Changes from report parliamentary committee draft to plenary report

Change 32

ChangedArticle 1 – paragraph 1 – point 18 – point b,6, Article 379 – paragraph 2: 2. Manufacturers, importers or downstream users of substances may3: submit3. toWhere the Agency a proposal for harmonisedcriteria classificationreferred andto labellingin ofparagraph those1 substancescannot and,be whereapplied appropriate,directly specificto concentrationavailable limits,identified M-factorsinformation, or acute toxicity estimates, provided that there is no entry in Partwhere 3properties ofare Annexdefined VIby formultiple suchcriteria, substancesmanufacturers, inimporters relationand todownstream theusers hazardshall classcarry orout differentiationan coveredevaluation by that proposal. In case ofapplying a proposal for harmonised classification and labellingweight of aevidence groupdetermination ofusing substances,expert thosejudgement substancesin shallaccordance bewith groupedsection together1.1.1 basedof onAnnex clearI andto cumulativethis scientificRegulation, criteria.weighing Theseall criteriaavailable shallinformation includehaving structurala similaritybearing andon similarthe evidence-baseddetermination hazardof andthe riskhazards profiles.of Thethe assessmentsubstance ofor the hazardmixture, and riskin profileaccordance shallwith besection carried1.2 outof inAnnex aXI Weightto ofRegulation Evidence(EC) manner.No 1907/2006.

Change 33

RemovedThe grouping of substances going into a harmonised classification of labelling must be based on clear scientific criteria. The allowed grouping criteria should be clearly defined as established under REACH. Chemical structure is the appropriate starting point to consider when grouping substances but cannot be conclusive. All grouping practices must be scientifically robust, coherent and transparent. Similar family name or backbone should not be confused with similar hazard profile. Grouping based merely on structural similarity may lead to inadequate worst-case classification. It must be complemented by an assessment of the hazard properties of the various substances of the group to identify similarities and differences within the group. The assessment of hazard profiles should be carried out in a Weight of Evidence manner in order to give priority to actual robust experimental data.

Regulation (EC) No 1272/2008

Change 34

RemovedArticle 1 – paragraph 1 – point 18 – point c, Article 37 – paragraph 2a – subparagraph 1: 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 and, in the case of the Commission, the request to the Agency or the European Food Safety Authority to prepare such proposal. The Agency shall be provided with the adequate resources to support this work, under a separate budgetary line. The ‘ECHA Founding Regulation’ shall take account of these needs.

AddedArticle 1 – paragraph 1 – point 7 a (new), Article 17: (7a) Article 17 is replaced by the following : / "Article 17 / (ha) where applicable, a link to the digital label where further information can be found. / Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used. / The information in points (h) and (ha) in paragraph 1 may be provided on the inner pages of a fold-out label."

RemovedThis right of initiative will create more work for ECHA therefore should be granted sufficient resources, under separate budgetary line, to carry out these tasks. This should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

Regulation (EC) No 1272/2008

Change 35

AddedArticle 1 – paragraph 1 – point 7 b (new), Article 18 – paragraph 3 – subparagraph 1– point b: (7b) In Article 18, paragraph 3, point (b) is replaced by the following: / "(b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, endocrine disruption for human health, endocrine disruption for the environment, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard, persistent, bioaccumulative and toxic (PBT), very persistent, very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent, very mobile (vPvM) properties."

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 8 a (new), Article 25 – paragraphs 2 and 3: (8a) In Article 25, paragraphs 2 and 3 are replaced by the following: / "2. A statement shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012. The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation. / 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 7, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) (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."

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 9, Article 25 – paragraph 6 – subparagraph 1: The specific labelling rules set out in Part 2 of Annex II shall apply to mixtures containing substances referred to in that Annex. The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label. The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture.

AddedArticle 1 – paragraph 1 – point 13 – introductory part: (13) in Article 31, paragraph 1, the following sentence is added:

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 13, Article 31 – paragraph 1: "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 also be presented in a form of a fold out label."

AddedRegulation (EC) 1272/2008

AddedArticle 1 – paragraph 1 – point 13, Article 31 – paragraph 3: 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 size and spacing as to be easily read.

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 13 a (new), Article 32 – paragraph 6: (13a) In Article 32, paragraph 6 is replaced by the following: / "6. Where the label elements referred to in Article 17(1) are provided by means of a fold-out label, the front page shall contain at least the information provided in accordance with Article 17(1)(e), (f) and (g) in all official languages of the Member State where the product is put on the market along with a reference to the additional information provided on the inside page or pages."

