Changes from report parliamentary committee draft to plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

▸7 unchanged paragraphs

on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures

(COM(2022)0748 – C90433/2022 – 2022/0432(COD))

(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 (C90433/2022),

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

Changed– having regard to RulesRule 59 and 40 of its Rules of Procedure,

Changed– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A90000/2023),(A9-0271/2023),

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

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.

Change 1

RemovedRecital 2: (2) Considering that the bioeconomy contributes to the objectives of the European Green Deal, appropriate classification of bio-sourced substances under the CLP Regulation is necessary to transform the European Union into a modern, resource-efficient and competitive economy. Considering also that there is scientific evidence that in certain cases the toxicological effect of substances with constituents (as an individual constituent, identified impurity or an additive) differs from the known toxicological effects of its constituents, even for those present at high concentrations. Although substances with constituents are not intentional mixtures from a chemical point of view, they are not different from mixtures composed of two or more substances, but they may differ from a toxicological point of view. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to limit animal testing, data on substances with constituents 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 is not available on a substance with constituents and where data on individual constituents is available, substances with constituents should be evaluated and classified following the same classification rules as mixtures unless Annex I to Regulation (…

AddedRecital 1: (1) In order to keep pace with globalisation, technological development and new means of sale, such as online sales, it is necessary to adapt Regulation (EC) No 1272/2008 of the European Parliament and of the Council. While under that Regulation it is assumed that all responsible actors in the supply chain are established in the Union, practical experience has shown that economic operators established outside the Union sell chemicals online directly to the general public in the Union. Hence, enforcement authorities are unable to enforce Regulation (EC) No 1272/2008 against economic operators not established in the Union. It is therefore necessary to require that there is a supplier established in the Union, which ensures that the substance or the mixture in question meets the requirements set out in that Regulation when it is being placed on the market, including via distance sales. This provision, together with the requirements in Regulation (EU) xxx/xxx [reference to adopted act to be inserted] on General Product Safety, Regulation (EU) 2022/2065, and Regulation (EU) 2019/1020 should improve compliance with and enforcement of Regulation (EC) No 1272/2008 and thereby ensure a high level of protection of human health and the environment. In order to prevent situations where a consumer becomes de jure and de facto an importer when buying the substance or the mixture via distance sales from the economic operators established outside the Union, it is necessary to specify that th…

RemovedIt is of paramount importance to ensure consistency between European policies and ambitions under the EU Green Deal. One of them is the EU's bioeconomy strategy, aiming at shifting the European economy towards a greater and more sustainable use of renewable resources. The definition of multi-constituent substance – a substance that contains more than one constituent – is different from the definition provided on the Guidance for identification and naming of substances under REACH, and this could create confusion. Therefore, we propose to delete the definition of multi-constituent substance. A natural substance (like essential oil, plant extract, etc.) is a “complex substance”, generally composed of many different constituents (sometimes several hundreds). The composition of a natural complex substance varies depending on the part of the plant, the geographical origin of the plant, the season and climate conditions, the method of extraction, etc. It is not an intentional addition of ingredients like a real mixture. The mixture approach is not adapted for substances with constituents, such as natural complex substances where the constituents are intrinsically part of the substance and, together, determine the toxicological properties of the substance. Studies have shown that, from a toxicological point of view, a natural complex substance tested as a whole may show different results than one or more of its constituents when tested as single chemicals. The proposed amendments would ensure continued alignment with the approach taken at international level (GHS - Global Harmonised System) and would therefore maintain the competitiveness of the European industry.

AddedRecital 2: (2) Substances containing more than one constituent are not intentional mixtures. From a toxicological point of view, substances containing more than one constituent are no different from mixtures composed of two or more substances. In accordance with Article 13 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council39, aimed to minimise animal testing, data on substances containing more than one constituent is to be generated under the same conditions as data on any other substance, while data on individual constituents of a substance is normally not to be generated, except where individual constituents are also substances registered on their own. Where data on individual constituents are available, substances containing more than one constituent should be evaluated and classified following the same classification rules as mixtures.

