The ECETOC approach to targeted risk assessment; lessons and experiences relevant to REACH.

ECETOC has been developed an approach by which the health and environmental risks arising from the supply and use of chemicals can be quickly and reliably evaluated by chemical suppliers. The approach has been available as a web-based tool since 2004. During the development and implementation of the approach, ECETOC has consulted widely so that the approach is seen to meet the required levels of science while also meeting the differing needs of affected stakeholders. The consultation process has yielded a number of findings in terms of the considerations necessary for implementing successful risk-informed decision-making in a multi-stakeholder environment. Concurrently, as the European Commission's REACH legislative package has begun to take shape, it has also become apparent that the approach has a number of potential applications for aiding the process of risk assessment under REACH. This paper reviews these experiences within the broader context of the expectations that REACH places on chemical manufacturers and suppliers. In particular, it highlights the key role that REACH Exposure Scenarios have for evaluating, managing and communicating chemical risks.

Dichloromethane marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on dichloromethane was carried out specifically for the marine environment, following methodology given in the EU risk assessment Regulation (1488/94) and Guidance Document of the EU New and Existing Substances Regulation (TGD, 1997). The study consists of collection and evaluation of data on effects and environmental concentrations from analytical monitoring programs in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of 'predicted environmental concentrations' (PEC) to 'predicted no-effect concentrations' (PNEC) for the marine aquatic environment. In total, 23 studies for fish, 17 studies for invertebrates and 6 studies for algae were evaluated. Both acute and chronic toxicity studies were taken into account and appropriate assessment factors used to define a PNEC value of 830 microg/l. Most of the available monitoring data apply to rivers and estuaries and were used to calculate PECs. The most recent data (1983--1995) support a typical PEC for dichloromethane lower than 0.2 microg/l and a worst case PEC of 13.6 microg/l. Dichloromethane is not a 'toxic, persistent and liable to bioaccumulate' substance sensu the Oslo and Paris Conventions for the Prevention of Marine Pollution (OSPAR-DYNAMEC). The calculated PEC/PNEC ratios give margins of 60 to 4000 between the PNEC and PEC, dilution within the sea would further increase these margins. It can be concluded that the present use of dichloromethane does not present a risk to the marine aquatic environment.

Carbon tetrachloride marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on carbon tetrachloride was carried out specifically for the marine environment, according to the methodology laid down in the European Union (EU) risk assessment Regulation (1488/94) and the Technical Guidance Documents for New and Existing Substances (TGD, 1996). The Montreal Protocol on ozone depleting substances scheduled a phase-out of carbon tetrachloride except for some essential and feedstock uses. This study consisted of the collection and evaluation of data on effects and environmental concentrations from analytical monitoring programs in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of the Predicted Exposure Concentration (PEC) and the Predicted No-Effect Concentration (PNEC) for the marine aquatic environment. In total 16 studies for fish, 7 studies for invertebrates and 5 for algae have been evaluated. The appropriate assessment factor has been used to calculate a PNEC of 7 microg/l based on long-term exposure for three trophic levels. For coastal waters and estuaries a typical and worst case PEC of 0.003 and 0.31 microg/l are derived. For river waters a typical and worst case PEC of 0.02 and 0.12 microg/l are derived, respectively. These ratios, which do not take into account any dilution within the sea, correspond to safety margins from 25 to 2500 between the aquatic effect and the exposure concentration. Carbon tetrachloride does not meet the criteria of 'toxic, persistent and liable to bioaccumulate' substances as mentioned by the Oslo and Paris Conventions for the Prevention of Marine Pollution (OSPAR-DYNAMEC). It can be concluded that the present use of carbon tetrachloride does not present a risk to the marine aquatic environment.

1,1,1-trichloroethane marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on 1,1,1-trichloroethane was carried out specifically for the marine environment, accordingly to the methodology laid down in the EU risk assessment Regulation (1488/94) and the Guidance Document of the EU New and Existing Substances Regulation (TGD, 1996). 1,1,1-trichloroethane is being phased out of most uses because of its ozone depletion potential (ODP) under the Montreal Protocol. Production for emissive uses has already been phased out end 1995 in Europe and 1996 in the United States, Japan and other industrial countries. The risk assessment study consists of the collection and evaluation of data on effects and environmental concentrations from analytical monitoring programmes in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of the Predicted Environmental Concentration (PEC) and the Predicted No-Effect Concentration (PNEC) for the marine aquatic environment. In total 14 studies for fish, 7 studies for invertebrates and 9 studies for algae have been evaluated. Both acute and chronic studies have been taken into account and the appropriate assessment factors have been used to calculate a PNEC value of 21 microg/l based on long term exposure. The PEC was derived from monitoring data. The PEC was set at 0.206 microg/l (worst case) and 0.024 microg/l (typical case) for coastal waters and estuaries and 0.6 microg/l (worst case) and <0.1 microg/l (typical case) for river waters. The calculated PEC/PNEC ratios, which do not take into account any dilution factor within the sea, correspond to a safety margin of 35 to 1000 between the aquatic effect and the exposure concentration. 1,1,1-trichloroethane is not a 'toxic, persistent and liable to bioaccumulate' substance according to the criteria as mentioned by the Oslo and Paris Conventions for the Prevention of Marine Pollution (OSPAR-DYNAMEC). It can be concluded that the present use of 1,1,1-trichloroethane does not present a risk to the marine aquatic environment.

