[ParlTrack]

Proposal for a regulation
Recital 2

(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances. _________________ 39 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 (OJ L 396, 30.12.2006, p. 1).deleted

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Recital 3

(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi-constituent substance should therefore normally be used as the basis for hazard identification of those multi- constituent substances or mixtures. However, in certain cases, data on those multi-constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those cases.deleted

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Recital 7 a (new)

(7a) Disposable electronic cigarettes and single use cartridges may contain a nicotine-containing mixture classified as having acute oral and/or acute dermal toxicity properties. However, the mixtures contained in these products cannot directly be ingested or touched. Therefore, it is appropriate to provide for labelling exemptions for these products, unless the mixtures contained are classified as having acute inhalation toxicity and/or respiratory sensitisation properties. This is without prejudice to specific EU and national legislation on the marketability of the mixtures contained.

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Article 1 – paragraph 1 – point 4

Regulation (EC) 1272/2008
Article 5 – paragraph 3

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2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Article 1 – paragraph 1 – point 8

Regulation 1272/2008
Article 23 – paragraph 1 – point e a (new)

In Article 23, the following point ea is added: '(ea) disposable electronic cigarettes, single use cartridges and refill containers as defined in Directive 2014/40/EU.'

2023/05/16
Committee: ENVI

Nicola PROCACCINI, Pietro FIOCCHI

Proposal for a regulation
Annex I – paragraph 1 – point 4 a (new)

Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.3.7 a (new)

(4a) In Part 1 of Annex I, the following Section 1.3.7.a is added: 1.3.7.a Mixtures designed to be inhaled via electronic cigarettes and contained in refill containers The labelling elements referred to in Article 17(1) shall only be provided on the outer packaging of disposable electronic cigarettes and single use cartridges. The elements referred to in Article 17(1) (d) to (g) shall only apply if the mixture contained is classified as having respiratory sensitisation and/or acute inhalation toxicity properties. This applies accordingly to the application of Articles 48 and 48a. For refill containers, the label elements in accordance with the first subparagraph of Article 17(2) shall be provided in accordance with sections 1.5.1 and 1.5.1.2 of Annex I. A tie-on tag shall not be used.

2023/05/16
Committee: ENVI

6 Amendments of Nicola PROCACCINI related to 2022/0432(COD)

ParlTrack - 2011-2024