(Ordinary legislative procedure: first reading)

The European Parliament,

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

–  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 (C9‑0433/2022),

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

–  having regard to the opinion of the European Economic and Social Committee of 27 April 2023(1),

–  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,

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

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

1.  Adopts its position at first reading hereinafter set out(2);

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

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

(1) OJ C 228, 29.6.2023, p. 121. (2) This position replaces the amendments adopted on 4 October 2023 (Texts adopted, P9_TA(2023)0340).

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(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(4). While under that Regulation it is assumed that all actors concerned 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 that Regulation when it is being placed on the market, including via distance sales, such as via online market places. That provision, together with requirements in Regulations (EU) 2019/1020(5), (EU) 2022/2065(6) and (EU) 2023/988(7) 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(8), which aimed 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 suitability for 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 those substances. However, when no relevant information is available on the substance itself, manufacturers, importers or downstream users might apply these classification 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 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. That is the case in particular where such data demonstrate endocrine-disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where such data support the conclusions based on 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 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.

(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, the 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 classification for human health acute toxicity of mixtures containing substances classified for acute toxicity. Substances can be classified into 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 specify the meaning of, and further specify, acute toxicity estimates to increase their clarity and consistency. As acute toxicity estimates are part of 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. When the available scientific evidence warrants a different classification linked to a specific form or physical state, it should nevertheless 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 and 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 that inner packaging ▌. Affixing a label to that 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 in Part 2 of that Annex. 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(9). 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. 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 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 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 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 general rules on application and formatting to ensure good readability and 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 are 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 the supplier who places a data carrier linking to such a label must satisfy. These technical requirements on the digital label should however not affect the responsibilities 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 instrumental 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 legislation, 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 put on the physical label, and taking into account the level of digital readiness among all population groups in the Union, the 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 type of sale andestablish 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 uncontrolled operation of the refill station by children as well as avoiding reaction between substances and mixtures dispensed through the refill station, or with residues in refilled packages.

(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 where 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(10) 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 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 case of a proposal for harmonised classification and labelling of a group of substances, those substances should be grouped together on the bais of clear scientific reasoning taking 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 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. 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. 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 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(11) and in Commission Delegated Regulation (EU) 2017/2100(12), and those to qualify as 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(13) and Commission Delegated Regulation (EU) 2017/2100 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.

(26)  As Article 5(1), point (e), of Regulation (EU) No 528/2012(14) refers to the persistent bioaccumulative and toxic and the very persistent, very bioaccumulative criteria included in Annex XIII to Regulation (EC) No 1907/2006 to identify the persistent bioaccumulative and toxic and very persistent, 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, 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, very bioaccumulative properties included in sections 3.7.2. and 3.7.3. of Annex II to Regulation (EC) No 1107/2009are 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, very bioaccumulative according to those criteria 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 20, 21 and 22 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 Regulation (EC) No 1272/2008 and Regulation (EC) 1907/2006, Regulation (EC) 1107/2009 and Regulation (EU) 528/2012, the Commission should also adopt delegated acts within an adequate deadline for substances which are envisaged 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(15) 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 should apply for a limited time 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 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, on the basis of on 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 after a decision to change the classification and labelling of a substance has been taken 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 packaging and with a tactile warning. It is important that those provisions ensure a high level of protection of human health. The Commission should therefore within 5 years of the entry into force of this Regulation, 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 that Regulation . If such need is identified, the Commission should adopt a delegated act amending Annex II to that Regulation 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 for 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 spot 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 adequate emergency health response. To address this 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 already set up and maintains a Union level poison centres notification portal, and established, developed and maintains a database containing information relating to emergency health response to assist some Member States in complying with that Regulation. 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 wish 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 submitted as part of registration under Regulation (EC) No 1907/2006, while enabling a better prioritisation of substances to be 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 to be concluded for purchase without first having sight of the label. That obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains the most importantinformation in terms of safety and protection of human health and the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard statements and supplemental EUH statements, with derogations for non-visual advertisement. The hazard category should not be provided, 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 coherence with statements and claims allowed on product labels regarding such claims 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 having information that it 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 is understood as being at the pre-stage of offers, notably as information designed to promote a product or service, whether or not against payment, offers are understood as invitations to conclude a purchase contract. That differentiation should justify the requirement of providing more hazard information in offers than in advertisements. To keep pace with technological development 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, applying to such cases 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(16). 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 12727/2008 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 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(17), 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 review of 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 be allowed to continue being placed on the market without being re-classified and 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 which allow the application of the new provisions at an earlier stage on a voluntary basis, 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 deferred 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 an 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,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 1272/2008 is amended as follows:

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

‘(f) providing an obligation for downstream users, importers and distributors referred to in Article 45(1b) and (1c) to submit information relevant to an adequate emergency health response to appointed bodies in accordance with Annex VIII.’;

(2)  in Article 2, the following points are added:

▌"

‘38. ‘acute toxicity estimates’ means numeric values which are used to classify substances and mixtures ▌ in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route.’;

39.   ‘data carrier’ means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device;

40.   ‘refill’ means an operation by which a consumer or a professional user fills packaging with a hazardous substance or mixture offered by a supplier in the course of a commercial activity, whether in return for payment or free of charge;

41.   ‘refill station’ means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be acquired through refill, either manually or through automatic or semi-automatic equipment.;’

(3)  ▌Article 4 is amended as follows:

(a)   paragraph 3 is replaced by the following:"

‘3. If a substance is subject to harmonised classification and labelling in accordance with Title V, through an entry in Part 3 of Annex VI, that substance shall be classified in accordance with that entry, and a classification of that substance in accordance with Title II shall not be carried out for the hazard classes, differentiations, or forms or physical states covered by that entry.

