Changes from report parliamentary committee draft to plenary report

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.

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

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.”

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).

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;

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;

Change 15

ChangedArticle 1 – paragraph 1 – point 4,2 Articlea 5(new), –paragraphArticle 3 – subparagraph 5: For theparagraph evaluation1: of(2a) substancesIn pursuantArticle to3, Chapterparagraph 21 inis relationreplaced toby the ‘germ cell mutagenicity’,following: ‘carcinogenicity’,/ ‘reproductive"A toxicity’,substance ‘endocrineor disruptinga propertymixture forfulfilling humanthe health’criteria andrelating ‘endocrineto disruptingphysical propertyhazards, forhealth thehazards environment’or hazardenvironmental classeshazards, referredlaid todown in sections 3.5., 3.6., 3.7.Parts 3.11.2 andto 4.2.5 of Annex I, where relevant information referred to inI paragraphis 1hazardous isand notshall availablebe onclassified thein substancerelation itself,to the manufacturer,respective importerhazard orclasses downstreamprovided userfor shallin usethat theAnnex. relevantGender availabledifferences informationwith referredregard to in paragraphthe 1susceptibility forto eachchemicals ofshall thebe individualtaken constituentsinto inconsideration, thewhere substance.relevant."

Change 16

RemovedOn the hazard classes referred to in the above sections, it is more appropriate to refer to the titles of the hazard classes (germ cell mutagenicity for example in 3.5) as they apply to both substances and mixtures, and remove the specific numbering (e.g. 3.5.3.1.) that only relates to the mixtures. That is the rational of removing the specific numbering.

Change 17

ChangedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 5: For the1: evaluationA ofsubstance substancescontaining pursuantmore tothan Chapterone 2constituent, 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 inform sectionsof 4.1.2.8an 4.1.2.9,individual 4.3.2.3.1,constituent, 4.3.2.3.2,an 4.4.2.3.1identified andimpurity 4.4.2.3.2or ofan Annexadditive I,for wherewhich relevant information referred to in paragraph 1 is notavailable, availableshall onbe theexamined substanceand itself,evaluated in accordance with the manufacturer,criteria importerset orout downstreamin userthis shallparagraph, useusing the relevant available information referredon tothose inknown paragraphconstituents 1above forthe eachapplicable ofconcentration thelimit individualas constituentswell inas on the substance.substance itself.

Change 18

RemovedWhere we have information on the natural complex substance as a whole, it is critical to continue being able to use this information as a basis for correct classification. (The over classification expected from a systematic application of the rules of mixtures under CLP and its cascading effects on the perception of natural complex substances and on downstream legislations (cosmetics, flavourings, etc.) would be very detrimental to the maintenance of those natural substances on the market although currently safely used in consumer products.) The proposed amendment 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.

Change 19

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 6 – introductory part: 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 4, Article 5 – paragraph 3 – subparagraph 2: For the evaluation of these 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 individual constituents, impurities and additives in the substance,

Change 20

RemovedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 7: deleted

AddedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 3 – introductory part: Relevant available information on the substance containing more than one constituent itself shall be taken into account where one of the following conditions are met:

RemovedMany natural complex substances (lemon, rose, basil, thyme, etc.) may contain constituents which as single substances could be classified. But this does not mean that these natural complex substances “in their totum” and which are commonly used as fragrance ingredients, cosmetic active substances, etc., present safety concerns for the consumers. An incorrect classification of naturals as substances of carcinogenic, mutagenic, toxic for reproduction (CMR) or endocrine disruptor nature would have severe negative consequences on these substances and would lead to their ban in certain consumer products for no safety reason and would have a negative impact on their use in food and daily nutrition.

Change 21

RemovedArticle 1 – paragraph 1 – point 4 a (new), Article 5 – paragraph 3 – subparagraph 7 a (new): (4a) in Article 5, paragraph 3, the subparagraph 7a is added: / ‘To modify Annex I and in light with all relevant information on substances, the Commission shall use the procedure of Article 53.’.

AddedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 3 – point a: (a) the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment;

RemovedThe procedure for amending Annex I, in light of all relevant information on substances with constituents, is not indicated. Article 53 specifically states that the Commission is empowered to adopt delegated acts in accordance with the amendment of section 1.6. of Annex I in order to adapt the labelling elements referred to in Article 34a(2) to technical progress, but does not mention the procedure for amending Annex I in light of all relevant information on substances with constituents.

Change 22

RemovedArticle 1 – paragraph 1 – point 5 a (new), Article 6 – paragraph 4 a (new): (5a) in Article 6, paragraph 4a is added: / ‘4a. The Agency shall develop robust and timely guidance to support the abovementioned evaluations. Once the Guidance is adopted, the abovementioned criteria shall begin to apply. The Agency shall be provided with the adequate resources, under a separate budgetary line, to support this work. The ‘ECHA Founding Regulation’ shall take account of these needs.’;

AddedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 4: Relevant available information on the substance containing more than one constituent itself showing absence of certain properties or less severe properties shall not override the relevant available information on the constituents in the substance.

RemovedECHA should be granted sufficient resources on the basis of a separate budget, to properly navigate the added workload to the introduction of new hazard classes, as well as the production of clear and robust guidance to support the evaluation of mixtures. These resources shall be provided under a separate budgetary line. This should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

Change 23

RemovedArticle 1 – paragraph 1 – point 5 b (new), Article 7: (5b) Article 7 is replaced by the following: / ‘Article 7 / Animal, non-animal and human testing / 3a. All data, including animal test data and non-animal data, shall be evaluated comparably and according to their biological relevance, mechanistic understanding, and ability to provide information suitable for meeting the requirements of this Regulation.’;

AddedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 5: For the evaluation of substances 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 individual known constituents, impurities or additives in the substance.

RemovedThe Commission’s legislative proposal states: “Under the CLP Regulation, the decision to classify a substance or a mixture for environmental and human health hazards is exclusively based on existing information.”. However, the current language of Article 7 clearly allows for new animal testing. This amendment is therefore necessary to correct this misalignment and bring the CLP Regulation into line with the Commission’s stated intent. It is likewise important to ensure that test data are evaluated fairly and without prejudice, as it continues to be the case that non-animal data are held to a more stringent standard than animal data, which leads to a lower level of use and acceptance of non-animal methods for generating information on chemical substances. As noted by several regulators and experts in the field, the robustness of a testing strategy is assessed according to its biological relevance, technical characterization, data integrity and transparency, and independent review. Therefore, the biological relevance of non-animal approaches should focus on their alignment with human biology, mechanistic understanding, and ability to provide information that leads to protective decisions, rather than solely comparing the data generated with those from traditional animal test methods.

Change 24

RemovedArticle 1 – paragraph 1 – point 6, Article 9 – paragraph 3: 3. Where the criteria referred to in paragraph 1 cannot be applied directly to all available identified information, or where hazards are defined by multiple criteria, 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 across all individual and relevant criteria 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.

AddedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 6 – introductory part: Relevant available information on the substance containing more than one constituent itself shall be taken into account where one of the following conditions are met:

RemovedWhere more comprehensive and more refined data are available for the assessment of substances, these data should be used in the hazard classification process to avoid false negative as well as false positive results. Otherwise, safe substances could be considered hazardous and banned from the use 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 geographic areas.

Change 25

RemovedArticle 1 – paragraph 1 – point 7, Article 10 – paragraph 9: 9. The Agency shall provide further guidance for the application of paragraphs 1, 2 and 3. 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 4, Article 5 – paragraph 3 – subparagraph 6 – point a: (a) the information demonstrates persistence, mobility and bioaccumulation properties or lack of biodegradation;

RemovedECHA should be granted sufficient resources to produce clear and robust guidance to support this work. These resources shall be provided under a separate budgetary line. This should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

Change 26

RemovedArticle 1 – paragraph 1 – point 7 a (new), Article 17: (7a) Article 17 is replaced by the following: / ‘Article 17 / A substance or mixture classified as hazardous and contained in packaging shall bear a label or a fold-out label including the following elements: / Suppliers may use more languages on their labels or fold-out labels than those required by the Member States, provided that the same details appear in all languages used. / The information in paragraph 1 (e), (f), (g) and (h) may be provided on the inner pages of a fold-out label. For multilingual fold-out labels, the languages shall be ordered in a logical way, e.g. alphabetically.’.

AddedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 – subparagraph 7: Relevant available information on the substance containing more than one constituent itself showing absence of the properties referred to in (a) or less severe properties shall not override the relevant available information on the constituents in the substance.

RemovedOne of the objectives of the Commission proposal is to create more flexibility for the use of fold-out labels (recital (11)) as shown in the amendment to Article 29. To ensure consistency and clarity for economic operators and Member State competent authorities, a corresponding reference to fold-out labels should be included.

Change 27

RemovedArticle 1 – paragraph 1 – point 11 – point a, Article 29 – paragraph 1: 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 or a fold-out label in the languages of the Member States in which the substance or mixture is placed on the market, the label elements set out in Article17(1), shall be provided in accordance with sections 1.5.1.1. and 1.5.1.2. of Annex I.;

AddedArticle 1 – paragraph 1 – point 4, Article 5 – paragraph 3 a (new): 3a. Article 5, paragraph 3 shall not apply to 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 1107/20091a or Regulation (EU) No 528/20121b. / 1a 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. / 1b Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.

Change 28

RemovedArticle 1 – paragraph 1 – point 12, Article 30 – paragraph 1: 1. In case of a change regarding the classification and 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 shall ensure that the label is updated within 18 months after the results of the new evaluation referred to in Article 15(4) were obtained.

AddedArticle 1 – paragraph 1 – point 5, Article 6 – paragraph 3 – subparagraph 1: For the evaluation of mixtures pursuant to chapter 2 of this Title in relation to the ‘germ cell mutagenicity’, ‘carcinogenicity’, ‘reproductive toxicity’, ‘endocrine disrupting property for human health’ and ‘endocrine disrupting property 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.

RemovedIt is critical to grant sufficient time for all actors in the supply chain to update their labels and to sustainably exhaust their stocks. The reason for a label update has absolutely no influence on the efforts required to update label artwork. Downstream users are in the middle of the supply chain and depend on their suppliers for classification information. The proposed six-month transition period is difficult for manufacturers to meet and would create scrappage, product-rework/relabel and unnecessary transport of goods which contradicts the objectives of the Green Deal. This should be aligned with the 18 months given under paragraph 2 and the typical transition period for delegated acts under paragraph 3 for harmonised classification.

Change 29

RemovedArticle 1 – paragraph 1 – point 13 a (new), Article 31: (13a) Article 31 is replaced by the following: / ‘Article 31 / General rules for the application of labels and fold-out labels / 1. Labels and fold-out 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. / 4. The shape, colour and the size of a hazard pictogram as well as the dimensions of the label or fold-out label shall be as set out in section 1.2.1 of Annex I. / 5. A label shall not be required when the label elements referred to in Article 17(1) are shown clearly on the packaging itself. In such cases, the requirements of this Chapter applicable to a label shall be applied to the information shown on the packaging.’;

AddedArticle 1 – paragraph 1 – point 5, Article 6 – paragraph 3 – subparagraph 2: However, for the one plant protection product or the one biocidal product for which the approval criteria of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 need to be met, respectively, for the approval of the corresponding active substance, or where the available test data on the mixture itself demonstrates germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disrupting properties 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, data on the mixture as a whole shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

RemovedOne of the objectives of the Commission proposal is to create more flexibility for the use of fold-out labels (recital (11)). To ensure consistency and clarity for economic operators and Member State competent authorities, a corresponding reference to fold-out labels as an alternative should be included in Article 31.

