Classification, Labelling and Packaging Regulation

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Article 1 Purpose and scope 1. The purpose of this Regulation is to ensure a high level of protection of human health and the environment as well as the free movement of substances, mixtures and articles as referred to in Article 4(8) by: (a) harmonising the criteria for classification of substances and mixtures, and the rules on labelling and packaging for hazardous substances and mixtures; (b) providing an obligation for: (i) manufacturers, importers and downstream users to classify substances and mixtures placed on the market; (ii) suppliers to label and package substances and mixtures placed on the market; (iii) manufacturers, producers of articles and importers to classify those substances not placed on the market that are subject to registration or notification under Regulation (EC) No 1907/2006; (c) providing an obligation for manufacturers and importers of substances to notify the Agency of such classifications and label elements if these have not been submitted to the Agency as part of a registration under Regulation (EC) No 1907/2006; (d) establishing a list of substances with their harmonised classifications and labelling elements at Community level in Part 3 of Annex VI; (e) establishing a classification and labelling inventory of substances, which is made up of all notifications, submissions and harmonised classifications and labelling elements referred to in points (c) and (d). (d); (f) providing an obligation for downstream users, importers and distributors referred to in Article 45(1b) and (1c) to submit information relevant to an adequate emergency health response to appointed bodies in accordance with Annex VIII. 2. This Regulation shall not apply to the following: (a) radioactive substances and mixtures within the scope of Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the danger arising from ionising radiation OJ L 159, 29.6.1996, p. 1.; (b) substances and mixtures which are subject to customs supervision, provided that they do not undergo any treatment or processing, and which are in temporary storage, or in a free zone or free warehouse with a view to re-exportation, or in transit; (c) non-isolated intermediates; (d) substances and mixtures for scientific research and development, which are not placed on the market, provided they are used under controlled conditions in accordance with Community workplace and environmental legislation. 3. Waste as defined in Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste OJ L 114, 27.4.2006, p. 9. is not a substance, mixture or article within the meaning of Article 2 of this Regulation. 4. Member States may allow for exemptions from this Regulation in specific cases for certain substances or mixtures, where necessary in the interests of defence. 5. This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user: (a) medicinal products as defined in Directive 2001/83/EC; (b) veterinary medicinal products as defined in Directive 2001/82/EC; (c) cosmetic products as defined in Directive 76/768/EEC; (d) medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC; (e) food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used: (i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC; (ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC; (iii) as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003; (iv) in animal nutrition within the scope of Directive 82/471/EEC. 6. Save where Article 33 applies this Regulation shall not apply to the transport of dangerous goods by air, sea, road, rail or inland waterways.

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Article 2 Definitions For the purpose of this Regulation, the following definitions shall apply: 1. hazard class means the nature of the physical, health or environmental hazard; 2. hazard category means the division of criteria within each hazard class, specifying hazard severity; 3. hazard pictogram … 1,056 unchanged words … packaging and its contents; 36. packaging means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions; 37. intermediate packaging means packaging placed between inner packaging, or articles, and outer packaging. packaging; 38. acute toxicity estimates means numeric values which are used to classify substances and mixtures in one of four acute toxicity hazard categories based on the oral, dermal or inhalation exposure route; 39. data carrier means a linear bar code symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device; 40. refill means an operation by which a consumer or a professional user fills packaging with a hazardous substance or mixture offered by a supplier in the course of a commercial activity, whether in return for payment or free of charge; 41. refill station means a place where a supplier offers to consumers or professional users hazardous substances or mixtures that can be acquired through refill, either manually or through automatic or semi-automatic equipment.

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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 articles and importers shall classify those substances not placed on the market in accordance with Title II where: (a) Articles 6, 7(1) or (5), 17 or 18 of Regulation (EC) No 1907/2006 provide for registration of a substance; (b) Articles 7(2) or 9 of Regulation (EC) No 1907/2006 provide for notification. 3. If a substance is subject to harmonised classification and labelling in accordance with Title V V, through an entry in Part 3 of Annex VI, that substance shall be classified in accordance with that entry, and a classification of that substance in accordance with Title II shall not be performed carried out for the hazard classes classes, differentiations, or differentiations forms or physical states covered by that entry. The harmonised classification of that substance shall apply to all its forms or physical states unless an entry in Part 3 of Annex VI specifies that a harmonised classification applies to a specific form or physical state of that substance. However, where the substance also falls within one or more hazard classes or differentiations or it is in a form or physical state not covered by an entry in Part 3 of Annex VI, its classification under in accordance with Title II shall be carried out for those hazard classes classes, differentiations and forms or differentiations. physical states. 4. Where a substance or mixture is classified as hazardous, suppliers shall ensure that the substance or mixture is labelled and packaged in accordance with Titles III and IV, before placing it on the market. 5. In fulfilling their responsibilities under paragraph 4, distributors may use the classification for a substance or mixture derived in accordance with Title II by an actor in the supply chain. 6. In fulfilling their responsibilities under paragraphs 1 and 4, downstream users may use the classification of a substance or mixture derived in accordance with Title II by an actor in the supply chain, provided that they do not change the composition of the substance or mixture. 7. A mixture referred to in Part 2 of Annex II that contains any substance classified as hazardous shall not be placed on the market, unless it is labelled in accordance with Title III. 8. For the purposes of this Regulation, the articles referred to in section 2.1 of Annex I shall be classified, labelled and packaged in accordance with the rules for substances and mixtures before 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.

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before (02008R1272-20231201)

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 (02008R1272-20241210)

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.

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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; (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).

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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.

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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.

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Article 13 Decision to classify substances and mixtures If the evaluation undertaken pursuant to Article Articles 9 and Article 12 shows that the hazards associated with the substance or mixture meet the criteria for classification in one or more hazard classes or differentiations in Parts 2 to 5 of Annex I, manufacturers, importers and downstream users shall classify the substance or mixture or, if scientifically justified, specific forms or physical states thereof, in relation to the relevant hazard class or classes or differentiations by assigning the following: (a) one or more hazard categories for each relevant hazard class or differentiation; (b) subject to Article 21, one or more hazard statements corresponding to each hazard category assigned in accordance with point (a).

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Article 18 Product identifiers 1. The label shall include details permitting the identification of the substance or mixture (hereinafter referred to as product identifiers). The term used for identification of the substance or mixture shall be the same as that used in the safety data sheet drawn up in accordance with Article 31 of Regulation (EC) No 1907/2006 (hereinafter referred to as safety data sheet), without prejudice to Article 17(2) of this Regulation. 2. The product identifier for a substance shall consist of at least the following: (a) if the substance is included in Part 3 of Annex VI, a name and an identification number as given therein; (b) if the substance is not included in Part 3 of Annex VI, but appears in the classification and labelling inventory, a name and an identification number as given therein; (c) if the substance is not included in Part 3 of Annex VI nor in the classification and labelling inventory, the number provided by the CAS (hereinafter referred to as the CAS number), together with the name set out in the nomenclature provided by the IUPAC (hereinafter referred to as the IUPAC Nomenclature), or the CAS number together with another international chemical name(s); or (d) if the CAS number is not available, the name set out in the IUPAC Nomenclature or another international chemical name(s). Where the name in the IUPAC nomenclature exceeds 100 characters, one of the other names (usual name, trade name, abbreviation) referred to in section 2.1.2 of Annex VI to Regulation (EC) No 1907/2006 may be used provided that the notification in accordance with Article 40 includes both the name set out in the IUPAC Nomenclature and the other name used. 3. The product identifier for a mixture shall consist of both of the following: (a) the trade name or the designation of the mixture; (b) the identity of all substances in the mixture that contribute to the classification of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) toxicity, aspiration hazard, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile properties, or aspiration hazard. endocrine disruption for human health or the environment. Where, in the case referred to in (b), that requirement leads to the provision of multiple chemical names, a maximum of four chemical names shall suffice, unless more than four names are needed to reflect the nature and the severity of the hazards. The chemical names selected shall identify the substances primarily responsible for the major health hazards which have given rise to the classification and the choice of the corresponding hazard statements.