Vinyl chloride marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on vinyl chloride was carried out specifically for the marine environment, according to the methodology laid down in the European Union (EU) risk assessment Regulation (1488/94) and the Technical Guidance Documents for New and Existing Substances (TGD, 1996). Vinyl chloride is used for the production of polyvinyl chloride (PVC). The study consisted of the collection and evaluation of data on effects and environmental concentrations from analytical monitoring programmes in large rivers and estuaries in the North Sea area. The risk is indicated by the ratio of the Predicted Exposure Concentration (PEC) and the Predicted No-Effect Concentration (PNEC) for the marine aquatic environment. In total 6 studies for fish, 3 studies for invertebrates and one for algae have been evaluated. The appropriate assessment factors have been used to calculate a PNEC of 210 microg/l based on short-term exposure. For coastal waters and estuaries a worst case PEC of 0.15 microg/l is derived. For river waters a typical and worst case PEC of <0.008 and 0.4 microg/l is derived, respectively. These concentrations, which do not take into account any dilution within the sea, correspond to safety margins from 500 to 250,000 between the aquatic effect and the exposure concentration. Vinyl chloride is not a 'toxic, persistent and liable to bioaccumulate' substance sensu the Oslo and Paris Conventions for the Prevention of Marine Pollution (OSPAR-DYNAMEC). It can be concluded that the present use of vinyl chloride does not present a risk to the marine aquatic environment.

Monochlorobenzene marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on monochlorobenzene was carried out for the marine environment, following methodology given in the EU risk assessment Regulation (1488/94) and Guidance Document of the EU New and Existing Substances Regulation (TGD, 1996). Data from analytical monitoring programmes in large rivers and estuaries in the North Sea area were collected and evaluated for effects and environmental concentrations. Risk is indicated by the ratio of predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) for the marine aquatic environment. In total, 27 data for fish, 24 data for invertebrates and 13 data for algae were evaluated. Acute and chronic toxicity studies were taken into account and appropriate assessment factors used to define a final PNEC value of 32 micro/l. Recent monitoring data indicate that monochlorobenzene levels in surface waters are below determination limits of 0.1, 0.2, 0.5 microg/l used in monitoring programs. Assuming that half of the lowest determination (0.1 microg/l) is typical, a PEC of 0.05 microg/l was derived. A worst case of 0.5 microg/l is assumed. PEC/PNEC ratios give safety factors of 60 to over 500, taking no account of dilution in the sea. Monochlorobenzene is not a 'toxic, persistent and liable to bioaccumulate' substance sensu the Oslo and Paris Conventions for the Prevention of Marine Pollution (OSPAR-DYNAMEC) criteria. Environmental fate and effects data indicate that current use of monochlorobenzene poses no unacceptable risk to the aquatic environment.

1,2-dichlorobenzene marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on 1,2-dichlorobenzene was carried out for the marine environment, following methodology given in the EU risk assessment Regulation (1488/94) and Guidance Document of the EU New and Existing Substances Regulation (TGD, 1996). Data from analytical monitoring programmes in large rivers and estuaries in the North Sea area were collected and evaluated on effects and environmental concentrations. Risk is indicated by the ratio of predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) for the marine aquatic environment. In total, 26 data for fish, 24 data for invertebrates and 17 data for algae were evaluated. Acute and chronic toxicity studies were taken into account and appropriate assessment factors used to define a final PNEC value of 37 microg/l. All available monitoring data indicate that 1,2-dichlorobenzene levels in estuaries are below 0.1 microg/l. Worst case concentrations in rivers are below 0.45 microg/l. With this value, calculated PEC/PNEC ratios give safety margins of 100 to 300, taking no account of dilution in the sea. 1,2-dichlorobenzene is not a 'toxic, persistent and liable to bioaccumulate' substance sensu the Oslo and Paris Convention for the Prevention of Marine Pollution (OSPAR-DYNAMEC) criteria. Environmental fate and effects data indicate that current use of 1,2-dichlorobenzene poses no risk to the aquatic environment.

1,4-dichlorobenzene marine risk assessment with special reference to the OSPARCOM region: North Sea.

This risk assessment on 1,4-dichlorobenzene was carried out for the marine environment, following methodology given in the EU risk assessment Regulation (1488/94) and Guidance Document of the EU New and Existing Substances Regulation (TGD, 1996). Data from analytical monitoring programs in large rivers and estuaries in the North Sea area were collected and evaluated on effects and environmental concentrations. Risk is indicated by the ratio of predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) for the marine aquatic environment. In total, 17 data for fish, 9 data for invertebrates and 7 data for algae were evaluated. Acute and chronic toxicity studies were taken into account and appropriate assessment factors used to define a final PNEC value of 20 microg/l. Recent monitoring data indicate that 1,4-dichlorobenzene levels in coastal waters and estuaries are below the determination limit of 0.1 microg/l used in monitoring programs. The worst case value recorded in river water is below 0.45 microg/l. Using these values, calculated PEC/PNEC ratios give safety margins of about 40-200, taking no account of dilution in the sea. Environmental fate and bioaccumulation data indicate that current use of 1,4-dichlorobenzene poses no risk to the aquatic environment.