REGISTRATION REPORT Part A EXTENSION OF USES Risk Management. (AG-QMM1-565 SC) Active Substances: Metamitron 525 g/l and Quinmerac: 40 g/l

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1 Part A National Assessment - Germany Goltix Titan AG-QMM1-565 SC Registration Report Page 1 of 29 REGISTRATION REPORT Part A EXTENSION OF USES Risk Management Product code: Goltix Titan (AG-QMM1-565 SC) Active Substances: Metamitron 525 g/l and Quinmerac: 40 g/l COUNTRY: Germany Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Date: 01/06/2015 ADAMA Deutschland GmbH Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

2 Part A National Assessment - Germany Goltix Titan Registration Report Page 2 of 29 Table of Contents PART A Risk Management 4 1 Details of the application Application background Annex I inclusion Regulatory approach Data protection claims Letters of Access 6 2 Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC Classification and labelling under Regulation (EC) No 1272/ Standard phrases under Regulation (EC) No 547/ Other phrases notified under Regulation (EC) No 547/ Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses 11 3 Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties (Part B, Section 1, Points 2 and 4) Methods of analysis (Part B, Section 2, Point 5) Analytical method for the formulation (Part B, Section 2, Point 5.2) Analytical methods for residues (Part B, Section 2, Points ) Mammalian Toxicology Acute Toxicity Operator, Worker, Bystander, and Resident Exposure Exposure Groundwater Metabolites Residues and Consumer Exposure Residues Consumer (Part B, Section 4, Point 8.10) Environmental fate and behaviour (Part B, Section 5, Point 9) Ecotoxicology (Part B, Section 6, Point 10) Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) Effects on Aquatic Species (Part B, Section 6, Point 10.2) 19 Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

3 Part A National Assessment - Germany Goltix Titan Registration Report Page 3 of Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) Effects on organic matter breakdown (Part B, Section 6, Point 10.6) Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) Efficacy (Part B, Section 7, Point 8) Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 23 Appendix 1 Copy of the product authorisation 24 Appendix 2 Copy of the product label 28 Appendix 3 Letter of Access 29 Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

4 Part A National Assessment - Germany Goltix Titan AG-QMM1-565 SC Registration Report Page 4 of 29 PART A Risk Management This document describes the acceptable use conditions required for the extension of uses on Goltix Titan containing metamitron and quinmerac in Germany. This evaluation is required subsequent to the approval of metamitron and quinmerac. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-8 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to Goltix Titan where that data has not been considered in the EU review. Otherwise assessments for the safe use of Goltix Titan have been made using endpoints agreed in the EU review of metamitron and quinmerac. This document describes the specific conditions of use and labelling required for Germany for the extension of uses of Goltix Titan. Appendix 1 of this document provides a copy of the final product authorisation in Germany. Appendix 2 of this document is a copy of the approved product label for Germany The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive 91/414/EEC. Appendix 3 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. Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. 1 Details of the application 1.1 Application background This application was submitted by Feinchemie Schwebda GmbH on 30/01/2014. However, during the registration process the name of the applicant was changed to ADAMA Deutschland GmbH. The application was for extension of uses of AG-QMM1-565 SC (in Germany: Goltix Titan), a suspension concentrate containing 525 g/l Metamitron and 40 g/l Quinmerac, for use as herbicide against annual monocotyledonous weeds, Galium aparine and other annual dicotyledonous weeds in splitting applications. 1.2 Annex I inclusion Metamitron The active substance Metamitron was listed on Annex I of Directive 91/414 with effect date 1 September 2009 (Commission Directive 2008/125/EC) and implemented under Regulation (EU) No 540/2011. Only Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

5 Part A National Assessment - Germany Goltix Titan Registration Report Page 5 of 29 uses as herbicide may be authorised. The applicant informs that MAK-FSG was main notifier (see SANCO/208/08 final 06/01/2009). For the implementation of the uniform principles of Annex VI, the conclusions of the review report on the active substance Metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account. In this overall assessment: In this overall assessment Member States must pay particular attention to: - operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate; - the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; - the risk to birds and mammals and non-target terrestrial plants. The Member States concerned shall request the submission of further information: - on the impact of soil metabolite M3 on groundwater, - on residues in rotational crops - on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field They shall ensure that the notifier at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest. These data have been submitted in the meantime. Quinmerac The active substance Quinmerac was listed on Annex I of Directive 91/414 with effect date 1 May 2011 (Commission Directive 2010/89/EU) and implemented under Regulation (EU) No 540/2011. Only uses as herbicide may be authorised.. The applicant informs that MAK-FSG has submitted data to support their own source of Quinmerac to the RMS UK for equivalence evaluation. The RMS UK has assessed the active substance source of MAK- FSG as being equivalent to the notified source of Quinmerac. The decision was taken on 16 December 2010 and is published on CIRCA for the other Member States. Further to this MAK-FSG owns an Annex II data compensation dossier, to match protected data according to the published List of Annex II studies which were considered as relied upon for the evaluation with a view to Annex I inclusion and for which the main data submitter has claimed data protection, version 2, February 2011, RMS UK, which has been submitted on 19 April 2011 to RMS UK. On 13 September 2011 the RMS UK confirmed that they considered the MAK-FSG Annex II data package to be complete. The evaluation of the RMS UK is available for other MS on CIRCA. The Annex II compensation data for Quinmerac however already have been summarised and are submitted with this dossier. For the implementation of the Uniform Principles of Annex VI, the conclusions of the review report on Quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account. In this overall assessment Member States must pay particular attention to: - the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

6 Part A National Assessment - Germany Goltix Titan Registration Report Page 6 of 29 - the dietary of consumers to residues of Quinmerac (and its metabolites) in succeeding rotational crops; - the risk to aquatic organisms and the long term risk for earthworms Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of information as regards: - the potential of plant metabolism to result in an opening of the quinoline ring; - residues in rotational crops and the long term risk for earthworms due to the metabolite BH They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April Concerns that are relevant for this application have been addressed within this submission. 1.3 Regulatory approach To obtain extension of uses the product Goltix Titan must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points. This application was submitted in order to allow extension of uses of an already approved product in Germany accordance with the above. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of Goltix Titan, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1-8 and Part C. 1.5 Letters of Access A letter of access isn t necessary. ADAMA is the holder of the main authorisation. 2 Details of the authorisation 2.1 Product identity Product Name Authorization Number (for re-registration) Function Applicant Composition Formulation type Packaging Goltix Titan /01 Herbicide ADAMA Deutschland GmbH 525 g/l metamitron and 40 g/l quinmerac Suspension concentrate [Code: SC] 1, 5, 10 and 20 L HDPE bottle or canister Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

7 Part A National Assessment - Germany Goltix Titan Registration Report Page 7 of Classification and labelling Classification and labelling under Directive 99/45/EC The following labelling is proposed in accordance with Directive 1999/45/EC: Symbol(s)/Indication(s) of danger: N Risk phrases: R 51/53 RA105 Safety phrases: S2 S24 Dangerous for the environment Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions. Keep out of the reach of children Avoid contact with skin S36/37 Wear suitable protective clothing and gloves. S35 S46 S57 SP001 Specific labelling requirement: This material and its container must be disposed of in a safe way. If swallowed, seek medical advice immediately and show this container or label Use appropriate container to avoid environmental contamination. To avoid riks to man and the environment, comply with the instructions for use. To avoid risks to man and the environment, comply with the instructions for use. Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

8 Part A National Assessment - Germany Goltix Titan Registration Report Page 8 of Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: Hazard classes and categories: Hazard pictograms: GHS09 Signal word: environment Hazard statements: H411 Toxic to aquatic life with long lasting effects. Precautionary statemtents: Not proposed by zrms Germany, to be decided by applicant Special rule for labelling of PPP: EUH401 To avoid risks to man and the environment, comply with the instructions for use. Further labelling statements under Regulation (EC) No 1272/2008: EUH Contains 1,2-benzisothiazole-3(2H)-one. May produce allergic reactions. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

9 Part A National Assessment - Germany Goltix Titan Registration Report Page 9 of Standard phrases under Regulation (EC) No 547/2011 None 2.3 Other phrases notified under Regulation (EC) No 547/ Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Human health protection SB001 SB005 SB110 SB166 SB199 SF1891 SS110 SS120 SS2101 SS2202 Avoid any unnecessary contact with the product. Misuse can lead to health damage. If medical advice is needed, have product container or label at hand. The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. Do not eat, drink or smoke when using this product. When applying the product with tractor-mounted, trailed or self-propelled application equipment, only vehicles with closed pressurized cabins (e.g. cabin category 3, if no respiratory protective equipment or particle-filtering masks are necessary or category 4, if gas-tight respiratory protective equipment is needed acc. to EN and -2) are suited to replace personal protective equipment during application. During all other activities outside of the cabin the prescribed personal protective equipment must be worn. In order to avoid contamination of the cabin, it is not permitted to enter the cabin with contaminated personal protective equipment (it should be deposited e.g. in an appropriate storage facility). Contaminated gloves should be washed before removing the gloves and hands should be washed before entering the cabin with pure water, respectively. Re-entering the treated areas/crops are only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. Wear standard protective gloves (plant protection) when handling the undiluted product. Wear standard protective gloves (plant protection) when handling/applying the product ready for application. Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. Integrated pest management (IPM)/sustainable use WMC1 WMO WH951 Mode of action (HRAC-group): C1 (for metamitron) Mode of action (HRAC-group): O (for quinmerac) The risk of resistance has to be indicated on the package and in the Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

10 Part A National Assessment - Germany Goltix Titan Registration Report Page 10 of 29 NB6641 Ecosystem protection NW 262 NW 263 NW 265 NW468 instructions of use. Particularly measures for an appropriate risk management have to be declared. The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4) The product is toxic for algae. The product is toxic for aquatic invertebrates. The product is toxic for higher aquatic plants. Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. The authorization of the PPP is linked to the following conditions (voluntary labelling): Integrated pest management (IPM)/sustainable use NN1001 NN1002 The product is classified as non-harmful for populations of relevant beneficial insects. The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders Specific restrictions linked to the intended uses The authorised use no. 001 is linked to the following conditions (mandatory labelling): See 2.4 (Product uses) Efficacy WH9161 Ecosystem protection The instructions for use must include a summary of weeds which can be controlled well, less well and insufficiently by the product, as well as a list of species and/or varieties showing which crops are tolerant of the intended application rate and which are not. NW 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 EUR. NG404 Between treated areas with an incline of more than 2% and surface water - except only occasionally but including periodically water-bearing surface water - there must be a border under complete plant cover. The border's protective function must not be impaired by the use of implements. It must be at least 20 m wide. This border is not necessary if: - sufficient catching systems are available for the water and soil transported by run-off, which do not flow into surface water or are not connected with the urban drainage system or - the product is used for mulch or direct drilling methods. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

11 Part A National Assessment - Germany Goltix Titan Registration Report Page 11 of Product uses GAP-Table of intended uses for Germany GAP rev. (No), date: PPP (product name/code) active substance 1 active substance 2 Goltix Titan Metamitron Quinmerac Formulation type: Conc. of as 1: Conc. of as 2: SC 525 g/l 40 g/l Applicant: Zone(s): Feinchemie Schwebda GmbH central/eu professional use non professional use X Verified by MS: yes Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) 001 DE Sugar beet BEAVA fodder beet BEAVC F G or I F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Annual monocotyledonous weeds TTTMS Annual dicotyledonous weeds TTTDS Method / Kind Spraying splitting 4 applications Application Application rate PHI Max. number kg, L product / g, kg as/ha Water L/ha (days) (min. interval ha between a) max. rate per a) max. rate min / max applications) appl. per appl. a) per use Timing / Growth stage of crop & season Spring BBCH st treatment beforeemergence 2 nd to 4 th treatment after emergence b) per crop/ season a) 4 b) 4 the 2 nd to 4 th treatment with an interval of 5 to 10 days b) max. total rate per crop/season a) timing 1: 3 L/ha timing 2: 1 L/ha timing 3: 1 L/ha timing 4: 1 L/ha b) max. total rate per crop/season a) timing 1: Metamitron 1575 g as/ha Quinmerac 120 g as/ha timing 2: Metamitron Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures *XF WH9161 Annual monocotyledonous weeds are withdrawn by the applicant, because not enough data regarding efficacy available. NG404, NW Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

12 525 g as/ha Quinmerac 40 g as/ha timing 3: Metamitron 525 g as/ha Quinmerac 40 g as/ha b) 6 L/ha maximum application rate for the intented crop per year timing 4: Metamitron 525 g as/ha Quinmerac 40 g as/ha b) Metamitron 3150 g as/ha Quinmerac 240 g as/ha maximum application rate for the intented crop per year *The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in days is not required resp. Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (2) Member State(s) or zone for which use is applied for (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) The maximum number of applications possible under practical conditions of use for each single application and per year (permanent crops) or crop (annual crops) must be provided (8) Min. interval between applications (days) were relevant situation should be described (e.g. fumigation of a structure) (10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) must be given in metric units (e.g. kg or L product / ha) (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of crop/season must be given in metric units (e.g. g or kg / ha) equipment used must be indicated (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, (12) The range (min/max) of water volume under practical conditions of use must be given (L/ha) Blackwell, ISBN ), including where relevant, information on season at time of (13) PHI - minimum pre-harvest interval application (14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

13 Part A National Assessment - Germany Goltix Titan Registration Report Page 13 of 29 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties (Part B, Section 1, Points 2 and 4) Overall Summary: AG-QMM1-565 SC is an off-white homogenous suspension with characteristic odour. It has no explosive and oxidising properties. AG-QMM1-565 SC has a self-ignition temperature of 505 C and it is a surface active mixture. Results of the technical tests (spontaneity of dispersion, suspensibility, wet sieve test, pourability and particle size distribution) showed that AG-QMM1-565 SC fulfils the general requirements of the FAO/WHO manual (2010). The formulation is stable when stored for 2 years in the commercial packaging at ambient temperature and after 14 days at 54 C. The technical characteristics are acceptable for a SC formulation. Implications for labelling: none Compliance with FAO specifications: There is no FAO specifications for quinmerac. For metamitron only specifications for TC, TK, WP and WG formulations are published. Compliance with FAO guidelines: The product AG-QMM1-565 SC complies with the general requirements according to the FAO/WHO manual (2010). Compatibility of mixtures: A complete report regarding physical and chemical compatibility of the tank mixes with Powertwin Plus, Oleo FC, Debut, Arma, Lontrel 100, Agil-S, Belvedere Extra and Kontakt 320 SC has been submitted which has demonstrated compatibility. These tank mixes can therefore be mentioned on the product label for AG-QMM1-565 SC.. 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 GOLTIX TITAN has been provided and is considered to be acceptable Methods of analysis (Part B, Section 2, Point 5) Analytical method for the formulation (Part B, Section 2, Point 5.2) The analytes are determined by HPLC on an Inertsil ODS-3V column. Detection is performed with a UV detector at 238 nm. The mobile phase consists of acetonitrile : acidified water 40:60 (v/v). With respect to precision, accuracy, linearity and specificity the method provided is suitable for the determination of metamitron and quinmerac in the SC-formulation. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

14 Part A National Assessment - Germany Goltix Titan Registration Report Page 14 of Analytical methods for residues (Part B, Section 2, Points ) Concerning the analytical methods for the determination of residues there is no change with respect to the main application. Adequate analytical methods are available to monitor all compounds given in the respective residue definition, i.e. metamitron in food of plant and animal origin, soil, water and air, and quinmerac in food of plant and animal origin and quinmerac and its metabolites BH and BH in soil and water. Metamitron residues can be monitored in food of plant and animal origin, soil, water and air by LC- MS/MS. Additionally, adequate validation data for the QuEChERS method (European Standard EN 15662:2008) are published in EURL Data Pool ( for food of plant origin. Quinmerac residues can be monitored in food of plant and animal origin, soil and water by LC-MS/MS. An analytical method for quinmerac in air is not required because it is not classified as Xi, Xn, T or T+. Methods for body fluids and tissues are also not required since metamitron and quinmerac are not classified as toxic or highly toxic Mammalian Toxicology Acute Toxicity Acute toxicity studies of Goltix Titan were not evaluated as part of the EU review of metamitron and quinmerac. Therefore, all relevant data were provided and are considered adequate. Goltix Titan, containing 525 g/l metamitron and 40 g/l quinmerac, has a low toxicity in respect to acute oral and dermal toxicity and is not irritating to the rabbit eye. It has been found to be not irritating to rabbit skin and is not a skin sensitiser to the guinea pig. Taking into account all submitted data some safety phrases are considered necessary due to the conent of 1,2-benzisothiazole-3(2H)-one (see 2.2) Operator, Worker, Bystander, and Resident Exposure Exposure The risk assessment according to the German model has shown that the estimated towards metamitron and quinmerac in Goltix Titan will not exceed the particular systemic AOEL for operators, workers, bystanders and residents. Operator and worker will be below the systemic AOEL only, if prescribed PPE is worn. The risk assessment according to the UK-POEM has shown that the estimated towards metamitron in Goltix Titan exceeds the particular systemic AOEL for operators. The risk assessment according to an study has shown that the estimated towards metamitron in Goltix Titan will not exceed the particular systemic AOEL for operators. Operator will be below the systemic AOEL only, if prescribed PPE is worn. The risk assessment according to the UK-POEM has shown that the estimated towards quinmerac in Goltix Titan will not exceed the particular systemic AOEL for operators. 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. Implications for labelling resulting from operator, worker, bystander assessments: See 2.2 and Groundwater Metabolites The quinmerac metabolites BH518-2 and BH518-5 are predicted to occur in groundwater in concentrations above 0.1 µg/l. The toxicological relevance assessment of these groundwater metabolites according to the EC guidance document SANCO/221/2000 rev.10 is presented in Section 8 of the RR. Concentrations of these metabolites can be accepted up to the trigger value of 10 µg/l. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