The harmonised classification of that substance shall apply to all its forms or physical states unless an entry in Part 3 of Annex VI specifies that a harmonised classification applies to a specific form or physical state of that substance.

However, where the substance also falls within one or more hazard classes or differentiations or it is in a form or physical state not covered by an entry in Part 3 of Annex VI, its classification in accordance with Title II shall be carried out for those hazard classes, differentiations and forms or physical states.’;

(b)   the following paragraph is added:"

‘11. A substance or a mixture shall not be placed on the market unless a supplier established in the Union, which shall be identified on the label, in the course of an industrial or professional activity fulfils the requirements set out in this Regulation with regard to the substances or mixture in question’;

(4)  in Article 5, is amended as follows:

(a)  in paragraph 1 the following point is inserted:"

'ca) data obtained from new approach methodologies;';

(b)   the following paragraphs are added:"

‘3. 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 evaluated, using the available information on those known constituents as well as on the substance itself.

4.  For the evaluation of 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 constituents ▌.

Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

5.  For the evaluation of a substance containing more than one constituent pursuant to Chapter 2 of this Title 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 known constituents in the substance.

Relevant available information on the substance containing more than one constituent itself showing an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

6.  Paragraphs 4 and 5 shall not apply to substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006.

7.  For the purpose of paragraph 6, ‘plants’ refers to living or dead organisms from the kingdoms Plantae and Fungi, and includes algae, lichens and yeasts.

8.  For certain substances containing more than one constituent that are not covered by paragraph 6, where the Commission receives evidence that the rules set out in paragraphs 4 or 5 might not be suitable for certain substances containing more than one constituent, the Commission may request the Agency to evaluate the available data.

‘ca) data obtained from new approach methodologies';’

(b)   paragraphs 3 and 4 are replaced by the following:"

‘3. For the evaluation of mixtures pursuant to chapter 2 of this Title 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 3.5.3.1., 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 only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself.

▌Where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disruption for human health or the environment which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, those data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

4.  For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the ”biodegradation, persistency, mobility and bioaccumulation” properties within the ”hazardous to the aquatic environment”, ”persistent, bioaccumulative and toxic” or ”very persistent and very bioaccumulative properties”, ”persistent, mobile and toxic” or ”very persistent and very mobile properties” 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 only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself ’;

(6)  in Article 9, paragraphs 3 and 4 are replaced by the following:"

‘3. Where the criteria referred to in paragraph 1 cannot be applied directly to available identified information, manufacturers, importers and downstream users shall carry out an evaluation by applying a weight of evidence determination using expert judgement in accordance with section 1.1.1 of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the substance or the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006.

4.  When evaluating hazard information for mixtures, manufacturers, importers and downstream users shall, where test data for the mixture itself are inadequate or unavailable, apply the bridging principles referred to in section 1.1.3. of Annex I and in each section of Parts 3 and 4 of that Annex for the purposes of the evaluation.

If more than one similar tested mixture is available when applying the bridging principles, manufacturers, importers and downstream users shall apply a weight of evidence determination using expert judgement in accordance with section 1.1.1. of Annex I to this Regulation, weighing all available information having a bearing on the determination of the hazards of the mixture, and in accordance with section 1.2. of Annex XI to Regulation (EC) No 1907/2006, to select the most suitable similar tested mixtures in accordance with Article 6(5) of this Regulation for decision on classification.

When evaluating the hazard information for mixtures, manufacturers, importers and downstream users shall, where that information does not permit the application of the bridging principles in accordance with the first and second subparagraphs, evaluate the information by applying the other method or methods set out in Parts 3 and 4 of Annex I.’;

(7)  Article 10 is replaced by the following:"

‘Article 10

Concentration limits, M-factors and acute toxicity estimates for classification of substances and mixtures

1.  Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.

Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when that substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.

Manufacturers, importers or downstream users may set a specific concentration limit of a substance in exceptional circumstances where adequate, reliable and conclusive scientific information shows that the hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.

2.  Manufacturers, importers and downstream users shall establish M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1▌.

3.  Manufacturers, importers and downstream users shall establish acute toxicity estimates for substances classified as acutely toxic for human health .

4.  By way of derogation from paragraph 1, second and third subparagraphs, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI▌.

5.  By way of derogation from paragraph 2, M-factors shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part.

However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, the manufacturer, importer or downstream user shall set an M-factor based on available data for the substance. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, that M-factor shall be used.

6.  By way of derogation from paragraph 3, acute toxicity estimates shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an acute toxicity estimate is given in that Part.

7.  When setting the specific concentration limit, M-factor or acute toxicity estimate, manufacturers, importers and downstream users shall take into account any specific concentration limits, M-factors or acute toxicity estimate for that substance which have been included in the classification and labelling inventory.

▌

8.  Specific concentration limits set in accordance with paragraph 1, second and third subparagraphs, shall take precedence over the concentration limits set out in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification set out in the relevant sections of Parts 3, 4 and 5 of that Annex.

9.  The Agency shall provide further guidance for the application of paragraphs 1, 2 and 3.

10.  Where a mixture contains a substance which is classified as hazardous solely due to the presence of an identified impurity, additive or individual constituent, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of that identified impurity, additive or individual constituent in the mixture.

