13 Amendments of Dennis RADTKE related to 2022/0432(COD)
Amendment 71 #
Proposal for a regulation
Recital 2
Recital 2
(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’)s for which the information is available for this constituent 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- constituentsubstances is to be generated under the same conditions as data on any otheris to be developpedon substances, 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).
Amendment 87 #
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-constituenta 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 or substances in the mixture. Therefore, it is appropriate that data on multi-constituent substancsubstances or mixtures are used in those cases.
Amendment 107 #
Proposal for a regulation
Recital 18
Recital 18
(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity based on a scientific evidence approach and justification allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.
Amendment 140 #
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 5 – paragraph 7a
Article 5 – paragraph 7a
Amendment 152 #
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.
Amendment 205 #
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 17 – paragraph 1
Article 17 – paragraph 1
(7a) In Article 17, paragraph 1 is replaced by the following: "1. A substance or mixture classified as hazardous and contained in packaging shall bear a label or fold-out label including the following elements: " Or. en (Regulation 1272/2008)
Amendment 207 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 b (new)
Article 1 – paragraph 1 – point 7 b (new)
Regulation (EC) 1272/2008
Article 17 paragraph 1 – point a
Article 17 paragraph 1 – point a
(7b) In Article 17, in paragraph 1, point a is replaced by the following: "(a) the name, address and telephone number of the supplier(s); distributers who do not change the product or packaging may use the provided label unchanged." Or. en (Regulation 1272/2008/EC)
Amendment 208 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 b (new)
Article 1 – paragraph 1 – point 7 b (new)
Regulation (EC) 1272/2008
Article 17 – paragraph 2
Article 17 – paragraph 2
(7b) In Article 17, paragraph 2 is replaced by the following: "2. The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.Suppliers may use more languages on their labels or fold-out labels than those required by the Member States, provided that the same details appear in all languages used. " Or. en (Regulation 1272/2008)
Amendment 215 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10 a (new)
Article 1 – paragraph 1 – point 10 a (new)
Regulation (EC) 1272/2008
Article 25 – paragraph 6
Article 25 – paragraph 6
(10a) In Article 25, paragraph 6 is replaced by the following: "6. Where a mixture contains any substance classified as hazardous, it shall be labelled in accordance with Part 2 of Annex II.The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label.The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture. Distributers who do not change the product or its packaging may use the provided label unchanged." Or. en (Regulation 1272/2008/EC)
Amendment 222 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EC) 1272/2008
Article 30 – paragraph 1
Article 30 – paragraph 1
1. In case of a change regarding the classification and labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier shall ensure thupdate the label is updated within 612 months after the supplier has received the results of the new evaluation referred to in Article 15 (4) were obtained.
Amendment 223 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EC) 1272/2008
Article 30 – paragraph 2
Article 30 – paragraph 2
2. Where a change regarding the classification and labelling of a substance or a mixture is required other than that referred to in paragraph 1, tThe supplier shall ensure that the label is updated within 18 months after the results ofsupplier has received the new evaluation referred to in Article 15(4) were obtained.
Amendment 225 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12
Article 1 – paragraph 1 – point 12
Regulation (EC) 1272/2008
Article 30 – paragraph 3a new
Article 30 – paragraph 3a new
3a. Paragraphs 1 and 2 shall not be applicable to distributers who do not modify the product, its packaging or label.
Amendment 228 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 a (new)
Article 1 – paragraph 1 – point 13 a (new)
Regulation (EC) 1272/2008
Article 31 – title
Article 31 – title