Classification, Labelling and Packaging Regulation

02008R1272-20241210 → 02008R1272-20250201

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); (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. (d). 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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before (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.

after (02008R1272-20250201)

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.

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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 and reproductive toxicity, endocrine disruption for human health and endocrine disruption for the environment toxicity hazard classes referred to in sections 3.5.3.1, 3.6.3.1, 3.7.3.1, 3.11.3.1 3.6.3.1 and 4.2.3.1 3.7.3.1 of Annex I, the manufacturer, importer and or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself. Where mixture. Further, in cases where the available test data on the mixture itself demonstrate germ cell mutagenic, carcinogenic or toxic to reproduction properties, or endocrine disruption for human health or the environment effects which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, substances, those data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph. account. 4. For the evaluation of mixtures pursuant to Chapter 2 of this Title in relation to the biodegradation, persistency, mobility biodegradation 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 environment hazard classes class 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 4.1.2.8 and 4.4.2.3.2 4.1.2.9 of Annex I, the manufacturer, importer and or downstream user shall only use the relevant available information referred to in paragraph 1 for the substances in the mixture and not for the mixture itself. mixture. 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. When evaluating hazard Where only the information for mixtures, referred to in Article 6(5) is available, manufacturers, importers and downstream users shall, where test data for the mixture itself are inadequate or unavailable, shall 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. If more than one similar tested mixture is available when applying However, where that information permits the application neither of the bridging principles, principles nor the principles for using expert judgement and weight of evidence determination as described in Part 1 of Annex I, 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 set out described 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 and M-factors and 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 that the 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. Manufacturers, importers and downstream users may set a In exceptional circumstances specific concentration limit for a substance in exceptional circumstances limits may be set by the manufacturer, importer or downstream user where he has adequate, reliable and conclusive scientific information shows that the a 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. 3. Manufacturers, 1, shall be established by manufacturers, importers and downstream users shall establish acute toxicity estimates for substances classified as acutely toxic for human health. 4. By way of derogation from users. 3. Notwithstanding 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. 5. By way of derogation from 4. Notwithstanding paragraph 2, M-factors shall not be established set 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. substance shall be set by the manufacturer, importer or downstream user. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, that this M-factor shall be used. 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 5. In setting the specific concentration limit, limit or M-factor or acute toxicity estimate, manufacturers, importers and downstream users shall take into account any specific concentration limits, limits or M-factors or acute toxicity estimate for that substance which have been included in the classification and labelling inventory. 8. 6. Specific concentration limits set in accordance with paragraph 1, second and third subparagraphs, 1 shall take precedence over the concentration limits set out concentrations 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 that Annex. 9. Annex I. 7. The Agency shall provide further guidance for the application of paragraphs 1, 2 1 and 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. 2.

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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, toxicity (STOT) or aspiration hazard, persistent, bioaccumulative and toxic, very persistent and very bioaccumulative, persistent, mobile and toxic, very persistent and very mobile properties, or endocrine disruption for human health or the environment. hazard. 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 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, 2 1 and 6 to 9, 2, provided that that information does not make it more difficult to identify the label elements referred to in Article 17(1), points 17(1) (a) to (g), (g) and that it provides further details and does not contradict or cast doubt on the validity of the information specified by those elements. 4. Statements such as non-toxic, non-harmful, non-polluting, ecological or any other statements indicating that the substance or mixture … 367 unchanged words … for an individual consumer or professional user at the point of sale by tinting or colour mixing. 9. Label elements resulting from requirements set out in other Union acts shall be placed in the section for supplemental information on the label.

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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 laid down in of 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(1), 17(2) 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. Where When a hazardous substance or mixture referred to in Part 5 of Annex II is supplied to the general public without packaging, the labelling information packaging it shall be provided accompanied by a copy of the label elements in accordance with the provision referring to that substance or mixture in that Part. Article 17. 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 (02008R1272-20241210)

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

after (02008R1272-20250201)

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.

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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 be spaced in such a way spacing 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.

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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 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, M-factors limits or acute toxicity estimates, M-factors, where applicable, in accordance with Article 10 of this Regulation, Regulation together with a justification as referred to in using 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); (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. 25(1). The information referred to in points (a) to (h) (f) 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 notifier(s) concerned at when, pursuant to the latest 6 months after review in Article 15(1), a decision to change the classification and labelling of the substance has been taken pursuant to the review referred to in Article 15(1). taken. 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. 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 Information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006; (d) the date of the latest update of the classification and labelling. Information referred to in Article 40(1), point (a), 1907/2006 shall be made publicly 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. accessible. The Agency shall provide grant access to the other information on legitimate grounds each substance in the inventory to the notifiers and registrants who have submitted information on which confidentiality claims may be made. The Agency that substance in accordance with Article 29(1) of Regulation (EC) No 1907/2006. It shall take measures grant access to identify undue confidentiality claims, including automated screening and random manual checks. such information to other parties subject to Article 118 of that Regulation. 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 relating to emergency health response and preventative measures, in accordance with Annex VIII. 1a. Member States may appoint the Agency as the body responsible for receiving information relating to emergency health response and preventative measures referred to in paragraph 1. 1b. Importers and downstream users 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. 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 importers, the importers and downstream users and distributors referred to in paragraph 1c, responsible for marketing to carry out the tasks for which they are responsible in accordance with paragraph 1. responsible. 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).

texts differ too much for an inline diff; shown separately

before (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.

after (02008R1272-20250201)

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..

deleted 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.

