Considerations on COM(2022)748 - Amendment of Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2022)748 - Amendment of Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures. |
|---|---|
| document | COM(2022)748  |
| date | December 19, 2022 |
(2) From a toxicological point of view, substances with more than one constituent (‘multi-constituent substances’) are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council 39 , aimed to limit animal testing, data on multi-constituent substances is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents is available, multi-constituent substances should be evaluated and classified following the same classification rules as mixtures, unless Annex I to Regulation (EC) No 1272/2008 provides for a specific provision for those multi-constituent substances.
(3) It is normally not possible to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a multi-constituent substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the multi-constituent substance should therefore normally be used as the basis for hazard identification of those multi-constituent substances or mixtures. However, in certain cases, data on those multi-constituent substances themselves may also be relevant. This is the case in particular where that data demonstrates endocrine disrupting properties for human health and the environment, as well as persistent, bioaccumulative and mobile properties, or where it supports data on the individual constituents. Therefore, it is appropriate that data on multi-constituent substances are used in those cases.
(4) In order to improve legal certainty and implementation with regard to the evaluation of hazard information for mixtures where no or inadequate test data are available for the mixture itself, the interaction between the application of the bridging principles and a weight of evidence determination using expert judgement should be clarified. Such clarification should ensure that the weight of evidence determination complements but does not substitute the application of the bridging principles. It should also be clarified that if bridging principles cannot be applied to evaluate a mixture, manufacturers, importers and downstream users should use the calculation method or other methods described in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008. It should also be clarified which criteria, when not met, determine when a weight of evidence determination using expert judgment is to be carried out.
(5) 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.
(6) 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 in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route according to certain numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates. It is appropriate to 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 elements 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 Agency in view of their inclusion in the classification and labelling inventory.
(7) Ammunition qualifying as a substance or a mixture is to bear a label affixed to the surface of the packaging immediately containing the substance or the mixture (inner packaging), which is typically the ammunitions’ cartridge. Affixing a label to the cartridge 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, which is exclusively used by national defence forces in combat zones, could, in specific cases, constitute an unacceptable safety or security risk for the cargo, soldiers and 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.
(8) In order to enhance clarity, all supplemental labelling requirements should be placed together in one Article.
(9) 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.
(10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/1435 40 . Where the new hazard class is additional to an existing hazard class or represents a more severe hazard class or category, or where new supplemental labelling elements are required under Article 25, the deadline to update the labelling information in the case of adaptation of the classification in accordance with the result of a new evaluation should be set at 6 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. In case where a classification is updated to a less severe hazard class or category without triggering classification in an additional hazard class or new supplemental labelling requirements, the deadline for updating the labels should remain at 18 months from the day on which the results of a new evaluation on the classification of that substance or that mixture were obtained. It should also be clarified that, in cases of harmonised classification and labelling, the deadlines to update the labelling information should be set at the date of application of the provisions setting out the new or amended classification and labelling of the substance concerned, which is usually 18 months from the date of entry into force of those provisions. The same applies in case of changes triggered by other delegated acts adopted in light of the adaptation to technical and scientific progress, for instance as a result of the implementation of new or amended provisions of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
(11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size, whilst it does not provide for a minimum font size of labels that would ensure readability. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while readability of labels should be ensured by laying down minimum font size and formatting requirements.
(12) Regulation (EC) No 1272/2008 needs to be adjusted to technological and societal changes in the field of digitalisation and be prepared for future developments. Digital labelling could improve the efficiency of hazard communication, especially for vulnerable population groups and people who do not speak the national language of a Member State. Therefore, it is necessary to provide for voluntary digital labelling and to lay down technical requirements for such labelling. In order to provide for legal certainty, it is appropriate to specify the label elements that are allowed to be provided in a digital format only. That possibility should only exist for information which is not instrumental for the safety of the user or the protection of the environment.
(13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among all population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs and a high level of protection of human health and the environment.
(14) 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 Treaty on the Functioning of the European Union to supplement Regulation (EC) No 1272/2008 by further specifying the technical requirements for the digital labelling.
(15) 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 to reduce waste and to facilitate more sustainable sales forms, it is appropriate to set out specific rules and conditions for such type of sales, and establish a list of hazard classes and categories prohibiting such refill station sales for substances of mixtures meeting the criteria for classification in those hazard classes and categories, in order to ensure safety and the protection of human health.
(16) 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 a better protection of citizens, it is appropriate to provide for the labelling elements of other chemicals, such as fuels supplied at filling stations and intended to be pumped into receptacles from where they are normally not intended to be removed.
(17) As the new hazard classes and criteria introduced by Commission Delegated Regulation 41 allow for the harmonised classification and labelling of substances of the highest concern with regard to health and 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 sufficient information 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 European Chemicals Agency (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.
(18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity allows for similar classification of all substances in the group. The purpose of such grouping is to alleviate the burden on manufacturers, importers or downstream users, the Agency and the Commission in the procedure for harmonisation of classification and labelling of substances. It also avoids testing of substances when similar substances can be classified as a group.
(19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. 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. 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.
(20) 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.
(21) 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 and in Commission Delegated Regulation (EU) 2017/2100, 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 and Commission Delegated Regulation (EU) 2017/2100 should be included as endocrine disruptors category 1 for human health or endocrine disruptors category 1 for the environment in Table 3 in Part 3 of Annex VI to Regulation (EC) No 1272/2008.
