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ENVIRONMENTAL EXPOSURE ASSESSMENT remaining amount of the substance in the product, e.g. corroding metals, the simplified equations 10-11 are used. If the amount of a substance in use in the society has not reached steady state and the accumulation is still ongoing, the calculated PEC will represent a future situation. If this is the case this should be considered when comparing PEC with monitoring data. Releases from articles will normally only contribute to the continental and regional releases. The emissions from indoor uses can be released to wastewater and therefore be regarded as a point source (stream “d” in Figure 5). Also outdoor uses may cause releases to STP if the storm water system is connected to the STP. This has to be considered case by case. For the calculation of a local scenario the B-table in Appendix I for Industry Category 5 Personal/domestic shall be used. Quantitative methods for estimating emissions from waste remaining in the environment are currently not available. Therefore such releases have to be considered on a case-by-case basis. As for substances in long-life articles, substances in “waste remaining in the environment” will also accumulate. As a simplification the emissions at steady state can be assumed to be equal to the annually formed amount of “waste remaining in the environment” (see Figure 5). If the degradation rate of the substance in the waste material is known, this should be taken into consideration. When the emission of a substance from waste remaining in the environment is very slow it will take a long time to reach steady state. In that case the calculated emission may reflect a future situation. As for emissions from articles releases from waste remaining in the environment will also contribute mainly to the continental and regional releases. 2.3.3.6 Emissions from waste disposal If the major share of a substance placed on the market remains in chemical products or articles at the end of their service life (releases during production, processing and use are comparatively small), the waste life-cycle stage of the substance may need particular attention. This refers e.g. to organic substances in landfills and metals in waste incineration processes. The underlying criterion for considering waste emissions in the risk assessment of substances, is that the waste stage will contribute significantly to the overall human exposure or environmental concentration in comparison to the emissions from other parts of the life-cycle of the substance (e.g. production and use stages). If this is not the case, waste considerations could be excluded from the assessment process and general risk management measures based on EU waste legislation should be sufficient. For certain types of substances, e.g. metals and persistent and toxic substances releases from waste may be slow compared to the release from the production and use phase but nevertheless the continued long-term release after use could be of concern. On a case-by-case basis, these aspects may be addressed in the risk assessment. To guide the decision whether an estimation of the releases from the waste stage is pertinent, the following considerations may be used. First, on the basis of the production volume and the use pattern a preliminary assessment on the volume that may end up in the waste streams should be performed. In doing so the toxicity and other adverse effects of the substance and of possible breakdown products should be taken into 40
ENVIRONMENTAL EXPOSURE ASSESSMENT account to qualify the significance of the possible impact of such a volume entering the waste stream. Even a small volume of a highly toxic compound may be of concern. Subsequently, information on anaerobic degradation in landfills or conditions simulating conditions in landfills may indicate that further assessment may not be needed. Water solubility, adsorption/desorption in soil (under landfill conditions) or if available from leaching experiments could also be included in the evaluation as an indicator for leaching potential. However, it is noted that even sorbed substances may leave the landfill via particle transport with leachates. The substance may also leave the landfill with the produced landfill gas. The Kow and Henry’s Law constant as well as the tropospheric persistency may be used to indicate whether the release through landfill gas may be of significance. A proposal for possible trigger values can be found in Danish EPA (2001). For incineration, inorganic substances are the predominant substances of concern. The concern is especially associated with possible leaching of such substances from incineration products whether landfilled or used e.g. for road construction. Furthermore, substances that contain halogens need special attention due to the possible formation of hazardous substances during incineration. In order to evaluate whether emissions from incineration of a substance containing an inorganic substance of concern should be included in the risk assessment, the predicted occurrence of the substance in a waste stream should be compared with typical background-ranges. If a substance or a specific use of a substance may contribute unduly to the influent concentration further release calculation should be carried out. 2.3.3.7 Delayed releases from waste disposal and dilution in time Releases from the waste life stage may occur several decades after production and processing of the substance under assessment. These delays are determined, inter alia, by: • the service life span of the substance as such, or in a chemical product or article; • intermediate storage after service life before waste collection (e.g. exhausted batteries); • exposure of residues from waste incineration to water. This source could be of particular relevance if the residues are re-introduced into the market as products (e.g. building material) exposed to water; • intensity of gas production in landfills; • exposure of landfilled waste to water and deterioration of the landfill bottom liner. The releases from landfills and residues from waste incineration residues usually take place over a long time period. Hence the daily or annual release may result in a very small PEC. If available, monitoring data may be a valuable source of information (see Section 2.2.1). The need for a long-term release assessment should be decided on a case-by-case basis, in particular for metals or organic substances that are persistent and toxic. 2.3.4 Characterisation of the environmental compartments In this section, the following parameters are derived: • definition of the standard environmental characteristics (Table 5); 41
Page 1: Institute for Health and Consumer P
Page 4 and 5: LEGAL NOTICE Neither the European C
Page 7: OVERVIEW This Technical Guidance Do
Page 11 and 12: CONTENTS 1 GENERAL INTRODUCTION ...
Page 13 and 14: 4.2.3.4 Use of biodegradation scree
Page 15 and 16: 1 GENERAL INTRODUCTION 1.1 BACKGROU
Page 17 and 18: GENERAL INTRODUCTION countries in t
Page 19 and 20: GENERAL INTRODUCTION PNEC is regard
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Page 25 and 26: 2.2 MEASURED DATA ENVIRONMENTAL EXP
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Page 35 and 36: Production ENVIRONMENTAL EXPOSURE A
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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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