Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 73
the rationale for non classification when this is the case. The rationale for the decision for a
classification can be clearly documented in each of the relevant sections of IUCLID. For
example the classification for human health should be justified under the relevant section (e.g.
acute toxicity, eye irritation, etc.).
Registration dossiers submitted from 1 December 2010 onwards must include information on
the classification and labelling of the substance according to the CLP criteria. Before 1
December 2010, the classification and labelling information required in the registration dossier
had to be developed in accordance with the criteria in Directive 67/548/EEC. 11
All registration dossiers submitted to ECHA before 1 December 2010 will have to be updated
without undue delay regarding the information on the classification and labelling, unless this
information was already provided according to the CLP Regulation criteria.
To ensure that the classification and labelling of hazardous substances are available to all
stakeholders and the general public, ECHA will record the classification and labelling proposed
in the registration dossier within the classification and labelling inventory established and
maintained by ECHA. The classification and labelling inventory will contain the classification of
all substances subject to registration as well as of all substances within the scope of the CLP
Regulation which meet the criteria for classification as hazardous and are placed on the
market.
It is recommended that registrants, before classifying their substance, consult Annex VI of the
CLP Regulation (where all harmonised classification and labelling of hazardous substances have
been listed) as well as the classification and labelling inventory in order to check if their
substance is already listed. If already listed in the CLP Regulation (and therefore harmonised
at EU level) they should follow this harmonised classification. If already listed in the inventory
but not in Annex VI of the CLP Regulation, they should make every effort to harmonise their
classification with other registrants, potential registrants having pre-registered and other
notifiers of the classification and labelling of the same substance.
5.2.3 Manufacture, use and exposure
Information on the manufacture and use(s) of the substance, as specified under section 3 of
Annex VI, must be documented in section 3 of IUCLID 5. Although it is up to the registrant to
decide on the level of detail to be reported, at least the following data must be provided:
Tonnage manufactured, imported or used for article production in tonnes per year,
including the tonnage used for own purposes and for intermediates uses (see section
5.2.3.1 below).
Brief description of the technological process used in the manufacture of the substance
or in the production of articles (not applicable for importers).
Information on the form (substance, mixture or article) and the physical state under
which the substance is made available in the supply chain. This includes the
concentration or concentration range of the substance in mixtures and the quantities of
the substance in articles if applicable.
Information on waste quantities and composition of waste.
Brief description of the identified uses of the substance.
Information on the uses advised against and why.
11
The reader is reminded that during the transition period from 1 December 2010 until 1 June 2015 Safety Data Sheets
for substances must however include information on the classification of the substance according to both Directive
67/548/EEC and the CLP Regulation (see section 6.1.1).
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