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Article 23 Derogations from labelling requirements for special cases The specific provisions on labelling laid down in section 1.3 of Annex I shall apply in respect of the following: (a) transportable gas cylinders; (b) gas containers intended for propane, butane or liquefied petroleum gas; (c) aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard; (d) metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers; (e) explosives, as referred to in section 2.1 of Annex I, placed on the market with a view to obtaining an explosive or pyrotechnic effect; (f) substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1); (g) ammunition as defined in Article 1(1), point (3), of Directive (EU) 2021/555 of the European Parliament and of the Council Directive (EU) 2021/555 of the European Parliament and of the Council of 24 March 2021 on control of the acquisition and possession of weapons (OJ L 115, 6.4.2021, p. 1).unless it is an article that falls within the scope of Article 4(8) of this Regulation.

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Article 24 Request for use of an alternative chemical name 1. The manufacturer, importer or downstream user of a substance in a mixture may submit a request to the Agency to use an alternative chemical name which refers to that substance in a mixture either by means of a name that identifies the most important functional chemical groups or by means of an alternative designation, where the substance meets the criteria set out in Part 1 of Annex I and where he can demonstrate that disclosure on the label or in the safety data sheet of the chemical identity of that substance puts the confidential nature of his business, in particular his intellectual property rights, at risk. 2. Any request referred to in paragraph 1 of this Article shall be made in the format referred to in Article 111 of Regulation (EC) No 1907/2006 and shall be accompanied by a fee. The level of the fees shall be determined by the Commission by means of implementing acts. Those implementing acts shall be adopted in accordance with the regulatory examination procedure referred to in Article 54(2) of this Regulation. A reduced fee shall be set for SMEs. 3. The Agency may require further information from the manufacturer, importer or downstream user making the request if such information is necessary to take a … 394 unchanged words … of Directive 1999/45/EC that the disclosure of the chemical identity of a substance in a mixture puts the confidential nature of his business at risk, he can continue to use the agreed alternative name for the purposes of this Regulation.

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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 is not hazardous or any other statements that are inconsistent with the classification of that substance or mixture shall not appear on the label or packaging of any substance or mixture. 5. Where a substance or mixture is classified in accordance with Part 5 of Annex I, (a) the hazard pictogram shall not be included on the label; (b) the signal words, hazard statements and precautionary statements shall be placed in the supplemental information section of the label. 6. Where a mixture contains any substance classified as hazardous, it shall be labelled The special labelling rules set out in accordance with Part 2 of Annex II. II shall apply to mixtures containing substances referred to in Part 2 of that Annex. The statements shall be worded in accordance with Part 3 of Annex III and shall be placed in the supplemental information section of the label. The label shall also include the product identifier referred to in Article 18 and the name, address and telephone number of the supplier of the mixture. 7. Where under Annex VIII the submitter creates a unique formula identifier, it shall be included in the supplemental information on the label in accordance with the provisions of Section 5 of Part A of that Annex. 8. In the case of a bespoke paint for which no submission in accordance with Annex VIII has been made and no corresponding unique formula identifier has been created, the unique formula identifiers of all the mixtures contained in the bespoke paint in a concentration exceeding 0,1 % which themselves are subject to notification under Article 45 shall be included in the supplemental information on the label of the bespoke paint, located together and listed in descending order of the mixtures’ concentration in the bespoke paint, in accordance with the provisions of Section 5 of Part A of Annex VIII. In a case falling within the first subparagraph, where the concentration of a mixture with a unique formula identifier in the bespoke paint exceeds 5 %, the concentration of that mixture shall also be included in the supplemental information on the label of the bespoke paint next to its unique formula identifier, in accordance with Section 3.4 of Part B of Annex VIII. For the purposes of this paragraph, bespoke paint means a paint that is formulated in limited amounts on a tailor-made basis 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.

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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.

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before (02008R1272-20231201)

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 (02008R1272-20241210)

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

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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. 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 they shall be of such a size and spacing be spaced in such a way as to be easily read. They shall be formatted in accordance with section 1.2.1 of Annex I. 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.

No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.

No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.

No text on either side: this unit was named by a signal that carries no text, and only the structural diff carries any.

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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.

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Article 36 Harmonisation of classification and labelling of substances 1. A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37: (a) respiratory sensitisation, category 1 1, 1A or 1B (Annex I, section 3.4); (b) germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5); (c) carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6); (d) reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7). 3.7); (e) endocrine disruption for human health, category 1 or 2 (Annex I, section 3.11); (f) endocrine disruption for the environment, category 1 or 2 (Annex I, section 4.2); (g) persistent, bioaccumulative and toxic (Annex I, section 4.3); (h) very persistent, very bioaccumulative (Annex I, section 4.3); (i) persistent, mobile and toxic (Annex I, section 4.4); (j) very persistent, very mobile (Annex I, section 4.4). 2. A substance Substances that is an are active substance in substances falling within the meaning scope of Directive 91/414/EEC Regulation (EC) No 1107/2009 or Directive 98/8/EC Regulation (EU) No 528/2012 shall normally be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37, paragraphs 1, 4, 5 37(1), (4), (5) and 6 (6) shall apply. 3. Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a harmonised classification and labelling in accordance with Article 37 may also be added to Annex VI on a case-by-case basis, if justification is provided demonstrating the need for such action at Community level.

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before (02008R1272-20231201)

Article 37
Procedure for harmonisation of classification and labelling of substances
1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits or M-factors, or a proposal for a revision thereof.
The proposal shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.
2. A manufacturer, importer or downstream user of a substance may submit to the Agency a proposal for harmonised classification and labelling of that substance and, where appropriate, specific concentration limits or M-factors, provided that there is no entry in Part 3 of Annex VI for such a substance in relation to the hazard class or differentiation covered by that proposal.
The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.
3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of a substance in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission in accordance with the regulatory procedure referred to in Article 54(2).
4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.
5. The Commission shall without undue delay adopt delegated acts in accordance with Article 53a, where it finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, to amend Annex VI by inclusion of that substance together with the relevant classification and labelling elements in Table 3.1 of Part 3 of Annex VI and, where appropriate, the specific concentration limits or M-factors.
A corresponding entry shall be included in Table 3.2 of Part 3 of Annex VI subject to the same conditions, until 31 May 2015.
Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.
6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling elements of a substance in Part 3 of Annex VI shall submit a proposal in accordance with the second subparagraph of paragraph 2 to the competent authority in one of the Member States in which the substance is placed on the market.

