Guidance on registration - ECHA - Europa

<strong>Guidance</strong> on registration
Version 2.0 May 2012 61
Where there were several previous registrants and a joint submission exists, the potential
registrant will need to contact the lead registrant to join the joint submission. Where the same
substance has previously been registered by only one other company, the potential registrant
will need to make contact with this previous registrant. They must agree on who will be the
lead registrant. In most cases, it would be most sensible if the previous registrant takes over
the role of the lead registrant, as he has already submitted a full dataset. However, the
previous registrant and the potential registrant are also free to agree that the potential
registrant will be the lead registrant and make the joint submission. In that case, the potential
registrant must create and submit a joint submission with the full dataset required for the
highest tonnage range of the two registrants, and the previous registrant will subsequently
need to join this submission.
In case the lead registrant ceases manufacture the other registrants will have to consider the
need to appoint a new lead registrant.
The registration fees, set by Commission Regulation (EC) No 340/2008 of 16 April 2008, take
into account whether the submission is joint or separate.
Legal references: Article 11, Article 19
3.3.2 Opt-out possibilities
A manufacturer or importer may submit certain information of the registration dossier
separately (opt-out) in cases where at least one of the following reasons (listed in Article 11(3)
or for substances in intermediates respectively in Article 19(2)) applies:
(a) it would be disproportionately costly for him to submit this information jointly; or
(b) submitting the information jointly would lead to disclosure of information which he
considers to be commercially sensitive and is likely to cause him substantial commercial
detriment; or
(c) he disagrees with the lead registrant on the selection of the information submitted in
the lead registration.
In this case the registrant has to submit along with his dossier an explanation as to why the
costs would be disproportionate, why disclosure of information would be likely to lead to
substantial commercial detriment or the nature of the disagreement, as the case may be.
Opting out can be partial and refer for example only to a specific study. More detailed guidance
on the opting out possibilities and mechanisms can be found in the <strong>Guidance</strong> on data sharing.
Note that even when the registrant decides to exercise his opt-out option, he
remains a member of the joint submission and will be able to submit his dossier only
after the lead dossier has been accepted for processing. Hence, a registrant can opt-out
from certain information requirements but not from the joint submission as such.
Legal references: Article 11 (3), Article 19 (2)
3.4 Access to information and confidential data
Although the REACH Regulation requires information to be provided to ECHA and potentially
exchanged with the other manufacturers and importers, some provisions (Articles 118 and
119) to protect commercially sensitive information are foreseen.
The general provisions on access to information are as follow:
Information that is listed in Article 119 (1) and submitted in the registration dossier will
be made publicly available on the ECHA website.
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