Regulation (EC) No 1272/2008 of the European Parliament ...

1 Changes to legislation: There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council. Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding changesRegulation (EC) No 1272/2008 of the European Parliament and of the Councilof 16 December 2008 on classification, labelling and packaging of substancesand mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance)TITLE IGENERAL ISSUESA rticle 1 Purpose and scope Article 2 Definitions Article 3 Hazardous substances and mixtures and specification of hazardclasses Article 4 General obligations to classify, label and package TITLE IIHAZARD CLASSIFICATIONCHAPTER 1 Identification and examination of informationArticle 5 Identification and examination of available information onsubstances Article 6 Identification and examination of available information onmixtures Article 7 Animal and human testing Article 8 Generating new information for substances and mixtures CHAPTER 2 Evaluation of hazard information and decision on classificationArticle 9 Evaluation of hazard information for substances and mixtures Article 10 Concentration limits and M-factors for classification ofsubstances and mixtures Article 11 Cut-off values Article 12 Specific cases requiring further evaluation Article 13 Decision to classify substances and mixtures Article 14 Specific rules for the classification of mixtures Article 15 Review of classification for substances and mixtures Article 16 Classification of substances included in the classification andlabelling inventory iiRegulation

2 (EC) No 1272/2008 of the European Parliament and of the Council of 16 Generated: 2022-01-24 Changes to legislation: There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council. Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding changesTITLE IIIHAZARD COMMUNICATION IN THE FORM OF LABELLINGCHAPTER 1 Content of the labelArticle 17 General rules Article 18 Product identifiers 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 Article 24 Request for use of an alternative chemical name Article 25 Supplemental information on the label Article 26 Principles of precedence for hazard pictograms Article 27 Principles of precedence for hazard statements Article 28 Principles of precedence for precautionary statements Article 29 Exemptions from labelling and packaging requirements Article 30 Updating information on labels CHAPTER 2 Application of labelsArticle 31 General rules for the application of labels Article 32 Location of information on the label Article 33 Specific rules for labelling of outer packaging.

3 Inner packagingand single packaging Article 34 Report on communication on safe use of chemicals TITLE IVPACKAGINGA rticle 35 Packaging TITLE VHARMONISATION OF CLASSIFICATION AND LABELLING OFSUBSTANCES AND THE CLASSIFICATION AND LABELLING INVENTORYCHAPTER 1 Establishing harmonised classification and labelling of substancesArticle 36 Harmonisation of classification and labelling of substances Article 37 Procedure for harmonisation of classification and labelling ofsubstances Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 Generated: 2022-01-24iiiChanges to legislation: There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council. Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding changesArticle 38 Content of opinions and decisions for harmonised classificationand labelling in Part 3 of Annex VI.

4 Accessibility of information CHAPTER 2 Classification and labelling inventoryArticle 39 Scope Article 40 Obligation to notify the Agency Article 41 Agreed entries Article 42 The classification and labelling inventory TITLE VICOMPETENT AUTHORITIES AND ENFORCEMENTA rticle 43 Appointment of competent authorities and enforcementauthorities and cooperation between authorities Article 44 Helpdesk Article 45 Appointment of bodies responsible for receiving informationrelating to emergency health response Article 46 Enforcement and reporting Article 47 Penalties for non-compliance TITLE VIICOMMON AND FINAL PROVISIONSA rticle 48 Advertisement Article 49 Obligation to maintain information and requests for information Article 50 Tasks of the Agency Article 51 Free movement clause Article 52 Safeguard clause Article 53 Adaptations to technical and scientific progress Article 53a Exercise of the delegation Article 53b Urgency procedure Article 53c Separate delegated acts for different delegated powers Article 54 Committee procedure Article 55 Amendments to Directive 67/548/EEC Article 56 Amendments to Directive 1999/45/EC Article 57 Amendments to Regulation (EC) No 1907/2006 from the entryinto force of this Regulation Article 58 Amendments to Regulation (EC) No 1907/2006 from 1 December 2010 Article 59 Amendments to Regulation (EC) No 1907/2006 from 1 June2015 Article 60 Repeal Article 61 Transitional provisions Article 62 Entry into force Signature ivRegulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 Generated: 2022-01-24 Changes to legislation: There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council.

