Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
(x) for substances registered in quantities between 1 and 10 tonnes, information on
exposure;
(xi) a request as to which information should be considered confidential, including a
justification.
The chemical safety report (CSR) is the documentation of the registrant's chemical safety
assessment (CSA) (see section 5.3). The requirement to prepare a CSA and document it in the
CSR is triggered by the yearly tonnage manufactured or imported by the registrant (the
threshold being 10 tonnes per year). The following exemptions apply:
a CSR need not be performed for a substance present in a mixture if the concentration
of the substance in the mixture is less than the lowest of the values defined in Article
14(2);
for uses in food contact materials and cosmetics, the CSR need not address human
health aspects because these are addressed under other legislation.
The obligations that apply to registrants regarding the information to be submitted in the
registration dossier are explained in more detail in section 5.
Legal references: Article 10, Article 14, Annex I, Annexes VI to X
3.2.2 Format of the registration dossier
The format of the registration dossier must be IUCLID (International Uniform Chemical
Information Database). Other IT tools can be used to prepare the dossier as long as they
produce the exact same format. The last version of this software is IUCLID 5 9 which will be
used as the reference in this document and for which a specific guidance is available (<strong>Guidance</strong>
on IUCLID).
IUCLID is a software application to capture, store, maintain and exchange data on the
properties and uses of chemical substances. Although the design and build of IUCLID 5 was
triggered by the entering into force of REACH, the software tool can be used for a large
number of purposes. The data storage formats have been developed in co-operation with the
OECD and have been accepted by many national and international regulatory authorities.
IUCLID 5 data can therefore be used in different chemical assessment programmes, such as
the OECD HPV Chemicals Programme, US HPV Challenge Programme, the Japan Challenge
Programme as well as in the EU Biocides Directive.
The IUCLID 5 software is downloadable from the IUCLID website at http://iuclid.eu for free by
all parties, if used for non-commercial purposes.
Legal reference: Article 111
3.2.2 Submission of the registration dossier
Each manufacturer or importer or only representative is individually obliged to submit a
registration dossier for each of his substances to ECHA in order to register them. The
registration dossier must be submitted electronically through the REACH-IT portal of the ECHA
website.
The submission of the registration dossier requires a number of practical steps with which the
registrant should be familiar before attempting it. Part II of this guidance offers a detail
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Although IUCLID 5.3 is the last version of IUCLID 5 available at the time of publishing this guidance, all the
descriptions contained in this document related to IUCLID 5 are also applicable to IUCLID 5.4.
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