in force 2026-07-01
02008R1272-20260501 → 02008R1272-20260701
Amended by Regulation (EU) 2024/2865 32024R2865
Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (Text with EEA relevance)
detected 2026-09-04
39 provisions touched — 39 substantive, 0 date-only, 28 disputed · 21 changes without an explanation
Emendrix checks every change against three independent sources. Where they disagree it says so rather than picking a winner.
MODIFIED ±0 Art. 1§
applies from: unknown
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MODIFIED ±0 Art. 2§
applies from: unknown
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MODIFIED +307 −0 Art. 4 General obligations to classify, label and package§
applies from: unchanged
A new paragraph 11 has been added stating that a substance or mixture shall not be placed on the market unless a supplier established in the Union, identified on the label, in the course of an industrial or professional activity fulfils the requirements set out in the Regulation with regard to that substance or mixture.
This paragraph does not appear in the earlier version of Article 4, which ends at paragraph 10.
Cited: Art. 4, v2 · Art. 4, v1
text before / after
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Article 4 General obligations to classify, label and package 1. Manufacturers, importers and downstream users shall classify substances or mixtures in accordance with Title II before placing them on the market. 2. Without prejudice to the requirements of paragraph 1, manufacturers, producers of … 381 unchanged words … being placed on the market. 9. Suppliers in a supply chain shall cooperate to meet the requirements for classification, labelling and packaging in this Regulation. 10. Substances and mixtures shall not be placed on the market unless they comply with this Regulation.11. A substance or a mixture shall not be placed on the market unless a supplier established in the Union, which shall be identified on the label, in the course of an industrial or professional activity fulfils the requirements set out in this Regulation with regard to the substances or mixture in question
MODIFIED +4,318 −0 Art. 5 Identification and examination of available information on substances§
applies from: unchanged
A new point (ca) is added to paragraph 1, listing data obtained from new approach methodologies among the relevant available information to be identified on a substance.
New paragraphs 3 to 8 are added, setting out how substances containing more than one constituent are to be evaluated using information on individual constituents versus the substance itself, including specific rules for mutagenicity, carcinogenicity, reproductive toxicity and endocrine disruption hazard classes, for biodegradation, persistence, mobility and bioaccumulation hazard classes, an exclusion for unmodified plant- or fungus-derived substances, a definition of plants for that exclusion, and a mechanism for the Commission to request Agency evaluation and adopt delegated acts creating derogations from these rules.
Paragraph 2 remains unchanged in wording between the two versions.
Cited: Art. 5, v2 · Art. 5, v1
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before (02008R1272-20260501)
Article 5 Identification and examination of available information on substances 1. Manufacturers, importers and downstream users of a substance shall identify the relevant available information for the purposes of determining whether the substance entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following: (a) data generated in accordance with any of the methods referred to in Article 8(3); (b) epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases; (c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006; (d) any new scientific information; (e) any other information generated under internationally recognised chemical programmes. The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used. 2. Manufacturers, importers and downstream users shall examine the information referred to in paragraph 1 to ascertain whether it is adequate, reliable and scientifically valid for the purpose of the evaluation pursuant to Chapter 2 of this Title.
after (02008R1272-20260701)
Article 5 Identification and examination of available information on substances 1. Manufacturers, importers and downstream users of a substance shall identify the relevant available information for the purposes of determining whether the substance entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following: (a) data generated in accordance with any of the methods referred to in Article 8(3); (b) epidemiological data and experience on the effects on humans, such as occupational data and data from accident databases; (c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006; (ca) data obtained from new approach methodologies; (d) any new scientific information; (e) any other information generated under internationally recognised chemical programmes. The information shall relate to the forms or physical states in which the substance is placed on the market and in which it can reasonably be expected to be used. 2. Manufacturers, importers and downstream users shall examine the information referred to in paragraph 1 to ascertain whether it is adequate, reliable and scientifically valid for the purpose of the evaluation pursuant to Chapter 2 of this Title. 3. A substance containing more than one constituent, 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 evaluated using the available information on those known constituents as well as on the substance itself. 4. For the evaluation of a substance 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 and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents. Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met: (a) the information demonstrates germ cell mutagenic, carcinogenic, or toxic to reproduction properties, or endocrine disruption for human health or the environment; (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance. 5. For the evaluation of a substance 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 or very persistent, very bioaccumulative properties and persistent, mobile and toxic or very persistent, very mobile properties 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 and downstream user shall use the relevant available information referred to in paragraph 1 for each of the known constituents in the substance. Relevant available information on a substance containing more than one constituent itself shall be taken into account where one of the following conditions is met: (a) the information demonstrates persistence, mobility and bioaccumulation properties or a lack of degradation. (b) the information supports the conclusions based on the relevant available information on the constituents in the substance. Relevant available information on the substance containing more than one constituent itself demonstrating an absence of the properties referred to in point (a) or less severe properties shall not override the relevant available information on the constituents in the substance. 6. Paragraphs 4 and 5 shall not apply to substances containing more than one constituent which are extracted from plants or plant parts and which are not chemically modified as defined in Article 3, point (40), of Regulation (EC) No 1907/2006. 7. For the purpose of paragraph 6, plants refers to living or dead organisms from the kingdoms Plantae and Fungi, and includes algae, lichens and yeasts. 8. For certain substances containing more than one constituent that are not covered by paragraph 6, where the Commission receives evidence that the rules set out in paragraphs 4 or 5 might not be suitable for certain substances containing more than one constituent, the Commission may request the Agency to evaluate the available data. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend Annex I by creating a new section and by including and modifying, in that section, the derogations from paragraph 4 or 5 on classification of substances containing more than one constituent. For those delegated acts, the Commission shall take into account scientific evidence, advances in knowledge, and the opinion of the Agency when available, to appropriately classify substances containing more than one constituent provided that a high level of protection of human health and the environment is ensured.
MODIFIED +811 −171 Art. 6 Identification and examination of available information on mixtures§
applies from: unchanged
A new point (ca) was added to paragraph 1 listing data obtained from new approach methodologies as a type of information to be identified.
