Art. 51 Extension of authorisation for minor uses. Risk Management

Transcription

1 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 1 of 12 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Carax Active Substances: Mepiquat 160,2 g/l as chloride 210 g/l Metconazole 30 g/l COUNTRY: Germany All Zones Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: BASF SE E-APE/DT, Li 556 Date: 04/09/2014 BVL_FO_05_2422_200_V1.0 Applicant BASF SE Date: 04/09/2014

2 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 2 of 12 Table of Contents PART A Risk Management Details of the application Application background Annex I inclusion Regulatory approach Uses applied for and registration decision Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/ R and S phrases under Regulation (EC) No 547/ Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Residues and Consumer Exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access BVL_FO_05_2422_200_V1.0 Applicant BASF SE Date: 04/09/2014

3 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 3 of 12 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of Carax containing mepiquat and metconazole in Germany. The risk assessment conclusions are based on the already existing registration of the PPP. The following sections of Registration Report, Part B were prepared on basis of new data: Section 3. Assessments for the safe use of Carax have been made using endpoints agreed in the EU reviews of mepiquat and metconazole. Appendix 1 of this document provides a copy of the final product authorisation in Germany. 1 Details of the application Application to extend the authorisation of a plant protection product (PPP) already authorised in Germany to minor uses not yet covered by that authorisation. The application is intended for use in Germany only. 1.1 Application background Details on applicant and application Plant protection product Type of application Carax Registration number /01 Applicant Authorisation holder Function Type of formulation Expiration of authorisation Zonal application according to Article 51, ZRMS=DE, first application (GV1) BASF SE E-APE/DT, Li 556, Speyerer Straße 2, Limburgerhof, Deutschland BASF SE E-APE/DT, Li 556, Speyerer Straße 2, Limburgerhof, Deutschland Plant growth regulator (W) Soluble concentrate (SL) BVL_FO_05_2422_200_V1.0 Applicant BASF SE Date: 04/09/2014

4 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 4 of Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Mepiquat (0510) Content in PPP 160,2 g/l Approval status Approved according to Regulation (EC) No 1107/2009 Approval Expiration of approval 28/02/2019 Metconazole (0945) Content in PPP Commission Directive 2008/108/EC 30 g/l Approval status Approved according to Regulation (EC) No 1107/2009 Approval Expiration of approval 31/05/2017 Commission Directive 2006/74/EC 1.3 Regulatory approach The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. Therefore the evaluation of the current application is limited to the points not covered by the existing registration Uses applied for and registration decision Number of use Plant/commodity/object Harmful organism/purpose decision 001 ornamentals dwarfing of ornamentals Authorise 002 ornamentals dwarfing of ornamentals Authorise Public interest and minor use BVL_FO_05_2422_200_V1.0 According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. In Germany the cultivated area of ornamentals is about 4500 ha, of which approx. 158 ha need to be controlled, the cultivated area of ornamentals is about 3500 ha, of which approx. 245 ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested uses. Upon this calculation and the examination of available alternative measures for the applied uses it can be stated that the applied uses is minor in nature and the authorisation is in the public interest. Applicant BASF SE Date: 04/09/2014

5 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 5 of Data protection claims The applicant is owner of the new studies submitted and claims data protectionn. 1.5 Letters of Access The applicant is owner of the new studies submitted. The authorisation holder is the applicant of this extension of authorisation. 2 Details of the authorisation 2.1 Product identity Product name Carax Authorisation number Composition Type of formulation Function Authorisation holder 2.2 Classification and labelling Mepiquat 160,2 g/l, metconazole 30 g/l Soluble concentrate (SL) Plant growth regulator (W) BASF SE E-APE/DT, Li 556, Speyerer Straße 2, Limburgerhof, Deutschland Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008 BVL_FO_05_2422_200_V1.0 C&L according to Directives 67/548/EEC and 1999/45/EC Xn N Harmful Dangerous for the environment R20/22 Harmful by inhalation and if swallowed R41 Risk of serious damage to eyes R51/53 Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment S2 S13 S26 S39 S46 SP001 Keep out of the reach of children Keep away from food, drink and animal feeding stuffs In case of contact with the eyes, rinse thoroughly and seek medical advice Wear eye/face protection If swallowed, seek medical advice immediately and show this container or label To avoid risks to man and the environment, comply with the instructions for use. C&L according to Regulation (EC) No 1272/2008 Hazard class(es), categories: Signal word: Hazard statement(s): Acute Tox. 4, Eye Damage 1 Danger Applicant BASF SE Date: 04/09/2014