5 Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding changesANNEX ICLASSIFICATION AND LABELLING REQUIREMENTSFOR HAZARDOUS SUBSTANCES AND MIXTURES This annex sets out the criteria for classification in 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND of substances and to meet the requirements in this role and application of expert judgement and weight the criteria cannot be applied directly to approach to classifying mixtures may include theapplication weight of evidence determination means that all the purpose of classification for health hazards (Part 3).. the purpose of classification for health hazards (Part 3).. concentration limits, M-factors and generic cut-off concentration limits or M-factors shall be applied values indicate when the presence of asubstance cut-off values referred to in Article 11 shall principles for the classification of mixtures where test of highly hazardous within one hazard similar of classification where the composition of a rules for the application of labels required by pictograms shall be in the shape of a pictograms as laid down in Annex V shall hazard pictogram shall cover at least one fifteenth dimensions of the label and of each pictogram from labelling requirements for special gas containers intended for propane, butane or liquefied propane, butane and liquefied petroleum gas or a information concerning the effects on human health (EC) No 1272/2008 of the European Parliament and of the Council of 16 Generated: 2022-01-24vChanges to legislation.

6 There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council. Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding consumers, sufficient information shall be transmitted toenable and containers fitted with a sealed spray attachment in massive form, alloys, mixtures containing polymers,mixtures in massive form, alloys, mixtures containing polymersand , the supplier shall provide the information todownstream placed on the market with a view to or mixtures classified as corrosive to metals but for use of an alternative chemical for use of an alternative chemical name under choice of the chemical name(s) for mixtures intended from labelling and packaging from Article 31 [(Article 29(1))] Article 29(1) applies, the label elements mentioned label on any inner packaging shall contain at from Article 17 [(Article 29(2))]

7 ] of packages where the contents do not exceed125 hazard statements and the precautionarystatements linked to precautionary statements linked to the hazardcategories listed pictogram, the signal word, the hazard statement,and of soluble packaging for single shall not apply to substances or of inner packaging where the contents do label elements required by Article 17 may sections and , thelabel on the shall not apply to substances or 2: PHYSICAL class of explosives the purposes of this Regulation the following , mixtures and articles of this class are , mixtures and articles of this class, which are , which are not classified as an unstable explosive, (EC) No 1272/2008 of the European Parliament and of the Council of 16 Generated: 2022-01-24 Changes to legislation: There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council.

8 Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding explosives are unpackaged or repacked in packaging Classification classification of substances, mixtures and articles in for assignment to a division in the class ( 1 )See Chapter of the UN RTDG, ModelRegulations for the classification of ammonium nitrateemulsion, suspension acceptance procedure for the hazard class explosives need the case of mixtures containing any known explosives, flammable gas is classified in Category 1A, 1B 1:Aerosols shall not be classified as flammablegases. See Section 2:In the absence of data allowing classification intoCategory 1B,..NOTE 3:Spontaneous ignition for pyrophoric gases is notalways immediate, 4:In the absence of data on its pyrophoricity, CommunicationFigure gases( 1 )In the absence of data on its pyrophoricity, Classification shall be determined by tests or, for shall be determined at 54 C in accordance classification procedure for pyrophoric gases need not instability shall be determined in accordance withthe shall be classified in one of the three aerosol shall be classified in one of the Classification chemical heat of combustion ( c ), in criteriaRegulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 Generated: 2022-01-24viiChanges to legislation: There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council.

9 Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding oxidising gas shall be classified in a single Classification under under pressure are gases which are contained in critical temperature is the temperature above which under pressure shall be classified, according to Classification flammable liquid shall be classified in one of Classification the classification of flammable liquids data on flash the case of mixtures containing known flammable suitable method is described in Gmehling and Rasmussen( test methods for determining the flash point with a flash point of more than 35 C test methods for determining the initial boiling flammable solid means a solid which is readilycombustible,.. , granular or pasty substances or mixtures (exceptpowders of metals or metal alloys shall be classified flammable solid shall be classified in one of 1:Note 2 substances and substances or mixtures are thermally unstableliquid or self-reactive substance or mixture is regarded as self-reactive substance or mixture shall be considered (EC) No 1272/2008 of the European Parliament and of the Council of 16 Generated: 2022-01-24 Changes to legislation: There are outstanding changes not yet made to Regulation (EC) No 1272/2008 of theEuropean Parliament and of the Council.))

10 Any changes that have already been made to the legislation appear inthe content and are referenced with annotations. (See end of Document for details) View outstanding of oxidising substances, meeting the criteria forclassification substances and mixtures shall be classified in for temperature Classification properties of self-reactive substances or mixtures whichare classification procedures for self-reactive substances andmixtures need pyrophoric liquid shall be classified in a single Classification classification procedure for pyrophoric liquids need notbe pyrophoric solid shall be classified in a single Classification classification procedure for pyrophoric solids need not substances and self-heating substance or mixture is a liquid or of a substance or a mixture is a substance or mixture shall be classified as a self-heating substance or mixture shall be classified in and mixtures with a temperature of spontaneouscombustion and mixtures with a spontaneous ignitiontemperature higher Classification detailed schemes for the decision logic for classification