11.  Where a mixture contains another mixture, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of the identified impurity, additive or individual constituent referred to in paragraph 10 in the resulting final mixture.’;

(8)   Article 13 is replaced by the following:"

‘Article 13

Decision to classify substances and mixtures

‘(g) ammunition as defined in Article 1(1), point (3), of Directive (EU) 2021/555 of the European Parliament and of the Council(18) unless it is an article that falls within the scope of Article 4(8) of this Regulation.’;

▌

(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:

(a)   paragraph 3 is replaced by the following:"

‘3. The supplier may include supplemental information in the section for supplemental information on the label other than that referred to in paragraphs 1, 2 and 6 to 9, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1), points (a) to (g), and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements.’;

(b)  in paragraph 6, the first subparagraph is replaced by the following: "

‘The special labelling rules set out in Part 2 of Annex II shall apply to mixtures containing substances referred to in Part 2 of that Annex.’;

(c)  the following paragraph is added:"

‘9. Label elements resulting from requirements set out in other Union acts shall be placed in the section for supplemental information on the label.’;

(13)  Article 29 is amended as follows:

(a)  paragraph 1 is replaced by the following:"

‘1. Where the packaging of a substance or a mixture is either in such a shape or form or is so small that it is impossible to meet the requirements laid down in Article 31 for a label ▌ in the languages of the Member State in which the substance or mixture is placed on the market, the label elements set out in Article 17(1), shall be provided in accordance with section 1.5.1 of Annex I.’;

(b)  paragraph 3 is replaced by the following:"

‘3. Where a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging, the labelling information shall be provided in accordance with the provision referring to that substance or mixture in that Part.’;

(c)  the following paragraph is added:"

‘4b. By way of derogation from Article 17(1), the labelling requirement set out in that Article shall not apply to packaging of ammunition that is intended for use by defence forces, where labelling in accordance with that requirement would constitute an unacceptable security risk for the ammunition or for the military or non-military staff, and sufficient camouflaging cannot be ensured.

In the case referred to in the first subparagraph, manufacturers, importers or downstream users shall provide to the defence forces the safety data sheet or, if no safety data sheet is required, a copy of the label elements as provided for in Article 17.’;

▌

(14)  Article 30 is replaced by the following:"

‘Article 30

Updating information on labels

1.  In the event of a change regarding the classification or labelling of a substance or a mixture, which results in the addition of a new hazard class or in a more severe classification, or which requires new supplemental information on the label in accordance with Article 25, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 6 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.

2.  Where a change regarding the classification or labelling of a substance or a mixture, other than those referred to in paragraph 1, is required, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 18 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier.

3.  Paragraphs 1 and 2 shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted pursuant to Article 37(5) or by a provision set out in a delegated act adopted pursuant to Article 53(1). In such cases, the supplier shall ensure that the label is updated by the date set out in the respective delegated act.

4.  The supplier of a substance or mixture that falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall update the label in accordance with those Regulations’;

(15)  ▌Article 31 is amended as follows:

(a)   paragraph 1 is replaced by the following:"

‘1. Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally. The label may be presented in the form of a fold-out label.’;

(b)   the following paragraphs are inserted:"

'1a. Where the label is presented in the form of a fold-out label, the label elements referred to in Article 17(1) shall be presented in accordance with Section 1.2.1.6 of Annex I.';

‘1b. Where a digital label as provided for in Article 34a(1) is used, a data carrier linking to that digital label shall be firmly affixed or printed on the physical label or on the packaging next to the label in such a way that it can be processed automatically by digital devices that are widely used.

Where label elements are provided on a digital label only pursuant to Article 34a(2), the data carrier shall be accompanied by the statement ”More hazard information available online” or by a similar indication.’;

(c)   paragraph 3 is replaced by the following :"

‘3. The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They shall stand out clearly from the background and they shall be of such a size and be spaced in such a way as to be easily read. They shall be formatted in accordance with section 1.2.1 of Annex I.’;

(16)  in Article 32, paragraph 6 is deleted;

(17)  in Title III, the following chapter is added:"

‘CHAPTER 3

Labelling formats

Article 34a

Physical and digital labelling

1.  The label elements for substances and mixtures referred to in Article 17 shall be provided on a label in a physical form (“physical label ”). In addition to the physical label, the label elements referred to in Article 17 may be provided in a digital form (“digital label”).

▌

▌

2.  By way of derogation from paragraph 1, suppliers may provide the label elements set out in section 1.6. of Annex I on a digital label only.

Where those label elements are provided on a digital label only, suppliers shall, upon oral or written request or when the digital label is temporarily unavailable at the time of purchase of the substance or mixture, provide those label elements by alternative means. Suppliers shall provide those elements independently of a purchase and free of charge.

3.   Where the information is provided through a digital label, the requirements for digital labels set out in Article 34b shall apply.

Article 34b

Requirements for digital labelling

1.  Where pursuant to Article 31(1b) a supplier affixes or prints a data carrier linking to a digital label, that supplier shall ensure that the digital label satisfies the following general rules and technical requirements:

▌

▌

▌

2.  It shall be prohibited to track, analyse or use any usage information for purposes going beyond what is absolutely necessary for the provision of digital labelling’;

(18)  in Article 35, the following paragraph is added:"

‘2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if▌ the conditions laid down in section 3.4 of Annex II are fulfilled.’;

The first subparagraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).

(19)  in Article 36, paragraph 1 is amended as follows:

(a)  point (a) is replaced by the following:"

‘(a) respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4.)’;

(b)  the following points are added:"

(c)  paragraph 2 is replaced by the following:"

‘2. Substances that are active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) 528/2012 shall be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37(1), (4), (5) and (6) shall apply.’;

(20)  Article 37 is amended as follows:

(a)  paragraph 1 is replaced by the following:"

‘1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for a revision thereof.

