CLE use map, April 2022, version 1<p><u><strong>Please read the text carefully, before starting an assessment!</strong></u></p><p>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. </p><p>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).</p><p>CropLife Europe (the former 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">https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/</a></p><p>This CHESAR use map has been created by CropLife Europe (CLE) 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 CLE Generic Exposure Scenarios developed in the CLE REACH-IN project and the relevant environmental, worker and consumer contributing scenarios. CLE recommends the following process for the assessment of substances used as a co-formulant in PPP in CHESAR: <br/><br/>The environmental contributing scenarios in the four exposure scenarios of the CHESAR use map developed by CLE contain the <strong><u>CLE SpERCs for the calculation of regional environmental concentrations </u></strong>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. <br/><br/>CLE has developed the Local Environment Tool (LET) and the underlying approach as a standalone replacement for the local scale nested box in the models based on the EU TGD. <strong><u>Local scale environmental exposure to a co-formulant for each contributing environmental scenario should be calculated with LET</u></strong>, and not with EUSES or ECETOC TRA. The regional concentrations calculated with the CLE SpERCs can be manually imported into LET.<br/><br/>Each worker and consumer contributing scenario in the four exposure scenarios of the CHESAR use map developed by CLE includes generic CLE SWEDs or SCEDs, which are intended as placeholders not containing relevant conditions of use required for the calculation of exposure. CLE has developed the Operator, Worker, Bystander Tool (OWB) for the assessment of human exposure to substances used as a co-formulant in PPP. <u><strong>Worker and consumer exposure to a co-formulant for each contributing worker or consumer scenario should be assessed with OWB</strong></u>, and not with ECETOC TRA or CHESAR.<br/><br/>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: <br/><br/><b>STEP 1</b>. Ensure the CLE use map file is uploaded in CHESAR box 2, so that the four CLE Generic Exposure Scenarios including 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.<br/><b>STEP 2</b>. 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 CLE REACH-IN tools (see additional information provided with the CHESAR use map file). Follow these steps:<br/>1. Calculate <u><b>regional</b></u> environmental exposure in CHESAR using the CLE 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 (CLE uses and all other identified uses).<br/>2. Assess <u><b>local</b></u> environmental exposure for the co-formulant use with LET after copying the calculated regional environmental concentrations (covering all identified uses) into the LET.<br/>3. Assess worker or consumer exposure for the co-formulant use with OWB. <br/>4. Generate the relevant exposure scenario for the co-formulant use with the functionality in OWB. <br/><b>STEP 3</b>. Integrate the outcome of the external assessments into CHESAR. In principle, the background information provided in the exposure scenario created with OWB, the conditions of use and the exposure and risk assessments obtained with the CLE REACH-IN tools can be copied into the relevant sections of the exposure scenarios generated from CHESAR. Follow these steps:<br/>1. Use the outputs of LET (e.g. safe application rate) to adapt the conditions of use in CHESAR box 3 for each environmental contributing activity.<br/>2. Use the outputs of 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.<br/>3. Generate the ES for communication (annex to the SDS) in box 5.<br/>4. Generate the CSR in box 4 and replace the environmental, worker and consumer contributing scenario with the corresponding scenario created with OWB.