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Regulation (EC) No 1272/2008 of the European Parliament and of the CouncilShow full title

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)

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  1. Introductory Text

  2. TITLE I GENERAL ISSUES

    1. Article 1.Purpose and scope

    2. Article 2.Definitions

    3. Article 3.Hazardous substances and mixtures and specification of hazard classes

    4. Article 4.General obligations to classify, label and package

  3. TITLE II HAZARD CLASSIFICATION

    1. CHAPTER 1 Identification and examination of information

      1. Article 5.Identification and examination of available information on substances

      2. Article 6.Identification and examination of available information on mixtures

      3. Article 7.Animal and human testing

      4. Article 8.Generating new information for substances and mixtures

    2. CHAPTER 2 Evaluation of hazard information and decision on classification

      1. Article 9.Evaluation of hazard information for substances and mixtures

      2. Article 10.Concentration limits and M-factors for classification of substances and mixtures

      3. Article 11.Cut-off values

      4. Article 12.Specific cases requiring further evaluation

      5. Article 13.Decision to classify substances and mixtures

      6. Article 14.Specific rules for the classification of mixtures

      7. Article 15.Review of classification for substances and mixtures

      8. Article 16.Classification of substances included in the classification and labelling inventory

  4. TITLE III HAZARD COMMUNICATION IN THE FORM OF LABELLING

    1. CHAPTER 1 Content of the label

      1. Article 17.General rules

      2. Article 18.Product identifiers

      3. Article 19.Hazard pictograms

      4. Article 20.Signal words

      5. Article 21.Hazard statements

      6. Article 22.Precautionary statements

      7. Article 23.Derogations from labelling requirements for special cases

      8. Article 24.Request for use of an alternative chemical name

      9. Article 25.Supplemental information on the label

      10. Article 26.Principles of precedence for hazard pictograms

      11. Article 27.Principles of precedence for hazard statements

      12. Article 28.Principles of precedence for precautionary statements

      13. Article 29.Exemptions from labelling and packaging requirements

      14. Article 30.Updating information on labels

    2. CHAPTER 2 Application of labels

      1. Article 31.General rules for the application of labels

      2. Article 32.Location of information on the label

      3. Article 33.Specific rules for labelling of outer packaging, inner packaging and single packaging

      4. Article 34.Report on communication on safe use of chemicals

  5. TITLE IV PACKAGING

    1. Article 35.Packaging

  6. TITLE V MANDATORY CLASSIFICATION AND LABELLING OF SUBSTANCES AND THE GB NOTIFICATION DATABASE

    1. CHAPTER 1 Establishing mandatory classification of substances

      1. Article 36. Mandatory classification and labelling of substances

      2. Article 37.Procedure for mandatory classification and labelling where the EU Risk Assessment Committee publishes an opinion

      3. Article 37A.Procedure for mandatory classification and labelling of substances where Article 37(1) does not apply

      4. Article 38.Content of opinions and decisions for mandatory classification and labelling in the GB mandatory classification and labelling list; accessibility of information

