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TESTING STRATEGIES Another possible option for the refinement of the PEC is the performance of simple monitoring (for example at point of release or in predicted worst-case environments). Long-term monitoring programmes should only be initiated: • in the case of borderline risk assessments, where immediate risk reduction action cannot be justified; • as a means of checking the effectiveness of risk reduction action; taking into account monitoring programmes established under other EU legislation. 6.2.1 Aquatic compartment In the following, a biodegradation testing strategy for the aquatic environment is presented in relation to standardised testing methods available (see also Sections 2.3.6 and 4.2.3). However, it should also be considered at each stage whether further abiotic testing, e.g. direct or indirect aquatic photolysis or a, full adsorption/desorption test, could refine the PEC (local or regional). In that respect it has to be considered whether the photolytic or hydrolytic degradation products themselves may constitute a risk, and it should be considered to determine the ultimate degradation half-life of these degradation products. Two cases can be distinguished: PEC/PNEC > 1 and the substance is readily biodegradable Further biotic testing is unlikely to affect the PEC, unless the producer/importer believes it is worth conducting a simulation test, which may generate a removal percentage greater than that assumed for readily biodegradable substances. PEC/PNEC > 1 and the substance is not readily biodegradable If the substance is inhibitory at a level below that used in the ready test, an STP simulation test that measures ultimate degradation should be performed at a non-inhibitory concentration. This will only help refine PEClocal if the concentration predicted in the sewage treatment plant is below the inhibition threshold. Simulation tests for surface water and/or aquatic sediments may be needed to refine the PECs for surface water and/or sediment for the regional assessment. Internationally standardised methods have recently been developed and should be used for this purpose (see Section 2.3.6). The results from such testing can be used directly in the calculation of PEC for the system being simulated. Care will need to be taken, however, that the conditions of the test substance concentration reflect those likely to be found in the relevant compartment (STP, surface water, sediment and/or soil) so that the degradation half-life for full mineralisation can be established. For slowly degrading substances it is in general recommended that any metabolites/degradation products are identified and that their mineralisation half-lives are also established. In deciding whether there is a need for further simulation degradation studies in one or more of the environmental compartments surface water (freshwater, marine water) and/or sediment it should be considered how a more precisely determined half-life for that compartment might influence the overall risk assessment of the substances. This should be done by taking into account the current production, use and environmental release and distribution of the substance. 182
TESTING STRATEGIES Performance of an inherent test is generally not justified and consideration should be given to conduct a simulation test giving relevant information on the degradation kinetics. A testing strategy on biodegradation of biocidal active substances has been developed, details of which can be found in the Technical Notes for Guidance on data requirements for Directive 98/88 on the placing of biocidal products on the market (TNsG on Data Requirements, 2000; http://ecb.jrc.it/biocides/). 6.2.2 Soil compartment If the PEC/PNEC ratio for the soil compartment is greater than one, further degradation testing will refine the assessment in several ways: • the estimation of the amount of substance entering the soil compartment via land-spreading of sludge can be refined by more sophisticated degradation or adsorption/desorption testing regarding sewage treatment plants; • it can also be refined by investigating the potential for anaerobic degradation in the sludge, which is otherwise assumed to have no effect on the concentration of the substance. For testing of anaerobic biodegradation a standard test method is available (ISO 11734, 1995). This screening test method is designed to investigate the potential for anaerobic degradation in STP digesters, and may thus be relevant for a rough estimation of degradation in anaerobic STP sludge, which is deposed on agricultural soil. Tests for anaerobic degradation and inhibition of anaerobic STP bacteria could therefore possibly be considered on a caseby-case basis in the risk characterisation of certain substances. A refined estimation of the fate of the substance once it has reached the soil compartment may also be possible using a simulation degradation test performed in soil (Draft EU Annex V C.23, OECD guideline 307, 2000b). Also in relation to the need for such a simulation test, it has to be considered how the results may influence or have an impact on the overall risk assessment of the substance. Also here account should be taken of the current production, use and environmental release and distribution of the substance. A testing strategy on degradation of biocidal active substances has been developed, details of which can be found in the Technical Notes for Guidance on data requirements for Directive 98/88 on the placing of biocidal products on the market (TNsG on Data Requirements, 2000; http://ecb.jrc.it/biocides/). • abiotic testing should also be considered. Tests include (direct) photolysis, and more refined adsorption/desorption in soil (see however the general remarks above). 6.2.3 Air compartment For the air compartment experimental testing of direct photodegradation and chemical reactions originating in atmospheric photochemistry is complicated and should only be required if there is a serious indication of possible adverse effects related to the PEC in the atmosphere. Instead it is preferable to use QSARs where they are available. 183
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Institute for Health and Consumer P
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LEGAL NOTICE Neither the European C
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OVERVIEW This Technical Guidance Do
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CONTENTS 1 GENERAL INTRODUCTION ...