<br/></p>CropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T14:29:402021-12-13T14:31:02ACTIVE1ESCom-15193135720Not applicableDO NOT use this SCED for an assessment of consumer exposure with ECETOC TRA and read information provided for this CLE use map.PC_27CLE_SCED_2_2CropLife EuropeSOLIDS_LIQUIDSTRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTEfalsefalseTRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE_YESTRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTEfalsefalseTRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE_YESTRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTEfalsetrueTRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE_NOC_DAILY_APPLICATION_RATEfalsetrueDecember 2021CropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T14:28:432021-12-13T14:31:11ACTIVE1ESCom-15193135719Not applicableDO NOT use this SCED for an assessment of consumer exposure with ECETOC TRA and read information provided for this CLE use map.PC_27CLE_SCED_1_2CropLife EuropeSOLIDS_LIQUIDSTRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTEfalsefalseTRA_CONSUMER_EXPOSURE_VIA_INHALATION_ROUTE_YESTRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTEfalsefalseTRA_CONSUMER_EXPOSURE_VIA_DERMAL_ROUTE_YESTRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTEfalsetrueTRA_CONSUMER_EXPOSURE_VIA_ORAL_ROUTE_NOC_DAILY_APPLICATION_RATEfalsetrueDecember 2021CropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T14:09:412021-12-13T14:25:47ACTIVE1CLE SpERC 8d.1.v4Direct application of plant protection products (granules or treated seeds) containing co-formulants to soilSolid 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 formulationsMixing 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.https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/falsePROFESSIONAL_WORKER_USEAGRICULTURALSU_1PC_270.0The “fraction of regional tonnage used locally” is set to zero in accordance with the CLE 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 CropLife Europe (CLE), 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 CLE 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 soilCLE SpERC 8d.1.v4ERC_8dSubstances 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 formulations0.00.0100.00.01ENVIRONMENT_PLACE_OF_USEIndoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario.falsetrueENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOORWATER_CONTACT_DURING_USEPlant 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.falsetrueWATER_CONTACT_DURING_USE_NOEUSES_BIOLOGICAL_STPfalsefalseEUSES_BIOLOGICAL_STP-NONEWATERWASTE_TREATMENT_CONSIDERATIONProduct 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.falsetrueWASTE_CONSIDERATION_NO_LOW_AMOUNTANNUAL_APPLICATION_RATEfalsetrueRELEASE_MODULE_REGIONAL_SCALEThe 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.falsefalse10.0December 2021CropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T14:18:542021-12-13T14:24:53ACTIVE1CLE SpERC 8d.2.v4Spray application of plant protection products containing co-formulantsSolid 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.https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/falsePROFESSIONAL_WORKER_USEAGRICULTURALSU_1PC_270.0The “fraction of regional tonnage used locally” is set to zero in accordance with the CLE 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 CropLife Europe (CLE), 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 CLE 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 PaCLE SpERC 8d.2d.v4ERC_8d1.0E-59.99E-5Substances having a vapour pressure 0.00001 - <0.0001 Pa and being used as a co-formulant in plant protection products0.210.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure 0.0001 - <0.001 PaCLE SpERC 8d.2c.v4ERC_8d1.0E-49.99E-4Substances having a vapour pressure 0.0001 - <0.001 Pa and being used as a co-formulant in plant protection products0.220.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure 0.001 - <0.01 PaCLE SpERC 8d.2b.v4ERC_8d0.0010.00999Substances having a vapour pressure 0.001 - <0.01 Pa and being used as a co-formulant in plant protection products0.250.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure <0.00001 PaCLE SpERC 8d.2e.v4ERC_8d9.99E-6Substances having a vapour pressure <0.00001 Pa and being used as a co-formulant in plant protection products0.21.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure greater than ≥0.01 PaCLE SpERC 8d.2a.v4ERC_8d0.01Substances 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.0.2100.00.0For 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).0.01ENVIRONMENT_PLACE_OF_USEIndoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario.falsetrueENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOORWATER_CONTACT_DURING_USEPlant 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.falsetrueWATER_CONTACT_DURING_USE_NOEUSES_BIOLOGICAL_STPfalsefalseEUSES_BIOLOGICAL_STP-NONEWATERWASTE_TREATMENT_CONSIDERATIONProduct 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.falsetrueWASTE_CONSIDERATION_NO_LOW_AMOUNTANNUAL_APPLICATION_RATEfalsetrueRELEASE_MODULE_REGIONAL_SCALEThe 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.falsefalse10.0December 2021CropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T14:16:182021-12-13T14:25:35ACTIVE1CLE SpERC 8d.1.v4Direct application