. / Arion 03 ! sp. ) on TGPA Tagetes patula ( French marigold 10024_02 ). Registration purpose. Poland 2011. _2011

230157

KIIIA1 Allemoz, Declaration de confirmite aux BPE pour les 2011 S11BSI06 6.1.2 P. etudes de plein champInsecticide trial in cage 3JDA13!F slug COA1169 35

230158

KIIIA1 Allemoz, Declaration de conformite aux BPE pour les 2011 S11BSI06 6.1.2 P. etudes de plein champInsecticide trial in cages 3JDA07! slug FCOA112 335

230159

KIIIA1 Speta, N. Trial report - The new COMPO slug baits 2011 I-11-S- 6.1.2 against slugs 052-02

230160

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S10COM 6.1.2 ornamentals or vegetables Final report _01_07

230161

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S10COM 6.1.3 ornamentals or vegetables Final report _02_10

230162

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S10COM 6.1.1 ornamentals or vegetables Final report _01_06

230163

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Annex Author Title Year Ref. App.

Point Ref. JKI

KIIIA1 Rohr, S. Test the new COMPO slug baits against slugs in 2010 S10COM 6.1.2 ornamentals or vegetables Final report _01_06

230164

KIIIA1 Wichura, Bekämpfung von Nacktschnecken in Kopfsalat 2010 S10COM 6.1.1 A. _01_01

230165

KIIIA1 Schneider, Bekämpfung von Schnecken in Gemüse 2010 S10COM 6.1.1 H. _01_05

230166

KIIIA1 Förster, K. PP 1/95 (3) Schnecken in Gemüse, Erdbeeren 2010 S10COM 6.1.1 und Zierpflanzen (künst. A) _01_04

230167

KIIIA1 Wilke, R. Scnecken an Tagetes, FR 2011 S10COM 6.1.1 _01_3

230168

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Appendix 2: GAP tables

GAP rev. 1, date: 2012-01-17

PPP (product name/code) COM 802 09 M RB Formulation: Type: RB active substance 1 Ferric phosphate Conc. of as 1: 12.5 g/kg

Applicant: Compo GmbH & Co KG professional use non professional use

Zone(s): central

Verified by MS: yes

31 / 36 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 32 of 36

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

Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation G controlled (days) or e.g. safener/synergist per ha (crop destination / I (additionally: develop- Method / Timing / Growth Max. number kg, L product / g, kg as/ha Water purpose of crop) mental stages of the Kind stage of crop & (min. interval ha L/ha e.g. recommended or mandatory pest or pest group) season between a) max. rate a) max. rate tank mixtures applications) per appl. per appl. min / max a) per use b) max. total b) max. total rate per rate per b) per crop/ crop/season crop/season season

1 DE, AT, Vegetables (NNNW) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

2 DE, AT, Vegetables (NNNW) G Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

3 DE, AT, Vegetables (NNNW) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ On terrace and balcony treatment casted pests organisms only in plant container. across

32 / 36 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 33 of 36

cultivated occur area, only between plants, bait treatment

4 DE, AT, Fresh herbs (NNNKF) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

5 DE, AT, Fresh herbs (NNNKF) G Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

6 DE, AT, Fresh herbs (NNNKF) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ On terrace and balcony treatment casted pests organisms only in plant container. across occur cultivated area, only between plants, bait treatment

33 / 36 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 34 of 36

7 DE, AT, Fruit crops (NNNOO) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

8 DE, AT, Fruit crops (NNNOO) G Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

9 DE, AT, Fruit crops (NNNOO) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ On terrace and balcony treatment casted pests organisms only in plant container. across occur cultivated area, only between plants, bait treatment

10 DE, AT, Ornamentals (NNNZZ) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between

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plants, bait treatment

11 DE, AT, Ornamentals (NNNZZ) G Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

12 DE, AT, Ornamentals (NNNZZ) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ On terrace and balcony treatment casted pests organisms only in plant container. across occur cultivated area, only between plants, bait treatment

13 DE, AT, Potatoes (SOLTU) F Slugs (MOLLNS) Spreading, At beginning of a) 4 (1 day) a) 50 kg/ha a) 625 g/ha n.a. Protection of emerging plants and BE, uniformly infestation/ when b) 4 b) 200 kg/ha b) 2,5 kg/ha reduction of leaf consumption. LU,NL; PL broad- first symptoms/ casted pests organisms across occur cultivated area, only between plants, bait treatment

