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LEGAL NOTICE Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa Server (http://europa.eu.int). © European Communities, 2003 Reproduction is authorised provided the source is acknowledged. Printed in Italy
FOREWORD I am pleased to present this Technical Guidance Document which is the result of in-depth cooperative work carried out by experts of the Member States, the Commission Services, Industry and public interest groups. This Technical Guidance Document (TGD) supports legislation on assessment of risks of chemical substances to human health and the environment. It is based on the Technical Guidance Document in support of the Commission Directive 93/67/EEC on risk assessment for new notified substances and the Commission Regulation (EC) No. 1488/94 on risk assessment for existing substances, published in 1996. This guidance was refined taking into account the experience gained when using it for risk assessments of about 100 existing substances and hundreds of new substances. Furthermore, it has been extended to address some of the needs of the Biocidal Products Directive (Directive 98/8/EC of the European Parliament and of the Council). Concerning Chapter 2 on Risk assessment for human health, the Exposure assessment (Assessment of workplace exposure and Consumer exposure assessment) as well as the Effects assessment were improved and refined. However, for the following sections the revision process is not yet finalised and thus, the current TGD version uses the previous text: section 2.4 on Assessment of indirect exposure via the environment and section 4 on Risk characterisation. These sections are expected to be available by the end of 2003. With respect to Chapter 3 on Environmental risk assessment, the Environmental exposure assessment and the Effects assessment underwent major improvements. A new chapter on Marine risk assessment was added. Concerning Chapter 7, five out of eight available Emission scenario documents (ESDs) were revised (IC-3 Chemical industry: Chemicals used in synthesis, IC-7 Leather processing industry; IC-8 Metal extraction industry, refining and processing industry; IC-10 Photographic industry; IC-13 Textiles processing industry). Furthermore, a document on Rubber industry (IC-15) and a number of ESDs for the Biocidal Product Types or parts thereof were added. Some of the Emission scenario documents are still subject to on-going consultation in the OECD and thus, may need to be revised at a later stage. In addition, ESDs to cover all 23 Biocidal Product Types are under development. Consequently, it is anticipated that the set of Emission scenario documents will be continuously expanding in the future. The White Paper outlining a future chemicals policy was adopted in February 2001 by the Commission. This TGD is therefore to be used in support of the current legislative instruments as described above until they are revoked and replaced by the future legislation implementing the White Paper. I hope you will agree that this TGD makes a valuable contribution to the development and harmonisation of risk assessment methodologies not only within the Community but also worldwide in the context of the activities of the Organisation of Economic Co-operation and Development and the WHO/ILO International Programme on Chemical Safety. Ispra, April 2003 Kees van Leeuwen Director Institute for Health and Consumer Protection III
Page 1: Institute for Health and Consumer P
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 and 40: ENVIRONMENTAL EXPOSURE ASSESSMENT T
Page 41 and 42: ENVIRONMENTAL EXPOSURE ASSESSMENT s
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
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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 T
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ENVIRONMENTAL EXPOSURE ASSESSMENT a
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Primary Settler Aeration Tank 2 5 3
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Explanation of symbols ENVIRONMENTA
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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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Page 278 and 279:
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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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