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ENVIRONMENTAL EXPOSURE ASSESSMENT the substance present in products imported/exported. The total volume released is averaged over the year and used for the PECregional calculation. The B-tables of Appendix I are used for the determination of the releases from point sources for the evaluation of PEClocal. They provide the fraction of the total volume released that can be assumed to be released through a single point source, and the number of days during which the substance is released, thus allowing the daily release rate at a main point source to be calculated. Despite the need for applying expert judgement when determining the fraction of main source, the following general guidelines for the emission estimation should be applied: • for production the input for the regional production volume is by default set at the EU production volume, which is also used as input for the B-tables. Based on the information available to the rapporteur on the number of production sites, size distribution and geographic distribution it can be decided to apply a 10% rule, where it is assumed that 10% of the amount that is produced and used in the EU is produced/used within a region and it is subsequently assumed that the size of the main local source can be obtained by multiplying this amount with the fraction of main source from the B-tables. Alternatively it can be decided to use another percentage or to use specific values as input for the regional model (e.g. the emissions from the largest source or the emissions from the largest emitter) where this reflects a more realistic worst case. Similarly this information can be used to set the fraction of main source for the local exposure calculation. It should be noted that if site-specific data are available then it can be the case that the largest site is not the largest source of emissions; • for formulation and processing (industrial use) a similar approach as for production is used: by default the EU volume is used as input for the region as well as for the B-tables unless it can be shown/is known that a large number of sites with a reasonable European distribution exists for the specific formulation/processing step of the substance involved. In that case again it can be decided to apply the 10% rule, to use another percentage or to use specific values. Whether or not the available information is sufficient for a specific substance will depend on the expert judgement by the rapporteur; • for private use the 10% rule is applied by default both for the input of the regional volume and for the input volume for the B-table in agreement with the assumption of 10% of the use occurring in the region. It must be realised that depending on the IC/UC combination this approach may in some cases lead to unreasonable worst-case assumptions, especially for the estimation of the emissions during formulation/processing. Hence, a case-by-case assessment using expert judgement remains warranted. For new substances the default should be overwritten anyway because it may be assumed that in most cases just one or at the most a few producers exist. To obtain the best entry to the tables for emission factors, Appendix I also contains a list of synonyms for functions of substances. The synonyms and their definitions have been derived from the US EPA ChemUSES list (US EPA, 1980). In general, the data supplied by industry will help to find the correct entry to the release tables apart from the classification specified in Chapter 5. The production volume is expressed in tonnes/year in the data set and denoted by PRODVOL. TONNAGE is the volume of substance that is used for subsequent life-cycle stages. In the emission tables of Appendix IB, PRODVOL must be used for T when estimating releases at production whereas TONNAGE should be used as T for the subsequent life-cycle stages. If at the disposal 32
ENVIRONMENTAL EXPOSURE ASSESSMENT stage the substance is recovered this amount should be added to the tonnage of the relevant lifecycle stages. Note that IMPORT and EXPORT refer to the EU, not Member States within the EU. Explanation of symbols TONNAGE = PRODVOL + IMPORT - EXPORT (4) PRODVOL production volume of substance [tonnes . yr -1 ] data set IMPORT volume of substance imported [tonnes . yr -1 ] data set EXPORT volume of substance exported [tonnes . yr -1 ] data set TONNAGE tonnage [tonnes . yr -1 ] The release (in tonnes.yr -1 ) per stage of the life-cycle and to every environmental compartment is calculated with the equations given in Appendix IA and denoted by RELEASEi,j (where i is the stage in the life-cycle and j is the compartment): i stage of the life-cycle j compartment 1 production a air 2 formulation w water 3 industrial/professional use s industrial soil (regional only) 4 private use 5 service life 6 waste disposal (including waste treatment and recovery) The following table presents the variables used as input for the emission tables in Appendix I, and the releases which are the output from emission tables and the calculation routine of Appendix I. Input MAINCAT main category (for existing substances) [-] data set INDCAT industrial category [-] data set USECAT use category [-] data set TONNAGE tonnage (production volume + import - export) [tonnes . yr -1 ] eq. (4) PRODVOL production volume of substance [tonnes . yr -1 ] data set SOL water solubility [mg . l -1 ] data set VP vapour pressure [Pa] data set BOILPT boiling point (for some estimations) [°C] data set Specific information on the use pattern of the substance Output RELEASEi,j release to compartment j during life-cycle stage i [-] App. IA Fmainsourcei fraction of release at the local main source at life-cycle stage i [-] App. IB Temissioni total number of days for the emission at life-cycle stage i [d] App. IB For each stage other than production, the losses in the previous stage are taken into account (see calculation in Appendix I). Releases during production are not taken into account in the other stages, as generally, these releases will not have been considered in the reported production volume. In certain cases this might lead to total releases exceeding 100%. The rapporteur must 33
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
Page 27 and 28: ENVIRONMENTAL EXPOSURE ASSESSMENT w
Page 29 and 30: ENVIRONMENTAL EXPOSURE ASSESSMENT o
Page 31 and 32: ENVIRONMENTAL EXPOSURE ASSESSMENT T
Page 33 and 34: ENVIRONMENTAL EXPOSURE ASSESSMENT r
Page 35 and 36: Production ENVIRONMENTAL EXPOSURE A
Page 37 and 38: Back to processing Product at end o
Page 39: ENVIRONMENTAL EXPOSURE ASSESSMENT T
Page 43 and 44: Explanation of symbols ENVIRONMENTA
Page 45 and 46: ENVIRONMENTAL EXPOSURE ASSESSMENT s
Page 47 and 48: ENVIRONMENTAL EXPOSURE ASSESSMENT U
Page 49 and 50: ENVIRONMENTAL EXPOSURE ASSESSMENT a
Page 51 and 52: ENVIRONMENTAL EXPOSURE ASSESSMENT F
Page 53 and 54: 2.3.5.1 Adsorption to aerosol parti
Page 55 and 56: ENVIRONMENTAL EXPOSURE ASSESSMENT I
Page 57 and 58: 2.3.6.1 Hydrolysis ENVIRONMENTAL EX
Page 59 and 60: 2.3.6.3 Photochemical reactions in
Page 61 and 62: constant of zero. However, if it ca
Page 63 and 64: ENVIRONMENTAL EXPOSURE ASSESSMENT A
Page 65 and 66: ENVIRONMENTAL EXPOSURE ASSESSMENT T
Page 67 and 68: ENVIRONMENTAL EXPOSURE ASSESSMENT a
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
Page 75 and 76: ENVIRONMENTAL EXPOSURE ASSESSMENT d
Page 77 and 78: ENVIRONMENTAL EXPOSURE ASSESSMENT e
Page 79 and 80: Table 10 Overview of different expo
Page 81 and 82: ENVIRONMENTAL EXPOSURE ASSESSMENT -
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
Page 89 and 90: 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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