| ARTICLE 22: |
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
or
import;
(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.
The
Agency 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,
41 or
46 or take into account a decision made in accordance with Articles
60 and
73, 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 or
19, 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.