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 15, Article 34b – paragraph 1 – point d: (d) the digital label shall be accessible free of charge, without the need to register, download or install specific applications, or to provide a password;

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 16, Article 35 – paragraph 2a: 2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if, in addition to the requirements set out in Titles III and IV, the conditions laid down in section 3.4 of Annex II are fulfilled. / This paragraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3).

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 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 revision thereof.

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 2: The Commission may ask the Agency or the European Food Safety 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. / The Agency and the Authority may, on their own initiative, provide scientific advice to the Commission and Member States on substances or a group of substances where a harmonised classification could be necessary to protect human and animal health and the environment.

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 3: The proposals for harmonised classification and labelling of a substance or a group of substances referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 18 – point a, Article 37 – paragraph 1 – subparagraph 3 a (new): 'Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall prioritise groups of substances rather than individual substances.'

AddedRegulation (EC) No 1272/2008

AddedArticle 1 – paragraph 1 – point 18 – point b, Article 37 – paragraph 2 – subparagraph 1: Manufacturers, importers or downstream users of substances may submit to the Agency a proposal for harmonised classification and labelling of those 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. In the event of a proposal for harmonised classification and labelling of a group of substances, those substances shall be grouped together based on clear scientific criteria, including structural similarity and similar evidence-based hazard profiles.

AddedRegulation (EC) No 1272/2008

Article 1 – paragraph 1 – point 18 – point c, Article 37 – paragraph 2a – subparagraph 2: Within one week from receipt of the notification, the Agency shall publish the name, the EC and CAS numbers of the substance(s), and where relevant, 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).

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Change 36

ChangedArticle 1 – paragraph 1 – point 18 – point c,e, Article 37 – paragraph 2a5 – subparagraph 3:1: WhereThe aCommission, competentwithin authoritytwelve receivesmonths aof proposalthe inpublication accordanceof withthe paragraphopinion 6,of itthe shallCommittee notifyfor theRisk AgencyAssessment, andshall provideadopt anydelegated relevantacts informationin onaccordance itswith reasonArticle for53a acceptingto oramend refusingAnnex theVI proposal.by Theinclusion Agencyof shallsubstances shareor thatmixtures informationtogether with the other competentrelevant authorities.classification /and Anylabelling groupingelements approachand, inwhere aappropriate, proposalthe forspecific harmonisedconcentration classificationlimits, andM-factors labellingor shouldacute betoxicity justifiedestimates onin theTable basis3 of criteria to bePart developed3 byof theAnnex Agency.’;VI.

Change 37

RemovedThere is no procedure to propose harmonised classification for a mixture. Therefore, substances with constituents cannot be subject to harmonised classification solely based on the classification criteria for mixtures.

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Change 38

RemovedArticle 1 – paragraph 1 – point 18 – point c a (new), Article 37 – paragraph 2 b (new): (ca) the following paragraph 2b is inserted: / ‘2b. A proposal for harmonised classification of a substance with constituents should be submitted as for any other substance following the procedure described under Article 37 (1) or (2) and cannot be solely based on the application of the classification criteria for mixtures.’;

AddedArticle 1 – paragraph 1 – point 18 – point e, Article 37 – paragraph 6: 6. Manufacturers, importers and downstream users who have new information which may lead to change of the harmonised classification and labelling elements 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.

RemovedThe sole application of the classification criteria for mixtures for the harmonisation procedure for classification and labelling of substances may lead to wrong and/or over-classification of natural complex substances and may trigger negative impacts on their perception, restrictions or even ban of these ingredients in consumer products through vertical (sectorial) legislations.

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Change 39

RemovedArticle 1 – paragraph 1 – point 18 – point d a (new), Article 37 – paragraph 4: (da) paragraph 4 is replaced by the following: / ‘4. The Committee for Risk Assessment of the Agency, set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 and the Committee for Socio-economic Analysis of the Agency set up pursuant to Article 76(1)(d) of Regulation (EC) No 1907/2006, shall check if the submitted proposal conforms with Annex VI Parts 1 and 2. The Committees of the Agency shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment including on the implications of harmonised classification on risk management measures under the Regulation mentioned hereinabove. The Committees shall provide further guidance on how the harmonised classification proposal for group(s) of substances is to be developed, taking into account the complexity of the proposal. The Committees shall forward this opinion and any comments to the Commission. Where harmonised classification may lead to risk management measures under the Regulation (EC) No 1907/2006, the procedure to submit comments described hereinabove shall be extended by at least 30 days.’;

AddedArticle 1 – paragraph 1 – point 18 – point f, Article 37 – paragraph 7 – subparagraph 1: By 1 January 2026, the Commission shall adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation by inclusion of substances as endocrine disruptor category 1 for human health properties, endocrine disruptor category 1 for environment properties, as persistent, bioaccumulative and toxic, as very persistent and very bioaccumulative, as persistent, mobile and toxic, or very persistent and very mobile together with relevant classification and labelling elements where, on 1 January 2025, those substances have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006.