Paragraph 3 now also covers endocrine disruption for human health and for the environment among the hazard classes for which only substance-level information is used, adds references to sections 3.11.3.1 and 4.2.3.1 of Annex I, states explicitly that this information is used for the substances and not for the mixture itself, and extends the rule on mixture test data showing unidentified effects to also cover endocrine disruption effects.
Paragraph 4 now also covers persistency and mobility properties, PBT/vPvB and PMT/vPvM hazard classes with added Annex I section references, and likewise states that substance-level information is used and not information on the mixture itself.
Cited: Art. 6, v2 · Art. 6, v1
text before / after
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Article 6
Identification and examination of available information on mixtures
1. Manufacturers, importers and downstream users of a mixture shall identify the relevant available information on the mixture itself or the substances contained in it for the purposes of determining whether the mixture entails a physical, health or environmental hazard as set out in Annex I, and, in particular, the following:
(a) data generated in accordance with any of the methods referred to in Article 8(3) on the mixture itself or the substances contained in it;
(b) epidemiological data and experience on the effects on humans for the mixture itself or the substances contained in it, such as occupational data or data from accident databases;
(c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it;
(ca) data obtained from new approach methodologies;
(d) any other information generated under internationally recognised chemical programmes for the mixture itself or the substances contained in it.
The information shall relate to the forms or physical states in which the mixture is placed on the market and, when relevant, in which it can reasonably be expected to be used.
2. Subject to paragraphs 3 and 4, where the information referred to in paragraph 1 is available for the mixture itself, and the manufacturer, importer or downstream user has ascertained that information to be adequate and reliable and where applicable, scientifically valid, that manufacturer, importer or downstream user shall use that information for the purposes of the evaluation pursuant to Chapter 2 of this Title.
3. For the evaluation of mixtures pursuant to Chapter chapter 2 of this Title in relation to the germ cell mutagenicity, carcinogenicity carcinogenicity, reproductive toxicity, endocrine disruption for human health and reproductive toxicity endocrine disruption for the environment hazard classes referred to in sections 3.5.3.1, 3.6.3.1 3.6.3.1, 3.7.3.1, 3.11.3.1 and 3.7.3.1 4.2.3.1 of Annex I, the manufacturer, importer or and downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture.
Further, in cases where mixture and not for the mixture itself.
Where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction effects properties, or endocrine disruption for human health or the environment which have not been identified from the relevant available information on the individual substances, substance referred to in the first subparagraph, those data shall also be taken into account. account for the purposes of the evaluation of the mixture referred to in the first subparagraph.
4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the biodegradation biodegradation, persistency, mobility and bioaccumulation properties within the hazardous to the aquatic environment environment, persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties and persistent, mobile and toxic or very persistent, very mobile properties hazard class classes referred to in sections 4.1.2.8 4.1.2.8, 4.1.2.9, 4.3.2.3.1, 4.3.2.3.2, 4.4.2.3.1 and 4.1.2.9 4.4.2.3.2 of Annex I, the manufacturer, importer or and downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture. mixture and not for the mixture itself.
5. Where no or inadequate test data on the mixture itself of the kind referred to in paragraph 1 are available, the manufacturer, importer or downstream user shall use other available information on individual substances and similar tested mixtures which may also be considered relevant for the purposes of determining whether the mixture is hazardous, provided that that manufacturer, importer or downstream user has ascertained that information to be adequate and reliable for the purpose of the evaluation pursuant to Article 9(4).
MODIFIED +930 −279 Art. 9 Evaluation of hazard information for substances and mixtures§
applies from: unchanged
Paragraph 3 now specifies that the criteria which cannot be applied directly are those referred to in paragraph 1, whereas the earlier text referred only to "the criteria" without that cross-reference.
Paragraph 4 has been rewritten to focus specifically on evaluating hazard information for mixtures, tying the bridging principles to cases where test data for the mixture itself are inadequate or unavailable, rather than to cases where only the information referred to in Article 6(5) is available as in the earlier text.
A new subparagraph has been inserted requiring a weight of evidence determination using expert judgement to select the most suitable similar tested mixtures when more than one similar tested mixture is available for applying the bridging principles, and the final subparagraph on using other methods now refers to information not permitting application of the bridging principles under the first and second subparagraphs, rather than referring to both bridging principles and weight of evidence principles as in the earlier text.
Cited: Art. 9, v1 · Art. 9, v2
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Article 9
Evaluation of hazard information for substances and mixtures
1. Manufacturers, importers and downstream users of a substance or a mixture shall evaluate the information identified in accordance with Chapter 1 of this Title by applying to it the criteria for classification for each hazard class or differentiation in Parts 2 to 5 of Annex I, so as to ascertain the hazards associated with the substance or mixture.
2. In evaluating available test data for a substance or a mixture which have been obtained from test methods other than those referred to in Article 8(3), manufacturers, importers and downstream users shall compare the test methods employed with those indicated in that Article in order to determine whether the use of those test methods affects the evaluation referred to in paragraph 1 of this Article.
3. Where the criteria referred to in paragraph 1 cannot be applied directly to available identified information, 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 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.
4. Where only the When evaluating hazard information referred to in Article 6(5) is available, for mixtures, manufacturers, importers and downstream users shall shall, where test data for the mixture itself are inadequate or unavailable, apply the bridging principles referred to in section 1.1.3 of Annex I and in each section of Parts 3 and 4 of that Annex I for the purposes of the evaluation.
However, where that information permits the application neither of If more than one similar tested mixture is available when applying the bridging principles nor the principles for using expert judgement and weight of evidence determination as described in Part 1 of Annex I, principles, manufacturers, importers and downstream users shall apply 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 having a bearing on the determination of the hazards of the mixture, and in accordance with section 1.2 of Annex XI to Regulation (EC) No 1907/2006, to select the most suitable similar tested mixtures in accordance with Article 6(5) of this Regulation for their decision on classification.
When evaluating the hazard information for mixtures, manufacturers, importers and downstream users shall, where that information does not permit the application of the bridging principles in accordance with the first and second subparagraphs, evaluate the information by applying the other method or methods described set out in each section of Parts 3 and 4 of Annex I.
5. When evaluating the available information for the purposes of classification, the manufacturers, importers and downstream users shall consider the forms or physical states in which the substance or mixture is placed on the market and in which it can reasonably be expected to be used.
