in force 2026-07-01 MODIFIED+499 −114§
Amended by Regulation (EU) 2024/2865 32024R2865
applies from: unchanged
Point (e) now also covers acute toxicity estimates alongside specific concentration limits and M-factors, with the justification wording rephrased slightly, and two new points, (g) and (h), require stating the reason for diverging from or introducing a more severe classification per hazard class compared to the inventory referred to in Article 42.
The closing sentence of paragraph 1 now refers to points (a) to (h) instead of (a) to (f), reflecting the added points.
Paragraph 2 changes the update obligation from an unspecified updating requirement to a requirement that the notifier notify the Agency at the latest 6 months after a classification and labelling change decision is taken under the Article 15(1) review.
Cited: Art. 40, v2 · Art. 40, v1
text before / after
02008R1272-20260501 → 02008R1272-20260701
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 limits, M-factors or M-factors, acute toxicity estimates, where applicable, in accordance with Article 10 of this Regulation Regulation, together with a justification using as referred to in the relevant Parts 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). 25(1);
(g) where applicable, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;
(h) where applicable, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42.
The information referred to in points (a) to (f) (h) 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) notifier concerned when, pursuant to at the review in Article 15(1), latest 6 months after a decision to change the classification and labelling of the substance has been taken. taken pursuant to the review referred to in Article 15(1).
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.