Introduction Continued...

All legal entities- producer or importer of such substances in Europe- will have to register their portfolio of substances.

All the Registration files - for substances above 1.000 tpy -  have been submitted before December 2010.
For the Registration file, the European Chemicals Agency (EA) will encourage the sharing of data and file preparation between the potential registrants through the Sharing Information Exchange Forum (SIEF) to be opened in 2009, i.e. a substance will only be registered once (OSOR-principle means that for One Substance, there will be One Registration).

The Registration file is under the form of a Chemical safety Report (CSR) including a Chemical Safety Assessment (CSA) of the intrinsic characteristics of the substance and their potential impact on Human Health and the Environment. In the case of Zinc and its compounds.

The same file must detail all the applications for which the substance is intended to be registered, the risks associated with such application and the risk reduction measures to be applied through the whole professional chain of transformation and use; this will be described together with the downstream users (DU) in Exposure Scenario's (ES)

When reliable data are missing for any compartment of the risk assessment, additional testing will be needed.

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