16 Amendments of Max ORVILLE related to 2022/0432(COD)
Amendment 64 #
Proposal for a regulation
Recital 2
Recital 2
Amendment 65 #
Proposal for a regulation
Recital 2
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. 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-substances containing 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 a specific provision for those multi-constituentsubstancessubstances containing more than one constituenton the basis of sufficient and reliable scientific argumentation. Such derogations would be warranted where using data on constituents and calculation rules would result in a less appropriate classification of the complexsubstances than by using data on the substance itself. This could be the case for example when a complex substance like essential oil contains only structurally similar constituents or when there is proof of antagonistic effects among constituents. The Committee for Risk Assessment of the Agency set up pursuant to Article 76/1/(c) of Regulation (EC) no 1907/2006 should provide an assessment of the derogations when needed.This regulatory approach should contribute to the objectives of the EU Chemical Strategy for Sustainability to better protect citizens and the environment and to boost innovation for safe and sustainable chemicals by ensuring implementation of existing legal provisions of Regulation 1272/2008 and corresponding Guidance on the Application of the CLP criteria. _________________ 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 73 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) Essential oils are derived from various sections of plants and are obtained by distillation, steam distillation or expression. They are complex substances that should warrant a tailored approach to their identification, including by providing for scientifically justified derogations from the rules applicable to the substances with more than one constituent under Article 5(3) of this Regulation. The European Commission and the Agency should assist the sector, particularly micro and small companies, that intends to benefit from the derogation, including by ensuring expeditious assessment of the dossier. This Regulation does not regulate safe use of essential oils in consumer products.
Amendment 82 #
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 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 85 #
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-substance containing more than one 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 substancesubstance containing more than one constituent 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-substance containing more than one 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 substancessubstances containing more than one constituent are used in those cases.
Amendment 137 #
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 – paragraph 7a
Article 2 – paragraph 7a
Amendment 139 #
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 – paragraph 7a
Article 2 – paragraph 7a
Amendment 148 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 1272/2008
Article 5 – paragraph 3
Article 5 – paragraph 3
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Amendment 153 #
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
Amendment 157 #
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 2
Article 5 paragraph 3 – subparagraph 2
For the evaluation of multi-constituent substancessubstances containing more than one constituent 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 classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1. and 4.2.3.1. of Annex I, 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.
Amendment 159 #
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 3
Article 5 – paragraph 3 – subparagraph 3
Relevant available information on the multi-constituent substancesubstances containing more than one constituent itself shall be taken into account where one of the following conditions are met, unless Annex I lays down a specific provision:
Amendment 164 #
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-constituent substancesubstances containing more than one constituent itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.
Amendment 169 #
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 5
Article 5 – paragraph 3 – subparagraph 5
For the evaluation of multi-constituent substancessubstances containing more than one constituent 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 I, 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.
Amendment 171 #
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
Article 5 – paragraph 3 – subparagraph 6
Relevant available information on the multi-constituent substancesubstances containing more than one constituent itself shall be taken into account where one of the following conditions are met, unless Annex I lays down a specific provision:
Amendment 179 #
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 substancesubstances containing more than one constituent itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.
Amendment 181 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) 1272/2008
Article 5 – paragraph 3a (new)
Article 5 – paragraph 3a (new)
In Article 5, the following paragraph 3a is added: 'The European Commission shall, where appropriate and scientifically justified, amend Annex I in accordance with the procedure referred to in Article 53, to lay down specific provisions granting derogation from the criteria set out in this Article for a substance containing more than one constituent. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall, where necessary, adopt an opinion on the scientific argumentation for a derogation from the rules for substances containing more than one constituent provided under this article.'