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Additional info for REACH USA 2008
Protecting confidential business information (CBI) is one of the most perplexing and challenging aspects of the European Union’s (EU) new chemicals regulation -- Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). One example of the need to protect CBI is the highly complex area of polymer composition and formulation. This paper presents a background discussion of polymer technology and design, a quantitative description of how CBI might be compromised under the REACH registration provisions, and practical methods of protecting such information.
Some Practical Steps to REACH IT Systems Implementation From a potential registrant’s perspective, the following steps embody a systemized approach to Registration: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Inventory development Understanding requirements, decisions and planning Pre-registration SIEFs and consortia formation - representation and management of activities Management of the supply chain - use and exposure Information requirements and data gathering Hazard Evaluation - Human Health, Environmental and Phys chemical Development of the Registration Dossier – information / test plan Development of Exposure scenarios Chemical Safety Report / Risk Characterization Extended Safety Data Sheet development Registration For multiple substances, this represents many activities in parallel with timelines dependant upon registration type with these activities, or process steps, needing to be integrated into existing business and EHS functions.
The major reason for this broad conclusion is that polymers generally are characterized as large molecules with very high molecular weights, sometimes in the millions. Consequently, they are too large to be absorbed through human skin or the membranes of fish. In addition, polymers are non-volatile substances, thus precluding inhalation exposure and airborne environmental release. Certain polymers, however, are not characterized by a very high molecular weight, and all polymers by definition contain a distribution of molecular weights.