      5. Article 38A.GB mandatory classification and labelling list

    2. CHAPTER 2 GB notification database

      1. Article 39.Scope

      2. Article 40.Obligation to notify the Agency

      3. Article 41.Agreed entries

      4. Article 42.The GB notification database

  7. TITLE VI HELPDESK AND APPOINTMENT OF BODIES

    1. Article 43.Appointment of competent authorities and enforcement authorities and cooperation between authorities

    2. Article 44.Helpdesk

    3. Article 45.Appointment of bodies responsible for receiving information relating to emergency health response

    4. Article 46.Enforcement and reporting

    5. Article 47.Penalties for non-compliance

  8. TITLE VII COMMON AND FINAL PROVISIONS

    1. Article 48.Advertisement

    2. Article 49.Obligation to maintain information and requests for information

    3. Article 50.Tasks of the Agency

    4. Article 51.Free movement clause

    5. Article 52.Safeguard clause

    6. Article 53.Adaptations to technical and scientific progress

    7. Article 53A.Regulation making power

    8. Article 53B.The consent requirement

    9. Article 53a. Exercise of the delegation

    10. Article 53b. Urgency procedure

    11. Article 53c. Separate delegated acts for different delegated powers

    12. Article 54.Committee procedure

    13. Article 55.Amendments to Directive 67/548/EEC

    14. Article 56.Amendments to Directive 1999/45/EC

    15. Article 57.Amendments to Regulation (EC) No 1907/2006 from the entry into force of this Regulation

    16. Article 58.Amendments to Regulation (EC) No 1907/2006 from 1 December 2010

    17. Article 59.Amendments to Regulation (EC) No 1907/2006 from 1 June 2015

    18. Article 60.Repeal

    19. Article 61.Transitional provisions

    20. Article 62.Entry into force

  9. Signature

    1. ANNEX I

      CLASSIFICATION AND LABELLING REQUIREMENTS FOR HAZARDOUS SUBSTANCES AND MIXTURES

      1. This annex sets out the criteria for classification in hazard...

      2. 1. PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING

        1. 1.0. Definitions

        2. 1.1. Classification of substances and mixtures

          1. 1.1.0. Cooperation to meet the requirements in this Regulation

          2. 1.1.1. The role and application of expert judgement and weight of...

            1. 1.1.1.1. Where the criteria cannot be applied directly to available identified...

            2. 1.1.1.2. The approach to classifying mixtures may include the application of...

            3. 1.1.1.3. A weight of evidence determination means that all available information...

            4. 1.1.1.4. For the purpose of classification for health hazards (Part 3)...

            5. 1.1.1.5. For the purpose of classification for health hazards (Part 3)...

          3. 1.1.2. Specific concentration limits, M-factors and generic cut-off values

            1. 1.1.2.1. Specific concentration limits or M-factors shall be applied in accordance...

            2. 1.1.2.2. Cut-off values

              1. 1.1.2.2.1. Cut-off values indicate when the presence of a substance needs...

              2. 1.1.2.2.2. The cut-off values referred to in Article 11 shall be...

              3. Note:

          4. 1.1.3. Bridging principles for the classification of mixtures where test data...

            1. 1.1.3.1. Dilution

            2. 1.1.3.2. Batching

            3. 1.1.3.3. Concentration of highly hazardous mixtures

            4. 1.1.3.4. Interpolation within one hazard category

            5. 1.1.3.5. Substantially similar mixtures

            6. 1.1.3.6. Review of classification where the composition of a mixture has...

            7. 1.1.3.7. Aerosols

        3. 1.2. Labelling

          1. 1.2.1. General rules for the application of labels required by Article...

            1. 1.2.1.1. Hazard pictograms shall be in the shape of a square...

            2. 1.2.1.2. Hazard pictograms as laid down in Annex V shall have...

            3. 1.2.1.3. Each hazard pictogram shall cover at least one fifteenth of...

            4. 1.2.1.4. The dimensions of the label and of each pictogram shall...

        4. 1.3. Derogations from labelling requirements for special cases

          1. 1.3.1. Transportable gas cylinders

          2. 1.3.2. Gas containers intended for propane, butane or liquefied petroleum gas...

            1. 1.3.2.1. If propane, butane and liquefied petroleum gas or a mixture...

            2. 1.3.2.2. No information concerning the effects on human health and the...

            3. 1.3.2.3. For consumers, sufficient information shall be transmitted to enable them...

          3. 1.3.3. Aerosols and containers fitted with a sealed spray attachment and...

          4. 1.3.4. Metals in massive form, alloys, mixtures containing polymers, mixtures containing...

            1. 1.3.4.1. Metals in massive form, alloys, mixtures containing polymers and mixtures...

            2. 1.3.4.2. Instead, the supplier shall provide the information to downstream users...

          5. 1.3.5. Explosives placed on the market with a view to obtaining...

          6. 1.3.6. Substances or mixtures classified as corrosive to metals but not...

        5. 1.4. Request for use of an alternative chemical name

          1. 1.4.1. Requests for use of an alternative chemical name under Article...

          2. 1.4.2. The choice of the chemical name(s) for mixtures intended for...

        6. 1.5. Exemptions from labelling and packaging requirements

          1. 1.5.1. Exemptions from Article 31 [(Article 29(1))]

            1. 1.5.1.1. Where Article 29(1) applies, the label elements mentioned in Article...

            2. 1.5.1.2. The label on any inner packaging shall contain at least...

