(1)

In order to keep pace with globalisation, technological developments 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 (3). While under Regulation (EC) No 1272/2008 it is assumed that all economic operators 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 be a supplier established in the Union which ensures that the substance or the mixture in question meets the requirements set out in Regulation (EC) No 1272/2008 when it is being placed on the market, including via distance sales, such as via online market places. Such provision, together with requirements in Regulations (EU) 2019/1020 (4), (EU) 2022/2065 (5) and (EU) 2023/988 (6) of the European Parliament and of the Council, would 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 avoid situations where a consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from 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 Regulation (EC) No 1272/2008 acts in the course of an industrial or professional activity.

(2)

Substances containing more than one constituent are complex substances. 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 Council (7), which aims to minimise animal testing, data on substances containing more than one constituent are to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance are 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.

(3)

Scientific data on certain substances containing more than one constituent extracted from plants have indicated that specific constituents considered in an isolated way can have hazard properties that might not be expressed in the substance as a whole. Therefore, in order to allow time for a scientific evaluation of the appropriateness of requiring substances containing more than one constituent extracted from plants to follow the rules on classification of substances containing more than one constituent, a derogation from certain rules should be introduced for the purpose of identification and examination of information on those substances. However, when no relevant information is available on the substance itself, manufacturers, importers and downstream users might apply these rules to their substances extracted from plants, in order to maintain the current level of protection and the existing good practice. The Commission should review the rules applicable to the identification and examination of the information on substances containing more than one constituent extracted from plants, within five years of the entry into force of this Regulation and submit, if appropriate, a legislative proposal.

(4)

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 substance containing more than one constituent or of a mixture on the basis of data on that substance or mixture. The data for the individual substances of the mixture or for the individual constituents of the substance containing more than one constituent should therefore as a rule be used as the basis for hazard identification of those substances containing more than one constituent or of mixtures. However, in certain cases, data on those substances containing more than one constituent themselves may also be relevant. That is the case in particular where such data demonstrate endocrine-disrupting properties for human health or the environment, or persistent, bioaccumulative and mobile properties, or where such data support the conclusions based on data on the individual constituents. Therefore, it is appropriate that data on substances containing more than one constituent be used in those cases.

(5)

In order to improve legal certainty and the application of the rules 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.

(6)

To avoid over-classification of mixtures which contain substances classified as hazardous solely due to the presence of an impurity, an additive or an individual constituent, and of mixtures which contain other mixtures with such substances, classification should only be mandatory if such impurity, additive or individual constituent is contained in the mixture or in the final mixture at or above a certain concentration limit as referred to in Annex I to Regulation (EC) No 1272/2008.

(7)

Acute toxicity estimates are mainly used to determine the acute toxicity for human health classification of mixtures containing substances classified for acute toxicity. Substances can be classified in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route according to certain numeric criteria. Acute toxicity values are expressed as approximate LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates. It is appropriate to further specify the meaning of,acute toxicity estimates to increase their clarity and consistency. As acute toxicity estimates are necessary for the harmonised classification and labelling of substances classified for acute toxicity, they should be included in the proposal, opinion and decision for harmonised classification of a substance for acute toxicity. In the same way as M-factors and concentration limits, acute toxicity estimates should, together with a justification, be notified to the European Chemicals Agency (the ‘Agency’) with a view to their being included in the classification and labelling inventory.

(8)

In general, substances and mixtures should be classified for any form or physical state. However, when the available scientific evidence warrants a different classification linked to a specific form or physical state, it should be possible for manufacturers, importers and downstream users in the self-classification process to classify a substance or mixture differently depending on the form or physical state. However, if a substance is subject to harmonised classification without being limited to a specific form or physical state, that harmonised classification should apply to all its forms or physical states. If a substance is subject to harmonised classification only for a specific form of that substance, it should be clarified that the classification of the substance for the other forms or physical states is to remain subject to self-classification.