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4.2.3.4 Use of biodegradation scree
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1 GENERAL INTRODUCTION 1.1 BACKGROU
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GENERAL INTRODUCTION countries in t
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GENERAL INTRODUCTION PNEC is regard
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2 ENVIRONMENTAL EXPOSURE ASSESSMENT
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ENVIRONMENTAL EXPOSURE ASSESSMENT r
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2.2 MEASURED DATA ENVIRONMENTAL EXP
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ENVIRONMENTAL EXPOSURE ASSESSMENT w
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ENVIRONMENTAL EXPOSURE ASSESSMENT o
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ENVIRONMENTAL EXPOSURE ASSESSMENT T
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ENVIRONMENTAL EXPOSURE ASSESSMENT r
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Production ENVIRONMENTAL EXPOSURE A
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Back to processing Product at end o
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ENVIRONMENTAL EXPOSURE ASSESSMENT s
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Explanation of symbols ENVIRONMENTA
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ENVIRONMENTAL EXPOSURE ASSESSMENT s
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ENVIRONMENTAL EXPOSURE ASSESSMENT U
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ENVIRONMENTAL EXPOSURE ASSESSMENT a
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ENVIRONMENTAL EXPOSURE ASSESSMENT F
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2.3.5.1 Adsorption to aerosol parti
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ENVIRONMENTAL EXPOSURE ASSESSMENT I
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2.3.6.1 Hydrolysis ENVIRONMENTAL EX
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2.3.6.3 Photochemical reactions in
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constant of zero. However, if it ca
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ENVIRONMENTAL EXPOSURE ASSESSMENT A
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ENVIRONMENTAL EXPOSURE ASSESSMENT a
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Primary Settler Aeration Tank 2 5 3
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ENVIRONMENTAL EXPOSURE ASSESSMENT I
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ENVIRONMENTAL EXPOSURE ASSESSMENT d
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ENVIRONMENTAL EXPOSURE ASSESSMENT e
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Table 10 Overview of different expo
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ENVIRONMENTAL EXPOSURE ASSESSMENT -
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2.3.8.3 Calculation of PEClocal for
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ENVIRONMENTAL EXPOSURE ASSESSMENT W
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Guidance for calculating PEClocal i
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Concentration (% of initial) 160 14
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Calculation of PEClocalsoil For soi
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ENVIRONMENTAL EXPOSURE ASSESSMENT
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Output ENVIRONMENTAL EXPOSURE ASSES
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3 EFFECTS ASSESSMENT 3.1 INTRODUCTI
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3.2.1.1 Completeness of data New su
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EFFECTS ASSESSMENT • it is clearl
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EFFECTS ASSESSMENT 3.3 EFFECTS ASSE
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Table 16 Assessment factors to deri
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Input data EFFECTS ASSESSMENT The m
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Estimation of the PNEC The PNEC is
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EFFECTS ASSESSMENT biodegradability
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Table 17 Test systems for derivatio
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EFFECTS ASSESSMENT representative o
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In the partitioning method, it is a
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EFFECTS ASSESSMENT As mentioned in
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3.6.2.1 Calculation of PNEC using t
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3.7 EFFECTS ASSESSMENT FOR THE AIR
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EFFECTS ASSESSMENT procedure availa
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EFFECTS ASSESSMENT bioaccumulation
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EFFECTS ASSESSMENT For some chemica
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EFFECTS ASSESSMENT i.e. without enh
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Conversion factors for laboratory a
Page 139 and 140: EFFECTS ASSESSMENT • relative sen
Page 141 and 142: EFFECTS ASSESSMENT Earthworms are a
Page 143 and 144: MARINE RISK ASSESSMENT environment
Page 145 and 146: MARINE RISK ASSESSMENT of equal rel
Page 147 and 148: 4.2.3.3 Marine biodegradation simul
Page 149 and 150: MARINE RISK ASSESSMENT In addition
Page 151 and 152: Explanation of symbols MARINE RISK
Page 153 and 154: MARINE RISK ASSESSMENT evaluate the
Page 155 and 156: MARINE RISK ASSESSMENT marine water
Page 157 and 158: MARINE RISK ASSESSMENT The addition
Page 159 and 160: MARINE RISK ASSESSMENT Statistical
Page 161 and 162: MARINE RISK ASSESSMENT sediment, fo
Page 163 and 164: Table 27 Assessment factors for der
Page 165 and 166: Table 28 continued Acute and chroni
