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RISK CARACTERISATION The base set testing package (Annex VII A) of the Directive generates relatively little data which are of relevance to the terrestrial and atmospheric compartments: further but nevertheless still limited data are foreseen at level 1 and level 2 (Annex VIII). Where consideration of either of these two compartments is of relevance to the environmental risk assessment of a particular substance, further testing and progressive revision of the PEC/PNEC should be carried out on a case-by-case basis in the light of the guidance set out in Section 6. For the risk characterisation for top predators a specific assessment scheme applies. This scheme is given in Figure 19. In this case the yearly average PEClocal for water is used to calculate PECoral. Based on the results of the provisional assessment of secondary poisoning where a calculated BCF value is used (see Section 3.8), it is decided whether or not a bioaccumulation test should be requested, either immediately or at the 10 tonnes per annum production level. It should be noted that a bioaccumulation test is a level 1 test. The result of the bioaccumulation test is used to refine the risk characterisation for top predators. If the ratio of PECoral and PNECoral is still greater than one, secondary poisoning could be a critical pathway for fish- 178 Testing of BCF at 10 tonnes Provisional assessment of secondary poisoning No PECoral/PNECoral >1 Yes PECoral/PNECoral >10 Yes Immediate testing of BCF Refinement of the assessment of secondary poisoning No No immediate concern Figure 19 Decision scheme for risk characterisation for secondary poisoning for new chemicals
RISK CHARACTERISATION eaters. This may lead to a request for more specific tests, for instance long-term dietary studies on birds, that can be used to facilitate a better calculation. 5.5 RISK CHARACTERISATION FOR BIOCIDES The environmental risk characterisation for biocidal active substances in the context of Article 5 and Annex VI of Directive 98/8 involves i.a. the comparison of PEC and PNEC values for relevant environmental compartments as well as for non-target organisms. According to Articles 10 and 11 of the Directive, the possible results of the risk assessment are: • there is a need for further information and/or testing; • the substance has unacceptable effects on the environment and consequently, it cannot be included in Annex I, IA or IB; • the substance may be considered for inclusion in Annex I, IA or IB of the Directive. The decision on inclusion in Annex I, IA or IB of the Directive also depends on other criteria regarding, e.g., other unacceptable effects and efficacy (cf. Directive 98/8 and the Technical Notes for Guidance on Annex I inclusion). The inclusion may, where appropriate, be subject to certain requirements and conditions for use. When it is concluded that the active biocidal substance can be included in Annex I, IA or IB, the inclusion may be granted for an initial period not exceeding 10 years (Article 10 of Directive 98/8). The inclusion of an active substance may be renewed on one or more occasions for periods not exceeding 10 years. Additional to these main conclusions, some substances included in Annex I, IA or IB may be candidates for a future comparative assessment (Article 10 of Directive 98/8). This may be the case when the PEC/PNEC ratio is > 0.1 and ≤ 1 (cf. the Technical Notes for Guidance (TNsG) on Annex I inclusion, 2001). It is considered an unacceptable effect if PEC/PNEC > 1 for non-target organisms and aquatic organisms, or if the bioconcentration factor (BCF) > 1 related to fat tissues in non-target vertebrates, if BCF for aquatic organisms > 1000 for readily biodegradable substances or if BCF for aquatic organisms > 100 for not readily biodegradable substances (cf. Annex VI to Directive 98/8). If the PEC/PNEC ratio is > 1 the Member State shall judge, on the basis of the size of that ratio and on other relevant factors, if further information and/or testing are required to clarify the concern, if risk reduction measures are necessary or if the substance cannot be included in Annex I, IA or IB at all. Finally, if a quantitative risk characterisation cannot be conducted, a qualitative risk characterisation should be conducted, cf. below. 5.6 QUALITATIVE RISK CHARACTERISATION Although the use of quantitative PEC/PNEC ratios is the preferred procedure for carrying out an environmental risk assessment, there may be cases where a quantitative risk characterisation cannot be carried out. This is, e.g., the case for assessment of risks for remote marine areas and for substances where either PEC or PNEC cannot be properly calculated. In these cases, the risk characterisation shall entail a qualitative evaluation of the likelihood that an effect will occur under the expected conditions of exposure (see Annex III, par. 4.2 of Directive 93/67). 179
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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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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
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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: Classified dangerous to the Environ
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
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Page 224 and 225: APPENDIX I manufacturing of motor c
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Page 228 and 229: APPENDIX I 220 A-tables Estimates f
Page 230 and 231: APPENDIX I PRIVATE USE Not applicab
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Page 234 and 235: 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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