Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)

TITLE I GENERAL ISSUES

Article 1

Purpose and scope

• (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.

• (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 ([^E0001]);

• (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.

• (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.

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;

• 1. ‘hazard category’ means the division of criteria within each hazard class, specifying hazard severity;

• 1. ‘hazard pictogram’ means a graphical composition that includes a symbol plus other graphic elements, such as a border, background pattern or colour that is intended to convey specific information on the hazard concerned;

• 1. ‘signal word’ means a word that indicates the relative level of severity of hazards to alert the reader to a potential hazard; the following two levels are distinguished:
• (a) ‘Danger’ means a signal word indicating the more severe hazard categories;
• (b) ‘Warning’ means a signal word indicating the less severe hazard categories;

• 1. ‘hazard statement’ means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard;

• 1. ‘precautionary statement’ means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal;

• 1. ‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

• 1. ‘mixture’ means a mixture or solution composed of two or more substances;

• 1. ‘article’ means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition;

• 1. ‘producer of an article’ means any natural or legal person who makes or assembles an article within the Community;

• 1. ‘polymer’ means a substance consisting of molecules characterised by the sequence of one or more types of monomer units. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units. A polymer comprises the following:
• (a) a simple weight majority of molecules containing at least three monomer units which are covalently bound to at least one other monomer unit or other reactant;
• (b) less than a simple weight majority of molecules of the same molecular weight. In the context of this definition a ‘monomer unit’ means the reacted form of a monomer substance in a polymer;

• 1. ‘monomer’ means a substance which is capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process;

• 1. ‘registrant’ means the manufacturer or the importer of a substance or the producer or importer of an article submitting a registration for a substance under Regulation (EC) No 1907/2006;

• 1. ‘manufacturing’ means production or extraction of substances in the natural state;

• 1. ‘manufacturer’ means any natural or legal person established within the Community who manufactures a substance within the Community;

• 1. ‘import’ means the physical introduction into the customs territory of the Community;

• 1. ‘importer’ means any natural or legal person established within the Community who is responsible for import;

• 1. ‘placing on the market’ means supplying or making available, whether in return for payment or free of charge, to a third party. Import shall be deemed to be placing on the market;

• 1. ‘downstream user’ means any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture, in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) of Regulation (EC) No 1907/2006 shall be regarded as a downstream user;

• 1. ‘distributor’ means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties;

• 1. ‘intermediate’ means a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as ‘synthesis’);

• 1. ‘non-isolated intermediate’ means an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place. Such equipment includes the reaction vessel, its ancillary equipment, and any equipment through which the substance(s) pass(es) during a continuous flow or batch process as well as the pipework for transfer from one vessel to another for the purpose of the next reaction step, but it excludes tanks or other vessels in which the substance(s) are stored after the manufacture;

• 1. ‘the Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;

• 1. ‘competent authority’ means the authority or authorities or bodies established by the Member States to carry out the obligations arising from this Regulation;

• 1. ‘use’ means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation;

• 1. ‘supplier’ means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture;

• 1. ‘alloy’ means a metallic material, homogeneous on a macroscopic scale, consisting of two or more elements so combined that they cannot be readily separated by mechanical means; alloys are considered to be mixtures for the purposes of this Regulation;

• 1. ‘UN RTDG’ means the United Nations Recommendations on the Transport of Dangerous Goods;

• 1. ‘notifier’ means the manufacturer or the importer, or group of manufacturers or importers notifying to the Agency;

• 1. ‘scientific research and development’ means any scientific experimentation, analysis or chemical research carried out under controlled conditions;

• 1. ‘cut-off value’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture, above which threshold these shall be taken into account for determining if the substance or the mixture, respectively, shall be classified;

• 1. ‘concentration limit’ means a threshold of any classified impurity, additive or individual constituent in a substance or in a mixture that may trigger classification of the substance or the mixture, respectively;

• 1. ‘differentiation’ means distinction within hazard classes depending on the route of exposure or the nature of the effects;

• 1. ‘M-factor’ means a multiplying factor. It is applied to the concentration of a substance classified as hazardous to the aquatic environment acute category 1 or chronic category 1, and is used to derive by the summation method the classification of a mixture in which the substance is present;

• 1. ‘package’ means the complete product of the packing operation, consisting of the packaging and its contents;

• 1. ‘packaging’ means one or more receptacles and any other components or materials necessary for the receptacles to perform their containment and other safety functions;

• 1. ‘intermediate packaging’ means packaging placed between inner packaging, or articles, and outer packaging;

• 1. ‘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;

• 1. ‘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;

• 1. ‘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;

• 1. ‘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.