RemovedRecital 3: (3) Under the current state of science, it may be difficult to sufficiently assess the endocrine disrupting properties for human health and the environment and the persistent, bioaccumulative and mobile properties of a mixture or of a substance on the basis of data on that mixture or substance. The data for the individual substances of the mixture or for the individual constituents of the substance should therefore normally be used as the basis for hazard identification of those substances or mixtures. However, in certain cases, data on those substances themselves may also be relevant.

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

Change 2

ChangedThe definition of multi-constituent substance –Recital a3: substance(3) thatUnder containsthe morecurrent thanstate oneof constituentscience, –it is differentdifficult fromto thesufficiently definitionassess providedthe byendocrine thedisrupting Guidanceproperties for identificationhuman health and namingthe ofenvironment substancesand underthe REACH,persistent, andbioaccumulative thisand couldmobile createproperties confusion.of Therefore,a wemixture proposeor toof deletea thesubstance definitioncontaining ofmore multi-constituentthan substance.one Fromconstituent aon legalthe standingbasis pointof wedata suggeston tothat introducemixture aor moresubstance. accurateThe approachdata atfor the beginningindividual substances of the recitalmixture “Underor for the currentindividual stateconstituents of the sciencesubstance (...)”containing insteadmore ofthan “itone isconstituent normallyshould nottherefore possiblenormally tobe (…)”.used Foras the Rapporteur, it seems difficultbasis tofor definehazard whatidentification “normality”of isthose andsubstances howcontaining tomore calculatethan it.one Moreover,constituent scienceor ismixtures. evolvingHowever, atin ancertain acceleratedcases, pacedata on the assessment of new hazard classes (including endocrine disruptors,those etc.)substances andcontaining itmore isthan thereforeone legitimateconstituent tothemselves refermay toalso thebe currentrelevant. stateThis ofis the science.case Thein recitalparticular specifieswhere that “in certain cases data ondemonstrates theendocrine multi-disrupting constituentproperties themselvesfor mayhuman behealth relevant”.and Thethe Rapporteurenvironment, suggestsas thatwell thisas wouldpersistent, bebioaccumulative sufficient.and Sciencemobile evolvesproperties, inor thesewhere areasit andsupports validationsdata on the whole substance are relevant from a toxicological point ofindividual view,constituents. whenTherefore, theyit showis anappropriate effectthat anddata alsoon whenmulti-constituent theysubstances doare notused showin anthose effect.cases.

Change 3

ChangedRecital 4: (4) In order to improve legal certainty and implementation with regard to the evaluation of hazard information for mixtures where no or inadequate test data are available for the mixture itself, the interaction between the application of the bridging principles and a weight of evidence determination using expert judgement should be clarified. Such clarification should ensure that the weight of evidence determination complements but does not substitute the application of the bridging principles. It should also be clarified that if bridging principles cannot be applied to evaluate a mixture, manufacturers, importers and downstream users should use the calculation method or other methods described in Parts 3 and 4 of Annex I to Regulation (EC) No 1272/2008. It should also be clarified which criteria, when not met, determine when a weight of evidence determination using expert judgment is to be carried out. RecognizingGiven that the application of criteria for information on the different hazard classes is not always straightforward and simple, and bearing in mind that a specific hazard class may be defined by multiple criteria, manufacturers, importers and downstream users should apply, as above, weight of evidence determinations involving expert judgement to arrive at adequate results. Theapply weight of evidence should give due consideration to all available information, irrespectively of possibilities for direct comparison with the criteria; it does not mean averaging results, nor it i…determinations.

Change 4

RemovedWhere more comprehensive and more refined data is available for the assessment of substances, these data should be also used in the hazard classification process to avoid false negative as well as false positive results. Otherwise, safe substances could be considered hazardous and its use banned in Europe under chemicals legislation relying on the CLP Regulation, putting competitiveness of European producers at risk while leading to more imports of finished products from other geographies, jeopardizing European strategic autonomy.