          2. 1.5.2. Exemptions from Article 17 [(Article 29(2)]

            1. 1.5.2.1. Labelling of packages where the contents do not exceed 125 ml...

              1. 1.5.2.1.1. The hazard statements and the precautionary statements linked to the...

              2. 1.5.2.1.2. The precautionary statements linked to the hazard categories listed below...

              3. 1.5.2.1.3. The pictogram, the signal word, the hazard statement, and the...

            2. 1.5.2.2. Labelling of soluble packaging for single use

            3. 1.5.2.3. Section 1.5.2.2 shall not apply to substances or mixtures within...

            4. 1.5.2.4. Labelling of inner packaging where the contents do not exceed...

              1. 1.5.2.4.1. The label elements required by Article 17 may be omitted...

              2. 1.5.2.4.2. Notwithstanding sections 1.5.1.2 and 1.5.2.4.1, the label on the inner...

            5. 1.5.2.5. Section 1.5.2.4 shall not apply to substances or mixtures within...

      3. 2. PART 2: PHYSICAL HAZARDS

        1. 2.1. Explosives

          1. 2.1.1. Definitions

            1. 2.1.1.1. The class of explosives comprises

            2. 2.1.1.2. For the purposes of this Regulation the following definitions shall...

          2. 2.1.2. Classification criteria

            1. 2.1.2.1. Substances, mixtures and articles of this class are classified as...

            2. 2.1.2.2. Substances, mixtures and articles of this class, which are not...

            3. 2.1.2.3. Explosives, which are not classified as an unstable explosive, shall...

            4. 2.1.2.4. If explosives are unpackaged or repacked in packaging other than...

          3. 2.1.3. Hazard Communication

          4. 2.1.4. Additional Classification Considerations

            1. 2.1.4.1. The classification of substances, mixtures and articles in the explosives...

              1. Figure 2.1.3 Procedure for assignment to a division in the class of...

                1. ( 1 ) See Chapter 3.3 of the UN RTDG, Model Regulations for...

              2. Figure 2.1.4 Procedure for the classification of ammonium nitrate emulsion, suspension or...

            2. 2.1.4.2. Screening procedure

              1. Note:

            3. 2.1.4.3. The acceptance procedure for the hazard class ‘explosives’ need not...

            4. 2.1.4.4. In the case of mixtures containing any known explosives, the...

        2. 2.2. Flammable gases

          1. 2.2.1. Definitions

          2. 2.2.2. Classification criteria

            1. 2.2.2.1. A flammable gas is classified in Category 1A, 1B or...

              1. NOTE 1: Aerosols shall not be classified as flammable gases. See Section 2.3....

              2. NOTE 2: In the absence of data allowing classification into Category 1B,...

              3. NOTE 3: Spontaneous ignition for pyrophoric gases is not always immediate, and...

              4. NOTE 4: In the absence of data on its pyrophoricity, a flammable...

          3. 2.2.3. Hazard Communication

            1. Figure 2.2.1 Flammable gases

              1. ( 1 ) In the absence of data on its pyrophoricity, a flammable...

          4. 2.2.4. Additional Classification Considerations

            1. 2.2.4.1. Flammability shall be determined by tests or, for mixtures where...

            2. 2.2.4.2. Pyrophoricity shall be determined at 54 °C in accordance with either...

            3. 2.2.4.3. The classification procedure for pyrophoric gases need not be applied...

            4. 2.2.4.4. Chemical instability shall be determined in accordance with the method...

        3. 2.3. Aerosols

          1. 2.3.1. Definitions

          2. 2.3.2. Classification criteria

            1. 2.3.2.1. Aerosols shall be classified in one of the three categories...

            2. 2.3.2.2. An aerosol shall be classified in one of the three...

              1. Note:

          3. 2.3.3. Hazard Communication

          4. 2.3.4. Additional Classification Considerations

            1. 2.3.4.1. The chemical heat of combustion (ΔΗ c ), in kilojoules...

        4. 2.4. Oxidising gases

          1. 2.4.1. Definitions

          2. 2.4.2. Classification criteria

            1. 2.4.2.1. An oxidising gas shall be classified in a single category...

