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ENVIRONMENTAL EXPOSURE ASSESSMENT specify if releases during each stage are relevant or not. If the release during a certain life stage is not applicable, the release fraction will be set to zero. Furthermore, few quantitative methods have been developed for estimation of the emissions during the service life of articles containing the substance (main category II) e.g. for emission of a flame retardant in plastics used for TV-sets, radios etc. However, though quantitative methodologies are at present scarce for these types of emissions, preliminary quantitative estimations may be performed on a case-by-case basis (see Section 2.3.3.5). After accounting for losses during the six stages of the life-cycle, the part of the tonnage that remains is assumed to end up in waste streams completely. Quantitative methods for estimating emissions at the disposal stage are currently available for municipal waste incineration and municipal landfills. However, at present there is not sufficient information available, to set up an emission scenario which is representative at EU level. Nevertheless, preliminary quantitative estimations modelling a reasonable worst case for the regional scenario may be performed on a case-by-case basis. Quantitative methods for the various types of waste operations aiming at recovery are at the stage of development. Preliminary quantitative estimations may be performed on a case-by-case basis (see Sections 2.3.3.6 and 2.3.7.2). For local emissions for every environmental compartment, the main point source and each stage of the life-cycle is considered. The emission rate is given averaged per day (24 hours). This implies that, even when an emission only takes place a few hours a day, the emission will be averaged over 24 hours. Emissions to air and water will be presented as release rates during an emission episode. Local emissions can be calculated for each stage of the life-cycle and each compartment: Explanation of symbols 34 1000 Elocal i, j = Fmainsource i • • RELEASEi, j Temission i RELEASEi,j release during life-cycle stage i to compartment j [tonnes . yr -1 ] App. IA Fmainsourcei fraction of release at the local main source at life-cycle stage i [-] App. IB Temissioni number of days per year for the emission in stage i [d . yr -1 ] App. IB Elocali,j local emission during episode to compartment j during stage i [kg . d -1 ] For local release estimates, point sources (and therefore, presumably single stages of the lifecycle) need to be identified. It will normally be necessary to assess each stage of the life-cycle to determine whether adverse effects can occur since decisions need to be made to clarify or reduce any identified risk for all life-cycle stages. This is not required if it is obvious that a certain stage is negligible. For the regional scale assessments, the release fractions for each stage of the life-cycle need to be summed for each compartment. The emissions are assumed to be a constant and continuous flux during the year. Regional emissions can be calculated as: 1000 Eregional j = RELEASEi, j (6) 365 6 • ∑ i= 1 (5)
Explanation of symbols ENVIRONMENTAL EXPOSURE ASSESSMENT RELEASEi,j release during life-cycle stage i to compartment j [tonnes . yr -1 ] App. IA Eregionalj total emission to compartment j (annual average) [kg . d -1 ] When assessing the releases on local and regional scales, the following points must be noted: • in particular High Production Volume Chemicals (HPVCs) often have more than one application, sometimes in different industrial categories. For these substances, the assessment proceeds by breaking down the production volume for every application according to data from industry. For the local situation, in principle, all stages of the lifecycle need to be considered for each application. Where more than one stage of the lifecycle occurs at one location, the PEClocal shall be calculated by summing all the relevant emissions from that location. For releases to wastewater, only one point source for the local STP is considered. For the regional situation, the emissions to each compartment have to be summed for each stage of the life-cycle and each application. The regional environmental concentrations are used as background concentrations for the local situation; • if substances are applied in products with an average life span of many years, after the initial arrival of the products onto the market the yearly emissions to the environment will increase. However, after a certain number of years with similar use of the products a steadystate situation will be reached. Examples are a plastic article or a paint coating where the substance assessed is applied as a plasticiser (see also Section 2.3.3.5). Emission reduction techniques have not been taken into account in the tables of Appendix IA as the kind of techniques applied (with possibly large differences in efficiencies) as well as the degree of penetration may differ between Member States or industry sectors. Only when for a certain process a specific reduction measure is common practice this will be taken into account. In all other cases, reasonable worst-case applies. 2.3.3.4 Intermittent releases Many substances are released to the environment from industrial sources as a result of batch, rather than continuous, processes. In extreme cases, substances may only be emitted a few times a year. Since the PECs associated with industrial releases can take into account both the amount released and the number of days of emission, the magnitude of the PECs in the risk assessment should not be affected. PEClocal is always calculated on the basis of a daily release rate, regardless of whether the discharge is intermittent or continuous. It represents the concentration expected at a certain distance from the source on a day when discharge occurs. The discharge is always assumed to be continuous over the 24-hour period. On the other hand, PECregional is calculated using the annual release rate. It represents the steady-state concentration to be expected, regardless of when the discharge occurred. Intermittent release needs to be defined, although rapporteurs will have to justify the use of this scenario on a case-by-case basis. Intermittent release can be defined as “intermittent but only recurring infrequently i.e. less than once per month and for no more than 24 hours”. This would correspond to a typical batch process only required for a short period of the year (releases to the environment may be only of limited duration). Thus, for the aquatic compartment, transport processes may ensure that the exposure of aquatic organisms is of short duration. Calculation of the likely exposure period should take into account the potential of a substance to substantially partition to the sediment. Such partitioning, while reducing the 35
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
Page 21 and 22: 2 ENVIRONMENTAL EXPOSURE ASSESSMENT
Page 23 and 24: ENVIRONMENTAL EXPOSURE ASSESSMENT r
Page 25 and 26: 2.2 MEASURED DATA ENVIRONMENTAL EXP
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Page 31 and 32: ENVIRONMENTAL EXPOSURE ASSESSMENT T
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Page 35 and 36: Production ENVIRONMENTAL EXPOSURE A
Page 37 and 38: Back to processing Product at end o
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Page 61 and 62: constant of zero. However, if it ca
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Page 69 and 70: Primary Settler Aeration Tank 2 5 3
Page 71 and 72: Explanation of symbols ENVIRONMENTA
Page 73 and 74: ENVIRONMENTAL EXPOSURE ASSESSMENT I
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Page 83 and 84: 2.3.8.3 Calculation of PEClocal for
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Page 87 and 88: Guidance for calculating PEClocal i
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Page 91 and 92: 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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