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ENVIRONMENTAL EXPOSURE ASSESSMENT function has only one mode), and the required 90 th percentile values, mean or median values of this distribution could be used in the PEC prediction. The mean of the 90 th percentiles of the individual sites within one region is recommended for regional PEC determination. Care should be taken that data from several sites obtained with different sampling frequencies should not be combined, without appropriate consideration of the number of data available from each site. If individual measurements are not available then results expressed as means and giving standard deviation will be of particular relevance because in most instances a log normal distribution of concentrations can be assumed and a 90 th percentile concentration may be calculated. If only maximum concentrations are reported, they should be considered as a worst-case assumption, providing they do not correspond to an accident or spillage. However, use of only the mean concentrations can result in an underestimation of the existing risk, because temporal and/or spatial average concentrations do not reflect periods and/or locations of high exposure. For intermittent release scenarios, even the 90-percentile values may not properly address emission episodes of short duration but of high concentration discharge. In these cases, mainly for PEClocal calculations, a more realistic picture of the emission pattern can be obtained from the highest value of average concentrations during emission episodes. Representative measured data from monitoring programmes or from literature, for comparison with calculated PECs should be compiled as tables and annexed to the risk assessment report. The measured data should be presented in the following manner: Location Substance Concentration Period Remark Reference Country 20 − location substance or metabolite Units: [µg/L], [ng/L] [mg/kg], etc Data - mean - average - range - percentile - daily - weekly - monthly - annual - etc month, year limit of quantitation (LOQ) relevant information on analytical method analytical quality control Literature reference When emissions of a substance from waste treatment or disposal stages are significant, measured data may be important along with model calculations in the assessment of the release of the substance from the waste life stage. Besides measured data on concentrations in leachate and landfill gases it is important that flows of water and, when appropriate, gases and solids, from principal treatment or disposal processes and facilities are measured (see Sections 2.3.3.6 and 2.3.7.2) to obtain flow-weighted concentrations. As a surrogate and complement, average time trend data on real runoff or landfill gas production data can be used, also to extend flux measures to long-term estimates. Emission data of higher quality may become available when the European Pollutant Emissions Register is fully implemented. However, for release scenarios from waste disposal operations including landfills, the measured concentration may underestimate the environmental concentration that might occur once a substance has passed through all the life-cycle stages including the possible delays (see Section 2.3.3.6). In selecting representative data for waste related releases, consideration should be given to the question whether or not production/import of the substance is in steady state with the
ENVIRONMENTAL EXPOSURE ASSESSMENT occurrence of substance in the waste streams and/or releases from waste treatment and/or releases from landfills. In a similar manner, if the amount of a substance in use in the society in long-life articles has not reached steady state and the accumulation is ongoing, only a calculated PEC will represent the future situation. This should be considered when comparing such a PEC with measured data representing a non-steady-state. For the evaluation of measured concentration in biota additional information on season, sex and dimension could be useful. 2.2.2 Allocation of the measured data to a local or a regional scale The measured data should be allocated to a local or regional scale in order to define the nature of the environmental concentration that is derived. This allows a comparison with the corresponding calculated PEC to be made to determine which PEC should be used in the risk characterisation (Section 2.5). Evaluation of the geographical relation between emission sources and sampling site If there is no spatial proximity between the sampling site and point sources of emission (e.g. from rural regions), the data represent a regional concentration (PECregional) that has to be added to the calculated PEClocal. If the measured concentrations reflect the releases into the environment through point sources, they are of a PEClocal-type. In a PEClocal based on measured concentrations, the regional concentration (i.e. PECregional) is already included. Measured concentrations in biota Samples of living organisms may be used for environmental monitoring. They can provide a number of advantages compared to conventional water and sediment sampling especially with respect to sampling at large distances from an emission source or on a regional scale. Furthermore they can provide a PECbiota and consequently an estimation of the body burden to be considered in the food chain. 2.3 MODEL CALCULATIONS 2.3.1 Introduction The first step in the calculation of the PEC is evaluation of the primary data. The subsequent step is to estimate the substance's release rate based upon its use pattern. All potential emission sources need to be analysed, and the releases and the receiving environmental compartment(s) identified. After assessing releases, the fate of the substance once released to the environment needs to be considered. This is estimated by considering likely routes of exposure and biotic and abiotic transformation processes. Furthermore, secondary data (e.g. partition coefficients) are derived from primary data. The quantification of distribution and degradation of the substance (as a function of time and space) leads to an estimate of PEClocal and PECregional. The PEC calculation is not restricted to the primary compartments; surface water (Section 2.3.8.3), soil (Section 2.3.8.5) and air (Section 2.3.8.2); but also includes secondary compartments such as 21
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
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Page 25 and 26: 2.2 MEASURED DATA ENVIRONMENTAL EXP
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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 41 and 42: ENVIRONMENTAL EXPOSURE ASSESSMENT s
Page 43 and 44: Explanation of symbols ENVIRONMENTA
Page 45 and 46: ENVIRONMENTAL EXPOSURE ASSESSMENT s
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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
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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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