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GENERAL INTRODUCTION Table 2 Relationship between different targets of the risk characterisation for different marine compartments 12 Target Medium of exposure (PEClocal / PECregional) Aquatic organisms Seawater 4.2.2 4.2.5 Benthic organisms Marine sediment 4.2.4.3 4.2.5 Fish-eating predators Section PNEC Section PNECwater 4.3.1 PNECmarine sed 4.3.2 Fish 4.3.3 PNECoralpredators 4.3.3 Top predators Fish-eaters 4.3.3 PNECoral, top predators 4.3.3 Table 3 Exposure levels used for indirect human exposure Target Medium of exposure (PEClocal / PECregional) Drinking water production Surface water (annual average) Groundwater Inhalation of air Air (annual average) Production of crops Agricultural soil (averaged over 180 days) Production of meat and milk Grassland (averaged over180 days) Fish for human consumption Surface water (annual average) Section 2.3.8.3 & 2.3.8.7 2.3.8.6 & 2.3.8.7 2.3.8.2 2.3.8.5 & 2.3.8.7 2.3.8.5 & 2.3.8.7 2.3.8.3 & 2.3.8.7
2 ENVIRONMENTAL EXPOSURE ASSESSMENT 2.1 INTRODUCTION ENVIRONMENTAL EXPOSURE ASSESSMENT The environment may be exposed to chemical substances during all stages of their life-cycle from production to disposal or recovery. For each environmental compartment (air, soil, water, sediment) potentially exposed, the exposure concentrations should be derived. The assessment procedure should in principle consider the following stages of the life-cycle of a substance: • production; • transport and storage; • formulation (blending and mixing of substances in preparations); • industrial/Professional use (large scale use including processing (industry) and/or small scale use (trade)); • private or consumer use; • service life of articles; • waste disposal (including waste treatment, landfill and recovery). When assessing the exposure of the environment to existing chemicals, previous releases of the chemical to the environment need to be considered. These releases may have a cumulative effect that gives rise to a “background concentration” in the environment. Exposure may also occur from sources not directly related to the life-cycle of the substance being assessed. Examples of such sources are substances of natural origin, substances formed in combustion processes and other indirect emissions of the substance (e.g. as by-product, contaminant or degradation product of another substance). These kinds of sources have been referred to as “unintentional sources”. Guidance on how to deal with emissions not covered by the life-cycle of the priority existing substance or biocidal active substance is given in Appendix XIII. In view of uncertainty in the assessment of exposure of the environment, the exposure levels should be derived on the basis of both measured data, if available, and model calculations. Relevant measured data from substances with analogous use and exposure patterns or analogous properties, if available, should also be considered when applying model calculations. Preference should be given to adequately measured, representative exposure data where these are available (Sections 2.2.1 and 2.5). Consideration should be given to whether the substance being assessed can be degraded, biotically or abiotically, to give stable and/or toxic degradation products. Where such degradation can occur, the assessment should give due consideration to the properties (including toxic effects) of the products that might arise. For new substances, it is unlikely that information will be available on such degradation products and thus only a qualitative assessment would normally be possible. For existing substances and biocidal active substances, however, known relevant degradation products should also be subject to risk assessment. Where no information is available, a qualitative description of the degradation pathways can be made. A summary of some of these is presented in Appendix X. Furthermore it should be noted that guidance on how to assess and test relevant metabolites and transformation products is under preparation for plant protection products under Directive 91/414. This guidance could be modified later for use for biocides, and where appropriate for new and existing substances. For many substances available biodegradation data is restricted to aerobic conditions. However, for some compartments, e.g. sediment or ground water, anaerobic conditions should also be 13
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Page 4 and 5: LEGAL NOTICE Neither the European C
Page 7: OVERVIEW This Technical Guidance Do
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Explanation of symbols ENVIRONMENTA
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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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Explanation of symbols ENVIRONMENTA
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Calculation of PEClocalsoil For soi
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ENVIRONMENTAL EXPOSURE ASSESSMENT
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ENVIRONMENTAL EXPOSURE ASSESSMENT T
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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
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EFFECTS ASSESSMENT • relative sen
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EFFECTS ASSESSMENT Earthworms are a
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MARINE RISK ASSESSMENT environment
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MARINE RISK ASSESSMENT of equal rel
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4.2.3.3 Marine biodegradation simul
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MARINE RISK ASSESSMENT In addition
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Explanation of symbols MARINE RISK
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MARINE RISK ASSESSMENT evaluate the
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MARINE RISK ASSESSMENT marine water
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MARINE RISK ASSESSMENT The addition
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MARINE RISK ASSESSMENT Statistical
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MARINE RISK ASSESSMENT sediment, fo
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Table 27 Assessment factors for der
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Table 28 continued Acute and chroni
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MARINE RISK ASSESSMENT of different
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MARINE RISK ASSESSMENT • a measur
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MARINE RISK ASSESSMENT b. the conce
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MARINE RISK ASSESSMENT mechanisms s
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MARINE RISK ASSESSMENT The use of t
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4.4.4.2 Assessment of measured BCF
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MARINE RISK ASSESSMENT required to
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Table 33 Overview of PEC/PNEC ratio
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RISK CHARACTERISATION If a refineme
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Classified dangerous to the Environ
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RISK CHARACTERISATION eaters. This
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6 TESTING STRATEGIES 6.1 INTRODUCTI
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TESTING STRATEGIES Performance of a
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TESTING STRATEGIES Care must be tak
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Algal testing Algae toxicity test (
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TESTING STRATEGIES • long-term te
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Microbial assays TESTING STRATEGIES
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TESTING STRATEGIES A soil bioassay
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REFERENCES Brandes LJ, den Hollande
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REFERENCES IPCS (2000). Framework f
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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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