EU Nickel Risk Assessmentunder EU Regulation 793/93

Human Health Classification

a review bya review by

Dr. Tony Hart – Nickel Institute ConsultantDr. Tony Hart – Nickel Institute ConsultantGiven to the Nickel Risk Assessment Symposium Given to the Nickel Risk Assessment Symposium

Birmingham, 16Birmingham, 16thth March 2006 March 2006

EU Risk Assessment where are we ?EU Risk Assessment where are we ?

Human HealthHuman Health final draft report available (December 2005)

Decisions on nickel salts classification wereDecisions on nickel salts classification were taken during 2005taken during 2005 Final decision on nickel metal classification will not be Final decision on nickel metal classification will not be

made until 2007made until 2007 A report has gone to Member States (TC NES meeting) A report has gone to Member States (TC NES meeting)

and the Commission and the Commission First consideration of risk reduction measures First consideration of risk reduction measures are to be

proposed by DEPA (2006?)by DEPA (2006?) OECD review in Autumn 2006OECD review in Autumn 2006

EU Nickel Risk AssessmentEU Nickel Risk Assessment

Can be considered in two separate categoriesCan be considered in two separate categories

Nickel MetalNickel Metal

Nickel SaltsNickel Salts

EU Nickel Risk AssessmentEU Nickel Risk Assessment

Nickel SaltsNickel Salts

Priority Substances !!

44 ‘Soluble’‘Soluble’ Nickel SaltsNickel Salts were selected aswere selected as ‘Priority ‘Priority Substances’Substances’ for Assessment for Assessment

SSulphateulphateChlorideChlorideNitrate Nitrate

HydroxycarbonateHydroxycarbonate

All have major implications All have major implications for the plating industry !!!!for the plating industry !!!!

Possible conclusions from the Risk Assessment– Human Health report

For each type of exposure, one of three For each type of exposure, one of three conclusions is admissible:conclusions is admissible:

11:: More data is required More data is required 22:: Risks are being managed Risks are being managed 33:: Additional risk-management measures Additional risk-management measures

are neededare needed

Soluble Nickel Conclusions from the RA – Health report

The The GOODGOOD News News

The report finds that for consumer issues: The report finds that for consumer issues:

Conclusion 2 appliesConclusion 2 applies

risks are being adequately managedrisks are being adequately managed

(However, further risk reduction measures may be (However, further risk reduction measures may be needed for dermatitis)needed for dermatitis)

Soluble Nickel Conclusions from the RA – Health report

The The BADBAD news news

The report finds that for Workplace Issues: The report finds that for Workplace Issues:

Conclusion 3 appliesConclusion 3 applies

Additional risk reduction measures are Additional risk reduction measures are requiredrequired (specifically related to inhalation)(specifically related to inhalation)

Classification ofClassification of Nickel SaltsNickel Salts – the major areas of concern– the major areas of concern

CarcinogenicityCarcinogenicity ReprotoxicityReprotoxicity MutagenicityMutagenicity

Soluble Nickel Salts – The New Classifications

Ni Ni sulphatesulphate

Ni nitrateNi nitrate Ni chlorideNi chloride Ni Ni carbonatecarbonate

CancerCancer Cat 1Cat 1 Cat 1Cat 1 Cat 1Cat 1 Cat 1Cat 1

ReprotoxReprotox Cat 2Cat 2 Cat 2Cat 2 Cat 2Cat 2 Cat 2Cat 2

MutagenMutagen Cat 3Cat 3 Cat 3Cat 3 Cat 3Cat 3 Cat 3Cat 3

What about other Nickel Compounds

Initial DEPA intention Initial DEPA intention READ ACROSS !!!!READ ACROSS !!!!

to classify approximately 300 Ni containing to classify approximately 300 Ni containing substances, substances, by ‘reading across’ toby ‘reading across’ to already classified already classified

Ni compoundsNi compounds on the on the solesole basis of similar solubility basis of similar solubility

Reaction to‘READ ACROSS’ proposalReaction to‘READ ACROSS’ proposal

Nickel Industry representatives have Nickel Industry representatives have challenged this approach on two counts:-challenged this approach on two counts:-

In the interim period before REACH, classification In the interim period before REACH, classification must concentrate on the priority substances listed must concentrate on the priority substances listed for Risk Assessmentfor Risk Assessment

Even in case of similar solubility, substances Even in case of similar solubility, substances display a different toxicitydisplay a different toxicity

What will happen to Occupational Exposure Levels (OELs) ?

These are being reviewed in the light of These are being reviewed in the light of these new hazard classificationsthese new hazard classifications

Occupational Exposure Levels (OELs)

The starting point will be a The starting point will be a science-based reviewscience-based review

(to be carried out by SCOEL (to be carried out by SCOEL = Scientific = Scientific

Committee on Occupational Exposure LimitsCommittee on Occupational Exposure Limits) )

Occupational Exposure Levels (OELs)

However, final OELs will be based on aHowever, final OELs will be based on a

Political CompromisePolitical Compromise

The Political Compromise

This will take account of:- This will take account of:-

Socio-economic factors Socio-economic factors Technical feasibilityTechnical feasibility

This evaluation will be undertaken by a new Ad-This evaluation will be undertaken by a new Ad-Hoc committee under EU DG Employment Hoc committee under EU DG Employment

EU Nickel Risk AssessmentEU Nickel Risk Assessment - Human Health

Nickel MetalNickel Metal

Nickel Metal Classification

Largely unchanged at presentLargely unchanged at present

CarcinogenicityCarcinogenicity : Remains Category 3 : Remains Category 3 Repro-toxicity:Repro-toxicity: NotNot classified classified Respiratory sensitiser:Respiratory sensitiser: Not classified Not classified Skin sensitisation: Skin sensitisation: Positive Positive classificationclassification

Review of Hazard Classification

Nickel Metal: Nickel Metal: The futureThe future

Carcinogenicity Carcinogenicity MutagenicityMutagenicity

These will be re-assessed when the animal These will be re-assessed when the animal inhalation study is complete – expected 2007inhalation study is complete – expected 2007

Future Decision Deadlines

???? 2006???? 2006

What deadlines are there in 06 ??What deadlines are there in 06 ??

20072007

Nickel metal Nickel metal (review Carcinogenicity & (review Carcinogenicity & Mutagenicity)Mutagenicity)

Do you need further information ?

For further information on the Classification For further information on the Classification and Labeling of Nickel Metal and Soluble and Labeling of Nickel Metal and Soluble Compounds, please visit the websiteCompounds, please visit the website

http://www.nickelforum-eura.orghttp://www.nickelforum-eura.org