25 Amendments of Jutta PAULUS related to 2022/0432(COD)
Amendment 67 #
Proposal for a regulation
Recital 2
Recital 2
(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) areare normally 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 lminimitseanimal testing, data on multi-substances with more than one constituentsubstances 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-substances containing more than one constituentsubstances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for aspecific provision f. However,specific provisions should be provided into Annex I forsubstances containing more than one constituent on the basis of robust scientific argumentation for cases where using data on constituents and calculation rules could result in a false classification as compared to using data on the substance containing more those multi-constituentsubstancesan one constituent as a whole. This could be the case for example when there is proof of antagonistic effects among constituents. At the same time, it must be ensured that any such differences are not due to dilution effects. In such cases, the Commisson should ask the Risk Assessment Committee for an opinion. _________________ 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 84 #
Proposal for a regulation
Recital 3
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 substancesubstance containing more than one constituent 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-substance containing more than one constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substancessubstances containing more than one constituent 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 demonstratesmixtures or on substances containing more than one constituent may also be relevant. This is the case in particular for the one plant protection product or the one biocidal product relevant for approval decisions of the corresponding active substance, or where data on mixtures or on substances containing more than one constituent demonstrate endocrine disrupting properties for human health and the environment, as well asor 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 usedixtures or on substances containing more than one constituent are taken into consideration in those cases.
Amendment 121 #
(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative test methods, suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods , including new approach methodologies,should be monitored and systematically and periodicallyevaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods, including new approach methods,in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without undue delay. _________________ 47 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).
Amendment 132 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1 a (new)
Article 1 – paragraph 1 – point 1 a (new)
Regulation (EC) 1272/2008
Article 1 – paragraph 5
Article 1 – paragraph 5
(1a) In Article 1, paragraph 5 is replaced by the following: "This Regulation shall not apply to human health hazard classes for substances and mixtures in the following forms, which are in the finished state, intended for the final user: '" Or. en (Regulation (EC) 1272/2008)
Amendment 133 #
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 144 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) 1272/2008
Article 3 – paragraph 1
Article 3 – paragraph 1
(2a) In Article 3, paragraph 1 is replaced by the following: "A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex. Gender differences with regard to the susceptibility to chemicals shall be taken into consideration, where relevant." Or. en (Regulation (EC) 1272/2008)
Amendment 149 #
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 1
Article 5 – paragraph 3 – subparagraph 1
A multi-constituent substance containing at leastmore than 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 is linked to amendments by the same author to the fourth and seventh sub-. (The first part of this amendment is a horizontal amendment: all references in the Commission proposal to "multi- constituent substance(s)" - other than the deletion of the definition - should be replaced with the wording provided here) Or. en paragraph of this paragraph.)
Amendment 162 #
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 4
Article 5 – paragraph 3 – subparagraph 4
Relevant available information on the multi-substance containing more than one 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, unless Annex I lays down a specific provision.
Amendment 173 #
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 – point a
Article 5 – paragraph 3 – subparagraph 6 – point a
(a) the information demonstrates lack of biodegradation, or persistence, mobility andor bioaccumulation properties.
Amendment 177 #
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
Relevant 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, unless Annex I lays down a specific provision.
Amendment 184 #
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 a (new)
Article 5 – paragraph 3 – subparagraph 7 a (new)
In Article 5, paragraph 3, the following subparagraph 7a is added: 'The Commission shall use the procedure in Article 53 to lay down specific provisions in Annex I.'
Amendment 192 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) 1272/2008
Article 6 – paragraph 3 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
However, for the one plant protection product or the one biocidal product for which the approval criteria of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 need to be met, respectively, for the approval of the corresponding active substance, or where the available test data on the mixture itself demonstrates germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting properties for human health or the environment which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, that datadata on the mixture as a whole shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.
Amendment 198 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EC) 1272/2008
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
(5a) In Article 7, the following paragraph 1a is added: '1a. Tests using new approach methodologies shall also be considered'.