(9)

While most ammunition is usually considered to be an article, in some cases, it could be a substance or a mixture. Where ammunition is determined to be a substance or a mixture, it should bear a label affixed to the surface of the packaging immediately containing the substance or the mixture that is to say the inner packaging. Affixing a label to the inner packaging might however cause safety problems for the user, as the label could interfere with the correct functioning of the ammunition and could damage the firearm. Such ammunition should therefore be allowed to bear a label affixed to the next packaging layer instead of the inner packaging. In addition, labelled ammunition that is intended for use by national defence forces, could, in specific cases, constitute an unacceptable security risk for the ammunition or for the military or non-military staff, if sufficient camouflaging cannot be ensured. For such cases, it is necessary to provide for an exemption from the labelling requirements and allow for alternative ways of communicating the hazard information.

(10)

In order to enhance clarity, all supplemental labelling requirements should be placed together in one article.

(11)

Part 2 of Annex II to Regulation (EC) No 1272/2008 sets out rules for additional hazard statements to be included on the label of certain mixtures listed therein. Given that those statements provide important additional information in specific cases, they should be applied to all mixtures referred to in Part 2 of Annex II, regardless of whether they are classified and whether they contain any classified substance.

(12)

To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification or 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) 2020/1435 (8). 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 label elements are required under Article 25, the deadline for a supplier 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 6 months from the date on which the results of a new evaluation on the classification of that substance or that mixture were obtained by, or communicated to, that supplier. 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 date on which the results of a new evaluation on the classification of that substance or that mixture were obtained by, or communicated to, that supplier. To ensure that the results of reviewed classifications of substances and mixtures are communicated throughout the whole supply chain, suppliers should cooperate in order to reduce the overall time needed to effectuate any necessary changes in classification, labelling or packaging.

(13)

It should also be clarified that, in cases of harmonised classification and labelling, the deadline to update the labelling information is 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 should apply for 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).

(14)

Regulation (EC) No 1272/2008 allows for the use of fold-out labels only 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. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a possibility to use fold-out labels on a regular basis. It is therefore appropriate to allow labels to be presented in the form of fold-out labels, applying the rules on application and formatting to ensure good readability, and the specific requirements for the content of the front, inner and back pages.

(15)

In order to ensure a high level of protection for human health and the environment, it is necessary that labels on substances and mixtures be legible. Minimum requirements on important parameters such as font size, distance and colour should therefore be laid down. A flexible approach should, however, be taken in respect of shades of those colours so as not to hamper efforts to achieve a circular economy through the use of recycled materials for packaging material.

(16)

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, such as people with visual impairments, and for 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 that a supplier who places a data carrier linking to such a digital label must satisfy. Such technical requirements on the digital label should, however, not affect the responsibility of suppliers to ensure that labelling requirements are fulfilled when placing a substance or mixture on the market. In order to keep pace with digitalisation, it is appropriate to allow certain label elements required under this Regulation to be provided in a digital format only. That possibility should only exist for information which is not essential for the safety of the user or the protection of the environment, while not affecting the labelling requirements or possibilities for digital labelling laid down in other Union law, and should take into account the need for a high level of protection of human health and the environment.

(17)

In order to adapt the label elements allowed to be provided only in a digital format to developments in GHS, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) to amend the list of label elements allowed to be provided on a digital label alone, provided that GHS does not require such label elements to be also put on the physical label, and taking into account the level of digital readiness among all population groups in the Union, societal needs and a high level of protection of human health and the environment.

(18)

In order to adjust to technological changes and developments in the field of digitalisation, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the TFEU to supplement Regulation (EC) No 1272/2008 by further specifying the technical requirements for the digital labelling provided for in this Regulation.

(19)

Regulation (EC) No 1272/2008 currently does not lay down any specific rules for labelling and packaging of substances or mixtures supplied to the general public and professional users via refill stations. Considering the increasing trend of selling products, including certain chemicals such as detergents, without packaging in order to reduce waste and to facilitate more sustainable sales forms, it is appropriate to set out specific rules and conditions for such types of sale and establish a list of hazard classes and categories for which the sale of substances or mixtures meeting the criteria for classification in those hazard classes and categories via refill stations is prohibited, in order to ensure safety and the protection of human health. Risk mitigation measures should be in place to ensure that refilling can be performed safely, for example by preventing overfilling, contamination and especially any uncontrolled operation of the refill station by children, as well as avoiding any reaction between substances or mixtures dispensed through the refill station, or between those substances or mixtures, and any residues in the packaging to be refilled.

