Direct application of plant protection products (granules or treated seeds) containing co-formulants to soil

ECPA use map, April 2020, version 2 Please read the text carefully, before starting an assessment!Co-formulants in plant protection products (PPP) are subject to the REACH Regulation (EC) No. 1907/2006, and human and environmental risk assessments are required eventually for hazardous substances contained in co-formulants. The standard tools for exposure and risk assessment under REACH, such as ECETOC Targeted Risk Assessment (TRA) and EUSES, are not set up to assess human and environmental exposure to a co-formulant in PPP properly. The human exposure assessment of PPP is placed outside of the applicability domain of ECETOC TRA based on regulatory scope, and concerns about the potential hazard profile of active substances. And the default local exposure assessment approach for the environment (“EU TGD”) does not take account of uses where substances are directly applied onto agricultural soil, or where emissions to surface water not initially directed to a municipal sewage treatment plant may occur (e.g., spray drift of a co-formulant).The European Crop Protection Association (ECPA) therefore has developed approaches and tools for the assessment of substances used as a co-formulant in PPP, which are freely available with accompanying information on a dedicated webpage: <a href="http://www.ecpa.eu/information-page/regulatory-affairs/reach">http://www.ecpa.eu/information-page/regulatory-affairs/reach</a>This CHESAR use map has been created by ECPA to support users of CHESAR with the exposure and risk assessment under REACH for substances used as a co-formulant in PPP. It reflects the four ECPA Generic Exposure Scenarios developed in the ECPA REACH-IN project and the relevant environmental, worker and consumer contributing scenarios. ECPA recommends the following process for the assessment of substances used as a co-formulant in PPP in CHESAR: The environmental contributing scenarios in the four exposure scenarios of the CHESAR use map developed by ECPA contain the ECPA SpERCs for the calculation of regional environmental concentrations of a co-formulant in compliance with ECHA guidance. All other identified uses of the substance and associated environmental emissions on the regional scale have to be considered in the calculation of regional environmental concentrations as well. ECPA has developed the Local Environment Tool (ECPA LET) and the underlying approach as a standalone replacement for the local scale nested box in the models based on the EU TGD. Local scale environmental exposure to a co-formulant for each contributing environmental scenario should be calculated with ECPA LET, and not with EUSES or ECETOC TRA. The regional concentrations calculated with the ECPA SpERCs can be manually imported into LET. Each worker and consumer contributing scenario in the four exposure scenarios of the CHESAR use map developed by ECPA includes generic ECPA SWEDs or SCEDs, which are intended as placeholders not containing relevant conditions of use required for the calculation of exposure. ECPA has developed the Operator, Worker, Bystander Tool (ECPA OWB) for the assessment of human exposure to substances used as a co-formulant in PPP. Worker and consumer exposure to a co-formulant for each contributing worker or consumer scenario should be assessed with ECPA OWB, and not with ECETOC TRA or CHESAR. The following steps are required for the assessment of environmental, worker and consumer exposure to a substance used as a co-formulant in PPP, using CHESAR: STEP 1. Ensure the ECPA use map file is uploaded in CHESAR box 2, so that the four ECPA Generic Exposure Scenarios inclusing all relevant environmental, worker and consumer contributing scenarios for the use of a substance as a co-formulant in plant protection products are imported into CHESAR. Ensure that you have included also a proper description of all other identified uses of the substance in CHESAR box 2. STEP 2. Predict the environmental, worker and consumer exposure to the substance used as a co-formulant. These calculations need to be done mostly in the external ECPA REACH-IN tools (see additional information provided with the CHESAR use map file). Follow these steps: 1. Calculate regional environmental exposure in CHESAR using the ECPA SpERCs for co-formulant use and considering all other uses of the substance. You need to ensure that you have assigned a tonnage (and an EUSES dataset) to each of the uses in box 2 (ECPA uses and all other identified uses). 2. Assess local environmental exposure for the co-formulant use with ECPA LET after copying the calculated regional environmental concentrations (covering all identified uses) into the ECPA LET tool. 3. Assess worker or consumer exposure for the co-formulant use with ECPA OWB. 4. Generate the relevant exposure scenario for the co-formulant use with the functionality in ECPA OWB. STEP 3. Integrate the outcome of the external assessments into CHESAR. In principle, the background information provided in the exposure scenario created with ECPA OWB, the conditions of use and the exposure and risk assessments obtained with the ECPA REACH-IN tools can be copied into the relevant sections of the exposure scenarios generated from CHESAR. Follow these steps: 1. Use the outputs of ECPA LET (e.g. safe application rate) to adapt the conditions of use in CHESAR box 3 for each environmental contributing activity. 2. Use the outputs of ECPA OWB (e.g. safe daily application rate, PPE) to adapt the conditions of use in CHESAR box 3 for each worker or consumer contributing scenario. To adapt other conditions of use than the daily application rate, the link to the SWED will need to be removed. 3. Generate the ES for communication (annex to the SDS) in box 5. 4. Generate the CSR in box 4 and replace the environmental, worker and consumer contributing scenario with the corresponding scenario created with ECPA OWB. ECPA use map, April 2020, version 2 0 false false ded344f1-ec9f-4f3d-b2be-bd6612a8127e ESCom-17297181000 Description of the activities and technical processes covered in the exposure scenario: This exposure scenario covers the professional use of a co-formulant in plant protection products, applied as a spray. This scenario includes both indoor and outdoor use. The transfer (and inherent dilution and mixing) of solid and liquid PPPs which occurs during loading of tractor mounted/trailed boom sprayers, loading of tractor mounted/trailed broadcast air-assisted sprayers, and loading of hand-held spray equipment. The spray application of PPPs using tractor mounted/trailed boom sprayers, tractor mounted/trailed broadcast air-assisted sprayers, and hand-held spray equipment for high-level targets, as well as the indirect exposure of workers on field re-entry and indirect exposure of bystanders. REACH_ARTICLE_OVER_10 ded344f1-ec9f-4f3d-b2be-bd6612a8127e 0 false false false false true true true Spray application ECPA guidance document ECPA LET, ECPA OWB The exposure scenario may be scaled using the ECPA LET with the stated maximum risk characterisation ratio using the parameters: co-formulant application rate, number of applications, application interval, crop (drift rate), location and period of application. The exposure scenario may be scaled using the ECPA OWB with the stated maximum risk characterisation ratio using the parameters: application rate, personal protection equipment (PPE), and respiratory protection (RPE). http://www.ecpa.eu/information-page/regulatory-affairs/reach ESCom-15193135718 0 ENVIRONMENT_PLACE_OF_USE Indoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario. false true ENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOOR WATER_CONTACT_DURING_USE Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Controlled application to agricultural crops in accordance with the product label and Good Agricultural Practice is