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

RemovedTo ensure all CLH dossier submitters (e.g., Member States, industry and – new proposal of the CLP revision – the European Commission) apply the same scientific principles to justify similar classification, there is a need for a formal quality check mechanism, i.e. a conformity check (as applied according to REACH Art 64 (3) for Authorisation and Art 69 (4) for Restriction processes), performed by ECHA Committees and for an ECHA guidance that clarifies the scientific basis from which a harmonised classification for a group of substances can be derived. Introduction of new hazard classes under CLP will increase the workload of authorities, industry and ECHA's committees, in particular RAC. Therefore, sufficient time should be given to allow for a thorough examination of each CLH dossier (including the extended possibility to comment for complex dossiers), ensuring harmonised classifications are assigned where justified based on a comprehensive review of the weight of scientific evidence. As far as potential implications of harmonised classification, recent REACH restriction developments show that there is an increasing reliance on harmonised classifications as a basis to restrict substances in mixtures or/and articles. These restrictions may lead to automatic bans or restrictions in mixtures and/or in articles, even where the concerned substances do not raise concerns for consumers, and where they are important for European competitiveness due to their reduced environmental footprint or market relevance. In addition, the compilation of information on the implications of harmonised classification on risk management measures is expected to be more time-consuming. A longer consultation period would, therefore, be required to ensure sufficient time for the collection of evidence.

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Change 40

RemovedArticle 1 – paragraph 1 – point 18 – point e, Article 37 – paragraph 6: 6. Manufacturers, importers and downstream users who have new information which may lead to change of the harmonised classification and labelling elements 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 or, alternatively, directly to the Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006, paragraph 4. The proposal of the manufacturer, importer or downstream user shall be accompanied by the payment of a fee covering all expected costs.

AddedArticle 1 – paragraph 1 – point 20 – point a – point ii, Article 40 – paragraph 1 – subparagraph 1 – point g: (g) where applicable, and without needing to acquire new data or new studies being necessary, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;

RemovedThe classification of substances under the CLP Regulation should be based on the most recent and reliable scientific evidence and research that have resulted from registration and evaluation of substances under the REACH legislation. For many substances classified as hazardous under the CLP, research has evolved to now allow the identification of differing potential health outcomes for different forms of the same basic substance, such as the differences in health risks between soluble and insoluble forms. The dissemination of the correct data according to the form of a substance is fundamental, for example, to allow workers to know more precisely the potential health risks of the substance they are working with rather than general health risks that may or may not apply to the form they are processing. Providing more scientifically accurate classification information will help employers focus on the most relevant necessary controls to best protect their workers. The reclassification process currently foreseen in the CLP Regulation, however, strongly relies on the action of the competent authorities in Member States. Unfortunately, these authorities often do not have the necessary expertise and resources to proceed with the reclassification process of a substance.

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Change 41

ChangedArticle 1 – paragraph 1 – point 20 – point a – point ii, Article 40 – paragraph 1 – subparagraph 1 – point g:h: (g)(h) where applicable and practicallywithout achievable,needing withoutto acquiringacquire new data or new studies being necessary, the reason for divergence fromintroducing thea mostmore severe classification per hazard class compared to those included in the inventory referred to in Article 42;

Change 42

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/her, but he/she 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 which notifier bears the responsibility of engaging with other notifiers(s) in case of divergence. The concept of lead registrant applies only to REACH, not CLP.

Regulation (EC) No 1272/2008

Change 43

RemovedArticle 1 – paragraph 1 – point 20 – point a – point ii, Article 40 – paragraph 1 – subparagraph 1 – point h: (h) where applicable and practically achievable, without acquiring new data or studies being necessary, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42.;

AddedArticle 1 – paragraph 1 – point 20 a (new), Article 41: (20a) Article 41 is replaced by the following: / "Article 41 / Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly. In case where notifiers and registrants cannot come to an agreed entry because of divergences about the level of scientific evidence supporting a classification and labelling of the same substance, the most protective classification shall prevail.'"

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/her, but he/she 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 which notifier bears the responsibility of engaging with other notifiers(s) in case of divergence. The concept of lead registrant applies only to REACH, not CLP.

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Change 44

RemovedArticle 1 – paragraph 1 – point 20 – point a – point ii a (new), Article 40 – paragraph 1 – point h a (new): (iia) point (ha) is added as follows: / ‘(ha) ECHA should develop guidance on when the requirements specified in (g) and (h) above are applicable and on how those requirements shall be fulfilled.’;