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RISK CARACTERISATION 5 RISK CHARACTERISATION 5.1 INTRODUCTION Having conducted the exposure assessment and the dose (concentration) - response (effect) assessment for all environmental compartments, either a quantitative risk characterisation or a qualitative risk characterisation is carried out. The quantitative risk characterisation is carried out by comparing the PEC with the PNEC. This is done separately for each of the environmental compartments identified in Section 1.2 and Tables 1 and 2: Inland environmental compartments: • aquatic ecosystem; • terrestrial ecosystem; • atmosphere; • top predators; • microorganisms in sewage treatment plants. Marine environmental compartments: • aquatic ecosystem; • top predators. A list of the different PEC/PNEC ratios that should be considered for the inland and marine environments is given in Tables 32 and 33, respectively. Depending on whether the risk characterisation is performed for a new substance, for an existing substance or for a biocidal active substance, different conclusions can be drawn on the basis of the PEC/PNEC ratio for the different endpoints, and different strategies can be followed when PEC/PNEC ratios greater than one are observed. Therefore, the descriptions of the risk characterisation approaches are given separately for new substances, for existing substances and for biocides. However, a number of general premises apply to the procedures that have to be followed. These are given first. Table 32 Overview of PEC/PNEC ratios considered for inland risk assessment * 172 Local Regional PEClocalwater/PNECwater PECregionalwater/PNECwater PEClocalsediment/PNECsediment PECregionalsediment/PNECsediment PEClocalsoil/PNECsoil PECregionalagr.soil/PNECsoil PECstp/PNECmicroorganisms (0.5 . PEClocal,oralfish + 0.5 . PECregional,oralfish)/PNECoral (0.5 . PEClocal,oralworm + 0.5 . PECregional,oralworm)/PNECoral * It has to be noted that these ratios have to be derived for all stages of the life-cycle of a compound.
Table 33 Overview of PEC/PNEC ratios considered for marine risk assessment * Local Regional PEClocalseawater/PNECsaltwater PECregionalseawater/PNECsaltwater PEClocalsediment/PNECmarine sediment PECregionalsediment/PNECmarine sediment [(PEClocalseawater,ann + PECregionalseawater) · 0.5 · BCFfish · BMF1]/PNECoralpredator [(0.1 · PEClocalseawater,ann + 0.9 · PECregionalseawater) · BCFfish · BMF1 · BMF2]/PNECoraltop predator * It has to be noted that these ratios have to be derived for all stages of the life-cycle of a compound. RISK CHARACTERISATION When no quantitative risk characterisation can be carried out, for example for remote marine areas or when either PEC or PNEC cannot be properly derived, a qualitative risk characterisation should be conducted. This is described in Section 5.6. 5.2 GENERAL PREMISES FOR RISK CHARACTERISATION In general, the risk characterisation phase is carried out along the following steps (see Figure 17): • determine the PEC/PNEC ratios for the different environmental compartments considered. Dependent on these PEC/PNEC ratios: • determine whether further information/testing may lead to a revision of these ratios; • ask for further information/testing when appropriate; • refine the PEC/PNEC ratio. This iterative process should be continued until a final conclusion regarding the environmental risks can be reached. For the risk characterisation for the aquatic and terrestrial ecosystems, including secondary poisoning, a direct comparison of the PEC and PNEC values is carried out, presuming that the relevant data are available. If the PEC/PNEC ratio is greater than one the substance is “of concern” and further action has to be taken. For the air compartment usually only a qualitative assessment of abiotic effects is carried out. If there are indications that one or more of these effects occur for a given substance, expert knowledge should be consulted or the substance be handed over to the relevant international group, e.g. to the responsible body in the United Nations Environment Programme (UNEP) for ozone depleting substances. In some cases also an assessment of the biotic effects to plants can be carried out. The risk characterisation for top predators is made by comparing the PECoral with the PNECoral in accordance with the procedure described in Sections 3.8 and 4.3.3. If the ratio PECoral / PNECoral is greater than one and a refinement of the PECoral or the PNECoral is not possible or reasonable, risk reduction measures should be considered. The risk characterisation for microorganisms in sewage treatment systems is done by comparing the PECstp with the PNECmicroorganisms. If the ratio of these two values is greater than one, this indicates that the substance may have a detrimental effect on the function of the STP and therefore is “of concern”. 173
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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
Page 129 and 130: EFFECTS ASSESSMENT procedure availa
Page 131 and 132: EFFECTS ASSESSMENT bioaccumulation
Page 133 and 134: EFFECTS ASSESSMENT For some chemica
Page 135 and 136: EFFECTS ASSESSMENT i.e. without enh
Page 137 and 138: 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
Page 171 and 172: MARINE RISK ASSESSMENT b. the conce
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
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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 and 190: 6 TESTING STRATEGIES 6.1 INTRODUCTI
Page 191 and 192: TESTING STRATEGIES Performance of a
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
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APPENDIX I PRIVATE USE Not applicab
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APPENDIX I IC = 3: CHEMICAL INDUSTR
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APPENDIX I IC = 5: PERSONAL /DOMEST
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APPENDIX I Table A4.1 continued Com
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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 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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