6 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 6 of 12 H302 H318 H332 Additional labelling phrases: Harmful if swallowed. Causes serious eye damage. Harmful if inhaled. To avoid risks to man and the environment, comply with the instructions for use. [EUH401] R and S phrases under Regulation (EC) No 547/2011 none Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Operator protection SB001 SB110 SE110 Avoid any unnecessary contact with the product. Misuse can lead to health damage. 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. Wear tight fitting eye protection when handling the undiluted product. SF Treated areas/crops may not be entered until the spray coating has dried. Ecosystem protection NW262 NW264 NW265 NW468 Honeybee The product is toxic for algae. The product is toxic for fish and 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. Integrated Pest Management (IPM) NN2842 The product is classified as slightly harmful for populations of the species Aphidius rhopalosiphi (braconid wasp). Mode of action (FRAC/-Group): Metconazole: G1; Mepiquat: none (Growth regulator) The authorization of the PPP is linked to the following conditions (voluntary labelling): BVL_FO_05_2422_200_V1.0 Honeybee NB6641 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) Applicant BASF SE Date: 04/09/2014

7 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 7 of 12 Integrated Pest Management (IPM) NN170 The product is classified as harmless for populations of the species Chrysoperla carnea (lacewing) Specific restrictions linked to the intended uses Some of the authorized uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) Operator protection SS110 Wear standard protective gloves (plant protection) when handling the undiluted product. Ecosystem protection NW605-1 When applying the product on areas adjacent to surface waters - except only occasionally but including periodically water bearing surface waters - the product must be applied with equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*". 50 %: 5 m, 75 %: *, 90 %: * NW606 The only case in which the product may be applied without loss reducing equipment is when at least the buffer zone stated below is kept from surface waters - except only occasionally but including periodically water bearing surface waters. Violations may be punished by fines of up to Euro. 5 m. * The binding minimum buffer zone to be kept from surface waters, provided for by state law, must be observed. BVL_FO_05_2422_200_V1.0 Applicant BASF SE Date: 04/09/2014

8 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 8 of Product uses PPP (product name/code) Carax ( ) active substance 1 Mepiquat (as chloride) active substance 2 Metconazole Formulation type: Conc. of as 1: Conc. of as 2: SL 160,2 g/l (chloride: 210 g/l) 30 g/l safener - synergist - Applicant: BASF SE E-APE/DT, Li 556 Zone(s): all zones Conc. of safener: - Conc. of synergist: - professional use non professional use Verified by MS: y BVL_FO_05_2422_200_V1.0 Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) 001 DE ornamentals (NNNZZ) (pot culture) F G or I F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) dwarfing of ornamentals (WXSXX) Method / Kind 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 b) per crop/ season spraying BBCH 17-51; a) 1 (7 to 14 days) b) 1 b) max. total rate per crop/season a) 1,4 L/ha b 1,4 L/ha up to the height of plants, up to 50 cm b) max. total rate per crop/season a1) 294 g as/ha a2) 42 g as/ha b1) 294 g as/ha b2) 42 g as/ha Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures <1000 N Restrictions (see ) NW605-1 NW606.. Central zone 002 DE ornamentals G dwarfing of spraying BBCH 17-51; a) 1,4 L/ha a1) 294 g <1000 N Restrictions (see ) Applicant BASF SE Date: 04/09/2014

9 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 9 of 12 (NNNZZ) (pot culture) ornamentals (WXSXX) b 1,4 L/ha up to the height of plants, up to 50 cm as/ha a2) 42 g as/ha b1) 294 g as/ha b2) 42 g as/ha NW605-1 NW606 All zones BVL_FO_05_2422_200_V1.0 Applicant BASF SE Date: 04/09/2014

10 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 10 of 12 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Not relevant for extension of authorisation according article Methods of analysis Analytical method for the formulation Not relevant for extension of authorisation according article Analytical methods for residues Not applicable application foreseen in ornamentals Mammalian Toxicology The PPP is already registered in Germany according to Directive 91/414/EEC. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected Residues and Consumer Exposure Not relevant - application foreseen in ornamentals only Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. The specific German assessment scheme for groundwater contamination considers the entry paths direct leaching and bank filtration from adjacent ditches after surface run-off and drainage. According to modelling results considering use patterns as laid down in 2.3 entries into groundwater of the active substances metconazole and mepiquat-chlorid above 0.1 µg/l can be excluded. Risk mitigation is not necessary to protect groundwater Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. BVL_FO_05_2422_200_V1.0 The PPP Carax and the active substances metconazole and mepiquat-chlorid are toxic to the aquatic environment (Lemna gibba, 7 d-ebc50 = 1500 g mepiquat-chlorid /L; Oncorhynchus mykiss, 95 d-noec = 2.91 g metconazole/l). Subsequently no additional entries as those according to the evaluated use pattern and good agricultural practise are acceptable. Therefore the safety phrases and conditions of use NW262, NW264, NW265 and NW468 are assigned, see also 2.2. Applicant BASF SE Date: 04/09/2014