AddedRecital 11: (11) Regulation (EC) No 1272/2008 only allows for the use of fold-out labels if the general rules for the application of labels cannot be met due to the shape or form of the packaging or its small size, whilst it does not provide for a minimum font size of labels that would ensure readability. As a result of advancements in labelling technologies, more flexibility should be given to suppliers by providing for a broader use of fold-out labels, while durability and good readability of all labels should be ensured, including by laying down minimum font size, and formatting requirements.

RemovedRecital 10: (10) To increase enforceability of the obligation placed on suppliers to update their labels after a change in the classification and labelling of their substance or mixture, a deadline should be laid down as regards that obligation. A similar obligation placed on registrants is set out in Commission Implementing Regulation (EU) 2020/143540. 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 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).

AddedRecital 12: (12) Regulation (EC) No 1272/2008 needs to be adjusted to technological and societal changes in the field of digitalisation and be prepared for future developments. Digital labelling could improve the efficiency of hazard communication, especially for vulnerable population groups and people who do not speak the national language of a Member State. Therefore, it is necessary to provide for voluntary digital labelling and to lay down technical requirements for such labelling. In order to provide for legal certainty, it is appropriate to specify the label elements that are allowed to be provided in a digital format only. That possibility should only exist for information which is not instrumental for the safety of the user or the protection of the environment and should be determined taking into account the need for a high level of protection of human health and the environment. The decision as to which information is not relevant for the safety of the user or the protection of the environment needs to be documented transparently. The Unique Formula Identifier, the hazard statement, the precautionary statement, the signal word, and the hazard pictogram should always remain on the on-pack label to ensure they are in sight of consumers.

RemovedThe new CLP Regulation proposal requires labels to be updated within 6 months in case a new hazard class or a more severe classification needs to be assigned to a substance or a mixture, or when new supplemental information on the label is required. This timeline is too short, in particular for complex value chains that involve several mixture formulators downstream, and is inconsistent with current practices, which have proven adequate to allow re-design, re-printing of labels and re-labelling of packages, increasing also the burden to adapt for SMEs. Consistently with current rules, the Rapporteur suggests that 18 months should be the timeline for all label updates - that is the usual timeline for ATP’s when CLH becomes mandatory for specific substances including when the classification of substance(s) is more severe.

AddedRecital 13: (13) In order to adapt the label elements allowed to be provided only in a digital format to technical progress or to the level of digital readiness among all population groups in the Union, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union to amend the list of label elements allowed to be provided only in a digital format, taking into account societal needs, ensuring high level of protection of human health and the environment and sufficient information on chemicals that citizens are exposed to.

Change 5

ChangedRecital 18: (18) Harmonised classification and labelling proposals need not necessarily be limited to individual substances and could cover a group of similar substances, where such similarity based on scientific justification (taking into account all available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach,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. The similarity ofWhere ait groupis ofscientifically substancesjustified shouldand bepossible, givenproposals for the specific endpointclassification andshould theprioritise severitygroups of the effect, which resultssubstances inrather thethan sameindividual classificationsubstances. forIn the respective hazard class. To ensure that all submittersevent of dossiersa proposal for harmonised classification and labelling apply the same scientific principles to justify the grouping approach, there isof a needgroup forof ECHAsubstances, tothose developsubstances guidanceshould clarifyingbe thegrouped principlestogether frombased whichon aclear harmonisedscientific classificationcriteria, forincluding astructural groupsimilarity ofand substancessimilar canevidence-based behazard derived.profiles.

