Guidance on registration - ECHA - Europa

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<strong>Guidance</strong> on registration
Version 2.0 May 2012
substance in a quantity over one tonne per year for the first time after 1 December 2008. To
benefit from this, the producer or importer will have to submit a pre-registration dossier within
six months of first using the substance for the production of the articles or first importing the
article containing the substance and no later than 12 months before the registration deadline
for their tonnage band.
Note that in the case of a non-EU manufacturer appointing an only representative, it will be
the only representative who will have to pre-register the substance in order to benefit from the
extended registration deadlines. An only representative appointed after 1 December 2008 can
pre-register the substance until 12 months before the relevant registration deadline, provided
that the substance originating from the non-EU manufacturer was not placed on the market
previously in a quantity at or above one tonne per year after 1 June 2008 (when the
registration obligations entered into force). If a non-EU manufacturer decides to change his
only representative and the previous only representative had pre-registered the substance
originating from the non-EU manufacturer, then the successor should communicate the change
of only representative to ECHA in order to continue to benefit from the phase-in deadlines for
registration of that substance.
Legal reference: Article 28
4.3 SIEF formation
All potential registrants and data holders for the same pre-registered phase-in substance are
participants in a ‘Substance Information Exchange Forum’ (SIEF). Registrants who registered
the same phase-in substance earlier, or whose substance is considered as registered (see
section 2.2.4) are also participants of the SIEF.
The aims of the SIEF are to:
facilitate data sharing for the purposes of registration, thereby avoiding the duplication
of studies, and
agree on the classification and labelling of the substance concerned where there is a
difference in the classification and labelling of the substance between the potential
registrants.
Participants are free to organise themselves as they see fit to carry out their duties and
obligations under REACH, The organisation used for the SIEF co-operation may also be used to
jointly submit the relevant information.
Note that the responsibility for defining the ‘sameness’ of the substances lies with the SIEF
participants.
The <strong>Guidance</strong> on data sharing provides extensive information on the rights and duties of SIEF
participants. The reader is advised to consult this guidance if in need of further information on
the subject.
Legal reference: Article 29
4.4 Inquiry for non phase-in and non pre-registered phase-in
substances
Inquiry is the process by which every potential registrant must inquire from ECHA whether a
registration has already been submitted for the same substance. This is to ensure that data
are shared by the relevant parties. The duty to inquire applies to non phase-in substances and
to phase-in substances that have not been pre-registered.
Therefore, for non phase-in substances and for phase-in substances that have not
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