This Title shall apply to:
substances subject to registration;
substances within the scope of Article 1 of Directive 67/548/EEC, which meet the criteria for classification as dangerous in accordance with that Directive, and which are placed on the market either on their own, or in a preparation above the concentration limits specified in Directive 1999/45/EC, where relevant, which results in the classification of the preparation as dangerous.
1. Any manufacturer, producer of articles or importer, or group of manufacturers or producers of articles or importers, who place on the market a substance within the scope of Article 112, shall notify to the Agency the following information in order for it to be included in the inventory in accordance with Article 114, unless submitted as part of the registration:
(a) the identity(ies) of the manufacturer(s), producer(s) of articles or importer(s) responsible for placing the substance(s) on the market as specified in Section 1 of Annex VI;
(b) the identity of the substance(s) as specified in Sections 2.1 to 2.3.4 of Annex VI;
(c) the hazard classification of the substance(s), resulting from the application of Articles 4 and 6 of Directive 67/548/EEC;
(d) the hazard label for the substance(s), resulting from the application of Article 23(c) to (f), of Directive 67/548/EEC;
(e) specific concentration limits, where applicable, resulting from the application of Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC.
2. Where the obligation under paragraph 1 results in different entries on the inventory for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory.
3. The information listed in paragraph 1 shall be updated by the notifier(s) whenever:
(a) any new scientific or technical information is generated which results in a change to the classification and labelling of the substance;
(b) notifiers and registrants of differing entries for a single substance come to an agreed entry in accordance with paragraph 2.
1. A classification and labelling inventory, listing the information referred to in Article 113(1), both for information notified under Article 113(1) as well as for information submitted as part of a registration, shall be established and maintained by the Agency in the form of a database. The information in this database identified in Article 119(1) shall be publicly accessible. The Agency shall grant access to the other data on each substance in the inventory to the notifiers and registrants who have submitted information on that substance in accordance with Article 29(1).
The Agency shall update the inventory when it receives updated information in accordance with Article 113(3).
2. In addition to the information referred to in paragraph 1, the Agency shall record the following information, where appropriate, against each entry:
(a) whether, in respect of the entry, there is a harmonised classification and labelling at Community level by inclusion in Annex I of Directive 67/548/EEC;
(b) whether, in respect of the entry, it is a joint entry between registrants of the same substance as per Article 11(1);
(c) if the entry differs from another entry on the inventory for the same substance;
(d) the relevant registration number(s), if available.
1. Harmonised classification and labelling at Community level shall, from 1 June 2007 , normally be added to Annex I of Directive 67/548/EEC for classification of a substance as carcinogenic, mutagenic or toxic for reproduction category 1, 2 or 3, or as a respiratory sensitiser. Harmonised classification and labelling for other effects may also be added to Annex I of Directive 67/548/EEC on a case-by-case basis if justification is provided demonstrating the need for action at Community level. To this end, Member State competent authorities may submit proposals to the Agency for harmonised classification and labelling in accordance with Annex XV.
2. The Committee for Risk Assessment shall adopt an opinion on the proposal, giving parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission, which shall take a decision in accordance with Article 4(3) of Directive 67/548/EEC.
The obligations set out in Article 113 shall apply from 1 December 2010 .]
Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).