15 Part A National Assessment - Germany Goltix Titan Registration Report Page 15 of Residues and Consumer Exposure Residues Regarding aspects of seasonal application rates the cgap of application /01 is comparable to that of the basic application of the product on sugar/fodder beets ( /00). Hence, the statement basically apply also for application /01. The available data is considered sufficient for risk assessment. An exceedance of the current MRLs of 0.2 mg/kg for metamitron and 0.5 mg/kg for quinmerac in sugar beet as laid down in Reg. (EU) No 396/2005 is not expected. A no-residue situation is indicated from the supervised residue trials for both actives and regarding both roots and leaves with tops. It is therefore not anticipated that the intended uses impact residues in commodities of animal origin Consumer (Part B, Section 4, Point 8.10) An estimation of dietary intake using EFSA PRIMo results in a maximum consumption of the respective ADIs/ARfDs below 100 %. Substance ADI/ARfD Model / Diet Metamitron ADI: 0.03 mg/kg bw TMDI, EFSA PRIMo, UK toddler ADI/ARfD Consumption 26.5 % ARfD: 0.1 mg/kg bw IESTI, EFSA PRIMo, UK children aged 4-6 years 3 % Quinmerac ADI: 0.08 mg/kg bw TMDI, EFSA PRIMo, UK toddler 18.4 % ARfD: 0.3 mg/kg bw IESTI, EFSA PRIMo, UK children aged 4-6 years 3 % The chronic and the short-term intake of metamitron and quinmerac residues are unlikely to present a public health concern Environmental fate and behaviour (Part B, Section 5, Point 9) A full assessment for the plant protection product in its intended uses in beets (sugar and fodder) is documented in detail in the core assessment of the plant protection product GOLTIX TITAN dated from May 2015 performed by the applicant. The following chapters summarize specific assessment for soil and surface water and the specific risk assessment for groundwater for the authorization of in Germany according to its intended use in beets (sugar and fodder) (use No ). Metabolites Metamitron No new study on the fate and behaviour of metamitron has been performed. The risk assessment for the metabolite desamino-metamitron of metamitron has already been performed for EU approval (see EFSA Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

16 Part A National Assessment - Germany Goltix Titan Registration Report Page 16 of 29 Scientific Report(2008) 185,1-95). The metabolite desamino-metamitron is considered ecotoxicologically not relevant. The metabolite desamino-metamitron did not penetrate into groundwater. For details see Part B, core assessment, section (Metabolites of metamitron). However, in the EU review report for the inclusion of metamitron in Annex I of Directive 91/414/EEC in the list of studies to be generated, information as regards the impact of soil metabolite M3 on groundwater is postulated (SANCO/208/08 final, 6 January 2009, point 7). The metabolite M3 did penetrate into groundwater with a default Koc value of 0. Quinmerac No new laboratory studies on the degradation of quinmerac in soil and water/sediment have been performed. The risk assessment for the metabolites of of quinmerac has already been performed for EU approval (see EFSA Journal 2010; 8(3):1523). The metabolites are considered ecotoxicologically not relevant. Therefore no new risk assessment hence no assessment for these metabolites is necessary. For details see Part B, core assessment, section 5, chapter (metabolites of quinmerac). The soil metabolites BH and BH of quinmerac were also included in the groundwater risk assessment considering the entry path surface run-off and drainage with subsequent bank filtration Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) For the intended use of the plant protection product in beets (sugar and fodder) according to use No PEC soil was calculated for the active substances quinmerac and metamitron considering a soil depth of 2.5 cm. Due to the fast degradation of the active substances quinmerac and metamitron in soil the accumulation potential was not considered. Details are given in Part B National Addendum-Germany, Section5, chapter 5.6. The results for PEC soil for the active substances and their metabolites were used for the ecotoxicological risk assessment Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 1. Direct leaching into groundwater Metamitron According to the results of the groundwater simulation with FOCUS-PELMO 5.5.3, a groundwater contamination of the active substance metamitron in concentrations of 0.1 µg/l is not expected for the intended use in sugar beet. For the metabolite desamino-metamitron, a groundwater concentration of 0.1 µg/l can be excluded for the application in sugar beet according to the results of the groundwater simulation with FOCUS-PELMO For the metabolite M3 a groundwater concentration of 0.1 µg/l cannot be excluded for the application in sugar beet according to the results of the groundwater simulation with FOCUS-PELMO In the EU review report for the inclusion of metamitron in Annex I of Directive 1107/2009 (SANCO/208/08 final document, 6 January 2009) information as regards the impact of soil metabolite M3 on groundwater was postulated in the list of studies to be generated. The inclusion directive (2008/125/EC resp. regulation 540/2011) lists the missing data on M3 as confirmatory data to be delivered to the Commission till August The evaluation of the information by the RMS is still ongoing. Therefore the relevance of the metabolite M3 for groundwater cannot be evaluated. No information is available concerning the ecotoxicological activity. However, subject to the provisions of the confirmatory data, the risk for organisms exposed via groundwater is expected to be low, because the PECgw was calculated using a worst case default Koc value of 0. Quinmerac Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

17 Part A National Assessment - Germany Goltix Titan Registration Report Page 17 of 29 Results of modelling show that the active substance quinmerac is not expected to penetrate into groundwater at concentrations of 0.1 µg/l in the intended uses in beets. For the metabolites BH and BH concentrations of 0.1 µg/l in groundwater cannot be excluded in all of the FOCUS groundwater scenarios in the intended use. Higher tier leaching studies indicate a lower leaching potential of metabolite BH as expected from the lower tier modelling. It has to be considered that the degradation rate used for modeling of DT 50 = d is a geomean that includes several default values of 1000 d. However the metabolites BH and BH are classified as not relevant for groundwater. For details see Part B, National Addendum-Germany, Section 5, chapter Consequences for authorization: As published in Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 the Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater. According to the applicant these confirmatory data have been submitted to the Commission (drr Part B, Sect. 5, Core Assessment, Oct.2011). 2. Ground water contamination by bank filtration due to surface water via run-off and drainage Metamitron According modelling with EXPOSIT 3.01, groundwater contamination at concentrations 0.1 µg/l by the active substance metamitron due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of 20 m) are applied. Quinmerac According modelling with EXPOSIT 3.01, groundwater contamination at concentrations 0.1 µg/l by the active substance quinmerac and its metabolites BH and BH due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded. For details see Part B, National Addendum-Germany, Section 5, chapter Consequences for authorization: The authorisation of the plant protection product is linked with following labeling: Use No. 001 NG404 Between treated areas with an incline of more than 2% and surface water - except only occasionally but including periodically water-bearing surface water - there must be a border under complete plant cover. The border's protective function must not be impaired by the use of implements. It must be at least 20 m wide. This border is not necessary if: - sufficient catching systems are available for the water and soil transported by run-off, which do not flow into surface water or are not connected with the urban drainage system or - the product is used for mulch or direct drilling methods Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) For the intended use of the plant protection product in beets (sugar and fodder) according to use No PECsw was calculated for the active substances metamitron and quinmerac considering the two routes of entry (i) spraydrift and (ii) run-off, drainage separately. The vapour pressure at 20 C of the active substances metamitron and quinmerac is < 10-5 Pa. Hence the active substances are regarded as non-volatile. Therefore of surface water by the active substances metamitron and quinmerac due to deposition following volatilization was not considered as relevant. Details are given in Part B, National Addendum-Germany, Section5, chapter 5.7. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

18 Part A National Assessment - Germany Goltix Titan Registration Report Page 18 of 29 The results for PECsw for the active substances and their metabolites were used for the ecotoxicological risk assessment Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) The vapour pressures of the active substances metamitron and quinmerac are < 10-5 Pa. Hence the active substances are regarded as non-volatile. Implications for labelling resulting from environmental fate assessment For the authorisation of the plant protection product following labeling and conditions of use are mandatory: Classification and labelling Based on the data on the active substances metamitron and quinmerac of the plant protection product are considered to be not readily degradable in the sense of the CLP regulation. The formulation is regarded as a candidate for R 53. Standard Phrases for special risks and safety precautions under Regulation (EU) 547/2011 Annex II and III / conditions of use Use No. 001: NG404 Between treated areas with an incline of more than 2% and surface water - except only occasionally but including periodically waterbearing surface water - there must be a border under complete plant cover. The border's protective function must not be impaired by the use of implements. It must be at least 20 m wide. This border is not necessary if: - sufficient catching systems are available for the water and soil transported by run-off, which do not flow into surface water or are not connected with the urban drainage system or - the product is used for mulch or direct drilling methods. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

19 Part A National Assessment - Germany Goltix Titan Registration Report Page 19 of Ecotoxicology (Part B, Section 6, Point 10) A full risk assessment according to Uniform Principles for the plant protection product in its intended uses in beets (sugar and fodder) is documented in detail in the core assessment of the plant protection product dated from October 2011 performed by Feinchemie Schwebda GmbH. The intended use of in Germany is generally covered by the uses evaluated in the course of the core assessment by zonal rapporteur member state Germany. The following chapters summarise specific risk assessment for non-target organisms and hence risk mitigation measures for the authorisation of in Germany according to its intended use in beets (sugar and fodder) (use No ). 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 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) There is no unacceptable risk for terrestrial vertebrates. For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.2 (birds) and 6.3 (terrestrial vertebrates other than birds) and National Addendum Germany, Section 6, Point 6.1 (birds) and Point 6.2 (other terrestrial vertebrates), respectively Effects on Aquatic Species (Part B, Section 6, Point 10.2) For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.4 and National Addendum Germany, Section 6, Point 6.3 respectively. Based on the intrinsic properties of the active substances metamitron and quinmerac, following national labelling and environmental restrictions are prescribed as mandatory: Risk mitigation measures: Use No. 001 Use No. 001 Labelling: NW642: The product is not authorized for use in or in the immediate vicinity of surface waters or coastal waters ( 6 (2) 'PflschG' [Plant Protection Act]). Irrespective of this fact, the binding minimum buffer zone to be kept from surface waters, provided for by state law, must be observed. Violations may be punished by fines of up to Euro NW468: Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rainwater and sewage canals. Because of the toxicity of the active ingredients as well as the formulation following labels must be given: NW262: The product is toxic for algae. NW263: The product is toxic for aquatic invertebrates. NW265: The product is toxic for higher aquatic plants. Studies of the acute toxicity of for algae [E bc 50Metamitron = 0.4 mg/l (P. subcapitata; EC 50Goltix Titan = 2.0 mg/l (P. subcapitata)], daphnia [LC 50Metamitron = 5.7 mg/l (D. magna)] and aquatic plants [E bc 50Metamitron = 0.4 mg/l (L. gibba); E bc 50Goltix Titan = 0.86 mg/l (L. gibba)] showed that this product should be labelled as very toxic for aquatic organisms. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

20 Part A National Assessment - Germany Goltix Titan Registration Report Page 20 of Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) Bees In the honey bee risk assessment for the main application it was concluded that the risk to bees is acceptable when Goltix Titan (AG-QMM1-565 SC) is used up to 6 L product/ha in pre-emergence or early post-emergence fodder and sugar beet fields. Since the recommended application rate does not exceed this rate no further risk assessment is required. Labelling phrase NB6641 is applied. Other non-target arthropods No risk management measures are required for other arthropod species for the intended use pattern. For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.5 and 6.6 and National Addendum Germany, Section 6, Point 6.4 and 6.5 respectively Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6) No risk management measures are required for the protection of earthworms and other soil macroorganisms for the intended use pattern. For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.7 and National Addendum Germany, Section 6, Point 6.6 respectively Effects on organic matter breakdown (Part B, Section 6, Point 10.6) For details of the risk assessment see Core Assessment, Part B, Section 6, Point No risk management measures are required for the protection of earthworms and other soil macroorganisms for the intended use pattern Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) No risk management measures are required for the protection of non-target soil micro-organisms for the intended use pattern. For details of the risk assessment see Core Assessment, Part B, Section 6, Point Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) No risk management measures are required for the protection of non-target plants for the intended use pattern. For details of the risk assessment see Core Assessment, Part B, Section 6, Point 6.9. Implications for labelling resulting from ecotoxicological assessment: Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

21 Part A National Assessment - Germany Goltix Titan Registration Report Page 21 of 29 Relevant toxicity data Goltix Tiitan EyC 50 = 1.5 mg/l (Lemna gibba) EyC 50 = 1.99 mg/l (P. subcapitata) Classification & Labelling according directives 67/548/EEC, 78/631/EEC and 1999/45/EEC Danger Symbol N, dangerous for the environment Risk Phrases R 51/53 C&L according directive 1272/2008 Danger Symbol GHS 09 Hazard Statements H Efficacy (Part B, Section 7, Point 8) Information on the active ingredients (Uptake and mode of action) Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used in fodder- and sugar beet for the control of mono- and dicotyledonous weeds. Primarily it is taken up by plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron transport at the photosystem II receptor site (Hill-reaction). Selectivity of weeds is based on different metabolisation. Susceptible weed seedlings become chlorotic, exhibit yellowed and cleared discolouration and finally get withered. Metamitron is highly selective in fodder and sugar beets. Metamitron is readily degraded by aqueous photolysis. The major metabolite in sugar beet is deaminated metamitron. Mode of action (HRAC-group): C1 Labelling phrase WMC1 Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake by roots and the onset of activity. Uptake by leaves depends on the concentration of the active ingredient and time. Its mode of action has been proposed as root growth inhibition which exhibits auxin type effects (similar to phenoxycarboxylic acids). Based on the auxin effects quinmerac stimulates the formation of the phytohormone ethylene in sensitive plants, leading to epinasty, altered uptake and other effects. In the biosynthesis the enzymatic activity of 1-aminocyclopropane-1-carboxylic-acid synthase will be induced. As a result an accumulation of abscisic acid (ABA) in the plant tissue occurs. The consequences are: deformation of plants, occlusion of stomata, inhibition of transpiration, CO2-assimilation and growth as well as the death of plant cells. The selective effect is based on plant tissue/target location selectivity in crop plants. In sugar beet the tolerance is supported by a faster degradation. Uptake and translocation has no great significance for herbicide efficacy. Mode of action (HRAC-group): O Labelling phrase WMO Minimum effective dose The dose response results against some weed species show that there is a trend that for most of the weed species the efficacy is reduced and the variability of the level of control is increased, if rates lower than x 1 L/ha of AG-QMM1-565 SC are applied. Efficacy A total of 17 efficacy trials were carried out in 2010, 2011, and 2012 in Belgium, Germany and the Netherlands.. The applied application rate of AG-QMM1-565 SC was 3 L/ha pre-emergence followed by Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

22 Part A National Assessment - Germany Goltix Titan Registration Report Page 22 of 29 up to 3 post-emergence splitting applications of 1 L/ha each. It can be concluded that AG-QMM1-565 SC provides sufficient control of a number of annual dicotyledonous weed species in fodder and sugar beets. POAAN and ECHCG are documented only in 2 trials. More annual monocotyledonous weed species didn t occur in the efficacy trials. So no final evaluation for annual monocotyledonous weed species could be done. Labelling phrase: WH9161. Effect on the yield and quality Based on the results of 8 selectivity trials carried out in sugar beets in Germany and the Netherlands in 2013 it can be concluded that there are no indications for a negative impact on quality of plants and plant products in sugar or fodder beets if the product is applied at the intended target application rates, even if the product is applied at double rate. Effects on the Processing Procedure Neither from trial experience nor from practical use of the active ingredients metamitron and quinmerac any cases were reported about negative influences on parameters influencing the processing procedure of sugar beets. Thus no special trials were carried out for the assessment of these criteria. Effects on the yield of treated plants and plant products There are no indications for a negative impact on quantity of yield in sugar or fodder beets if AG-QMM1-565 SC is applied at the intended target application rates. Even at the double rate there is no substantial risk for an impact on yield quantity. Phytotoxicity to host crop The effects AG-QMM1-565 SC applied in splitting applications (3 L/ha pre-emergence + 3 x 1 L/ha postemergence) on the target crop were rated in a total of 25 trials.the results show that the product is tolerated well by sugar beets. For this indication only one year results (2013) are available from trials carried out with the double rate included under almost weed free conditions. Impacts on succeeding and on adjacent crops According to EPPO standard PP1/207 no unacceptable risk for all succeeding crops in common crop rotations could be shown. Information on the possible Occurrence of the Development of Resistance or Cross-Resistance The evaluation of the inherent risk for resistance development of AG-QMM1-565 SC shows that for the active ingredient metamitron there is a high risk for the development of weed resistance while the inherent risk of target weeds to develop resistance against quinmerac is considered low to medium. The applicant claims that the risk for the development of resistant weed biotypes in major sugar beet production areas is considered medium because of the fact that despite many years of intensive use of metamitron only very occasional proven problems with weed resistance are reported in Europe, and that no proven problems of quinmerac with this active ingredient are reported. This conclusion cannot be fully followed. As the number of metamitron resistance cases reported for Chenopodium album has substantially increased in the last years, the resistance risk for metamitron has to be rated as high especially for Germany and Belgium. As the spectrum of weed species controlled by metamitron and quinmerac is not overlapping and because the above mentioned high risk weed species (especially Chenopodium album) are nor controlled by quinmerac, the resistance risk of the herbicide has to be rated a medium to high. Due to this resistance risk, management strategies are required. The applicant claims that basic recommendations for resistance risk management will be clearly recommended on the label. Labelling phrase: WH951. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