              1. Note:

          3. 2.4.3. Hazard Communication

          4. 2.4.4. Additional Classification Considerations

        5. 2.5. Gases under pressure

          1. 2.5.1. Definition

            1. 2.5.1.1. Gases under pressure are gases which are contained in a...

            2. 2.5.1.2. The critical temperature is the temperature above which a pure...

          2. 2.5.2. Classification criteria

            1. 2.5.2.1. Gases under pressure shall be classified, according to their physical...

          3. 2.5.3. Hazard Communication

            1. Note:

          4. 2.5.4. Additional Classification Considerations

        6. 2.6. Flammable liquids

          1. 2.6.1. Definition

          2. 2.6.2. Classification criteria

            1. 2.6.2.1. A flammable liquid shall be classified in one of the...

              1. Note:

          3. 2.6.3. Hazard Communication

          4. 2.6.4. Additional Classification Considerations

            1. 2.6.4.1. For the classification of flammable liquids data on flash point...

            2. 2.6.4.2. In the case of mixtures containing known flammable liquids in...

            3. 2.6.4.3. One suitable method is described in Gmehling and Rasmussen (Ind....

            4. 2.6.4.4. Possible test methods for determining the flash point of flammable...

            5. 2.6.4.5 Liquids with a flash point of more than 35 °C and...

            6. 2.6.4.6. Possible test methods for determining the initial boiling point of...

        7. 2.7. Flammable solids

          1. 2.7.1. Definition

            1. 2.7.1.1. A flammable solid means a solid which is readily combustible,...

          2. 2.7.2. Classification criteria

            1. 2.7.2.1. Powdered, granular or pasty substances or mixtures (except powders of...

            2. 2.7.2.2. Powders of metals or metal alloys shall be classified as...

            3. 2.7.2.3. A flammable solid shall be classified in one of the...

              1. Note 1:

              2. Note 2:

          3. 2.7.3. Hazard Communication

        8. 2.8. Self-reactive substances and mixtures

          1. 2.8.1. Definition

            1. 2.8.1.1. Self-reactive substances or mixtures are thermally unstable liquid or solid...

            2. 2.8.1.2. A self-reactive substance or mixture is regarded as possessing explosive...

          2. 2.8.2. Classification criteria

            1. 2.8.2.1. Any self-reactive substance or mixture shall be considered for classification...

            2. 2.8.2.2. Mixtures of oxidising substances, meeting the criteria for classification as...

            3. 2.8.2.3. Self-reactive substances and mixtures shall be classified in one of...

            4. 2.8.2.4. Criteria for temperature control

          3. 2.8.3. Hazard Communication

          4. 2.8.4. Additional Classification Considerations

            1. 2.8.4.1. The properties of self-reactive substances or mixtures which are decisive...

            2. 2.8.4.2. The classification procedures for self-reactive substances and mixtures need not...

        9. 2.9. Pyrophoric liquids

          1. 2.9.1. Definition

          2. 2.9.2. Classification criteria

            1. 2.9.2.1. A pyrophoric liquid shall be classified in a single category...

          3. 2.9.3. Hazard Communication

          4. 2.9.4. Additional Classification Considerations

            1. 2.9.4.1. The classification procedure for pyrophoric liquids need not be applied...

        10. 2.10. Pyrophoric solids

          1. 2.10.1. Definition

          2. 2.10.2. Classification criteria

            1. 2.10.2.1. A pyrophoric solid shall be classified in a single category...

              1. Note

          3. 2.10.3. Hazard Communication

          4. 2.10.4. Additional Classification Considerations

            1. 2.10.4.1. The classification procedure for pyrophoric solids need not be applied...

        11. 2.11. Self-heating substances and mixtures

          1. 2.11.1. Definition

            1. 2.11.1.1. A self-heating substance or mixture is a liquid or solid...

            2. 2.11.1.2. Self-heating of a substance or a mixture is a process...

          2. 2.11.2. Classification criteria

            1. 2.11.2.1. A substance or mixture shall be classified as a self-heating...

            2. 2.11.2.2. A self-heating substance or mixture shall be classified in one...

              1. Note

            3. 2.11.2.3. Substances and mixtures with a temperature of spontaneous combustion higher...

            4. 2.11.2.4. Substances and mixtures with a spontaneous ignition temperature higher than...

