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MARINE RISK ASSESSMENT − knowledge of the mode of action as some substances by virtue of their structure may be known to act in a non-specific manner. A lower factor may therefore be considered. Equally a known specific mode of action may lead to a higher factor. − the availability of data from a variety of species covering the taxonomic groups of the base set species across at least three trophic levels. In such a case the assessment factors may only be lowered if multiple data points are available for the most sensitive taxonomic group (i.e. the group showing acute toxicity more than 10 times lower than for the other groups). There are cases where a complete short-term dataset even for freshwater algal, crustacean and fish species will not be available, for example for substances which are produced at < 1 t/a (notifications according to Annex VII B of Directive 92/32). In these situations, the only data may be short-term L(E)C50 data for Daphnia. In these exceptional cases, the PNEC should be calculated with a factor of 10,000. Variation from an assessment factor of 10000 should be fully reported with accompanying evidence. b) An assessment factor of 1000 applies where data from a wider selection of species are available covering additional taxonomic groups (such as echinoderms or molluscs) other than those represented by algal, crustacean and fish species; if at least data are available for two additional taxonomic groups representative of marine species. An assessment factor of 1000 applies to a single long-term NOEC (freshwater or saltwater crustacean or fish) if this NOEC was generated for the taxonomic group showing the lowest L(E)C50 in the short-term algal, crustacean or fish tests. If the only available long-term NOEC is from a species which does not have the lowest L(E)C50 in the short-term tests, it cannot be regarded as protective of other more sensitive species using the assessment factors available. Thus, the effects assessment is based on the short-term data with an assessment factor of 10,000. However, normally the lowest PNEC should prevail. An assessment factor of 1000 applies also to the lowest of the two long-term NOECs covering two trophic levels (freshwater or saltwater algae and/or crustacean and/or fish) when such NOECs have not been generated for the species showing the lowest L(E)C50 of the short-term tests. This should not apply in cases where the acutely most sensitive species has an L(E)C50-value lower than the lowest NOEC value. In such cases the PNEC might be derived by applying an assessment factor of 1000 to the lowest L(E)C50 of the short-term tests. c) An assessment factor of 500 applies to the lowest of two NOECs covering two trophic levels (freshwater or saltwater algae and/or crustacean and/or fish) when such NOECs have been generated covering those trophic levels showing the lowest L(E)C50 in the short-term tests with these species. Consideration can be given to lowering this factor in the following circumstances: − It may sometimes be possible to determine with a high probability that the most sensitive species covering fish, crustacea and algae has been examined, that is that a further longer-term NOEC from a third taxonomic group would not be lower than the data already available. In such circumstances an assessment factor of 100 would be justified; − a reduced assessment factor (to 100 if only one short-term test, to 50 if two short-term tests on marine species are available) applied to the lowest NOEC from only two species may be appropriate where: − short-term tests for additional species representing marine taxonomic groups (for example echinoderms or molluscs) have been carried out and indicate that these are not the most sensitive group, and; − it has been determined with a high probability that long-term NOECs generated for these marine groups would not be lower than that already obtained. This is particularly important if the substance does not have the potential to bioaccumulate. An assessment factor of 500 also applies to the lowest of three NOECs covering three trophic levels, when such NOECs have not been generated from the taxonomic group showing the lowest L(E)C50 in short-term tests. This should, however, not apply in the case where the acutely most sensitive species has an L(E)C50 value lower than the lowest NOEC value. In such cases the PNEC might be derived by applying an assessment factor of 1000 to the lowest L(E)C50 in the short-term tests. d) An assessment factor of 100 will be applied when longer-term toxicity NOECs are available from three freshwater or saltwater species (algae, crustaceans and fish) across three trophic levels. The assessment factor may be reduced to a minimum of 10 in the following situations: − where short-term tests for additional species representing marine taxonomic groups (for example echinoderms or molluscs) have been carried out and indicate that these are not the most sensitive group, and it has been determined with a high probability that long-term NOECs generated for these species would not be lower than that already obtained; − where short-term tests for additional taxonomic groups (for example echinoderms or molluscs) have indicated that one of these is the most sensitive group acutely and a long-term test has been carried out for that species. This will only apply when it has been determined with a high probability that additional NOECs generated from other taxa will not be lower than the NOECs already available. A factor of 10 cannot be decreased on the basis of laboratory studies only. 150