11 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 11 of 12 In agreement with the German modelling scheme TERs are calculated for all relevant routes; i.e. entry by spraydrift, run-off and drainage. Regarding the entry pathways run-off and drainage, calculation is based on the model Exposit The regulatory endpoint for the risk to aquatic organisms is the NOEC of 2.91 g metconazole/l for Oncorhynchus mykiss, the relevant TER is 10. For spray drift, the calculated TER value for the active substance metconazole will only exceed the trigger, if a buffer zone of 5 m is applied (NW606). Using spraying equipment with drift reduction, no buffer zone is necessary for a drift reduction of 75 %, and 90 %, a buffer zone of 5 m is necessary for a drift reduction of 50 %, the minimum buffer zones stipulated by state law must be observed (NW605-1). Risk Assessment for Honeybees The honeybee risk assessment for the main application covers the use(s) in accordance with Article 51 of regulation (EC) No 1107/2009 (see also point 2.2). The labelling NB6641 (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)) is assigned Efficacy Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the uses applied for under the terms of Article 51 of regulation (EC) No 1107/ The categories and labelling for mode of action for the main application cover the uses applied for under the terms of Article 51 of regulation (EC) No 1107/2009. According to Article 51 of the regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products not need to be checked. Depending on crops, varieties, cultivation methods and environmental conditions the product may cause phytotoxic effects. The sensitivity of the crop should be tested under the specific conditions of the application. BVL_FO_05_2422_200_V Conclusions PPP Carax is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of uses. The intended use in ornamentals is not relevant with regards to existing MRLs and consumer health protection. Limited further risk mitigation measures are regarded necessary which deviates from the existing registration. Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. An authorisation can be granted. Applicant BASF SE Date: 04/09/2014

12 Part A Core Assessment Carax Art. 51 Extension of authorisation for minor uses BVL Registration Number: /01 Registration Report All Zones Country Germany Page 12 of Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation None Appendix 1 Copy of the product authorisation See below. Appendix 2 Copy of the product label No product label available. Not mandatory according to Article 51 (5) Appendix 3 Letter of Access No letter of access necessary. The applicant is owner of the new studies submitted. BVL_FO_05_2422_200_V1.0 Applicant BASF SE Date: 04/09/2014

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20 REGISTRATION REPORT Part B Section 3: Mammalian Toxicology Detailed summary of the risk assessment Product code/name: Carax Active Substances: 210 g/l Mepiquat 30 g/l Metconazol Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: BASF SE, Limburgerhof, Deutschland Date: 04/09/2014 Page 1 / 36

21 Table of Contents 3 Mammalian Toxicology (IIIA 7) Summary Toxicological Information on Active Substance(s) Dermal Absorption (IIIA 7.6) Justification for proposed values mepiquat chloride Justification for proposed values - metconazole Exposure Assessment of Plant Protection Product Selection of critical use(s) 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...11 Appendix 1 Reference list...12 Appendix 2 Detailed evaluation of the studies relied upon...13 A 2.1 Studies on dermal absorption (IIIA 7.6)...13 Appendix 3 Exposure calculations...15 A 3.1 Operator calculations (IIIA )...15 A Calculations for mepiquat chloride...15 A Calculations for metconazole...22 A 3.2 Worker calculations (IIIA )...29 A Calculations for mepiquat chloride...29 A Calculations for metconazole...29 A 3.3 Bystander and resident calculations (IIIA )...30 A Calculations for mepiquat chloride...30 A Calculations for metconazole...31 Appendix 4 Detailed evaluation of and/or DFR studies relied upon (IIIA 7.3.2, IIIA 7.4.2, IIIA 7.5.2, IIIA 7.7)...33 A 4.1 Greenhouse study (Mich, 1996)...33 Page 2 / 36

22 A 4.2 Southern Greenhouse model...34 Page 3 / 36

23 3 Mammalian Toxicology 3.1 Summary Table 3.1-1: Information on Carax (BAS W) Product name and code Carax (BAS W) Formulation type Active substance(s) (incl. content) Function Product already evaluated as the representative formulation during the Annex I inclusion Product previously evaluated in an other MS according to Uniform Principles Justified proposals for classification and labelling SL Mepiquat chloride; 210 g/l Metconazole; 30 g/l Fungicide / Growth regulator No No In accordance with Directives 67/548/EEC and 1999/45/EC and according to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 the following classification 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 Directives 67/548/EEC and 1999/45/EC Hazard symbol(s): Indication(s) of danger: Xn Harmful Risk phrases: Safety phrases: Additional labelling phrases: C&L according to Regulation (EC) No 1272/2008 Hazard class(es), categories: Acute Tox. 4, Eye Damage 1 Signal word: To avoid risks to man and the environment, comply with the instructions for use. Danger Hazard statement(s): Precautionary statement(s): (mandatory from 2015) Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. [EUH401] Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents for Carax (BAS W) Result PPE / Risk mitigation measures Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to health damage. - The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection Page 4 / 36

