BETA

6 Amendments of Salvatore DE MEO related to 2022/0432(COD)

Amendment 61 #
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
Amendment 75 #
Proposal for a regulation
Recital 2 a (new)
(2a) The development of products that are safe and sustainable by design must help to achieve the objectives of the green deal. In that context, the products of natural and renewable origin, by essence sustainable, could play a key role in facilitating the development of a circular and sustainable economy.
2023/05/16
Committee: ENVI
Amendment 77 #
Proposal for a regulation
Recital 2 b (new)
(2b) Essential oils are natural and renewable products, of agricultural and plants origin, of heterogeneous components that cannot be formulated or dosed. An essential oil cannot be reproduced chemically by the addition of its individual components. An essential oil is therefore intrinsically a substance, similarly to vegetal oils, and not a mixture of ingredients, that taken separately could not enable its full identification. In addition, scientific evidences on essential oils show that specific ingredients considered in isolation can have hazardous properties that are not expressed when they are naturally present in an essential oil assessed as a whole substance.
2023/05/16
Committee: ENVI
Amendment 81 #
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
Amendment 183 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 a (new)
In Article 5, the following paragraph 3a is added: 'Substances which occur in nature, as defined under article 3.39 of REACH, as well as substances obtained directly from plants occurring from renewable origin, intrinsically sustainable, justify that the determination of the classification can take into account data obtained on the whole substance.'
2023/05/16
Committee: ENVI