required. false true WATER_CONTACT_DURING_USE_NO EUSES_BIOLOGICAL_STP false false EUSES_BIOLOGICAL_STP-NONE WATER 0.0 84edc657-64c0-444a-9dcd-bc25c510c0c0 true WASTE_TREATMENT_CONSIDERATION Product labels provide guidance for users on how to dispose of plant protection products and emptied containers. It is recommended that plant protection product containers are triple or pressure rinsed or rinsed with a system that is an integral part of the sprayer. Rinse water should be added to the sprayer at time of filling. Properly rinsed containers may be disposed of as non-hazardous waste. false true WASTE_CONSIDERATION_NO_LOW_AMOUNT ANNUAL_APPLICATION_RATE false true RELEASE_MODULE_REGIONAL_SCALE The regional tonnage depends on the geographical distribution of the co-formulant use, which is assumed to be 10% of the manufacturer’s total European tonnage for PPP uses. false false 10.0 RELEASE_MODULE_DAILY_WIDE_DISPERSIVE_USE The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. false ENVIRONMENT_AGRICULTURAL_SOIL false false QUALITATIVE_PBT ENVIRONMENT_AIR false false QUALITATIVE_PBT ENVIRONMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_TERRESTRIAL false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_STP false false QUALITATIVE_PBT ENVIRONMENT_TOP_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT 84edc657-64c0-444a-9dcd-bc25c510c0c0 ENVIRONMENT_AGRICULTURAL_SOIL MAIN ENVIRONMENT_AIR MAIN ENVIRONMENT_FRESH_WATER MAIN ENVIRONMENT_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_FRESH_WATER MAIN ENVIRONMENT_PREDATOR_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_TERRESTRIAL MAIN ENVIRONMENT_SEDIMENT_FRESH_WATER MAIN ENVIRONMENT_SEDIMENT_MARINE_WATER MAIN ENVIRONMENT_STP MAIN ENVIRONMENT_TOP_PREDATOR_MARINE_WATER MAIN MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM MAIN true DRINKING_WATER 84edc657-64c0-444a-9dcd-bc25c510c0c0 FISH 84edc657-64c0-444a-9dcd-bc25c510c0c0 LEAF_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 MEAT 84edc657-64c0-444a-9dcd-bc25c510c0c0 MILK 84edc657-64c0-444a-9dcd-bc25c510c0c0 ROOT_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 84edc657-64c0-444a-9dcd-bc25c510c0c0 AGRIC_SOIL SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 AIR SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 WATER SPERC 0.0 false bd3eb5ca-3b77-4b61-8f15-7423f164bc71 84edc657-64c0-444a-9dcd-bc25c510c0c0 DEFAULT 1515 92c4e6de-6c9c-4074-bc82-1be8257db229 ERC_8d false ERC_8a ESCom-15193135719 1 DAILY_APPLICATION_RATE false true TRA-WORKER-DERMAL-PROTECTION false true TRA-WORKER-DERMAL-PROTECTION_PPE90 WORKER_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED WORKER_COMBINED_SYSTEMIC_SHORT_TERM true false NOT_NEEDED WORKER_DERMAL_LOCAL_LONG_TERM false UNDEFINED WORKER_DERMAL_LOCAL_SHORT_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_SHORT_TERM false UNDEFINED WORKER_EYE_LOCAL false UNDEFINED WORKER_INHALATION_LOCAL_LONG_TERM false UNDEFINED WORKER_INHALATION_LOCAL_SHORT_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_SHORT_TERM false UNDEFINED dabaa228-ce44-4a2b-80c7-884b0f598603 1515 e1fca8e6-15e7-4b98-acd9-8968b31ab653 PROC_8a false ESCom-15193135720 ESCom-15193135718 2 DAILY_APPLICATION_RATE false true WORKER_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED WORKER_COMBINED_SYSTEMIC_SHORT_TERM true false NOT_NEEDED WORKER_DERMAL_LOCAL_LONG_TERM false UNDEFINED WORKER_DERMAL_LOCAL_SHORT_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_SHORT_TERM false UNDEFINED WORKER_EYE_LOCAL false UNDEFINED WORKER_INHALATION_LOCAL_LONG_TERM false UNDEFINED WORKER_INHALATION_LOCAL_SHORT_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_SHORT_TERM false UNDEFINED 41098155-65a4-49a8-ba6e-680011854d75 1515 1858c927-0dfe-4b5a-925d-71786a0fe732 PROC_11 false ff440161-c49d-4759-af82-18ba828531ac ECPA_PW_001_v1 SU_1 false false PC_27 ESCom-17297181100 Description of the activities and technical processes covered in the exposure scenario: This exposure scenario covers the professional use of a co-formulant in PPPs, applied as granular product or treated seeds. This scenario includes both indoor and outdoor use. The transfer of treated seed and granular PPPs which occurs during loading of tractor-mounted broadcast spreaders, and the loading of manual belly-grinders and “push-type” spreaders; and the delivery and dispersion of treated seeds and granular PPPs from manual spreading (by hand), mechanical spreading (belly grinders and push-type rotary spreaders), and from tractor-mounted broadcast spreaders. REACH_ARTICLE_OVER_10 ded344f1-ec9f-4f3d-b2be-bd6612a8127e 1 false false false false true true true Granular and treated seeds application ECPA guidance document ECPA LET, ECPA OWB The exposure scenario may be scaled using the ECPA LET with the stated maximum risk characterisation ratio using the parameters: co-formulant application rate, number of applications, application interval, crop (drift rate), location and period of application. The exposure scenario may be scaled using the ECPA OWB with the stated maximum risk characterisation ratio using the parameters: application rate, personal protection equipment (PPE), and respiratory protection (RPE). http://www.ecpa.eu/information-page/regulatory-affairs/reach ESCom-12355002152 0 ENVIRONMENT_PLACE_OF_USE Indoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario. false true ENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOOR WATER_CONTACT_DURING_USE Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Controlled application to agricultural crops in accordance with the product label and Good Agricultural Practice is required. false true WATER_CONTACT_DURING_USE_NO EUSES_BIOLOGICAL_STP false false EUSES_BIOLOGICAL_STP-NONE WATER 0.0 84edc657-64c0-444a-9dcd-bc25c510c0c0 true WASTE_TREATMENT_CONSIDERATION Product labels provide guidance for users on how to dispose of plant protection products. Used packaging must be disposed of in accordance with the product label and local regulations. false true WASTE_CONSIDERATION_NO_LOW_AMOUNT ANNUAL_APPLICATION_RATE false true RELEASE_MODULE_REGIONAL_SCALE The regional tonnage depends on the geographical distribution of the co-formulant use, which is assumed to be 10% of the manufacturer’s total European tonnage for PPP uses. false false 10.0 RELEASE_MODULE_DAILY_WIDE_DISPERSIVE_USE The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. false ENVIRONMENT_AGRICULTURAL_SOIL false false QUALITATIVE_PBT ENVIRONMENT_AIR false false QUALITATIVE_PBT ENVIRONMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_TERRESTRIAL false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_STP false false QUALITATIVE_PBT ENVIRONMENT_TOP_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT 84edc657-64c0-444a-9dcd-bc25c510c0c0 ENVIRONMENT_AGRICULTURAL_SOIL MAIN ENVIRONMENT_AIR MAIN ENVIRONMENT_FRESH_WATER MAIN ENVIRONMENT_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_FRESH_WATER MAIN ENVIRONMENT_PREDATOR_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_TERRESTRIAL MAIN ENVIRONMENT_SEDIMENT_FRESH_WATER MAIN ENVIRONMENT_SEDIMENT_MARINE_WATER MAIN ENVIRONMENT_STP MAIN ENVIRONMENT_TOP_PREDATOR_MARINE_WATER MAIN MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM MAIN true DRINKING_WATER 84edc657-64c0-444a-9dcd-bc25c510c0c0 FISH 84edc657-64c0-444a-9dcd-bc25c510c0c0 LEAF_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 MEAT 84edc657-64c0-444a-9dcd-bc25c510c0c0 MILK 84edc657-64c0-444a-9dcd-bc25c510c0c0 ROOT_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 84edc657-64c0-444a-9dcd-bc25c510c0c0 AGRIC_SOIL 100.0 For granular products and treated seeds, the worst case is that the total applied fraction reaches the soil. The emission fraction to soil was set to 1. SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 AIR 0.0 For granular products and treated seeds, use of co-formulants with significant volatility is unlikely, because these are typically liquids, and as such cannot be added in