35 / 36 Part B – Section 7 COM 802 09 M RB Registration Report Core Assessment ZV1 007517-00/00 Central Zone Page 36 of 36

General remarks/explanations:

Remarks: (a) In case of group of crops the Codex classification should be used (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (b) Outdoor or field use (F), glasshouse application (G) or (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the indoor application (I) plants (c) e.g. biting and sucking insects, soil born insects, foliar fungi (i) g/kg or g/l (d) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (j) Growth stage at last treatment (e) Use CIPAC/FAO Codes where appropriate (k) PHI = Pre-harvest interval (f) All abbreviations used must be explained (l) Remarks may include: Extent of use/economic importance/restrictions (e.g. feeding, grazing)/minimal intervals between applications

Julius Kühn-Institut 2011-10-25 Reporting table

Active substance: Ferric phosphate Trade name/Formulation type: COM 802 09 M RB (12.5 g/kg ferric phosphate) Rapporteur: Germany Applicant: COMPO GmbH & Co. KG

Annex III Member Comment Reply ZRMS point State/ Applicant dRR - overall GENERAL COMMENTS dRR – Part A Part A, 2.3 Applicant Please correct formulations type. The formulation is a RB and corrected Product uses not a GB formulation. Part A, 2.3 Applicant Typo in column 7 of the GAP table: please correct “bail corrected Product uses treatment” to “bait treatment”. Part A, 3.1.3.1. Applicant Please correct “g/L” to “g/kg” corrected Acute toxicity Part A, 3.1.3.4 Applicant Page 13: Table Classification and labelling according to modified to 97 %, see comment under Part B IIIA 7.5 Worker exposure Regulation (EC) No 1272/2008: Labelling texts and restrictions Please delete the phrase “> 99 percent of the mixture consist of ingredients of unknown inhalation toxicity.“ The product has been experimentally shown to exert no adverse effects upon oral or dermal application at a limit dose of 5000 mg/kg bw. The product consists >90% of (non toxic) food grade components. The products contains no components >1% that are classified as hazardous. Based on these data a lack of toxicity by the inhalation route is extrapolated for COM 802 09 M RB.

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Annex III Member Comment Reply ZRMS point State/ Applicant Furthermore the low level of dustiness was demonstrated, thus inhalation is not a relevant route of exposure. According to Reg (EU) 1272/2008 the proposed phrase is applicable In the event that an ingredient without any useable information at all is used in a mixture at a concentration of 1 % or greater This is not the case for COM 802 09 M RB. Part A, 3.1.3.4. Applicant Safety phrases for instructions for use, Please delete the phrase see comment under Part B IIIA 7.5 ´VH297 Packaging/containers for use in amateur gardening must be provided with a childproof seal´ The safety phrase VH297 is already covered by the phrase SB010 “Keep out of the reach of children”. Furthermore, the product is non-hazardous and does not contain hazardous components at levels >1%. – Similar products are marketed for amateur home garden use in containers without child-proof seal. Moreover this is at present not a packaging requirement for home and garden products in most Member States incl. Germany. Part A, III 3.1.6.1 Applicant Please correct point numbers and section number (section 6 amended. -3.1.6.7 instead of 7) in various parts of the headers and sentences which refer to details of risk assessment Part A Applicant Conclusion is missing from the Table of Contents corrected 3.2 Conclusion Part A Applicant Typo: Please delete double negation in No adverse health corrected 3.2 Conclusions effects for operators and bystanders will not be expected, worker re-entry exposure is considered to be negligible. Part A Applicant Two year shelf life: noted 3.3 Conclusions Results for the 12 month storage period are now available for the two final packaging materials (with and without PE-bag). The final study (after 24 months of storgae) will be finalised in March 2013 and the final report will be submitted directly after finalisation.

