What changed between the adopted text of 4 Oct 2023 and the adopted text of 23 Apr 2024

Removed:P9_TA(2023)0340

Added:TEXTS ADOPTED

Added:P9_TA(2024)0296

Classification, labelling and packaging of substances and mixtures

Committee on the Environment, Public Health and Food Safety

PE745.493

Changed:Amendments adopted by the European Parliament onlegislative 4resolution Octoberof 202323 April 2024 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (COM(2022)0748 – C9-0433/2022 – 2022/0432(COD))

(Ordinary legislative procedure: first reading)

Removed: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 necessary 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, together with the requirements in Regulation (EU) xxx/xxx [reference to adopted act to be inserted] on General Product Safety, Regulation (EU) 2022/2065, and Regulation (EU) 2019/1020 should improve compliance with and enforcement of Regulation (EC) No 1272/2008 and thereby ensure a high level of protection of human health and the environment. In order to prevent situations where a 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 th…

Change 1

Added:The European Parliament,

Removed:Recital 2: (2) Substances containing more than one constituent are not intentional mixtures. From a toxicological point of view, substances containing more than one 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 minimise animal testing, data on substances containing more than one constituent 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 are available, substances containing more than one constituent should be evaluated and classified following the same classification rules as mixtures.

Added:– having regard to the Commission proposal to Parliament and the Council (COM(2022)0748),

Removed:Recital 2 a (new): (2a) Scientific evidence on substances containing more than one constituent of renewable botanical origin shows that specific constituents considered in an isolated way can have hazard properties that might not be expressed in the substance as a whole. Substances of renewable botanical origin are substances obtained from living plant algae and fungi organisms, renewable on a human time scale (non-fossil sources). The Commission should review the identification and examination of substances containing more than one constituent of renewable botanical origin that are not chemically or genetically modified and are not covered by Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012. In the context of such review, the Commission should also assess the social and economic impact on micro and small enterprises.

Added:– having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90433/2022),

Removed:Recital 3: (3) Under the current state of science, it is 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 substance containing more than one constituent 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 substance containing more than one constituent should therefore normally be used as the basis for hazard identification of those substances containing more than one constituent or mixtures. However, in certain cases, data on those substances containing more than one constituent 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.

Added:– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

Removed: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. 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. Given that the application of criteria on the different hazard classes is not always straightforward and bearing in mind that a specific hazard class may be defined by multiple criteria, manufacturers, importers and downstream users should apply weight of evidence determinations.

Added:– having regard to the opinion of the European Economic and Social Committee of 27 April 2023,

Removed: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 labels should be ensured, including by laying down minimum font size, and formatting requirements.

Added:– having regard to the provisional agreement approved by the committee responsible under Rule 74(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 22 December 2023 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

Removed: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 and should be determined taking into account the need for a high level of protection of human health and the environment. The decision as to which information is not relevant for the safety of the user or the protection of the environment needs to be documented transparently. The Unique Formula Identifier, the hazard statement, the precautionary statement, the signal word, and the hazard pictogram should always remain on the on-pack label to ensure they are in sight of consumers.

Added:– having regard to Rule 59 of its Rules of Procedure,

Removed: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 all 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, ensuring high level of protection of human health and the environment and sufficient information on chemicals that citizens are exposed to.

Added:– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A9-0271/2023),

Removed: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 scientific justification, 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. Where it is scientifically justified and possible, proposals for classification should prioritise groups of substances rather than individual substances. In the event of a proposal for harmonised classification and labelling of a group of substances, those substances should be grouped together based on clear scientific criteria, including structural similarity and similar evidence-based hazard profiles.

Added:1. Adopts its position at first reading hereinafter set out;

Removed: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. 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. Interested parties should be given the opportunity to comment where appropriate. 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. To increase the efficiency of the harmonized classification and labelling process, the Commission should adopt a delegated act, no later than 12 months following the publication of the RAC opinion.

Added:2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

Removed:Recital 24: (24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human health and the environment. Therefore, the notifiers should be required, without needing to acquire new data or new studies being necessary, to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation. Moreover, the Agency shou…

Added:3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Removed:Recital 25: (25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, all information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.

Added:P9_TC1-COD(2022)0432

Removed:Recital 29: (29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and mixtures in a general manner and provides that an advertisement for a substance classified as hazardous is to mention the hazard classes or hazard categories concerned, and an advertisement for a mixture classified as hazardous or a mixture containing a classified substance is to mention the types of hazards indicated on the label where such advertisement allows concluding a contract for purchase without first having sight of the label. This obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains all the information which is most important in terms of safety and protection of health and the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard class and the hazard statements. The hazard category should not be provided, as it is reflected by the hazard statement.

Added:Position of the European Parliament adopted at first reading on 23 April 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures

Removed:Recital 33: (33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council47, it is necessary to replace, reduce or refine testing on animals, with a view to phasing out the use of animals for testing as soon as possible. Implementation of Regulation (EC) No 1272/2008 should be based on the promotion and use of New Approach Methodologies (NAM), suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be promoted, monitored and systematically and periodically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods, including new approach methods, in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without delay.

Added:(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2024/2865.)

Removed:Recital 35 a (new): (35a) Where appropriate, the Agency should provide further guidance on the application of the provisions relating to the review of this Regulation.

Removed:Recital 36 a (new): (36a) The amendments introduced by this regulation expand the tasks, workload and remit of the Agency. In order to provide adequate expertise, support, and thorough scientific evaluations, appropriate and stable funding for the Agency should be ensured under the framework of the upcoming Regulation establishing the ECHA.

Removed:Recital 37: (37) To ensure that suppliers of substances and mixtures have time to adapt to new rules on classification, labelling and packaging, the application of some provisions of this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re-labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point -1 (new), Article 1 – paragraph 1: -1 In Article 1, paragraph 1 is replaced by the following: / "The purpose of this Regulation is to ensure a high level of protection of human health and the environment including the promotion of alternative methods, for assessment of hazards of substances and mixtures, 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;"

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 2, Article 2 – paragraph 1 – point 7a: deleted

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 2, Article 2 – paragraph 1 – point 38 a (new): 38a. ‘refill’ means an operation through which a consumer or a professional user fills its own container, which fulfils the packaging function, with a hazardous substance or mixture offered by a supplier in the context of a commercial transaction;

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 2, Article 2 – paragraph 1 – point 38 b (new): 38b. ‘refill station’ means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be purchased through refill;

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 2 a (new), Article 3 – paragraph 1: (2a) In Article 3, paragraph 1 is replaced by the following: / "A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex. Gender differences with regard to the susceptibility to chemicals shall be taken into consideration, where relevant."

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 1: A substance containing more than 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 and evaluated in accordance with the criteria set out in this paragraph, using the available information on those known constituents above the applicable concentration limit as well as on the substance itself.

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 2: For the evaluation of these substances containing more than one constituent pursuant to Chapter 2 in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disruption for human health’ and ‘endocrine disruption for the environment’ hazard classes referred to in sections 3.5., 3.6., 3.7., 3.11. and 4.2. of Annex I, the manufacturer, importer or downstream user shall use the relevant available information referred to in paragraph 1 for each of the known individual constituents, impurities and additives in the substance,

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 3 – introductory part: Relevant available information on the substance containing more than one constituent itself shall be taken into account where one of the following conditions are met:

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 3 – point a: (a) the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment;

Removed:Regulation (EC) No 1272/2008

Removed:Article 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 4: Relevant available information on the substance 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.

Removed:Regulation (EC) No 1272/2008