The REACH registration process: A case study of metallic aluminium, aluminium oxide and aluminium hydroxide.

The European Union's REACH Regulation requires determination of potential health and environmental effects of chemicals in commerce. The present case study examines the application of REACH guidance for health hazard assessments of three high production volume (HPV) aluminium (Al) substances: metallic aluminium, aluminium oxide, and aluminium hydroxide. Among the potential adverse health consequences of aluminium exposure, neurotoxicity is one of the most sensitive targets of Al toxicity and the most critical endpoint. This case study illustrates integration of data from multiple lines of evidence into REACH weight of evidence evaluations. This case study then explains how those results support regulatory decisions on classification and labelling. Challenges in the REACH appraisal of Al compounds include speciation, solubility and bioavailability, application of assessment factors, read-across rationale and differences with existing regulatory standards. Lessons learned from the present case study relate to identification and evaluation of toxicologic and epidemiologic data; assessing data relevance and reliability; development of derived no-effect levels (DNELs); addressing data gaps and preparation of chemical safety reports.

Overview of REACH: Issues Involved in the Registration of Metals.

New European legislation known as REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) was introduced in 2007 to increase the speed at which the health and/or environmental risks of industrial chemicals were being assessed and managed (REACH (EC) No 1907/2006). REACH consolidated earlier chemicals-control statutes and placed the burden of assessing, and identifying the means to manage risks on industry. This paper details the REACH process for controlling and managing hazardous chemicals and challenges encountered in applying the provisions of REACH and the guidance documents available from European Chemical Agency. Special attention is paid to challenges in evaluating potential health risks of metals such as aluminum and aluminum compounds. Lessons learned from over a decade of experience with REACH legislation are also noted.

Cobalt and chromium levels in blood and urine following hip resurfacing arthroplasty with the Conserve Plus implant.

BACKGROUND: The purpose of the present study was to determine cobalt and chromium ion levels in the blood and urine of patients in whom a modern-generation metal-on-metal hip resurfacing device had been implanted. METHODS: A total of ninety-seven patients with a Conserve Plus metal-on-metal hip resurfacing implant were followed prospectively for two years. Cobalt and chromium levels in erythrocytes, serum, and urine were measured preoperatively as well as three, six, twelve, and twenty-four months postoperatively. RESULTS: The median serum cobalt and chromium ion levels were 1.04 µg/L (range, 0.31 to 7.42 µg/L) and 2.00 µg/L (range, 0.28 to 10.49 µg/L), respectively, at one year after surgery and 1.08 µg/L (range, 0.44 to 7.13 µg/L) and 1.64 µg/L (range, 0.47 to 10.95 µg/L), respectively, at two years after surgery. The corresponding mean levels (and standard deviations) of serum cobalt and chromium were 1.68 ± 1.66 µg/L and 2.70 ± 2.22 µg/L, respectively, at one year after surgery and 1.79 ± 1.66 µg/L and 2.70 ± 2.37 µg/L, respectively, at two years after surgery. CONCLUSIONS: These levels compare favorably with other published ion results for metal-on-metal hip resurfacing and replacement implants. No pseudotumors or other adverse soft-tissue reactions were encountered in our study population. Further research is needed to determine the clinical importance of increased cobalt and chromium ion levels in serum and urine following metal-on-metal hip resurfacing.

Regulatory and nonregulatory strategies for improving children's environmental health in Canada.

Epidemiological and toxicological studies established positive associations between environmental hazards and adverse child health outcomes, including cancer, learning disabilities, behavioral problems, developmental effects, low birth weight, and birth defects. The economic and societal costs associated with children's environmental health disorders were estimated to be substantial. The existence of knowledge gaps, lack of capacity, and the jurisdictional overlap of children's environmental health issues are some of the barriers that impede effective policy decision making. To improve children's environmental health and reduce economic and societal costs, current legislative frameworks could implement a series of amendments. The main federal, provincial, and municipal legislation used to protect children in Canada, either explicitly or implicitly, is reviewed. Recommendations for improving the existing framework for protecting and strengthening children's environmental health are proposed.