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Annex III Member Comment Reply ZRMS point State/ Applicant dRR – Part B Section 1 - Identity, physical and chemical properties, other information IIIA 1.4.1 Applicant Please delete marks ´1´and `2´in Table “Pure active substance”, Marks are kept as additional information. Content if they are not needed. active substance Please correct the molecular formula for Ferric orthophosphate Formula was corrected. and formulants tetrahydrate to FePO4 * 4H2O. IIIA 1.4.1 FR FAO Tolerance should be reported. Tolerances according to FAO/WHO manual are added. IIIA 1.4.3 Applicant Please insert structural formula for FePO4 and Structural formulas for FePO4 and FePO4 · 2H2O FePO4 · 2H2O are identical to FePO4 · 4H2O except for Please replace `222.9 (150.82 g/mol, anhydrous / 186,86 the content of water. Therefore no need is seen to insert g/mol, dihydrate)´ by `150.82 g/mol, anhydrous / 186.86 the other structural formulas. g/mol, dehydrate / 222.9 g/mol, tetrahydrate´ The molecular mass has been amended accordingly. IIIA 2.7.5 Applicant Results for the 12 month storage period are now available for The results of the interim report after 12 month are the two final packaging materials (with and without PE-bag). unknown to BVL. The final study (after 24 months of storage) will be finalised in March 2013 and the final report will be submitted directly after It is noted that the final report will be submitted in finalisation. March 2013. IIIA 2.7.5 FR The ambient temperature shelf life in commercial packagings It is already required in Part A, 3.3. should be required. Text in B(1) is revised to make this clearer. IIIA 2.7.6 Applicant Row appears twice. One row is deleted. IIIA 3.6 Applicant Typo: bail treatment. corrected Please replace by bait treatment. IIIA 3.7.3 Applicant Typo: bail treatment impies… corrected Please replace by bait treatment implies …... Appendix 2 Applicant Please correct formulations type. The formulation is a RB and corrected not a GB formulation. Appendix 2: Applicant Typo: Use-No. 001, 002, … - 013: please exchange bail by corrected bait Appendix 3 Applicant Weight loss of unopened container was: 0.9% cardboard box 7.2 % weight loss was determined in the BVL Lab with PE-inner bag and 4.5% without inner bag. The value of according to CIPAC MT 46.3 (stored in glass bottle). 7.2% is not understandable. Please correct.

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Annex III Member Comment Reply ZRMS point State/ Applicant

Section 2 – Analytical Methods IIIA 5.3 Applicant IIIA 5.3 Description of Analytical Methods for the The additional wording has been removed from the Determination of Residues. header. Please remove from header 5.3 und Inhaltsvberzeichnigs anpassen Section 3 – Mammalian Toxicology IIIA 7.1.1, Applicant Table IIIA 7.1-2 The agreed EU endpoint ADI (MTDI) = 70 agreed mg/kg bw/d corresponds to phosphate and not ferric phosphate. IIIA7.2 Applicant Table III A7.2-2 (page 4) row 7, column 3 agreed Please include “Yes” (Acceptability of skin sensitisation study is indicated in A 2.6 on page 16) IIIA7.3 Dermal AT In general, we agree with DE evaluation of COM 802 09 M RMS DE suggests in the EU evaluation for the renewal absorption RB. of the approval of ferric phosphate again that “No Remark: relevant dermal absorption of FePO4 is expected In the Review report on Ferric phosphate (SANCO/3035/99-rev. (extremely low solubility in water and lipids). The 48 March 2002) it is stated that “No relevant dermal absorption oral absorption is an active energy dependent of FePO4 is expected“. German authorities rejected the dermal process which will not take place in the skin.“ absorption values proposed by the applicant (default 10%) and considered dermal absorption to be zero (0%). We do not A final decision on this end point is to be taken at EU believe that dermal absorption would ever be zero and it is not level. current practice to do so. Additionally, for Iron sulphate, For this reason the exposure assessment was not default value of 10% is considered appropriate in Conclusion recalculated by ZRMS. on the peer review of the pesticide risk assessment of the active substance iron sulfate (EFSA Journal 2012;10(1):252). We would kindly propose to set dermal absorption, as proposed by the applicant, at 10% (default) and recalculate exposure assessment (even if it is recognized that this will not affect the safe use of the product). IIIA 7.4.2.1 FR The German model is used to determine the operator exposure In DE, we use exposure values from the PHED model by RMS. for granular applications, too. Only some default values

