6 Amendments of Anna ZALEWSKA related to 2022/0432(COD)
Amendment 62 #
Proposal for a regulation
Recital 2
Recital 2
Amendment 83 #
Proposal for a regulation
Recital 3
Recital 3
(3) It is normally not possibleUnder the current state of science, it may be difficult 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 cases.
Amendment 104 #
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 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 groupbased on scientific justification (taking into account all available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach, allows for similar classification of all substances in the group. The grouping process should be scientifically robust, coherent and transparent for all stakeholders. 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. The similarity of a group of substances should be given for the specific endpoint and the severity of the effect, which results in the same classification for the respective hazard class. To ensure that all submitters of dossiers for harmonised classification and labelling apply the same scientific principles to justify the grouping approach, there is a need for ECHA to develop guidance clarifying the principles from which a harmonised classification for a group of substances can be derived.
Amendment 136 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Regulation (EC) No 1272/2008
Article 2 – point 7a
Article 2 – point 7a
Amendment 147 #
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
[...] d e [...] l e t e d
Amendment 325 #
Proposal for a regulation
Annex II a (new)
Annex II a (new)
In Annex VI, Part 2 is replaced by the following: ‘2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: — Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. — Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. — Justification for the proposed grouping of substances to harmonized classification and labelling Where a harmonised classification and labelling proposal is made for group(s) of substances, the dossier shall include scientific justification (based on assessment of available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach, for the grouping of substances and for applying a similar classification. — Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC.’.