15 Amendments of Maria Veronica ROSSI related to 2022/0432(COD)
Amendment 70 #
Proposal for a regulation
Recital 2
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. Iand 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-constituentsubstances is to be generated under the same conditions as data on any other substance with more than one costituent, 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 individualthe substance with more than one constituents is not available, multi- constituent and where relevant data onindividual constituents is available, thesesubstances 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-constituentsubstances. _________________ 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).
Amendment 80 #
Proposal for a regulation
Recital 3
Recital 3
(3) It is normally not possible to sufficiently assess theFor the assessment of 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 casboth whole substance data and data for the individual constituents of the substance with more than one constituent, impurity or additive should be used as the basis for hazard classification of those substances.
Amendment 94 #
Proposal for a regulation
Recital 11
Recital 11
(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size, whilst it does not provide for a minimum font size of labels that would ensure readability. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while readability of labels should be ensured by layadding down minimum font size and formatting requirementsmore examples of label in the Guidance on Labelling and Packaging.
Amendment 124 #
Proposal for a regulation
Recital 37
Recital 37
Amendment 134 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) 1272/2008
Article 2 – point 7a
Article 2 – point 7a
Amendment 151 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3
Article 5 – paragraph 3
A multi-constituent substance containing at least one constituent, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined in accordance with the criteria set out in this paragraph, using the available information on those constituents as well as on the substance, unless Annex I lays down a specific provision. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
Amendment 156 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 2
Article 5 – paragraph 3 – subparagraph 2
For the evaluation of multi-constituentthese substances pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property for the environment’ hazard classesand ‘hazardous to the aquatic environment’ referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3, and 4.1. and 4.2.3.1. of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance. , impurities and additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
Amendment 168 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 5
Article 5 – paragraph 3 – subparagraph 5
For the evaluation of multi-constituentthese substances pursuant to Chapter 2 in relation to the ‘biodegradation, persistence, mobility and bioaccumulation’ properties within the ‘hazardous to the aquatic environment’ ‘persistent, bioaccumulative and toxic’, ‘very persistent and very bioaccumulative’, ‘persistent, mobile and toxic’ and ‘very persistent and very mobile’ hazard classes referred to in sections 4.1.2.8 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.4.2.3.2 of Annex I3 and 4.4 of Annex I, where relevant information referred to in paragraph 1 is not available on the substance itself, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the individual constituents in the substance. , impurities or additives in the substance. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
Amendment 170 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 6
Article 5 – paragraph 3 – subparagraph 6
Amendment 176 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 7
Article 5 – paragraph 3 – subparagraph 7
Amendment 216 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point a
Article 1 – paragraph 1 – point 11 – point a
Regulation (EC) 1272/2008
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label or a fold-out label in the languages of the Member States in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.; (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 29 paragraph 1)
Amendment 290 #
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Article 1 – paragraph 1 – point 30
Regulation (EC) 1272/2008
Article 61 – paragraph 7
Article 61 – paragraph 7
Substances and mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II, Part A, the first sub- paragraph of section 2.4, of Annex VIII, Part B, section 1, of Annex VIII, Part B, the third paragraph of section 3.1, of Annex VIII , Part B, section 3.6, of Annex VIII, Part B, the first row of Table 3 of Section 3.7, of Annex VIII, Part B, the first paragraph of Section 4.1, of Annex VIII, Part C, sections 1.2 and 1.4, of Annex VIII, and Part D, sections 1, 2 and 3, of Annex VIII as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 1824 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation]. (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Article 61 – paragraph 7))
Amendment 292 #
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Article 1 – paragraph 1 – point 30
Regulation (EC) 1272/2008
Article 61 – paragraph 7 a (new)
Article 61 – paragraph 7 a (new)
Amendment 300 #
Proposal for a regulation
Annex I – Paragraph 1 – point 2
Annex I – Paragraph 1 – point 2
Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.4. – Table 1.3
Annex I – Part 1 – Section 1.2.1.4. – Table 1.3
Capacity of the Dimensions of the Dimensions of each Minimum font-size package label (in pictogram (in millimetres) for the millimetres) information required by Article 17 Not exceeding 3 If possible, at least Not smaller than 8pt litres: 52x74 10x10 If possible, at least 16x16 Greater than 3 At least 74x105 At least 23x23 12pt litres but not exceeding 50 litres: Greater than 50 At least 105x148 At least 32x32 16pt litres but not exceeding 500 litres: Greater than 500 At least 148x210 At least 46x46 20pt’; litres:
Amendment 301 #
Proposal for a regulation
Annex I – paragraph 1 – point 3
Annex I – paragraph 1 – point 3
Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5
Annex I – Part 1 – Section 1.2.1.5