Change 30

RemovedArticle 1 – paragraph 1 – point 13 b (new), Article 32 – paragraph 3: (13b) Article 32, paragraph 3, is replaced by the following: / ‘3. Groups of hazard statements and groups of precautionary statements referred to in paragraph 2 shall be located together on the label or the fold-out label by language. The languages shall be ordered in a logical way, e.g. alphabetically.’;

AddedArticle 1 – paragraph 1 – point 5, Article 6 – paragraph 4: 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’, ‘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 only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself ; / However, where the available test data on the mixture itself demonstrate a lack of biodegradation, persistency, mobility and bioaccumulation properties that have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, such data shall also be taken into account for the purpose of evaluating the mixture referred to in the first subparagraph.

RemovedOne of the objectives of the Commission proposal is to create more flexibility for the use of fold-out labels (recital (11)). To ensure consistency and clarity for economic operators and Member State competent authorities, a corresponding reference to fold-out labels as an alternative should be included in Article 32. This is line with suggested corresponding changes in Article 31. Additionally, to achieve the desired flexibility, the supplier of the substance or mixture should follow ECHA’s guidance on language order.

Change 31

RemovedArticle 1 – paragraph 1 – point 15, Article 34 b – 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;

AddedArticle 1 – paragraph 1 – point 5 a (new), Article 7: (5 a) Article 7 is replaced by the following: / "Article 7 / Non-animal, animal, and human testing / 4. Tests using new approach methodologies shall also be considered."

RemovedA general reference not to download or install an application could de facto also prevent the use of a QR code reader application, as some people may need to install it on their mobile.

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.

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.

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:

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.

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.

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.

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.

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.

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.

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.

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.’;

AddedArticle 1 – paragraph 1 – point 21, Article 42 – paragraph 1 – subparagraph 3 – introductory part: The following information shall be made publicly available free of charge online in a user-friendly format:

RemovedThe legal text should clarify that aligning on diverging classifications should only be required when practically achievable, without having to acquire new data or studies (this would imply costs and such costs would change 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.

Change 45

RemovedArticle 1 – paragraph 1 – point 22 – point c, Article 45 – paragraph 2 – point b: (b) where requested by a Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed. 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 21, Article 42 – paragraph 1 – subparagraph 3 – point a: (a) information referred to in Article 40(1), point (a);

RemovedMember States may appoint ECHA as the body responsible for receiving information relating to emergency health response and preventative measures. ECHA therefore should be granted sufficient resources, under a separate budget to carry out these tasks. This should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

Change 46

RemovedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 1: 1. Any advertisement for the sale to the general public of a substance classified as hazardous shall request the user to “always read and follow product label information”, indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements.

AddedArticle 1 – paragraph 1 – point 21 a (new), Article 42 – paragraph 3 a (new): (21a) In the Article 42, the following paragraph 3a is added: / "3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall delete the corresponding entry from the inventory after having informed the notifier."

RemovedThe advertisement requirements currently proposed would carry disproportionate burdens, without improving human health and environmental protection. Hazardous substances offered to industrial and professional users must be accompanied by Safety Data Sheets. More specific requirements on advertisement should therefore only be directed to the general public.

Change 47

RemovedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2: 2. Any advertisement for the sale to the general public of a mixture classified as hazardous or covered by Article 25(6) shall request the user to “always read and follow product label information”.

AddedArticle 1 – paragraph 1 – point 21 b (new), Article – 43 (new): (21b) The following Article -43 is inserted: / Article -43 / Right to request action from competent authorities and the Commission / 1. Any natural or legal person, individually or in association, shall be entitled to submit substantiated evidence to competent authorities as referred to in Article 43 or the Commission, such as peer-reviewed studies, human biomonitoring data, or environmental monitoring data, on the hazardous properties of a substance or mixture, or of substances or mixtures, showing that hazardous properties of a substance or mixture or of substances or mixtures may not have been sufficiently considered in the classification or labelling process. / 2. The competent authorities or the Commission shall diligently and impartially assess the information submitted in accordance with paragraph 1, adding the evidence submitted to all other available evidence using a weight of evidence approach. / 3. Where the evidence submitted shows non-compliance with one or several of the requirements on the classification, labelling and packaging of substances and mixtures, enforcement measures shall be initiated in accordance with Article 47. / 4. Where the assessment has shown that the substance meets the criteria for classification in any of the hazard classes referred to in Article 36(1), the competent authority or the Commission shall initiate a process of harmonised classification and labelling. Where the assessment has shown a wide dispersive use of and/or consumer exposu…

