Human Health Risk Assessment For Metallic Chromium And Trivalent Chromium In Accordance With European Union Legislation

The Unit of Toxicological Risk Assessment of the Finnish Institute of Occupational Health (FIOH) is conducting a 'Health Risk Assessment for Metallic Chromium and Trivalent Chromium' under the sponsorship of the International Chromium Development Association (ICDA) and the International Stainless Steel Forum (ISSF). This risk assessment will be conducted in accordance with the current European Union legislation in force (Council Regulation 793/93/EEC, Commission Regulation 1488/94/EEC, Dir. 67/548/EEC), but also to meet the regulatory obligations as set out in the European Commission REACH legislation proposal (Consultation Document, the Registration, Evaluation, Authorisation and Restrictions of CHemicals). Further aims include outlining the criteria for the setting of occupational exposure limits for metallic chromium and trivalent chromium compounds. Human Health Risk Assessment according to the current legislation shall entail hazard identification of the toxic end points (acute toxicity, irritation/corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, reproductive toxicity) including, as appropriate, dose (concentration) - response assessment, and derivation of the N(L)OAELs (No (Lowest) Observed Adverse Effect Level) and/or DNELs (Derived No Effect Level). Exposure assessments for workers, consumers and humans exposed via the environment take into account all the known intended uses. Risk characterisation will compare the typical and/or reasonable worst case exposure estimates to the N(L)OAELs or DNELs to determine Margins of Safety (MOS) for all human populations by each exposure scenario and type of effect, followed by conclusions about the presence or absence of risk. Although all of the key elements of existing legislation remain in REACH, the principal change is that, the burden of proof will be transferred from the member state authorities to industry. The new proposed format of Chemical Safety Report (CSR) will include Risk Management Measures (RMM) as an essential part of the report in addition to the risk assessment. The RMM plays a role in the evaluation of further testing needs and advocating reasons for possible waiwer of requirements. The research programme started in March 2002 and will be completed within the time frame of two years.