MODIFIED +1,586 −343 Art. 10 Concentration limits, M-factors and acute toxicity estimates for classification of substances and mixtures§
applies from: unchanged
The heading and text now add acute toxicity estimates alongside concentration limits and M-factors, with a new paragraph 3 requiring manufacturers, importers and downstream users to establish acute toxicity estimates for substances classified as acutely toxic for human health, and later paragraphs renumbered to accommodate this addition.
The former paragraphs 3 and 4 on exemptions from setting specific concentration limits and M-factors are renumbered as paragraphs 4 and 5, and a new paragraph 6 adds a corresponding exemption for acute toxicity estimates where one is given in Part 3 of Annex VI.
Two entirely new paragraphs, 10 and 11, are added addressing how the concentration limits referred to in paragraph 1 apply to an identified impurity, additive or individual constituent within a mixture and within a mixture contained in another mixture, provisions that were absent from the earlier text.
Cited: Art. 10, v2 · Art. 10, v1
text before / after
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Article 10
Concentration limits limits, M-factors and M-factors acute toxicity estimates for classification of substances and mixtures
1. Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.
Specific concentration limits shall be set by the manufacturer, importer or downstream user where adequate and reliable scientific information shows that the hazard of a substance is evident when the that substance is present at a level below the concentrations set for any hazard class in Part 2 of Annex I or below the generic concentration limits set for any hazard class in Parts 3, 4 and 5 of Annex I.
In Manufacturers, importers and downstream users may set a specific concentration limit for a substance in exceptional circumstances specific concentration limits may be set by the manufacturer, importer or downstream user where he has adequate, reliable and conclusive scientific information shows that a the hazard of a substance classified as hazardous is not evident at a level above the concentrations set for the relevant hazard class in Part 2 of Annex I or above the generic concentration limits set for the relevant hazard class in Parts 3, 4 and 5 of that Annex.
2. Manufacturers, importers and downstream users shall establish M-factors for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, shall be established by manufacturers, 1.
3. Manufacturers, importers and downstream users.
3. Notwithstanding users shall establish acute toxicity estimates for substances classified as acutely toxic for human health.
4. By way of derogation from paragraph 1, second and third subparagraphs, specific concentration limits shall not be set for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI.
4. Notwithstanding 5. By way of derogation from paragraph 2, M-factors shall not be set established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an M-factor is given in that Part.
However, where an M-factor is not given in Part 3 of Annex VI for substances classified as hazardous to the aquatic environment, acute category 1 or chronic category 1, the manufacturer, importer or downstream user shall set an M-factor based on available data for the substance shall be set by the manufacturer, importer or downstream user. substance. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, this that M-factor shall be used.
5. In 6. By way of derogation from paragraph 3, acute toxicity estimates shall not be established for harmonised hazard classes or differentiations for substances included in Part 3 of Annex VI for which an acute toxicity estimate is given in that Part.
7. When setting the specific concentration limit limit, M-factor or M-factor acute toxicity estimate, manufacturers, importers and downstream users shall take into account any specific concentration limits limits, M-factors or M-factors acute toxicity estimate for that substance which have been included in the classification and labelling inventory.
6. 8. Specific concentration limits set in accordance with paragraph 1 1, second and third subparagraphs, shall take precedence over the concentrations concentration limits set out in the relevant sections of Part 2 of Annex I or the generic concentration limits for classification set out in the relevant sections of Parts 3, 4 and 5 of Annex I.
7. that Annex.
9. The Agency shall provide further guidance for the application of paragraphs 1 1, 2 and 2. 3.
10. Where a mixture contains a substance which is classified as hazardous solely due to the presence of an identified impurity, additive or individual constituent, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of that identified impurity, additive or individual constituent in the mixture.
11. Where a mixture contains another mixture, the concentration limits referred to in paragraph 1, second and third subparagraphs, shall apply to the concentration of the identified impurity, additive or individual constituent referred to in paragraph 10 in the resulting final mixture.
MODIFIED ±0 Art. 13§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
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MODIFIED ±0 Art. 18§
applies from: unknown
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MODIFIED ±0 Art. 23§
applies from: unknown
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MODIFIED ±0 Art. 24§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
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MODIFIED +28 −11 Art. 25 Supplemental information on the label§
applies from: unchanged
Paragraph 3 now excludes information covered by paragraphs 6 to 9, in addition to paragraphs 1 and 2, from the supplemental information a supplier may add to the label.
The reference to Article 17(1) points (a) to (g) is also reformatted with a comma and the word 'points', with no change to the substance of that cross-reference.
Cited: Art. 25, v2 · Art. 25, v1
text before / after
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Article 25
Supplemental information on the label
1. Statements shall be included in the section for supplemental information on the label where a substance or mixture classified as hazardous has the physical properties or health properties referred to in sections 1.1 and 1.2 of Annex II.
The statements shall be worded in accordance with sections 1.1 and 1.2 of Annex II and Part 2 of Annex III.
Where a substance is included in Part 3 of Annex VI, any supplemental hazard statements given therein for the substance shall be included in the supplemental information on the label.
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 Directive 91/414/EEC.
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 1, 2 and 2, 6 to 9, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1) 17(1), points (a) to (g) (g), and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements.
4. Statements such as non-toxic, non-harmful, non-polluting, ecological or any other statements indicating that the substance or mixture … 367 unchanged words … for an individual consumer or professional user at the point of sale by tinting or colour mixing.
9. Label elements resulting from requirements set out in other Union acts shall be placed in the section for supplemental information on the label.
MODIFIED +803 −118 Art. 29 Exemptions from labelling and packaging requirements§
applies from: unchanged
Paragraph 1 now points to the label elements set out in Article 17(1) instead of those under the first subparagraph of Article 17(2), alongside a minor wording change to the cross-reference to Article 31.
Paragraph 3 replaces the requirement to accompany an unpackaged hazardous substance or mixture with a copy of the label elements under Article 17 with a requirement that labelling information be provided in accordance with the provision referring to that substance or mixture in Part 5 of Annex II.