RemovedFor the general public, a request to “always read and follow product label information” is considered a more effective way to draw attention to the hazards and precautionary information on the label. It will also be more straightforward to implement in the context of advertisements, which would otherwise always need to be updated following changes in labels. This is particularly important as “any advertisement” will cover a broad range of advertising materials, including company websites, TV commercials, internet videos, customer presentations, brochures, weekly supermarket circulars and other materials, including updated in case of label changes. Such advertisements are often not made specifically for jurisdictions where CLP is the applicable legislation on hazard communication. Incorporating CLP label elements into a global promotional video will be confusing to non-EU viewers.

Change 48

RemovedArticle 1 – paragraph 1 – point 24, Article 48a – paragraph 1: Suppliers placing substances or mixtures on the market through distance sales to the general public shall clearly indicate the label elements referred to in Article 17.

AddedArticle 1 – paragraph 1 – point 21 c (new), Article – 43 a (new): (21c) The following Article -43a is added: / Article -43a / Access to justice / 1. Any natural or legal person which has submitted a substantiated concern in accordance with Article -43a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant competent authority under this Regulation. / 2. Member States shall ensure access to administrative or judicial procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions, acts and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. / 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.

RemovedHazardous substances offered to industrial and professional users must be accompanied by Safety Data Sheets. Including a copy of the CLP label in B2B ordering systems will therefore not improve human health and environmental protection. In such cases, the label would often be visible to a procurement agent who has no relation to the way the purchased hazardous substances and mixtures are used by the employees of the purchasing company. The proposed amendment therefore targets the new requirements to distance sales to the general public.

Change 49

RemovedArticle 1 – paragraph 1 – point 25 – point b, Article 50 – paragraph 3: 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 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. 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 23, Article 48 – paragraph 1: 1. Any advertisement for a substance classified as hazardous shall indicate the relevant hazard pictogram, the signal word, the hazard class and the hazard statements. Any advertisement for a substance for sale to the general public shall in addition indicate “always read and follow the information on the product label.

RemovedArticle 50 as foreseen provides for the possibility to designate the Agency as the appointed body to receive relevant information for emergency health responses under Article 45. It further tasks the Agency with ensuring the availability of appropriate tools to share information with national appointed authorities so they fulfil their other obligations under Article 45. Therefore, ECHA should be granted adequate resources to carry out these tasks, on a separate budgetary basis.

Change 50

RemovedArticle 1 – paragraph 1 – point 25 a (new), Article 53 – paragraph 1: (25a) In Article 53, paragraph 1, is replaced by the following: / ‘1. The Commission may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VII to technical and scientific progress, including opportunities to promote the inclusion of harmonised criteria based on available non-animal approaches, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases, and subject to the provisions of Article 1.1(b)(iv). Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4).’;

AddedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2: 2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictogram, the signal word, the hazard class and the hazard statements. Any advertisement for sale of mixtures to the general public shall, in addition, indicate “always read and follow the information on the product label.

RemovedAccording to the Rapporteur, this amendment is necessary to ensure that the Commission’s powers to introduce delegated acts are guided by the provisions of Article 1, as amended, to ensure alignment with the Union’s goal of fully replacing animal testing.

Change 51

RemovedArticle 1 – paragraph 1 – point 29, Article 54 – paragraph 1: 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*. The committee shall be provided with the adequate resources to support this work, under a separate budgetary line. This shall be clearly reflected in the ‘ECHA Founding Regulation’.