Change 6

RemovedIn order to speed up harmonised classification the Commission seeks to move away from a substance-by-substance approach and proposes to classify groups of substances based on ‘similar classification’. Due to the fact that structurally similar substances can have different behaviour and effects, the assessment of ‘similarity’ must be based on a review of all available data, especially based on the substances’ physico-chemical, ecotoxicological and toxicological properties, as already has been performed under REACH (Annex XI, part 1.5 on grouping of substances and read-across approach). This review must be in line with well-established scientific practices and include a Weight of Evidence assessment across all relevant criteria for the hazard in question. Such an approach will help avoid over-classifying and over-regulating substances based on ‘presumed’ adverse effects. For the Rapporteur it is critical to develop clear, transparent criteria for the grouping of chemical substances, and guidance to apply such criteria with a high degree of scientific rigour and robustness, which is a must for legal clarity and certainty. To ensure that all submitters of dossiers for harmonised classification and labelling (e.g., Member States, industry and – new proposal of the revision – the European Commission) apply the same scientific principles to justify the grouping approach, there is a need for ECHA to develop guidance clarifying the scientific principles from which a harmonised classification for a group of substances can be derived. The development of such a guidance document for the grouping process is also essential to ensure consistency with ongoing processes under REACH, where registrants are developing data to meet REACH requirements for individual substances.

AddedRecital 19: (19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. Interested parties should be given the opportunity to comment where appropriate. For the same reason, a competent authority that receives a proposal for revision of a harmonised classification and labelling submitted by a manufacturer, importer or downstream user should be required to communicate its decision to accept or refuse the proposal for revision to the Agency, which should share that information with the other competent authorities. To increase the efficiency of the harmonized classification and labelling process, the Commission should adopt a delegated act, no later than 12 months following the publication of the RAC opinion.

RemovedRecital 19: (19) To increase transparency and predictability of the proposals submitted to the Agency, the Member States’ competent authorities, manufacturers, importers or downstream users should be required to notify the Agency of their intention to submit a proposal for harmonised classification and labelling, while the Commission should be required to notify the Agency of its request to the Agency or to the Authority to prepare such proposal. Furthermore, the Agency should be required to publish information on such intention or request and update the information regarding the submitted proposal at each stage of the procedure for the harmonised classification and labelling of substances. Interested parties should be given the opportunity to comment, and provide information on the proposal at every stage. 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.

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

RemovedIt is important that interested parties that have relevant data are able to provide the relevant information for the proposal of harmonized classification on one substance or on a group of substances at all stages of the process.

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

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

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

RemovedAs the Classification and Labelling Inventory does not contain any supporting data or study, it is important to bear in mind that the notifier may normally justify only its own classification based on supporting data available to him, but he is generally not able to assess why another notifier concludes a different classification due to lack of access to data from the other notifier(s), unless they have both registered under REACH for the same volume band. Therefore, a justification of divergence from another notification is not always possible, without having access to the supporting data of that notification. In addition, it is unclear whether the notifier bears the responsibility of engaging with other notifier(s) in case of divergence. The concept of lead registrant applies only to REACH, not to CLP. For that reason, the text should clarify that aligning on diverging classifications should only be required when practically achievable, without having to acquire new data nor studies (this would imply costs and such costs would change the outcome on the topic of the Commission’s Impact Assessment). Further guidance on when that requirement is applicable and how that requirement should be fulfilled in practice would need to be developed by ECHA.

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

Change 7

ChangedRecital 3635 a (new): (36a) The revision of this regulation expands the tasks and(35a) remitWhere ofappropriate, the Agency. In orderAgency toshould provide adequate expertise, support, andfurther thoroughguidance evaluations,on the resourcesapplication of the Agency shouldprovisions berelating enhanced,to underthe areview separateof budgetarythis line.Regulation.

Change 8

ChangedIt isRecital of36 paramounta importance,(new): in(36a) orderThe foramendments theintroduced Agencyby tothis continueregulation performingexpands atthe hightasks, level,workload thatand itremit shouldof bethe grantedAgency. sufficientIn resourcesorder to properlyprovide navigateadequate theexpertise, addedsupport, workloadand detailedthorough onscientific thisevaluations, regulation.appropriate Theseand resourcesstable funding for the Agency should be providedensured under athe separateframework budgetaryof line.the upcoming Regulation establishing the ECHA.