A new paragraph 4b is added, providing a derogation from the Article 17(1) labelling requirement for packaging of ammunition intended for use by defence forces in certain security-risk circumstances, and requiring manufacturers, importers and downstream users to provide the defence forces with a safety data sheet or, where none is required, a copy of the label elements under Article 17.
Cited: Art. 29, v1 · Art. 29, v2
text before / after
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Article 29
Exemptions from labelling and packaging requirements
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 of laid down in Article 31 for a label in the languages of the Member State in which the substance or mixture is placed on the market, the label elements set out in accordance with the first subparagraph of Article 17(2) 17(1), shall be provided in accordance with section 1.5.1 of Annex I.
2. If the full label information cannot be provided in the way specified in paragraph 1 the label information may be reduced in accordance with section 1.5.2 of Annex I.
3. When Where a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging it packaging, the labelling information shall be accompanied by a copy of the label elements provided in accordance with Article 17. the provision referring to that substance or mixture in that Part.
4. For certain mixtures classified as hazardous to the environment, exemptions to certain provisions on environmental labelling or specific provisions in relation to environmental labelling may be determined in accordance with the procedure referred to in Article 53, where it can be demonstrated that there would be a reduction in the environmental impact. Such exemptions or specific provisions are defined in Part 2 of Annex II.
4a. Where under Annex VIII the submitter creates a unique formula identifier, the submitter may, instead of including it in the supplemental information on the label, opt to show it in another way permitted by Section 5 of Part A of that Annex.
4b. By way of derogation from Article 17(1), the labelling requirement set out in that Article shall not apply to packaging of ammunition that is intended for use by defence forces, where labelling in accordance with that requirement would constitute an unacceptable security risk for the ammunition or for the military or non-military staff, and sufficient camouflaging cannot be ensured.
In the case referred to in the first subparagraph of this paragraph, manufacturers, importers and downstream users shall provide to the defence forces the safety data sheet or, if no safety data sheet is required, a copy of the label elements as provided for in Article 17.
5. The Commission may request the Agency to prepare and submit to it further draft exemptions from labelling and packaging requirements.
MODIFIED +1,287 −477 Art. 30 Updating information on labels§
applies from: unchanged
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
Paragraph 1 changes from a general obligation to update labels without undue delay for more severe hazards or new supplemental elements into an obligation that ties the update to a specific timeframe of no later than 6 months after the results of a new evaluation under Article 15(4) are obtained by or communicated to the supplier, and it drops the earlier reference to supplier cooperation under Article 4(9).
Paragraph 2 similarly changes from a flat 18-month update requirement into an 18-month period measured from when the results of a new evaluation under Article 15(4) are obtained by or communicated to the supplier.
A new paragraph 3 is added stating that paragraphs 1 and 2 do not apply where the labelling change was triggered by a harmonised classification set out in a delegated act under Article 37(5) or a provision set out in a delegated act under Article 53(1), requiring instead that the label be updated by the date set in that delegated act, and the former paragraph 3 becomes paragraph 4, now referencing Regulation (EC) No 1107/2009 and Regulation (EU) No 528/2012 instead of the earlier Directives 91/414/EEC and 98/8/EC.
Cited: Art. 30, v1 · Art. 30, v2
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before (02008R1272-20260501)
Article 30 Updating information on labels 1. The supplier shall ensure that the label is updated, without undue delay, following any change to the classification and labelling of that substance or mixture, where the new hazard is more severe or where new supplemental labelling elements are required under Article 25, taking into account the nature of the change as regards the protection of human health and the environment. Suppliers shall cooperate in accordance with Article 4(9) to complete the changes to the labelling without undue delay. 2. Where labelling changes are required other than those referred to in paragraph 1, the supplier shall ensure that the label is updated within 18 months. 3. The supplier of a substance or a mixture within the scope of Directives 91/414/EEC or 98/8/EC shall update the label in accordance with those Directives.
after (02008R1272-20260701)
Article 30 Updating information on labels 1. In the event of a change regarding the classification or 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 of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 6 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier. 2. Where a change regarding the classification or labelling of a substance or a mixture, other than those referred to in paragraph 1 of this Article, is required, the supplier of that substance or that mixture shall ensure that the label is updated without undue delay and in any event no later than 18 months after the results of the new evaluation referred to in Article 15(4) are obtained by, or communicated to, that supplier. 3. Paragraphs 1 and 2 shall not apply where a change regarding the classification and labelling of a substance or a mixture was triggered by a harmonised classification and labelling of a substance set out in a delegated act adopted pursuant to Article 37(5) or by a provision set out in a delegated act adopted pursuant to Article 53(1). In such cases, the supplier shall ensure that the label is updated by the date set out in the respective delegated act. 4. The supplier of a substance or mixture that falls within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall update the label in accordance with those Regulations
MODIFIED +752 −0 Art. 31 General rules for the application of labels§
applies from: unchanged
The after text adds a new sentence to paragraph 1 allowing the label to be presented in the form of a fold-out label, and adds new paragraphs 1a and 1b that were not present before.
Paragraph 1a states that where a fold-out label is used, the label elements referred to in Article 17(1) must be presented in accordance with section 1.2.1.6 of Annex I.
Paragraph 1b sets out requirements for a data carrier linking to a digital label under Article 34a(1), including that it be firmly affixed or printed so it can be automatically processed, and that where label elements appear only on a digital label under Article 34a(2), the data carrier be accompanied by a statement such as "More hazard information available online" or a similar indication.
Cited: Art. 31, v2
text before / after
02008R1272-20260501 → 02008R1272-20260701
Article 31 General rules for the application of labels 1. Labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance or mixture and shall be readable horizontally when the package is set down normally. The label may be presented in the form of a fold-out label. 1a. Where the label is presented in the form of a fold-out label, the label elements referred to in Article 17(1) shall be presented in accordance with section 1.2.1.6 of Annex I. 1b. Where a digital label as provided for in Article 34a(1) is used, a data carrier linking to that digital label shall be firmly affixed or printed on the physical label or on the packaging next to the label in such a way that it can be processed automatically by digital devices that are widely used. Where label elements are provided on a digital label only pursuant to Article 34a(2), the data carrier shall be accompanied by the statement More hazard information available online or by a similar indication. 2. The colour and presentation of any label shall be such that the hazard pictogram stands out clearly. 3. The label elements referred to in Article 17(1) shall be clearly and indelibly marked. They shall stand out clearly from the background and be of such size and spacing as to be easily read. 4. The shape, colour and the size of a hazard pictogram as well as the dimensions of the 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.