(22) As Article 5(1), point (e), of Regulation (EU) No 528/2012 42 refers to the PBT and vPvB criteria included in Annex XIII to Regulation (EC) No 1907/2006 to identify the PBT and vPvB 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 PBT and vPvB 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 PBT and vPvB properties included in sections 3.7.2. and 3.7.3. of Annex II to Regulation (EC) No 1107/2009 of the European Parliament and of the Council 43 are equivalent to those included in Annex I to Regulation (EC) No 1272/2008, the active substances meeting the criteria to qualify as PBT and vPvB 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.
(23) As the substances referred to in recitals 30 and 31 have already been assessed by the European Food Safety Authority or the Agency as well as the Commission which has decided upon by them, 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.
(24) Manufacturers and importers often notify different information for the same substance to be included in the Agency’s inventory for classification and labelling. In some cases, such divergences result from different impurities, physical states or other differentiations and may be justified. In other cases, the divergences are due to differences in data used for classification, or to disagreement between notifiers or registrants in the case of joint submission of data in accordance with Regulation (EC) No 1907/2006, or to obsolete classification entries. As a result, the classification and labelling inventory contains divergent classifications, which makes the inventory less effective as a hazard collection and communication tool and leads to incorrect classifications, ultimately hindering the ability of Regulation (EC) No 1272/2008 to protect human health and the environment. Therefore, the notifiers should be required to provide reasons for divergence from the most severe classification or for introducing a more severe classification per hazard class for the same substance to the Agency. To address divergences between more recent and obsolete classifications, notifiers should be required to update their notifications within 6 months after a decision to change the classification and labelling of a substance has been taken pursuant to a review in Article 15(1) of that Regulation.
(25) In order to enhance transparency of notifications as well as to facilitate the notifiers’ duty to come to an agreed notification entry for the same substance, certain information notified to the Agency’s classification and labelling inventory should be made publicly available, free of charge. Without prejudice to the protection of commercial interests, that information should include the identity of the notifiers as, knowing whom to contact, would facilitate the objective of coming to an agreed entry to be included in that classification and labelling inventory. In the case of notifications by a group of manufacturers or importers, it should suffice to make publicly available the identity of the notifier submitting the information on behalf of the other members of the group.
(26) 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 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.
(27) 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 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, should a Member State wish to do so.
(28) In addition to the Member States’ appointed bodies, the Commission or the Agency should be able to use the information relating to emergency health responses for the purpose of carrying out statistical analysis. That would usefully complement information 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.
(29) Regulation (EC) No 1272/2008 regulates advertisement of hazardous substances and mixtures in a general manner and provides that an advertisement for a substance classified as hazardous is to mention the hazard classes or hazard categories concerned, and an advertisement for a mixture classified as hazardous or a mixture containing a classified substance is to mention the types of hazards indicated on the label where such advertisement allows concluding a contract for purchase without first having sight of the label. This obligation should be changed to ensure that the advertisement of hazardous substances and mixtures contains all the information which is most important in terms of safety and protection of the environment. Therefore, the advertisement should contain the hazard pictogram, the signal word, the hazard class and the hazard statements. The hazard category should not be provided, as it is reflected by the hazard statement.
(30) Regulation (EC) No 1272/2008 does not explicitly refer to offers, let alone to distance sales offers. 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 messages of a natural or legal person, whether or not against remuneration, offers are understood as invitations by a natural or legal person to conclude a purchase contract. This differentiation should justify the requirement of providing more hazard information in offers than in advertisements. In order to keep pace with technological development and new means of sale, 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 44 should apply for the purpose of labelling information required by Article 17 of Regulation (EC) No 1272/2008. The enforcement of those obligations is subject to the rules laid down in Chapter IV of Regulation (EU) 2022/2065.
(31) Apart from providing industry with technical and scientific tools on how 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 more in detail set out the Agency’s remit in this regard. Furthermore, the Agency, acting as a body appointed by a Member State competent authority for receiving information for emergency health response, should provide the relevant national appointed body of that Member State access to that information.
(32) After consultation of the Commission expert group of Competent Authorities for REACH 45 and CLP 46 , the Commission regularly adapts the Annexes to Regulation (EC) No 1272/2008 to technical and scientific progress. According to Article 53c of that Regulation, 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 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 themselves in the same Annex, adoption of separated delegated acts has resulted in artificially separating intrinsically related provisions and thereby affecting 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.
(33) In accordance with Directive 2010/63/EU of the European Parliament and of the Council 47 , it is necessary to replace, reduce or refine testing on animals. Implementation of Regulation (EC) No 1272/2008 should be based on the use of alternative 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 methods, with the ultimate goal of fully replacing animal testing, as well as to improve the efficiency of chemical hazard assessments, innovation in the field of non-animal methods should be monitored and systematically evaluated, and the Commission and the Member States acting in the interest of the Union should promote the inclusion of harmonised criteria based on available alternative methods in UN GHS and subsequently include those criteria in Regulation (EC) No 1272/2008 without undue delay.
(34) 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 forth 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, that Regulation should define the term ‘composition conforming with a standard formula’, the obligation to provide the name and product description of the standard formula in the submission and of the fuel should be introduced, and the option to submit information on components even if they are not always present in certain cases should be provided for.
(35) 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.
(36) Regulation (EC) No 1272/2008 should therefore be amended accordingly.
(37) To ensure that suppliers of substances and mixtures have time to adapt to rules on classification, labelling and packaging, the application of some provisions of this Regulation should be deferred. Substances and mixtures which are already placed on the market before the end of that deferral period, should be allowed to continue being placed on the market without being re-classified and re-labelled in accordance with this Regulation, to avoid additional burden on suppliers of substances and mixtures.
(38) 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 on a voluntary basis before the date of deferred application of this Regulation.
(39) 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,