Amendment 211 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Regulation (EC) 1272/2008
Article 18 – paragraph 3 – point b
Article 18 – paragraph 3 – point b
(7a) In Article 18, paragraph 3, point (b) is replaced by the following: "the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard. , aspiration hazard, endocrine disruption for human health, endocrine disruption for the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, or very persistent and very mobile properties." Or. en (Regulation (EC) 1272/2008)
Amendment 241 #
Proposal for a regulation
Article 1 – paragraph 1 – point 16 a (new)
Article 1 – paragraph 1 – point 16 a (new)
"HARMONISATION OF CLASSIFICATION AND LABELLING OF SUBSTANCES AND MIXTURES AND THE CLASSIFICATION AND LABELLING INVENTORY " (Horizontal amendment that should apply throughout the text.) Or. en (Regulation (EC) 1272/2008)
Amendment 242 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a
Article 1 – paragraph 1 – point 18 – point a
Regulation (EC) 1272/2008
Article 37 – paragraph 1 – first subparagraph
Article 37 – paragraph 1 – first subparagraph
A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substancesa substance or a group of substances or a mixture and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof.
Amendment 245 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point a
Article 1 – paragraph 1 – point 18 – point a
Regulation (EC) 1272/2008
Article 37 – paragraph 1 – subparagraph 2
Article 37 – paragraph 1 – subparagraph 2
The Commission may ask the Agency or the European Food Safety Authority established in accordance with Article 1(2) of Regulation (EC) No 178/2002* to prepare a proposal for harmonised classification and labelling of substancesa substance or a group of substances or a mixture and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency. Or. en (Linked to the amendment on the first subparagraph of this Article by the same author.)
Amendment 251 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e
Article 1 – paragraph 1 – point 18 – point e
Regulation (EC) 1272/2008
Article 37 – paragraph 5
Article 37 – paragraph 5
The Commission shall adopt without undue delay,within nine months following the receipt of the opinion of the Committee for Risk Assessment adopt delegated acts in accordance with Article 53a to amend Annex VI by inclusion of substances or mixtures together with the relevant classification and labelling elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.
Amendment 253 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point e Regulation (EC) 1272/2008
Article 1 – paragraph 1 – point 18 – point e Regulation (EC) 1272/2008
6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market. A proposal of a manufacturer, importer or downstream user for a change of the harmonised classification and labelling elements of substances in Part 3 of Annex VI to a less severe harmonised classification and labelling shall be accompanied by the fee determined by the Commission in accordance with the procedure referred to in Article 54(2);
Amendment 256 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f
Article 1 – paragraph 1 – point 18 – point f
Regulation (EC) 1272/2008
Article 37 – paragraph 7
Article 37 – paragraph 7
Amendment 257 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point f
Article 1 – paragraph 1 – point 18 – point f
Regulation (EC) 1272/2008
Article 37 – paragraph 8
Article 37 – paragraph 8
Amendment 280 #
Proposal for a regulation
Article 1 – paragraph 1 – point 25 a (new)
Article 1 – paragraph 1 – point 25 a (new)
Regulation (EC) 1272/2008
Article 53 – paragraph 1
Article 53 – paragraph 1
(25 a) In Article 53, paragraph 1 is replaced by the following: "'The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. , and to adopt specific provisions in Annex I for substances containing more than one constituent." Or. en (Regulation (EC) 1272/2008)
Amendment 284 #
Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point b
Article 1 – paragraph 1 – point 26 – point b
Regulation (EC) 1272/2008
Article 53 – paragraph 2
Article 53 – paragraph 2
2. The Commission or the Member States acting in the interest of the Union shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as well as alternative test methods at the level of the UN.;the development of criteria for immunotoxic and neurotoxic substances and as well as alternative test methods, including new approach methods and in particular non- animal methods at the level of the UN to address existing and emerging hazard classes.
Amendment 285 #
Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point c
Article 1 – paragraph 1 – point 26 – point c
Regulation (EC) 1272/2008
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Commission shall regularly evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, including new approach methods and in particular non- animal test methods, at least every two years, and update Annex I of this Regulation to reflect such technical progress, if relevant. The Commission shall update Annex I of this Regulation no more than six months after non- animal data are taken up into harmonised criteria for classification and labelling at the level of the UN.
Amendment 296 #
Proposal for a regulation
Annex I – paragraph 1 – point 1
Annex I – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex I – Part 1 – point 1.1.1.3
Annex I – Part 1 – point 1.1.1.3
1.1.1.3. A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, results of adequate non-mammalian embryo models such as aquatic eleutheroembryos as well as invertebrate species, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) and, (Q)SAR, and omics' results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, as appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination.;