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TITLE-II: REGISTRATION OF SUBSTANCES
CHAPTER-3: Obligation to register and information requirements for certain types of isolated intermediates
ARTICLE 18: Registration of transported isolated intermediates
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ARTICLE 18: 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), 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. A registration for a transported isolated intermediate in quantities of more than 1000 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.
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 38: Obligation for downstream users to report information
ARTICLE 74: Fees and charges