Article 3

Hazardous substances and mixtures and specification of hazard classes

A substance or a mixture fulfilling the criteria relating to physical hazards, health hazards or environmental hazards, laid down in Parts 2 to 5 of Annex I is hazardous and shall be classified in relation to the respective hazard classes provided for in that Annex.

Where, in Annex I, hazard classes are differentiated on the basis of the route of exposure or the nature of the effects, the substance or mixture shall be classified in accordance with such differentiation.

Article 4

General obligations to classify, label and package

• (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.

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 in accordance with Title II shall be carried out for those hazard classes, differentiations and forms or physical states.

TITLE II HAZARD CLASSIFICATION

CHAPTER 1 Identification and examination of information

Article 5

Identification and examination of available information on substances

• (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.

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.

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.

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.

Article 6

Identification and examination of available information on mixtures

• (a) data generated in accordance with any of the methods referred to in Article 8(3) on the mixture itself or the substances contained in it;

• (b) epidemiological data and experience on the effects on humans for the mixture itself or the substances contained in it, such as occupational data or data from accident databases;

• (c) any other information generated in accordance with section 1 of Annex XI to Regulation (EC) No 1907/2006 for the mixture itself or the substances contained in it;

• (ca) data obtained from new approach methodologies;

• (d) any other information generated under internationally recognised chemical programmes for the mixture itself or the substances contained in it.

The information shall relate to the forms or physical states in which the mixture is placed on the market and, when relevant, in which it can reasonably be expected to be used.

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 which have not been identified from the relevant available information on the individual substance referred to in the first subparagraph, those data shall also be taken into account for the purposes of the evaluation of the mixture referred to in the first subparagraph.

Article 7

Animal and human testing

Article 8

Generating new information for substances and mixtures

• (a) the test methods referred to in Article 13(3) of Regulation (EC) No 1907/2006; or

• (b) sound scientific principles that are internationally recognised or methods validated according to international procedures.

CHAPTER 2 Evaluation of hazard information and decision on classification

Article 9

Evaluation of hazard information for substances and mixtures

If more than one similar tested mixture is available when applying the bridging 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 set out in Parts 3 and 4 of Annex I.

Article 10

Concentration limits, M-factors and acute toxicity estimates for classification of substances and mixtures

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 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 specific concentration limit for a substance in exceptional circumstances where adequate, reliable and conclusive scientific information shows that 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.

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. When a mixture including the substance is classified by the manufacturer, importer or downstream user using the summation method, that M-factor shall be used.

Article 11

Cut-off values

Article 12

Specific cases requiring further evaluation

Where, as a result of the evaluation carried out pursuant to Article 9, the following properties or effects are identified, manufacturers, importers and downstream users shall take them into account for the purposes of classification:

• (a) adequate and reliable information demonstrates that in practice the physical hazards of a substance or a mixture differ from those shown by tests;

• (b) conclusive scientific experimental data show that the substance or mixture is not biologically available and those data have been ascertained to be adequate and reliable;

• (c) adequate and reliable scientific information demonstrates the potential occurrence of synergistic or antagonistic effects among the substances in a mixture for which the evaluation was decided on the basis of the information for the substances in the mixture.

Article 13

Decision to classify substances and mixtures

If the evaluation undertaken pursuant to Articles 9 and 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).

Article 14

Specific rules for the classification of mixtures

• (a) that the substances in the mixture react slowly with atmospheric gases, in particular oxygen, carbon dioxide, water vapour, to form different substances at low concentration;

• (b) that the substances in the mixture react very slowly with other substances in the mixture to form different substances at low concentration;

• (c) that the substances in the mixture may self-polymerise to form oligomers or polymers, at low concentration.

• (a) none of the substances in the mixture possesses any of those properties and, on the basis of the information available to the supplier, the mixture is unlikely to present hazards of this kind;

• (b) in the event of a change in the composition of a mixture, scientific evidence indicates that an evaluation of the information on the mixture will not lead to a change in classification.

Article 15

Review of classification for substances and mixtures

• (a) a change in the composition of the initial concentration of one or more of the hazardous constituents in concentrations at or above the limits in Table 1.2 of Part 1 of Annex I;

• (b) a change in the composition involving the substitution or addition of one or more constituents in concentrations at or above the cut-off value referred to in Article 11(3).

