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CHAPTER-3: Obligation to register and information requirements for certain types of isolated intermediates
ARTICLE 17: Registration of on-site isolated intermediates
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ARTICLE 17: Registration of on-site isolated intermediates
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.
The 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.
Referred by:
ARTICLE 6: General obligation to register substances on their own or in preparations
ARTICLE 9: Exemption from the general obligation to register for product and process orientated research and development (PPORD)
ARTICLE 19: Joint submission of data on isolated intermediates by multiple registrants
ARTICLE 20: Duties of the Agency
ARTICLE 23: Specific provisions for phase-in substances
ARTICLE 74: Fees and charges