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14 Amendments of Silvia SARDONE related to 2022/0432(COD)

Amendment 70 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
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. 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).
2023/05/16
Committee: ENVI
Amendment 80 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
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.
2023/05/16
Committee: ENVI
Amendment 94 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
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.
2023/05/16
Committee: ENVI
Amendment 124 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Recital 37
(37) To ensure that suppliers of (37) substances and mixtures have time to adapt to rules on classification, labelling and packaging, the application of some provisions of this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re- labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures. In addition, differentiated dates for substances and mixtures should be maintained.
2023/05/16
Committee: ENVI
Amendment 134 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) 1272/2008
Article 2 – point 7a
(a) the following point is inserted: ‘7a. ‘multi-constituent substance’ means a substance that contains more than one constituent.’ deleted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 2 point 7a (new))
2023/05/16
Committee: ENVI
Amendment 151 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
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))
2023/05/16
Committee: ENVI
Amendment 156 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
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))
2023/05/16
Committee: ENVI
Amendment 168 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
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))
2023/05/16
Committee: ENVI
Amendment 170 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 6
Rdelevant available information on the multi-constituent substance itself shall be taken into accted (This amendment applies throughount wthere one of the following conditions are met: (a) the information demonstrates biodegradation, persistence, mobility and bioaccumulation properties. (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
2023/05/16
Committee: ENVI
Amendment 176 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3 – subparagraph 7
Rdelevant available information on the multi-constituent substance itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance. ted (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.) Or. en (Art 5 §3 (new))
2023/05/16
Committee: ENVI
Amendment 216 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 11 – point a
Regulation (EC) 1272/2008
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)
2023/05/16
Committee: ENVI
Amendment 290 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Regulation (EC) 1272/2008
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))
2023/05/16
Committee: ENVI
Amendment 292 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Article 1 – paragraph 1 – point 30
Regulation (EC) 1272/2008
Article 61 – paragraph 7 a (new)
In Article 61, the following paragraph 7a is added: '7a. 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 36 months [VC1] 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 60 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 a (new))
2023/05/16
Committee: ENVI
Amendment 301 #
Danilo Oscar LANCINI, Silvia SARDONE, Matteo ADINOLFI, Rosanna CONTE, Gianantonio DA RE, Gianna GANCIA, Maria Veronica ROSSI, Aurélia BEIGNEUX, Elisabetta DE BLASIS
Proposal for a regulation
Annex I – paragraph 1 – point 3
Regulation (EU) No 1272/2008
Annex I – Part 1 – Section 1.2.1.5
1.2.1.5. The text on the label shall have the following characteristics: (a) be white; (b) shall be equal or above 120 % of the font size; (c) easily legible and without serifs; (d) appropriate for thdeleted the background of the label shall the distance between two lines a single font shall be uselected font to be comfortably legible. For the labelling of innd that is the letter spackaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains legible for a person with average eyesight, where itis deemed important to place the most critical hazard statement and where the outer packaging meets the requirements of Article 17.shall be (This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)
2023/05/16
Committee: ENVI
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