Article 16

Classification of substances included in the classification and labelling inventory

TITLE III HAZARD COMMUNICATION IN THE FORM OF LABELLING

CHAPTER 1 Content of the label

Article 17

General rules

• (a) the name, address and telephone number of the supplier(s);

• (b) the nominal quantity of the substance or mixture in the package made available to the general public, unless this quantity is specified elsewhere on the package;

• (c) product identifiers as specified in Article 18;

• (d) where applicable, hazard pictograms in accordance with Article 19;

• (e) where applicable, signal words in accordance with Article 20;

• (f) where applicable, hazard statements in accordance with Article 21;

• (g) where applicable, the appropriate precautionary statements in accordance with Article 22;

• (h) where applicable, a section for supplemental information in accordance with Article 25.

Suppliers may use more languages on their labels than those required by the Member States, provided that the same details appear in all languages used.

Article 18

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.

• (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.

• (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, 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.

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.

Article 19

Hazard pictograms

Article 20

Signal words

Article 21

Hazard statements

Article 22

Precautionary statements

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 ([^E0004]) unless it is an article that falls within the scope of Article 4(8) of this Regulation.

Article 24

Request for use of an alternative chemical name

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 examination procedure referred to in Article 54(2) of this Regulation.

A reduced fee shall be set for SMEs.

Article 25

Supplemental information on the label

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.

The statement shall be worded in accordance with Part 4 of Annex II and Part 3 of Annex III to this Regulation.

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.

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.

Article 26

Principles of precedence for hazard pictograms

• (a) if the hazard pictogram ‘GHS01’ applies, the use of the hazard pictograms ‘GHS02’ and ‘GHS03’ shall be optional, except in cases where more than one of these hazard pictograms are compulsory;

• (b) if the hazard pictogram ‘GHS06’ applies, the hazard pictogram ‘GHS07’ shall not appear;

• (c) if the hazard pictogram ‘GHS05’ applies, the hazard pictogram ‘GHS07’ shall not appear for skin or eye irritation;

• (d) if the hazard pictogram ‘GHS08’ applies for respiratory sensitisation, the hazard pictogram ‘GHS07’ shall not appear for skin sensitisation or for skin and eye irritation;

• (e) if the hazard pictogram ‘GHS02’ or ‘GHS06’ applies, the use of the hazard pictogram ‘GHS04’ shall be optional.

For substances that are included in Part 3 of Annex VI and also subject to classification pursuant to Title II, the label shall include the hazard pictogram corresponding to the most severe hazard category for each relevant hazard class.

Article 27

Principles of precedence for hazard statements

If a substance or mixture is classified within several hazard classes or differentiations of a hazard class, all hazard statements resulting from the classification shall appear on the label, unless there is evident duplication or redundancy.

Article 28

Principles of precedence for precautionary statements

In all other cases, a precautionary statement addressing disposal shall not be required, where it is clear that the disposal of the substance or mixture or the packaging does not present a hazard to human health or the environment.

Article 29

Exemptions from labelling and packaging requirements

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.

Article 30

Updating information on labels

CHAPTER 2 Application of labels

Article 31

General rules for the application of labels

1a. Where the label is presented in the form of a fold-out label, the label elements referred to in Article 17(1) shall be presented in accordance with section 1.2.1.6 of Annex I.

1b. Where a digital label as provided for in Article 34a(1) is used, a data carrier linking to that digital label shall be firmly affixed or printed on the physical label or on the packaging next to the label in such a way that it can be processed automatically by digital devices that are widely used.

Where label elements are provided on a digital label only pursuant to Article 34a(2), the data carrier shall be accompanied by the statement ‘More hazard information available online’ or by a similar indication.

Article 32

Location of information on the label

The supplier may decide the order of the precautionary statements on the label. However, subject to paragraph 4, all precautionary statements shall be grouped on the label by language.

Article 33

Specific rules for labelling of outer packaging, inner packaging and single packaging

Article 34

Report on communication on safe use of chemicals

Chapter 3 Labelling formats

Article 34a

Physical and digital labelling

Where the label elements set out in section 1.6 of Annex I are provided on a digital label only, suppliers shall, upon oral or written request or when the digital label is temporarily unavailable at the time of purchase of the substance or mixture, provide those label elements by alternative means. Suppliers shall provide those elements independently of a purchase and free of charge.

Article 34b

Requirements for digital labelling

• (a) all label elements referred to in Article 17(1) shall be provided together in one place and separately from other information;

• (b) the information on the digital label shall be searchable;

• (c) the information on the digital label shall be accessible to all users in the Union and shall remain accessible for a period of at least 10 years or for a longer period where required by other Union legislation;

• (d) the digital label shall be accessible free of charge, without the need to register or to download or install applications, or to provide a password;

• (e) the information on the digital label shall be presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access to the information by those groups;

• (f) the information on the digital label shall be accessible with no more than two clicks;

• (g) the digital label shall be accessible through digital technologies widely used, and compatible with all major operating systems and browsers;