of plant protection products (granules or treated seeds) containing co-formulants to soilSolid 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 formulationsMixing 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.https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/falseCONSUMER_USEAGRICULTURALSU_1PC_270.0The “fraction of regional tonnage used locally” is set to zero in accordance with the CLE 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 CropLife Europe (CLE), 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 CLE 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 soilCLE SpERC 8d.1.v4ERC_8dSubstances 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 formulations0.00.0100.00.01ENVIRONMENT_PLACE_OF_USEIndoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario.falsetrueENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOORWATER_CONTACT_DURING_USEPlant 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.falsetrueWATER_CONTACT_DURING_USE_NOEUSES_BIOLOGICAL_STPfalsefalseEUSES_BIOLOGICAL_STP-NONEWATERWASTE_TREATMENT_CONSIDERATIONProduct 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.falsetrueWASTE_CONSIDERATION_NO_LOW_AMOUNTANNUAL_APPLICATION_RATEfalsetrueRELEASE_MODULE_REGIONAL_SCALEThe 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.falsefalse10.0December 2021CropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T14:20:562021-12-13T14:25:08ACTIVE1CLE SpERC 8d.2.v4Spray application of plant protection products containing co-formulantsSolid 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.https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/falseCONSUMER_USEAGRICULTURALSU_1PC_270.0The “fraction of regional tonnage used locally” is set to zero in accordance with the CLE 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 CropLife Europe (CLE), 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 CLE 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 PaCLE SpERC 8d.2d.v4ERC_8d1.0E-59.99E-5Substances having a vapour pressure 0.00001 - <0.0001 Pa and being used as a co-formulant in plant protection products0.210.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure 0.0001 - <0.001 PaCLE SpERC 8d.2c.v4ERC_8d1.0E-49.99E-4Substances having a vapour pressure 0.0001 - <0.001 Pa and being used as a co-formulant in plant protection products0.220.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure 0.001 - <0.01 PaCLE SpERC 8d.2b.v4ERC_8d0.0010.00999Substances having a vapour pressure 0.001 - <0.01 Pa and being used as a co-formulant in plant protection products0.250.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure <0.00001 PaCLE SpERC 8d.2e.v4ERC_8d9.99E-6Substances having a vapour pressure <0.00001 Pa and being used as a co-formulant in plant protection products0.21.0100.0Release 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).0.01Spray application of plant protection products containing co-formulants, vapour pressure greater than ≥0.01 PaCLE SpERC 8d.2a.v4ERC_8d0.01Substances 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.0.2100.00.0For 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).0.01ENVIRONMENT_PLACE_OF_USEIndoor and outdoor use of a substance used as a co-formulant in plant protection products is covered by this exposure scenario.falsetrueENVIRONMENT_PLACE_OF_USE_INDOOR_OUTDOORWATER_CONTACT_DURING_USEPlant 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.falsetrueWATER_CONTACT_DURING_USE_NOEUSES_BIOLOGICAL_STPfalsefalseEUSES_BIOLOGICAL_STP-NONEWATERWASTE_TREATMENT_CONSIDERATIONProduct 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.falsetrueWASTE_CONSIDERATION_NO_LOW_AMOUNTANNUAL_APPLICATION_RATEfalsetrueRELEASE_MODULE_REGIONAL_SCALEThe 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.falsefalse10.0December 2021CropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T15:05:012021-12-13T15:07:08ACTIVE1
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CLE_SWED_PW_1Not applicableNot applicableDO NOT use this SWED for an assessment of worker exposure with ECETOC TRA and read information provided for this CLE use map.Not applicablefalseESCom-15193135719PROC_8aDURATION_OF_ACTIVITYfalsetrue8.0TRA-WORKER-RESPIRATORY-PROTECTIONfalsefalseTRA-WORKER-RESPIRATORY-PROTECTION_NOT_USED_VOTRA-WORKER-DERMAL-PROTECTIONfalsetrueTRA-WORKER-DERMAL-PROTECTION_PPE90USE_EYE_PROTECTIONfalsefalseUSE_EYE_PROTECTION-NODAILY_APPLICATION_RATEfalsetrueDecember 2021falseCropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T15:05:372021-12-13T15:07:26ACTIVE1
<standardPhrases>
<standardPhraseRefid>ESCom-15193135720</standardPhraseRefid>
</standardPhrases>