significant concentrations in a solid product without modifying the physical state. Furthermore, solid substances with low melting points or prone to sublimation would pose product storage/stability issues. Due to these reasons, potential volatilisation of co-formulants from granular products and treated seeds on the timescale relevant for the emission fraction (during and shortly after initial application) was considered unrealistic. The specific case of a volatile solvent used in a liquid seed treatment formulation is covered by the SpERC for spray application. SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 WATER 0.0 Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Furthermore, the physical properties of granules and treated seeds limits the potential for direct release to surface water. SPERC 0.01 Product labels provide guidance for users on how to dispose of plant protection products. Specific estimates of residual product remaining in packaging for granular formulations or treated seeds are not available. The OECD emission scenario document for plastic additives (OECD 2009) gives a reasonable number for powders of particle size >40 µm of 0.01% remaining in the package. Based on this analogous scenario (i.e. solid substance of relatively large particle size in a plastic container) this value was adopted without modification. false faaea88e-1eab-4373-b7dc-a8b00ad8f382 84edc657-64c0-444a-9dcd-bc25c510c0c0 1593 DEFAULT 1515 e8a9b5a2-418a-42b6-aee2-2eebbce1a675 ERC_8d false ERC_8a ESCom-15193135719 1 DAILY_APPLICATION_RATE false true TRA-WORKER-DERMAL-PROTECTION false true TRA-WORKER-DERMAL-PROTECTION_PPE90 WORKER_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED WORKER_COMBINED_SYSTEMIC_SHORT_TERM true false NOT_NEEDED WORKER_DERMAL_LOCAL_LONG_TERM false UNDEFINED WORKER_DERMAL_LOCAL_SHORT_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_SHORT_TERM false UNDEFINED WORKER_EYE_LOCAL false UNDEFINED WORKER_INHALATION_LOCAL_LONG_TERM false UNDEFINED WORKER_INHALATION_LOCAL_SHORT_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_SHORT_TERM false UNDEFINED dabaa228-ce44-4a2b-80c7-884b0f598603 1515 0242d79f-7c14-4791-b495-dd0ea095b540 PROC_8a false ESCom-15193135720 ESCom-15193135728 2 DAILY_APPLICATION_RATE false true WORKER_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED WORKER_COMBINED_SYSTEMIC_SHORT_TERM true false NOT_NEEDED WORKER_DERMAL_LOCAL_LONG_TERM false UNDEFINED WORKER_DERMAL_LOCAL_SHORT_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_DERMAL_SYSTEMIC_SHORT_TERM false UNDEFINED WORKER_EYE_LOCAL false UNDEFINED WORKER_INHALATION_LOCAL_LONG_TERM false UNDEFINED WORKER_INHALATION_LOCAL_SHORT_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_LONG_TERM false UNDEFINED WORKER_INHALATION_SYSTEMIC_SHORT_TERM false UNDEFINED daa17d48-a6eb-4711-b751-e5f8bda5c081 1515 3988d212-8cc5-4bfb-84d1-920a9a19243b PROC_8a false c58cf6d6-aaca-45fc-a645-e2ae7905b485 ECPA_PW_002_v1 SU_1 false false PC_27 ESCom-17297181101 Description of the activities and technical processes covered in the exposure scenario: This exposure scenario covers the consumer use of a co-formulant in plant protection products (PPPs), applied as a spray. This scenario includes both indoor and outdoor use. Two sub-activities are considered: 1) The transfer (and inherent diluting and mixing) of solid and liquid PPPs which occurs during loading of hand-held spray equipment. 2) The spray application of PPPs using hand-held spray equipment for high-level targets. REACH_ARTICLE_OVER_10 ded344f1-ec9f-4f3d-b2be-bd6612a8127e 2 false false false false true true true Spray application ECPA guidance document ECPA LET, ECPA OWB The exposure scenario may be scaled using the ECPA LET with the stated maximum risk characterisation ratio using the parameters: co-formulant application rate, number of applications, application interval, crop (drift rate), location and period of application. The exposure scenario may be scaled using the ECPA OWB with the stated maximum risk characterisation ratio using the parameters: application rate, personal protection equipment (PPE), and respiratory protection (RPE). http://www.ecpa.eu/information-page/regulatory-affairs/reach ESCom-15193135718 0 ENVIRONMENT_PLACE_OF_USE Indoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario. false true ENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOOR WATER_CONTACT_DURING_USE Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Controlled application to agricultural crops in accordance with the product label and Good Agricultural Practice is required. false true WATER_CONTACT_DURING_USE_NO EUSES_BIOLOGICAL_STP false false EUSES_BIOLOGICAL_STP-NONE WATER 0.0 84edc657-64c0-444a-9dcd-bc25c510c0c0 true WASTE_TREATMENT_CONSIDERATION Product labels provide guidance for users on how to dispose of plant protection products and emptied containers. It is recommended that plant protection product containers are triple or pressure rinsed or rinsed with a system that is an integral part of the sprayer. Rinse water should be added to the sprayer at time of filling. Properly rinsed containers may be disposed of as non-hazardous waste. false true WASTE_CONSIDERATION_NO_LOW_AMOUNT ANNUAL_APPLICATION_RATE false true RELEASE_MODULE_REGIONAL_SCALE The regional tonnage depends on the geographical distribution of the co-formulant use, which is assumed to be 10% of the manufacturer’s total European tonnage for PPP uses. false false 10.0 RELEASE_MODULE_DAILY_WIDE_DISPERSIVE_USE The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. false ENVIRONMENT_AGRICULTURAL_SOIL false false QUALITATIVE_PBT ENVIRONMENT_AIR false false QUALITATIVE_PBT ENVIRONMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_TERRESTRIAL false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_STP false false QUALITATIVE_PBT ENVIRONMENT_TOP_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT 84edc657-64c0-444a-9dcd-bc25c510c0c0 ENVIRONMENT_AGRICULTURAL_SOIL MAIN ENVIRONMENT_AIR MAIN ENVIRONMENT_FRESH_WATER MAIN ENVIRONMENT_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_FRESH_WATER MAIN ENVIRONMENT_PREDATOR_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_TERRESTRIAL MAIN ENVIRONMENT_SEDIMENT_FRESH_WATER MAIN ENVIRONMENT_SEDIMENT_MARINE_WATER MAIN ENVIRONMENT_STP MAIN ENVIRONMENT_TOP_PREDATOR_MARINE_WATER MAIN MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM MAIN true DRINKING_WATER 84edc657-64c0-444a-9dcd-bc25c510c0c0 FISH 84edc657-64c0-444a-9dcd-bc25c510c0c0 LEAF_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 MEAT 84edc657-64c0-444a-9dcd-bc25c510c0c0 MILK 84edc657-64c0-444a-9dcd-bc25c510c0c0 ROOT_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 84edc657-64c0-444a-9dcd-bc25c510c0c0 AGRIC_SOIL SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 AIR SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 WATER SPERC 0.0 false ad930d19-337b-4252-8be2-19afc9045dda 84edc657-64c0-444a-9dcd-bc25c510c0c0 DEFAULT 1515 149a0b3e-4d2b-46d4-8b0f-4ff7bc0c917d ERC_8d false ERC_8a ESCom-15193135719 1 TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE false true TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE_NO C_DAILY_APPLICATION_RATE false true CONSUMER_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED CONSUMER_COMBINED_SYSTEMIC_SHORT_TERM true false NOT_NEEDED CONSUMER_DERMAL_LOCAL_LONG_TERM false UNDEFINED CONSUMER_DERMAL_LOCAL_SHORT_TERM false UNDEFINED CONSUMER_DERMAL_SYSTEMIC_LONG_TERM false UNDEFINED CONSUMER_DERMAL_SYSTEMIC_SHORT_TERM false UNDEFINED CONSUMER_EYE_LOCAL false UNDEFINED CONSUMER_INHALATION_LOCAL_LONG_TERM false UNDEFINED CONSUMER_INHALATION_LOCAL_SHORT_TERM false UNDEFINED CONSUMER_INHALATION_SYSTEMIC_LONG_TERM false UNDEFINED CONSUMER_INHALATION_SYSTEMIC_SHORT_TERM false UNDEFINED CONSUMER_ORAL_SYSTEMIC_LONG_TERM false UNDEFINED 066bf51b-9032-4c3b-a48f-459c52941df2 1515 2fd2a887-bec3-48d6-a9df-b4089f2375a3 PC_27 ESCom-15193135720 ESCom-15193135718 2 TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE false true TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE_NO C_DAILY_APPLICATION_RATE false true CONSUMER_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED CONSUMER_COMBINED_SYSTEMIC_SHORT_TERM true false NOT_NEEDED CONSUMER_DERMAL_LOCAL_LONG_TERM false UNDEFINED CONSUMER_DERMAL_LOCAL_SHORT_TERM false UNDEFINED CONSUMER_DERMAL_SYSTEMIC_LONG_TERM false UNDEFINED CONSUMER_DERMAL_SYSTEMIC_SHORT_TERM false UNDEFINED CONSUMER_EYE_LOCAL false UNDEFINED CONSUMER_INHALATION_LOCAL_LONG_TERM false UNDEFINED CONSUMER_INHALATION_LOCAL_SHORT_TERM false UNDEFINED CONSUMER_INHALATION_SYSTEMIC_LONG_TERM false UNDEFINED CONSUMER_INHALATION_SYSTEMIC_SHORT_TERM false UNDEFINED CONSUMER_ORAL_SYSTEMIC_LONG_TERM false UNDEFINED a17914d6-201a-4e38-8978-e49ad01e4f70 1515 863554b3-373f-4c8c-91a4-b438868bd8d6 PC_27 8c4df67e-e2cd-4e2e-9376-972bb666beb8 ECPA_SCED_PC27_1_v1 false false ESCom-17297181200 Description of the activities and technical processes covered in the exposure scenario: This exposure scenario covers the consumer use of a co-formulant in PPPs, applied as granular products or treated seeds. This scenario includes both indoor and outdoor use. This generic exposure scenario covers the following tasks: manual spreading by hand/spoon/cup, push rotary spreader, or belly grinder, of granular PPPs or treated seeds on residential lawns/turf, gardens (flowers, fruits, vegetables), and trees (fruits, nuts, shrubs, ornamentals). REACH_ARTICLE_OVER_10 ded344f1-ec9f-4f3d-b2be-bd6612a8127e 3 false false false false true true true Granular and treated seeds application ECPA guidance document ECPA LET, ECPA OWB The exposure scenario may be scaled using the ECPA LET with the stated maximum risk characterisation ratio using the parameters: co-formulant application rate, number of applications, application interval, crop (drift rate), location and period of application. The exposure scenario may be scaled using the ECPA OWB with the stated maximum risk characterisation ratio using the parameters: application rate, personal protection equipment (PPE), and respiratory protection (RPE). http://www.ecpa.eu/information-page/regulatory-affairs/reach ESCom-12355002152 0 ENVIRONMENT_PLACE_OF_USE Indoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario. false true ENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOOR WATER_CONTACT_DURING_USE Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Controlled application to agricultural crops in accordance with the product label and Good Agricultural Practice is required. false true WATER_CONTACT_DURING_USE_NO EUSES_BIOLOGICAL_STP false false EUSES_BIOLOGICAL_STP-NONE WATER 0.0 84edc657-64c0-444a-9dcd-bc25c510c0c0 true WASTE_TREATMENT_CONSIDERATION Product labels provide guidance for users on how to dispose of plant protection products. Used packaging must be disposed of in accordance with the product label and local regulations. false true WASTE_CONSIDERATION_NO_LOW_AMOUNT ANNUAL_APPLICATION_RATE false true RELEASE_MODULE_REGIONAL_SCALE The regional tonnage depends on the geographical distribution of the co-formulant use, which is assumed to be 10% of the manufacturer’s total European tonnage for PPP uses. false false 10.0 RELEASE_MODULE_DAILY_WIDE_DISPERSIVE_USE The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. false ENVIRONMENT_AGRICULTURAL_SOIL false false QUALITATIVE_PBT ENVIRONMENT_AIR false false QUALITATIVE_PBT ENVIRONMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_PREDATOR_TERRESTRIAL false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_FRESH_WATER false false QUALITATIVE_PBT ENVIRONMENT_SEDIMENT_MARINE_WATER false false QUALITATIVE_PBT ENVIRONMENT_STP false false QUALITATIVE_PBT ENVIRONMENT_TOP_PREDATOR_MARINE_WATER false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM false false QUALITATIVE_PBT 84edc657-64c0-444a-9dcd-bc25c510c0c0 ENVIRONMENT_AGRICULTURAL_SOIL MAIN ENVIRONMENT_AIR MAIN ENVIRONMENT_FRESH_WATER MAIN ENVIRONMENT_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_FRESH_WATER MAIN ENVIRONMENT_PREDATOR_MARINE_WATER MAIN ENVIRONMENT_PREDATOR_TERRESTRIAL MAIN ENVIRONMENT_SEDIMENT_FRESH_WATER MAIN ENVIRONMENT_SEDIMENT_MARINE_WATER MAIN ENVIRONMENT_STP MAIN ENVIRONMENT_TOP_PREDATOR_MARINE_WATER MAIN MAN_VIA_ENVIRONMENT_INHALATION_LOCAL_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_INHALATION_SYSTEMIC_LONG_TERM MAIN MAN_VIA_ENVIRONMENT_ORAL_SYSTEMIC_LONG_TERM MAIN true DRINKING_WATER 84edc657-64c0-444a-9dcd-bc25c510c0c0 FISH 84edc657-64c0-444a-9dcd-bc25c510c0c0 LEAF_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 MEAT 84edc657-64c0-444a-9dcd-bc25c510c0c0 MILK 84edc657-64c0-444a-9dcd-bc25c510c0c0 ROOT_CROPS 84edc657-64c0-444a-9dcd-bc25c510c0c0 84edc657-64c0-444a-9dcd-bc25c510c0c0 AGRIC_SOIL 100.0 For granular products and treated seeds, the worst case is that the total applied fraction reaches the soil. The emission fraction to soil was set to 1. SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 AIR 0.0 For granular products and treated seeds, use of co-formulants with significant volatility is unlikely, because these are typically liquids, and as such cannot be added in significant concentrations in a solid product without modifying the physical state. Furthermore, solid substances with low melting points or prone to sublimation would pose product storage/stability issues. Due to these reasons, potential volatilisation of co-formulants from granular products and treated seeds on the timescale relevant for the emission fraction (during and shortly after initial application) was considered unrealistic. The specific case of a volatile solvent used in a liquid seed treatment formulation is covered by the SpERC for spray application. SPERC 84edc657-64c0-444a-9dcd-bc25c510c0c0 WATER 0.0 Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Furthermore, the physical properties of granules and treated seeds limits the potential for direct release to surface water. SPERC 0.01 Product labels provide guidance for users on how to dispose of plant protection products. Specific estimates of residual product remaining in packaging for granular formulations or treated seeds are not available. The OECD emission scenario document for plastic additives (OECD 2009) gives a reasonable number for powders of particle size >40 µm of 0.01% remaining in the package. Based on this analogous scenario (i.e. solid substance of relatively large particle size in a plastic container) this value was adopted without modification. false 15889f71-f9bb-4e0d-a962-e519e43dfc0b 84edc657-64c0-444a-9dcd-bc25c510c0c0 1571 DEFAULT 1515 440ec128-5900-4e16-9457-07e6c213ab84 ERC_8d false ERC_8a ESCom-15193135720 ESCom-15193135728 1 TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE false true TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE_NO C_DAILY_APPLICATION_RATE false true CONSUMER_COMBINED_SYSTEMIC_LONG_TERM true false NOT_NEEDED CONSUMER_COMBINED_SYSTEMIC_SHORT_TERM true false NOT_NEEDED CONSUMER_DERMAL_LOCAL_LONG_TERM false UNDEFINED CONSUMER_DERMAL_LOCAL_SHORT_TERM false UNDEFINED CONSUMER_DERMAL_SYSTEMIC_LONG_TERM false UNDEFINED CONSUMER_DERMAL_SYSTEMIC_SHORT_TERM false UNDEFINED CONSUMER_EYE_LOCAL false UNDEFINED CONSUMER_INHALATION_LOCAL_LONG_TERM false UNDEFINED CONSUMER_INHALATION_LOCAL_SHORT_TERM false UNDEFINED CONSUMER_INHALATION_SYSTEMIC_LONG_TERM false UNDEFINED CONSUMER_INHALATION_SYSTEMIC_SHORT_TERM false UNDEFINED CONSUMER_ORAL_SYSTEMIC_LONG_TERM false UNDEFINED a17914d6-201a-4e38-8978-e49ad01e4f70 1515 428ff7ef-e03a-4ce4-81c6-0f2ca42088c8 PC_27 582db6d6-d513-425f-a681-a68f95400a42 ECPA_SCED_PC27_2_v1 false false European Crop Protection Association IUC5-750a7b49-56c9-429c-989b-3be4a0e71a64 2020-02-04T12:31:18 2020-02-04T12:32:03 ACTIVE Version 2 ESCom-15193135719 Not applicable DO NOT use this SCED for an assessment of consumer exposure with ECETOC TRA and read information provided for this ECPA use map. PC_27