Change 9

RemovedRecital 36 b (new): (36b) The ‘ECHA Founding Regulation’ should take account of these needs.

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

RemovedThe abovementioned needs, which are the basis of the excessive workload, and that need to be performed for the revision of the current Regulation, should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

RemovedRecital 37 a (new): (37a) To ensure that, for all the direct and indirect costs for producers that result from the adopted provisions in this regulation, the Commission should conduct an assessment on these costs. The assessment should be the basis to establish an EU support scheme, based on the existing financial instruments, that should cover the regulatory compliance costs for the most vulnerable along the production chain of essential oils. The scheme should mainly target micro, small and medium enterprises. The support scheme should aim to reduce the risk of detriment to EU's competitiveness and should prevent insolvency of producers.

RemovedThe existing Impact assessment by the Commission does not examine the inevitable costs along the value chain, including on the pre-classification and the information and compliance requirements for registration dossiers. Therefore, the burden on the revenues of the industry is widely unknown. The disproportionate weight on SMEs could easily push them out of business, especially in the context of the recent crises. As a result, local jobs, regional economies and traditional industries are at risk, while the EU opens the door to competitor imports from third countries.

Regulation (EC) No 1272/2008

Change 10

ChangedArticle 1 – paragraph 1 – point 1 a-1 (new), Article 1 – paragraph 1: (1a)-1 In Article 1, paragraph 1 is replaced by the following: / ‘Article 1 / 1. The"The purpose of this Regulation is to ensure a high level of protection of human health and the environment,environment including the promotion of alternative methods, for assessment of hazards of substances and mixtures, as well as the free movement of substances, mixtures and articles as referred to in Article 4(8),4(8) andby: advance(a) harmonising the ultimatecriteria goalfor classification of fullysubstances replacingand animalmixtures, testing,and by:the /rules (iv)on thelabelling Commissionand packaging for hazardous substances and mixtures; (b) providing an obligation for: (i) manufacturers, importers and downstream users to ensure,classify priorsubstances and mixtures placed on the market; (ii) suppliers to introducinglabel newand hazardpackage classessubstances orand classificationmixtures criteria,placed thaton suchthe classesmarket; or(iii) criteriamanufacturers, canproducers beof fullyarticles satisfiedand withimporters existingto dataclassify alignedthose withsubstances not placed on the EU’smarket goalthat ofare fullysubject replacingto animalregistration testing.’.or notification under Regulation (EC) No 1907/2006;"

Change 11

Removed(https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32008R1272&from=EN)

RemovedThe Union’s goal of fully replacing animal testing as articulated in Recital (33) of the Commission’s legislative proposal should be reflected and reinforced in Article 1 to translate aspiration into action and accountability. In order for this goal to be achieved, it must be positioned as an overarching priority that guides downstream activity governed under this Regulation, including decisions to introduce new hazard classes, and the classification criteria defined therein, to ensure they can be satisfied without recourse to new animal testing. This amendment is consistent with the Commission’s own vision that implementation of the CLP Regulation “should be based on the use of alternative test methods.”

Regulation (EC) No 1272/2008

Change 12

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 1: A substance containing at least one constituent above the applicable concentration limit, in the form of an individual constituent, an identified impurity or an additive for which relevant information referred to in paragraph 1 is available, shall be examined and evaluated in accordance with the criteria set out in this paragraph 3, using the available information on those constituents as well as on the substance as a whole, unless Annex I lays down a more specific provision.

AddedArticle 1 – paragraph 1 – point 2 – point a, Article 2 – paragraph 1 – point 7a: deleted / (deleted) / (deleted)

RemovedThe Reference to “paragraph 3” should be added simply to clarify that the provision refers to this paragraph (and not to paragraph 1, quoted just before).

Regulation (EC) No 1272/2008

Change 13

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 3: In particular, relevant available information on the substance itself shall be taken into account where one of the following conditions are met:

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

Regulation (EC) No 1272/2008

Change 14

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 4: deleted

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

Regulation (EC) No 1272/2008