Data Submission Manual part 14 – How to Prepare ... - ECHA - Europa

6 Data Submission Manual Version: 2.0
1. INTRODUCTION
Under the CLP Regulation, substances and mixtures placed on the market shall be well
identified.
However, a manufacturer (M), importer (I) or downstream user (DU) may be concerned that
disclosure on the label and/or on the Safety Data Sheet (SDS) of the chemical identity of one
or several substances contained in the mixture(s) puts the confidential nature of their
business, in particular intellectual property rights, at risk.
In such cases, the CLP Regulation allows the M/I/DU to submit a request to use an alternative
chemical name which refers to that substance(s) in a mixture (either by means of a name that
identifies the most important functional chemical groups or by means of an alternative
designation). The criteria for approving such a request are defined in the CLP Regulation (Part
1 of Annex I, point 1.4.1).
In accordance with Article 24(8) of the CLP Regulation, where a justification
claiming confidentiality of the IUPAC name for substances listed in Articles
119(2)(f) and (g) in accordance with Article 10(a)(xi) of the REACH Regulation has
been accepted as valid by ECHA, the M/I/DU may use the name that is made
publicly available over the internet (ECHA website) also on the label and in the
safety data sheet of the mixture(s). For those substances in a mixture for which
Article 119(2)(f) or (g) of the REACH Regulation no longer applies, the M/I/DU
may submit a request to the Agency to use an alternative chemical name.
The purpose of this manual is to assist in the preparation of a request for use of an alternative
chemical name for a substance in a mixture and its submission to the European Chemicals
Agency (ECHA). More particularly it outlines, in chapter 5, the IUCLID 5 sections and fields to
be filled-in to prepare a request according to Article 24 of CLP.
It should be noted that the aim of this users’ manual is to help the request submitter to
identify which of the numerous IUCLID 5 fields are of prime importance for a successful
submission of a request: all the “mandatory” sections (see chapter 5.2) need to be filled in to
enable ECHA to process the request. The generated IUCLID 5 alternative name request dossier
can then be submitted to ECHA using a specific web form (see chapter 9).
Currently requests for use of an alternative chemical name for a substance in a
mixture cannot be submitted through REACH-IT. This functionality will become
available at a later stage. Note that even if the dossier submission is taking place
through a web form, the request submitter should have a REACH-IT account in any
case.
The sections of this manual marked with the symbol to the left indicate information
essential for the processing of the dossier.
The manual assumes that IUCLID 5 has been installed and that you have a user account
assigned to the Legal entity created during the installation of IUCLID 5 (for further
instructions, see chapter 2). If IUCLID 5 has not yet been installed, please consult the
IUCLID 5 website available at: http://iuclid.echa.europa.eu
On this website, you can download the software free of charge, and also find more
comprehensive guidance about the use of IUCLID 5.
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