          3. 2.11.3. Hazard Communication

          4. 2.11.4. Additional Classification Considerations

            1. 2.11.4.1. For detailed schemes for the decision logic for classification and...

            2. 2.11.4.2. The classification procedure for self-heating substances or mixtures need not...

        12. 2.12. Substances and mixtures which in contact with water emit flammable...

          1. 2.12.1. Definition

          2. 2.12.2. Classification criteria

            1. 2.12.2.1. A substance or mixture which, in contact with water, emits...

              1. Note:

            2. 2.12.2.2. A substance or mixture shall be classified as a substance...

          3. 2.12.3. Hazard Communication

          4. 2.12.4. Additional Classification Considerations

            1. 2.12.4.1. The classification procedure for this class need not be applied...

        13. 2.13. Oxidising liquids

          1. 2.13.1. Definition

          2. 2.13.2. Classification criteria

            1. 2.13.2.1. An oxidising liquid shall be classified in one of the...

          3. 2.13.3. Hazard Communication

          4. 2.13.4. Additional Classification Considerations

            1. 2.13.4.1. For organic substances or mixtures the classification procedure for this...

            2. 2.13.4.2. For inorganic substances or mixtures the classification procedure for this...

            3. 2.13.4.3. In the event of divergence between test results and known...

            4. 2.13.4.4. In cases where substances or mixtures generate a pressure rise...

        14. 2.14. Oxidising solids

          1. 2.14.1. Definition

          2. 2.14.2. Classification criteria

            1. 2.14.2.1. An oxidising solid shall be classified in one of the...

              1. Note 1

              2. Note 2

          3. 2.14.3. Hazard Communication

          4. 2.14.4. Additional Classification Considerations

            1. 2.14.4.1. For organic substances or mixtures the classification procedure for this...

            2. 2.14.4.2. For inorganic substances or mixtures the classification procedure for this...

            3. 2.14.4.3. In the event of divergence between test results and known...

        15. 2.15. Organic peroxides

          1. 2.15.1. Definition

            1. 2.15.1.1. Organic peroxides means liquid or solid organic substances which contain...

            2. 2.15.1.2. An organic peroxide is regarded as possessing explosive properties when...

          2. 2.15.2. Classification criteria

            1. 2.15.2.1. Any organic peroxide shall be considered for classification in this...

              1. Note

            2. 2.15.2.2. Organic peroxides shall be classified in one of the seven...

            3. 2.15.2.3. Criteria for temperature control

          3. 2.15.3. Hazard Communication

          4. 2.15.4. Additional Classification Considerations

            1. 2.15.4.1. Organic peroxides are classified by definition based on their chemical...

            2. 2.15.4.2. Mixtures of already classified organic peroxides may be classified as...

        16. 2.16. Corrosive to metals

          1. 2.16.1. Definition

          2. 2.16.2. Classification criteria

            1. 2.16.2.1. A substance or a mixture which is corrosive to metals...

              1. Note

          3. 2.16.3. Hazard Communication

            1. Note:

          4. 2.16.4. Additional Classification Considerations

            1. 2.16.4.1. The corrosion rate can be measured according to the test...

        17. 2.17. Desensitised explosives

          1. 2.17.1. Definitions and general considerations

            1. 2.17.1.1. Desensitised explosives are solid or liquid explosive substances or mixtures...

            2. 2.17.1.2. The hazard class of desensitised explosives comprises:

          2. 2.17.2. Classification criteria

            1. 2.17.2.1. Any explosive while in a desensitised state shall be considered...

            2. 2.17.2.2. Desensitised explosives shall be classified and packaged for supply and...

          3. 2.17.3. Hazard communication

          4. 2.17.4. Additional classification considerations

            1. Figure 2.17.1. Desensitised explosives

            2. 2.17.4.1. The classification procedure for desensitised explosives does not apply if:...

            3. 2.17.4.2. The exothermic decomposition energy shall be determined using the explosive...

      4. 3. PART 3: HEALTH HAZARDS

        1. 3.1. Acute toxicity

          1. 3.1.1. Definitions

            1. 3.1.1.1. Acute toxicity means serious adverse health effects (i.e., lethality) occurring...

