Changes from report parliamentary committee draft to plenary report

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.

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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.

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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,

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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.

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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.

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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.

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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.

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

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.

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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.

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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.

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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.

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

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.

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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.

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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.

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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.

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

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.

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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.

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

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.

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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.

Regulation (EC) No 1272/2008