Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 99
If the registration of a pre-registered phase-in substance is rejected after the expiry of the
relevant registration deadline, or if no registration dossier is submitted by the relevant
registration deadline, the manufacturer or importer will not be allowed to manufacture or
import this substance in the EU. In order to be allowed to manufacture or import the substance
again, the manufacturer or importer will need to submit a new registration dossier and pay the
fee required. Then he may start importing or manufacturing once ECHA has confirmed the
completeness of the registration, or three weeks after the submission date, if there is no
indication to the contrary from ECHA.
Similarly, if the registration dossier for a non phase-in substance or for a phase-in substance
which is not pre-registered is rejected, the company will need to submit a new registration
dossier and pay the required fee in order to be allowed to manufacture or import the
substance. The import or manufacture can be commenced once ECHA has confirmed that the
registration is complete, or three weeks after the submission of the dossier, if there is no
indication to the contrary from ECHA.
10.5 Assigning a Registration Number
Once the registration is complete the REACH IT system at ECHA automatically assigns a
registration number to the registrant for the substance concerned and a registration date that
will be the same as the submission date. ECHA without delay communicates the registration
number and date to the concerned registrant. From that moment on the registrant shall use
the registration number for the subsequent correspondence regarding registration procedures
(Articles 20 (3)).
For a given substance, distinct dossier types may apply. For example, a substance initially
notified as a PPORD may require the submission of a registration dossier at the end of the
exemption period if the PPORD leads to a commercial use of the substance. Also, a substance
for which initially a notification of the classification and labelling was submitted may later lead
to the submission of a registration dossier. In those cases, the substance will hold an
identification number of each kind, a PPORD number and a registration number in the first
above example, and a classification and labelling number and a registration number in the
second above example. All those numbers are called ‘reference numbers’. The reference
number is unique for every dossier type, substance and company and is issued only once at
the end of the initial and successful submission process.
10.6 Informing the relevant Member State Competent Authority
Within 30 days of the submission date, ECHA has to notify the Competent Authority of the
Member State within which the manufacture takes place or the importer is established that the
registration has been submitted and that the information is available in the ECHA database
(Article 20(4).
If the manufacturer has production sites in more than one Member State, all relevant Member
States will be notified.
ECHA will also notify about any request for further information including deadlines set and
when any further information submitted by the registrant is available on ECHA database.
10.7 Agency Procedure in the case of a registration update
New relevant information prepared either on the registrant's own initiative or in response to a
request by the authorities has to be communicated to ECHA without undue delay. If the
changes trigger an update of the registration dossier, the updated dossier will undergo upon
submission a similar process to the initial dossier: initial verification, assignment of a
submission number and completeness check.
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