23 Part A National Assessment - Germany Goltix Titan Registration Report Page 23 of 29 Adverse effects on beneficial organisms other than bees Under extended laboratory test conditions effects of less than 25 % at the proposed application rate of maximum 6 L/ha per year were demonstrated. The herbicide AG-QMM1-565 SC is therefore considered to be harmless for Aphidius rhopalosiphi and Typhlodromus pyri. Besides the two indicator species, only the rove beetle Aleochara bilineata was tested with SCformulations of the both active ingredients of the test product, metamitron and quinmerac. Metamitron was shown to be slightly harmful with an effect between % under worst case conditions. No effects occurred in a laboratory study with the combination product AG-QM2-500 SC and in an extended laboratory study with metamitron, but the latter test did not fulfil the validity criteria. Thus it could not be excluded, that the test product can be slightly harmful for Aleochara bilineata. On the basis of the results of an extended laboratory study with Metamitron, the test product has to be considered as slightly harmful for the ladybird beetle Coccinella septempunctata. Labelling phrases: NN1001, NN Conclusions With respect to physical, chemical and technical properties and analytical methods (formulation, residues) an authorisation can be granted Regarding toxicology, residues and consumer protection an authorisation can be granted. With respect to efficacy an authorization can be granted for the control of annual dicotyledonous weeds. Due to the letter of the applicant dated the control of annual monocotyledonous weeds is no longer pursued. Concerning fate and ecotoxicology an authorisation can be granted. The product is classified as non-hazardous to bees. An authorisation can be granted. 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation No further information is required. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

24 Part A National Assessment - Germany Goltix Titan Registration Report Page 24 of 29 Appendix 1 Copy of the product authorisation Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

25 Part A National Assessment - Germany Goltix Titan Registration Report Page 25 of 29 Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

26 Part A National Assessment - Germany Goltix Titan Registration Report Page 26 of 29 Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

27 Part A National Assessment - Germany Goltix Titan Registration Report Page 27 of 29 Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

28 Part A National Assessment - Germany Goltix Titan Registration Report Page 28 of 29 Appendix 2 Copy of the product label The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label has to fulfil the requirements according to Article 16 of Directive 91/414/EEC. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 25/09/2015

29 Part A National Assessment - Germany Goltix Titan Registration Report Page 29 of 29 Appendix 3 Letter of Access Letter(s) of access is/are classified as confidential and, thus, are not attached to this document. Applicant: ADAMA Deutschland GmbH Evaluator: DE Date: 01/06/2016

30 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 1 of 23 REGISTRATION REPORT Part B Section 1: Identity, physical and chemical properties, other information Detailed summary of the risk assessment Product code: Goltix Titan (AG-QMM1-565 SC) Active Substance: Metamitron 525 g/l Quinmerac 40 g/l Rapporteur Member State: Germany CORE ASSESSMENT Applicant: ADAMA Deutschland GmbH Submission Date: January 2014 Date : February 2016 Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

31 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 2 of 23 Table of Contents IIIA 1 IDENTITY OF THE PLANT PROTECTION PRODUCT... 6 IIIA 1.1 Applicant... 6 IIIA 1.2 Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s)... 6 IIIA Manufacturer(s) of the preparation... 6 IIIA Manufacturer(s) of the active substance(s)... 7 IIIA 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... 7 IIIA Content of active substance and formulants... 7 IIIA Certified limits of each component... 8 IIIA Common names and code numbers for the active substance(s)... 8 IIIA Co-formulant details: identity, structure, codes, trade name, specification and function IIIA Formulation process... 9 IIIA Description of formulation process... 9 IIIA Discussion of the formation of impurities of toxicological concern... 9 IIIA 1.5 Type of Preparation and Code... 9 IIIA 1.6 Function... 9 IIIA 1.7 Other/Special Studies... 9 IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

32 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 3 of 23 IIIA 3 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT IIIA 3.1 Field of Use IIIA 3.2 Nature of the Effects on Harmful Organisms IIIA 3.3 Details of Intended Use IIIA Details of existing and intended uses Please refer to Appendix 2 Critical Uses and Part B Section IIIA Details of harmful organisms against which protection is afforded Please refer to Appendix 2 Critical Uses and Part B Section IIIA Effects achieved Please refer to Part B Section IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) Please refer to Appendix 2 Critical Uses and Part B Section IIIA 3.5 Concentration of the Active Substance in the Material Used Please refer to Appendix 2 Critical Uses and Part B Section IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent Please refer to Appendix 2 Critical Uses and Part B Section IIIA 3.7 Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection IIIA Maximum number of applications and their timings Please refer to Appendix 2 Critical Uses and Part B Section IIIA Growth stages of crops or plants to be protected Please refer to Appendix 2 Critical Uses and Part B Section IIIA Development stages of the harmful organism concerned Please refer to Appendix 2 Critical Uses and Part B Section IIIA Duration of protection afforded by each application Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

33 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 4 of 23 Please refer to Part B Section IIIA Duration of protection afforded by the maximum number of applications Please refer to Part B Section IIIA 3.8 IIIA Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops Please refer to Part B Section IIIA Limitations on choice of succeeding crops Please refer to Part B Section IIIA Description of damage to rotational crops Please refer to Part B Section IIIA 3.9 Proposed Instructions for Use as Printed on Labels IIIA 3.10 Other/Special Studies IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT IIIA 4.1 Packaging and Compatibility with the Preparation IIIA 4.2 Procedures for Cleaning Application Equipment IIIA 4.3 Re-entry Periods to Protect Man, Livestock and the Environment IIIA Pre-harvest interval (in days) for each relevant crop IIIA Re-entry period (in days) for livestock, to areas to be grazed IIIA Re-entry period (in hours or days) for man to crops, buildings or spaces treated IIIA Withholding period (in days) for animal feeding stuffs IIIA IIIA Waiting period (in days) between application and handling of treated products Waiting period (in days) between last application and sowing or planting succeeding crops Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

34 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 5 of 23 IIIA IIIA 4.4 Information on specific conditions under which the preparation may or may not be used Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks IIIA 11 FURTHER INFORMATION IIIA 11.1 Information of Authorisations in Other Countries IIIA 11.2 Information on Established Maximum Residue Limits (MRL) in Other Countries IIIA 11.3 Justified Proposals for Classification and Labelling IIIA 11.4 Proposals for Risk and Safety Labels IIIA 11.5 Proposed Label IIIA 11.6 Specimens of Proposed Packaging Appendix 1: List of data used in support of the evaluation Appendix 2: Critical Uses justification and GAP tables 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 AG-QMM1-565 SC containing the active substances metamitron and quinmerac which were 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. Where appropriate this document refers to the conclusions of the EU review of metamitron and quinmerac. This will be where: the active substance data are relied upon in the risk assessment of the formulation; or when the EU review concluded that additional data/information should be considered at national reregistration. New annex II data of quinmerac have been generated to match protected data. These data are summarised in Annex 4 of this section. The SANCO report for Metamitron (SANCO/208/08 final 6 Januar 2009) and Quinmerac (SANCO/12192/2010 final 7 December 2010) are considered to provide the relevant review Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

35 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 6 of 23 information or a reference to where such information can be found. Each section will begin with a table providing the EU endpoints to be used in this evaluation. 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. The following table provides the EU endpoints to be used in the evaluation. Agreed EU End-points End-Point Metamitron (Reg. (EU) No. 540/2011) Quinmerac (Reg. (EU) No. 540/2011) Purity of active substance min 960 g/kg min 980 g/kg 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 AG-QMM1-565 SC. Information on the detailed composition of AG-QMM1-565 SC can be found in the confidential dossier of this submission (Registration Report - Part C). IIIA 1 IIIA 1.1 IDENTITY OF THE PLANT PROTECTION PRODUCT Applicant ADAMA Deutschland GmbH Edmund-Rumpler-Straße 6 D Köln Germany IIIA 1.2 IIIA Manufacturer of the Preparation, Manufacturer and Purity of the Active Substance(s) Manufacturer(s) of the preparation Name: Address: ADAMA Agan Ltd. Industrial Zone P.O. Box 262, Ashdod, 77102, Israel Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

36 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 7 of 23 Contact: Dr. Tali Ehrlich Tel.: Tali.ehrlich@ma-industries.com Location of manufacturing site CONFIDENTIAL information data provided separately (Part C). IIIA Manufacturer(s) of the active substance(s) Confidential information - data provided separately (Part C). IIIA Statement of purity (and detailed information on impurities) of the active substance(s) Metamitron: minimum 980 g/kg Quinmerac: minimum 980 g/kg Further information/justification is provided in Part C. IIIA 1.3 Trade Names and Manufacturer s Code Numbers for the Preparation Trade name: Goltix Titan for Germany. Company code number: development code: AG-QMM1-565 SC FSG-code: FSG H IIIA 1.4 IIIA Detailed Quantitative and Qualitative Information on the Composition of the Preparation Content of active substance and formulants The formulation was not the representative formulation. Pure active substance: content of pure metamitron: content of pure quinmerac: limits metamitron: limits quinmerac: 525 g/l 40 g/l g/l g/l Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

37 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 8 of 23 Technical active substance: content of technical metamitron at minimum purity (98.0 %): content of technical quinmerac at minimum purity (98.0 %): g/l 40.8 g/l None of the active substances in the formulation are present in the form of a salt, ester, anion or cation. Further information on the active substances and on the certified limits of formulants is considered confidential and is provided separately (Part C). IIIA Certified limits of each component This is not an EC data requirement/ not required by regulation (EU) 2011/545. IIIA Common names and code numbers for the active substance(s) Data Point Type Name/Code Number ISO common name Metamitron Quinmerac CAS No EINECS No None CIPAC No ELINCS None Salt, ester anion or cation present None None IIIA Co-formulant details: identity, structure, codes, trade name, specification and function. CONFIDENTIAL information - data provided separately (Part C). Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

38 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 9 of 23 IIIA Formulation process IIIA Description of formulation process This is not an EC data requirement/ not required regulation (EU) 2011/545. IIIA Discussion of the formation of impurities of toxicological concern There are no relevant impurities in the technical active Substances metamitron and quinmerac as manufactured and the manufacturing process of the formulation AG-QMM1-565 SC is such that no new relevant impurities can be formed. IIIA 1.5 Type of Preparation and Code Type : Suspension concentrate Code : SC IIIA 1.6 Function The product will be used as herbicide. IIIA 1.7 None. Other/Special Studies Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

39 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 10 of 23 IIIA 2 PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT The product AG-QMM1-565 SC is already registered in Germany, Belgium and Netherlands. The complete set of studies on physical, chemical properties of the product has been evaluated and accepted. The storage stability at ambient temperature over a period of 2 years was submitted post authorisation. The results are adequate and demonstrate that the technical characteristics of AG-QMM1-565 SC are acceptable for the suspension concentrate formulation. This study is presented in the following table: Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments Ambient temperature shelf life (IIIA 2.7.5) Standard Operating procedures of AGAN, based on CIPAC methods. Quinmerac 40 g/l + Metamitron 525 g/l SC batch K g/l quinmerac g/l metamitron The product was stable during a two-year storage stability test when stored in original HDPE commercial containers: 1. Appearance and stability of packaging: Initial results: off-white suspension, characteristic odour Final results: same as initial. Y Edelson, 2012, (F10-03/5) Acceptable After storage slight bleeding (~15 %) and slight sedimentation. Nonetheless the product was homogenous after five inversions. 2. A.I. content (g/l) Initial results: Metamitron 540 g/l (46.45%) Quinmerac 41.2 g/l (3.54%) Final results: Metamitron g/l (46.33%) Quinmerac 41.0 g/l (3.53%) Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

40 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 11 of 23 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments 3. ph 1% in deionized water Initial result:3.7 Final result: ph undiluted Initial result:4.4 Final result: Spontaneity of dispersion (%) (water D) 5% v/v Initial result: Quinmerac 94%, Metamitron 95% Final results: Quinmerac 96%, Metamitron 98% 5. Suspensibility (%), water D at 0.5% and at 2.0% Initial results at 0.5% Quinmerac 94%, Metamitron 98% Final result at 0.5%: Quinmerac 90%, Metamitron 97% Initial results at 2.0%: Quinmerac 88%, Metamitron 93% Final result at 2.0%: Quinmerac 85%, Metamitron 93% 6. Wet sieve residue (%) Initial results: Final results: Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

41 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 12 of 23 Test or study & Annex point Method used / deviations Test material purity and specification Findings GLP Y/N Reference Acceptability / comments 7. Particle size distribution (%) Initial results: D (0.9) 9.44 D (0.5) 3.08 D (0.1) 0.81 Final results: D (0.9) D (0.5) 2.28 D (0.1) Pourability (%) Initial results: 3.05 Final results: Rinsed (%) Initial result: 0.17 Final result: 0.23 Conclusion: The product was stable during a two-year storage stability test when stored in original HDPE commercial containers. Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

42 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 13 of 23 IIIA 2.16 Summary and Evaluation of Data Presented Under Points 2.1 to 2.15 The storage stability at ambient temperature over a period of 2 years showed good stability in terms of active substance content and product characteristics. In the present application the lowest in use concentration is 0.25 % (1 L in 400 L water), while in the main application the lowest in use concentration is 0.5 %. No information is available on the suspensibility at 0.25 %, but this is considered acceptable, as the results at 0.5 % are > 90 %. IIIA 3 IIIA 3.1 DATA ON APPLICATION OF THE PLANT PROTECTION PRODUCT Field of Use The application was for approval of AG-QMM1-565 SC (in Germany: Goltix Titan), a suspension concentrate containing 525 g/l Metamitron and 40 g/l Quinmerac, for use as herbicide against annual monocotyledonous weeds, Galium aparine and other annual dicotyledonous weeds in splitting applications. IIIA 3.2 Nature of the Effects on Harmful Organisms Metamitron belongs to the chemical group of triazinones. Metamitron is a selective herbicide to be used in fodder- and sugar beet for the control of mono- and dicotyledonous weeds. Primarily it is taken up by plant roots and shoots and is translocated acropetally to the chloroplasts. Also a plant uptake through the leaves is possible. Like other triazinones, metamitron acts as an inhibitor of photosynthetic electron transport at the photosystem II receptor site (Hill-reaction). Mode of action (HRAC-group): C1 Quinmerac belongs to the chemical group of quinolinecarboxylic acids. Quinmerac is absorbed primarily via the root system but can also be absorbed from the foliage. Adequate soil moisture supports the uptake by roots and the onset of activity. Uptake by leaves depends on the concentration of the active ingredient and time. Light increases the uptake rate. In contrast dependence on temperature is slight. Its mode of action has been proposed as root growth inhibition which exhibits auxin type effects (similar to phenoxycarboxylic acids). Mode of action (HRAC-group): O IIIA 3.3 IIIA Details of Intended Use Details of existing and intended uses Please refer to Appendix 2 Critical Uses and Part B Section 7. IIIA Details of harmful organisms against which protection is afforded Please refer to Appendix 2 Critical Uses and Part B Section 7. IIIA Effects achieved Please refer to Part B Section 7. IIIA 3.4 Proposed Application Rates (Active Substance and Preparation) Please refer to Appendix 2 Critical Uses and Part B Section 7. IIIA 3.5 Concentration of the Active Substance in the Material Used Please refer to Appendix 2 Critical Uses and Part B Section 7. IIIA 3.6 Method of Application, Type of Equipment Used and Volume of Diluent Please refer to Appendix 2 Critical Uses and Part B Section 7. Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

43 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 14 of 23 IIIA 3.7 IIIA Number and Timings of Applications, Timing, Growth Stages (of Crop and Harmful Organism) and Duration of Protection Maximum number of applications and their timings Please refer to Appendix 2 Critical Uses and Part B Section 7. IIIA Growth stages of crops or plants to be protected Please refer to Appendix 2 Critical Uses and Part B Section 7. IIIA Development stages of the harmful organism concerned Please refer to Appendix 2 Critical Uses and Part B Section 7. IIIA Please refer to Part B Section 7. IIIA Please refer to Part B Section 7. IIIA 3.8 IIIA Please refer to Part B Section 7. IIIA Please refer to Part B Section 7. IIIA Please refer to Part B Section 7. IIIA 3.9 Duration of protection afforded by each application Duration of protection afforded by the maximum number of applications Necessary Waiting Periods or Other Precautions to Avoid Phytotoxic Effects on Succeeding Crops Minimum waiting periods or other precautions between last application and sowing or planting succeeding crops Limitations on choice of succeeding crops Description of damage to rotational crops Proposed Instructions for Use as Printed on Labels Please refer to Registration Report Part A, Appendix 2 for the relevant country. IIIA 3.10 Other/Special Studies This is not an EC data requirement/ not required by Directive 91/414/EEC. Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