(20)

Regulation (EC) No 1272/2008 does not lay down rules on the labelling of chemicals supplied to the general public without packaging except for ready mixed cement and concrete, in a wet state. In order to enhance legal clarity and ensure that citizens are better protected, it is appropriate to provide for the label elements of certain chemicals, such as fuels, diesel exhaust fluids and wind-screen fluids, supplied at filling stations and intended to be pumped into receptacles from which they are normally not intended to be removed. For the same reason, in the case of vehicle fuels supplied in portable receptacles, it is necessary to ensure that labelling information is available for the user.

(21)

As the new hazard classes and criteria introduced by Commission Delegated Regulation (EU) 2023/707 (9) allow for the harmonised classification and labelling of substances of the highest concern with regard to human health and the environment, they should normally be subject to harmonised classification and labelling and added to the list of hazard classes which includes respiratory sensitisation, germ cell mutagenicity, carcinogenicity and reproductive toxicity. Sub-categorisation of the hazard class for respiratory sensitisation in sub-category 1A or 1B should be performed where information sufficient to classify in those hazard sub-categories is available, in order to avoid over- or under-classification. In view of the rapid development of scientific knowledge and the long-standing expertise of the Agency and the European Food Safety Authority (the ‘Authority’) on the one hand, and the limited resources of Member States’ competent authorities to develop harmonised classification proposals on the other, the Commission should have the right to request the Agency and the Authority to develop a harmonised classification and labelling proposal.

(22)

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 and 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 case of a proposal for harmonised classification and labelling of a group of substances, those substances should be grouped together on the basis of clear scientific reasoning that takes into account how the available information supports the grouping of substances and allows the properties of the substances to be reliably predicted from other substances in the group.

(23)

To increase the transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers and 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 a 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. For the same reason, a competent authority that receives a proposal for revision of 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. In that regard, the Commission should adopt delegated acts, without undue delay, and preferably before the end of the calendar year following the publication of the opinion of the Committee for Risk Assessment.

(24)

The criteria for inclusion of substances in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006 are equivalent to those of certain hazard classes and categories included in Annex I to Regulation (EC) No 1272/2008. In view of the high level of evidence required for inclusion in the candidate list, the substances currently on that list should be included in Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008. Substances included in the candidate list as having endocrine-disrupting properties should be included as ‘endocrine disruption for human health category 1’ or ‘endocrine disruption for the environment category 1’ in Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

(25)

As the criteria for substances to qualify as an endocrine disruptor for human health or the environment included in sections 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 of the European Parliament and of the Council (10) and in Commission Delegated Regulation (EU) 2017/2100 (11), and those to qualify as an endocrine disruptor for human health or the environment included in Annex I to Regulation (EC) No 1272/2008, are equivalent, substances which qualify as meeting the criteria for endocrine disruptor properties in accordance with Commission Regulation (EU) 2018/605 (12) and Delegated Regulation (EU) 2017/2100 should be included in ‘endocrine disruption for human health category 1’ or ‘endocrine disruption for the environment category 1’ in Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

(26)

As Article 5(1), point (e), of Regulation (EU) No 528/2012 (13) refers to the persistent, bioaccumulative and toxic and the very persistent and very bioaccumulative criteria included in Annex XIII to Regulation (EC) No 1907/2006 to identify the persistent, bioaccumulative and toxic and very persistent and very bioaccumulative properties of active substances and as those criteria are equivalent to those included in Annex I to Regulation (EC) No 1272/2008, the active substances meeting the criteria to qualify as persistent, bioaccumulative and toxic and very persistent and very bioaccumulative under Regulation (EU) No 528/2012 and under Annex XIII to Regulation (EC) No 1907/2006 should be included in Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008. As persistent, bioaccumulative and toxic and very persistent and very bioaccumulative properties included in sections 3.7.2 and 3.7.3 of Annex II to Regulation (EC) No 1107/2009 are equivalent to those included in Annex I to Regulation (EC) No 1272/2008, the active substances meeting the criteria to qualify as persistent, bioaccumulative and toxic and very persistent and very bioaccumulative in sections 3.7.2 and 3.7.3 of Annex II to Regulation (EC) No 1107/2009 should be included in Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

(27)

As the substances referred to in recitals 24, 25 and 26 have already been assessed by the Authority or the Agency, and are in the process of being or have already been assessed and decided upon by the Commission, they should be included in Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 by a delegated act, without prior consultation of the Agency as provided for in Article 37(4) of Regulation (EC) No 1272/2008.

