TITLE-II: REGISTRATION OF SUBSTANCES
CHAPTER-1: General obligation to register and information requirements
ARTICLE 7: Registration and notification of substances in articles
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| ARTICLE 7: | Registration and notification of substances in articles |
1. Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:
(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
2. Any producer or importer of articles shall notify the Agency, in accordance with paragraph 4 of this Article, if a substance meets the criteria in Article 57 and is identified in accordance with Article 59(1), if both the following conditions are met:
(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
(b) the substance is present in those articles above a concentration of 0,1 % weight by weight (w/w).
3. Paragraph 2 shall not apply where the producer or importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal.
In such cases, the producer or importer shall supply appropriate instructions to the recipient of the article.
4. The information to be notified shall include the following:
(a) the identity and contact details of the producer or importer as specified in section 1 of Annex VI, with the exception of their own use sites;
(b) the registration number(s) referred to in Article 20(1), if available;
(c) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI;
(d) the classification of the substance(s) as specified in sections 4.1 and 4.2 of Annex VI;
(e) a brief description of the use(s) of the substance(s) in the article as specified in section 3.5 of Annex VI and of the uses of the article(s);
(f) the tonnage range of the substance(s), such as 1 to 10 tonnes, 10 to 100 tonnes and so on.
5. The Agency may take decisions requiring producers or importers of articles to submit a registration, in accordance with this Title, for any substance in those articles, if all the following conditions are met:
(a) the substance is present in those articles in quantities totalling over one tonne per producer or importer per year;
(b) the Agency has grounds for suspecting that:
(i) the substance is released from the articles, and
(ii) the release of the substance from the articles presents a risk to human health or the environment;
(c) the substance is not subject to paragraph 1.
A submission for registration shall be accompanied by the fee required in accordance with Title IX.
6. Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use.
7. From 1 June 2011 paragraphs 2, 3 and 4 of this Article shall apply six months after a substance is identified in accordance
with Article 59(1).
8. Any measures for the implementation of paragraphs 1 to 7 shall be adopted in accordance with the procedure referred to
in Article 133(3).
- Referred by:
- ARTICLE 5: No data, no market
- ARTICLE 9: Exemption from the general obligation to register for product and process orientated research and development (PPORD)
- ARTICLE 10: Information to be submitted for general registration purposes
- ARTICLE 11: Joint submission of data by multiple registrants
- ARTICLE 20: Duties of the Agency
- ARTICLE 23: Specific provisions for phase-in substances
- ARTICLE 74: Fees and charges
- ARTICLE 77: Tasks
- ARTICLE 118: Access to information
- ARTICLE FOOTNOTES: List of Footnotes