        ECPA_SCED_1_2

European Crop Protection Association SOLIDS_LIQUIDS TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE false false TRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE_YES TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE false true TRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE_NO C_DAILY_APPLICATION_RATE false true January 2020 European Crop Protection Association IUC5-750a7b49-56c9-429c-989b-3be4a0e71a64 2020-02-04T12:31:43 2020-02-04T12:32:13 ACTIVE Version 2 ESCom-15193135720 Not applicable DO NOT use this SCED for an assessment of consumer exposure with ECETOC TRA and read information provided for this ECPA use map. PC_27


        ECPA_SCED_2_2


        ECPA SpERC 8d.1.v4

Direct application of plant protection products (granules or treated seeds) containing co-formulants to soil Solid and liquid substances used as a co-formulant. Products (substances and mixtures) applied directly to soil as granular solids or treated seeds, including solid substances with vapour pressure <0.01 Pa and ≥0.01 Pa and liquid substances with vapour pressure <0.01 Pa used in seed treatment formulations Mixing and loading of plant protection products into delivery equipment. Delivery and dispersion of plant protection products or treated seeds. Cleaning and maintenance of equipment is included. http://www.ecpa.eu/information-page/regulatory-affairs/reach false CONSUMER_USE AGRICULTURAL SU_1 PC_27 0.0 The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. For granular products and treated seeds, use of co-formulants with significant volatility is unlikely, because these are typically liquids, and as such cannot be added in significant concentrations in a solid product without modifying the physical state. Furthermore, solid substances with low melting points or prone to sublimation would pose product storage/stability issues. Due to these reasons, potential volatilisation of co-formulants from granular products and treated seeds on the timescale relevant for the emission fraction (during and shortly after initial application) was considered unrealistic. The specific case of a volatile solvent used in a liquid seed treatment formulation is covered by the SpERC for spray application. Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Furthermore, the physical properties of granules and treated seeds limits the potential for direct release to surface water. For granular products and treated seeds, the worst case is that the total applied fraction reaches the soil. The emission fraction to soil was set to 1. Product labels provide guidance for users on how to dispose of plant protection products. Specific estimates of residual product remaining in packaging for granular formulations or treated seeds are not available. The OECD emission scenario document for plastic additives (OECD 2009) gives a reasonable number for powders of particle size >40 µm of 0.01% remaining in the package. Based on this analogous scenario (i.e. solid substance of relatively large particle size in a plastic container) this value was adopted without modification. Direct application of plant protection products (granules or treated seeds) containing co-formulants to soil


