This section is specific to REACH. It is aimed at storing specific information to apply for an authorisation of use in case the Substance is listed in Annex XIV of the regulation ("List of substances subject to authorisation"). This information will then be compiled with Legal entity information, Substance identification and the Chemical Safety Report - if appropriate - to prepare an application for authorisation for one or several uses.
This section is a repeatable block
section. It enables to specify multiple applications for
authorisation. Click the green Plus button
to open the repeatable block. If more than one
application for authorisation has to be specified, add a new block for each
one.
Set the confidentiality flag and regulatory purpose. For a description of these flags see chapter D.4.5.7 Flags used for filtering data.
This subsection is repeatable. It
enables to regroup several uses of the Substance in the same application
provided that all subsequent information (i.e. analysis of the alternatives,
socio-economic analysis, substitution plan, etc.) is valid for all the
regrouped uses. Click the green Plus button
to open the repeatable block and describe a use for
which the application is intended. An empty block is now ready to be filled
in. If more than one use needs to be specified, add a new block for each
one.
Use concerned by the request
: Indicate the use of
the substance. If appropriate, use the combination Application technique /
Use category / Industry category (as described in chapter E.3.5 Identified uses and exposure scenarios) to better
categorise the use.
Describe the analysis of the alternatives considering their risks and the technical and economic feasibility of substitution. The analysis of the alternative should include all appropriate information about any relevant research and development activities made by you.
The socio-economic analysis (SEA) shall be provided following the format and the "Technical Guidance Document on carrying out a Socio-Economic Analysis or input for one" made by the European Chemical Agency (www.echa.eu) on preparation of SEAs.
Remarks
: If necessary provide any additional
comment here.
Document
: Add the SEA documentation by clicking the
Attachment button and the green Plus
button
from the context menu appearing. Specify the path and
the name of the file to be inserted and indicate any remarks if appropriate
in the Properties window.
If suitable alternatives are available, attach the substitution plan foreseen, including a timetable for your proposed actions.
Remarks
: If necessary provide any additional
comment here.
Document:
Attach the substitution plan document by
clicking the Attachment button
and the green Plus
button
from the context menu appearing. Specify the path and
the name of the file to be inserted and indicate any remarks if appropriate
in the Properties window.
Remarks
: Enter the justification for not
considering risks to human health and the environment arising either from
emissions of a substance or discharges of a substance.
If you have the permission from a previous applicant who applies for authorisation of the same specific use of your substance, you can refer to the appropriate parts of the previous application submitted. Furthermore if you have the permission form the holder of a previous granted authorisation, you may refer to the appropriate parts of the previous application submitted.
Click green Plus button
to open the repeatable block and describe the
reference to previous authorisations or other applications for which you
have a written permission. An empty block is now ready to be filled in. If
more than one reference needs to be specified, add a new block for each
one.
Written permission:
Select the checkbox only if you
have a written permission from the previous applicant.
Remarks
: If necessary provide any additional
comment on the previous authorisation.