(28)

To avoid duplication of ongoing work by authorities under Regulations (EC) No 1907/2006, (EC) No 1272/2008, (EC) No 1107/2009 and (EU) No 528/2012, the Commission should also adopt delegated acts within an adequate timeframe for substances which are intended to be added to the candidate list under Article 59 of Regulation (EC) No 1907/2006; substances for which applications for approval or renewal of approval have been submitted in accordance with the relevant provisions of Regulation (EC) No 1107/2009; substances for which the evaluating competent authority has submitted its draft assessment report on the approval or renewal of approval to the Agency in accordance with Regulation (EU) No 528/2012; or substances for which the application was submitted for the purposes of Directive 98/8/EC of the European Parliament and of the Council (14) and the Member State’s evaluation in accordance with that Directive was completed by 1 September 2013 but no decision on the approval was adopted before that date, or substances for which the Agency has submitted to the Commission an opinion pursuant to Article 75(1)(g) of Regulation (EU) No 528/2012 concluding that they meet those criteria. Furthermore, in order to ensure that new dossiers or on-going dossiers still at an early stage of the assessment contain a dossier for harmonised classification and labelling, the transitional provisions provided for in this Regulation should apply for a limited period.

(29)

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 such divergences could 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, on the basis of the available data that were used for classification, 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 of the taking of a decision to change the classification and labelling of a substance pursuant to a review in Article 15(1) of Regulation (EC) No 1272/2008. Moreover, the Agency should be able to require the notifier to rectify an entry that is incomplete, incorrect or obsolete and to notify the Agency thereof.

(30)

Regulation (EC) No 1272/2008 lays down specific rules on packaging that should be fitted with child-resistant fastenings and with a tactile warning. It is important that those provisions ensure a high level of protection of human health. Within 5 years of the entry into force of this Regulation the Commission should therefore assess the effectiveness of those provisions and the need to extend provisions to other hazard classes, in particular to extend requirements for child-resistant fastenings to eye damage category 1, and consult the expert group set up in accordance with Article 53a(4) of the Regulation (EC) No 1272/2008. If such need is identified, the Commission should adopt a delegated act amending Annex II to Regulation (EC) No 1272/2008 as soon as possible.

(31)

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 because it would facilitate the objective of coming to an agreement on an entry to be included in that classification and labelling inventory if notifiers knew whom to contact. 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. The Agency should provide information on the conditions for notifiers to claim confidentiality and display them in the inventory. It should put in place adequate measures to prevent and identify undue confidentiality claims, in particular by performing IT screening and manual random checks.

(32)

Pursuant to Article 45(1) of Regulation (EC) No 1272/2008, appointed bodies in the Member States are to receive relevant information relating to emergency health response submitted by importers and downstream users placing on the market mixtures that are hazardous based on their health or physical effects. Distributors are not required to submit such information. In certain cases of distribution across borders from one Member State to another, or where distributors rebrand or relabel mixtures, the absence of such a submission obligation causes information loss for the appointed bodies which may prevent them from providing an adequate emergency health response. To address that situation, an obligation to submit information relating to emergency health response should also be introduced for distributors, where they further distribute hazardous mixtures in other Member States or where they rebrand or relabel hazardous mixtures.

(33)

Pursuant to Article 45(3) of Regulation (EC) No 1272/2008, appointed bodies are to have all the required information available to provide adequate emergency health response. The Agency has set up and maintains a Union level poison centres notification portal, and established, developed and maintains a database containing information relating to emergency health responses to assist some Member States in complying with Regulation (EC) No 1272/2008. Therefore, the Agency would be in a position to fulfil the task of receiving that information. To reduce the administrative burden for Member States and take advantage of economies of scale, Regulation (EC) No 1272/2008 should provide for the option of appointing the Agency as a body responsible for receiving the relevant information, in the event that a Member State wishes to do so.

