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1. Any manufacturer of an on-site isolated intermediate in quantities of one tonne or more per year shall submit a registration
to the Agency
for the on-site isolated intermediate.
2. A registration
for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is
able to submit it without any additional testing:
(a) the identity of the manufacturer as specified in Section 1 of Annex VI
(b) the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI
(c) the classification of the intermediate as specified in Section 4 of Annex VI
(d) any available existing information on physicochemical, human health or environmental properties of the intermediate. Where
a full study
report is available, a study
summary shall be submitted;
(e) a brief general description of the use, as specified in Section 3.5 of Annex VI
(f) details of the risk management measures applied.
Except in cases covered under Article 25
(3), Article 27
(6) or Article 30
(3), the registrant shall be in legitimate possession of or have permission to refer to the full study
report summarised under (d) for the purpose of registration
shall be accompanied by the fee required in accordance with Title IX.
3. Paragraph 2 shall apply only to on-site isolated intermediates
if the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that
it is rigorously contained by technical means during its whole lifecycle. Control and procedural technologies shall be used
to minimise emission and any resulting exposure.
If these conditions are not fulfilled, the registration
shall include the information specified in Article 10