after (02008R1272-20241210)

Article 37
Procedure for harmonisation of classification and labelling of substances
1. A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for a revision thereof.
The Commission may request the Agency or the European Food Safety Authority (the Authority) established in accordance with Article 1(2) of Regulation (EC) No 178/2002 to prepare a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency.
The proposals for harmonised classification and labelling of a substance or a group of substances referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.
1a. Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall aim to prioritise groups of substances rather than individual substances.
1b. The Agency and the Authority may, on their own initiative, provide scientific advice to the competent authorities and the Commission indicating that a harmonised classification and labelling of a substance or a group of substances would be appropriate.
2. Manufacturers, importers and downstream users may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, provided that there is no entry in Part 3 of Annex VI for such substances in relation to the hazard class or differentiation covered by that proposal.
The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.
2a. Before submitting a proposal to the Agency, a competent authority, manufacturer, importer or downstream user shall notify the Agency of its intention to submit a proposal for harmonised classification and labelling.
Where the Commission has requested the preparation of a proposal pursuant to paragraph 1, second subparagraph, it shall notify the Agency of that request.
Within one week of receipt of the notification referred to in the first and the second subparagraphs, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance or substances, the status of the proposal and the name of the submitter. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in paragraphs (4) and (5).
Where a competent authority receives a proposal in accordance with paragraph 6, it shall notify the Agency and provide any relevant information on its reason for accepting or refusing the proposal. The Agency shall share that information with the other competent authorities.
3. Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of substances in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission by means of implementing act adopted in accordance with the examination procedure referred to in Article 54(2).
4. The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.
5. Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall adopt without undue delay, and preferably before the end of the calendar year following the publication of the opinion of the Committee for Risk Assessment, delegated acts in accordance with Article 53a to amend Annex VI by including substances together with the relevant classification and label elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.
Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.
6. Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market.
7. In order to avoid duplication of assessment of hazardous properties of substances, the Commission is empowered to adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation to:
(a) include substances by 11 June 2026 as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of respective criteria where by 11 June 2025, those substances:
(i) have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006 as having endocrine-disrupting properties for human health or the environment, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative,
(ii) have been identified as having endocrine-disrupting properties in accordance with section 3.6.5 or section 3.8.2 of Annex II to Regulation (EC) No 1107/2009, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with section 3.7.2 or 3.7.3 of Annex II to that Regulation and a decision on the application for approval or the renewal of approval of those substances has been adopted under that Regulation;
(iii) have been identified as having endocrine-disrupting properties in accordance with Article 1 of Delegated Regulation (EU) 2017/2100, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with Article 5(1), point (e), of Regulation (EU) No 528/2012 and a decision on the application for approval or renewal of approval of those substances has been adopted under Regulation (EU) No 528/2012; and
(b) include substances in Table 3 of Part 3 of Annex VI as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of the respective criteria where:
(i) those substances have been included in the candidate list referred to in Article 59 of Regulation (EC) No 1907/2006 before 11 June 2026 as having one of the properties mentioned in the introductory part and for which a dossier as provided for in Annex XV to that Regulation was under assessment by 11 June 2025;
(ii) a decision on the application for approval or the renewal of approval of those substances identified as having one of the properties mentioned in the introductory part has been adopted under Regulation (EC) No 1107/2009 before 11 June 2032 and an application for approval or renewal of approval of those substances in accordance with the relevant provisions of that Regulation was submitted before 11 June 2025;
(iii) a decision on the application for approval or the renewal of approval of those substances identified as having one of the properties mentioned in the introductory part has been adopted under Regulation (EU) No 528/2012 before 11 June 2030 and where, by 11 June 2025:
the evaluating competent authority has submitted its draft assessment report on the application for approval or renewal of approval to the Agency in accordance with the relevant provisions of Regulation (EU) No 528/2012;
the application was submitted for the purposes of Directive 98/8/EC and the Member State evaluation in accordance with that Directive was completed by 1 September 2013, but no decision on the application for approval or renewal of approval was adopted before that date; or
the Agency has submitted to the Commission an opinion pursuant to Article 75(1), point (g), of Regulation (EU) No 528/2012 following a request to establish whether the respective criteria are met.
8. In the case of a proposal for harmonised classification and labelling of a group of substances, those substances shall be grouped together on the basis of clear scientific reasoning taking into account how the available information supports the grouping of substances and allows the property or properties of the substance or substances to be reliably predicted from information on other substances in the group.

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Article 38 Content of opinions and decisions for harmonised classification and labelling in Part 3 of Annex VI; accessibility of information 1. Any opinion referred to in Article 37(4) and any decision according to Article 37(5) shall at least specify for each substance: (a) the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006; (b) the classification of the substance referred to in Article 36, including a statement of reasons; (c) the specific concentration limits limits, M-factors or M-factors, acute toxicity estimates, where applicable; (d) the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1); (e) any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant. 2. When making publicly available an opinion or a decision as referred to in Article 37(4) and (5) of this Regulation, Article 118(2) and Article 119 of Regulation (EC) No 1907/2006 shall apply.

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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.

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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).

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Article 45 Appointment of bodies responsible for receiving information relating to emergency health response 1. Member States shall appoint a body or bodies responsible for receiving the relevant harmonised information relevant, in particular, for formulating relating to emergency health response and preventative and curative measures, in particular in accordance with Annex VIII. 1a. Member States may appoint the event of Agency as the body responsible for receiving information relating to emergency health response, from importers response and preventative measures referred to in paragraph 1. 1b. Importers and downstream users placing mixtures on the market. This information shall include the chemical composition of mixtures placed on the market and mixtures that are classified as hazardous on the basis of their health or physical effects, including shall submit to the chemical identity of substances in mixtures for which a request for use of an alternative chemical name has been accepted by the Agency, body or bodies appointed in accordance with Article 24. paragraph 1 the information referred to in Part B of Annex VIII. 1c. Distributors placing on the market mixtures that are classified as hazardous on the basis of their health or physical effects shall submit to the body or bodies appointed in accordance with paragraph 1 the information referred to in Part B of Annex VIII where they subsequently distribute those mixtures in other Member States, or where they rebrand or relabel the mixtures. That obligation shall not apply if the distributors can demonstrate that the appointed body or bodies already received the same information from importers and downstream users. 2. The appointed bodies shall provide all requisite guarantees for maintaining the confidentiality of the information received. Such information may only be used: (a) to meet medical demand by formulating preventative and curative measures, in particular in the event of an emergency; and (b) where requested by the Member State, the Commission or the Agency, to undertake a statistical analysis to identify where improved risk management measures may be needed. The information shall not be used for other purposes. 3. The appointed bodies shall have at their disposal all the information required from the importers and importers, downstream users responsible for marketing and distributors referred to in paragraph 1c, to carry out the tasks for which they are responsible. responsible in accordance with paragraph 1. 4. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Annex VIII to further harmonise the information relating to emergency health response and preventative measures, following consultation with relevant stakeholders such as the European Association of Poison Centres and Clinical Toxicologists (EAPCCT).

