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APPENDIX XII +40% compared to 1992. Increases to date in individual member states include +27% for Germany, +51% for France, +82% UK, +91% for Spain and +95% for Portugal. It has been concluded that by the implementation deadline, the capacity of the treatment plants would be sufficient to treat the total projected combined organic load for agglomerations >2000 pe in all the 14 EU MS (EC, 1999). Indeed, projected final treatment capacity (469 million p.e.) is approximately 11% greater than the total organic load (424 million p.e.). However, distribution of treatment capacity will not necessarily be homogenous. For example, projected treatment capacity post-implementation exceeds 1992 baseline organic loads by +28% in the Netherlands, +35% in Germany and +74% in Sweden. Treatment capacity in Italy is forecast to increase by 73% from a baseline of 59 million p.e. to 102 million p.e. in 2005 (EEWG, 1997). 324
APPENDIX XIII Appendix XIII Risk assessment of sources not covered by the life-cycle of the substance Introduction Exposure may occur from other sources than the life-cycle of the produced or imported substance under assessment. Such sources have been referred to as “unintentional sources”. Examples are substances of natural origin, substances formed in combustion processes and indirect emissions of the substance, e.g. as by-product, contaminant or degradation product of another substance. In these cases information is necessary on emissions which are not covered by the life-cycle of the substance being assessed. Knowledge of the extent of the sources not covered by the life-cycle of the substance under review is necessary for a full evaluation of the risks posed by the priority existing substance or biocidal product. The information is needed for example for a correct interpretation of measured environmental concentrations. The information is also required for an evaluation of the relative contribution of the emissions of the substance under review to the overall risks posed by the substance through all possible sources. Such information might be relevant in the eventual development of a risk reduction strategy. In this appendix some recommendations are given on how to deal with these kind of sources, based on the practical experience gained with the implementation of the ESR. There is still a need for an EU decision on how to handle these cases at the time of revision of the TGD. Legal background The Existing Substances Regulation (EEC) 793/93 (ESR) requires that all information needed to carry out the risk assessment of a priority substances is submitted to the rapporteur by the Producers and Importers of the substance. The risk assessment however is one of a selected priority substance, the sources of which can be from the produced and imported substance, but also from other sources. Commission Regulation (EC) 1488/94 for example foresees that the risk assessment of a priority substance entails an exposure assessment which, in particular is to consider the exposures resulting from the life-cycle of the produced and imported priority substance, but need not do so exclusively. The Biocidal Products Directive (98/8/EC) (BPD) states that cumulation of effects from the biocidal products containing the same active substances shall be taken into account, where relevant, in the assessment of a biocidal active substance. Recommendation for sources not covered by the life-cycle of the substance The rapporteur should clearly list other sources, which can give rise to exposure by the substance being assessed. The risk assessment should include as much readily available information on these sources as possible. Whether or not this information can be taken into account in the risk characterisation is dependent on the quantity and quality of the available information. If there is not sufficient confidence in the available database to make a conclusion of concern/no concern, the risk assessment should be finalised with the conclusion “further information is needed” (Conclusion (i)). If the emissions originate from the life-cycle of another substance that can be prioritised under the ESR (i.e. a substance listed in EINECS), it is not required to take these sources into account in the risk characterisation, as they can be covered by prioritising the other substance. If the 325
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Institute for Health and Consumer P
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LEGAL NOTICE Neither the European C
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OVERVIEW This Technical Guidance Do
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CONTENTS 1 GENERAL INTRODUCTION ...
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4.2.3.4 Use of biodegradation scree
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1 GENERAL INTRODUCTION 1.1 BACKGROU
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GENERAL INTRODUCTION countries in t
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GENERAL INTRODUCTION PNEC is regard
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2 ENVIRONMENTAL EXPOSURE ASSESSMENT
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ENVIRONMENTAL EXPOSURE ASSESSMENT r
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2.2 MEASURED DATA ENVIRONMENTAL EXP
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ENVIRONMENTAL EXPOSURE ASSESSMENT w
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ENVIRONMENTAL EXPOSURE ASSESSMENT o
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ENVIRONMENTAL EXPOSURE ASSESSMENT T
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ENVIRONMENTAL EXPOSURE ASSESSMENT r
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Production ENVIRONMENTAL EXPOSURE A
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Back to processing Product at end o
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ENVIRONMENTAL EXPOSURE ASSESSMENT s
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Explanation of symbols ENVIRONMENTA
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ENVIRONMENTAL EXPOSURE ASSESSMENT s
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ENVIRONMENTAL EXPOSURE ASSESSMENT U
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ENVIRONMENTAL EXPOSURE ASSESSMENT a
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ENVIRONMENTAL EXPOSURE ASSESSMENT F
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2.3.5.1 Adsorption to aerosol parti
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ENVIRONMENTAL EXPOSURE ASSESSMENT I
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2.3.6.1 Hydrolysis ENVIRONMENTAL EX
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2.3.6.3 Photochemical reactions in
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constant of zero. However, if it ca
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ENVIRONMENTAL EXPOSURE ASSESSMENT A
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ENVIRONMENTAL EXPOSURE ASSESSMENT a
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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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Calculation of PEClocalsoil For soi
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ENVIRONMENTAL EXPOSURE ASSESSMENT
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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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