Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
In addition, for substances manufactured or imported between 1 and 10 tonnes per year for
which no CSR is required, the registrant will have to provide information on exposure as
specified under section 6 of Annex VI. This information will include at least the types of use for
the substance (industrial, professional or consumer), the significant routes for human and
environmental exposure and the pattern of exposure and will be also reported in section 3 of
IUCLID 5.
Please, note that although exposure scenario(s) (see section 5.3.1.2) will be attached to the
IUCLID 5 file as an integral part of the CSR where the CSR is required, IUCLID 5 includes
relevant fields to be filled in under section 3 12 .
5.2.3.1 How to report the tonnage
The following fields will have to be completed:
Year: calendar year for which the tonnage is reported.
Tonnage: total tonnes per year (see section 2.2.6) manufactured or imported in the
form of substance on its own or in mixtures, including ‘intermediate’ uses reported (see
below). It should NOT include the tonnes of the substance imported in articles per year.
The registrant is requested to report the tonnage for the year of submission of the
dossier.
Own use: tonnes per year used by the registrant. This should include both uses as an
intermediate and as a non- intermediate.
Intermediate (on-site): tonnes per year of the substance manufactured for use as onsite
intermediate under strictly controlled conditions.
Intermediate (transported): tonnes per year of the substance manufactured or
imported and used as intermediate under strictly controlled conditions.
If part of the tonnage is used for the purpose of PPORD and covered by a PPORD notification it
should not be included here. If it is not covered by a PPORD notification it should be reported
here and included in the tonnage used for the determination of the information requirements.
5.2.4 Information requirements on intrinsic properties (Annexes VII to X)
All relevant available information on the physicochemical, toxicological and ecotoxicological
properties of the substance as specified under Annexes VII to X (and its adaptations according
to Annex XI) have to be provided in sections 4 to 7 in IUCLID 5 in the form of study
summaries or robust study summaries.
According to REACH, robust study summaries need to be provided only when a chemical safety
report is required, i.e. for substances above 10 tonnes per year, and only for key studies (see
text box above). However, it is recommended to provide robust study summaries for all key
studies including for substances manufactured or imported at less than 10 tonnes per year.
This would facilitate the evaluation work to be done by ECHA and eventually Member States in
the frame of substance evaluation and may potentially avoid the need for them to request
further information.
In addition there might be cases where it could be useful to provide robust study summaries
for non key studies. For example, in case the key study is not the one giving rise to the
highest concern it might be useful to prepare a robust study summary for this study as well as
for all the studies demonstrating a higher concern, or at least to report sufficient information to
justify the disregard of these results so that the choice of the key study is better justified.
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Fields available from IUCLID version 5.4 onwards.
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