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Article 46 Enforcement and reporting 1. Member States shall take all necessary measures, including maintaining a system of official controls, to ensure that substances and mixtures are not placed on the market, unless they have been classified, labelled, notified and packaged in accordance with this Regulation. 1a. For the purpose of paragraph 1, the authorities responsible for enforcement referred to in Article 43 of this Regulation shall follow up on complaints or reports related to non-compliance with this Regulation, and verify that the corrective action referred to in Article 3, point (16), of Regulation (EU) 2019/1020 has been taken. 2. Member States shall submit a report to the Agency every five years by 1 July on the results of the official controls, and other enforcement measures taken. The first report shall be submitted by 20 January 2012. The Agency shall make those reports available to the Commission, which shall take them into account for its report under Article 117 of Regulation (EC) No 1907/2006. 3. The Forum referred to in Article 76(1)(f) of Regulation (EC) No 1907/2006 shall undertake the tasks specified in Article 77(4)(a) to (g) of Regulation (EC) No 1907/2006 concerning enforcement of this Regulation.

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before (02008R1272-20231201)

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 (02008R1272-20241210)

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 text (02008R1272-20241210)

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.

02008R1272-20231201 → 02008R1272-20241210

Article 50 Tasks of the Agency 1. The Agency shall provide the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall within its remit and which are referred to it in accordance with this Regulation. 2. The Secretariat of the Agency shall: (a) provide industry with up-to-date technical and scientific guidance and tools where appropriate on how to comply with the obligations laid down by this Regulation; (b) provide competent authorities with up-to-date technical and scientific guidance and tools on the operation application and implementation of this Regulation and provide support to the helpdesks established by Member States under Article 44.3. Where the Agency acts as an appointed body in accordance with Article 45(1a), it shall put in place the tools necessary to provide access to the information referred to in Article 45(1) to the relevant appointed body or bodies of the appointing Member State to fulfil their tasks with regard to emergency health response and preventative measures. 4. The Agency shall be provided with adequate resources to support its work.

02008R1272-20231201 → 02008R1272-20241210

Article 52 Safeguard clause 1. Where a Member State has justifiable grounds for believing that a substance or a mixture, although satisfying the requirements of this Regulation, constitutes a serious risk to human health or the environment due to reasons of classification, labelling or packaging, it may take appropriate provisional measures. The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving the reasons for its decision. 2. Within 60 days of receipt of the information from the Member State, the Commission shall adopt implementing acts in accordance with the regulatory examination procedure referred to in Article 54(2) either to authorise the provisional measure for a time period defined in the decision or to require the Member State to revoke the provisional measure. 3. In the case of an authorisation of a provisional measure related to classification or labelling of a substance as referred to in paragraph 2, the competent authority of the Member State concerned shall in accordance with the procedure laid down in Article 37 submit a proposal to the Agency for harmonised classification and labelling, within three months of the date of the Commission decision.

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before (02008R1272-20231201)

Article 53
Adaptations to technical and scientific progress
1. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases.
Where imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.
2. Member States and the Commission shall, in the manner appropriate to their role in the relevant UN fora, promote the harmonisation of the criteria for classification and labelling of persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) substances at the level of the UN.

after (02008R1272-20241210)

Article 53
Adaptations to technical and scientific progress
1. The Commission is empowered to adopt delegated acts in accordance with Article 53a amending Article 6(5), Article 11(3), Articles 12 and 14, point (b) of Article 18(3), Article 23, Articles 25 to 29, the second and third subparagraphs of Article 35(2) and Annexes I to VIII in order to adapt them to technical and scientific progress, taking due account of the further development of the GHS, in particular any UN amendments relating to the use of information on similar mixtures, and considering the developments in internationally recognised chemical programmes and of the data from accident databases.
Where imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.
1a. The Commission is empowered to adopt delegated acts in accordance with Article 53a to amend section 1.6 of Annex I in order to include the label elements that may be put on a digital label only, provided that GHS does not require such label elements to appear on the physical label. When adopting those delegated acts, the Commission shall take into account the level of digital readiness among all population groups in the Union, societal needs and the need for a high level of protection of human health and the environment.
1b. In order to adjust to technological changes and future developments in the field of digitalisation, the Commission is empowered to adopt delegated acts in accordance with Article 53a to supplement this Regulation by laying down further details on the requirements for the digital labelling referred to in Articles 34a and 34b. Those details shall cover, in particular, the IT solutions which may be used, and the alternative means for providing the information. When adopting such delegated acts, the Commission shall:
(a) ensure consistency with other relevant Union acts;
(b) encourage innovation;
(c) ensure technological neutrality by not imposing constraints or requirements with regard to choices of technology or equipment, within the bounds of compatibility and interference avoidance;
(d) take into account the level of digital readiness among all population groups in the Union, as well as the readiness of the necessary wireless and other technological infrastructure allowing unrestricted access to the information on chemicals;
(e) ensure that digitalisation does not compromise the protection of human health and the environment.
2. The Commission, acting on behalf of the Union, and the Member States shall, in a manner appropriate to their role in the relevant UN fora, cooperate with a view to promoting the harmonisation of the criteria for classification and labelling of endocrine disruptors for human health, endocrine disruptors for the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic and very persistent and very mobile substances as well as the adaptation of criteria for alternative approaches, in particular non-animal test methods, and the assessment of the need for new criteria for immunotoxic and neurotoxic substances.
3. The Commission shall regularly evaluate the development of alternative approaches such as the alternative methods referred to in Article 13(1) of Regulation (EC) No 1907/2006 for classification of substances and mixtures, in particular non-animal test methods, and adopt delegated acts in accordance with Article 53a to update Annex I to this Regulation to reflect such technical progress, if relevant. The Commission shall adopt a delegated act in accordance with Article 53a to update Annex I to this Regulation to adapt the criteria, preferably within 18 months from the date the criteria for non-animal data being included in harmonised criteria for classification and labelling at the level of the UN.

02008R1272-20231201 → 02008R1272-20241210

Article 53a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The power to adopt delegated acts referred to in Article 37(5), 5(8), Article 45(4) 37(5) and (7), Article 45(4), and Article 53(1) 53(1), (1a), (1b) and (3) shall be conferred on the Commission for a period of five years from 26 July 2019. 10 December 2024. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Articles 37(5), Article 45(4) 5(8), Article 37(5) and(7), Article 45(4), and Article 53(1) 53(1), (1a), (1b) and (3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making OJ L 123, 12.5.2016, p. 1.. 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 37(5), 5(8), Article 37(5) and (7), Article 45(4) and or Article 53(1) 53(1), (1a), (1b) or (3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

02008R1272-20231201 → 02008R1272-20241210

Article 53c Separate delegated acts for different delegated powers The Commission shall adopt a separate delegated act in respect of each power delegated to it pursuant to this Regulation. Regulation, with the exception of the powers delegated pursuant to Article 37(5) and Article 53(1) to amend Annex VI, where Parts 1 and 2 of that Annex may be amended together with Part 3 of that Annex in one single act.