            ECPA SpERC 8d.1.v4


        ECPA SpERC 8d.2.v4

Spray application of plant protection products containing co-formulants Solid and liquid substances used as a co-formulant. Products (substances and mixtures) applied by spray application, including solvents with vapour pressure ≥0.01 Pa used in liquid seed treatment formulations. Mixing and loading of plant protection products into delivery equipment. Spray application of plant protection products. Cleaning and maintenance of equipment is included. http://www.ecpa.eu/information-page/regulatory-affairs/reach false CONSUMER_USE AGRICULTURAL SU_1 PC_27 0.0 The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. The pesticides field application module in USES 4.0 (RIVM 2002, Table A-2 p211 and Table D-3 p318) implemented vapour pressure dependent emission fractions to air. The total emission to air values were derived from the averaged 24 hour emission strength, based on a 1 kg/m2 application, assuming 90% of the emission occurs in the first day. These values were adopted. Direct release of a co-formulant to surface water may occur by spray drift. The realistic worst case spray drift, expressed as a percentage of the application rate, was assumed to be 15.7%. This corresponds to the regulatory accepted 90th percentile spray drift value for citrus, olives and late applications to pome and stone fruit; and represents orchard and vineyard scenarios where high spray drift may be expected. The standard plant protection drift scenario assumes that a 1 hectare field is adjacent to a water body that constitutes 1% of the area of the treated field. Therefore, even if the water body was over sprayed at the same rate as the field, only 1% of the applied dose would enter that water body. Given that direct overspray does not in fact occur, and taking the worst case spray drift value of 15.7%, the fraction of the applied dose entering the water body reduces to 0.00157, or rounded to 0.002. The drainage density (the amount of land adjacent to water bodies and available for potential drift events) has not been considered in this calculation, which would lead to a further significant reduction in the tonnage of a co-formulant reaching surface water at the regional scale. The fraction of a co-formulant reaching the soil can be significantly reduced due to volatilisation from spray droplets, and from plant surfaces and soil within the first 24 hours after application of the plant protection product. Product labels provide guidance for users on how to dispose of plant protection products. It is recommended that emptied containers are triple or pressure rinsed, or rinsed with a system that is integrated in the sprayer, prior to disposal. Washing in this manner has been demonstrated to retain negligible amounts of the formulation in the container. The rinse water should be added to the spray dilution at the time of filling, thus being accounted for within the overall emission fractions. Spray application of plant protection products containing co-formulants, vapour pressure 0.00001 - <0.0001 Pa


            ECPA SpERC 8d.2d.v4

ERC_8d 1.0E-5 9.99E-5 Substances having a vapour pressure 0.00001 - <0.0001 Pa and being used as a co-formulant in plant protection products 0.2 10.0 100.0 Release of 100% of the applied substance to soil was considered for all substances considered to be non-volatile under environmental conditions (i.e substance with a vapour pressure <0.01 Pa at 20 °C). 0.01 Spray application of plant protection products containing co-formulants, vapour pressure 0.0001 - <0.001 Pa


            ECPA SpERC 8d.2c.v4

ERC_8d 1.0E-4 9.99E-4 Substances having a vapour pressure 0.0001 - <0.001 Pa and being used as a co-formulant in plant protection products 0.2 20.0 100.0 Release of 100% of the applied substance to soil was considered for all substances considered to be non-volatile under environmental conditions (i.e substance with a vapour pressure <0.01 Pa at 20 °C). 0.01 Spray application of plant protection products containing co-formulants, vapour pressure 0.001 - <0.01 Pa


            ECPA SpERC 8d.2b.v4

ERC_8d 0.001 0.00999 Substances having a vapour pressure 0.001 - <0.01 Pa and being used as a co-formulant in plant protection products 0.2 50.0 100.0 Release of 100% of the applied substance to soil was considered for all substances considered to be non-volatile under environmental conditions (i.e substance with a vapour pressure <0.01 Pa at 20 °C). 0.01 Spray application of plant protection products containing co-formulants, vapour pressure <0.00001 Pa


            ECPA SpERC 8d.2e.v4

ERC_8d 9.99E-6 Substances having a vapour pressure <0.00001 Pa and being used as a co-formulant in plant protection products 0.2 1.0 100.0 Release of 100% of the applied substance to soil was considered for all substances considered to be non-volatile under environmental conditions (i.e substance with a vapour pressure <0.01 Pa at 20 °C). 0.01 Spray application of plant protection products containing co-formulants, vapour pressure greater than ≥0.01 Pa


            ECPA SpERC 8d.2a.v4

ERC_8d 0.01 Substances having a vapour pressure ≥0.01 Pa and being used as a co-formulant in plant protection products, including volatile solvents with vapour pressure ≥0.01 Pa used in liquid seed treatment formulations. 0.2 100.0 0.0 For substances with a vapour pressure of equal to or greater than 0.01 Pa that are volatile under environmental conditions, no release to soil was assumed (i.e. 0% release factor to soil). 0.01 ENVIRONMENT_PLACE_OF_USE Indoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario. false true ENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOOR WATER_CONTACT_DURING_USE Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Controlled application to agricultural crops in accordance with the product label and Good Agricultural Practice is required. false true WATER_CONTACT_DURING_USE_NO EUSES_BIOLOGICAL_STP false false EUSES_BIOLOGICAL_STP-NONE WATER WASTE_TREATMENT_CONSIDERATION Product labels provide guidance for users on how to dispose of plant protection products and emptied containers. It is recommended that plant protection product containers are triple or pressure rinsed or rinsed with a system that is an integral part of the sprayer. Rinse water should be added to the sprayer at time of filling. Properly rinsed containers may be disposed of as non-hazardous waste. false true WASTE_CONSIDERATION_NO_LOW_AMOUNT ANNUAL_APPLICATION_RATE false true RELEASE_MODULE_REGIONAL_SCALE The regional tonnage depends on the geographical distribution of the co-formulant use, which is assumed to be 10% of the manufacturer’s total European tonnage for PPP uses. false false 10.0 April 2020 European Crop Protection Association IUC5-750a7b49-56c9-429c-989b-3be4a0e71a64 2020-05-05T16:32:54 2020-05-05T16:35:25 ACTIVE 1