MARINE RISK ASSESSMENT Statistical extrapolation methods for calculation of PNEC for marine organisms could be used when sufficient data are available. More information on these methods and the prerequisites to apply them for risk assessment purposes can be found in Section 3.3.1.2. 4.3.2 Effects assessment for the sediment compartment 4.3.2.1 Introduction Substances that are highly hydrophobic may be assessed as of low risk for pelagic fauna but can accumulate in sediments to concentrations at which they might exert significant toxic effects (SETAC, 1993). This may be of concern particular in the marine environment, where the sediment may act as a permanent sink for highly hydrophobic substances that can be accumulated to a large extent. Because marine sediment constitutes an important compartment of marine ecosystems it may be important to perform an effects assessment for the marine sediment compartment for those substances. In principle the same strategy as applied to freshwater sediment is recommended (see Section 3.5) for the effects assessment of marine sediment). Several test methods on sediment are developed and used in Member States of the European Union. Most of the tests are used for sediment management purposes; only a few tests are conducted for risk assessment of substances. An inventory of tests with marine organisms for the evaluation of dredged material and sediments has been compiled by the Federal Environment Agency of Germany, UBA (Herbst and Nendza, 2000). It comprises of biotests with various species of marine organisms of different trophic levels on whole sediment, pore water or sediment extracts. In addition OECD has prepared a detailed review paper on aquatic ecotoxicity tests including marine sediment test methods (OECD, 1998a). Only whole sediment tests with infaunal and epibentic organisms are considered suitable for being used in a risk assessment of the marine sediment compartment. From examination of the UBA and OECD inventories it is clear that no fully internationally accepted, standardised test methods for whole sediment are currently available. Most of the existing whole sediment tests measure acute toxicity; only a few measure long-term, sub-lethal endpoints. Only the latter tests are considered applicable to marine risk assessment because of the long-term exposure of benthic organisms to sediment-bound substances that occur under field conditions. In Section 4.3.1 freshwater toxicity data are compared to marine and estuarine data. It is concluded that the use of freshwater acute effects data in lieu or together with saltwater effects data is acceptable for risk assessment purposes. Although it is not sure that this also applies to marine and freshwater sediment data, it is nevertheless recommended to use pooled marine and freshwater sediment toxicity data for effect assessment for the sediment compartment. However, when sufficient data for ecologically relevant saltwater species are available lower assessment factors can be applied. 4.3.2.2 Strategy for effects assessment for sediment organisms Substances that are potentially capable of depositing on or sorbing to sediments to a significant extent have to be assessed for toxicity to sediment-dwelling organisms. In addition, marine sediment effects assessment is necessary for substances that are known to be persistent in marine 151
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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
Page 107 and 108: EFFECTS ASSESSMENT 3.3 EFFECTS ASSE
Page 109 and 110: Table 16 Assessment factors to deri
Page 111 and 112: Input data EFFECTS ASSESSMENT The m
Page 113 and 114: Estimation of the PNEC The PNEC is
Page 115 and 116: EFFECTS ASSESSMENT biodegradability
Page 117 and 118: Table 17 Test systems for derivatio
Page 119 and 120: EFFECTS ASSESSMENT representative o
Page 121 and 122: In the partitioning method, it is a
Page 123 and 124: EFFECTS ASSESSMENT As mentioned in
Page 125 and 126: 3.6.2.1 Calculation of PNEC using t
Page 127 and 128: 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: MARINE RISK ASSESSMENT The addition
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
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 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
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REFERENCES Pack S. (1993). A review
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REFERENCES US EPA (1996). Whole Sed
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APPENDIX I volume imported in the E
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APPENDIX I MC IV “Wide dispersive
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APPENDIX I 210 Stage Main category
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APPENDIX I the number of days over
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APPENDIX I Stage Main category Ia I
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APPENDIX I manufacturing of motor c
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APPENDIX I 1. extension of the tabl
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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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