02008R1272-20231201 → 02008R1272-20241210

Article 54 Committee procedure 1. The Commission shall be assisted by the Committee instituted established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011 of the European Parliament and of the Council Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).. 2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5 (6) of Decision 1999/468/EC Regulation (EU) No 182/2011 shall be set at three months. apply. 3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

inserted text (02008R1272-20241210)

Article 54a
Reporting and review
1. By 11 December 2029, the Commission shall present a scientific report to the European Parliament and to the Council regarding the examination of the information on substances containing more than one constituent extracted from plants. The report may be accompanied, if appropriate, by a legislative proposal.
2. By 11 December 2029, the Commission shall present an evaluation report to the European Parliament, the Council and the European Economic and Social Committee, assessing the need to extend requirements in sections 3.1 and 3.2 of Annex II on child-resistant fastenings and tactile warnings to other hazard classes. If justified by the results of the report, the Commission shall act in accordance with Article 53(1).

02008R1272-20231201 → 02008R1272-20241210

Article 61 Transitional provisions 1. Until 1 December 2010, substances shall be classified, labelled and packaged in accordance with Directive 67/548/EEC. Until 1 June 2015, mixtures shall be classified, labelled and packaged in accordance with Directive 1999/45/EC. 2. By way of derogation from the … 368 unchanged words … labelling submitted under the first subparagraph is not included or is included in an amended form in Part 3 of Annex VI in accordance with Article 37(5), the exemption in the first subparagraph of this paragraph is no longer valid.7. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 5, Article 6(3) and (4), Article 9(3) and (4), Article 10, Article 25(3), Articles 29 and section 1.5.1.2 of Annex I, section 1.5.2.4.1 of Annex I as applicable on 9 December 2024 and which were placed on the market before 1 July 2026 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj) until 1 July 2028. 8. Substances and mixtures which have been classified, labelled and packaged in accordance with Article 18(3), Article 31(3) and section 1.2.1 of Annex I, as applicable on 9 December 2024 and which were placed on the market before 1 January 2027 shall not be required to be classified, labelled and packaged in accordance with this Regulation as amended by Regulation (EU) 2024/2865 of the European Parliament and of the Council Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L, 2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj) until 1 January 2029.

02008R1272-20231201 → 02008R1272-20241210

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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. … 16 unchanged lines … 1.1.1. The role and application of expert judgement and weight of evidence determination 1.1.1.1. Where the criteria cannot be applied directly to available identified information, or where only the information referred to in Article 6(5) is available, the weight of evidence determination using expert judgment shall be applied in accordance with Article 9(3) or 9(4) respectively. 1.1.1.2. The approach to classifying mixtures may include the application of expert judgement in a number of areas in order to ensure existing information can be used for as many mixtures as possible in order to provide protection for human health and the environment. Expert judgement may also be required in interpreting data for hazard classification of substances, especially where weight of evidence determinations are needed. 1.1.1.3. A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, information from the application of the category approach (grouping, read-across), (Q)SAR results, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. The quality and consistency of the data shall be given appropriate weight. Information on substances or mixtures related to the substance or mixture being classified shall be considered as appropriate, as well as site of action and mechanism or mode of action study results. Both positive and negative results shall be assembled together in a single weight of evidence determination. 1.1.1.3. A weight of evidence determination means that all available information bearing on the determination of hazard is considered together, such as the results of suitable in vitro tests, relevant animal data, human experience such as occupational data and data from accident databases, epidemiological and clinical studies and well-documented case reports and observations. For substances, information from the application of the category approach (grouping, read-across) and (Q)SAR results are also considered. The quality and consistency of the data shall be given appropriate weight. Information on substances related to the substance being classified shall be considered, where appropriate. Information on substances or mixtures related to the mixture being classified shall be considered in accordance with Article 9(4). Information on the site of action and the mechanism or mode of action found in study results shall also be considered. Both positive and negative results shall be assembled together in a single weight of evidence determination. 1.1.1.4. For the purpose of classification for health hazards (Part 3) established hazardous effects seen in appropriate animal studies or from human experience that are consistent with the criteria for classification shall normally justify classification. Where evidence is available from both humans and animals and there is a conflict between the findings, the quality and reliability of the evidence from both sources shall be evaluated in order to resolve the question of classification. Generally, adequate, reliable and representative data on humans (including epidemiological studies, scientifically valid case studies as specified in this Annex or statistically backed experience) shall have precedence over other data. However, even well-designed and conducted epidemiological studies may lack a sufficient number of subjects to detect relatively rare but still significant effects, to assess potentially confounding factors. Therefore, positive results from well-conducted animal studies are not necessarily negated by the lack of positive human experience but require an assessment of the robustness, quality and statistical power of both the human and animal data. 1.1.1.5. For the purpose of classification for health hazards (Part 3) route of exposure, mechanistic information and metabolism studies are pertinent to determining the relevance of an effect in humans. When such information, as far as there is reassurance about the robustness and quality of the data, raises doubt about relevance in humans, a lower classification may be warranted. When there is scientific evidence that the mechanism or mode of action is not relevant to humans, the substance or mixture should not be classified. 1.1.2. Specific concentration limits, M-factors and generic cut-off values … 95 unchanged lines … Explosives, as referred to in section 2.1, placed on the market with a view to obtaining an explosive or pyrotechnic effect shall be labelled and packaged in accordance with the requirements for explosives only. 1.3.6. Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1) Substances or mixtures classified as corrosive to metals but not classified as skin corrosion or as serious eye damage (Category 1) which are in the finished state and packaged for consumer use do not require on the label the hazard pictogram GHS05. 1.3.7. Ammunition In the case of ammunition that is a substance or mixture and that is shot through a firearm, the label elements may be provided on the intermediate packaging instead of on the inner packaging, or, if there is no intermediate packaging, on the outer packaging. 1.4. Request for use of an alternative chemical name 1.4.1. Requests for use of an alternative chemical name under Article 24 may be granted only where (I) the substance has not been assigned a Community workplace exposure limit; and (II) the manufacturer, importer or downstream user can demonstrate that the use of the alternative chemical name meets the need to provide enough information for necessary health and safety precautions to be taken in the workplace and the need to ensure that risks from handling the mixture can be controlled; and (III) the substance is classified exclusively as one or more of the following hazard categories: (a) any of the hazard categories referred to in Part 2 of this Annex; (b) Acute toxicity, Category 4; (c) Skin corrosion/irritation, Category 2; (d) Serious eye damage/eye irritation, Category 2; (e) Specific target organ toxicity — Single exposure, Category 2 or 3; (f) Specific target organ toxicity — Repeated exposure, Category 2; (g) Hazardous to the aquatic environment — Chronic, Category 3 or 4. 1.4.2. The choice of the chemical name(s) for mixtures intended for the fragrance or perfume industry In the case of substances occurring in nature, a chemical name or chemical names of the type essential oil of … or extract of … may be used instead of the chemical names of the components of that essential oil or extract as referred to in Article 18(3)(b). 1.5. Exemptions from labelling and packaging requirements 1.5.1. Exemptions from Article 31 [(Article 29(1))] 1.5.1.1. Where Article 29(1) applies, the label elements mentioned in Article 17 may be provided in one of the following ways: (a) in fold-out labels; or (b) on tie-on tags; or (c) 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. 1.5.2. Exemptions from Article 17 [(Article 29(2)] 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. 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: (a) the contents of the package do not exceed 125 ml; and … 33 unchanged lines … (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

02008R1272-20231201 → 02008R1272-20241210

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.