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Annex III Member Comment Reply ZRMS point State/ Applicant Could RMS provide details on the calculation of the operator (e.g. body weight) are used from the German model. exposure given that the RB formulation and the type of Therefore, in the dRR the following models for operator equipment “hand held machinery” are not proposed by the exposure estimation are indicated: model available on: ‘Health and Safety Executive (HSE, UK), The Applicant http://www.bfr.bund.de/cm/343/anwendersicherheit_deutsches_mode Guide: Completing An Application Overview For ll_v1.xls ? Operator And Consumer Exposure - Granular formulations (GR), EXPOSURE TO GRANULAR FORMULATIONS: HAND-HELD EQUIPMENT (available on http://www.pesticides.gov.uk/applicant_guide.asp?id=1 246), and German model (available on http://www.bfr.bund.de/cm/343/anwendersicherheit_deu tsches_modell_v1.xls) [Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products (Uniform Principles for Operator Protection), Mitteilungen aus der Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin- Dahlem, Heft 277, 1992]’ IIIA 7.4.2.1 FR In France, we will use PHED model: EXPOSURE TO see previous comment GRANULAR FORMULATIONS: HAND-HELD EQUIPMENT (available on http://www.pesticides.gov.uk/Resources/CRD/Migrated- Resources/Documents/P/PHED20GRANULE20MODEL.XLS ). We agree to consider this model as the most relevant for this type of use. Especially because it is based on outdoor applications, and formulation and application technique are similar to COM 802 09M RB. The estimated operator exposure according to PHED model is similar to that assessed by the German model, (0.01% of the AOEL without PPE.)

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Annex III Member Comment Reply ZRMS point State/ Applicant IIIA 7.5 Applicant Table IIIA 7.5-2: Classification and labelling according to Without further confirmation (e.g. regarding mode of Regulation (EC) No 1272/2008 action, absorption, distribution, metabolism and Please delete the phrase “> 99 percent of the mixture consist of excretion) it does not seem appropriate to use oral and ingredients of unknown inhalation toxicity“ dermal toxicity as a surrogate for inhalation toxicity. Please refer to comment at Part A Point 3.1.3.4 We agree, that the product contains > 90 % of food grade components (without classification as hazardous), however according to the material safety datasheets provided by the applicant, no information regarding acute inhalation toxicity of these components is available. According to Reg. (EU) 1272/2008, as a general principle this regulation should apply to all substances and mixtures supplied in the Community, except where other Community legislation lays down more specific rules on classification and labelling. No specific rules for mixtures containing food grade components are laid down in food related regulations. Acc. to Reg. (EU) 1272/2008 a preparation needs the additional statement that x percent of the mixture consists of ingredient(s) of unknown toxicity if no useable information is available for particular ingredients (at a concentration of 1 % or higher in the mixture). In addition, classification and labelling refers to intrinsic toxicological properties. In general, aspects regarding the likelihood of exposure are not relevant for classification and labelling. In summary ca. 97 % of the mixture consist of ingredients of unknown inhalation toxicity (for the active ingredient surrogate information based on Ferric (III) sulphate is available) IIIA 7.5, Applicant Table IIIA 7.5-3 Please delete the phrase ´VH297 The safety instruction SB010 is a general safety Packaging/containers for use in amateur gardening must be instruction for plant protection products. However, blue

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Annex III Member Comment Reply ZRMS point State/ Applicant provided with a childproof seal´ coloured ‘pills’ containing wheat and sugar (and no Please refer to comment at Part A Point 3.1.3.4 bittering agent) are very attractive especially to small children. In order to avoid ingestion of larger amounts of these ‘pills’, recent authorisations in DE contain the additional safety instruction ‘VH297’ for slug pellets ‘Packaging/containers for use in amateur gardening must be provided with a childproof seal’ (the safety instruction is based on the following consideration: AOEL 0.8 mg/kg bw, i.e. 8 mg/child with a body weight of 10 kg, COM 802 09 M RB contains 0.463 % iron, i.e. 1.8 g COM 802 09 M RB contains ca. 8 mg Fe). Thus, it seems possible, that a small child could easily ingest this amount of the ppp. Section 4 – Metabolism and Residues Table IIIA 8.2- FR In the frame of intended uses, we think that an F PHI is not ZRMS regards it not necessary to set a PHI in days. PHI 1: List of all appropriate. F is common practice in DE. intended uses According to EU Guidelines, it seems that F PHI is linked to the growth stage of the treated plants at last application. In case of ferric phosphate application is linked to the presence of the slugs/snails, then, don’t you think that a 1 day PHI (as 0 days PHI is not possible at EU level) should be more appropriate? Section 5 – Environmental Fate FR The risk assessment is agreed. Nevertheless, we emphasize that Noted, no action required. ferric phosphate is particular case which does not require a “standard” ground water and aquatic organisms risk assessment (as stated in EU review).