MODIFIED ±0 Art. 32§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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INSERTED +978 −0 Art. 34a Physical and digital labelling§
applies from: unknown (an inserted provision states its own application date only in prose)
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
This is a newly inserted article establishing that label elements for substances and mixtures under Article 17 must be provided in physical form, with an option to also provide them digitally.
It further permits suppliers to provide the label elements set out in section 1.6 of Annex I in digital form only, subject to an obligation to supply those elements by alternative means on request or when the digital label is temporarily unavailable, and independently of a purchase and free of charge.
It also states that where information is provided through a digital label, the requirements for digital labels set out in Article 34b apply.
Cited: Art. 34a, v2
text before / after
inserted text (02008R1272-20260701)
Article 34a Physical and digital labelling 1. The label elements for substances and mixtures referred to in Article 17 shall be provided on a label in a physical form (physical label). In addition to the physical label, the label elements referred to in Article 17 may be provided in a digital form (digital label). 2. By way of derogation from paragraph 1, suppliers may provide the label elements set out in section 1.6 of Annex I on a digital label only. Where the label elements set out in section 1.6 of Annex I are provided on a digital label only, suppliers shall, upon oral or written request or when the digital label is temporarily unavailable at the time of purchase of the substance or mixture, provide those label elements by alternative means. Suppliers shall provide those elements independently of a purchase and free of charge. 3. Where the information is provided through a digital label, the requirements for digital labels set out in Article 34b shall apply.
INSERTED +1,674 −0 Art. 34b Requirements for digital labelling§
applies from: unknown (an inserted provision states its own application date only in prose)
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
This new article sets out general rules and technical requirements that a digital label must satisfy when a supplier affixes or prints a data carrier linking to it under Article 31(1b), covering matters such as grouping of label elements, searchability, minimum accessibility duration, free access, accessibility for vulnerable groups, click-limits, technology compatibility, and language choice.
It also prohibits tracking, analysing or using usage information for purposes beyond what is absolutely necessary for providing the digital labelling.
Cited: Art. 34b, v2
text before / after
inserted text (02008R1272-20260701)
Article 34b Requirements for digital labelling 1. Where, pursuant to Article 31(1b), a supplier affixes or prints a data carrier linking to a digital label, that supplier shall ensure that the digital label satisfies the following general rules and technical requirements: (a) all label elements referred to in Article 17(1) shall be provided together in one place and separately from other information; (b) the information on the digital label shall be searchable; (c) the information on the digital label shall be accessible to all users in the Union and shall remain accessible for a period of at least 10 years or for a longer period where required by other Union legislation; (d) the digital label shall be accessible free of charge, without the need to register or to download or install applications, or to provide a password; (e) the information on the digital label shall be presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access to the information by those groups; (f) the information on the digital label shall be accessible with no more than two clicks; (g) the digital label shall be accessible through digital technologies widely used, and compatible with all major operating systems and browsers; (h) where the information on the digital label is accessible in more than one language, the choice of language shall not be conditioned by the geographical location from which that information is accessed. 2. It shall be prohibited to track, analyse or use any usage information for purposes going beyond what is absolutely necessary for the provision of digital labelling.
MODIFIED +341 −0 Art. 35 Packaging§
applies from: unchanged
A new paragraph 2a has been added, stating that hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if the conditions laid down in section 3.4 of Annex II are fulfilled.
This new paragraph also states that its first subparagraph does not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3), a provision absent from the earlier text.
Cited: Art. 35, v2 · Art. 35, v1
text before / after
02008R1272-20260501 → 02008R1272-20260701
Article 35 Packaging 1. Packaging containing hazardous substances or mixtures shall satisfy the following requirements: (a) the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed; (b) the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents; (c) the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling; (d) packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping. 2. Packaging containing a hazardous substance or a mixture supplied to the general public shall not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers. Where the packaging contains a substance or mixture which meets the requirements in section 3.1.1 of Annex II it shall have a child-resistant fastening in accordance with sections 3.1.2, 3.1.3 and 3.1.4.2 of Annex II. Where the packaging contains a substance or mixture which meets the requirements in section 3.2.1 of Annex II it shall bear a tactile warning of danger in accordance with section 3.2.2 of Annex II. Where a liquid consumer laundry detergent, as defined in Article 2(1a) of Regulation (EC) No 648/2004 of the European Parliament and of the Council Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents (OJ L 104, 8.4.2004, p. 1)., is contained in a soluble packaging for single use, the additional requirements of section 3.3 of Annex II shall apply. 2a. Hazardous substances or mixtures may be supplied to consumers and professional users via refill stations only if the conditions laid down in section 3.4 of Annex II are fulfilled. The first subparagraph shall not apply to hazardous substances or mixtures supplied to the general public without packaging in accordance with Article 29(3). 3. The packaging of substances and mixtures shall be deemed to satisfy the requirements of paragraph 1(a), (b) and (c) if it complies with the requirements of the rules on the transport of dangerous goods by air, sea, road, rail or inland waterways.
MODIFIED ±0 Art. 36§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
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MODIFIED ±0 Art. 37§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED ±0 Art. 38§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED +499 −114 Art. 40 Obligation to notify the Agency§
applies from: unchanged
Point (e) now also covers acute toxicity estimates alongside specific concentration limits and M-factors, with the justification wording rephrased slightly, and two new points, (g) and (h), require stating the reason for diverging from or introducing a more severe classification per hazard class compared to the inventory referred to in Article 42.
The closing sentence of paragraph 1 now refers to points (a) to (h) instead of (a) to (f), reflecting the added points.
Paragraph 2 changes the update obligation from an unspecified updating requirement to a requirement that the notifier notify the Agency at the latest 6 months after a classification and labelling change decision is taken under the Article 15(1) review.