24 products" of the Federal Office of Consumer Protection and Food Safety must be observed. - Wear tight fitting eye protection when handling the undiluted product. - Wear standard protective gloves (plant protection) when handling the undiluted product. Workers Acceptable - Treated areas/crops may not be entered until the spray coating has dried. Bystanders Acceptable None Residents Acceptable None No unacceptable risk for operators, workers, bystanders and residents was identified when the product is used as intended and provided that the PPE/ risk mitigation measures stated in Table are applied. A summary of the critical uses and the overall conclusion regarding for operators, workers and bystanders/residents is presented in Table Table 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 Water L/ha Remarks: (e.g. surfactant (L /ha)) Ornamentals (in pots) Ornamentals (in pots) F G Method / Kind (incl. application technique 3) ) Foliar spray (LCHH) Foliar spray (LCHH) Max. number (min. interval between applications) a) per use b) per crop/ season a) 1 b) 1 a) 1 b) 1 a) max. rate per appl. b) max. total rate per crop/season a) kg mepiquat chloride; kg metconazole b) kg mepiquat chloride; kg metconazole a) kg mepiquat chloride; kg metconazole b) kg mepiquat chloride; kg metconazole min / max Max Max critical gap for operator, worker, bystander or resident based on [Exposure model] 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) e.g. LC: low crops, HC: high crop, TM: tractor-mounted, HH: hand-held Page 5 / 36

25 3.2 Toxicological Information on Active Substances Information regarding classification of the active substances and on EU endpoints and critical areas of concern identified during the EU review are given in Table Table 3.2-1: Information on active substances Active substance A Active substance B Common Name Mepiquat chloride Metconazole CAS-No Classification and proposed labelling With regard to toxicological enpoints (according to the criteria in Dir. 67/548/EEC) With regard to toxicological enpoints (according to the criteria in Reg. 1272/2008) Xn R22 - Harmful - Harmful if swallowed Acute toxicity, cat. 4 H302 - Harmful if swallowed Xn R22 R63 - Harmful - Harmful if swallowed - Possible risk of harm to the unborn child (Repr. Cat. 3) Acute toxicity, cat. 4 Reproductive toxicity, cat. 2 H302 - Harmful if swallowed H361d - Suspected of damaging the unborn child Additional C&L proposal Proposal BfR: none additional Proposal BfR: none additional Agreed EU endpoints AOEL systemic 0.3 mg/kg bw/d 0.01 mg/kg bw/d Reference Review Report SANCO/106/08-rev.2 20 May 2008 Conditions to take into account/critical areas of conern with regard to toxicology Review Report for active substance None Review Report SANCO/10027/2006 final 23 May 2006 the operator safety 3.3 Dermal Absorption A summary of the dermal absorption endpoints for the active substances in Carax (BAS W) are presented in Table Table 3.3-1: Dermal absorption endpoints for active substances in Carax (BAS W) Mepiquat chloride Metconazole Value Reference Value Reference Concentrate 25 % Default (EFSA Journal, 2012) Dilution (dilution factor) 75 % Default (EFSA Journal, 2012) 4 % based on SL formulation BAS W ASB % (1:273) based on SL formulation BAS W ASB Page 6 / 36

26 3.3.1 Justification for proposed values mepiquat chloride No data on dermal absorption for mepiquat chloride in Carax (BAS W) is available. Justification for default values according to Guidance on Dermal Absorption (EFSA Journal 2012; 10(4):2665) are presented in Table Table 3.3-2: Default dermal absorption endpoints for mepiquat chloride Value Justification for value Acceptability of justification Concentrate 25 % product containing 210 g/kg active substance (> 50 g/kg); MW of active substance: g/mol (< 500 g/mol) Dilution 75 % in use dilution containing g/l active substance ( 50 g/l); MW of active substance: g/mol (< 500 g/mol) no dermal absorption study on mepiquat chloride in SL formulation available and data on other formulation types not applicable; default value used no dermal absorption study on mepiquat chloride in SL formulation available and data on other formulation types not applicable; default value used Justification for proposed values - metconazole Proposed endpoint for metconazole is based on a dermal absorption study on a formulation similar to Carax (BAS W). Table 3.3-3: Test In-vivo (rat) Concentrate Summary of dermal absorption studies for metconazole Spray dilution (1:273) Formulation in study 4 % 30 % BAS W Acceptability of study Justification provided on representativ ity of study formulation for current product Acceptability of justification Yes Not required. Endpoint can be used for current product. Reference* Fabian E., Leibold E., Exposure Assessment of Plant Protection Product Table 3.4-1: Product information and toxicological reference values used for assessment Product name and code Carax (BAS W) Formulation type SL Category Fungicide / Growth regulator Container size(s), short description 1 L container (HDPE) with 42 mm Ø closure; 3 L, 5 L or 10 L container (HDPE) with 54 mm Ø closure Active substances (incl. content) Mepiquat chloride 210 g/l Metconazole 30 g/l AOEL systemic 0.3 mg/kg bw/d 0.01 mg/kg bw/d Inhalative absorption 100 % 100 % Oral absorption 100 % 100 % Dermal absorption Concentrate: 25 % Dilution: 75 Default values (EFSA guidance) Concentrate: 4 % Dilution: 30 % (Dilution rate: 1:273) BAS W Page 7 / 36