        ECPA SpERC 8d.2.v4

Spray application of plant protection products containing co-formulants Solid and liquid substances used as a co-formulant. Products (substances and mixtures) applied by spray application, including solvents with vapour pressure ≥0.01 Pa used in liquid seed treatment formulations. Mixing and loading of plant protection products into delivery equipment. Spray application of plant protection products. Cleaning and maintenance of equipment is included. http://www.ecpa.eu/information-page/regulatory-affairs/reach false PROFESSIONAL_WORKER_USE AGRICULTURAL SU_1 PC_27 0.0 The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. The pesticides field application module in USES 4.0 (RIVM 2002, Table A-2 p211 and Table D-3 p318) implemented vapour pressure dependent emission fractions to air. The total emission to air values were derived from the averaged 24 hour emission strength, based on a 1 kg/m2 application, assuming 90% of the emission occurs in the first day. These values were adopted. Direct release of a co-formulant to surface water may occur by spray drift. The realistic worst case spray drift, expressed as a percentage of the application rate, was assumed to be 15.7%. This corresponds to the regulatory accepted 90th percentile spray drift value for citrus, olives and late applications to pome and stone fruit; and represents orchard and vineyard scenarios where high spray drift may be expected. The standard plant protection drift scenario assumes that a 1 hectare field is adjacent to a water body that constitutes 1% of the area of the treated field. Therefore, even if the water body was over sprayed at the same rate as the field, only 1% of the applied dose would enter that water body. Given that direct overspray does not in fact occur, and taking the worst case spray drift value of 15.7%, the fraction of the applied dose entering the water body reduces to 0.00157, or rounded to 0.002. The drainage density (the amount of land adjacent to water bodies and available for potential drift events) has not been considered in this calculation, which would lead to a further significant reduction in the tonnage of a co-formulant reaching surface water at the regional scale. The fraction of a co-formulant reaching the soil can be significantly reduced due to volatilisation from spray droplets, and from plant surfaces and soil within the first 24 hours after application of the plant protection product. Product labels provide guidance for users on how to dispose of plant protection products. It is recommended that emptied containers are triple or pressure rinsed, or rinsed with a system that is integrated in the sprayer, prior to disposal. Washing in this manner has been demonstrated to retain negligible amounts of the formulation in the container. The rinse water should be added to the spray dilution at the time of filling, thus being accounted for within the overall emission fractions. Spray application of plant protection products containing co-formulants, vapour pressure 0.00001 - <0.0001 Pa


            ECPA SpERC 8d.2d.v4


            ECPA SpERC 8d.2c.v4


            ECPA SpERC 8d.2b.v4


            ECPA SpERC 8d.2e.v4


            ECPA SpERC 8d.2a.v4


        ECPA SpERC 8d.1.v4

Direct application of plant protection products (granules or treated seeds) containing co-formulants to soil Solid and liquid substances used as a co-formulant. Products (substances and mixtures) applied directly to soil as granular solids or treated seeds, including solid substances with vapour pressure <0.01 Pa and ≥0.01 Pa and liquid substances with vapour pressure <0.01 Pa used in seed treatment formulations Mixing and loading of plant protection products into delivery equipment. Delivery and dispersion of plant protection products or treated seeds. Cleaning and maintenance of equipment is included. http://www.ecpa.eu/information-page/regulatory-affairs/reach false PROFESSIONAL_WORKER_USE AGRICULTURAL SU_1 PC_27 0.0 The “fraction of regional tonnage used locally” is set to zero in accordance with the ECPA SpERC, because the local scale output of the nested multimedia mass balance models as implemented in EUSES is not used. Local scale PECs were calculated with the Local Environment Tool (LET) approach developed by the European Crop Protection Association (ECPA), which is a standalone replacement for the local scale nested box in the models based on the EU TGD. Boundary concentrations were calculated using the ECPA SpERC and manually imported into the LET. Instead of “Amount of substance use per day”, the maximum use rate [kg/ha] output of the LET is communicated as an outcome of the risk assessment in the extended Safety Data Sheet as an operational condition. For granular products and treated seeds, use of co-formulants with significant volatility is unlikely, because these are typically liquids, and as such cannot be added in significant concentrations in a solid product without modifying the physical state. Furthermore, solid substances with low melting points or prone to sublimation would pose product storage/stability issues. Due to these reasons, potential volatilisation of co-formulants from granular products and treated seeds on the timescale relevant for the emission fraction (during and shortly after initial application) was considered unrealistic. The specific case of a volatile solvent used in a liquid seed treatment formulation is covered by the SpERC for spray application. Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Furthermore, the physical properties of granules and treated seeds limits the potential for direct release to surface water. For granular products and treated seeds, the worst case is that the total applied fraction reaches the soil. The emission fraction to soil was set to 1. Product labels provide guidance for users on how to dispose of plant protection products. Specific estimates of residual product remaining in packaging for granular formulations or treated seeds are not available. The OECD emission scenario document for plastic additives (OECD 2009) gives a reasonable number for powders of particle size >40 µm of 0.01% remaining in the package. Based on this analogous scenario (i.e. solid substance of relatively large particle size in a plastic container) this value was adopted without modification. Direct application of plant protection products (granules or treated seeds) containing co-formulants to soil