The Commission may request the Agency or the European Food Safety Authority (the ‘Authority’) established in accordance with Article 1(2) of Regulation (EC) No 178/2002 to prepare a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency.

1a.   Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall aim to prioritise groups of substances rather than individual substances.

1b.  The Agency and the Authority may, on their own initiative, provide scientific advice to the competent authorithies and the Commission indicating that a harmonised classification and labelling of a substance or a group of substances would be appropriate.’;

(c)  in paragraph 2, the first subparagraph is replaced by the following:"

‘2. Manufacturers, importers or downstream users may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, provided that there is no entry in Part 3 of Annex VI for such substances in relation to the hazard class or differentiation covered by that proposal.’;

(d)  the following paragraph is inserted:"

‘2a. Before submitting a proposal to the Agency, a competent authority, manufacturer, importer or downstream user shall notify the Agency of its intention to submit a proposal for harmonised classification and labelling.

Where the Commission has requested the preparation of a proposal pursuant to Article 37(1), second subparagraph, it shall notify the Agency of that request.

Within one week of receipt of the notification referred to in the first and the second subparagraphs, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance or substances, the status of the proposal and the name of the submitter. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in Article 37(4) and (5).

Where a competent authority receives a proposal in accordance with paragraph 6, it shall notify the Agency and provide any relevant information on its reason for accepting or refusing the proposal. The Agency shall share that information with the other competent authorities.’;

(d)  paragraph 3 is replaced by the following:"

‘3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of substances in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission by means of implementing act adopted in accordance with the examination procedure referred to in Article 54(2).’;

(e)  paragraphs 5 and 6 are replaced by the following:"

‘5. Where the Comission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall adopt without undue delay, and preferably before the end of the calendar year following the publication of the opinion of the Committee for Risk Assessment, delegated acts in accordance with Article 53a to amend Annex VI by including substances together with the relevant classification and label elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.

6.  Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling 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.’;

(f)  The following paragraphs are inserted:"

8.  In the case of a proposal for harmonised classification and labelling of a group of substances, those substances shall be grouped together on the basis of clear scientific reasoning taking into account how the available information supports the grouping of substances and allows the property or properties of the substance or substances to be reliably predicted from information on other substances in the group.’

▌

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

‘(c) the specific concentration limits, M-factors or acute toxicity estimates, where applicable;’;

(22)  Article 40 is amended as follows:

(a)  in paragraph 1, the first subparagraph is amended as follows:

(i)  point (e) is replaced by the following:"

‘(e) specific concentration limits, M-factors or acute toxicity estimates, where applicable, in accordance with Article 10 of this Regulation, together with a justification as referred to in the relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;’;

(ii)  the following points are added:"

(iii)  the second subparagraph is replaced by the following:"

‘The information referred to in points (a) to (h) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.’;

(b)  paragraph 2 is replaced by the following:"

‘2. The information listed in paragraph 1 shall be notified to the Agency by the notifier concerned at the latest 6 months after a decision to change the classification and labelling of the substance has been taken pursuant to the review referred to in Article 15(1).’;

(23)  Article 42 is amended as follows:

(a)  in paragraph 1, the third subparagraph is replaced by the following:"

Information referred to in Article 40(1)(a) shall be made publicly available except where a notifier duly justifies why such publication is potentially harmful for its commercial interests or the commercial interests of any other concerned party.

The Agency shall provide information on legitimate grounds on which confidentiality claims may be made.

The Agency shall take measures to identify undue confidentiality claims, including automated screening and random manual checks.’;

▌

(b)  the following paragraph is added: "

‘3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall request the notifier to notify the correct entry.’;

(24)  Article 45 is amended as follows:

(a)  paragraph 1 is replaced by the following:"

‘1. Member States shall appoint a body or bodies responsible for receiving the relevant harmonised information relating to emergency health response and preventative measures, in accordance with Annex VIII.’;

(b)  the following paragraphs are inserted:"

‘1a. Member States may appoint the Agency as the body responsible for receiving information relating to emergency health response and preventative measures referred to in paragraph 1.’;

1b.  Importers and downstream users placing on the market mixtures that are classified as hazardous on the basis of their health ▌ or physical effects, shall submit to the body or bodies appointed in accordance with paragraph 1 the ▌ information referred to in Part B of Annex VIII.

1c.  Distributors placing on the market mixtures that are classified as hazardous on the basis of their health ▌ or physical effects shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII where they distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. That obligation shall not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers or downstream users.’;

(c)  in paragraph 2, point (b) is replaced by the following:"

‘(b) where requested by the Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed.’;

(d)  paragraph 3 is replaced by the following:"

‘3. The appointed bodies shall have at their disposal all the information required from importers, downstream users and distributors referred to in paragraph 1c, to carry out the tasks for which they are responsible in accordance with paragraph 1.’;

(25)  In Article 46, the following paragraph is inserted: "

‘1a. For the purpose of paragraph 1, the authorities responsible for enforcement referred to in Article 43 of this Regulation shall follow up on complaints or reports related to non-compliance with this Regulation, and verify that the corrective action referred to in Article 3(16) of Regulation 2019/1020 has been taken.’;

(26)  Article 48 is replaced by the following:"

‘Article 48

Advertisement

1.  Any advertisement for a substance classified as hazardous shall indicate, as applicable, the▌ hazard pictograms, ▌ signal word, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for a substance for sale to the general public shall in addition state: “Always read and follow the information on the product label.”.