27 3.4.1 Selection of critical uses and justification The critical GAPs used for the assessment of the plant protection product are shown in Table Operator Estimation of operator A summary of the models used for estimation of operator to the active substances during application of Carax (BAS W) according to the critical uses is presented in Table Outcome of the estimation is presented in Table Detailed calculations are given in Appendix 3. Table 3.4-2: Critical use Model Critical use Model Exposure models for intended uses Ornamentals in pots outdoor (max. 1.4 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] Ornamentals in pots outdoor (max. 1.4 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 3.4-3: Estimated operator Mepiquat chloride Model data Level of PPE Total absorbed dose (mg/kg/day) Hand-held equipment, low crop Application rate: kg mepiquat chloride/ha kg metconazole/ha German Model 1) (Geometric mean) Body weight: 70 kg UK POEM (Application volume: 1000 L/ha Container: 5 L, 45 or 63 mm closure 4) Body weight: 60 kg % of systemic AOEL Metconazole Total absorbed dose (mg/kg/day) % of systemic AOEL no PPE 2) gloves m/l no PPE 3) gloves m/l + appl. and impermeable coverall appl ) based on high crop scenario (low crop scenario for hand-held application not available in German model) 2) no PPE: Operator wearing T-shirt and shorts 3) no PPE: Operator wearing long sleeved shirt, long trousers ( permeable ) but no gloves 4) Based on the work rate of 1 ha/day and the proposed maximum application rate of 1.4 L product /ha, the amount of product required to treat 1 hectare would be 1.4 litres. It is unrealistic to consider that a 10 litre container would be used. Therefore, the 5 litre container gives the realistic worst case dermal during mixing/loading. Page 8 / 36

28 Measurement of operator Since there are no representative data in available calculation models for the use of plant protection products in greenhouses, operator was estimated using a GLP study performed for the generic assessment of products applied in greenhouses. In addition operator for application in greenhouses was calculated using the Southern European Greenhouse data. Detailed considerations and calculations as well as a summary of the study/data are presented in Appendix 3 and 4, respectively. Estimation of operator based on measured values after greenhouse applications and risk assessment Table 3.4-4: Critical use Model Critical use Model Exposure models for intended uses Ornamentals in pots, greenhouse (max. 1.4 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] and Exposure study according to Mich (1996) Ornamentals in pots, greenhouse (max. 1.4 L product/ha) Southern European Greenhouse model; Members of the European Crop Protection Association, Occupational & Bystander Exposure Expert Group, October 2010 (Revision 9) Table 3.4-5: Estimated operator Mepiquat chloride Model data Level of PPE Total absorbed dose (mg/kg/day) Hand-held spray application indoors, low crop % of systemic AOEL Metconazole Total absorbed dose (mg/kg/day) % of systemic AOEL Application rate: kg mepiquat chloride/ha kg metconazole/ha German Model and Mich, 1996 Body weight: 70 kg no PPE 1) coverall during appl. 2) Southern European Greenhouse model (standard scenario) Body weight: 70 kg 1) no PPE: Operator wearing T-shirt and shorts 2) non-ppe scenario (without coverall during appl.) not available Worker Estimation of worker Tble shows the model used for estimation of worker after entry into a previously treated area or handling a crop treated with Carax (BAS W) according to the critical use. Outcome of the estimation is presented in Table Detailed calculations are presented in Appendix 3. Tble 3.4-6: Exposure models for intended uses Critical use Ornamentals (max. 1 x 1.4 L product/ha) 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] Page 9 / 36