            ECPA SpERC 8d.1.v4

ERC_8d Substances used as a co-formulant in granular products and treated seeds, including solid substances with vapour pressure ≥0.01 and <0.01 Pa and liquid substances with vapour pressure <0.01 Pa used as a co-formulant in seed treatment formulations 0.0 0.0 100.0 0.01 ENVIRONMENT_PLACE_OF_USE Indoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario. false true ENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOOR WATER_CONTACT_DURING_USE Plant protection product approvals under Regulation (EC) No. 1107/2009 include specific labelling instructions designed to prevent emission to surface water / waste water. No intentional emission to surface water or waste water is permitted. Controlled application to agricultural crops in accordance with the product label and Good Agricultural Practice is required. false true WATER_CONTACT_DURING_USE_NO EUSES_BIOLOGICAL_STP false false EUSES_BIOLOGICAL_STP-NONE WATER WASTE_TREATMENT_CONSIDERATION Product labels provide guidance for users on how to dispose of plant protection products. Used packaging must be disposed of in accordance with the product label and local regulations. false true WASTE_CONSIDERATION_NO_LOW_AMOUNT ANNUAL_APPLICATION_RATE false true RELEASE_MODULE_REGIONAL_SCALE The regional tonnage depends on the geographical distribution of the co-formulant use, which is assumed to be 10% of the manufacturer’s total European tonnage for PPP uses. false false 10.0 April 2020 ECPA – SWED migration 3347d656-8a6d-4b36-8c7e-ac40011b6ca4 2020-12-07T12:47:31 2020-12-07T12:54:43 ACTIVE 30/11/2020 <standardPhrases> <standardPhraseRefid>ESCom-15193135720</standardPhraseRefid> </standardPhrases> ECPA_SWED_PW_2 DO NOT use this SWED for an assessment of worker exposure with ECETOC TRA and read information provided for this ECPA use map. false ESCom-15193135720 PROC_11 DAILY_APPLICATION_RATE false true January 2020 false ECPA – SWED migration 3347d656-8a6d-4b36-8c7e-ac40011b6ca4 2020-12-07T12:48:00 2020-12-07T12:54:51 ACTIVE 30/11/2020 <standardPhrases> <standardPhraseRefid>ESCom-15193135720</standardPhraseRefid> </standardPhrases> ECPA_SWED_PW_3 DO NOT use this SWED for an assessment of worker exposure with ECETOC TRA and read information provided for this ECPA use map. false ESCom-15193135720 PROC_8a DAILY_APPLICATION_RATE false true January 2020 false ECPA – SWED migration 3347d656-8a6d-4b36-8c7e-ac40011b6ca4 2020-12-07T12:47:09 2020-12-07T12:54:56 ACTIVE 30/11/2020 <standardPhrases> <standardPhraseRefid>ESCom-15193135719</standardPhraseRefid> </standardPhrases> ECPA_SWED_PW_1 DO NOT use this SWED for an assessment of worker exposure with ECETOC TRA and read information provided for this ECPA use map. false ESCom-15193135719 PROC_8a DAILY_APPLICATION_RATE false true TRA-WORKER-DERMAL-PROTECTION false true TRA-WORKER-DERMAL-PROTECTION_PPE90 January 2020 false Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 ACTIVE ENVIRONMENT Annual application rate The maximum annual application rate in kg/ha, relevant for substances in products applied directly to soil true AIR SOIL WATER E_W_2 E_C_2 ECPA LET 0.0 <= ESCom-9269144377 ESCom-17297181201 true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 ACTIVE CONSUMERS Daily application rate The maximum daily application rate in kg/ha; relevant for substances used as a co-formulant in plant protection products, fertilisers, or products with similar use patterns. true DERMAL INHALATION ORAL C_1 ECPA OWB 0.0 ESCom-9269144377 ESCom-15193135721 true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 ACTIVE WORKERS Daily application rate The maximum daily application rate in kg/ha; relevant for substances used as a co-formulant in plant protection products, fertilisers, or products with similar use patterns. true DERMAL INHALATION W_1 ECPA OWB 0.0 ESCom-9269144377 ESCom-15193135721 true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE ENVIRONMENT Place of use true AIR SOIL WATER E_W_6 E_C_4 Indoor false ESCom-9313213237 true Outdoor false ESCom-9313213238 true Indoor/Outdoor false ESCom-10133220202 true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE ENVIRONMENT Biological STP EUSES Determinant true WATER E_W_4 E_C_4 EUSES 2.1.2 Standard true ESCom-11133170613 true WATER 0.0 100.0 Site specific false ESCom-11133171638 true WATER 0.0 100.0 None false false WATER 0.0 0.0 0.0 Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE ENVIRONMENT Daily local widespread use amount ReleaseModule's Determinant true AIR SOIL WATER E_W_2 E_C_2 EUSES 2.1.2 0.0 <= ESCom-15193135620 false Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE ENVIRONMENT Percentage of EU tonnage used at regional scale ReleaseModule's Determinant true AIR SOIL WATER E_W_2 E_C_2 EUSES 2.1.2 0.0 100.0 = ESCom-9269144102 false Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE WORKERS Dermal protection Core worker condition of use true DERMAL W_4 ECETOC TRA worker;ART;MEASE;Stoffenmanager;EMKG No true false Yes (effectiveness ≥ 80%) false ESCom-10133224896 ESCom-17297180800 ESCom-12355002165 true Chemical resistant dermal protection with basic employee training. (effectiveness ≥ 90%) false ESCom-11133171457 ESCom-17297180800 ESCom-12355002165 true Chemical resistant dermal protection with specific employee training. (effectiveness ≥ 95%) false ESCom-11133171458 ESCom-17297180800 ESCom-12355002165 true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE CONSUMERS Exposure via dermal route true DERMAL C_1 TRA Consumer 3.1 Yes true false No dermal contact false Assumes no dermal contact true Dermal exposure assumed to be negligible false Dermal exposure assumed to be negligible true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE CONSUMERS Exposure via inhalation route true INHALATION C_1 TRA Consumer 3.1 Yes true false Inhalation exposure is considered to be not relevant false ESCom-12355002171 true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE CONSUMERS Exposure via oral route true ORAL C_1 TRA Consumer 3.1 Yes true false Oral exposure is considered to be not relevant false ESCom-12355002172 true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 2015-03-16T16:40:11 ACTIVE ENVIRONMENT Particular considerations on the waste treatment operations Specific conditions during the waste life stage of the substance potentially going beyond the local or national legal requirements for waste treatment (disposal or recovery) operations. The determinant values either provide i) a generic justification why no particular considerations regarding environmental risks from the waste life stage are needed or ii) indicate particular conditions to be met during waste treatment. For both assessment cases the single registrant can edit justification/conditions if the generic determinant values do not cover his case. true WATER E_W_5 E_C_3 EUSES 2.1.2 No (no waste) false No waste generated. ESCom-11133170674 true No (low risk) false ERC based assessment demonstrating control of risk with default conditions. Low risk assumed for waste life stage. Waste disposal according to national/local legislation is sufficient. ESCom-11133171479 true No (low amount) false Particular risks from waste treatment unlikely due to small fraction of used substance entering into the waste stage. Waste disposal according to national/local legislation is sufficient. ESCom-11133171479 true No (low concentration) false Particular risks from waste treatment unlikely due low concentration of substance in waste stream. Waste disposal according to national/local legislation is sufficient. ESCom-11133171479 true No (other reason) false Waste disposal according to national/local legislation is sufficient. "Explanation for the CSR" to be reported by each registrant: ESCom-11133171479 true Dedicated recollection infrastructure required false ESCom-12355002107 true Biological treatment not appropriate false ESCom-12355002101 true Incineration not appropriate false ESCom-12355002100 true Prevent formation of hazardous break down products during thermal waste treatment destruction. false Prevent formation of hazardous break down products during thermal waste treatment. true Closed system required to minimise release to the environment. false Closed system required to minimise release to the environment during waste treatment. true Other false "Explanation for the CSR" to be reported by each registrant on the specific conditions required for waste treatment: true Chesar IUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5 ACTIVE ENVIRONMENT Water contact during use true WATER E_W_6 E_C_4 Yes false false No false ESCom-16354140700 true Indoor or outdoor use false false false Wear suitable gloves tested to EN374. false false false Municipal sewage treatment plant is assumed. false false false No waste from process false false false Wear chemically resistant gloves (tested to EN374) in combination with ‘basic’ employee training. false false false Wear chemically resistant gloves (tested to EN374) in combination with specific activity training. false false false Dispose of waste product or used containers according to local regulations. false false false Provide onsite wastewater treatment. false false false Incineration is not appropriate for waste. false false false Biological treatment is not appropriate for waste. false false false Dedicated recollection infrastructure required for waste false false false Direct application of plant protection products (e.g. granules or treated seeds) to soil false false false For further specification, refer to section 8 of the SDS. false false false Inhalation exposure is considered to be not relevant. false false false Oral exposure is considered to be not relevant. false false false tonnes/day false false false Spray application of plant protection products containing co-formulants false false false Mixing and loading of plant protection products into delivery equipment false false false Delivery and dispersion of plant protection products false false false Application rate false false false Granule application / Seed treatment false false false No water contact during use. false false false If skin contamination is expected to extend to other parts of the body, then these body parts should also be protected with impervious garments in a manner equivalent to those described for the hands. false false false Use as a co-formulant in plant protection products, spray application by professionals false false false Use as a co-formulant in plant protection products, seed and granular applications by professionals false false false Use as a co-formulant in plant protection products, spray application by consumers false false false Use as a co-formulant in plant protection products, seed and granular applications by consumers false false false Annual application rate true true true % false false false kg/ha false false false Indoor use false false false Outdoor use false false false