Please note that for other compounds (i.e. organic AS); because of the zonal approach, France may now require more comprehensive risk assessment for home and garden uses from notifiers if not covered by agricultural uses (PECgw calculations and PECsw).

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Annex III Member Comment Reply ZRMS point State/ Applicant KIII1 9.4 – AT Table 5.5-1: Please change the soil relevant application rate Section 5 CA has been amended. Estimation of from g/ha to kg/ha. concentration in soil Section 6 - Ecotoxicology FR We agree with your approach regarding the risk assessment to non target organisms for preparation to be used in home gardens that is covered by agricultural uses. We intend to Noted, no action required. proceed in the same way at national level, and will propose it in the Southern zone dossier. IIIA 10.4.2 Applicant Please include the summary of the study IBA 14144 on page Section 6 core assessment has been amended. 39 of Part B-Section 6 IIIA 10.6.1 Applicant Please correct in Part B.6 nati, point 6.6.2.1 (III 10.6.1) (page 5) and Part.B core, point 6.7.2.1 (page 25) and point IIIA 10.6.2 (page 41, in title) that the peat content of the acute earthworm study (Report No. RRA14144) with the formulation COM 802 09 M RB is not 5% but 10%. Normally the endpoint Section 6 core assessment and national addendum has is divided by 2 if the logKow>2 and the peat content is >5%. been amended. In this case no correction of the endpoint is required since the logKow cannot be defined since Ferric Phosphate is not soluble in water.

IIIA 10.6.2 Applicant See above See above. Section 7 – Efficacy IIIA 6 Applicant Typo: Please correct formulations type. The formulation is a Agreed; corrected RB and not a MB formulation. IIIA 6 Applicant General Information: COM 80209 M RB is also used in Agreed, added potatoes. Please add “potatoes” IIIA1 6 It is agreed that Arion vulgaris (Syn. Arion AT The invasive Southern European omnivorous species Arion lusitanicus (Mabille 1868)) is a very damaging vulgaris Moquin Tandon 1855 (Syn. Arion lusitanicus species, especially in gardens but sometimes also in (Mabille 1868) is the major damaging species in horticulture in

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Annex III Member Comment Reply ZRMS point State/ Applicant AT and causes even considerable damage in arable crops. In field crops. Most trials with Arion species were indeed some areas and under certain circumstances this species is the performed against this species (10 of 16) according to main pest even in arable crops. As Arion vulgaris is a good the reports. deal bigger and more mobile and ravening than most It can however be very difficult to distinguish Deroceras and other Arion spp. the damage potential of Arion between some of the bigger Arion species (ater, rufus, vulgaris is considered quite high. A. vulgaris moreover is vulgaris), since there is a broad overlap in colour and explicitely mentioned in the relevant EPPO guidelines as test size between these three species. Furthermore at some organism. sites in northern Europe hybridisation seems to occur between these slugs. Safe identification is possible From the Austrian point of view A. vulgaris should have been through dissection and investigation of the genitalia. the test organism in a considerable number of trials. These How then is guaranteed that the species tested is trials thereafter would have represented the most challenging Arion vulgaris? conditions. Without evidence that the test product is efficient However, today A. vulgaris is the commonest pest against A. vulgaris an authorization of COM 802 09 M RB will species of genus Arion in small house gardens or be recommended under AT conditions possibly with allotments and is found in many European countries restrictions and additional obligations. with a potential for establishment in the whole region. It would therefore have been useful to mention somewhere in a Therefore it can be assumed that the majority table which slug species had been used in the different trials as of trials on Arion species have been performed with test organisms and to compare efficiency of the product in Arion vulgaris, even in cases where this is not relation to the combated test organisms. explicitely stated. A paragraph has been added giving the efficacy results against Deroceras sp., Arion sp. and against slugs considered by the person performing the trial to be Arion vulgaris. For Arion vulgaris , the wider known synonym lusitanicus has been kept to avoid confusion. IIIA1 6.1.2 Applicant Conclusion last sentence: Typo: Please correct“…from This is not a typing error: The Intended use 007517- intended use 007517-00/00-001 instead of 00/00-002 00/00-001 is evaluated concerning minimum effective dose. In the conclusion it is stated that evaluation of minimum effective dose trials is also valid for all following intended uses from Intended use 007517- 00/00-002 to Intended use 007517-00/00-013.

