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ENVIRONMENTAL EXPOSURE ASSESSMENT considered. The same applies to anaerobic conditions in landfills and treatment of sewage sludge. Salinity and pH are examples of other environmental conditions that may influence the degradation. In the risk assessment a proper functioning of waste treatment is assumed. However, if thermal treatment of waste is operated at insufficient technical conditions, organic substances may be formed having a PBT 1 or POP profile. This may be the case in particular in the presence of halogens (Cl and Br) and catalysing metals (e.g. copper). If the formation of PBT or POP substances is identified as a special concern, this should be noted in the risk assessment. In that case it could be considered to add an appendix to the risk assessment report with further information on the possible formation of substances with a PBT or POP profile. 2.1.1 Measured / calculated environmental concentrations No measured environmental concentrations will normally be available for new substances. Therefore, concentrations of a substance in the environment must be estimated. In contrast, the exposure assessment of existing substances does not always depend upon modelling. Data on measured levels in various environmental compartments have been gathered for a number of existing substances. They can provide the potential for greater insight into specific steps of the exposure assessment procedure (e.g. concentration in industrial emissions, “background” concentrations in specific compartments, characterisation of distribution behaviour). The specific guidance for existing and new chemicals given below should also be applied in general for biocides. In many cases, a range of concentrations from measured data or modelling will be obtained. This range can reflect different conditions during manufacturing and use of the substance, or may be due to assumptions in or limitations of the modelling or measurement procedures. It may seem that measurements always give more reliable results than model estimations. However, measured concentrations can have a considerable uncertainty associated with them, due to temporal and spatial variations. Both approaches complement each other in the complex interpretation and integration of the data. Therefore, the availability of adequate measured data does not imply that PEC calculations are unnecessary. For existing substances, the rapporteur should initially make the generic “reasonable worst-case” exposure assessment based on modelling, to derive an EU environmental concentration. Measured data, i.e., site-specific or monitoring information, can then be used to revise the calculated concentrations. Other site-specific information such as effluent volumes, size of STP, river flow etc. may also be useful. In carrying out this revision, the rapporteur is recommended to include in the exposure assessment of existing substances, a table containing availability of site-specific information for each production site (if limited in number) or group of production sites (if numerous), as far as confidentiality issues allow. The “site-specific” concentrations estimated may involve the use of actual site-specific information and more generic values (and possibly extrapolated values as described below). The rapporteur should then consider in which cases extrapolation is possible from sites with site-specific information to a site without information. Aspects to consider here include the proportion of the industry covered by specific information, the nature of the industry and information about its distribution, the comparative size of sites, the types of process used etc. The rapporteur should justify in the risk assessment 1 Substances being persistent, bioaccumulative and toxic (PBT) or substances classified as a persistent organic pollutant under the UN Stockholm Convention on Persistent Organic Pollutants. 14
ENVIRONMENTAL EXPOSURE ASSESSMENT report the grounds on which the extrapolation has been done. It may be possible to extrapolate some aspects but not others, for example emission factors (on the basis of similar processes) but not effluent flows (on the basis of differing sizes of site). If no such extrapolation can be justified, then the modelling approach described in the TGD should be followed for the (group of) site(s). For new substances, a generic assessment would normally be conducted. However, there may be circumstances where environmental exposure for some life-cycle stages is limited to specific sites (e.g. production of chemicals, processing of intermediates etc). It may, therefore, be adequate to carry out a site-specific risk assessment only, if the Competent Authority (CA) is satisfied that such specific information will enable a full evaluation of the risks. In such cases, it is the responsibility of the notifier to provide site-specific data and to show that the available information is valid for the sites being assessed. The risk assessment should make clear that a site-specific assessment has been conducted. In these cases, the notifier is obliged to confirm in writing that they will inform the CA of any relevant changes, which may affect the risk assessment conducted. The CA should confirm details of the assessment not later than two years after completion of the risk assessment, and at any subsequent tonnage trigger, or as deemed necessary. The CA should distribute relevant information appropriately. It should be noted that the site-specific risk assessment is not based on a detailed and complete description of the environmental conditions. The aim is to estimate environmental concentrations that are reasonably applicable for a European-level risk assessment. Some site-specific data may be used to replace the default data characterising the standard scenario. For measured data, the reliability of the available data has to be assessed as a first step. Subsequently, it must be established how representative the data are of the general emission situation. Section 2.2 provides guidance on how to perform this critical evaluation of measured data. For model calculations, the procedure to derive an exposure level should be made transparent. The parameters and default values used for the calculations must be documented. If different models are available to describe an exposure situation, the best model for the specific substance and scenario should be used and the choice should be explained. If a model is chosen which is not described in this document, that model should be explained and the choice justified. Section 2.3 discusses modelling in detail. Section 2.5 gives further advice on critical comparison between calculated and measured PECs. 2.1.2 Relationship between PEClocal and PECregional For the release estimation of substances, a distinction is usually made between substances that are emitted through point sources at specific locations and substances that enter the environment through diffuse releases. Point source releases have a major impact on the environmental concentration on a local scale (PEClocal) and also contribute to the environmental concentrations on a larger scale (PECregional). When determining a PEC for new substances at base-set level, or at the 10 tonnes per annum production level, Annex III, paragraph 3.4 of Directive 93/67 foresees that such estimates will usually focus on the generic local environment to which releases may occur. In the case of persistent and/or highly toxic chemicals, however, a regional assessment may still be relevant at low tonnages. Therefore, derivation of a PECregional is required, unless it can be justified that a regional assessment is not relevant for the substance at these low tonnages. 15
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: 2 ENVIRONMENTAL EXPOSURE ASSESSMENT
Page 25 and 26: 2.2 MEASURED DATA ENVIRONMENTAL EXP
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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
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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
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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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