[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

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 casixtures.

2023/05/16
Committee: ENVI

Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a

Regulation (EC) No 1272/2008
Article 2 – paragraph 7a

~~7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.~~deleted

2023/05/16
Committee: ENVI

Andrey NOVAKOV, Asim ADEMOV, Andrey KOVATCHEV, Emil RADEV, Eva MAYDELL, Alexander ALEXANDROV YORDANOV, Radan KANEV, Ivo HRISTOV, Tsvetelina PENKOVA, Petar VITANOV, Elena YONCHEVA, Atidzhe ALIEVA-VELI, Ilhan KYUCHYUK, Iskra MIHAYLOVA, Marc ANGEL

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

Regulation (EC) No 1272/2008
Article 5 – paragraph 3

~~[...] [...] [...]~~d e [...] l e t e d

2023/05/16
Committee: ENVI

4 Amendments of Elena YONCHEVA related to 2022/0432(COD)

ParlTrack - 2011-2024