29 Table 3.4-7: Estimated worker Model data Level of PPE Total absorbed dose (mg/kg/day) Mepiquat chloride % of systemic AOEL Total absorbed dose (mg/kg/day) Metconazole % of systemic AOEL Number of applications and application rate: 1 x kg mepiquat chloride/ha + 1 x kg metconazole/ha 8 hours/day 1), TC: 5000 cm 2 /person/h 2) Body weight: 60 kg no PPE 3) ) 8 h/day for professional applications for harvesting, pruning, tying, thinning or weeding activities etc. 2) EUROPOEM II, 2002, Post-Application Exposure of Workers to Pesticides in Agriculture 3) no PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves Measurement of worker Since the worker estimations carried out indicated that the acceptable operator level (AOEL) will not be exceeded under conditions of the intended uses, a study to provide measurements of worker was not necessary and was therefore not performed Bystander and resident Estimation of bystander and resident Table shows the model used for estimation of bystander and resident to mepiquat chloride and metconazole. Outcome of the estimation is presented in Table Detailed calculations are presented in Appendix 3. Table 3.4-8: Critical use Model Table 3.4-9: Exposure models for intended uses Ornamentals outdoors (max. 1 x 1.4 L product/ha) 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 Estimated bystander and resident Model data Total absorbed dose (mg/kg/day) Mepiquat chloride % of systemic AOEL Hand-held application outdoors, low crops Application rate: 1 x kg mepiquat chloride/ha + 1 x kg metconazole/ha Bystanders (adult) Drift rate: 2.77 % (1 m) Body weight: 60 kg Bystanders (children) Drift rate: 2.77 % (1 m) Body weight: 60 kg Residents (adult) Drift rate: 2.77 % (1 m) Body weight: 60 kg Total absorbed dose (mg/kg/day) Metconazole % of systemic AOEL Page 10 / 36

30 Residents (children) Drift rate: 2.77 % (1 m) Body weight: 60 kg Measurement of bystander and/or resident Since the bystander and/or resident estimations carried out indicated that the acceptable operator level (AOEL) for mepiquat chloride and metconazole 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. The combined toxicological effect of these active substances has not been investigated with regard to repeated dose toxicity. Page 11 / 36

31 Appendix 1 Reference list Annex point/ reference No Author(s) Year Title Report-No. Authority registration No. Owner KIIIA1 7.3 Anon Southern European greenhouse model overview 2010/ ! Rev. 9! M ! European Crop Protection Association GLP: Open Published: No BVL , ASB BAS KIIIA1 7.3 Mich, G Operator in greenhouses during practical use of plant protection products EF ! MO ! M BVL , BVL , BVL , BVL , BVL , TOX *Y, Yes/relied on; N, No/not relied on; Add, Additional, Relied on/study not submitted by applicant but necessary for evaluation How considere d in drr * Add Add Page 12 / 36

32 Appendix 2 Detailed evaluation of the studies relied upon A 2.1 Studies on dermal absorption (IIIA 7.6) xxxxxxxxxxxxxxxxxxx Study on the dermal penetration of 14C_BAS 555 F in BAS W in rats; 2005 (ASB ) Page 13 / 36

33 Comments of zrms: acceptable Agreed endpoint: 4 % for the concentrate (applied dose appr. 300 µg/cm 2 ) and 30 % for the dilution (applied dose appr. 1.1 µg/cm 2 ) based on rat in vivo (ASB ) Page 14 / 36