44 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 15 of 23 IIIA 4 FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT IIIA 4.1 Packaging and Compatibility with the Preparation There is no change compared to the main application. Therefore no further evaluation is necessary. IIIA 4.2 Procedures for Cleaning Application Equipment There is no change compared to the main application. Therefore no further evaluation is necessary. IIIA 4.3 IIIA IIIA IIIA IIIA IIIA IIIA IIIA IIIA 4.4 Re-entry Periods to Protect Man, Livestock and the Environment Pre-harvest interval (in days) for each relevant crop See section 4. Re-entry period (in days) for livestock, to areas to be grazed See section 4. Re-entry period (in hours or days) for man to crops, buildings or spaces treated See section 4. Withholding period (in days) for animal feeding stuffs See section 4. Waiting period (in days) between application and handling of treated products See section 4. Waiting period (in days) between last application and sowing or planting succeeding crops See section 4. Information on specific conditions under which the preparation may or may not be used See section 4. Statement of the Risks Arising and the Recommended Methods and Precautions and Handling Procedures to Minimise Those Risks There is no change compared to the main application. Therefore no further evaluation is necessary. IIIA 11 IIIA 11.1 FURTHER INFORMATION Information of Authorisations in Other Countries An overview of the existing approvals in EC member states of metamitron and quinmerac is given in Appendix 3A and Appendix 3B, respectively. 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 on June 8, 2010, Internet: index.cfm). See also Table and Table in chapter 8.7. Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

45 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 16 of 23 MRLs established in exporting countries for pyraclostrobin and epoxiconazole are given in Appendix 3C and Appendix 3D, respectively. IIIA 11.3 Justified Proposals for Classification and Labelling Proposals for classification and labelling of AGG-QMM1-565 SC in accordance with the EC Directive on dangerous preparations 1999/45/EC and Directive 2001/59/EC (as amended) are presented below: Physico - chemical properties There is no change compared to the main application. Therefore no further evaluation is necessary. Toxicology Please refer to Registration Report Part B section 3. Ecotoxicology/Environment Please refer to Registration Report Part B section 6. IIIA 11.4 Proposals for Risk and Safety Labels 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 not provided as there was no request.. Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

46 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 17 of 23 Appendix 1: List of data used in support of the evaluation Annex point/ reference No Author(s) Year Title Source (where different from company) Report-No. GLP or GEP status (where relevant) Data protection claimed Owner How considered in drr Study-Status / Usage * KIIIA Edelson, T., Nahmoud, S Determination of storage stability and phys-chem properties of (quinmerac 40 g/l + metamitron 525 g/l) SC stored at ambient temperature for two years AGAN Chemical Manufacturers, Ltd., Ashdod, Israel Quena Plant Protection N.V., F10-03/5, GLP: Yes Published: No yes ADAMA 1 * 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) Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

47 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 18 of 23 Appendix 2: Critical Uses justification and GAP tables GAP-Table of intended uses for Germany PPP (product name/code) active substance 1 active substance 2 Goltix Titan Metamitron Quinmerac Formulation type: Conc. of as 1: Conc. of as 2: GAP rev. (No), date: SC 525 g/l 40 g/l Applicant: Zone(s): central/eu Feinchemie Schwebda GmbH professional use non professional use X Verified by MS: yes Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) 001 DE Sugar beet BEAVA fodder beet BEAVC F G or I F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Annual monocotyledonous weeds TTTMS Annual dicotyledonous weeds TTTDS Method / Kind Spraying splitting 4 applications Application Application rate PHI Max. number kg, L product / g, kg as/ha Water L/ha (days) (min. interval ha between a) max. rate per a) max. rate min / max applications) appl. per appl. a) per use Timing / Growth stage of crop & season Spring BBCH st treatment beforeemergence 2 nd to 4 th treatment after emergence b) per crop/ season a) 4 b) 4 the 2 nd to 4 th treatment with an interval of 5 to 10 days b) max. total rate per crop/season a) timing 1: 3 L/ha timing 2: 1 L/ha timing 3: 1 L/ha timing 4: 1 L/ha b) max. total rate per crop/season a) timing 1: Metamitron 1575 g as/ha Quinmerac 120 g as/ha Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures *XF WH9161 Annual monocotyledonous weeds are withdrawn by the applicant, because not enough data regarding efficacy available. timing 2: Metamitron Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

48 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 19 of g as/ha Quinmerac 40 g as/ha timing 3: Metamitron 525 g as/ha Quinmerac 40 g as/ha b) 6 L/ha maximum application rate for the intented crop per year timing 4: Metamitron 525 g as/ha Quinmerac 40 g as/ha b) Metamitron 3150 g as/ha Quinmerac 240 g as/ha maximum application rate for the intented crop per year *The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in days is not required resp. Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

49 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 20 of 23 Remarks: (1) Numeration of uses in accordance with the application/as verified by MS (2) Member State(s) or zone for which use is applied for (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (4) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (5) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds, developmental stages (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (7) Growth stage of treatment(s) (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (8) The maximum number of applications possible under practical conditions of use for each single application and per year (permanent crops) or crop (annual crops) must be provided (8) Min. interval between applications (days) were relevant (10) The application rate of the product a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. kg or L product / ha) (11) The application rate of the active substance a) max. rate per appl. and b) max. total rate per crop/season must be given in metric units (e.g. g or kg / ha) (12) The range (min/max) of water volume under practical conditions of use must be given (L/ha) (13) PHI - minimum pre-harvest interval (14) Remarks may include: Extent of use/economic importance/restrictions/minor use etc. Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

50 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 21 of 23 GAP-Table of intended uses for all cms (without Germany), not verified by zrms PPP (product name/code) AG-QMM1-565 SC Formulation type: SC (suspension concentrate) active substance 1 Metamitron Conc. of as 1: 525 g/l active substance 2 Quinmerac Conc. of as 2: 40 g/l active substance Conc. of as: safener - synergist - Conc. of safener: - Conc. of synergist: - Applicant: Zone(s): central/eu Feinchemie Schwebda GmbH professional use non professional use Verified by MS: no Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Application Application rate PHI (days) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures Method / Kind Timing / Growth stage of crop & season Max. number (min. interval between applications) a) per use b) per crop/ season kg, L product / ha a) max. rate per appl. b) max. total rate per crop/season g as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha min / max 1 NL, BE Beets (sugar and F GALAP and other annual spraying BBCH 10- a) 1-3 (5) a) 2 a) Metamitron: / 400 F Max. 2.0 L product/ha per treatment Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

51 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 22 of 23 fodder) Use already authorised dicotyledonous weed species 19 b) 3 b) 6 Quinmerac: 80 b) Metamitron: 3150 Quinmerac: 240 Total 6.0 L product/ha Max. once per three years on same field 2 NL, BE Beets (sugar and fodder) F Poa annua POAAN, Galium aparine GALAP, annual dicotyledonous weeds (TTTDS) spraying BBCH BBCH a) 1 b) 1 a) 1-3 (5) b) 3 a) 3 b) 3 a) 1 b) 3 a) Metamitron: 1575 Quinmerac: 120 b) Metamitron: 1575 Quinmerac: 120 a) Metamitron: 525 Quinmerac: 40 b) Metamitron: 1575 Quinmerac: / / 400 F F Total 6.0 L product/ha Max. once per three years on same field 3 NL, BE Beets (sugar and fodder) withdrawn by applicant on 14 February 2014 F POAAN, GALAP and other annual dicotyledonous weed species spraying BBCH BBCH BBCH a) 1 b) 1 a) 1-4 (5) b) 4 a) 3 b) 3 a) 1,25 b) 3,25 a) Metamitron: 1575 Quinmerac: 120 b) Metamitron: 1575 Quinmerac: 120 a) Metamitron: 656 Quinmerac: 50 b) Metamitron: 1706 Quinmerac: 130 a) Metamitron: 525 Quinmerac: 40 b) Metamitron: 1575 Quinmerac: / / / 400 F F F Pre-emergence: L fp/ha Post-emergence: Max. individual application rate: 3.0 L fp/ha, E.g L; L L L; L + 1 x 1.75 L fp/ha; or combinations of other uses with 0.75 L/ha min). Max. total post-emergence applied of 3.25 L fp/ha Max use rate of 250 g/ha Quinmerac is restricted on Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

52 Part B Section 1 Core Assessment Germany AG-QMM1-565 SC Goltix Titan Registration Report Page 23 of 23 the same field per year. withdrawn by applicant on 14 February NL, BE Beets (sugar and fodder) withdrawn by applicant on 14 February 2014 F POAAN, GALAP and other annual dicotyledonous weed species spraying BBCH a) 1 (5) b) 6 a) 0,75 b) 1,25 a) Metamitron: 394 Quinmerac: 30 b Metamitron: 656 Quinmerac: / 400 F Max. individual application rate: 1.25 L fp/ha, e.g L fp/ha or uses in between Max use rate of 250 g/ha Quinmerac is restricted on the same field per year. withdrawn by applicant on 14 February 2014 Indication 1 is already authorised Indication 3 and 4 only as national addendum withdrawn by applicant on 14 February 2014 Applicant ADAMA Deutschland GmbH Evaluator: DE Date February 2016

53 Part B Section 2 Core Assessment Germany AG-QMM1-565 SC Goltix Gold Registration Report Page 1 of 4 REGISTRATION REPORT Part B Section 2 Analytical Methods Detailed summary of the risk assessment Product code: Goltix Titan (AG-QMM1-565 SC) Active Substance: Metamitron g/l Quinmerac 40.0 g/l Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Feinchemie Schwebda GmbH Submission Date: October 2011 Date: June 2015 Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015

54 Part B Section 2 Core Assessment Germany AG-QMM1-565 SC Goltix Gold Registration Report Page 2 of 4 Table of Contents IIIA 5 METHODS OF ANALYSIS... 3 IIIA 5.1 Analytical Standards and Samples... 3 IIIA 5.2 Methods for the Analysis of the Plant Protection Product... 3 IIIA 5.3 Description of Analytical Methods for the Determination of Residues... 3 IIIA 5.4 Other/Special Studies... 3 Appendix 1 List of data submitted in support of the evaluation... 4 Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015

55 Part B Section 2 Core Assessment Germany AG-QMM1-565 SC Goltix Gold Registration Report Page 3 of 4 IIIA 5 METHODS OF ANALYSIS This document summarises the information related to the analytical methods for the product Goltix Titan (AQMM1-565 SC) containing the active substances metamitron and quinmerac which were 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. Where appropriate this document refers to the conclusions of the EU review of metamitron and quinmerac. This will be where: the active substance data are relied upon in the risk assessment of the formulation; or when the EU review concluded that additional data/information should be considered at national reregistration. The SANCO report for Metamitron (SANCO/208/08 final 6 Januar 2009) and Quinmerac (SANCO/12192/2010 final 7 December 2010) are considered to provide the relevant review information or a reference to where such information can be found. 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. The Annex I Inclusion Directive for Metamitron (2008/125/EC) and Quinmerac (2010/89/EU) 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. However, these provisions do not pertain the methods of analysis of the active ingredients and the authorization of the product AG-QMM1-565 SC. 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 AG-QMM1-565 SC can be found in the confidential dossier of this submission (Registration Report - Part C). IIIA 5.1 Analytical Standards and Samples There is no change compared to the main application. Therefore, no further evaluation is necessary. IIIA 5.2 Methods for the Analysis of the Plant Protection Product There is no change compared to the main application. Therefore, no further evaluation is necessary. IIIA 5.3 Description of Analytical Methods for the Determination of Residues There is no change compared to the main application. Therefore, no further evaluation is necessary. IIIA 5.4 Other/Special Studies None Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015

56 Part B Section 2 Core Assessment Germany AG-QMM1-565 SC Goltix Gold Registration Report Page 4 of 4 Appendix 1 List of data submitted in support of the evaluation Annex point OECD Author Year Title Source (where different from company) Company, Report No. GLP or GEP status (where relevant) Published or Unpublished Data protection claimed Yes/No Owner Applicant ADAMA Deutschland GmbH Evaluator: DE Date: June 2015

57 ZV /01 Part B Section 3 - Core Assessment zrms version REGISTRATION REPORT Part B Section 3: Mammalian Toxicology Detailed summary of the risk assessment Product name/code: Active Substances: Metamitron (525 g/l) Quinmerac (40 g/l) Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: ADAMA Deutschland GmbH Date: April 2016 Page 1 / 22

58 ZV /01 Part B Section 3 - Core Assessment zrms version Table of Contents 3 Mammalian Toxicology (IIIA 7) Summary Toxicological Information on Active Substances Toxicological Evaluation of Plant Protection Product Toxicological evaluation of groundwater metabolites Dermal Absorption (IIIA 7.6) Justification for proposed values - metamitron Justification for proposed values - quinmerac Exposure Assessment of Plant Protection Product Selection of critical use and justification Operator (IIIA 7.3) Estimation of operator Measurement of operator Worker (IIIA 7.5) Estimation of worker Measurement of worker Bystander and resident (IIIA 7.4) Estimation of bystander and resident Measurement of bystander and/or resident Statement on combined... 9 Appendix 1 Exposure calculations A 1.1 Operator calculations (IIIA ) A Calculations for metamitron A Calculations for quinmerac A 1.2 Worker calculations (IIIA ) A Calculations for metamitron A Calculations for quinmerac A 1.3 Bystander and resident calculations (IIIA ) A Calculations for metamitron A Calculations for quinmerac Page 2 / 22

59 ZV /01 Part B Section 3 - Core Assessment zrms version 3 Mammalian Toxicology (IIIA 7) 3.1 Summary Table 3.1-1: Information on Goltix Titan/AG-QMM1-565 SC * Product name and code Formulation type Active substances (incl. content) Function Product already evaluated as the representative formulation during the Annex I inclusion Goltix Titan/AG-QMM1-565 SC (ADD H-0-SC) Suspension concentrate Metamitron; 525 g/l Quinmerac; 40 g/l Herbicide No Toxicity and other GAPs for this product previously evaluated according to Uniform Principles Yes, in Germany * Information on the detailed composition of Goltix Titan/AG-QMM1-565 SC can be found in the confidential Part C of the RR (main application). Justified proposals for classification and labelling In accordance 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 and labelling with regard to toxicological data is proposed for the preparation: Table 3.1-2: Justified proposals for classification and labelling C&L according to Regulation (EC) No 1272/2008 Hazard classes, categories: Signal word: Hazard statements: Precautionary statements: Additional labelling phrases: None None None None To avoid risks to human health and the environment, comply with the instructions for use. [EUH401] 'Contains 1,2-Benzisothiazol-3-(2H)-one (CAS No ). May produce an allergic reaction.' [EUH208] * * This phrase is necessary due to the concentration of this compound (> %) in the formulation according to Regulation (EC) No 286/2011 in conjunction with Regulation (EC) No 1272/2008 Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents for Goltix Titan/AG-QMM1-565 SC Result PPE / Risk mitigation measures Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to health damage. [SB001] - If medical advice is needed, have product container or label at hand. [SB005] - Keep out of children's reach. [SB010] - The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection Page 3 / 22

60 ZV /01 Part B Section 3 - Core Assessment zrms version products" of the Federal Office of Consumer Protection and Food Safety must be observed. [SB110] - Do not eat, drink or smoke when using this product. [SB166] - When applying the product with tractor-mounted, trailed or selfpropelled application equipment, only vehicles with closed pressurized cabins (e.g. cabin category 3, if no respiratory protective equipment or particle-filtering masks are necessary or category 4, if gas-tight respiratory protective equipment is needed acc. to EN and -2) are suited to replace personal protective equipment during application. During all other activities outside of the cabin the prescribed personal protective equipment must be worn. In order to avoid contamination of the cabin, it is not permitted to enter the cabin with contaminated personal protective equipment (it should be deposited e.g. in an appropriate storage facility). Contaminated gloves should be washed before removing the gloves and hands should be washed before entering the cabin with pure water, respectively. [SB199] - Wear standard protective gloves (plant protection) when handling the undiluted product. [SS110] - Wear standard protective gloves (plant protection) when handling/applying the product ready for application. [SS120] - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. [SS2101] - Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. [SS2202] Workers Acceptable - Re-entering the treated area(s)/crop(s) is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn. [SF1891] Bystanders Acceptable None Residents Acceptable None The risk assessment according to the German model has shown that the estimated towards metamitron and quinmerac in Goltix Titan/AG-QMM1-565 SC within this extended application will not exceed the particular systemic AOEL for operators, workers, bystanders and residents. Operator and worker will be below the systemic AOEL only, if prescribed PPE is worn. The risk assessment according to the UK-POEM has shown that the estimated towards metamitron and quinmerac in Goltix Titan/AG-QMM1-565 SC within this extended application will exceed the particular systemic AOEL for operators even if PPE is worn. Further reduction of is to be expected due to necessary PPE allocated according to dangerous substances regulations. A summary of the critical uses and the overall conclusion regarding for operators, workers and bystanders/residents is presented in Table Page 4 / 22