CLE_SWED_PW_2Not applicableNot applicableDO NOT use this SWED for an assessment of worker exposure with ECETOC TRA and read information provided for this CLE use map.Not applicablefalseESCom-15193135720ESCom-17297181000PROC_11DURATION_OF_ACTIVITYfalsetrue8.0TRA-WORKER-RESPIRATORY-PROTECTIONfalsefalseTRA-WORKER-RESPIRATORY-PROTECTION_NOT_USED_VOTRA-WORKER-DERMAL-PROTECTIONfalsefalseTRA-WORKER-DERMAL-PROTECTION_NOUSE_EYE_PROTECTIONfalsefalseUSE_EYE_PROTECTION-NODAILY_APPLICATION_RATEfalsetrueDecember 2021falseCropLife Europe3d96087e-d9d8-4843-b97a-71e8832cf9c62021-12-13T15:06:112021-12-13T15:07:43ACTIVE1
<standardPhrases>
<standardPhraseRefid>ESCom-15193135720</standardPhraseRefid>
</standardPhrases>
CLE_SWED_PW_3Not applicableNot applicableO NOT use this SWED for an assessment of worker exposure with ECETOC TRA and read information provided for this CLE use map.Not applicablefalseESCom-15193135720ESCom-17297181100PROC_8aDURATION_OF_ACTIVITYfalsetrue8.0TRA-WORKER-RESPIRATORY-PROTECTIONfalsefalseTRA-WORKER-RESPIRATORY-PROTECTION_NOT_USED_VOTRA-WORKER-DERMAL-PROTECTIONfalsefalseTRA-WORKER-DERMAL-PROTECTION_NOUSE_EYE_PROTECTIONfalsefalseUSE_EYE_PROTECTION-NODAILY_APPLICATION_RATEfalsetrueDecember 2021falseChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5ACTIVEENVIRONMENTThe maximum annual application rate in kg/ha, relevant for substances in products applied directly to soiltrueAIRSOILWATERE_W_2E_C_2ECPA LET0.0<=ESCom-9269144377ESCom-17297181201trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5ACTIVECONSUMERSThe 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.trueDERMALINHALATIONORALC_1ECPA OWB0.0ESCom-9269144377ESCom-15193135721trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5ACTIVEWORKERSThe 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.trueDERMALINHALATIONW_1ECPA OWB0.0ESCom-9269144377ESCom-15193135721trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEWORKERSTRA Worker condition of usetrueDERMALINHALATIONW_2TRA Worker 3.08.00.024.0<=ESCom-15193135624ESCom-11133171521trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEENVIRONMENTtrueAIRSOILWATERE_W_6E_C_4IndoorfalseESCom-9313213237trueOutdoorfalseESCom-9313213238trueIndoor/OutdoorfalseESCom-10133220202trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEENVIRONMENTEUSES DeterminanttrueWATERE_W_4E_C_4EUSES 2.1.2StandardtrueESCom-11133170613trueWATER0.0100.0Site specificfalseESCom-11133171638trueWATER0.0100.0NonefalsefalseWATER0.00.00.0ChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEENVIRONMENTReleaseModule's DeterminanttrueAIRSOILWATERE_W_2E_C_2EUSES 2.1.20.0<=ESCom-15193135620falseChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEENVIRONMENTReleaseModule's DeterminanttrueAIRSOILWATERE_W_2E_C_2EUSES 2.1.20.0100.0=ESCom-9269144102falseChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEWORKERSCore worker condition of usetrueDERMALW_4ECETOC TRA worker;ART;MEASE;Stoffenmanager;EMKGNotruefalseYes (effectiveness ≥ 80%)falseESCom-10133224896ESCom-17297180800ESCom-12355002165trueChemical resistant dermal protection with basic employee training. (effectiveness ≥ 90%)falseESCom-11133171457ESCom-17297180800ESCom-12355002165trueChemical resistant dermal protection with specific employee training. (effectiveness ≥ 95%)falseESCom-11133171458ESCom-17297180800ESCom-12355002165trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEWORKERSCore worker condition of usetrueINHALATIONW_4ECETOC TRA worker;ART;MEASE;Stoffenmanager;EMKGNotruefalseYes (APF ≥ 10)falseWear a respirator which reduces the air impurities by at least a factor of 10 (APF ≥ 10). For further specification, refer to section 8 of the SDStrueYes (APF ≥ 20)falseWear a respirator which reduces the air impurities by at least a factor of 20 (APF ≥ 20). For further specification, refer to section 8 of the SDStrueYes (APF ≥ 4)falseWear a respirator which reduces the air impurities by at least a factor of 4 (APF ≥ 4). For further specification, refer to section 8 of the SDStrueYes (APF ≥ 5)falseWear a respirator which reduces the air impurities by at least a factor of 5 (APF ≥ 5). For further specification, refer to section 8 of the SDStrueYes (APF ≥ 40)falseWear a respirator which reduces the air impurities by at least a factor of 40 (APF ≥ 40). For further specification, refer to section 8 of the SDStrueYes (APF ≥ 200)falseWear a respirator which reduces the air impurities by at least a factor of 200 (APF ≥ 200). For further specification, refer to section 8 of the SDStrueYes (APF ≥ 2000)falseWear a respirator which reduces the air impurities by at least a factor of 2000 (APF ≥ 2000). For further specification, refer to section 8 