02008R1272-20241210 → 02008R1272-20250201

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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. … 137 unchanged lines … 1.5. Exemptions from labelling and packaging requirements 1.5.1. Exemptions from Article 31 in accordance with Article 29(1) 1.5.1.1. Where Article 29(1) applies, the label elements referred to in Article 17 may be provided on a tie-on tag or on an outer packaging. 1.5.1.2. 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. 1.5.1.2. 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 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: … 34 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 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. 1.5.2.4.1. 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. 1.5.2.4.2. 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

02008R1272-20241210 → 02008R1272-20250201

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 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. state.

02008R1272-20241210 → 02008R1272-20250201

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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. … 497 unchanged lines … H302 H318 H317 H410 005-007-00-2 boric acid [1] H410 005-007-00-2 boric acid; [1] boric acid [2] 233-139-2 [1] 234-343-4 [2] 10043-35-3 [1] 11113-50-1 [2] Repr. 1B H360FD GHS08 Dgr H360FD 005-008-00-8 diboron trioxide 215-125-8 1303-86-2 Repr. 1B H360FD GHS08 Dgr H360FD 005-009-00-3 tetrabutylammonium butyltriphenylborate 418-080-4 120307-06-4 Skin Sens. 1 Dgr H360FD 11 005-008-00-8 diboron trioxide 215-125-8 1303-86-2 Repr. 1B H360FD GHS08 Dgr H360FD 11 005-009-00-3 tetrabutylammonium butyltriphenylborate 418-080-4 120307-06-4 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H317 H400 H410 GHS07 GHS09 Wng H317 H410 005-010-00-9 N, N-dimethylanilinium tetrakis(pentafluorophenyl)borate 422-050-6 118612-00-3 Carc. 2 Acute Tox. 4 * Skin Irrit. 2 Eye Dam. 1 H351 H302 H315 H318 GHS08 GHS05 GHS07 Dgr H351 H302 H315 H318 005-011-00-4 tetraboron disodium heptaoxide, hydrate; [1] disodium tetraborate, anhydrous; [2] orthoboric acid, sodium salt [3] disodium tetraborate decahydrate [4] orthoboric acid, sodium salt; [3] disodium tetraborate decahydrate; [4] disodium tetraborate pentahydrate [5] 235-541-3 [1] 215-540-4 [2] 237-560-2 [3] 215-540-4 [4] 215-540-4 [5] 12267-73-1 [1] 1330-43-4 [2] 13840-56-7 [3] 1303-96-4 [4] 12179-04-3 [5] Repr. 1B H360FD GHS08 Dgr H360FD 005-012-00-X diethyl{4-[1,5,5-tris(4-diethylaminophenyl)penta-2,4-dienylidene]cyclohexa-2,5-dienylidene}ammonium butyltriphenylborate 418-070-1 141714-54-7 Skin Sens. 1 Dgr H360FD 11 005-012-00-X diethyl{4-[1,5,5-tris(4-diethylaminophenyl)penta-2,4-dienylidene]cyclohexa-2,5-dienylidene}ammonium butyltriphenylborate 418-070-1 141714-54-7 Skin Sens. 1 Aquatic Acute 1 Aquatic Chronic 1 H317 H400 … 17,227 unchanged lines … H302 H319 H335 H315 607-230-00-6 2-ethylhexanoic acid and its salts, with the exception of those specified elsewhere in this Annex — — Repr. 1B H360D GHS08 Dgr H360D 607-231-00-1 clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid 216-935-4 1702-17-6 Eye Dam. 1 H318 GHS05 H315 607-230-00-6 2-ethylhexanoic acid and its salts, with the exception of those specified elsewhere in this Annex - - Repr. 1B H360D GHS08 Dgr H360D A, X, 12 607-231-00-1 clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid 216-935-4 1702-17-6 Eye Dam. 1 H318 GHS05 Dgr H318 607-232-00-7 pyridate (ISO); O-(6-chloro-3-phenylpyridazin-4-yl) S-octyl thiocarbonate 259-686-7 55512-33-9 Acute Tox. 4 Skin Irrit. 2 … 39,041 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

02008R1272-20241210 → 02008R1272-20250201

ANNEX VIII HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES PART A GENERAL REQUIREMENTS 1. APPLICATION 1.1. Importers, Importers and 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, Importers and 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, Importers and 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, Importers and 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, importers and downstream users and distributors referred to in Article 45(1b) and (1c) shall comply with this Annex before placing the mixture concerned that mixture, as changed, on the market. 2. PURPOSE, SCOPE AND DEFINITIONS 2.1. This Annex sets out the requirements that importers, importers and downstream users and distributors referred to in Article 45(1c) (submitters) placing mixtures on the market market, hereinafter submitters 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; (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. met. 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 those components they 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 formula formulas 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 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 (in case of group submission, all product identifiers shall be listed Name and listed) Other names, synonyms Unique Formula Identifier(s) (UFI) Other identifiers (authorisation number, company product 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) codes) Contact details of the submitter, as defined in Section 2.1 of Part A of this Annex, submitter 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) A list as provided for in List according to 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 Product description Ready mixed concrete with concrete 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 Product description Ready mixed concrete with concrete 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