61 ZV /01 Part B Section 3 - Core Assessment zrms version Table 3.1-4: Critical uses and overall conclusion of assessment Crops 1) and situation (e.g. growth stage of crop) F/G or I 2) Application Application rate kg as/ha Remarks: (e.g. surfactant (L /ha)) Sugar and fodder beet (BBCH 00-19), 1 st application pre-emergence, 2 nd to 4 th application postemergence F Method / Kind (incl. application technique 3) ) Spraying, splitting: 4 applications; LCTM Max. number (min. interval between applications) a) per use b) per crop/ season a) 4 b) 4 (2 nd to 4 th application: 5-10 days) a) max. rate per appl. b) max. total rate per crop/season a) Metamitron: 1 st : kg/ha 2 nd : kg/ha 3 rd : kg/ha 4 th : kg/ha Quinmerac: 1 st : kg/ha 2 nd : kg/ha 3 rd : kg/ha 4 th : kg/ha b) Metamitron: kg/ha Quinmerac: kg/ha Water L/ha min / max critical gap for operator, worker, bystander or resident based on [Exposure model] German model UK POEM Acceptability of assessment Operator Worker Bystander Residents Exposure acceptable without PPE / risk mitigation measures Further refinement and/or risk mitigation measures required Exposure not acceptable/ Evaluation not possible 1) Pooled critical GAPS with the same max. application rate per application and using the same application technique 2) F: field or outdoor application, G: greenhouse application, I: indoor application 3) LC: low crops, TM: tractor-mounted 3.2 Toxicological Information on Active Substances For the toxicological information on the active substances quinmerac and metamitron it is referred to the RR in the context of the main application. 3.3 Toxicological Evaluation of Plant Protection Product For the toxicological evaluation for Goltix Titan/AG-QMM1-565 SC it is referred to the RR in the context of the main application. The resulting classification and labelling for Goltix Titan/AG-QMM1-565 SC is given above in Table Toxicological evaluation of groundwater metabolites The quinmerac metabolites BH and BH are predicted to occur in groundwater in concentrations above 0.1 µg/l. The toxicological relevance assessment of these groundwater metabolites according to the EC guidance document SANCO/221/2000 rev.10 is presented in Section 8 of the drr. 3.5 Dermal Absorption (IIIA 7.6) A summary of the dermal absorption endpoints for the active substances in Goltix Titan/AG-QMM1-565 SC is presented in Table Page 5 / 22

62 ZV /01 Part B Section 3 - Core Assessment zrms version Table 3.5-1: Dermal absorption endpoints used for the risk assessment for active substances in Goltix Titan/AG-QMM1-565 SC Metamitron Quinmerac Value Reference Value Reference Concentrate 1 % EFSA Conclusion for Goltix SC 700 Dilution (1 : 400) 20 % EFSA Conclusion for Goltix SC % Default according to EFSA Guidance on Dermal Absorption, EFSA Journal 2012; 10(4): % Default according to EFSA Guidance on Dermal Absorption, EFSA Journal 2012; 10(4): Justification for proposed values - metamitron Proposed endpoints for metamitron are based on dermal absorption studies with the very similar formulation Goltix 700 SC containing 700 g/l metamitron. The studies were summarised in the EFSA conclusion on metamitron (EFSA Scientific Report (2008) 185, 1-95, ASB ). Goltix 700 SC, in comparison to Goltix Titan, contains the same or similar co-formulants in similar amounts. It is noted that the highest tested dilution in the studies was 1:200 (3.5 g/l metamitron) whereas the highest dilution for this use is 1:400 (1.3 g/l). Since the studies have already been assessed and accepted at EU level no summaries are provided Justification for proposed values - quinmerac Since the composition of the product tested in the dermal absorption study submitted for the main application of Goltix Titan, i.e. an SC formulation containing 125 g/l quinmerac and 375 g/l metazachlor (Fuego Top, ), cannot be considered comparable to Goltix Titan according to the criteria by EFSA Guidance on Dermal Absorption (content of co-formulants exceeds ± 25 % w/w of that in the reference formulation), the results of this study (ASB ) cannot be used for this risk assessment. Therefore, default values are taken into account for the risk assessment within this extended authorisation. Thus, 75 % dermal absorption have to be considered for the concentrate (< 5 % w/w of active substance in the product) as well as for the dilution. In contrast to the present evaluation, bridging of the submitted dermal absorption study on Fuego Top was accepted for the risk assessment during the main application procedure, because this was carried out prior to implementation of the criteria laid down in the EFSA Guidance on Dermal Absorption. 3.6 Exposure Assessment of Plant Protection Product Table 3.6-1: Product information and toxicological reference values used for assessment Product name and code Goltix Titan/AG-QMM1-565 SC (ADD H-0-SC) Formulation type Suspension concentrate Category Herbicide Container sizes, short Bottles (1 L) and canisters (5-20 L), HDPE, openings mm description Active substance(s) (incl. content) Metamitron 525 g/l Quinmerac 40 g/l AOEL systemic mg/kg bw/d 0.08 mg/kg bw/d Inhalative absorption 100 % 100 % Oral absorption 100 % 100 % Page 6 / 22

63 ZV /01 Part B Section 3 - Core Assessment zrms version Dermal absorption Concentrate: 1 % Dilution: 20 % (tested: 3.5 g/l) Goltix SC 700 Concentrate: 75 % (active substance < 5 % w/w in the product) Dilution: 75 % (active substance < 5 % w/w in the spray dilution) Both values defaults Selection of critical use and justification The critical GAP used for the assessment within the scope of this approval extension for the plant protection product is shown in Table Operator (IIIA 7.3) Estimation of operator A summary of the models used for estimation of operator to the active substances during application of Goltix Titan/AG-QMM1-565 SC according to the critical use presented in Table Outcome of the estimation is presented in Table Detailed calculations are in Appendix 1. Table 3.6-2: Critical use Model Critical use Model Exposure models for intended uses Sugar and fodder beets (max. 3 L product/ha) German model [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] Sugar and fodder beets (max. 3 L product/ha) Revised UK-POEM [Estimation of Exposure and Absorption of Pesticides by Spray Operators, Scientific subcommittee on Pesticides and British Agrochemical Association Joint Medical Panel Report (UK MAFF), 1986 and the Predictive Operator Exposure Model (POEM) V 1.0, (UK MAFF), 1992] Table 3.6-3: Estimated operator Metamitron Model data Level of PPE Total absorbed dose (mg/kg/day) Tractor mounted boom spray application outdoors to low crops % of systemic AOEL Quinmerac Total absorbed dose (mg/kg/day) % of systemic AOEL Application rate: kg a.s./ha kg a.s./ha German Model no PPE 1) Body weight: 70 kg + Gloves mixing/loading UK POEM Application volume: 200 L/ha Container: 10 L, 63 mm closure Body weight: 60 kg and application as well as protective suit application) no PPE 2) Gloves mixing/loading and application ) no PPE: Operator wearing T-shirt and shorts 2) no PPE: Operator wearing long sleeved shirt, long trousers ( permeable ) but no gloves Page 7 / 22

64 ZV /01 Part B Section 3 - Core Assessment zrms version Measurement of operator Since the operator estimations carried out according to the German model indicated that the acceptable operator level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of operator was not necessary and was therefore not performed Worker (IIIA 7.5) Estimation of worker Table shows the model used for estimation of worker after entry into a previously treated area or handling a crop treated with Goltix Titan/AG-QMM1-565 SC according to the critical use. Outcome of the estimation is presented in Table Detailed calculations are in Appendix 1. Table 3.6-4: Exposure models for intended uses Critical use Sugar and fodder beets (max. 6 L product/ha and year *), worst case Model German re-entry model, Krebs et al. (2000) [Uniform Principles for Safeguarding the Health of Workers Re-entering Crop Growing Areas after Application of Plant Protection Products, Nachrichtenbl. Deut. Pflanzenschutzdienst., 52(1), p. 5-9] * maximum application rate in theses crops per year irrespective of number of applications Table 3.6-5: Estimated worker Model data Level of PPE Total absorbed dose (mg/kg/day) Metamitron % of systemic AOEL Total absorbed dose (mg/kg/day) Quinmerac Max. application rate per year: kg a.s./ha kg a.s./ha 2 hours/day 1), TC: 2500 cm 2 /person/h 2) Body weight: 60 kg % of systemic AOEL no PPE 3) with PPE 4) ) 2 h/day for professional applications for maintenance, inspection or irrigation activities etc. 2) US-EPA policy paper [EPA, Science Advisory Council for Exposure; 2000; Agricultural Default Transfer Coefficients, Policy # 003.1, May revised 7 August 2000]. 3) no PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves 4) with PPE: see 'Instructions for use' Measurement of worker Since the worker estimations carried out indicated that the acceptable operator level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of worker was not necessary and was therefore not performed Bystander and resident (IIIA 7.4) Estimation of bystander and resident Table shows the model used for estimation of bystander and resident to metamitron and quinmerac. Outcome of the estimation is presented in Table Detailed calculations are in Appendix 1. Page 8 / 22

65 ZV /01 Part B Section 3 - Core Assessment zrms version Table 3.6-6: Exposure models for intended uses Critical use Model Sugar and fodder beets (max. 3 L product/ha (bystander) or 6 L product/ha and year, worst case, with 4 applications * (resident), respectively) Martin, S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and Residents Exposed to Plant Protection Products During and After Application; J. Verbr. Lebensm. 3 (2008): Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06 January 2012, Issue No. 4, pp * maximum application rate in theses crops per year irrespective of number of applications Table 3.6-7: Estimated bystander and resident Model data Total absorbed dose (mg/kg/day) Metamitron % of systemic AOEL Total absorbed dose (mg/kg/day) Quinmerac Tractor mounted boom spray application outdoors to low crops Application rate: kg a.s./ha kg a.s./ha Bystanders (adult) Drift rate: 2.77 % (1 m) Body weight: 60 kg Bystanders (children) Drift rate: 2.77 % (1 m) Body weight: kg % of systemic AOEL Tractor mounted boom spray application outdoors to low crops Application rate: kg a.s./ha kg a.s./ha Residents (adult) Drift rate: 1.85 % *(1 m) Body weight: 60 kg Residents (children) Drift rate: 1.85 % *(1 m) Body weight: kg * for 4 applications Measurement of bystander and/or resident Since the bystander and/or resident estimations carried out indicated that the acceptable operator level (AOEL) for metamitron and quinmerac will not be exceeded under conditions of intended uses, a study to provide measurements of bystander/resident was not necessary and was therefore not performed Statement on combined The product is a mixture of two active substances. From a scientific point of view it is regarded necessary to take into account potential combination effects. However, the evaluation of cumulative or synergistic effects as requested by 4 (3b) of Regulation (EC) No. 1107/2009 should only be performed, if harmonised scientific methods accepted by the authorities are available. The combined toxicological effect of metamitron and quinmerac has not been investigated with regard to repeated dose toxicity. Page 9 / 22

66 ZV /01 Part B Section 3 - Core Assessment zrms version Appendix 1 Exposure calculations A 1.1 Operator calculations (IIIA ) A Calculations for metamitron Table A 1: Input parameters considered for the estimation of operator Formulation type: Application rate (AR): SC kg a.s./ha Application technique: Field Crop Tractor Mounted (FCTM) Area treated per day (A): 20 ha Dermal hands m/l (DM(H)): 2.4 mg/person/kg a.s. Dermal absorption (DA): 1 % (concentr.) Dermal hands appl. (DA(H)): 0.38 mg/person/kg a.s. 20 % (dilution) Dermal body appl. (DA(B)): 1.6 mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 0.06 mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (IM): mg/person/kg a.s. AOEL mg/kg bw/d Inhalation appl. (IA): mg/person/kg a.s. Table A 2: Estimation of operator towards metamitron using the German model Without PPE With PPE Operators: Systemic dermal after application in sugar and fodder beets Dermal during mixing/loading Hands SDEOM(H) = (DM(H) x AR x A x DA) / BW Hands SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW (2.4 x x 20 x 1%) / 70 (2.4 x x 20 x 0.01 x 1%) / 70 External dermal External dermal 75.6 mg/person mg/person External dermal External dermal 1.08 mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Dermal during application Hands SDEOA(H) = (DA(H) x AR x A x DA) / BW Hands SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW (0.38 x x 20 x 20%) / 70 (0.38 x x 20 x 0.01 x 20%) / 70 External dermal External dermal mg/person mg/person External dermal External dermal mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Body Body SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE 2) x DA) / BW (1.6 x x 20 x 20%) / 70 (1.6 x x 20 x 0.05 x 20%) / 70 External dermal External dermal 50.4 mg/person 2.52 mg/person External dermal External dermal 0.72 mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Head Head SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW (0.06 x x 20 x 20%) / 70 (0.06 x x 20 x 1 x 20%) / 70 External dermal External dermal 1.89 mg/person 1.89 mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Page 10 / 22

67 ZV /01 Part B Section 3 - Core Assessment zrms version Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Total systemic dermal : SDEO = SDEOM(H) + SDEOA(H) + SDEOA(B) + SDEOA(C) Total systemic dermal : SDEO = SDEOM(H) + SDEOA(H) + SDEOA(B) + SDEOA(C) Total external dermal Total external dermal mg/person mg/person Total external dermal Total external dermal mg/kg bw/d mg/kg bw/d Total systemic Total systemic mg/kg bw/d dermal dermal mg/kg bw/d Operators: Systemic inhalation after application in sugar and fodder beets Inhalation during mixing/loading SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW ( x x 20 x 100%) / 70 ( x x 20 x 1 x 100%) / 70 External inhalation External inhalation mg/person mg/person External inhalation External inhalation mg/kg bw/d mg/kg bw/d Systemic inhalation Systemic inhalation mg/kg bw/d mg/kg bw/d Inhalation during application SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW (0.001 x x 20 x 100%) / 70 (0.001 x x 20 x 1 x 100%) / 70 External inhalation External inhalation mg/person mg/person External inhalation External inhalation mg/kg bw/d mg/kg bw/d Systemic inhalation Systemic inhalation mg/kg bw/d mg/kg bw/d Total systemic inhalation : SIEO = SIEOM + SIEOA Total systemic inhalation : SIEO = SIEOM + SIEOA Total external Total external mg/person inhalation inhalation mg/person Total external Total external mg/kg bw/d inhalation inhalation mg/kg bw/d Total systemic Total systemic mg/kg bw/d inhalation inhalation mg/kg bw/d Total systemic : SEO = SDEO + SIEO Total systemic : SEO = SDEO + SIEO Total systemic Total systemic mg/person mg/person Total systemic Total systemic mg/kg bw/d mg/kg bw/d % of AOEL % % of AOEL 38.3 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.) Table A 3: Estimation of operator towards metamitron using the UK POEM Without PPE Active substance Metamitron Product Goltix Titan (AG-QMM1-565 SC) Formulation type water-based Concentration of a.s. 525 mg/ml Dose 3 L preparation/ha (1.575 kg a.s./ha) Application volume 200 L/ha Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles Container 10 litres 63 mm closure Work rate/day 50 ha Duration of spraying 6 h PPE during mix./loading None Page 11 / 22

68 ZV /01 Part B Section 3 - Core Assessment zrms version PPE during application None Dermal absorption from product 1 % Dermal absorption from spray 20 % EXPOSURE DURING MIXING AND LOADING Container size 10 Litres Hand contamination/operation 0,05 ml Application dose 3 Litres product/ha Work rate 50 ha/day Number of operations 15 /day Hand contamination 0.75 ml/day Protective clothing None Transmission to skin 100 % Dermal to formulation 0.75 ml/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles Application volume 200 spray/ha Volume of surface contamination 10 ml/h Distribution Hands Trunk Legs 65% 10% 25% Clothing None Permeable Permeable Penetration 100% 5% 15% Dermal ml/h Duration of 6 h Total dermal to spray ml/day ABSORBED DERMAL DOSE Mix/load Application Dermal 0.75 ml/day ml/day Concen. of a.s. product or spray 525 mg/ml mg/ml Dermal to a.s mg/day mg/day Percent absorbed 1 % 20 % Absorbed dose mg/day mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation 0.01 ml/h Duration of 6 h Concentration of a.s. in spray mg/ml Inhalation to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator mg/kg bw/day Amount of AOEL % With PPE Active substance Metamitron Product Goltix Titan (AG-QMM1-565 SC) Formulation type water-based Concentration of a.s. 525 mg/ml Dose 3 L preparation/ha (1.575 kg a.s./ha) Application volume 200 L/ha Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles Container 10 litres 63 mm closure Work rate/day 50 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves Dermal absorption from product 1 % Dermal absorption from spray 20 % Page 12 / 22

