Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
in the role of the registrant regarding the registered substance (e.g. a manufacturer becoming
an importer) will have to be reported to ECHA through an update of the registration dossier.
b) Any change in the composition of the substance
If the composition of the substance changes, e.g. due to a change of process, this should be
reported to ECHA by resubmitting the updated registration dossier. It is important that the
registrant evaluates whether the change in the composition of its substance has some
influence on its intrinsic properties. Further guidance on when a change in, for example, the
degree of purity would trigger an update is available in the <strong>Guidance</strong> on substance
identification.
c) Changes in the annual or total quantities manufactured or imported by the registrant or in
the quantities of substances present in articles produced or imported by the registrant, if these
result in a change of tonnage band, including cessation of manufacture or import
As soon as the volume of a registered substance reaches a higher tonnage band, the
information requirements of the registration dossier change, i.e. at 10, at 100 and at 1000
tonnes per year. Before submitting an update of the registration dossier the registrant has to
inform ECHA of the additional information that he would require to comply with the information
requirements for the new tonnage level (Article 12(2)). This is achieved by submitting an
inquiry dossier to ECHA (see section 4.4). ECHA will then inform the registrant of the names
and addresses of the previous registrants (and any potential registrants) and of any relevant
study summaries already submitted by them in order to share existing data and ensure that
studies on vertebrate animals are not unnecessarily repeated.
If a registrant has ceased the manufacture or import of the substance, or the production or
import of an article, he needs to inform ECHA of this fact with the consequence that the
registered volume in his registration, if appropriate, shall be put to zero (Article 50(2)). He
must keep the relevant information for 10 years after last manufacture or import and make it
available on request (Article 36(1)). In the case where he restarts the manufacture or import
of the substance or he restarts the production or import of the article he has to notify ECHA
accordingly.
d) New identified uses and new uses advised against for which the substance is
manufactured or imported
If a downstream user informs the registrant about a new use of the substance, not identified in
the registration dossier, there might be two situations:
If the registrant has registered in a tonnage band starting at 10 tonnes per year and
therefore is required to prepare a chemical safety report (CSR), he must assess the
chemical safety for this use, and include that use in his CSR if the results of the
chemical safety assessment (CSA) indicate that risks to human health and the
environment from that use are controlled. He will then, where relevant, provide the
downstream user with a revised safety data sheet (SDS), including the new use as well
as the exposure scenarios (ES) describing the operational conditions for which the
substance can be used safely. If on the basis of the CSA he is unable to include that
new identified use for reasons of human health or environmental protection, he must
inform without delay ECHA and the downstream user(s) in writing with the reason for
this decision. The registrant must not supply the downstream user(s) with the
substance without updating the SDS by indicating the use(s) advised against.
If the registrant has registered in a tonnage band of less than 10 tonnes per year, he
has no obligation to perform a CSA. However he may decide to include or not the new
use(s) in the SDS.
In both situations the registrant needs to update his registration to take into account the new
identified use or the new use advised against.
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