34 Appendix 3 A 3.1 A Exposure calculations Operator calculations Calculations for mepiquat chloride Hand-held equipment outdoors (German model) Table A 1: Input parameters considered for the estimation of operator Formulation type: SL High crop hand held (no hand held Application technique: scenario for low crops available in Application rate (AR): kg a.s./ha German model) Area treated per day (A): 1 ha Dermal hands m/l (D M(H)): 205 mg/person/kg a.s. 25 % (concentr.) Dermal hands appl. (D A(H)): 10.6 mg/person/kg a.s. Dermal absorption (DA): 75 % (dilution) Dermal body appl. (D A(B)): 25 mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (D A(C)): 4.8 mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (I M): 0.05 mg/person/kg a.s. AOEL 0.3 mg/kg bw/d Inhalation appl. (I A): 0.3 mg/person/kg a.s. Table A 2: Estimation of operator towards mepiquat chloride using the German model Without PPE Operators: Systemic dermal after application in ornamentals Dermal during mixing/loading Hands SDE OM(H) = (D M(H) x AR x A x DA) / BW With PPE Hands SDE OM(H) = (D M(H) x AR x A x PPE 1) x DA) / BW (205 x x 1 x 25%) / 70 (205 x x 1 x 0.01 x 25%) / 70 External dermal mg/person External dermal mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Systemic dermal mg/kg bw/d Systemic dermal mg/kg bw/d Dermal during application Hands SDE OA(H) = (D A(H) x AR x A x DA) / BW Hands SDE OA(H) = (D A(H) x AR x A x PPE x DA) / BW (10.6 x x 1 x 75%) / 70 (10.6 x x 1 x 1 x 75%) / 70 External dermal mg/person External dermal mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Systemic dermal mg/kg bw/d Systemic dermal mg/kg bw/d Body Body SDE OA(B) = (D A(B) x AR x A x DA) / BW SDE OA(B) = (D A(B) x AR x A x PPE x DA) / BW (25 x x 1 x 75%) / 70 (25 x x 1 x 1 x 75%) / 70 External dermal 7.35 mg/person External dermal 7.35 mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Systemic dermal mg/kg bw/d Systemic dermal mg/kg bw/d Head Head SDE OA(C) = (D A(C) x AR x A x DA) / BW SDE OA(C) = (D A(C) x AR x A x PPE x DA) / BW (4.8 x x 1 x 75%) / 70 (4.8 x x 1 x 1 x 75%) / 70 External dermal mg/person External dermal mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Systemic dermal mg/kg bw/d Systemic dermal mg/kg bw/d Total systemic dermal : SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total systemic dermal : SDE O = SDE OM(H) + SDE OA(H) + SDE OA(B) + SDE OA(C) Total external dermal mg/person Total external dermal mg/person Total external dermal mg/kg bw/d Total external dermal mg/kg bw/d Total systemic dermal mg/kg bw/d Total systemic dermal mg/kg bw/d Operators: Systemic inhalation after application in ornamentals Inhalation during mixing/loading SIE OM = (I M x AR x A x IA) / BW SIE OM = (I M x AR x A x PPE x IA) / BW (0.05 x x 1 x 100%) / 70 (0.05 x x 1 x 1 x 100%) / 70 Page 15 / 36

35 External inhalation mg/person External inhalation mg/person External inhalation mg/kg bw/d External inhalation mg/kg bw/d Systemic inhalation mg/kg bw/d Systemic inhalation mg/kg bw/d Inhalation during application SIE OA = (I A x AR x A x IA) / BW SIE OA = (I A x AR x A x PPE x IA) / BW (0.3 x x 1 x 100%) / 70 (0.3 x x 1 x 1 x 100%) / 70 External inhalation mg/person External inhalation mg/person External inhalation mg/kg bw/d External inhalation mg/kg bw/d Systemic inhalation mg/kg bw/d Systemic inhalation mg/kg bw/d Total systemic inhalation : SIE O = SIE OM + SIE OA Total systemic inhalation : SIE O = SIE OM + SIE OA Total external inhalation Total external inhalation mg/person mg/person Total external inhalation Total external inhalation mg/kg bw/d mg/kg bw/d Total systemic inhalation Total systemic inhalation mg/kg bw/d mg/kg bw/d Total systemic : SE O = SDE O + SIE O Total systemic : SE O = SDE O + SIE O Total systemic mg/person Total systemic mg/person Total systemic mg/kg bw/d Total systemic mg/kg bw/d % of AOEL % % of AOEL 43.6 % 1) reduction factor for gloves is 0.01 (professional appl.) Hand-held equipment outdoors (UK POEM) Table A 3: Estimation of operator towards mepiquat chloride using the UK- POEM (low level target; no PPE) THE UK PREDICTIVE OPERATOR EXPOSURE MODEL (POEM) Active substance mepiquat-chloride Product Carax Formulation type water-based Concentration of a.s. 210 mg/ml Dose 1.4 L preparation/ha (0.294 kg a.s./ha) Application volume 1000 L/ha Application method Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target Container 5 litres 45 or 63 mm closure Work rate/day 0.4 ha Duration of spraying 6 h PPE during mix./loading None PPE during application None Dermal absorption from product 25 % Dermal absorption from spray 75 % EXPOSURE DURING MIXING AND LOADING Container size 5 Litres Hand contamination/operation 0,01 ml Application dose 1.4 Litres product/ha Work rate 0.4 ha/day Number of operations 27 /day Hand contamination 0.27 ml/day Protective clothing None Transmission to skin 100 % Dermal to formulation 0.27 ml/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target Application volume 1000 spray/ha Volume of surface contamination 50 ml/h Distribution Hands Trunk Legs 25% 25% 50% Page 16 / 36