69 ZV /01 Part B Section 3 - Core Assessment zrms version EXPOSURE DURING MIXING AND LOADING Container size 10 Litres Hand contamination/operation 0,05 ml Application dose 3 Litres product/ha Work rate 50 ha/day Number of operations 15 /day Hand contamination 0.75 ml/day Protective clothing Gloves Transmission to skin 5 % Dermal to formulation ml/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles Application volume 200 spray/ha Volume of surface contamination 10 ml/h Distribution Hands Trunk Legs 65% 10% 25% Clothing Gloves Permeable Permeable Penetration 10% 5% 15% Dermal ml/h Duration of 6 h Total dermal to spray 6.45 ml/day ABSORBED DERMAL DOSE Mix/load Application Dermal ml/day 6.45 ml/day Concen. of a.s. product or spray 525 mg/ml mg/ml Dermal to a.s mg/day mg/day Percent absorbed 1 % 20 % Absorbed dose mg/day mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation 0.01 ml/h Duration of 6 h Concentration of a.s. in spray mg/ml Inhalation to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator mg/kg bw/day Amount of AOEL % A Table A 4: Calculations for quinmerac Input parameters considered for the estimation of operator Formulation type: Application rate (AR): SC 0.12 kg a.s./ha Application technique: Field Crop Tractor Mounted (FCTM) Area treated per day (A): 20 ha Dermal hands m/l (DM(H)): 2.4 mg/person/kg a.s. 75 % (concentr.) Dermal hands appl. (DA(H)): 0.38 mg/person/kg a.s. Dermal absorption (DA): 75 % (dilution) Dermal body appl. (DA(B)): 1.6 mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 0.06 mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (IM): mg/person/kg a.s. AOEL 0.08 mg/kg bw/d Inhalation appl. (IA): mg/person/kg a.s. Page 13 / 22

70 ZV /01 Part B Section 3 - Core Assessment zrms version Table A 5: Estimation of operator towards quinmerac using the German model Without PPE With PPE Operators: Systemic dermal after application in sugar and fodder beets Dermal during mixing/loading Hands SDEOM(H) = (DM(H) x AR x A x DA) / BW Hands SDEOM(H) = (DM(H) x AR x A x PPE 1) x DA) / BW (2.4 x 0.12 x 20 x 75%) / 70 (2.4 x 0.12 x 20 x 0.01 x 75%) / 70 External dermal External dermal 5.76 mg/person mg/person External dermal External dermal mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Dermal during application Hands SDEOA(H) = (DA(H) x AR x A x DA) / BW Hands SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW (0.38 x 0.12 x 20 x 75%) / 70 (0.38 x 0.12 x 20 x 0.01 x 75%) / 70 External dermal External dermal mg/person mg/person External dermal External dermal mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Body Body SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE 2) x DA) / BW (1.6 x 0.12 x 20 x 75%) / 70 (1.6 x 0.12 x 20 x 0.05 x 75%) / 70 External dermal External dermal 3.84 mg/person mg/person External dermal External dermal mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Head Head SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW (0.06 x 0.12 x 20 x 75%) / 70 (0.06 x 0.12 x 20 x 1 x 75%) / 70 External dermal External dermal mg/person mg/person External dermal External dermal mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Total systemic dermal : SDEO = SDEOM(H) + SDEOA(H) + SDEOA(B) + SDEOA(C) Total systemic dermal : SDEO = SDEOM(H) + SDEOA(H) + SDEOA(B) + SDEOA(C) Total external dermal Total external dermal mg/person mg/person Total external dermal Total external dermal mg/kg bw/d mg/kg bw/d Total systemic Total systemic mg/kg bw/d dermal dermal mg/kg bw/d Operators: Systemic inhalation after application in Sugar and fodder beets Inhalation during mixing/loading SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW ( x 0.12 x 20 x 100%) / 70 ( x 0.12 x 20 x 1 x 100%) / 70 External inhalation External inhalation mg/person mg/person External inhalation External inhalation mg/kg bw/d mg/kg bw/d Page 14 / 22

71 ZV /01 Part B Section 3 - Core Assessment zrms version Systemic inhalation mg/kg bw/d Inhalation during application SIEOA = (IA x AR x A x IA) / BW Systemic inhalation SIEOA = (IA x AR x A x PPE x IA) / BW mg/kg bw/d (0.001 x 0.12 x 20 x 100%) / 70 (0.001 x 0.12 x 20 x 1 x 100%) / 70 External inhalation External inhalation mg/person mg/person External inhalation External inhalation mg/kg bw/d mg/kg bw/d Systemic inhalation Systemic inhalation mg/kg bw/d mg/kg bw/d Total systemic inhalation : SIEO = SIEOM + SIEOA Total systemic inhalation : SIEO = SIEOM + SIEOA Total external Total external mg/person inhalation inhalation mg/person Total external Total external mg/kg bw/d inhalation inhalation mg/kg bw/d Total systemic Total systemic mg/kg bw/d inhalation inhalation mg/kg bw/d Total systemic : SEO = SDEO + SIEO Total systemic : SEO = SDEO + SIEO Total systemic Total systemic mg/person mg/person Total systemic Total systemic mg/kg bw/d mg/kg bw/d % of AOEL % % of AOEL 5.5 % 1) reduction factor for gloves is 0.01 (professional appl.) 2) reduction factor for protective garment is 0.05 (professional appl.) Table A 6: Without PPE Estimation of operator towards quinmerac using the UK POEM Active substance Quinmerac Product Goltix Titan (AG-QMM1-565 SC) Formulation type water-based Concentration of a.s. 40 mg/ml Dose 3 L preparation/ha (0.12 kg a.s./ha) Application volume 200 L/ha Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles Container 10 litres 63 mm closure Work rate/day 50 ha Duration of spraying 6 h PPE during mix./loading None PPE during application None Dermal absorption from product 75 % Dermal absorption from spray 75 % EXPOSURE DURING MIXING AND LOADING Container size 10 Litres Hand contamination/operation 0,05 ml Application dose 3 Litres product/ha Work rate 50 ha/day Number of operations 15 /day Hand contamination 0.75 ml/day Protective clothing None Transmission to skin 100 % Dermal to formulation 0.75 ml/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles Application volume 200 spray/ha Volume of surface contamination 10 ml/h Distribution Hands Trunk Legs Page 15 / 22

72 ZV /01 Part B Section 3 - Core Assessment zrms version 65% 10% 25% Clothing None Permeable Permeable Penetration 100% 5% 15% Dermal ml/h Duration of 6 h Total dermal to spray ml/day ABSORBED DERMAL DOSE Mix/load Application Dermal 0.75 ml/day ml/day Concen. of a.s. product or spray 40 mg/ml 0.6 mg/ml Dermal to a.s. 30 mg/day mg/day Percent absorbed 75 % 75 % Absorbed dose 22.5 mg/day mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation 0.01 ml/h Duration of 6 h Concentration of a.s. in spray 0.6 mg/ml Inhalation to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator mg/kg bw/day Amount of AOEL % With PPE Active substance Quinmerac Product Goltix Titan (AG-QMM1-565 SC) Formulation type water-based Concentration of a.s. 40 mg/ml Dose 3 L preparation/ha (0.12 kg a.s./ha) Application volume 200 L/ha Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles Container 10 litres 63 mm closure Work rate/day 50 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves Dermal absorption from product 75 % Dermal absorption from spray 75 % EXPOSURE DURING MIXING AND LOADING Container size 10 Litres Hand contamination/operation 0,05 ml Application dose 3 Litres product/ha Work rate 50 ha/day Number of operations 15 /day Hand contamination 0.75 ml/day Protective clothing Gloves Transmission to skin 5 % Dermal to formulation ml/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles Application volume 200 spray/ha Volume of surface contamination 10 ml/h Distribution Hands Trunk Legs 65% 10% 25% Clothing Gloves Permeable Permeable Penetration 10% 5% 15% Page 16 / 22

73 ZV /01 Part B Section 3 - Core Assessment zrms version Dermal ml/h Duration of 6 h Total dermal to spray 6.45 ml/day ABSORBED DERMAL DOSE Mix/load Application Dermal ml/day 6.45 ml/day Concen. of a.s. product or spray 40 mg/ml 0.6 mg/ml Dermal to a.s. 1.5 mg/day 3.87 mg/day Percent absorbed 75 % 75 % Absorbed dose mg/day mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation 0.01 ml/h Duration of 6 h Concentration of a.s. in spray 0.6 mg/ml Inhalation to a.s mg/day Percent absorbed 100 % Absorbed dose mg/day PREDICTED EXPOSURE Total absorbed dose mg/day Operator body weight 60 kg Operator mg/kg bw/day Amount of AOEL 84.7 % A 1.2 Worker calculations (IIIA ) A Calculations for metamitron Table A 7: Input parameters considered for the estimation of worker Intended use(s): Sugar and fodder beets Dislodgeable foliar residues (DFR): 1 µg/cm 2 /kg a.s. Application rate (AR): 3.15 kg a.s./ha 1) Transfer coefficient (TC): 2500 cm 2 /person/h Number of applications (NA): 1 see explanation below Work rate per day (WR): 2 h/d Body weight (BW): 60 kg/person PPE 5 % Dermal absorption (DA): 20 % ('worst case') AOEL mg/kg bw/d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), worst case Table A 8: Estimation of worker towards metamitron using the German reentry model Without PPE 1) With PPE 2) Worker (re-entry): Systemic dermal after application in sugar and fodder beets SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW (1 x 2500 x 2 x 3.15 x 1 x 20%) / 60 (1 x 2500 x 2 x 3.15 x 1 x 5% x 20%) / 60 External dermal mg/person External dermal mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Total systemic 3.15 mg/person Total systemic mg/person Total systemic mg/kg bw/d Total systemic mg/kg bw/d % of AOEL % % of AOEL 7.3 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves 2) acceptable only with PPE: see 'Instructions for use' Page 17 / 22

74 ZV /01 Part B Section 3 - Core Assessment zrms version A Table A 9: Calculations for quinmerac Input parameters considered for the estimation of worker Intended use(s): Sugar and fodder beets Dislodgeable foliar residues (DFR): 1 µg/cm 2 /kg a.s. Application rate (AR): 0.24 kg a.s./ha 1) Transfer coefficient (TC): 2500 cm 2 /person/h Number of applications (NA): 1 see explanation below Work rate per day (WR): 2 h/d Body weight (BW): 60 kg/person PPE 5 % Dermal absorption (DA): 75 % ('worst case') AOEL 0.08 mg/kg bw/d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), worst case Table A 10: Estimation of worker towards quinmerac using the German re-entry model Without PPE 1) With PPE 2) Worker (re-entry): Systemic dermal after application in sugar and fodder beets SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW (1 x 2500 x 2 x 0.24 x 1 x 75%) / 60 (1 x 2500 x 2 x 0.24 x 1 x 5% x 75%) / 60 External dermal 1.2 mg/person External dermal 0.06 mg/person External dermal 0.02 mg/kg bw/d External dermal mg/kg bw/d Total systemic 0.9 mg/person Total systemic mg/person Total systemic mg/kg bw/d Total systemic mg/kg bw/d % of AOEL 18.8 % % of AOEL 0.9 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves 2) acceptable only with PPE: see 'Instructions for use' A 1.3 Bystander and resident calculations (IIIA ) A Calculations for metamitron Table A 11: Input parameters considered for the estimation of bystander Intended use(s): Sugar and fodder beets Drift (D): 2.77 % (FC, 1 m) Application rate (AR): 1.575kg a.s./ha Exposed body surface area 1 m² (adults) 157.5mg/m 2 (BSA): 0.21 m² (children) Body weight (BW): mg/kg a.s. (6 hours, 60kg/person (adults) Specific Inhalation adults) Exposure (I*A): mg/kg a.s. (6 hours, 16.15kg/person (children) children) Dermal absorption (DA): 20% ('worst case') ha/d (based on Area Treated (A): 20 Inhalation absorption (IA): 100% FCTM) AOEL: 0.036mg/kg bw/d Exposure duration (T): 5 min Table A 12: Estimation of bystander towards metamitron Adults Children Bystander: Systemic dermal during/after application in (via spray drift) SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW (157.5 x 2.77% x 1 x 20%) / 60 (157.5 x 2.77% x 0.21 x 20%) / External dermal External dermal mg/person mg/person External dermal External dermal mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Page 18 / 22

75 ZV /01 Part B Section 3 - Core Assessment zrms version Bystander: Systemic inhalation during/after application in Sugar and fodder beets (via spray drift) SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW (0.001 / 360 x x 20 x 5 x 100%) / 60 ( / 360 x x 20 x 5 x 100%) / External inhalation External inhalation mg/person mg/person External inhalation External inhalation mg/kg bw/d mg/kg bw/d Systemic inhalation Systemic inhalation mg/kg bw/d mg/kg bw/d Total systemic : SEB = SDEB + SIEB Total systemic : SEB = SDEB + SIEB Total systemic Total systemic mg/person mg/person Total systemic Total systemic mg/kg bw/d mg/kg bw/d % of AOEL 40.4 % % of AOEL 31.6 % Table A 13: Input parameters considered for the estimation of resident Intended use(s): Sugar and fodder beets Drift (D): 1.85 % (FC, 1 m, 4 appl.) Application rate (AR): 3.15 kg a.s./ha 1) Transfer coefficient 7300 cm 2 /h (adults) mg/cm 2 (TC): 2600 cm 2 /h (children) Number of applications Turf Transferable 1 see explanation below (NA): Residues (TTR): 5 % 60 kg/person (adults) Exposure Duration (H): 2 h Body weight (BW): Airborne Concentration kg/person (children) 0 of Vapour (ACV): mg/m 3 Dermal absorption (DA): 20 % ('worst case') m 3 /d (adults) Inhalation Rate (IR): Inhalation absorption (IA): 100 % 8.31 m 3 /d (children) Oral absorption (OA): 100 % Saliva Extraction Factor (SE): 50 % AOEL: mg/kg bw/d Surface Area of Hands (SA): 20 cm 2 Frequency of Hand to Mouth (Freq): 20 events/h Dislodgeable foliar residues (DFR): 20 % Ingestion Rate for Mouthing of Grass/Day (IgR): 25 cm 2 /d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), worst case Table A 14: Estimation of resident towards metamitron Adults Children Residents: Systemic dermal after application in sugar and fodder beets (via deposits caused by spray drift) SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW ( x 1 x 1.85% x 5% x 7300 x 2 x 20%) / 60 ( x 1 x 1.85% x 5% x 2600 x 2 x 20%) / External dermal External dermal mg/person mg/person External dermal External dermal mg/kg bw/d mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Residents: Systemic inhalation after application in sugar and fodder beets (via vapour) SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW (0 x x 100%) / 60 (0 x 8.31 x 100%) / External inhalation External inhalation none none Systemic inhalation none Systemic inhalation none Page 19 / 22

76 ZV /01 Part B Section 3 - Core Assessment zrms version Total systemic : SER = SDER + SIER Residents: Systemic oral (hand-to-mouth transfer) SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x OA) / BW ( x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / External oral mg/person External oral mg/kg bw/d Systemic oral mg/kg bw/d Residents: Systemic oral (object-to-mouth transfer) SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW ( x 1 x % x 20% x 25 x 100%) / External oral mg/person External oral mg/kg bw/d Systemic oral mg/kg bw/d Total systemic : SER = SDER + SIER + SOER(H) + SOER(O) Total systemic Total systemic mg/person mg/person Total systemic Total systemic mg/kg bw/d mg/kg bw/d % of AOEL 3.9 % % of AOEL 7.7 % A Table A 15: Calculations for quinmerac Input parameters considered for the estimation of bystander Intended use(s): Sugar and fodder beets Drift (D): 2.77 % (FC, 1 m) Application rate (AR): 0.12 kg a.s./ha Exposed body surface 1 m² (adults) 12 mg/m 2 area (BSA): 0.21 m² (children) Body weight (BW): mg/kg a.s. (6 60 kg/person (adults) Specific Inhalation hours, adults) kg/person Exposure (I*A): mg/kg a.s. ( (children) hours, children) Dermal absorption (DA): 75 % ('worst case') ha/d (based on Area Treated (A): 20 Inhalation absorption (IA): 100 % FCTM) AOEL: 0.08 mg/kg bw/d Exposure duration (T): 5 min Table A 16: Adults Estimation of bystander towards quinmerac Children Bystander: Systemic dermal during/after application in sugar and fodder beets (via spray drift) SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW (12 x 2.77% x 1 x 75%) / 60 (12 x 2.77% x 0.21 x 75%) / External dermal mg/person External dermal mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Bystander: Systemic inhalation during/after application in sugar and fodder beets (via spray drift) SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW (0.001 / 360 x 0.12 x 20 x 5 x 100%) / 60 ( / 360 x 0.12 x 20 x 5 x 100%) / Page 20 / 22