2.  Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictograms, ▌signal word, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for sale of mixtures to the general public shall, in addition, state: “Always read and follow the information on the product label.”.

3.  Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not to appear on the label or packaging of that substance or mixture in accordance with Article 25(4).

4.  By way of derogation from paragraphs 1 and 2, the hazard pictograms and signal word may be omitted where the advertisement is non-visual.’;

(27)  the following article is added:"

‘Article 48a

Distance sales offers

When substances or mixtures are placed on the market through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.’;

(28)  Article 50 is amended as follows:

(a)  in paragraph 2, point (a) is amended as follows:"

‘(a) provide industry with up-to-date technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation;’;

(b)  in paragraph 2, point (b) is replaced by the following:"

‘(b) provide competent authorities with up-to-date technical and scientific guidance and tools on the operation and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44.’;

(c)  the following paragraphs are added:"

‘3. Where the Agency acts as an appointed body in accordance with Article 45(1a), it shall put in place the tools necessary to provide access to the information referred to in Article 45(1) to the relevant appointed body or bodies of the appointing Member State to fulfil their tasks with regard to emergency health response and preventative measures.

4.  The Agency shall be provided with adequate resources to support its work.’;

(29)  in Article 52, paragraph 2 is replaced by the following:"

‘2. Within 60 days of receipt of the information from the Member State, the Commission shall adopt implementing acts in accordance with the examination procedure referred to in Article 54(2) either to authorise the provisional measure for a time period defined in the decision or to require the Member State to revoke the provisional measure.’

(30)  Article 53 is amended as follows:

(a)  the following paragraphs are inserted:"

‘1a. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend section 1.6. of Annex I in order to include the label elements that may be put on a digital label only, provided that GHS does not require such label elements to appear on the physical label. When adopting those delegated acts, the Commission shall take into account the level of digital readiness among all population groups in the Union, the societal needs and the objective of achieving a high level of protection of human health and the environment.

1b.  In order to adjust to technological changes and ▌future▌ developments in the field of digitalisation, the Commission is empowered to adopt delegated acts in accordance with Article 53a to supplement this Regulation by laying down further details on the requirements for the digital labelling referred to in Articles 34a and 34b. Those details shall cover, in particular, the IT solutions which may be used, and the alternative means for providing the information. When adopting such delegated acts, the Commission shall:

‘2. The Commission, acting on behalf of the Union and the Member States, shall, in the manner appropriate to their role in the relevant UN fora, cooperate with a view to promoting the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic , very persistent and very bioaccumulative , persistent, mobile and toxic and very persistent and very mobile substances as well as the adaptation of criteria for alternative approaches, in particular non-animal test methods, and the assessment of the need for new criteria for immunotoxic and neurotoxic substances.’;

(c)  the following paragraph is added:

3.  The Commission shall regularly evaluate the development of alternative approaches such as the alternative methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, in particular non-animal test methods, and adopt delegated acts in accordance with Article 53a, to update Annex I to this Regulation to reflect such technical progress, if relevant. The Commission shall adopt a delegated act in accordance with Article 53a to update Annex I to this Regulation to adapt the criteria, preferably within 18 months of non-animal data being included in harmonised criteria for classification and labelling at the level of the UN.

(31)  Article 53a is amended as follows:

(a)  paragraphs 2 and 3 are replaced by the following:"

‘2. The power to adopt delegated acts referred to in Articles 5(8), 37(5), 37(7), ▌ 45(4) 53(1), 53(1a),53(1b) and 53(3) shall be conferred on the Commission for a period of five years from [the date of entry into force of this Regulation]. . The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.  The delegation of power referred to in Articles 5(8), 37(5), 37(7)▌, 45(4), 53(1), 53(1a), 53(1b) and 53(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.’;

(b)  paragraph 6 is replaced by the following:"

‘6. A delegated act adopted pursuant to Articles 5(8), 37(5), 37(7), ▌ 45(4) 53(1), 53(1a), 53(1b) or 53(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.’;

(32)  Article 53c is replaced by the following:"

‘Article 53c

Separate delegated acts for different delegated powers

The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation, with the exception of the powers delegated pursuant to Article 37(5) and Article 53(1) to amend Annex VI, where Parts 1 and 2 of that Annex may be amended together with Part 3 of that Annex in one single act.’;

(33)  Article 54 is replaced by the following:"

‘1.The Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council**.’;

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

(34)  the following article is added:"

‘Article 54a

Reporting and review

1.  By ... [five years from the date of entry into force of this Regulation], the Commission shall present a scientific report to the European Parliament and the Council regarding the examination of the information on substances containing more than one constituent extracted from plants. The report may be accompanied, if appropriate, by a legislative proposal.’

2.  By ... [please insert date = 5 years from the date of entry into force of this Regulation], the Commission shall present an evaluation report to the European Parliament and the Council and the European Economic and Social Committee, assessing the need to extend requirements in sections 3.1 and 3.2 of Annex II on child-resistant fastenings and tactile warnings to other hazard classes. If justified by the results of the report, the Commission shall act in accordance with Article 53(1).

(35)  in Article 61, the following paragraphs are added:"

‘7. ‘Substances and mixtures which have been classified, labelled and packaged in accordance with ▌ Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(3), Articles 29 and section 1.5.1.2. of Annex I, section 1.5.2.4.1. of Annex I as applicable on … [ = the day before the entry into force of this Regulation] and which were placed on the market before ... [ = the first day of the month following 18 months from the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) …/… of the European Parliament and of the Council* [OJ: please complete the reference in the footnote – it should be the reference to this amending Regulation] by … [the first day of the month following 42 months from the date of entry into force of this Regulation].