Cited: Art. 40, v2 · Art. 40, v1
text before / after
02008R1272-20260501 → 02008R1272-20260701
Article 40
Obligation to notify the Agency
1. Any manufacturer or importer, or group of manufacturers or importers (hereinafter referred to as the notifier(s)), who places on the market a substance referred to in Article 39, shall notify to the Agency the following information in order for it to be included in the inventory referred to in Article 42:
(a) the identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006;
(b) the identity of the substance or substances as specified in section 2.1 to 2.3.4 to Annex VI to Regulation (EC) No 1907/2006;
(c) the classification of the substance or substances in accordance with Article 13;
(d) where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;
(e) specific concentration limits limits, M-factors or M-factors, acute toxicity estimates, where applicable, in accordance with Article 10 of this Regulation Regulation, together with a justification using as referred to in the relevant Parts parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;
(f) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1). 25(1);
(g) where applicable, the reason for divergence from the most severe classification per hazard class included in the inventory referred to in Article 42;
(h) where applicable, the reason for introducing a more severe classification per hazard class compared to those included in the inventory referred to in Article 42.
The information referred to in points (a) to (f) (h) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.
The notifier shall submit this information in the format specified pursuant to Article 111 of Regulation (EC) No 1907/2006.
2. The information listed in paragraph 1 shall be updated and notified to the Agency by the notifier(s) notifier concerned when, pursuant to at the review in Article 15(1), latest 6 months after a decision to change the classification and labelling of the substance has been taken. taken pursuant to the review referred to in Article 15(1).
3. Substances placed on the market on or after 1 December 2010 shall be notified in accordance with paragraph 1 within one month after their placing on the market.
However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.
MODIFIED +974 −328 Art. 42 The classification and labelling inventory§
applies from: unchanged
The provision replaces the prior rule limiting public access to information matching Article 119(1) of Regulation (EC) No 1907/2006 with a broader requirement that the Agency make several specified categories of information, including notifier identity in group notifications and the date of the latest update, publicly available online and free of charge, alongside a mechanism for notifiers to justify withholding certain information and for the Agency to screen confidentiality claims.
A new paragraph 3a is added requiring the Agency to request a notifier to notify a correct entry where it considers an existing entry incomplete, incorrect or obsolete.
Cited: Art. 42, v1 · Art. 42, v2
text before / after
02008R1272-20260501 → 02008R1272-20260701
Article 42
The classification and labelling inventory
1. The Agency shall establish and maintain a classification and labelling inventory in the form of a database.
The information notified pursuant to Article 40(1) shall be included in the inventory, as well as information submitted as part of registrations under Regulation (EC) No 1907/2006.
Information The Agency shall make the following information publicly available online and free of charge:
(a) the information referred to in Article 40(1), point (a);
(b) the identity of the importer or manufacturer submitting the information on behalf of the other members of the group, in the case of group notifications;
(c) information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006 1907/2006;
(d) the date of the latest update of the classification and labelling.
Information referred to in Article 40(1), point (a), shall be made publicly accessible. available except where a notifier duly justifies why such publication is potentially harmful for its commercial interests or the commercial interests of any other concerned party.
The Agency shall grant access to the other provide information on each substance in the inventory legitimate grounds on which confidentiality claims may be made.
The Agency shall take measures to the notifiers identify undue confidentiality claims, including automated screening and registrants who have submitted information on that substance in accordance with Article 29(1) of Regulation (EC) No 1907/2006. It shall grant access to such information to other parties subject to Article 118 of that Regulation. random manual checks.
2. The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.
3. In addition to the information referred to in paragraph 1, the Agency shall, where applicable, include the following information in each entry:
(a) whether, in respect of the entry, there is harmonised classification and labelling at Community level by inclusion in Part 3 of Annex VI;
(b) whether, in respect of the entry, it is a joint entry between registrants of the same substance as referred to in Article 11(1) of Regulation (EC) No 1907/2006;
(c) whether it is an agreed entry of two or more notifiers or registrants in accordance with Article 41;
(d) whether the entry differs from another entry on the inventory for the same substance.
The information referred to in (a) shall be updated where a decision is taken in accordance with Article 37(5).3a. Where the Agency considers that an entry is incomplete, incorrect or obsolete it shall request the notifier to notify the correct entry.
MODIFIED ±0 Art. 45§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED ±0 Art. 46§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED +832 −392 Art. 48 Advertisement§
applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)
dates removed: 1997-05-20
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
The requirement for advertisements of hazardous substances shifted from mentioning the hazard classes or categories concerned to indicating, as applicable, the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II, with an added statement directing the general public to always follow the label information.
The requirement for advertisements of hazardous mixtures similarly changed from mentioning the type or types of hazard on the label to indicating the same Annex II pictograms, signal words, hazard statements and supplemental EUH statements, adding the same instruction to always follow the label information for sales to the general public, and the earlier reference to Directive 97/7/EC on distance contracts was removed.
Two new provisions were added: one prohibiting advertisements from containing statements that are not permitted on the label or packaging under Article 25(4), and another allowing the hazard pictograms and signal words to be omitted from non-visual advertisements.
Cited: Art. 48, v1 · Art. 48, v2
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before (02008R1272-20260501)
Article 48 Advertisement 1. Any advertisement for a substance classified as hazardous shall mention the hazard classes or hazard categories concerned. 2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) which allows a member of the general public to conclude a contract for purchase without first having sight of the label shall mention the type or types of hazard indicated on the label. The first subparagraph shall be without prejudice to Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts OJ L 144, 4.6.1997, p. 19..
after (02008R1272-20260701)
Article 48 Advertisement 1. Any advertisement for a substance classified as hazardous shall indicate, as applicable, the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a substance for sale to the general public shall in addition state: Always follow the information on the product label.. 2. Any advertisement for a mixture classified as hazardous or covered by Article 25(6) shall indicate the hazard pictograms, signal words, hazard statements and supplemental EUH statements set out in Annex II. Any advertisement for such a mixture for sale to the general public shall, in addition, state: Always follow the information on the product label.. 3. Any advertisement for a substance or a mixture classified as hazardous shall not contain statements that are not to appear on the label or packaging of that substance or mixture in accordance with Article 25(4). 4. By way of derogation from paragraphs 1 and 2, the hazard pictograms and signal words may be omitted where the advertisement is non-visual.
