Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
submission will require an update of the registration dossier and a new submission to ECHA.
7.3 Update as a consequence of an ECHA or A Commission decision
The registrant may have to update his registration as a consequence of an ECHA a Commission
decision under the evaluation procedure or he may have to take into account decisions made
under the auhorisation or restriction processes. This task has to be performed within the
deadline specified by ECHA/ the Commission in their decision.
a) Evaluation procedures
There are two main types of evaluation procedures, a substance evaluation and a dossier
evaluation. The latter is further subdivided into an examination of any testing proposal and a
compliance check of the registration dossier. The different decisions taken under the
evaluation process that can have an impact on the updating obligations of registrants will be
analysed separately below.
In the examination of testing proposals, all proposals for tests specified in Annexes IX and X
submitted as part of registrations have to be examined by ECHA within certain timelines. The
examination of a testing proposal by ECHA could trigger the need for the registrant to update
his registration dossier when a decision requesting one or several tests to be carried out is
taken by ECHA or the Commission (for more details see the <strong>Guidance</strong> on evaluation).
All tests carried out based on a decision of ECHA on a testing proposal have to be submitted in
the form of a study summary, or a robust study summary (if required by Annex I), in an
updated registration dossier. Moreover, depending on the outcome of the new test conducted,
the registrant may have to update the hazard profile of the substance and/or the CSR including
the ES.
In the compliance check, ECHA may examine any registration dossier in order to check
whether the registrant has met his obligations and the registration dossier complies with the
provisions of REACH (for details on compliance check see the <strong>Guidance</strong> on evaluation).
As the outcome of the compliance check ECHA or the Commission can require the registrant to
submit, within a given time limit, any information needed to bring this registration into
compliance with the relevant information requirements. In response the registrant should
update his registration dossier, including the CSR, with any additional information requested.
The substance evaluation aims to clarify a concern that a given substance constitutes a risk to
human health or the environment.
Substance evaluation provides a mechanism for authorities to require industry to obtain and
submit additional information in case of suspicion of a risk to human health or the
environment. When the Member State competent authority considers that additional
information is necessary for clarifying the suspicion, it will prepare a draft decision stating the
reasons for this request.
When a decision is taken by ECHA or the Commission under the evaluation process, the
registrant has to provide the requested information by way of submitting an update of his
registration dossier to ECHA by the deadline set.
b) Authorisation/Restrictions
If the use of a substance is authorised through a Commission decision, the conditions for the
authorisation should be reflected in the registration dossier. As a consequence, the registration
dossier will have to be updated if it does not take into account these conditions already.
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