8.  Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3), Article 31(3) and section 1.2.1. of Annex I, as applicable on … [ = the day before the entry into force of this Regulation] and which were placed on the market before [ = the first day of the month following 24 months after the date of entry into force of this Regulation ] are not required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation …/… of the European Parliament and of the Council* [reference to this amending Regulation] until … [the first day of the month following 48 months after the date of entry into force of this Regulation].

* Regulation (EU) .../... of the European Parliament and of the Council of ... on ... (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 VIII is amended in accordance with Annex III to this Regulation.

Article 2

1.  This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

2.  Article 1, point (3)(b), Article 1, points (4) to (7), Article 1, point (12)(a), Article 1, points (13) and (14), Article 1, points (15)(a)and (b), Article 1, points (17), (18), (22), (23), (26) and (27), points (3)(a), (7), (9) and (10) of Annex I and Annex II shall apply from [the first day of the month following 18 months after the date of entry into force of this Regulation]..

▌

3.   Article 1, point (1), Article 1, point (9), Article 1, point (15)(c), Article 1, points (24)(b) and (d), points (2) and (3) of Annex I and Annex III shall apply from [the first day of the month following 24 months after the date of entry into force of this Regulation].

4.  By way of derogation from Article ▌5, Article 6(3) and (4), Article 9(3) and (4), Article 10, Article 25(3), Articles 29, Article 30, Article 31(1), Article 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48 of Regulation (EC) No 1272/2008, section 1.2.1. of Annex I, section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I, Parts 3 and 5 of Annex II▌ to Regulation (EC) No 1272/2008 as applicable on [ = the day before the date of entry into force of this Regulation], substances and mixtures may until … [ = the last day of the month following 17 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008as amended by Article 1, points ▌(4) to (7), Article 1, point (12)(a), Article 1, points (13), (14), Article 1, point (15)(a) and b), Article 1, points (18), (22), Article 1, point (23)(a) and Article 1, point (26), points (3)(a), (7) and (9) of Annex I and Annex II to this Regulation.

▌

5.  By way of derogation from Article 1(1), 18(3)(b), Article 31(3), Article 45(1) and (3) of Regulation (EC) No 1272/2008 and section 1.2.1 of Annex I, part A, section 1 of Annex VIII, part A, section 2.1, of Annex VIII, part A, the first sub-paragraph of section 2.4 of Annex VIII, Part B, section 1 of Annex VIII, Part B, the third paragraph of section 3.1 of Annex VIII, Part B, section 3.6 of Annex VIII, Part B, the first row of Table 3 of Section 3.7 of Annex VIII, Part B, the first paragraph of Section 4.1 of Annex VIII, Part C, sections 1.2 and 1.4 of Annex VIII, and Part D, sections 1, 2 and 3 of Annex VIII to Regulation (EC) No 1272/2008 as applicable on [ = the day before the date of entry into force of this Regulation], substances and mixtures may until … [ = the last day of the month following 23 months after the date of entry into force of this Regulation] be classified, labelled and packaged in accordance with Regulation (EC) No 1272/2008 as amended by Article 1, point (1), Article 1, point (9) , Article 1, point (15)(c), Article 1, point (24)(b) and (d) of this Regulation, points (2) and (3) of Annex I and Annex III to this Regulation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …,

For the European Parliament For the Council

The President The President

ANNEX I

Part 1 of Annex I to Regulation (EC) No 1272/2008 is amended as follows:

(1)  Section 1.1.1.3. is replaced by the following:

‘1.1.1.3. A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) and (Q)SAR results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, as appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination.’;

(2)  Section 1.2.1.4. is replaced by the following:

‘1.2.1.4. The dimensions of the label and of each pictogram, and the font size of letters shall be as follows:

Table 1.3

Minimum dimensions of labels and pictograms and minimum font size

(3)  the following sections are added:

‘1.2.1.5. The text on the label shall have the following characteristics:

(a)  printed in black on a white background;

(b)  the distance between two lines shall be at least 120 % of the font size;

(c)  a single font that is easily legible and without serifs shall be used;

(d)  the letter spacing shall be appropriate for the selected font to be easily legible.

For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may be smaller than indicated in Table 1.3, as long as it remains easily legible, where it is deemed important to place the most critical statement, such as a hazard statement or EUH statement, and where the outer packaging meets the requirements of Article 17.

1.2.1.6  Fold-out labels

1.2.1.6.1  The front page of the fold-out label shall include at least the following elements:

(i)  name, address and phone number of supplier(s);

(ii)  where applicable, hazard pictograms;

(iii)  where applicable, signal words in all languages of the label that are used in the inside pages;

(iv)  where applicable, the unique formula identifier, unless printed or affixed on the inner packaging in accordance with Part A, point 5.3, of Annex VIII to this Regulation;

(v)  a reference to the full safety information inside the fold-out label in all languages of the label or a symbol to inform a user that the label can be opened and to illustrate that additional information is available on inside pages;

(vi)  an abbreviation of the language (country code or language code) for all the languages that are used in the inside pages.

1.2.1.6.2  The inner pages of the fold-out label shall contain all the label elements provided for in Article 17(1), except for the hazard pictogram and the supplier identification, in each of the languages mentioned on the front page and grouped by language, using the language abbreviation (country code or language code).

1.2.1.6.3  The back page of the fold-out label shall contain all the label elements provided on the front page, except for the abbreviations of the languages that are used in the inside pages.

