1. Project leader of the Nickel Risk Assessment
Impact of Ni RA
Paola Di Discordia
Project leader of the Nickel Risk Assessment
CETS, Birmingham, 16 March 2006

2. Conclusion (iii)  strategies for limiting risks
Marketing and Use restrictions
Establish / revise community level occupational exposure limit values
Determine workplace exposure as low as technically possible
Potential removal from consumer market
Preparations with special classification (corrosive, CMR)

3. Consequences - Actions
Market related issues
Operations related issues  

4. Exposure pathways of humans
Occupational environment
Environment
air
water
food
soil
Consumer products
inhalation
dermal

5. Market related issues : public perception
Ni salts to be put on a publicly available list of substances to be subject to authorization
Ni salts to undergo authorisation of use process under REACH
Growing pressure for substitution
Potential extension of grey lists with materials to ban or avoid
Increase of product stewardship requirements, notably to satisfy authorization requirements under REACH
Extended producers’ responsibility
Potential impact on product (medical devices etc.)
Impact on customers’ operations
Changes in MSDS, labelling and packaging
ACTION : Education of workers, transporters, sales staff, customers, local authorities and public re. actual hazards and risks

6. MSDS, label changes
If data are available, manufacturer has to use the data and package/label accordingly
If classification is agreed at EU level, no market access if not packaged/labelled accordingly
Applicable to substances and also to the preparations in which substances are present, according to the specific ruling for preparations

7. EU classification: what and how
Article 6
Obligation to carry out investigations
Manufacturers, distributors and importers of dangerous substances which appear in the EINECS but which have not yet been introduced into Annex I shall be obliged to carry out an investigation to make themselves aware of the relevant and accessible data which exist concerning the properties of such substances. On the basis of this information, they shall package and provisionally label these substances according to the rules laid down in Articles 22 to 25 and the criteria in Annex VI.
Conclusion:
If data are available, manufacturer has to use the data and package/label accordingly
If classification is agreed at EU level, no market access if not packaged/labelled accordingly
Applicable to substances and also to the preparations in which substances are present, according to the specific ruling for preparations

8. Operation related issues
Operating permits to be reconsidered in EU, with public participation
More detailed mandatory environmental impact assessment
National emission limit values may be laid down for Ni salts as Carc. and Reprotox
Possible total containment of processes and strict control regimes.
Engineering design of new processes and upgrading of older equipments
Handling of packaging, transport
 huge costs

9. Operation related issues
HEALTH
Possible lower OEL
Very stringent measures cf. Dir. on protection of workers from exposure to carcinogens
Diminution OR replacement of the substance at workplace OR exposure reduction
Information to competent authority
Information and training of workers
Measures to protect pregnant workers
Prohibition of young workers (< 18 years)

10. Operation related issues
HEALTH
Education of workers
More frequent and detailed health checks
Management of worker compensation claims
Handling, packaging and transport

11. Operation related issues
ENVIRONMENT
RA will influence the setting of
EU Aquatic Quality Standards (control of emissions, discharges, losses)
EU Soil/ Sediments Quality Standards (future EU strategy)
Revision of ambient air target values with tougher targets on Ni
… and may lead to more stringent environmental liabilities
Tougher need to demonstrate that activities or emissions are not likely to cause environmental damage in order to gain an exemption in environmental liability
 Develop risk communication re. Risk maps and emergency plans to be publicly available

12. Risk Management Priorities
DEVELOP A BUSINESS PLAN INCLUDING
Initiate stewardship action re. assessment of exposure, risk for identified uses, MSDS etc.
Evaluate technical feasibility for lowest possible exposure
Evaluate local and corporate socio-economic consequences
Educate workers, sales staff and customers
“Educate” authorities
Consider development of public communication (local communities, media, green NGO)
Information is also a way to control risks

13. QUESTIONS ?
Paola Di Discordia