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

CropLife Europe 3d96087e-d9d8-4843-b97a-71e8832cf9c6 2021-12-13T14:09:41 2021-12-13T14:25:47 ACTIVE 1


        CLE 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. https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/ 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 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 soil


            CLE 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 December 2021 CropLife Europe 3d96087e-d9d8-4843-b97a-71e8832cf9c6 2021-12-13T14:18:54 2021-12-13T14:24:53 ACTIVE 1


        CLE 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. https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/ 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 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 Pa


            CLE 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


            CLE 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


            CLE 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


            CLE 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


            CLE SpERC 8d.2a.v4


        CLE 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. https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/ 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 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 soil


            CLE SpERC 8d.1.v4


        CLE 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. https://croplifeeurope.eu/pre-market-resources/reach-in-registration-evaluation-authorisation-and-restriction-of-chemicals/ 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 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 Pa


            CLE SpERC 8d.2d.v4


            CLE SpERC 8d.2c.v4


            CLE SpERC 8d.2b.v4


            CLE SpERC 8d.2e.v4


            CLE 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 December 2021 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 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 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 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 Municipal sewage treatment plant is assumed. false false false No waste from process 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 No water contact during use. 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