02008R1272-20231201 → 02008R1272-20241210

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX VI Harmonised classification and labelling for certain hazardous substances Part 1 of this Annex provides an introduction to the list of harmonised classification and labelling, including information listed for each entry and related classifications and hazard statements in Table 3. … 289 unchanged lines … The entries with physical hazards that need to be confirmed by testing are indicated by the reference **** in Table 3. 2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING This Part lays down general principles for preparing dossiers to propose and justify harmonised classification and labelling. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. The relevant parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 shall be used for the methodology and format of any dossier. For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used. For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier. A dossier for harmonised classification and labelling shall contain the following: Proposal The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed. The proposal shall include the identity of the substance or substances concerned and the harmonised classification and labelling proposed; Justification for the proposed harmonised classification and labelling A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1, of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. A comparison of the available information with the criteria contained in Parts 2 to 5, taking into account the general principles in Part 1 of Annex I to this Regulation shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I to Regulation (EC) No 1907/2006. Justification for the proposed grouping of substances for the purpose of harmonised classification and labelling Where a harmonised classification and labelling proposal is made for a group of substances, the dossier shall include a scientific justification. Justification for other effects at Community level For other effects than carcinogenity, mutagenicity, reprotoxicity and respiratory sensitisation a justification shall be provided that there is a need for action demonstrated at Community level. This does not apply for an active substance in the meaning of Directive 91/414/EEC or Directive 98/8/EC. For effects other than carcinogenity, mutagenicity, reprotoxicity, endocrine disruption for human health and the environment, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile, and respiratory sensitisation, a justification that there is a need for action demonstrated at Union level shall be provided. This shall not apply for an active substance within the meaning of Regulation (EU) No 1107/2009 or Regulation (EU) No 528/2012. 3. PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLE Table 3.1: List of harmonised classification and labelling of hazardous substances. Table 3.2: The list of harmonised classification and labelling of hazardous substances from Annex I to Directive 67/548/EEC. … 54,407 unchanged lines … Carc. Cat. 1; R45 Muta. Cat. 2; R46 F+; T R: 45-46-12 S: 53-45 H K S: 53-45 H 649-208-00-9 Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-rich acid-free; Petroleum gas; [A complex combination of hydrocarbons obtained from fractionation of catalytic cracked gas oil hydrocarbon stream and treated to remove hydrogen sulfide and other acidic components. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4.] 270-752-4 68477-71-4 F+; R12 … 2,097 unchanged lines … S: 61 650-055-00-5 silver sodium zirconium hydrogenphosphate 422-570-3 155925-27-2 N; R50-53 N R: 50/53 S: 60-61