(4)  the following section is added:

‘1.3.7. Ammunition

In the case of ammunition that is a substance or mixture and that is shot through a firearm, the label elements may be provided on the intermediate packaging instead of on the inner packaging, or, if there is no intermediate packaging, on the outer packaging.’;

(5)  the heading of Section 1.5.1. is replaced by the following:

‘1.5.1. Exemptions from Article 31 in accordance with Article 29(1)’

(6)  Section 1.5.1.1. is replaced by the following:

‘1.5.1.1. Where Article 29(1) applies, the label elements referred to in Article 17 may be provided on a tie-on tag or on an outer packaging.’;

(7)  Section 1.5.1.2. is replaced by the following:

‘1.5.1.2. Where section 1.5.1.1. applies, the label on any inner packaging shall contain at least hazard pictograms, the signal word, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and telephone number of the suppliers of the substance or mixture.’;

(8)  the heading of Section 1.5.2 is replaced by the following:

‘1.5.2. Exemptions from Article 17 in accordance with Article 29(2)’;

(9)  Section 1.5.2.4.1 is replaced by the following:

‘1.5.2.4.1 The label elements required by Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml and any of the following applies:

(a)  the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis and the inner packaging is contained within outer packaging that meets the requirements set out in Article 17;

(b)  the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories:

(i)  acute toxicity, any category;

(ii)  specific target organ toxicity – single exposure, categories 1 and 2;

▌

(iii)  specific target organ toxicity – repeated exposure, any category

▌

(iv)  skin corrosion, category 1, any sub-category;

(v)  serious eye damage, category 1;

(vi)  respiratory sensitisation, any category;

(vii)  aspiration hazard;

(viii)  germ cell mutagenicity, any category;

(ix)  carcinogenity, any category;

(ix)  reproductive toxicity, any category;

▌

(xi)  Endocrine disruption for human health, any category;

(c)  the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II but is not classified in any of the hazard classes and categories referred to in point (b) of this Section and has an inner packaging that is contained within outer packaging that meets the requirements set out in Article 17.’;

(10)  the following section is added:

‘1.6. Label elements that may be provided on a digital label only

Supplemental information referred to in Article 25(3).’

ANNEX II

Annex II to Regulation (EC) No 1272/2008 is amended as follows:

(1)  in Part 3, the following section is added:

‘3.4. Supply via refill stations

When hazardous substances or mixtures are supplied in accordance with Article 35(2a), the supplier shall ensure that the following conditions are met:

(a)  the refill station shall carry labels corresponding to the labels for each hazardous substance or mixture supplied at the station;

(b)  the labels on the refill station shall be firmly affixed horizontally on a visible place and fulfil the requirements in Article 31 paragraphs 2 to 4 mutatis mutandis;

▌

(c)  risk mitigation measures are applied to minimise the exposure of humans, especially of children, and of the environment;

(d)  measures are taken to prevent uncontrolled use of the refill station by children;

(e)  at the moment of refill, the supplier is available on site for maintenance and immediate assistance, including emergency assistance;

(f)  refill stations can be operated outdoors and outside business hours only if immediate assistance can be provided;

(g)  the substances or mixtures provided through a refill station do not react with each other in a way that could endanger clients or staff;

(h)  staff of the supplier are appropriately trained to minimise safety risks to consumers, professional users and themselves▌;

(i)  for every refilled package, the requirements on hazard communication in the form of labelling set out in Title III of this Regulation are fulfilled;

(j)  for every refilled package the requirements on packaging set out in Title IV of this Regulation are fulfilled;

(k)  hazardous substances or mixtures shall not be provided at a refill station if the criteria for classification in any of the following hazard classes or differentiations are met:

(i)  acute toxicity, any category;

(ii)  specific target organ toxicity – Single exposure, any category;

(iii)  specific target organ toxicity – repeated exposure, any category;

(iv)  skin corrosion, category 1, any sub-category;

(v)  serious eye damage category 1;

(vi)  respiratory sensitisation, any category;

(vii)  skin sensitisation, any category;

(viii)  aspiration hazard;

(ix)  germ cell mutagenicity, any category;

(x)  carcinogenicity, any category;

(xi)  eproductive toxicity, any category;

(xii)  flammable gases, any category;

(xiii)  flammable liquids, categories 1 and 2;

(xiv)  flammable solids, any category;

(xv)  ▌endocrine disruption for human health, any category.▌;

(xvi)  ▌endocrine disruption for the environment, any category ▌;

(xvii)  ▌persistent, bioaccumulative and toxic ▌;

(xviii)  ▌very persistent and very bioaccumulative ▌;

(xix)  ▌ersistent, mobile and toxic ▌;

(xx)  ▌very persistent and very mobile ▌.

By way of derogation from point (a), a single label on the refill station may be used for several substances or mixtures for which the label elements referred to in Article 17(1) are identical, provided that the label clearly indicates the name of each substance or mixture that it applies to.’;

(2)  Part 5 is replaced by the following:

‘PART 5: HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES

Ready mixed cement and concrete in the wet state shall be accompanied by a copy of the label elements in accordance with Article 17.

For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the label elements referred to in Article 17 shall be provided on a visible place on the respective pump. When vehicle fuels are supplied at a filling station through pumping into portable receptacles designed to be used for fuels, a physical copy of the label elements referred to in Article 17 shall, in addition to the visible place on the pump, also be provided to be attached on the receptacle.’.

ANNEX III

In 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.

—  Justification for the proposed grouping of substances for the purpose of harmonise classification and labelling

Where a harmonised classification and labelling proposal is made for a group of substances, the dossier shall include a scientific justification.