INSERTED +201 −0 Art. 48a Distance sales offers§
applies from: unknown (an inserted provision states its own application date only in prose)
Sources disagree — the text comparison and the amending act's instructions found this change; the EU's own amendment metadata does not list it. All are shown; none is overruled.
A new Article 48a is added, requiring that when substances or mixtures are placed on the market through distance sales, the offer must clearly and visibly indicate the label elements referred to in Article 17.
Cited: Art. 48a, v2
text before / after
inserted text (02008R1272-20260701)
Article 48a Distance sales offers When substances or mixtures are placed on the market through distance sales, the offer shall clearly and visibly indicate the label elements referred to in Article 17.
MODIFIED ±0 Art. 50§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED ±0 Art. 52§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED ±0 Art. 53§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED ±0 Art. 53a§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED ±0 Art. 53c§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED ±0 Art. 54§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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INSERTED ±0 Art. 54a§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
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MODIFIED ±0 Art. 61§
applies from: unknown
Sources disagree — the amending act's instructions found this change; the text comparison finds no difference in the provision's text and the EU's own amendment metadata does not list it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
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MODIFIED +3,688 −643 Annex I CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES§
applies from: unchanged
Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.
A new section 1.2.1.6 on fold-out labels has been added, setting out required content for the front page, inner pages and back page of such labels.
Section 1.5.1.2 now specifies additional label content for inner packaging, including signal words and a trade name or designation for mixtures, where section 1.5.1.1 applies, replacing the earlier shorter requirement.
Section 1.5.2.4.1 has been restructured into a list of three alternative conditions, referencing hazard classes and categories from Annex II and outer packaging requirements, and a new section 1.6 on label elements that may be provided on a digital label only, referring to Article 25(3), has been added.
Cited: Annex I, v2 · Annex I, v1
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ANNEX I
CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES
This annex sets out the criteria for classification in hazard classes and in their differentiations and sets out additional provisions on how the criteria may be met.
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Greater than 3 litres but not exceeding 50 litres: At least 74 × 105 At least 23 × 23
Greater than 50 litres but not exceeding 500 litres: At least 105 × 148 At least 32 × 32
Greater than 500 litres: At least 148 × 210 At least 46 × 46
1.2.1.6. Fold-out labels
1.2.1.6.1. The front page of the fold-out label shall include at least the following elements:
(i) the name, address and phone number of suppliers;
(ii) nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;
(iii) the product identifiers in accordance with Article 18(2) for substances and Article 18(3)(a) for mixtures in all languages of the label that are used in the inside pages;
(iv) where applicable, the hazard pictograms;
(v) where applicable, the signal words in all languages of the label that are used in the inside pages;
(vi) where applicable, the unique formula identifier, unless printed or affixed on the inner packaging in accordance with Part A, point 5.3, of Annex VIII to this Regulation;
(vii) a reference to the full safety information inside the fold-out label in all languages of the label or a symbol to inform a user that the label can be opened and to illustrate that additional information is available on inside pages;
(viii) an abbreviation of the language (country code or language code) for all the languages that are used in the inside pages.
1.2.1.6.2. The inner pages of the fold-out label shall contain all the label elements provided for in Article 17(1), except for the hazard pictogram and the supplier identification, in each of the languages mentioned on the front page and grouped by language, using the language abbreviation (country code or language code).
1.2.1.6.3. The back page of the fold-out label shall contain all the label elements provided on the front page, except for the abbreviations of the languages that are used in the inside pages.
1.3. Derogations from labelling requirements for special cases
In accordance with Article 23 the following derogations shall apply:
1.3.1. Transportable gas cylinders
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1.5. Exemptions from labelling and packaging requirements
1.5.1. Exemptions from Article 31 in accordance with Article 29(1)
1.5.1.1. Where Article 29(1) applies, the label elements referred to in Article 17 may be provided on a tie-on tag or on an outer packaging.
1.5.1.2. The label on any inner packaging shall contain at least hazard pictograms, the product identifier referred to in Article 18 and name and telephone number of the supplier of the substance or mixture. 1.5.1.2. Where section 1.5.1.1 applies, the label on any inner packaging shall contain at least the hazard pictograms, the signal words, the product identifier referred to in Article 18(2) for substances or the trade name or designation referred to in Article 18(3), point (a) for mixtures, and the name and telephone number of the suppliers of the substance or mixture.
1.5.2. Exemptions from Article 17 in accordance with Article 29(2)
1.5.2.1. Labelling of packages where the contents do not exceed 125 ml
1.5.2.1.1. The hazard statements and the precautionary statements linked to the hazard categories listed below may be omitted from the label elements required by Article 17 where:
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(c) The soluble packaging is contained within outer packaging that fully meets the requirements of Article 17.
1.5.2.3. Section 1.5.2.2 shall not apply to substances or mixtures within the scope of Directives 91/414/EEC or 98/8/EC.
1.5.2.4. Labelling of inner packaging where the contents do not exceed 10 ml
1.5.2.4.1. The label elements required by Article 17 may be omitted from the inner packaging where:
(a) the contents of the inner packaging do not exceed 10 ml;
(b) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis; and
(c) the inner packaging is contained within outer packaging that meets the requirements of Article 17. 1.5.2.4.1. The label elements required by Article 17 may be omitted from the inner packaging where the contents of the inner packaging do not exceed 10 ml and any of the following applies:
(a) the substance or mixture is placed on the market for supply to a distributor or downstream user for scientific research and development or quality control analysis and the inner packaging is contained within outer packaging that meets the requirements set out in Article 17;
(b) the substance or mixture does not require labelling in accordance with Part 1 or 2 of Annex II and is not classified in any of the following hazard classes and categories:
(i) acute toxicity, any category;
(ii) specific target organ toxicity – single exposure, categories 1 and 2;
(iii) specific target organ toxicity – repeated exposure, any category;
(iv) skin corrosion, category 1, any sub-category;
(v) serious eye damage, category 1;
(vi) respiratory sensitisation, any category;
(vii) aspiration hazard;
(viii) germ cell mutagenicity, any category;
(ix) carcinogenity, any category;
(x) reproductive toxicity, any category;
(xi) endocrine disruption for human health, any category;
(c) the substance or mixture requires labelling in accordance with Part 1 or 2 of Annex II but is not classified in any of the hazard classes and categories referred to in point (b) of this section and has an inner packaging that is contained within outer packaging that meets the requirements set out in Article 17.