(34)

In addition to the Member States, the Commission or the Agency should be able to use statistical information relating to emergency health responses for the purpose of identifying where improved risk management measures may be needed. That would complement information in a useful way on the uses of substances which is submitted as part of registration under Regulation (EC) No 1907/2006, while enabling a better prioritisation of substances that are subject to harmonised classification and labelling under Regulation (EC) No 1272/2008 and feeding into the risk management processes under Regulation (EC) No 1907/2006, and potentially under other Union acts.

(35)

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 hazard indicated on the label where such advertisement allows a contract for purchase to be concluded without first having sight of the label. That obligation should be changed to ensure that advertisements for hazardous substances and mixtures contain the most important information in terms of safety and protection of human health and the environment. Therefore, such advertisements should contain the hazard pictogram, the signal words, the hazard statements and supplemental EUH statements, with derogations for non-visual advertisements. The hazard category should not be provided in the advertisements, as it is reflected by the hazard statement.

(36)

In order to ensure proper communication of information on the hazards and safe use of chemicals to consumers and consistency with statements and claims allowed on product labels under this Regulation, it is appropriate to clarify that advertisements for a substance or a mixture classified as hazardous should not contain statements such as ‘non-toxic’, ‘non-harmful’, ‘non-polluting’, ‘ecological’ or other statements indicating that such substance or mixture is not hazardous or any other statements that are inconsistent with its classification. This approach, together with other provisions in Union law, would ensure that consumers can make informed purchasing decisions as a result of having information that is clear, reliable and not misleading with regard to hazardous substances and mixtures.

(37)

Regulation (EC) No 1272/2008 does not explicitly refer to offers in general or to distance sales offers, in particular. Consequently, it does not address specific problems arising from distance sales, such as online sales. Whereas advertisements are understood as being a stage that precedes offers, in particular as information designed to promote a product or service, whether or not in return for payment, offers are understood as invitations to conclude a purchase contract. As a result of that distinction, more hazard information should be required to be provided in offers than in advertisements. To keep pace with technological developments and new means of sale, it is necessary to require that the label elements be indicated in the event of distance sales, including via online market places. The compliance by design obligations laid down for providers of online marketplaces in Article 31 of Regulation (EU) 2022/2065 of the European Parliament and of the Council will therefore apply to the display of these label elements. The enforcement of such obligations is subject to the rules laid down in Chapter IV of Regulation (EU) 2022/2065.

(38)

Apart from providing industry with technical and scientific tools to comply with Regulation (EC) No 1272/2008, the Agency should also provide competent authorities with such tools, for example databases, in order to foster implementation. Regulation (EC) No 1272/2008 should set out the Agency’s remit in this regard in a more detailed way. Furthermore, the Agency, acting as a body appointed by a Member State competent authority for the purpose of receiving information for emergency health response, should provide the relevant national appointed body of that Member State access to that information.

(39)

After consultation of the Commission expert group of Competent Authorities for Regulations (EC) No 1907/2006 and (EC) No 1272/2008, the Commission regularly adapts the Annexes to Regulation (EC) No 1272/2008 to technical and scientific progress. Pursuant to Article 53c of Regulation (EC) No 1272/2008, the Commission is to adopt a separate delegated act in respect of each power delegated to it. It has been difficult to apply that provision when amending different parts of Annex VI to Regulation (EC) No 1272/2008 that are subject to different empowerments. In particular in the case of the simultaneous introduction of new notes into Part 1 of Annex VI to Regulation (EC) No 1272/2008 pertaining to new entries in Table 3 of Part 3 of Annex VI to Regulation (EC) No 1272/2008 and the introduction of new entries in the same Annex, adoption of separate delegated acts has resulted in artificially separating intrinsically related provisions and has thereby adversely affected coherence by requiring simultaneous adoption of two different but related delegated acts. In such cases, it should be possible to adopt a single delegated act in respect of different delegated powers.

(40)

In accordance with Directive 2010/63/EU of the European Parliament and of the Council (15), 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 scientifically possible. Implementation of Regulation (EC) No 1272/2008 should aim at the promotion and use of alternative approaches, in particular non-animal test methods, suitable for the assessment of health and environmental classification of chemicals, wherever possible. In order to speed up the transition to non-animal test 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 test methods should be promoted, monitored and regularly evaluated. The Commission and the Member States should cooperate with a view to promoting the adaptation of criteria to alternative approaches, in particular non-animal test methods, in GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without delay.