36 Clothing None Permeable Permeable Penetration 100% 20% 18% Dermal ml/h Duration of 6 h Total dermal to spray 102 ml/day ABSORBED DERMAL DOSE Mix/load Application Dermal 0.27 ml/day 102 ml/day Concen. of a.s. product or spray 210 mg/ml mg/ml Dermal to a.s mg/day mg/day Percent absorbed 25 % 75 % Absorbed dose mg/day mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation 0.02 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 % Table A 4: Estimation of operator towards mepiquat chloride using the UK- POEM (low level target; gloves during m/l + appl.) THE UK PREDICTIVE OPERATOR EXPOSURE MODEL (POEM) Active substance mepiquat-chloride Product Carax Formulation type water-based Concentration of a.s. 210 mg/ml Dose 1.4 L preparation/ha (0.294 kg a.s./ha) Application volume 1000 L/ha Application method Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target Container 5 litres 45 or 63 mm closure Work rate/day 0.4 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves Dermal absorption from product 25 % Dermal absorption from spray 75 % EXPOSURE DURING MIXING AND LOADING Container size 5 Litres Hand contamination/operation 0,01 ml Application dose 1.4 Litres product/ha Work rate 0.4 ha/day Number of operations 27 /day Hand contamination 0.27 ml/day Protective clothing Gloves Transmission to skin 5 % Dermal to formulation ml/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target Application volume 1000 spray/ha Page 17 / 36

37 Volume of surface contamination 50 ml/h Distribution Hands Trunk Legs 25% 25% 50% Clothing Gloves Permeable Permeable Penetration 10% 20% 18% Dermal ml/h Duration of 6 h Total dermal to spray 49.5 ml/day ABSORBED DERMAL DOSE Mix/load Application Dermal ml/day 49.5 ml/day Concen. of a.s. product or spray 210 mg/ml mg/ml Dermal to a.s mg/day mg/day Percent absorbed 25 % 75 % Absorbed dose mg/day mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation 0.02 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 64.8 % Table A 5: Estimation of operator towards mepiquat chloride using the UK- POEM (low level target; gloves during m/l + appl., impermeable coverall during appl.) THE UK PREDICTIVE OPERATOR EXPOSURE MODEL (POEM) Active substance mepiquat-chloride Product Carax Formulation type water-based Concentration of a.s. 210 mg/ml Dose 1.4 L preparation/ha (0.294 kg a.s./ha) Application volume 1000 L/ha Application method Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target Container 5 litres 45 or 63 mm closure Work rate/day 0.4 ha Duration of spraying 6 h PPE during mix./loading Gloves PPE during application Gloves and impermeable coveralls Dermal absorption from product 25 % Dermal absorption from spray 75 % EXPOSURE DURING MIXING AND LOADING Container size 5 Litres Hand contamination/operation 0,01 ml Application dose 1.4 Litres product/ha Work rate 0.4 ha/day Number of operations 27 /day Hand contamination 0.27 ml/day Protective clothing Gloves Transmission to skin 5 % Dermal to formulation ml/day Page 18 / 36

38 DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Hand-held sprayer (15 L tank): hydraulic nozzles. Outdoor, low level target Application volume 1000 spray/ha Volume of surface contamination 50 ml/h Distribution Hands Trunk Legs 25% 25% 50% Clothing Gloves Impermeable Impermeable Penetration 10% 5% 5% Dermal ml/h Duration of 6 h Total dermal to spray ml/day ABSORBED DERMAL DOSE Mix/load Application Dermal ml/day ml/day Concen. of a.s. product or spray 210 mg/ml mg/ml Dermal to a.s mg/day mg/day Percent absorbed 25 % 75 % Absorbed dose mg/day mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation 0.02 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 27.1 % Hand-held equipment greenhouse (Mich, 1996) Table A 6: Input parameters considered for the estimation of operator Formulation type: SL Application rate (AR): kg a.s./ha Application technique: Low crop hand held Area treated per day (A): 1 ha Dermal hands m/l (D M(H)): 205 mg/person/kg a.s. Dermal absorption (DA): 25 % (concentr.) Dermal hands appl. (D A(H)): mg/person/kg a.s. 75 % (dilution) Dermal body appl. (D A(B)): mg/person/kg a.s. Inhalation absorption (IA): 100 % Dermal head appl. (D A(C)): mg/person/kg a.s. Body weight (BW): 70 kg/person Inhalation m/l (I M): 0.05 mg/person/kg a.s. AOEL 0.3 mg/kg bw/d Inhalation appl. (I A): mg/person/kg a.s. Table A 7: Operator towards mepiquat-chloride Without PPE Operators: Systemic dermal after application in ornamentals Dermal during mixing/loading Hands SDE OM(H) = (D M(H) x AR x A x DA) / BW With PPE Hands SDE OM(H) = (D M(H) x AR x A x PPE 1) x DA) / BW (205 x x 1 x 25%) / 70 (205 x x 1 x 0.01 x 25%) / 70 External dermal mg/person External dermal mg/person External dermal mg/kg bw/d External dermal mg/kg bw/d Systemic dermal mg/kg bw/d Systemic dermal mg/kg bw/d Dermal during application Hands Hands Page 19 / 36