Wednesday, April 6, 2011
ECHA Provides Tools to Help Chemical Companies Prepare Authorization Applications for REACH
Authorization, of course, is the part of REACH where ECHA has determined that a particular "substance of very high concern" presents too great a risk and therefore intends to remove it from commerce. Manufacturers of those chemicals put onto Annex XIV of REACH, the authorization list, must apply to receive authorization to continue using the chemical. If no authorization is granted the chemical will be banned from commerce in the EU at the end of the specified sunset perios, which for the handful of chemicals added so far is 2014 or 2015. If authorized, the chemical would be limited to uses that are critical and can be controlled, and where there are no available substitutes, and for only a limited period of time allotted to find or develop a substitute.
The new tools include "templates to document an analysis of alternatives, a socio-economic analysis and a substitution plan." There is also a "Fee Calculator" to estimate how much it will cost to submit their application (but not how much to prepare the application). There are also a new Data Submission Manual that "explains in detail how to prepare an Application for Authorisation using IUCLID 5.3, and how to use the web forms for dossier submission."
More information is available on the ECHA web site.
Guidance on how to prepare the authorization application can be downloaded as a PDF here.
Guidance on how to prepare the socio-economic analysis can be downloaded as a PDF here.