(41)

Annex VIII to Regulation (EC) No 1272/2008 provides for harmonised information relating to emergency health response and preventative measures to be received by appointed bodies, and sets out the general requirements, the information to be contained in a submission, the submission format and certain standard formulas. In order to provide legal certainty and clarity on the option for submission of information relating to standardised mixtures and fuels in the context of Annex VIII to Regulation (EC) No 1272/2008, a definition of the term ‘composition conforming with a standard formula’, and the obligation to provide the name and product description of the standard formula in the submission and of the fuel should be introduced in that Regulation, and the option to submit information on components even if they are not always present in certain cases should also be provided for therein.

(42)

In order to provide further legal certainty and clarity of Annex VIII to Regulation (EC) No 1272/2008, that Regulation should further specify when submission updates are required, as well as ways of identifying the mixture, submitter and contact point by means of their product identifier.

(43)

Where appropriate, the Agency should provide further guidance on the application of the provisions relating to the reviews required by this Regulation.

(44)

Regulation (EC) No 1272/2008 should therefore be amended accordingly.

(45)

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.

(46)

To ensure that suppliers of substances and mixtures have time to adapt to the 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 not be required to be reclassified or re-labelled in accordance with this Regulation, to avoid an additional burden on suppliers of substances and mixtures.

(47)

In line with the transitional provisions of Regulation (EC) No 1272/2008, suppliers should have the possibility of applying the new classification, labelling and packaging provisions introduced by this Regulation on a voluntary basis before the date of application of this Regulation.

(48)

Since the objectives of this Regulation cannot be sufficiently achieved by the Member States because environmental pollution is transboundary and the citizens of the Union should benefit from equal protection of their health and environment and because substances and mixtures should circulate freely on the Union market, but can rather, by reason of their scale, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

(1)

in Article 1(1), the following point is added:

;

(2)

in Article 2, the following points are added:

(3)

Article 4 is amended as follows:

(4)

in Article 5, is amended as follows:

(5)

in Article 6 is amended as follows:

(6)

in Article 9, paragraphs 3 and 4 are replaced by the following:

(7)

Article 10 is replaced by the following:

(8)

Article 13 is replaced by the following:

(9)

in Article 18(3), point (b) is replaced by the following:

;

(10)

in Article 23, the following point is added:

(*1)  Directive (EU) 2021/555 of the European Parliament and of the Council of 24 March 2021 on control of the acquisition and possession of weapons (OJ L 115, 6.4.2021, p. 1).’;"

(11)

in Article 24(2), the second subparagraph is replaced by the following:

‘The level of the fees shall be determined by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 54(2) of this Regulation.’

(12)

Article 25 is amended as follows:

(13)

Article 29 is amended as follows:

(14)

Article 30 is replaced by the following:

(15)

Article 31 is amended as follows:

(16)

in Article 32, paragraph 6 is deleted;

(17)

in Title III, the following chapter is added:

(18)

in Article 35, the following paragraph is added:

(19)

in Article 36, paragraph 1 is amended as follows:

(20)

Article 37 is amended as follows:

(21)

in Article 38(1), point (c) is replaced by the following:

;

(22)

Article 40 is amended as follows:

(23)

Article 42 is amended as follows:

(24)

Article 45 is amended as follows:

(25)

in Article 46, the following paragraph is inserted:

(26)

Article 48 is replaced by the following:

(27)

the following article is added:

(28)

Article 50 is amended as follows:

(29)

in Article 52, paragraph 2 is replaced by the following:

(30)

Article 53 is amended as follows:

(31)

Article 53a is amended as follows:

(32)

Article 53c is replaced by the following:

(33)

Article 54 is replaced by the following:

(*2)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).’;"

(34)

the following article is added:

(35)

in Article 61, the following paragraphs are added:

(*3)  Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj)"

(*3)  Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj)"

(36)

Annex I is amended in accordance with Annex I to this Regulation;

(37)

Annex II is amended in accordance with Annex II to this Regulation;

(38)

Annex VI is amended in accordance with Annex III to this Regulation;

(39)

Annex VIII is amended in accordance with Annex IV to this Regulation.