AddedArticle 1 – paragraph 1 – point 23, Article 48 – paragraph 2a (new): 2a. The use of environmental claims, as defined in Article 2, point (o), of Directive 2005/29/EC, is prohibited.

RemovedArticle 54 makes reference to the work of the RAC. In order to carry out future tasks, the committee should be provided with adequate resources. These resources shall be provided under a separate budgetary line. This should be clearly reflected in the envisaged standalone ECHA Founding Regulation.

Change 52

RemovedArticle 1 – paragraph 1 – point 30, Article 61 – paragraph 7: 7. Substances which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, 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, 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 as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 18 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* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 42 months after the date of entry into force of this Regulation].

AddedArticle 1 – paragraph 1 – point 25 – point -a (new), Article 50 – paragraph 2 – point a: (-a) in Article 50, paragraph 2, point a is amended as following: / "(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;"

RemovedDifferentiated dates for substances and mixtures should be introduced in this paragraph, as in paragraph 2 of article 2, allowing 18 months for substances and 24 months for mixtures. This is consistent with the CLP Regulation, and the delegated act for hazard classes.

Change 53

RemovedArticle 1 – paragraph 1 – point 30 a (new), Article 61 – paragraph 7 a (new): (30a) in Article 61, the paragraph 7a is added: / ‘7a. Mixtures which have been classified, labelled and packaged in accordance with Article 1(1), Article 4(10), Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 25(6) and (9), Articles 29, 30 and 35, Article 40(1) and (2), Article 42(1), third sub-paragraph, Article 48, 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, 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 as applicable on … [OP: please insert the date = the day before the entry into force of this Regulation] and which were placed on the market before [OP: please insert the date = the first day of the month following 24 months [VC1] 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* [OP: please complete the reference in the footnote – it should be the reference to this Regulation] until … [OP: please insert the date = the first day of the month following 48 months after …

AddedArticle 1 – paragraph 1 – point 25 – point a, Article 50 – paragraph 2 – point b: (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.

RemovedDifferentiated dates for substances and mixtures should be introduced in this paragraph, as in 2 of article 2, allowing 18 months for substances and 24 months for mixtures. This is consistent with the CLP Regulation, and the delegated act for hazard classes.

RemovedArticle 2 – paragraph 2 – introductory part: 2. The following provisions shall apply to substances from … [OP: please insert the date = the first day of the month following 18 months after the date of entry into force of this Regulation]:

RemovedCurrently there is the same application date for substances and mixtures, which makes it very challenging if not impossible for suppliers of mixtures to comply. Given the significance of these changes in the CLP OLP text (first substance, then mixtures), a differentiated timeline should be provided as foreseen in when CLP was first introduced, and as it is also in line with the delegated act on the new hazard classes. A reasonable timeline for application of these provisions would be 18 months for substances and 24 months for mixtures.

RemovedArticle 2 – paragraph 2 a (new): 2a. The following provisions shall apply to mixtures from … [OP: please insert the date = the first day of the month following 24 months after the date of entry into force of this Regulation]: / (a) Article 1, points (1), (4), (5), (6), (7), (10), (11), (12), (15), (16), (20), (21), (23) and (24); / (b) Annex I, points (2), (3), (7), (9) and (10); / (c) Annex II; / (d) Annex III, points (1)(c), (2), (3) and (4).

Change 54

AddedArticle 1 – paragraph 1 – point 25 – point b a (new), Article 50 – paragraph 3 a (new) and 3 b (new): (ba) the following paragraphs are added: / “3a. The Agency shall be provided with adequate resources to support its work. / 3b. In order to provide adequate expertise, support, and thorough scientific evaluations, appropriate and stable funding for the Agency shall be ensured.”

Change 55

AddedArticle 1 – paragraph 1 – point 26 – point -a (new), Article 53 – paragraph 1: (-a) In Article 53, paragraph 1 is replaced by the following: / "1. The Commission may adjust and adapt Articles 6(5), 11(3), 12, 14, 18(3)(b), 23, 25 to 29 and 35(2) second and third subparagraph and Annexes I to VII to technical and scientific progress, including the promotion of alternative methods for assessment of hazards of substances and mixtures, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases. Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 54(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 54(4)."

