(PH172) Experience from the European Silicone Industry of the potential practical implications of the REACH process under the proposed new EU Chemicals Policy.
Stevens, C1, 1 Dow Corning Europe, Seneffe, BELGIUM
ABSTRACT- In 2000, the Oslo Paris Commission (OSPAR) identified hexamethyldisiloxane (HMDS) as a potential Priority Hazardous Substance. The French Competent Authority was assigned the responsibility of conducting a risk assessment for the marine environment, using the EU Risk Assessment model, EUSES. The European Silicone Industry (CES) agreed to prepare the environmental exposure assessment. This provided a very valuable insight as to what may be required when the Registration, Evaluation and Authorization of Chemicals (REACH) process is implemented under the proposed European Union Chemicals Policy. This presentation will discuss the challenges encountered with preparing the environmental exposure assessment on HMDS. This primary use of HMDS in the Silicone Industry is to terminate the polymerization process in silicone polymer manufacturing. It is also used in small volumes in the Personal Care industry, with many of these sales occurring via distributors concerned about maintaining customer confidentiality. The life-cycle of HMDS is further complicated by the fact that HMDS is a by-product from pharmaceutical manufacturing that is recycled into alternative end-uses. Hence, an independent consultant was essential for maintaining the confidentiality of customer-sensitive information and to manage the very large amount of in-coming data. The exercise highlighted the importance of communicating to down-stream users and to industries outside of the European Silicone Industry, the reasons why their assistance was needed in supplying data. In the absence of actual data, the EUSES imposes conservative default values to the Emission Scenarios that are an integral part of the EU risk assessment model. For substances such as silicones, which have very unusual physicochemical properties, model outputs often do not reflect reality. The European Silicone Industry therefore conducted monitoring to challenge the output of the model. Furthermore, ecotoxicity testing was performed which took nearly two years to complete, and required considerable financial and man-power support. The resources that will be required for conducting a similar exercise on the thousands of other substances implicated within the REACH process are daunting and needs to be fully recognized in order to effectively manage the process.
Key words: REACH, Registration, Evaluation and Authorization of Chemicals, European Union Chemicals Policy, environmental exposure assessment