8 Amendments of Marian-Jean MARINESCU related to 2022/0432(COD)
Amendment 88 #
Proposal for a regulation
Recital 4
Recital 4
(4) In order to improve legal certainty and implementation with regard to the evaluation of hazard information for mixtures where no or inadequate test data are available for the mixture itself, the interaction between the application of the bridging principles and a weight of evidence determination using expert judgement should be clarified. Such clarification should ensure that the weight of evidence determination complements but does not substitute the application of the bridging principles. It should also be clarified that if bridging principles cannot be applied to evaluate a mixture, manufacturers, importers and downstream users should use the calculation method or other methods described in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008. Commission shall provide detailed guidance regarding adjusted calculation method for special mixture. It should also be clarified which criteria, when not met, determine when a weight of evidence determination using expert judgment is to be carried out.
Amendment 103 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) The process of classification of a substance or mixture under this Regulation should identify, assess and communicate the regulatory links between this Regulation and the relevant EU legislation.
Amendment 109 #
Proposal for a regulation
Recital 19
Recital 19
(19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Stakeholders should have better acces to CARACAL and the platform should provide a higher transparency. to include among others meeting minutes, discussions and decisions related to CLP classification proposals. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. The proposals should be based on socio- economic assessments. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities.
Amendment 129 #
Proposal for a regulation
Article 1 – paragraph 1 – point -1 (new)
Article 1 – paragraph 1 – point -1 (new)
Regulation (EC) 1272/2008
Article 1 – paragraph 1
Article 1 – paragraph 1
-1 In Article 1 Purpose and Scope , paragraph 1 is replaced by the following: "1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures;b) providing an obligation for: (i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market; (ii) suppliers to label and package substances and mixtures placed on the market; (iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006; (iv) the Commission to ensure, prior to introducing new hazard classes or classification criteria, that such classes or criteria can be fully satisfied with existing data aligned with the EU’s goal of using alternative test methods, and thus avoiding animal testing where feasible." Or. en (Regulation 1272/2008)
Amendment 191 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Amendment 196 #
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
Article 7
(5a) Article 7 is replaced by the following: "Article 7 Article 7 Animal and human testing 1. Where new tests are carried out for the purposes of this Regulation, tests on animals within the meaning of Directive 86/ 609/EEC shall be undertaken only where no other alternatives, which provide adequate reliability and quality of data, are possible. 2. Tests on non-human primates shall be prohibited for the purposes of this Regulation. 3. Tests on humans shall not be performed for the purposes of this Regulation. Data obtained from other sources, such as clinical studies, can however be used for the purposes of this Regulation. All data shall be evaluated comparably and according to their biological relevance, mechanistic understanding, and ability to provide information suitable for meeting the requirements of this Regulation." Or. en (Regulation 1272/ 2008)
Amendment 204 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Regulation (EC) 1272
Article 17
Article 17
(7a) Article 17 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: (a) the name, address and telephone number of the supplier(s); (b) the nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package; (c) product identifiers as specified in Article 18; (d) where applicable, hazard pictograms and signal words in accordance with Article 19 and 20; (e) where applicable, signal words in accordance with Article 20; (f) where applicable, hazard statements in accordance with Article 21; (g) where applicable, the appropriate precautionary statements in accordance with Article 22; (h) where applicable, a section for a statement indicating that supplemental information in accordance with Article 25, and other sector specific labelling information, can be found online. 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. The information in paragraph 1 (e), (f), (g) and (h) may be provided on the inner pages of a fold-out label. For multilingual fold-out labels, the languages shall be ordered in a logical way, e.g. alphabetically. The Commission shall develop clear guidance to outline further the details of the criteria in this article prior to the entry into force of this Regulation." Or. en (32008R1272)
Amendment 273 #
Proposal for a regulation
Article 1 – paragraph 1 – point 23
Article 1 – paragraph 1 – point 23
Regulation (EC) 1272/2008
Article 48 – paragraph 1
Article 48 – paragraph 1
1. Any advertisement ofor a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements and request the user to always read and follow product label information.