1. 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

2. 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)

3. 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

4. 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

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

6. EU Risk Assessment

7. 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

8. 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

9. Risk Assessment Exposure Assessment Effects Assessment
Risk Characterization

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

11. 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

12. 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

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

14. Nickel Risk Assessment

15. 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

16. Environment

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

18. Exposure Assessment

19. 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

20. Emissions Inventory for Nickel

21. Exposure Assessment

22. 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

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

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

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

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

27. PECadded, local air (µg/m3)
Platers

28. Effects assessment

29. 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

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

31. 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

32. Risk Characterisation
PEC/PNEC
BUT refinement possible
Bioavailability incorporation

33. 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

34. Aquatic Biotic Ligand Model (BLM)

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

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

37. ! Thank you for your attention !