35 Amendments of María Soraya RODRÍGUEZ RAMOS related to 2022/0432(COD)
Amendment 60 #
Proposal for a regulation
Recital 1
Recital 1
(1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore appropriatenecessary to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision wshould improve compliance with and enforcement of the Regulation (EC) No 12727/2008 and thereby ensure a high level of protection of human health and the environment. In order to prevent situations where consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that the supplier which ensures that the substance or the mixture in question meets the requirements set out in that Regulation acts in course of an industrial or professional activity.
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 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 90 #
Proposal for a regulation
Recital 10
Recital 10
(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at maximum6 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). _________________ 40 Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 331, 12.10.2020, p.24.)
Amendment 92 #
Proposal for a regulation
Recital 11
Recital 11
(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size, whilst it does not provide for a minimum font size of labels that would ensure readability. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while durability and good readability of all physical labels should be ensured, including by laying down minimum font size and formatting requirement, using optimal typesets and contrasts between the print and the background and other formatting requirements. In order to ensure compatibility between bigger flexibility and minimum consumers safety, the front page of a fold-out label should display at least signal words, precautionary statement and hazard pictograms.
Amendment 97 #
Proposal for a regulation
Recital 12
Recital 12
(12) Regulation (EC) No 1272/2008 needs to be adjusted to technological and societal changes in the field of digitalisation and be prepared for future developments. Digital labelling could improve the efficiency of hazard communication, especially for vulnerable population groups and people who do not speak the national language of a Member State. Therefore, it is necessary to provide for voluntary digital labelling and to lay down technical requirements for such labelling. In order to provide for legal certainty, it is appropriate to specify the label elements that are allowed to be provided in a digital format only. That possibility should only exist for information which is not instrumental for the safety of the user or the protection of the environment. Unique Formula Identifier, the hazard statement, the signal word, and the hazard pictogram should always remain at the on-pack label to ensure they are in sight of consumers.
Amendment 99 #
Proposal for a regulation
Recital 13
Recital 13
(13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among alldifferent population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs and aensuring high level of protection of human health and the environment and sufficient information on chemicals that the citizens are exposed to.
Amendment 106 #
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 group. The grouping approach to harmonsied classification should therefore be used by default, whenever possible and scientifically justified.
Amendment 131 #
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 – point c
Article 1 – paragraph 5 – point c
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 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.'
Amendment 210 #
(7a) In Article 18, paragraph 3, point b is replaced by the following: "(b) 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, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard. , persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM)." Or. en (32008R1272)
Amendment 246 #
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 3
Article 37 – paragraph 1 – subparagraph 3
The proposals for harmonised classification and labelling of a substance and also groups of substances referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.
Amendment 249 #
Proposal for a regulation
Article 1 – paragraph 1 – point 18 – point d a (new)
Article 1 – paragraph 1 – point 18 – point d a (new)
Regulation (EC) 1272/2008
Article 37 – paragraph 4
Article 37 – paragraph 4
(da) In Article 37, paragraph 4 is replaced by the following "4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission. The Agency may provide further guidance on the development of harmonised classification proposal for group(s) of substances and take into consideration the complexity of the proposal to allow sufficient time for the relevant stakeholders to provide comments." Or. en (32008R1272)
Amendment 252 #
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 6
Article 37 – paragraph 6
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. The manufacturer, importer or downstream user that has, after refusal of submission to adapt classification to a less severe hazard class or category by a competent authority in one of the Member States, resorted to submitting the proposal to a competent authority in another Member States, shall be rejected and contribute with a fee to compensate for the costs borne by the competent authorities;
Amendment 267 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) 1272/2008
Article 42 – paragraph 2 – subparagraph 1 a (new)
Article 42 – paragraph 2 – subparagraph 1 a (new)
In Article 42, paragraph 2, the following subparagraph 1a is added: 'The Agency may, where appropriate, delete obsolete and out-of-date information from the inventory;'
Amendment 282 #
Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point a
Article 1 – paragraph 1 – point 26 – point a
Regulation (EC) 1272/2008
Article 53 – paragraph 1a
Article 53 – paragraph 1a
Amendment 283 #
Proposal for a regulation
Article 1 – paragraph 1 – point 26 – point a
Article 1 – paragraph 1 – point 26 – point a
Regulation (EC) 1272/2008
Article 53 – paragraph 1b – point d
Article 53 – paragraph 1b – point d
(d) take into account the level of digital readiness among all population groups in the Union, as well as readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;
Amendment 288 #
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 a (new)
Article 53 – paragraph 3 a (new)
3a. In Article 53, the following paragraph 3a is added: 'The Commission shall by December 2024 assess hazard criteria for immunotoxicity and neurotoxicity and, where appropriate, adopt delegated acts in accordance with Article 53;'
Amendment 309 #
Proposal for a regulation
Annex I – paragraph 1 – point 9
Annex I – paragraph 1 – point 9
Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.5.2.4.1. – point b – point iv a (new)
Annex I – Part 1 – Section 1.5.2.4.1. – point b – point iv a (new)
(iva) Serious eye damage/irritation, category 1;
Amendment 310 #
Proposal for a regulation
Annex I – paragraph 1 – point 9
Annex I – paragraph 1 – point 9
Regulation (EC) No 1272/2008
Annex I – Part 1 – Section 1.5.2.4.1 – point b – point v a (new)
Annex I – Part 1 – Section 1.5.2.4.1 – point b – point v a (new)
(va) Skin sensitisation, category 1 (sub- categories 1A and 1B);
Amendment 311 #
Proposal for a regulation
Annex II – paragraph 1 – point -1 (new)
Annex II – paragraph 1 – point -1 (new)
Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.1.1.1
Annex II – Part 3 – Section 3.1.1.1
Amendment 313 #
Proposal for a regulation
Annex II – paragraph 1 – point -1 a (new)
Annex II – paragraph 1 – point -1 a (new)
Regulation (EC) No 1272/2008
Annex II – Part 3 – section 3.2.1.
Annex II – Part 3 – section 3.2.1.
-1a. In in Part 3 of Annex II, section 3.2.1. is replaced by the following: ‘3.2.1. Packaging to be fitted with a tactile warning Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion/skin irritation, serious eye damage/eye irritation, endocrine disruption for human health category 2, endocrine disruption for the environment category 2, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory or skin sensitiszation, or Stot,STOT categories 1 andor 2, aspiration hazard, or flammable gases, liquids and solids in categories 1 and 2flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.’
Amendment 315 #
Proposal for a regulation
Annex II – paragraph 1 – point 1
Annex II – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex II – Part 3 – section 3.4. – point b
Annex II – Part 3 – section 3.4. – point b
(b) a label is firmly affixed on a visible place of the refill station and with a font size that is easily legible and without serifs and is provided free of charge by suppliers;
Amendment 320 #
Proposal for a regulation
Annex II – paragraph 1 – point 1
Annex II – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4. – point iv a (new)
Annex II – Part 3 – Section 3.4. – point iv a (new)
(iva) Serious eye damage/irritation, category 1;
Amendment 322 #
Proposal for a regulation
Annex II – paragraph 1 – point 1
Annex II – paragraph 1 – point 1
Regulation (EC) No 1272/2008
Annex II – Part 3 – Section 3.4. – point v a (new)
Annex II – Part 3 – Section 3.4. – point v a (new)
(va) Skin sensitisation, category 1 (sub- categories 1A and 1B);
Amendment 327 #
Proposal for a regulation
Annex II a (new)
Annex II a (new)
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. For dossier for harmonised classification and labelling of groups of substances, justification for the grouping. —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.’