Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilDangos y teitl llawn

Article 40 Obligation to notify the Agency

1. Any manufacturer or importer, or group of manufacturers or importers (hereinafter referred to as ‘the notifier(s)’), who places on the market a substance referred to in Article 39, shall notify to the Agency the following information in order for it to be included in the inventory referred to in Article 42:

(a) the identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006;

(b) the identity of the substance or substances as specified in section 2.1 to 2.3.4 to Annex VI to Regulation (EC) No 1907/2006;

(c) the classification of the substance or substances in accordance with Article 13;

(d) where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;

(e) specific concentration limits or M-factors, where applicable, in accordance with Article 10 of this Regulation together with a justification using the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;

(f) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1).

The information referred to in (a) to (f) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.

The notifier shall submit this information in the format specified pursuant to Article 111 of Regulation (EC) No 1907/2006.

2. The information listed in paragraph 1 shall be updated and notified to the Agency by the notifier(s) concerned when, pursuant to the review in Article 15(1), a decision to change the classification and labelling of the substance has been taken.

3. Substances placed on the market on or after 1 December 2010 shall be notified in accordance with paragraph 1 within one month after their placing on the market.

However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.