Page 167 and 168: MARINE RISK ASSESSMENT of different
Page 169 and 170: MARINE RISK ASSESSMENT • a measur
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Page 173 and 174: MARINE RISK ASSESSMENT mechanisms s
Page 175 and 176: MARINE RISK ASSESSMENT The use of t
Page 177 and 178: 4.4.4.2 Assessment of measured BCF
Page 179 and 180: MARINE RISK ASSESSMENT required to
Page 181 and 182: Table 33 Overview of PEC/PNEC ratio
Page 183 and 184: RISK CHARACTERISATION If a refineme
Page 185 and 186: Classified dangerous to the Environ
Page 187 and 188: RISK CHARACTERISATION eaters. This
Page 189: 6 TESTING STRATEGIES 6.1 INTRODUCTI
Page 193 and 194: TESTING STRATEGIES Care must be tak
Page 195 and 196: Algal testing Algae toxicity test (
Page 197 and 198: TESTING STRATEGIES • long-term te
Page 199 and 200: Microbial assays TESTING STRATEGIES
Page 201 and 202: TESTING STRATEGIES A soil bioassay
Page 203 and 204: REFERENCES Brandes LJ, den Hollande
Page 205 and 206: REFERENCES IPCS (2000). Framework f
Page 207 and 208: REFERENCES OECD (1984f). Activated
Page 209 and 210: REFERENCES Pack S. (1993). A review
Page 211: REFERENCES US EPA (1996). Whole Sed
Page 214 and 215: APPENDIX I volume imported in the E
Page 216 and 217: APPENDIX I MC IV “Wide dispersive
Page 218 and 219: APPENDIX I 210 Stage Main category
Page 220 and 221: APPENDIX I the number of days over
Page 222 and 223: APPENDIX I Stage Main category Ia I
Page 224 and 225: APPENDIX I manufacturing of motor c
Page 226 and 227: APPENDIX I 1. extension of the tabl
Page 228 and 229: APPENDIX I 220 A-tables Estimates f
Page 230 and 231: APPENDIX I PRIVATE USE Not applicab
Page 232 and 233: APPENDIX I IC = 3: CHEMICAL INDUSTR
Page 234 and 235: APPENDIX I IC = 5: PERSONAL /DOMEST
Page 236 and 237: APPENDIX I Table A4.1 continued Com
Page 238 and 239: APPENDIX I IC = 7: LEATHER PROCESSI
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APPENDIX I IC = 9: MINERAL OIL AND
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APPENDIX I WASTE TREATMENT Table A5
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APPENDIX I For the emission factors
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APPENDIX I INDUSTRIAL USE Table A3.
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APPENDIX I INDUSTRIAL USE Table A3.
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APPENDIX I PRIVATE USE Table A4.5 C
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APPENDIX I PRIVATE USE Table A3.16
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APPENDIX I 246 B-tables Estimates f
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APPENDIX I FORMULATION Table B2.2 f
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APPENDIX I IC = 3: CHEMICAL INDUSTR
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APPENDIX I IC = 5: PERSONAL/DOMESTI
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APPENDIX I IC = 7: LEATHER PROCESSI
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APPENDIX I IC = 9: MINERAL OIL AND
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APPENDIX I IC = 11: POLYMERS INDUST
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APPENDIX I IC =13: TEXTILE PROCESSI
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APPENDIX I IC = 16: ENGINEERING IND
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APPENDIX I Appendix I-a: List of sy
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APPENDIX I No. Use Category No. Fun
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APPENDIX I Appendix I-b: List of sy
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APPENDIX I 290 Organic intermediate
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APPENDIX I Other IC/UC combinations
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APPENDIX II Appendix II Fate of che
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APPENDIX II b) Inherent biodegradab
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APPENDIX II log H % removal -4 -3 -
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APPENDIX III Appendix III Evaluatio
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APPENDIX III Field studies In gener
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APPENDIX IV together the mentioned
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290 Table 1 Selected soil test meth
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292 Table 1 continued Selected soil
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298 Table 1 Selected freshwater sed
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APPENDIX VII Appendix VII Toxicity
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APPENDIX VIII collection), and that
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APPENDIX VIII chemicals (see Sectio
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APPENDIX VIII Multimedia fate model
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APPENDIX VIII Monitoring data Metal
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APPENDIX VIII homeostatic regulatio
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APPENDIX IX based on the proportion
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APPENDIX IX Definition of “blocks
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APPENDIX IX these “blocks” will
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APPENDIX IX and PNECs for the “bl
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APPENDIX XI Appendix XI Environment
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APPENDIX XII Appendix XII Connectio
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APPENDIX XII +40% compared to 1992.
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APPENDIX XIII other substance is be
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APPENDIX XIV Taxonomic group No. of
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