1.5.2.4.2. Notwithstanding sections 1.5.1.2 and 1.5.2.4.1, the label on the inner packaging shall contain the product identifier and, where appropriate, the hazard pictograms GHS01, GHS05, GHS06 and/or GHS08. Where more than two pictograms are assigned, GHS06 and GHS08 may take precedence over GHS01 and GHS05.
1.5.2.5. Section 1.5.2.4 shall not apply to substances or mixtures within the scope of Regulation (EC) No 1107/2009 or (EU) No 528/2012.
1.6. Label elements that may be provided on a digital label only
Supplemental information referred to in Article 25(3).
2. PART 2: PHYSICAL HAZARDS
2.1. Explosives
2.1.1. Definitions
… 3,320 unchanged lines …
Symbol/pictogram Signal word Warning
Hazard statement H420: Harms public health and the environment by destroying ozone in the upper atmosphere
Precautionary statements P502
MODIFIED +3,561 −13 Annex II SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES§
applies from: unchanged
Sources disagree — the text comparison and the EU's own amendment metadata found this change; the amending act's instructions do not mention it. All are shown; none is overruled.
A new section 3.4 has been added covering supply via refill stations, setting out conditions suppliers must ensure are met, including labelling and packaging requirements, risk mitigation, staff training, restrictions based on hazard classification, and a derogation allowing a single label to cover multiple substances or mixtures with identical label elements.
Part 5 has been retitled by dropping the word "LIST OF" from its heading, and its content has been expanded from a single line naming ready mixed cement and concrete in the wet state to add requirements that such cement and concrete be accompanied by a copy of the label elements, and that label elements be provided at filling station pumps and, in certain cases, attached to portable receptacles.
Cited: Annex II, v2 · Annex II, v1
text before / after
02008R1272-20260501 → 02008R1272-20260701
ANNEX II
SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES
This Annex consists of 5 parts:
Part 1 contains special rules for the labelling of certain classified substances and mixtures.
Part 2 sets out rules for additional hazard statements to be … 2,422 unchanged words … seconds, in case of accidental oral exposure;
(ii) retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;
(iii) resist mechanical compressive strength of at least 300 N under standard test conditions.
3.4. Supply via refill stations
When hazardous substances or mixtures are supplied in accordance with Article 35(2a), the supplier shall ensure that the following conditions are met:
(a) the refill station carries labels corresponding to the labels for each hazardous substance or mixture supplied at the station;
(b) the labels on the refill station are firmly affixed horizontally on a visible place and fulfil the requirements in Article 31(2), (3) and (4) mutatis mutandis;
(c) risk mitigation measures are applied to minimise the exposure of humans, especially of children, and of the environment;
(d) measures are taken to prevent uncontrolled use of the refill station by children;
(e) at the moment of refill, the supplier is available on site for maintenance and immediate assistance, including emergency assistance;
(f) refill stations can be operated outdoors and outside business hours only if immediate assistance can be provided;
(g) the substances or mixtures provided through a refill station do not react with each other in a way that could endanger clients or staff;
(h) staff of the supplier are appropriately trained to minimise safety risks to consumers, professional users and themselves;
(i) for every refilled package, the requirements on hazard communication in the form of labelling set out in Title III of this Regulation are fulfilled;
(j) for every refilled package the requirements on packaging set out in Title IV of this Regulation are fulfilled;
(k) hazardous substances or mixtures are not provided at a refill station if the criteria for classification in any of the following hazard classes or differentiations are met:
(i) acute toxicity, any category;
(ii) specific target organ toxicity – Single exposure, any category;
(iii) specific target organ toxicity – repeated exposure, any category;
(iv) skin corrosion, category 1, any sub-category;
(v) serious eye damage category 1;
(vi) respiratory sensitisation, any category;
(vii) skin sensitisation, any category;
(viii) aspiration hazard;
(ix) germ cell mutagenicity, any category;
(x) carcinogenicity, any category;
(xi) reproductive toxicity, any category;
(xii) flammable gases, any category;
(xiii) flammable liquids, categories 1 and 2;
(xiv) flammable solids, any category;
(xv) endocrine disruption for human health, any category.;
(xvi) endocrine disruption for the environment, any category;
(xvii) persistent, bioaccumulative and toxic;
(xviii) very persistent and very bioaccumulative;
(xix) persistent, mobile and toxic;
(xx) very persistent and very mobile.
By way of derogation from point (a), a single label on the refill station may be used for several substances or mixtures for which the label elements referred to in Article 17(1) are identical, provided that the label clearly indicates the name of each substance or mixture that it applies to.
4. PART 4: SPECIAL RULE FOR LABELLING OF PLANT PROTECTION PRODUCTS
Without prejudice to the information required in accordance with Article 16 of Directive 91/414/EEC and Annex V of that Directive, the labelling for plant protection products subject to Directive 91/414/EEC shall also include the following wording:
EUH401 — To avoid risks to human health and the environment, comply with the instructions for use
5. PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH ARTICLE 29(3) APPLIES
Ready mixed cement and concrete in the wet state. state shall be accompanied by a copy of the label elements in accordance with Article 17.
For a substance or a mixture supplied at a filling station and directly pumped into a receptacle that forms an integral part of a vehicle and from where the substance or mixture is normally not intended to be removed, the label elements referred to in Article 17 shall be provided on a visible place on the respective pump. When vehicle fuels are supplied at a filling station through pumping into portable receptacles designed to be used for fuels, a physical copy of the label elements referred to in Article 17 shall, in addition to the visible place on the pump, also be provided to be attached to the receptacle.
MODIFIED ±0 TIS III§
applies from: unknown
Sources disagree — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text and the amending act's instructions do not mention it. All are shown; none is overruled.
No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.
text before / after
No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.
The full entry, with the citation mapping v1 = 02008R1272-20260501, v2 = 02008R1272-20260701, is committed at eu/32008R1272/CHANGELOG.md.