Change 56

AddedArticle 1 – paragraph 1 – point 26 – point a, Article 53 – paragraph 1a: 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 adapt the label elements referred to in Article 34a(2) to technical progress or to the level of digital readiness among all population groups in the Union. When adopting those delegated acts, the Commission shall ensure a high level of protection of human health and the environment and take into account societal needs. The Commission shall make sure that information which is critical to protect human health and the environment shall be easily accessible on the label;

Change 57

AddedArticle 1 – paragraph 1 – point 26 – point a, Article 53 – paragraph 1b – point d: (d) take into account the level of digital readiness among all population groups in the Union, as well as the readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;

Change 58

RemovedAnnex I – paragraph 1 – point 3, Annex I - part I – point 3: deleted / (deleted) / (deleted) / (deleted) / (deleted) / (deleted)

AddedArticle 1 – paragraph 1 – point 26 – point b, Article 53 – paragraph 2: 2. The Commission or the Member States acting in the interest of the Union shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as well the development of criteria for immunotoxic and neurotoxic substances as well as alternative test methods, including new approach methods and in particular non-animal methods at the level of the UN to address existing and emerging hazard classes.;

RemovedThe new rules for formatting labels are too stringent and too specific, particularly those prescribing a minimum font size and spacing requirements. A slight increase in font size would increase legibility, but the proposed increase is unnecessary and impractical: it would make current label sizes unusable for the majority of products and would reduce the number of languages that can be placed on one label and thus, considerably limit flexibility. In addition, companies would need new or updated software’s to manage those requirements. Therefore, we suggest to reach a common ground by maintaining the minimum font size (while increasing it/per category) and eliminating the part 1.2.1.5, as specific formatting rules should be kept in the guidance document. This approach has been underlined also by ECHA Guidance on labelling and packaging in accordance with Regulation (EC) No 1272/2008 Version 4.2 March 2021, according to which: ”Readability is determined by the combination of font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width-height ratio of the letters, the surface of the material and significant contrast between the print and the background.”. Overly prescriptive additional requirements regarding font size, distance between two lines and background colour are not justified and severely limit the flexibility of suppliers. It is sufficient if the label or fold-out label is easily readable and clearly stand out from the background. In fact, the additional requirements would hinder the free movement of products in the Single Market, which in turn would entail an adjustment of logistics.

Change 59

RemovedAnnex II a (new), Annex VI: ANNEX IIa / Annex VI is amended as follows: / ‘ANNEX VI / — Justification for the proposed grouping of substances to harmonized classification and labelling / Where a harmonised classification and labelling proposal is made for group(s) of substances, the dossier shall include scientific justification (based on assessment of available data on physico-chemical, ecotoxicological and toxicological properties as specified in REACH Annex XI (1.5)) using a weight of evidence approach, for the grouping of substances and for applying a similar classification. / — Justification for other effects at Community level / For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC.’.

AddedArticle 1 – paragraph 1 – point 26 – point c, Article 53 – paragraph 3: 3. The Commission shall promote and evaluate the development of alternative test methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, including new approach methods and in particular non-animal test methods, at least every three years, 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 no more than twelve months after non-animal data are included in harmonised criteria for classification and labelling at the level of the UN.

AddedRegulation (EC) No 1272/2008

RemovedThere is a need 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.

AddedArticle 1 – paragraph 1 – point 26 – point c a (new), Article 53 – paragraph 3 a (new): (ca) In Article 53, paragraph 3a is added as following: / "3a. The Commission shall assess the introduction of hazard criteria for immunotoxicity and neurotoxicity by 31 December 2025 and, where appropriate, adopt delegated acts in accordance with Article 53a. The Commission shall foster the rapid introduction of those hazard classes at the UNGHS."

AddedRegulation (EC) No 1272/2008