77 ZV /01 Part B Section 3 - Core Assessment zrms version External inhalation External inhalation mg/person mg/person External inhalation External inhalation mg/kg bw/d mg/kg bw/d Systemic inhalation Systemic inhalation mg/kg bw/d mg/kg bw/d Total systemic : SEB = SDEB + SIEB Total systemic : SEB = SDEB + SIEB Total systemic mg/person Total systemic mg/person Total systemic mg/kg bw/d Total systemic mg/kg bw/d % of AOEL 5.2 % % of AOEL 4.1 % Table A 17: Input parameters considered for the estimation of resident Intended use(s): Sugar and fodder beets Drift (D): 1.85 % (FC, 1 m, 4 appl.) Application rate (AR): 0.24 kg a.s./ha 1) Transfer coefficient 7300 cm 2 /h (adults) mg/cm 2 (TC): 2600 cm 2 /h (children) Number of applications Turf Transferable 1 see explanation below (NA): Residues (TTR): 5 % 60 kg/person (adults) Exposure Duration (H): 2 h Body weight (BW): Airborne Concentration kg/person (children) 0 of Vapour (ACV): mg/m 3 Dermal absorption (DA): 75 % ('worst case') m 3 /d (adults) Inhalation Rate (IR): Inhalation absorption (IA): 100 % 8.31 m 3 /d (children) Oral absorption (OA): 100 % Saliva Extraction Factor (SE): 50 % AOEL: 0.08 mg/kg bw/d Surface Area of Hands (SA): 20 cm 2 Frequency of Hand to Mouth (Freq): 20 events/h Dislodgeable foliar residues (DFR): 20 % Ingestion Rate for Mouthing of Grass/Day (IgR): 25 cm 2 /d 1) maximum total application rate per year (4 applications with different application rates, cf. Table 3.1-4), worst case Table A 18: Estimation of resident towards quinmerac Adults Children Residents: Systemic dermal after application in sugar and fodder beets (via deposits caused by spray drift) SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW ( x 1 x 1.85% x 5% x 7300 x 2 x 75%) / 60 ( x 1 x 1.85% x 5% x 2600 x 2 x 75%) / External dermal mg/person External dermal mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Systemic dermal Systemic dermal mg/kg bw/d mg/kg bw/d Residents: Systemic inhalation after application in sugar and fodder beets (via vapour) SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW (0 x x 100%) / 60 (0 x 8.31 x 100%) / External inhalation External inhalation none none Systemic inhalation none Systemic inhalation none Residents: Systemic oral (hand-to-mouth transfer) Page 21 / 22

78 ZV /01 Part B Section 3 - Core Assessment zrms version Total systemic : SER = SDER + SIER SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x OA) / BW ( x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / External oral External oral mg/person mg/kg bw/d Systemic oral mg/kg bw/d Residents: Systemic oral (object-to-mouth transfer) SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW ( x 1 x % x 20% x 25 x 100%) / External oral External oral mg/person mg/kg bw/d Systemic oral mg/kg bw/d Total systemic : SER = SDER + SIER + SOER(H) + SOER(O) Total systemic mg/person Total systemic mg/person Total systemic mg/kg bw/d Total systemic mg/kg bw/d % of AOEL 0.5 % % of AOEL 0.8 % Page 22 / 22

79 ZV /01 Part B Section 4 - Core Assessment zrms version DRAFT REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product name: Active Substance: Metamitron (525 g/l) Quinmerac (40 g/l) Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: ADAMA Deutschland GmbH Date: March 2015 Page 1 / 24

80 ZV /01 Part B Section 4 - Core Assessment zrms version Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Evaluation of the intended uses Selection of critical use and justification Sugar/fodder beet Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Consumer intake and risk assessment Metamitron Quinmerac Proposed maximum residue levels (MRLs) Conclusion... 8 Appendix 1 Reference list... 9 Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability A Storage stability of residues in plant products A Storage stability of residues in animal products A 2.2 Residues in primary crops A Nature of residues A Magnitude of residues in sugar beets A 2.3 Residues in processed commodities A 2.4 Residues in rotational crops A 2.5 Residues in livestock A 2.6 Other studies/information Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) Page 2 / 24

81 ZV /01 Part B Section 4 - Core Assessment zrms version 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances It is referred to the main application procedure of Goltix Titan. 4.2 Evaluation of the intended uses Selection of critical use and justification The critical GAPs used for consumer intake and risk assessment are presented in Table Page 3 / 24

82 ZV /01 Part B Section 4 - Core Assessment zrms version Table 4.2-1: Critical Uses (worst case) used for consumer intake and risk assessment Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) (a) 1 DE Sugar beet, Fodder beet 2 NL, BE Sugar beet, Fodder beet F G or I (b) F F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) (c) Annual monocotyledonous weeds, Annual dicotyledonous weeds Annual dicotyledonous weeds Application Application rate PHI Method / Kind (d-f) Spraying Timing / Growth stage of crop & season (g) Spring, BBCH before emergence (1 st treatment), after emergence (2 nd to 4 th treatment) Max. number (min. interval between applications) a) per use b) per crop/ season (h) a) 4 b) 4 2 nd to 4 th treatment at intervals of 5 to 10 days Spraying BBCH a) 1-3 (5 days) b) 3 L product / ha a) max. rate per appl. b) max. total rate per crop/season a) timing 1: 3 timing 2: 1 timing 3: 1 timing 4: 1 b) 6 a) 2 b) 6 kg as/ha a) max. rate per appl. b) max. total rate per crop/season a) timing 1: Metamitron: 1.58 Quinmerac: 0.12 timings 2-4: Metamitron: 0.53 Quinmerac: 0.04 b) Metamitron: 3.15 Quinmerac: 0.24 a) Metamitron: 1.05 Quinmerac: 0.08 b) Metamitron: 3.15 Quinmerac: 0.24 Water L/ha min / max (days) (i) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures (j) F Total 6.0 L product/ha F Total 6.0 L product/ha 3 NL, BE Sugar beet, Fodder beet F Annual dicotyledonous weeds Spraying BBCH a) 1 b) 1 a) 3 b) 3 a) Metamitron: 1.58 Quinmerac: 0.12 b) Metamitron: 1.58 Quinmerac: F Total 6.0 L product/ha (max. once per 3 years on the same field) BBCH a) 1-3 (5 days) b) 3 a) 1 b) 3 a) Metamitron: 0.53 Quinmerac: 0.04 b) Metamitron: 1.58 Quinmerac: F Page 4 / 24

83 ZV /01 Part B Section 4 - Core Assessment zrms version Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (d) All abbreviations used must be explained (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (h) The minimum and maximum number of application possible under practical conditions of use must be provided (i) PHI - minimum pre-harvest interval (j) Remarks may include: Extent of use/economic importance/restrictions Page 5 / 24

84 ZV /01 Part B Section 4 - Core Assessment zrms version Sugar/fodder beet Residues in primary crops The following tables are summarizing the results of the supervised residue trials selected for the assessment of metamitron in sugar beet. For more details on those residue trials used in evaluating the GAP, it is referred to Appendix 2. Table 4.2-2: Overview of the selected supervised residue trials for metamitron Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (metamitron) Risk assessment (metamitron) STMR (mg/kg) (b) HR (mg/kg) (c) Existing MRL (mg/kg) beet root NEU Outdoor 3 x <0.010; 4 x < x <0.010; 4 x < beet leaves and tops NEU Outdoor 3 x <0.010; 4 x < x <0.010; 4 x < Median CF (d) (a): (b): (c): (d): NEU, SEU, EU or Import (country code). Median value of the individual trial results according to the risk assessment residue definition. Highest value of the individual trial results according to the risk assessment residue definition. The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Table 4.2-3: Overview of the selected supervised residue trials for quinmerac Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (quinmerac) Risk assessment (quinmerac + BH BH 518-4, expressed as quinmerac) STMR (mg/kg) (b) HR (mg/kg) (c) Existing MRL (mg/kg) beet root NEU Outdoor 3 x <0.05; 4 x < x <0.14; 4 x < n.a. beet leaves and tops NEU Outdoor 3 x <0.05; 4 x < x <0.14; 4 x < n.a. Median CF (d) (a): NEU, SEU, EU or Import (country code).. (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. ( ) molecular masses of BH and BH are and g/mol respectively (conversion factors 0.88, 0.93) It is emphasized that in four of the trials the samples were stored frozen for periods considerably longer than 12 months prior to extraction. Storage stability of residues of parent quinmerac and its metabolites BH and BH was reported in the DAR for at least 24 months in sugar beet roots and leaves. Storage stability of residues of parent quinmerac and its metabolites BH and BH in watery matrices (wheat green matter) was demonstrated in a study of the applicant for only 12 months (ASB ). It is unclear if the applicant has access to a study cited in the DAR (ASB ) demonstrating sufficient stability in/on sugar beet items over at least 24 months. If there would be no such right of use the number of trials in support of the no-residue situation would be insufficient (i.e. < n=4) for sugar beets, which is a major crop in northern Europe Distribution of the residue in peel/pulp Not relevant. Page 6 / 24

85 ZV /01 Part B Section 4 - Core Assessment zrms version Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required Proposed pre-harvest intervals, withholding periods The proposed pre-harvest interval (PHI)/withholding period is deemed appropriate, due to application at early growth stage of the crop. 4.3 Consumer intake and risk assessment Metamitron The consumer intake and risk assessment is based on the input values given in Table IIIA and the toxicological reference values stated in Table IIIA For the detailed calculation results it is referred to Appendix 3. Table IIIA 4.3-1: Residue input values for the consumer risk assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Input value (mg/kg) Acute risk assessment Comment Sugar beet 0.05 STMR 0.05 STMR All other commodities of Annex I to Reg (EC) No 396/2005 variable MRLs as laid down in Reg. (EC) No 149/2008 not calculated Table IIIA 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS IImodel IEDI (EFSA PRIMo) (% ADI) NEDI (German NVS II-model) (% ADI) Factors included in IEDI and NEDI ARfD IESTI (EFSA PRIMo) (% ARfD) NESTI (German NVS II-model) (% ARfD) Factors included in IESTI and NESTI 0.03 mg/kg bw 26.5 % (based on UK toddlers diet) % (based on DE children, aged 2-4 years, individual consumption/body mass ratio) not required not required none 0.1 mg/kg bw Sugar beet: 3 % (based on UK children 4-6 years) Sugar beet: <1 % (based on DE children 2-4 years) none Quinmerac The consumer intake and risk assessment is based on the input values given in Table IIIA and the toxicological reference values stated in Table IIIA For the detailed calculation results it is referred to Appendix 3. In the absence of conversion factors for the vast majority of plant commodities and information on the GAPs underlying the MRLs the dietary intake is based on the MRLs. Although this approach will Page 7 / 24

86 ZV /01 Part B Section 4 - Core Assessment zrms version underestimate consumer intake it is nevertheless anticipated with a view to the TMDI (based almost completely on LOQs for important commodities) that long-term dietary intake of EU consumers will not exceed the ADI of quinmerac. Table IIIA 4.3-3: Residue input values for the consumer risk assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Acute risk assessment Input value (mg/kg) Comment Sugar beet 0.10 STMR 0.10 STMR All other commodities variable MRLs as laid down in Reg. (EC) No 149/2008 not calculated Table IIIA 4.3-4: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS IImodel IEDI (EFSA PRIMo) (% ADI) NEDI (German NVS II-model) (% ADI) Factors included in IEDI and NEDI ARfD IESTI (EFSA PRIMo) (% ARfD) NESTI (German NVS II-model) (% ARfD) Factors included in IESTI and NESTI 0.08 mg/kg bw 18.4 % (based on UK toddlers diet) 6.6 % (based on DE children aged 2-4 years, individual consumption/body mass ratio) not required not required none 0.3 mg/kg bw Sugar beet: 3 % (based on UK children 4-6 years) Sugar beet: <1 % (based on DE children 2-4 years) none 4.4 Proposed maximum residue levels (MRLs) No new MRL is required. 4.5 Conclusion Regarding aspects of seasonal application rates the cgap of application /01 is comparable to that of the basic application of the product on sugar/fodder beets ( /00). Hence, the statement basically apply also for application /01. The available residue data is sufficient for dietary risk assessment, provided that there is access of the applicant to a storage stability study showing storage stability of quinmerac and its relevant metabolites in watery matrices for up to 17 months (such storage stability was reported up to 24 months in the DAR, but access is unclear for the application under consideration). If there is no such right of use, the number of independent trials is too small (n=3) to support a no-residue situation in sugar/fodder beets for quinmerac. Residues of quinmerac and its metabolites were continuously seen below the respective LOQ. Hence, no meaningful statement can be made for converting residues of quinmerac in compliance with the existing residue definition for enforcement to that of risk assessment. An exceedance of the current MRL of 0.2 mg/kg for metamitron and 0.5 mg/kg for quinmerac in sugar Page 8 / 24

87 ZV /01 Part B Section 4 - Core Assessment zrms version beet roots as laid down in EU residue legislation (Reg. (EC) No ) is not expected. A no-residue situation is indicated from the supervised residue trials for both actives and regarding both roots and leaves with tops. It is therefore not anticipated that the intended uses impact residues in commodities of animal origin. The long-term and the short-term intake of residues of metamitron and quinmerac residues is unlikely to present a public health concern. With respect to consumer health protection issues, BfR/Germany agrees with the authorization of the intended uses on sugar and fodder beet. Appendix 1 Reference list Table A 1: Annex point/ reference No OECD KIIA OECD KIIA OECD KIIA OECD KIIA OECD KIIA OECD KIIA Reference list Author(s) Year Title Report-No. Authority registration No Mackenroth, C.; Krotzky, A Investigation of the storage stability in sugar beet 95/10753! 3996! DE-H-LST/Z-91 GLP: Yes Published: No BVL , ASB Meyer, M Determination of the storage stability of Quinmerac and metabolites in plant matrices IF-09/ GLP: Yes Published: No BVL , BVL , BVL , ASB Fuchsbichler, G Determination of the residues of metamitron and desamino-metamitron in sugar beets 2 (3)! HVA 8/95! GER 94400/1 ASB Fuchsbichler, G Determination of the residues of Metamitron and Desomino-metamitron in sugar beets (4 trials in 1994) HVA 8/95! GER 94400/1! 14185! 14186! 14187! GLP: Yes Published: No BVL , ASB Hauck, E. J.; Schulz, H. Hoenzelaers, R.; Schulz, J Study on the magnitude of residue of Metamitron and its metabolite and Quimmerac and its metabolites in sugar beets after one application of Goltix WG 70 formulation or three applications of Quinmerac and Metamitron in Northern Europe 2010 RA-2131/01! IF-10/ GLP: Yes Published: No BVL , ASB Final report about testing the residual behaviour of AGH 211 (MAC H) in sugar beet under field conditions AGR/RP-H 94/MAC H GLP: Yes Published: No BVL , ASB Data protection claimed Owner Yes BAS Add Yes FSG Add** Yes How considered in drr * Add Yes FSG Add** Yes FSG Add** Yes FSG Add** Page 9 / 24

88 ZV /01 Part B Section 4 - Core Assessment zrms version Annex point/ reference No Author(s) Year Title Report-No. Authority registration No Data protection claimed Owner KIIA 6.3 Simek, I Determination of Quinmerac and Metamitron residues in Sugar Beet (RAC) following treatment with the formulated product MAF0617 under field conditions in Northern France in 2007 R A7091! FR-qut-07-1 GLP: Yes Published: No BVL , ASB Yes ADAMA Y * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation ** Studies provided by the applicant for the main application procedure of (ZV /00) How considered in drr * Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability A Storage stability of residues in plant products A new study was submitted by the applicant on storage stability of Quinmerac and its metabolites in various wheat matrices. Reference: KIIIA 8.1.1/01 Report Guideline(s): Deviations: GLP: Acceptability: Meyer, M. (2011) Determination of the Storage Stability of Quinmerac and Metabolites in Plant Matrices; ASB YES Chemikaliengesetz der Bundesrepublik Deutschland (ChemG) 19, sowie der Anhänge 1 und 2 in the valid form; OECD document OECD-DOC. ENV/MC/CHEM(98)17, Paris 1998; Storage stability of Residue Samples, EC doc. 7032/VI/95-rev.5, dated 22/7/97 No Yes Yes Materials and methods Untreated samples of wheat green matter, wheat grain, wheat straw, and carrot roots were fortified with either Quinmerac or BH and BH at a fortification level of 0.5 mg/kg and stored deep-frozen at -18 C protected from light over a period of 12 months. Samples were analysed after immediately after specimen preparation (day 0), 3 months, 11 months, and 12 months. On each day of analysis 1 control specimen, 1 freshly prepared Quinmerac fortified specimen, 1 freshly prepared BH and BH fortified specimen, 2 storage stability specimens fortified with Quinmerac, and 2 storage stability specimens fortified with BH and BH were analysed per matrix. Samples were analysed using the method Determination of Residues of Quinmerac and its metabolites BH and BH in Plant Matrices which was validated by M. Meyer, SGS Institut Fresenius under the Project No. IF-09/ in April Samples were extracted with methanol/0.4 M hydrochloric acid (70/30; v/v) and partitioned with Extrelut comprising a washing step with cyclohexane and elution with ethyl acetate/formic acid (99/1; v/v). The eluate was evaporated to dryness under nitrogen. Residues were reconstituted in acetonitrile/water (4/6; v/v + 0.1% formic acid). Final determination was performed with LC-MS/MS. The limit of quantification was 0.05 mg/kg for all matrices. Page 10 / 24