02008R1272-20231201 → 02008R1272-20241210

ANNEX VIII HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES PART A GENERAL REQUIREMENTS 1. APPLICATION 1.1. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for consumer use, within the meaning of Section section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021. 1.2. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for professional use, within the meaning of Section section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2021. 1.3. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) placing on the market mixtures for industrial use or mixtures with an end use not subject to notification within the meaning of Section section 2.4 of Part A of this Annex, shall comply with this Annex from 1 January 2024. 1.4. Importers and Importers, downstream users and distributors referred to in Article 45(1b) and (1c) having submitted information relating to hazardous mixtures to a body appointed in accordance with Article 45(1) before the dates of applicability mentioned in Sections sections 1.1, 1.2 and 1.3 and which are not in accordance with this Annex, shall for those mixtures not be required to comply with this Annex until 1 January 2025. 1.5. By way of derogation from Section section 1.4, if one of the changes described in Section section 4.1 of Part B of this Annex occurs before 1 January 2025, importers and importers, downstream users and distributors referred to in Article 45(1b) and (1c) shall comply with this Annex before placing that mixture, as changed, the mixture concerned on the market. 2. PURPOSE, SCOPE AND DEFINITIONS 2.1. This Annex sets out the requirements that importers and importers, downstream users and distributors referred to in Article 45(1c) (submitters) placing mixtures on the market, hereinafter submitters market shall fulfil in respect of the submission of information so that appointed bodies shall have at their disposal the information required to carry out the tasks for which they are responsible under Article 45. 2.2. This Annex shall not apply to mixtures for scientific research and development and to mixtures for product and process oriented research and development as defined in Article 3(22) of Regulation (EC) No 1907/2006. This Annex shall not apply to mixtures classified only for one or more of the following hazards: (1) Gases under pressure; (2) Explosives (Unstable explosives and Divisions 1.1 to 1.6). 2.2a. In the case of bespoke paints, submitters may, without prejudice to Article 25(8), opt not to submit information and not to create a Unique Formula Identifier in accordance with this Annex. 2.3. In the case of mixtures with an end use not subject to notification or mixtures placed on the market for industrial use only, submitters may opt for a limited submission, as an alternative to general submission requirements, in accordance with the second subparagraph of Section 3.1 of Part B, provided that a rapid access to additional detailed product information is available in accordance with Section 1.3 of that Part. 2.4. For the purposes of this Annex, the following definitions shall apply: (1) mixture for consumer use means a mixture intended to be used by consumers, either on its own or incorporated in another mixture that is intended to be used by consumers and is subject to the information requirements in Article 45; (2) mixture for professional use means a mixture intended to be used by professional users but not at industrial sites, either on its own or incorporated in another mixture that is intended to be used by professional users but not at industrial sites and is subject to the information requirements in Article 45; (3) mixture for industrial use means a mixture intended to be used at industrial sites only; (4) mixture with an end use not subject to notification means a mixture, incorporated in another mixture where the latter is intended to be used by consumers or professional users, but which is not subject to the information requirements in Article 45; (5) bespoke paint means a paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing. Where mixtures have more than one use, the requirements for all relevant categories of use shall be met. met; (6) composition conforming with a standard formula specified in Part D means a composition which includes all the components listed in one of the standard formulas referred to in Part D of this Annex, where those components are present in the mixture in concentrations within the ranges specified in that standard formula. 3. SUBMISSION REQUIREMENTS 3.1. Before placing mixtures on the market, submitters shall provide information relating to mixtures classified as hazardous on the basis of their health or physical effects to the bodies appointed under Article 45(1) (appointed bodies), in the Member … 824 unchanged words … of the mixture shall be provided, including, where relevant, brand name(s), name of the product and variant names as they appear on the label, without abbreviations and enabling its specific identification. In addition, the UFI(s) shall be included in the submission. 1.1a. Name and product description of standard formula or name of fuel For mixtures with a composition conforming with a standard formula specified in Part D, the name and product description of the relevant standard formula as indicated in that Part shall be included in the submission. For fuels listed in Table 3, the name of the fuel shall be provided as indicated in that table. 1.2. Details of the submitter and contact point The name, full address, telephone number and email address of the submitter shall be provided, and, if different, the name, full address, telephone number and email address of the point of contact to … 437 unchanged words … with Annex II to Regulation (EC) No 1907/2006, provided that additional information on the composition is rapidly available on request in emergencies in accordance with Section 1.3. Components which are not present in a mixture shall not be notified. However, if they those components are notified as part of an interchangeable component group in accordance with Section 3.5 section 3.5. or their concentration has been submitted as a range of percentages in accordance with Sections sections 3.6 or 3.7, they may be notified if it is certain that they will certainly be present in the mixture at some point in time. In addition, for mixtures with a composition conforming with a standard formula specified in Part D for which the composition is notified in accordance with section 3.6, first indent, components listed in the relevant standard formula shall be notified even if the component is potentially not, or not permanently, present in cases where the indicated concentration range in Part D includes 0 %. By way of derogation from the third subparagraph, in a group submission, perfume components in mixtures shall be present in at least one of the mixtures For group submissions where the perfumes vary between the mixtures contained in the group, a … 1,400 unchanged words … in an interchangeable component group not classified as hazardous, shall be expressed, in accordance with Table 2 of Section 3.4.2, as ranges of percentages in descending order by mass or volume. As an alternative, exact percentages may be provided. 3.6. Mixtures complying with a composition conforming with a standard formulas formula By way of derogation from Sections 3.2, 3.3 and 3.4, for a mixture with a composition conforming with a standard formula specified in Part D, where the mixture classification does not change depending on the components’ concentration within the ranges of percentages specified in the corresponding standard formula: if the information on composition in the standard formula, together with information as specified in Sections 3.2 to 3.4 on the identity and concentration of the components not specified in the standard formula, is not less detailed than that contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006, the identity and concentration of one or more of the mixture’s components may be submitted as specified in the standard formula for the components mentioned in that formula and as specified in Sections 3.2 to 3.4 for the other components, if the information referred to in the previous indent is less detailed than that contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006, the information on the identity and concentration of all the mixture’s components contained in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006 shall be given. 3.7. Fuels By way of derogation from Sections 3.2, 3.3 and 3.4, for those fuels listed in Table 3, the identity and concentration of the mixture’s components listed in the Safety Data Sheet in accordance with Annex II to Regulation (EC) No 1907/2006 may be submitted. The identity and concentration of any other known component shall also be submitted. Table 3 List of fuels Fuel name Product description Gasoline EN228 Automotive fuels – Unleaded petrol Gasoline E85 Automotive fuels – Ethanol (E85) automotive fuel Gasoline alkylate Motor fuels – special petrol for powered implements LPG Liquefied Petroleum Gas used as fuel LNG Liquefied Natural Gas used as fuel Diesel fuel Automotive fuels … 343 unchanged words … the mixture beyond the concentration range provided in the original submission; (c) the exact concentration of a component was provided in accordance with Sections 3.4.1 or 3.4.2, and a change occurs to that concentration beyond the limits identified in Table 4. when there are other changes to a mixture placed on the market which are relevant for the emergency health response referred to in Article 45 By way of derogation from the fourth indent of the first subparagraph, the following shall apply: (a) a submission update for mixtures with a composition conforming with any of the standard formulas specified in Part D is required only when the composition of the mixture changes in such a manner that the mixture’s composition no longer conforms with the standard formula; (b) for mixtures where the information on composition is provided based on the Safety Data sheet in accordance with Section 3.6 or 3.7 a submission update is required when Section 3 of the Safety Data Sheet is updated. Table 4 Variations of the concentration of components requiring a submission update Exact concentration of the component contained in the mixture (%) Variations (±) of the initial component concentration requiring a submission update > 25 – ≤ 100 5 % > 10 – ≤ 25 10 % > 2,5 – ≤ 10 20 % ≤ 2,5 30 % When perfumes in a group submission change, the list of mixtures and the perfumes they contain as required in Section 3.1 shall be updated. 