—  Justification for other effects at Community level.

For effects other than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM), and respiratory sensitisation, a justification that there is a need for action demonstrated at Union level shall be provided. This will not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012.’.

ANNEX IV

Annex VIII to Regulation (EC) No 1272/2008 is amended as follows:

(1)  Part A is amended as follows:

(a)  Section 1 is replaced by the following:

‘1. Application

1.1  Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for consumer use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.

1.2.  Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for professional use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021.

1.3.  Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for industrial use or mixtures with an end use not subject to notification within the meaning of Section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024.

1.4.  Importers, downstream users and distributors referred to in Article 45(1b) and (1c) having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025.

1.5.  By way of derogation from Section 1.4, if one of the changes described in Section 4.1 of Part B of this Annex occurs before 1 January 2025, importers, downstream users and distributors referred to in Article 45(1b) and (1c) shall comply with this Annex before placing that mixture▌ on the market.’;

(b)  Section 2.1 is replaced by the following:

‘2.1 This Annex sets out the requirements that importers, downstream users and distributors referred to in Article 45(1c) (‘submitters’) placing mixtures on the market shall fulfil in respect of the submission of information so that appointed bodies have at their disposal the information required to carry out the tasks for which they are responsible under Article 45.’;

(c)  in Section 2.4., first subparagraph, the following point (6) is added:

‘(6) ‘composition conforming with a standard formula specified in Part D’ means a composition which includes all the components listed in one of the standard formulas referred to in Part D of this Annex, where those components are present in the mixture in concentrations within the ranges specified in that standard formula.’;

(2)  Part B is amended as follows:

(a)  the following section 1.1a. is inserted:

‘1.1a. Name and product description of standard formula or name of fuel

For mixtures with a composition conforming with a standard formula specified in Part D, the name and product description of the relevant standard formula as indicated in that Part shall be included in the submission.

For fuels listed in Table 3, the name of the fuel shall be provided as indicated in that table.’;

(b)  in Section 3.1, the third paragraph is replaced by the following:

‘Components which are not present in a mixture shall not be notified. However, if those components are notified as part of an interchangeable component group in accordance with Section 3.5. or their concentration has been submitted as a range of percentages in accordance with Sections 3.6. or 3.7, they may be notified if it is certain that they will be present in the mixture at some point in time. In addition, for mixtures with a composition conforming with a standard formula specified in Part D for which the composition is notified in accordance with Section 3.6, first indent, components listed in the relevant standard formula shall be notified even if the component is potentially not, or not permanently, present in cases where the indicated concentration range in Part D includes 0 %.’;

(c)  the title of Section 3.6. is replaced by the following:

‘3.6. Mixtures with a composition conforming with a standard formula’;

(d)  in Section 3.7, the first row of Table 3 is replaced by the following:

(e)  in Section 4.1, the first paragraph, the following indent is added; :

‘- when there are other changes to a mixture placed on the market which are relevant for the emergency health response referred to in Article 45’;

(3)  Part C is amended as follows:

(a)  Section 1.2. is replaced by the following:

‘1.2 Identification of the mixture, submitter and contact point

Product identifier

–  Complete trade name(s) of the product including, where relevant, brand name(s), name of the product and variant names as they appear on the label, without abbreviations or non-alphanumerical symbols and enabling specific identification of the product.

–  Unique formula identifier(s) (UFI)

–  Other identifiers (authorisation number, company product codes)

–  In the case of group submission, all product identifiers shall be listed.

Name and product description of standard formula or name of fuel

–  Standard formula name and product description as specified in Part D (where applicable)

–  Fuel name as specified in Table 3 of Part B (where applicable)

Contact details of the submitter, as defined in section 2.1 of Part A of this Annex, and contact point

–  Name

–  Full address

–  Telephone number

–  Email address

Contact details for rapid access to additional product information (24 hours/7 days). Only for limited submission.

–  Name

–  Telephone number (accessible 24 hours per day, 7 days per week)

–  Email address’;

(b)  Section 1.4. is replaced by the following:

‘1.4. Information on the mixture components and interchangeable

component groups

Identification of the mixture components

—  Chemical/trade name of the components

—  CAS number (where applicable)

—  EC number (where applicable)

—  UFI (where applicable)

—  Standard formula name and product description (where applicable)

▌

Name of interchangeable component groups (where applicable)

Concentration and concentration ranges of the mixture components

—  Exact concentration or concentration range

Classification of mixture components

—  Hazard classification (where applicable)

—  Additional identifiers (where applicable and relevant for health response)

List according to Part B, Section 3.1, fifth subparagraph (where applicable) ’;

(4)  Part D is amended as follows:

(a)  In section 1, the first row of the tables with standard formulas for cement are replaced by the following:

(b)  In section 2, the ▌ first row of the table with standard formula for gypsum is replaced by the following two rows:

(c)  In section 3, the ▌ first row of the tables with standard formulas for ready mixed concrete are replaced by the following:

(1) * TEXT HAS UNDERGONE PARTIAL LEGAL-LINGUISTIC FINALISATION. (2) OJ C 228, 29.6.2023, p. 121. (3) Position of the European Parliament of 23 April 2024. (4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1). (5) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). (6) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1). (7) Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1). (8) 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). (9) 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.) (10) Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7). (11) Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1). (12) Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1). (13) Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine-disrupting properties (OJ L 101, 20.4.2018, p. 33). (14) Regulation (EC) No 528/2012 of 22 May 2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1). (15) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1). (16) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1). (17) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33). (18) 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).’