Tuesday, February 22, 2011

ECHA Says - Time to Start Preparing Chemical Authorization Applications Under REACH

I mentioned last week that the European Commission had formally published the first six chemical substances onto Annex XIV of REACH, the Registration Evaluation and Authorization (and Restriction) of CHemicals regulation in Europe.  Now ECHA, the European Chemicals Agency in Helsinki, Finland, is telling companies that manufacture those six chemicals that the time is now to start preparing their authorization applications if they want to save some uses of those chemicals for a period of time beyond the assigned "sunset" dates.  Authorization would only be for specific uses and for specific periods of time, though renewals are possible.

Applications can be pretty comprehensive.  They require a full Chemical Safety Report, which summarizes the health and safety hazard data, the exposure potential for all uses, and demonstrates how the risk will be controlled for specific uses.  In addition, companies have to provide a "alternatives analysis," i.e, an analysis of existing or potential chemicals of lower risk that can be substituted for the Annex XIV listed "substances of very high concern (SVHC)."  For chemicals in which no alternative appears to be available, the companies requesting authorization must describe a plan for how they (or someone else) might develop an alternative. Companies can also provide a socioeconomic assessment (SEA) in which they quantify the societal benefit of the chemical substance, or the loss of such benefit should it be removed from the market with no suitable alternative.

Since it is likely that a particular chemical substance would have more than one manufacturer, authorization applications may be made both by individual companies and by groups of companies.  An authorization fee would be charged to cover the costs of the ECHA review. 

To facilitate the preparation of the application ECHA has recently published two new guidance documents.  The first "explains how to prepare an application for authorisation, the analysis of alternatives and the substitution plan."  The second "shows how to prepare a socio-economic analysis if the risks of the continued use of the substance cannot be adequately controlled."  Both documents can be downloaded here.

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