4.2. Content of the submission update The submission update shall comprise a revised version of the previous submission containing the new information available as described in Section 4.1. PART C SUBMISSION FORMAT 1. SUBMISSION FORMAT 1.1. Submission Format The submission of information to appointed bodies in accordance with Article 45 shall be in a format to be provided by the Agency. The submission format shall address the following elements: 1.2. Identification of the mixture, submitter and contact point Product identifier Complete trade name(s) of the product (in including, where relevant, brand name(s), name of the product and variant name(s) as they appear on the label, without abbreviations or non-alphanumerical symbols and enabling specific identification of the product Unique formula identifier(s) (UFI) Other identifiers (authorisation number, company product codes) In the case of group submission, all product identifiers shall be listed) Other names, synonyms Unique Formula Identifier(s) (UFI) Other identifiers (authorisation number, company listed Name and product codes) description of standard formula or name of fuel Standard formula name and product description as specified in Part D (where applicable) Fuel name as specified in Table 3 of Part B (where applicable) Contact details of the submitter submitter, as defined in Section 2.1 of Part A of this Annex, and contact point Name Full address Telephone number Email address Contact details for rapid access to additional product information (24 hours/7 days). Only for limited submission. Name Telephone number (accessible 24 hours per day, 7 days per week) Email address 1.3. Classification of the mixture, label elements and toxicology Classification of the mixture and label elements Hazard class and category Hazard pictogram codes (Annex V) Signal word Hazard statement codes, including supplemental hazard information codes (Annex III) Precautionary statement codes (Annex IV) Toxicological information Description of the toxicity of the mixture or its components (as required in Section 11 of the Safety Data Sheet in accordance with Annex II to Regulation No 1907/2006) Additional information on the mixture Colour(s) The pH, if available, of the mixture as supplied, or where the mixture is a solid, the pH of an aqueous liquid or solution at a given concentration. The concentration of the test mixture in water shall be indicated. If the pH is not available, the reasons shall be given. Physical state(s) Packaging (type(s) and size(s)) Intended use (product category) Uses (consumer, professional, industrial) 1.4. Information on the mixture components and interchangeable component groups Identification of the mixture components Chemical/trade name of the components CAS number (where applicable) EC number (where applicable) UFI (where applicable) Standard formula name and product description (where applicable) Name of interchangeable component groups (where applicable) Concentration and concentration ranges of the mixture components Exact concentration or concentration range Classification of mixture components Hazard classification (where applicable) Additional identifiers (where applicable and relevant for health response) List according to A list as provided for in Part B, Section section 3.1, fifth subparagraph (where applicable) PART D STANDARD FORMULAS For standard formulas 1-17 the following conditions apply: Heavy metal, trace elements: As, Ba, Cd, Cr, Co, Cu, Hg, Mo, Ni, Pb, Sb, Sn, Te, Tl, V are below 0,1 w/w % and Mn, Sr, Zn are below 1 w/w % PAHs are not present Note applying to standard formulas 1-17: (1) UVCB substance consists of variable amounts of calcite, tricalcium silicate, dicalcium silicate, calcium oxide, quartz, potassium chloride, potassium sulfate, calcium sulfate, sodium aluminium silicate, magnesium aluminium silicate, muscovite, … 1. CEMENT Standard formula name Cement Standard Formula – 1 Product description Portland cement with one main constituent: clinker Component name EC No Concentration (w/w%) Portland cement clinker 266-043-4 86,5 – 100 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 2 Product description Portland-slag cement and Blast furnace cement with two main constituents: clinker and slag Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 4,6 – 94 Granulated blast furnace slag 266-002-0 5,5 – 95 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 3 Product description Portland-silica fume cement Portland cements with two main constituents: clinker and silica fume Component name EC No Concentration (w/w%) Portland cement clinker 266-043-4 82 – 94 Silica fume 273-761-1 5,5 – 10 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 4 Product description Portland-pozzolana cement, Pozzolanic cement Portland cements with two main constituents: clinker and pozzolan (natural or natural calcined pozzolan) Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 41 – 94 Natural (calcined) pozzolana 310-127-6 5,5 – 55 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-303-2 0 – 0,1 Standard formula name Cement Standard Formula – 5 Product description Portland-fly ash cement, Pozzolanic cement Portland cements with two main constituents: clinker and fly ash (siliceous and calcareous fly ash) Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 41 – 94 Fly ash 931-322-8 5,5 – 55 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 6 Product description Portland-burnt shale cement Portland cements with two main constituents: clinker and burnt shale Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 59 – 94 Burnt shale 297-648-1 5,5 – 35 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 7 Product description Portland-limestone cement Portland cements with two main constituents: clinker and limestone Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 59 – 94 Limestone 215-279-6 5,5 – 35 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 8 Product description Portland-composite cement, Composite cement (slag – limestone) Portland cements with three main constituents: clinker, slag and limestone Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 31,9 – 88 Granulated blast furnace slag 266-002-0 5,5 – 59 Limestone 215-279-6 5,5 – 29 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 9 Product description Portland-composite cement, Composite Cement (slag – fly ash) Portland cements with three main constituents: clinker, blast-furnace slag, siliceous and calcareous fly ash Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 18,2 – 88 Granulated blast furnace slag 266-002-0 5,5 – 59 Fly ash 931-322-8 5,5 – 49 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 10 Product description Portland-composite cement, Composite cement (slag – pozzolana) Portland cements with three main constituents: clinker, blast-furnace slag, natural or natural calcined pozzolan Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 18,2 – 88 Granulated blast furnace slag 266-002-0 5,5 – 49 Natural (calcined) pozzolana 310-127-6 5,5 – 49 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 11 Product description Portland-composite cement (slag – burnt shale) Portland cements with three main constituents: clinker, blast-furnace slag, burnt shale Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 59 – 94 Granulated blast furnace slag 266-002-0 5,5 – 29 Burnt shale 297-648-1 5,5 – 29 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 12 Product description Portland-composite cement (limestone – fly ash) Portland cements with three main constituents: clinker, limestone, siliceous and calcareous fly ash Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 46 – 94 Limestone 215-279-6 5,5 – 29 Fly ash 931-322-8 5,5 – 44 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 13 Product description Portland-composite cement (limestone – pozzolana) Portland cements with three main constituents: clinker, limestone, natural or natural calcined pozzolan Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 46 – 94 Limestone 215-279-6 5,5 – 29 Natural (calcined) pozzolana 310-127-6 5,5 – 44 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 14 Product description Portland-composite cement (limestone – burnt shale) Portland cements with three main constituents: clinker, limestone and burnt shale Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 59 – 94 Limestone 215-279-6 5,5 – 29 Burnt shale 297-648-1 5,5 – 29 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 15 Product description Portland-composite cement, Pozzolanic cement (fly ash – pozzolana) Portland cements with three main constituents: clinker, siliceous and calcareous fly ash, natural or natural calcined pozzolan Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 41 – 94 Natural (calcined) pozzolana 310-127-6 5,5 – 55 Fly ash 931-322-8 5,5 – 55 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 16 Product description Portland-composite Portland cements with four main constituents: clinker and three of these constituents: blast-furnace slag, silica fume, fly ash, pozzolan, burnt shale, limestone Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 59 – 94 Granulated blast furnace slag Natural (calcined) pozzolana Fly ashes Burnt shale Limestone Silica fume 266-002-0 310-127-6 931-322-8 297-648-1 215-279-6 273-761-1 5,5 – 23 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 17 Product description Composite cement Portland cements with four main constituents: clinker, slag, siliceous fly ash and natural or natural calcined pozzolan Constituent EC No Concentration (w/w%) Portland cement clinker 266-043-4 18,3 – 64 Granulated blast furnace slag 266-002-0 16,5 – 49 Natural (calcined) pozzolana 310-127-6 5,5 – 43 Fly ash 931-322-8 5,5 – 43 Calcium sulfate 231-900-3 0 – 8 Flue dust (1) 270-659-9 0 – 5 Inorganic natural mineral materials 310-127-6 Iron(II) sulfate 231-753-5 0 – 1 Tin(II) sulfate 231-302-2 0 – 0,1 Standard formula name Cement Standard Formula – 18 Product description Calcium aluminate cement Constituent EC No Concentration (w/w %) Calcium aluminate cement clinker 266-045-5 86,5 – 100 Grinding aid - 0 – 0,2 Standard formula name Cement Standard Formula – 19 Product description Masonry cements – with clinker and lime – MC 5, MC 12,5, MC 22,5 Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 25 – 60 Building lime acc. to EN 459 215-138-9, 1 – 75 Hydrated lime acc. to EN 459 215-137-3 Other, non-hazardous inorganic constituent 310-127-6 0 – 74 Inorganic pigments acc. to EN 12878 - 0 – 1 Standard formula name Cement Standard Formula – 20 Product description Masonry cements – with clinker and without lime – MC 5, MC 12,5, MC 22,5 Component name EC No Concentration (w/w %) Portland cement clinker 266-043-4 25 – 60 Other, non-hazardous inorganic constituent 310-127-6 40 – 75 Inorganic pigments acc. to EN 12878 0 – 1 2. GYPSUM BINDER Standard formula name Gypsum binder Standard Formula Product description Gypsum binder Component name EC No Concentration (w/w %) Calcium sulphate 231-900-3 ≥ 50 and < 100 Calcium dihydroxide 215-137-3 > 0 and ≤ 5 3. READY MIXED CONCRETE Standard formula name Ready mixed concrete Standard Formula 1 Concrete Product description Ready mixed concrete with concrete strength classes C8/10, C12/15, C16/20, C20/25, C25/30, C28/35, C32/40, C35/45, C40/50, C45/55, C50/60 C50/60, LC8/9, LC12/13, LC16/18, LC20/22, LC25/28, LC30/33, LC35/38, LC40/44, LC45/50, LC50/55, LC55/60 Component name EC No Concentration (w/w %) Cement 270-659-9 3 – 18 Water 231-791-2 5 – 8 Aggregates 273-727-6 70 – 80 Air entrainers (admixture) - 0 – 0,08 Plasticisers/superplasticisers (admixture) - 0 – 0,15 Retarders (admixture) - 0 – 0,4 Accelerators (admixture) - 0 – 0,2 Water resisting (admixture) - 0 – 0,25 Fly ash 931-322-8 0 – 8 Silica fume 273-761-1 0 – 3 GGBS 266-002-0 0 – 6 Standard formula name Ready mixed concrete Standard Formula 2 Concrete Product description Ready mixed concrete with concrete strength classes C55/67, C60/75, C70/85, C80/95, C90/105, C100/105, LC 60/66, LC70/77, LC80/88 Component name EC No Concentration (w/w %) Cement 270-659-9 12 – 25 Water 231-791-2 5 – 8 Aggregates 273-727-6 70 – 80 Air entrainers (admixture) - 0,04 – 0,08 Plasticisers/superplasticisers (admixture) - 0 – 0,15 Retarders (admixture) - 0 – 0,4 Accelerators (admixture) - 0 – 0,2 Water resisting (admixture) - 0 – 0,25 Fly ash 931-322-8 0 – 8 Silica fume 273-761-1 0 – 3 GGBS 266-002-0- 0 – 6