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Annex III Member Comment Reply ZRMS point State/ Applicant IIIA1 6.1.3 Applicant Page 14 last paragraph: „concerning the dosing in potted Agreed. Conclusion plants“ on balcony and terraces (Application areas -003, -006, - This dosing proposal can be accepted. It also has to be 009 and -012) : The following dosing is proposed: added to the use instructions on the label.

Diameter of the pot/number of pellets: Up to 13 cm: 2-3* pellets Up to 17 cm: 4-5* pellets Up to 20 cm: 6-7* pellets Up to 23 cm: 7-9* pellets Up to 26 cm: 9-12* pellets Up to 29 cm: 12-15* pellets Up to 32 cm: 14-18* pellets *The higher amount of pellets is for angled pots

Plants on balconies in flower boxes: 4-8 pellets per plant or per 13-15 cm box lengths. IIIA1 6.1.3 AT Even though slugs a polyphagous pests from the AT point of Lettuce, Tagetes patula and strawberry are highly view it would generally have been desirable to increase the attractive for slugs and are often planted in gardens, total number or trials having in mind the to a certain degree therefore for the intended “non-professional use” these varying agricultural/horticultural and climatic conditions trials could be considered sufficient. within the particular zones, the differences within the pest Using a highly attractive plant in a concurrence situation spectrum, the severities of attack and the high variability with a granular bait and reducing the damage of the within the results. plants sufficiently indicates that the bait is highly Moreover, according to EPPO standard PP 1/96(3) and PP attractive to slugs in itself. 1/95(3) the trials should be carried out on the crop(s) and test organism(s) specified for the intended use. Considering that the product is intended only for “non professional use” only, nevertheless the total number of trials seems acceptable. IIIA1 6.1.3 AT Indended use: 007517-00/00-013 Intended use: 007517-00/00-013 As the growing conditions of arable crops (e.g. potato) differ This use on potato is also only „non-professional use”, from vegetables, ornamentals and orchards to a certain degree therefore in this special case the lack of potato trials

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Annex III Member Comment Reply ZRMS point State/ Applicant it would have been desirable to have also some trials could be accepted performed with the crop and test organism specified for the intended use as written down in EPPO standard PP 1/96(3). IIIA1 6.1.3 AT ad conclusion: Agreed It seems worth mentioning that – as cited in the dRR for The inclusion of potato was meant in the text, and is Germany – the product is considered for vegetables and now explicitely specified. ornamentals only for protection of emergence and protection against leaf consumption by slugs. The same is valid for potato. IIIA1 6.1.3 AT ad conclusion: Trials on Arion species were mainly on A. vulgaris A. vulgaris is regarded as the most challenging pest under according to the reports. Austrian growing condition in horticulture and partly also in A paragraph has been added giving the efficacy arable crops. Because of the potential lack of trials with this results against Deroceras sp., Arion sp. and against slugs test organism restrictions and obligations will possibly be considered by the person performing the trial recommended from the efficacy point of view in AT. to be Arion vulgaris. For Arion vulgaris , the still wider known synonym lusitanicus has been kept here to avoid confusion Appendix 1 Applicant List of data submitted in support of the evaluation: Author for Agreed trials from Agrartest GmbH and Agrartest SP zo.o. is Johannes Rohr, not Rohr, S. Appendix 2 Applicant GAP tables: the product is a “bait” (listed is “bail”) Agreed, typing error, changed to “bait” Section 8 – Groundwater Metabolites

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