Nickel Risk Assessment Introduction to EU Risk Assessments + Status of the Nickel Risk Assessment part Environment Wouter Ghyoot, ENIA Nickel Risk Assessment part Human Health Tony Hart, consultant to the Nickel Institute Business Implications Paola DiDiscordia, ENIA

ENIA Formed in April 2005 by merger of Nickel Institute Europe European Nickel Group ENIA = European branch of the Nickel Institute Offices in Brussels and Alvechurch (UK) www.enia.org

Aim A practical view on complex regulatory science Background and results of EU Nickel Risk Assessment Consequences of the outcomes within the EU regulatory system

Introduction to EU Risk Assessments Status of Environmental Risk Assessment Wouter Ghyoot European Nickel Industry Association Information Day for the Surface Finishing Industry Birmingham, 16th March 2006

Content EU Risk Assessment Nickel Risk Assessment - Environment Exposure Assessment Effects Assessment Bioavailability EU regulatory impact Water Framework Directive 5

EU Risk Assessment

EU framework EU regulation 793/93/EEC Protect Priority-list Rapporteur Requires from MS the evaluation and control of risks from the production and use of existing substances Protect General population, consumers, workers Environmental compartments: air, water, soil, sediments Priority-list Existing substances enter full Risk Assessment when determined as EC priority-list substances. Rapporteur A Member State volunteers as rapporteur

EU framework Legal instruments Manufacturers and importers are required to supply data Technical Guidance Document (European Commission) Sets out the methods for carrying out Risk Assessment TC NES (Technical Committee on New and Existing Substances) Discusses and validates the sections of the RA Report as regards scientific aspects EU Commission – JRC – ECB manage TC NES SCHER (Scientific Committee) Peer review of Rapporteur’s final draft report EC Committee Discusses and promulgates needed risk reduction measures http://www.nickelinstitute.org/index.cfm/ci_id/12913/la_id/1.htm

Risk Assessment Exposure Assessment Effects Assessment Risk Characterization

Exposure Assessment Human Health: workers, consumers and via the environment Environment: water, air, soil, sediments For different scenarios (Ni production and Ni use)

Effects Assessment Hazard identification Dose-response (effect) assessment For different endpoints: Human Health: acute and chronic toxicity, respiratory sensitization, dermal sensitization, carcinogenicity, mutagenicity, reproductive toxicity, … Environment: acute and chronic toxicity

Risk Characterization Evaluation of effects data Comparison with exposure data Possible conclusions: (i) Further testing/information needed (ii) Risks are adequately controlled (iii) Additional risk reduction measures required

Metals undergoing Risk Assessment Priority list metals Zn Cd Ni Sb2O3 Voluntary Risk Assessment: Cu Pb 13

Nickel Risk Assessment

Nickel RA Five listed nickel priority substances Metallic nickel Nickel sulphate Nickel chloride Nickel nitrate Nickel carbonate D-EPA is Rapporteur for the Nickel RA and carries final responsibility Industry contribution: Filling the data gaps, research programmes Bilateral discussions with DEPA

Environment

Environmental Risk Assessment Exposure assessment  PEC = Predicted Environmental Concentration Effects assessment  PNEC = Predicted No Effect Concentration Risk Characterization PEC/PNEC > 1  risk

Exposure Assessment

Exposure Assessment Components of Exposure Analysis: Emissions Inventory diffuse and point sources of Ni within the EU Regional Exposure Assessment estimation of PEC at the (hypothetical) regional scale representative of a worst case for EU area of 40,000 km, population of 20 million (close to NL) Local Exposure Assessment estimation of PEC at the operational level, using site estimation of emission characteristics when sector coverage is sufficient critical for risk management process

Emissions Inventory for Nickel

Exposure Assessment

Exposure Assessment PEC determined on the Continental level (PECcont) Regional level (PECreg) Local level (PEClocal) PEClocal = Clocal + PECregional PECreg = Creg + PECcont PECcont = Ccont + natural background

water, sediment, soil, air Nickel producing/processing sectors Overview PEC values water, sediment, soil, air Nickel producing/processing sectors

PECtotal, local water (µg/l) Platers: wide spread; Median values in range of other sectors

PECtotal, local sediment (mg/kg) Platers: wide spread; Median values in range of other sectors

PECtotal, local soil (mg/kg) Platers: wide spread; Median values in range of other sectors

PECadded, local air (µg/m3) Platers

Effects assessment

Aquatic Aim of effects assessment is to determine the PNEC = Predicted No Effect Concentration Methodology Establish dose-response curves For different species Determine NOEC or LOEC Species Sensitivity Distribution (SSD) Cumulative frequency distribution of NOECs/LOECs for different species Derive PNEC

Species Sensitivity Distribution (SSD) Oncorhynchus mykiss Ceriodaphnia dubia Daphnia magna Raphidocelis subcapitata Ni Species Sensitivity Distribution HC5

PNEC derivation Derive HC5 = 5th percentile of SSD HC5 = concentration at which 5% of the species is affected Determine assessment factor (AF) AF depends on number of species in distribution etc. There are rules to derive AF  PNEC = HC5/AF

Risk Characterisation PEC/PNEC BUT refinement possible Bioavailability incorporation

Bioavailability Not the total or dissolved concentration is relevant for the biological effects, but the concentration at the biotic ligand The concentration at the biotic ligand is influenced by complexation (e.g. organic carbon) and competition (e.g. cations) processes

Aquatic Biotic Ligand Model (BLM)

Status Research programme about finalized Dossier reviewed at TC NES (Technical Committee New and Existing Substances): March 2006 June 2006 September 2006 (risk characterization)

Use of the outcomes in EU legislation Example: Water Framework Directive and setting of EQS (Environmental Quality Standards)

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