89 ZV /01 Part B Section 4 - Core Assessment zrms version Results and discussions The recovery values in percentage of quinmerac and its metabolites BH and BH over the whole storage time period and for all matrices are given in the table below. They were not corrected by the mean recovery values of the simultaneously analysed freshly fortified specimens Table A 2: Quinmerac mean BH mean BH mean Quinmerac mean BH mean BH mean Quinmerac mean BH mean BH mean Quinmerac mean BH mean BH mean Summary of storage stability of quinmerac and its metabolites BH and BH in wheat green matter, wheat grain, wheat straw, and carrot roots at -18 C Time [months] Wheat green matter, recovery values [%] 91; 94 88; 89 86; ; ; ; 92 96; ; ; 98 79; 79 81; 80 83; Wheat grain, recovery values [%] 107; 93 89; 91 90; 88 92; ; 99 95; ; 95 98; ; 93 77; 75 78; 79 78; Wheat straw, recovery values [%] 91; 93 86; 86 90; 87 90; ; 99 93; 92 94; 98 94; ; 94 77; 81 77; 86 77; Carrot roots, recovery values [%] 90; 88 88; 89 85; 87 87; ; 93 90; 90 98; ; ; 85 77; 77 80; 83 88; The accuracy of the analytical method was by simultaneous analysis of one freshly prepared fortified specimen from each matrix on each date of analysis (same level as for storage stability specimens). The results are shown in the following table. Page 11 / 24

90 ZV /01 Part B Section 4 - Core Assessment zrms version Table A 3: Summary of concurrent recoveries of quinmerac and its metabolites BH and BH from various wheat matrices and carrot roots No. of fortified specimens Mean recovery rates [%] Standard deviation Relative standard deviation [%] Wheat green matter Quinmerac BH BH Wheat grain Quinmerac BH BH Wheat straw Quinmerac BH BH Carrot roots Quinmerac BH BH Conclusion Quinmerac and its metabolites BH and BH were found to be stable for at least 12 months under deep freeze storage conditions in wheat green matter, wheat grain, wheat straw, and carrot roots. Comments of zrms: The study is acceptable to demonstrate stability of residues of quinmerac and its metabolites over 12 months under deep freeze conditions in matrices of high water content. A Storage stability of residues in animal products No new studies were submitted on the storage stability of residues in animal products. A 2.2 Residues in primary crops A Nature of residues No further study was submitted on the nature of residues. Page 12 / 24

91 ZV /01 Part B Section 4 - Core Assessment zrms version A Magnitude of residues in sugar beets Reference: OECD KIIA 6.3 Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box Deviations: no relevant deviations unless stated otherwise in the commenting box GLP: see reference list Acceptability: acceptable unless stated otherwise in the commenting box Table A 4: Residues of metamitron in sugar beets RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Metamitron (Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 710 g/kg Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : WG Other a.i. in formulation Commercial product (name) : submitted to AG-QMM1-565 SC (content and common name) : treated with MAC H, WDG (710 g/kg Metamitron) Applicant : Feinchemie Schwebda GmbH Residues calculated as : 8.1 Metamitron 8.2 Desaminometamitron Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) AGR / RP-H 94 / MAC H, GER /R, trial MAK 12, sugar beet / Sophie 1) ) 3) BBCH 19 (c) sprayings Germany Goch plant leaf leaf leaf root root root 107 <0.050 <0.050 <0.050 <0.050 <0.050 < <0.050 <0.050 <0.050 <0.050 < analytical method: GC-NPD and GC-MSD LOQ: 0.05 mg/kg, max. sample storage: 16 months, ASB (field part), ASB (analytical part) ASB Page 13 / 24

92 ZV /01 Part B Section 4 - Core Assessment zrms version Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) AGR / RP-H 94 / MAC 93 sugar beet / 1) (c) sprayings 001 H, GER /R, trial MAK 13, Meta 2) 3) BBCH 19 Germany Bühren AGR / RP-H 94 / MAC H, GER /R, trial MAK 14, Germany Angermünde AGR / RP-H 94 / MAC H, GER /R, trial MAK 15, Germany Niederkirchen sugar beet / Meta sugar beet / Kawe-Tuka 1) ) 3) ) ) 3) BBCH BBCH 19 Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate plant leaf leaf leaf root root root plant leaf leaf leaf root root root plant leaf leaf leaf root root root <0.050 <0.050 <0.050 < <0.050 <0.050 < <0.050 < <0.050 <0.050 <0.050 <0.050 < <0.050 <0.050 <0.050 <0.050 < <0.050 <0.050 <0.050 <0.050 < <0.050 <0.050 <0.050 <0.050 <0.050 < analytical method: GC-NPD and GC-MSD LOQ: 0.05 mg/kg, max. sample storage: 16 months, ASB (field part), ASB (analytical part) ASB (c) sprayings analytical method: GC-NPD and GC-MSD LOQ: 0.05 mg/kg, max. sample storage: 16 months, ASB (field part), ASB (analytical part) ASB (c) sprayings analytical method: GC-NPD and GC-MSD LOQ: 0.05 mg/kg, max. sample storage: 16 months, ASB (field part), ASB (analytical part) ASB Comments of zrms: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. Page 14 / 24

93 ZV /01 Part B Section 4 - Core Assessment zrms version Table A 5: Residues of metamitron in sugar beets RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Metamitron (Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 525 g/l / 700 g/kg Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC / WG Other a.i. in formulation Commercial product (name) : AG-QMM1-565 SC / Goltix WG 700 (content and common name) : 40 g/l Quinmerac Applicant : Feinchemie Schwebda GmbH Residues calculated as : 8.1 Metamitron 8.2 Desaminometamitron Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) IF-10/ , , sugar beet / Pauletta 1) ) plant leaf with top < < (c) spraying s AG-QMM1-565 SC, 525 g/l trial 10-DE-001, plot 3 3) BBCH 19 beet root <0.010 < Germany Biebersheim analytical methods: IF-10/ (HPLC-MS/MS), LOQ 0.01 mg/kg, max. sample storage: 8 months IF-10/ , , trial 10-DE-001, plot 2 Germany Biebersheim sugar beet / Pauletta 1) ) 3) BBCH 37 plant leaf, with top beet root 46.0 <0.010 < <0.010 < ASB (c) spraying Goltix WG 700 g/kg analytical method: IF-10/ (HPLC-MS/MS), LOQ 0.01 mg/kg, max. sample storage: 8 months IF-10/ , , trial 10-DE-002, plot 2 Germany Groß-Rohrheim sugar beet / Theresa 1) ) 3) BBCH 19 plant plant plant leaf with top leaf with top root root 17.9 <0.010 <0.010 <0.010 <0.010 <0.010 < <0.010 <0.010 <0.010 <0.010 <0.010 < ASB (c) spraying s AG-QMM1-565 SC, 525 g/l analytical methods: IF-10/ (HPLC-MS/MS), LOQ 0.01 mg/kg, max. sample storage: 8.5 months ASB Page 15 / 24

94 ZV /01 Part B Section 4 - Core Assessment zrms version Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) IF-10/ , , sugar beet / Ricada (KWS) 1) ) plant leaf with top 35.9 < < (c) spraying s AG-QMM1-565 SC, 525 g/l trial 10-DE-003, plot 3 3) BBCH 19 beet root <0.010 < Germany Emstek analytical methods: IF-10/ (HPLC-MS/MS), LOQ 0.01 mg/kg, max. sample storage: 7.5 months IF-10/ , , trial 10-DE-004, plot 2 Germany Emstek IF-10/ , , trial 10-DE-003, plot 2 Germany Emstek sugar beet / Ricada (KWS) sugar beet / Ricada (KWS) 1) ) 3) ) ) 3) BBCH 19 plant plant plant leaf with top leaf with top root root BBCH 37 plant leaf, with top beet root <0.010 <0.010 <0.010 <0.010 < <0.010 < <0.010 <0.010 <0.010 <0.010 < <0.010 < ASB s(c) spraying s AG-QMM1-565 SC, 525 g/l analytical methods: IF-10/ (HPLC-MS/MS), LOQ 0.01 mg/kg, max. sample storage: 7.5 months ASB (c) spraying Goltix WG 700 g/kg analytical method: IF-10/ (HPLC-MS/MS), LOQ 0.01 mg/kg, max. sample storage: 7.5 months ASB Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Comments of zrms: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. It is noted however that plot 2 and plot 3 of trial 10- DE-001 as well as plot 2 and plot 3 of trial 10-DE-003 including plot 2 of trial trial 10-DE-003were not sufficiently independend from one another Page 16 / 24

95 ZV /01 Part B Section 4 - Core Assessment zrms version Table A 6: Residues of metamitron in sugar beets RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : metamitron (Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet Crop Code : BEAVA Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 500 g/l Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : MAF06017 (content and common name) : 150 g/l quinmerac Applicant : ADAMA Deutschland GmbH Residues calculated as : metamitron Report-No. Location Commodity/ Variety Date of 1)Sowing Application rate per treatment Dates of treatments Growth stage Portion analysed Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl at last treatment (a) (b) (c) (a) (d) (e) study R A7091 trial AN1, sugar beet / Nordika (c) spraying France (north) Seebach 1) ) 3) BBCH 12 whole plant leaf with top root body <0.050 <0.050 < analytical method: Bayer 39/1986 (GC-MS) LOQ: 0.05 mg/kg max. sample storage 16 months study R A7091 trial BP1, France (north) Engenville sugar beet / Radar 1) ) 3) BBCH 31 whole plant leaf with top root body <0.050 <0.050 < ASB (c) spraying analytical method: Bayer 39/1986 (GC-MS) LOQ: 0.05 mg/kg max. sample storage 16 months study R A7091 trial BM1, France (north) Thoree les Pins sugar beet / Ardan 1) ) 3) BBCH 11 whole plant leaf with top root body <0.050 <0.050 < ASB (c) spraying analytical method: Bayer 39/1986 (GC-MS) LOQ: 0.05 mg/kg max. sample storage 15 months ASB Page 17 / 24

96 ZV /01 Part B Section 4 - Core Assessment zrms version Report-No. Location Commodity/ Variety Date of 1)Sowing Application rate per treatment Dates of treatments Growth stage Portion analysed Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl at last treatment (a) (b) (c) (a) (d) (e) study R A7091 trial OB1, sugar beet / Radar (c) spraying France (north) Ploudalmezeau 1) ) 3) BBCH 12 whole plant leaf with top root body <0.050 <0.050 < analytical method: Bayer 39/1986 (GC-MS) LOQ: 0.05 mg/kg max. sample storage 16 months ASB Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Comments of zrms: Not acceptable. The trials cannot be used to suport the intended use of the product on sugar/fodder beet for reasons of not addressing the critical GAP Page 18 / 24

97 ZV /01 Part B Section 4 - Core Assessment zrms version Table A 7: Residues of quinmerac in sugar beets RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Quinmerac (Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 40 g/l Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : AG-QMM1-565 SC (content and common name) : 525 g/l Metamitron Applicant : Feinchemie Schwebda GmbH All residues were calculated as quinmerac equivalents : 8.1 Quinmerac 8.2 BH (7-chloro-3-hydroxymethyl-quinoline-8-carboxylic acid) 8.3 BH (7-chloroquinoline-3,8-dicarboxylic acid) Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at Portion analysed Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl last treatment (a) (b) (c) (a) (d) (e) IF-10/ , , trial 10-DE-001, plot 3 sugar beet / Pauletta 1) ) 3) BBCH 11 BBCH 14 BBCH 19 plant leaf with top beet root <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 < (c) sprayings Germany Biebersheim analytical method: IF-09/ (HPLC-MS/MS), LOQ 0.05 mg/kg max. sample storage: 8 months IF-10/ , , trial 10-DE-002, plot 2 Germany Groß-Rohrheim IF-10/ , , trial 10-DE-003, plot 3 Germany Emstek sugar beet / Theresa sugar beet / Ricada (KWS) 1) ) 3) ) ) 3) BBCH 10 BBCH 14 1BCH 19 BBCH 10 BBCH 14 BBCH 19 plant plant plant leaf, with top leaf with top root root plant leaf with top beet root 1.7 <0.050 <0.050 <0.050 <0.050 <0.050 < <0.050 < <0.050 <0.050 <0.050 <0.050 <0.050 < <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 < ASB (c) sprayings analytical method: IF-09/ (HPLC-MS/MS), LOQ 0.05 mg/kg max. sample storage: 8.5 months ASB (c) sprayings analytical method: IF-09/ (HPLC-MS/MS), LOQ 0.05 mg/kg max. sample storage: 7.5 months ASB Page 19 / 24

98 ZV /01 Part B Section 4 - Core Assessment zrms version Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at Portion analysed Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl last treatment (a) (b) (c) (a) (d) (e) F-10/ , , trial 10-DE-004, plot 2 sugar beet / Ricada (KWS) 1) ) 3) BBCH 10 BBCH 14 BBCH 19 spraying Germany Emstek plant plant plant leaf with top leaf with top root root Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included 2.7 <0.050 <0.050 <0.050 <0.050 <0.050 < <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 <0.050 < analytical method: F-09/ (HPLC-MS/MS), LOQ 0.05 mg/kg max. sample storage: 7.5 months ASB Comments of zrms: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. However, two of the trials are not sufficiently independent to present separate residue level figures (trial 10-DE-003 and 10-DE-004). Page 20 / 24

99 ZV /01 Part B Section 4 - Core Assessment zrms version Table A 8: Residues of quinmerac in sugar beets RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS Active ingredient : quinmerac (SUMMARY) (Application on agricultural and horticultural crops) Crop / crop group : Sugar Beet Crop Code : BEAVA Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 150 g/l Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SC Other a.i. in formulation Commercial product (name) : MAF06017 (content and common name) : 500 g/l metamitron Applicant : ADAMA Deutschland GmbH Residues calculated as : 8.1 Quinmerac 8.2 BH (7-chloro-3-hydroxymethyl-quinoline-8-carboxylic acid) 8.3 BH (7-chloroquinoline-3,8-dicarboxylic acid) Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) study R A7091, trial AN1, sugar beet / Nordika France (north) Seebach ) ) 3) BBCH 12 whole plant leaf with top root <0.010 <0.010 <0.010 <0.050 <0.050 <0.050 <0.050 <0.050 < (c) spraying analytical method: CEN/TC 275 WG 4 (LC-MS/MS), LOQ: 8.1: 0.01 mg/kg 8.2: 0.05 mg/kg 8.3: 0.05 mg/kg max. sample storage 17 months study R A7091, trial BP1, France (north) Engenville sugar beet / Radar 1) ) 3) BBCH 31 whole plant leaf with top root body <0.010 <0.010 <0.010 <0.050 <0.050 <0.050 <0.050 <0.050 < ASB (c) spraying analytical method: CEN/TC 275 WG 4 (LC-MS/MS), LOQ: 8.1: 0.01 mg/kg 8.2: 0.05 mg/kg 8.3: 0.05 mg/kg max. sample storage 17 months ASB Page 21 / 24

100 ZV /01 Part B Section 4 - Core Assessment zrms version Report-No. Location Commodity/ Variety Date of 1) Sowing Application rate per treatment Dates of treatments Growth stage at last Portion analysed Residues (mg/kg) Residues (mg/kg) Residues (mg/kg) PHI (days) Remarks incl. postal code and date 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl treatment (a) (b) (c) (a) (d) (e) study R A7091, trial BM1, harvest trial sugar beet / Ardan 1) ) 3) BBCH 11 whole plant leaf with top root body <0.010 <0.010 <0.010 <0.050 <0.050 <0.050 <0.050 <0.050 < France (north) Thoree les Pins study R A7091, trial OB1, France (north) Ploudalmezeau sugar beet / Radar 1) ) 3) BBCH 12 whole plant leaf with top root body Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included <0.010 <0.010 <0.010 <0.050 <0.050 <0.050 <0.050 <0.050 < (c) spraying analytical method: CEN/TC 275 WG 4 (LC-MS/MS), LOQ: 8.1: 0.01 mg/kg 8.2: 0.05 mg/kg 8.3: 0.05 mg/kg max. sample storage 16 months ASB (c) spraying analytical method: CEN/TC 275 WG 4 (LC-MS/MS), LOQ: 8.1: 0.01 mg/kg 8.2: 0.05 mg/kg 8.3: 0.05 mg/kg max. sample storage 17 months ASB Comments of zrms: Acceptable. The trials can be used to suport the intended use of the product on sugar/fodder beet. Event though conducted considerably overdosed the results clearly show a nil-residue situation. It is however unclear, if the applicant has access to the storage stability study on sugar bee tmatrices (ASB ) demonstrating integrity of samples over periods of at least 24 months. In its own study on wheat matrices stability was demonstrated for only 12 months. Page 22 / 24

101 ZV /01 Part B Section 4 - Core Assessment zrms version A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted and none is needed due to low residues at harvest. A 2.4 Residues in rotational crops No new study on residues in rotational crops has been submitted. A 2.5 Residues in livestock No new study on residues in livestock has been submitted. A 2.6 None Other studies/information Page 23 / 24

102 ZV /01 Part B Section 4 - Core Assessment zrms version Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) Result of chronic risk assessment (EFSA PRIMo rev.2), based on input data as outlined in table Result of chronic risk assessment (EFSA PRIMo rev.2), based on input data as outlined in table Page 24 / 24