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[X1 TITLE II U.K. REGISTRATION OF SUBSTANCES

CHAPTER 3 U.K. Obligation to register and information requirements for certain types of isolated intermediates

Article 17 U.K. 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) [F1or Article 27(6)] , 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.

Textual Amendments

Article 18 U.K. Registration of transported isolated intermediates

1. Any manufacturer or importer of a transported isolated intermediate in quantities of one tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate.

2. A registration for a transported isolated intermediate shall include all the following information:

(a) the identity of the manufacturer or importer 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) information on risk management measures applied and recommended to the user in accordance with paragraph 4.

Except in cases covered under Article 25(3) [F2or Article 27(6)] , 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. A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2.

For the generation of this information, Article 13 shall apply.

4. Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions:

(a) the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;

(b) procedural and control technologies shall be used that minimise emission and any resulting exposure;

(c) only properly trained and authorised personnel handle the substance;

(d) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;

(e) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;

(f) substance-handling procedures are well documented and strictly supervised by the site operator.

If the conditions listed in the first subparagraph are not fulfilled, the registration shall include the information specified in Article 10.

Textual Amendments

Article 19 U.K. Joint submission of data on isolated intermediates by multiple registrants

1. When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in [F3Great Britain] by one or more manufacturers and/or imported by one or more importers, the following shall apply.

Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as ‘ the lead registrant ’ ).

Each registrant shall subsequently submit separately the information specified in Article 17(2)(a), (b), (e) and (f) and Article 18(2)(a),(b), (e) and (f).

2. A manufacturer or importer may submit the information referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d) separately if:

(a) it would be disproportionately costly for him to submit this 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 manufacturer or importer 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.

3. A submission for registration shall be accompanied by the fee required in accordance with Title IX. ]

Textual Amendments

Editorial Information