of the SDStrueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVECONSUMERStrueDERMALC_1TRA Consumer 3.1YestruefalseNo dermal contactfalseAssumes no dermal contacttrueDermal exposure assumed to be negligiblefalseDermal exposure assumed to be negligibletrueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVECONSUMERStrueINHALATIONC_1TRA Consumer 3.1YestruefalseInhalation exposure is considered to be not relevant falseESCom-12355002171trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVECONSUMERStrueORALC_1TRA Consumer 3.1YestruefalseOral exposure is considered to be not relevant falseESCom-12355002172trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5ACTIVEWORKERSCore worker condition of usetrueEYEW_4ECETOC TRA worker;ART;MEASE;Stoffenmanager;EMKGEye protectionfalseESCom-11133171467trueNotruefalseFace protection/visorfalseESCom-11133170516trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b52015-03-16T16:40:11ACTIVEENVIRONMENTSpecific 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.trueWATERE_W_5E_C_3EUSES 2.1.2No (no waste)falseNo waste generated.ESCom-11133170674trueNo (low risk)falseERC 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-11133171479trueNo (low amount)falseParticular 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-11133171479trueNo (low concentration)falseParticular risks from waste treatment unlikely due low concentration of substance in waste stream. Waste disposal according to national/local legislation is sufficient.ESCom-11133171479trueNo (other reason)falseWaste disposal according to national/local legislation is sufficient. "Explanation for the CSR" to be reported by each registrant:ESCom-11133171479trueDedicated recollection infrastructure requiredfalseESCom-12355002107trueBiological treatment not appropriatefalseESCom-12355002101trueIncineration not appropriatefalseESCom-12355002100truePrevent formation of hazardous break down products during thermal waste treatment destruction.falsePrevent formation of hazardous break down products during thermal waste treatment.trueClosed system required to minimise release to the environment.falseClosed system required to minimise release to the environment during waste treatment.trueOtherfalse"Explanation for the CSR" to be reported by each registrant on the specific conditions required for waste treatment:trueChesarIUC5-97ce9eec-ebfd-4b2d-a61b-b9a975e920b5ACTIVEENVIRONMENTtrueWATERE_W_6E_C_4YesfalsefalseNofalseESCom-16354140700trueIndoor or outdoor usefalsefalsefalseWear suitable gloves tested to EN374.falsefalsefalseWear suitable face shield.falsefalsefalseMunicipal sewage treatment plant is assumed.falsefalsefalseNo waste from processfalsefalsefalseWear chemically resistant gloves (tested to EN374) in combination with ‘basic’ employee training.falsefalsefalseWear chemically resistant gloves (tested to EN374) in combination with specific activity training.falsefalsefalseUse suitable eye protection.falsefalsefalseDispose of waste product or used containers according to local regulations.falsefalsefalseCovers use up tofalsetruetrueProvide onsite wastewater treatment.falsefalsefalseIncineration is not appropriate for waste.falsefalsefalseBiological treatment is not appropriate for waste.falsefalsefalseDedicated recollection infrastructure required for wastefalsefalsefalseDirect application of plant protection products (e.g. granules or treated seeds) to soilfalsefalsefalseFor further specification, refer to section 8 of the SDS.falsefalsefalseInhalation exposure is considered to be not relevant.falsefalsefalseOral exposure is considered to be not relevant.falsefalsefalsetonnes/dayfalsefalsefalseh/dayfalsefalsefalseSpray application of plant protection products containing co-formulantsfalsefalsefalseMixing and loading of plant protection products into delivery equipmentfalsefalsefalseDelivery and dispersion of plant protection productsfalsefalsefalseApplication ratetruetruetrueGranule application / Seed treatmentfalsefalsefalseNo water contact during use.falsefalsefalseIf 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.falsefalsefalseUse as a co-formulant in plant protection products, spray application by professionalsfalsefalsefalseUse as a co-formulant in plant protection products, seed and granular applications by professionalsfalsefalsefalseUse as a co-formulant in plant protection products, spray application by consumersfalsefalsefalseUse as a co-formulant in plant protection products, seed and granular applications by consumersfalsefalsefalseAnnual application ratetruetruetrue%falsefalsefalsekg/hafalsefalsefalseIndoor usefalsefalsefalseOutdoor usefalsefalsefalse