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||Further duties of registrants
1. Following registration
, a registrant shall be responsible on his own initiative for updating his registration
without undue delay with relevant new information and submitting it to the Agency
in the following cases:
(a) any change in his status, such as being a manufacturer, an importer
or a producer of articles, or in his identity, such as his name or address;
(b) any change in the composition of the substance as given in Section 2 of Annex VI
(c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances
present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture
(d) new identified uses and new uses advised against as in Section 3.7 of Annex VI
for which the substance is manufactured or imported;
(e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected
to have become aware which leads to changes in the safety data sheet
or the chemical safety report;
(f) any change in the classification and labelling of the substance;
(g) any update or amendment of the chemical safety report or Section 5 of Annex VI
(h) the registrant identifies the need to perform a test listed in Annex IX
or Annex X
, in which cases a testing proposal shall be developed;
(i) any change in the access granted to information in the registration
shall communicate this information to the competent authority of the relevant Member State.
2. A registrant shall submit to the Agency
an update of the registration
containing the information required by the decision made in accordance with Articles 40
or take into account a decision made in accordance with Articles 60
, within the deadline specified in that decision. The Agency
shall notify the competent authority of the relevant Member State that the information is available on its database.
3. The Agency
shall undertake a completeness check according to Article 20
(2) first and second subparagraphs of each updated registration
. In cases where the update is in accordance with Article 12
(2) and with paragraph 1(c) of this Article then the Agency
shall check the completeness of the information supplied by the registrant and Article 20
(2) shall apply adapted as necessary.
4. In cases covered by Articles 11
, each registrant shall submit separately the information specified in paragraph 1(c) of this Article.
5. An update shall be accompanied by the relevant part of the fee required in accordance with Title IX.