Version in force , Modified +161 −10§
Amended by Regulation (EU) 2018/1881 32018R1881 on EUR-Lex (external, EUR-Lex)
Explanation, written by a model and checked against the cited text
The introductory sentence now adds a reference to nanoforms of substances, where applicable, alongside the substances themselves, for the purposes of the 1-10 tonne registration criteria.
Point (b)(ii) has been expanded so that, in addition to the existing criterion about predicted classification under Regulation (EC) No 1272/2008, it now also covers substances with nanoforms, unless those nanoforms are soluble in biological and environmental media.
Cited: Annex III, v2 (external, EUR-Lex) · Annex III, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 30 October 2019 02006R1907-20191030 → this version, in force 1 January 2020 02006R1907-20200101
ANNEX III
CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
Criteria for substances and, when applicable, for nanoforms thereof, registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):
(a) substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII;
(b) substances:
(i) with dispersive or diffuse use(s) particularly where such substances are used in consumer mixtures or incorporated into consumer articles; and
(ii) for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008. 1272/2008 or for substances with nanoforms, unless those nanoforms are soluble in biological and environmental media.