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||Joint submission of data by multiple registrants
1. When a substance is intended to be manufactured in the Community by one or more manufacturers
and/or imported by one or more importers
, and/or is subject to registration
under Article 7
, the following shall apply.
Subject to paragraph 3, the information specified in Article 10
(a)(iv), (vi), (vii) and (ix), and any relevant indication under Article 10
(a)(viii) shall first be submitted by the one registrant acting with the agreement of the other assenting registrant(s) (hereinafter
referred to as the lead registrant).
Each registrant shall subsequently submit separately the information specified in Article 10
(a)(i), (ii), (iii) and (x), and any relevant indication under Article 10
The registrants may decide themselves whether to submit the information specified in Article 10
(a)(v) and (b) and any relevant indication under Article 10
(a)(viii) separately or whether one registrant is to submit this information on behalf of the others.
2. Each registrant need only comply with paragraph 1 for items of information specified in Article 10
(a)(iv), (vi), (vii) and (ix) that are required for the purposes of registration
within his tonnage band in accordance with Article 12
3. A registrant may submit the information referred to in Article 10
(a)(iv), (vi), (vii) or (ix) separately if:
(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 this information.
If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would
be disproportionate, why disclosure of information was likely to lead to substantial commercial detriment or the nature of
the disagreement, as the case may be.
4. A submission for registration
shall be accompanied by the fee required in accordance with Title IX.