            2. 3.1.1.2. The hazard class Acute Toxicity is differentiated into:

          2. 3.1.2. Criteria for classification of substances as acutely toxic

            1. 3.1.2.1. Substances can be allocated to one of four hazard categories...

            2. 3.1.2.2. Specific considerations for classification of substances as acutely toxic

              1. 3.1.2.2.1. The preferred test species for evaluation of acute toxicity by...

            3. 3.1.2.3. Specific considerations for classification of substances as acutely toxic by...

              1. 3.1.2.3.1. Units for inhalation toxicity are a function of the form...

              2. 3.1.2.3.2. Of particular importance in classifying for inhalation toxicity is the...

              3. 3.1.2.3.3. In addition to classification for inhalation toxicity, if data are...

          3. 3.1.3. Criteria for classification of mixtures as acutely toxic

            1. 3.1.3.1. The criteria for classification of substances for acute toxicity as...

            2. 3.1.3.2. For acute toxicity each route of exposure shall be considered...

            3. 3.1.3.3. In order to make use of all available data for...

            4. 3.1.3.4. Classification of mixtures where acute toxicity data are available for...

              1. 3.1.3.4.1. Where the mixture itself has been tested to determine its...

            5. 3.1.3.5. Classification of mixtures where acute toxicity data are available for...

              1. 3.1.3.5.1. Where the mixture itself has not been tested to determine...

              2. 3.1.3.5.2. If a tested mixture is diluted with a diluent that...

            6. 3.1.3.6. Classification of mixtures based on ingredients of the mixture (Additivity...

              1. 3.1.3.6.1. Data available for all ingredients

              2. 3.1.3.6.2. Classification of mixtures when data are not available for all...

                1. 3.1.3.6.2.1. Where an ATE is not available for an individual ingredient...

                2. 3.1.3.6.2.2. In the event that a component without any useable information...

                3. 3.1.3.6.2.3. If the total concentration of the relevant ingredient(s) with unknown...

                4. Note 1

          4. 3.1.4. Hazard Communication

            1. 3.1.4.1. Label elements shall be used for substances or mixtures meeting...

              1. Note 1

              2. Note 2

            2. 3.1.4.2. The acute toxicity hazard statements differentiate the hazard based on...

        2. 3.2. Skin corrosion/irritation

          1. 3.2.1. Definitions and general considerations

            1. 3.2.1.1. Skin corrosion means the production of irreversible damage to the...

            2. 3.2.1.2. In a tiered approach, emphasis shall be placed upon existing...

          2. 3.2.2. Classification criteria for substances

            1. 3.2.2.1. Classification based on standard animal test data

              1. 3.2.2.1.1. Skin corrosion

                1. 3.2.2.1.1.1. A substance is corrosive to skin when it produces destruction...

                2. 3.2.2.1.1.2. Corrosive substances shall be classified in Category 1 where data...

                3. 3.2.2.1.1.3. When data are sufficient substances shall be classified in one...

                4. 3.2.2.1.1.4. Three sub-categories are provided within the corrosion category: sub-category 1A —...

                5. 3.2.2.1.1.5. The use of human data is discussed in Sections 3.2.1.2 and...

              2. 3.2.2.1.2. Skin irritation

                1. 3.2.2.1.2.1. A substance is irritant to skin when it produces reversible...

                2. 3.2.2.1.2.2. A single irritation category (Category 2) is presented in Table...

                3. 3.2.2.1.2.3. Reversibility of skin lesions is also considered in evaluating irritant...

                4. 3.2.2.1.2.4. Animal irritant responses within a test can be variable, as...

                5. 3.2.2.1.2.5. The use of human data is discussed in Sections 3.2.1.2...

            2. 3.2.2.2. Classification in a tiered approach

              1. 3.2.2.2.1. A tiered approach to the evaluation of initial information shall...

              2. 3.2.2.2.2. Existing human and animal data including information from single or...

              3. 3.2.2.2.3. Acute dermal toxicity data may be used for classification. If...

              4. 3.2.2.2.4. In vitro alternatives that have been validated and accepted shall...

              5. 3.2.2.2.5. Likewise, pH extremes like ≤ 2 and ≥ 11,5 may indicate the...

              6. 3.2.2.2.6. In some cases, sufficient information may be available from structurally...

              7. 3.2.2.2.7. The tiered approach provides guidance on how to organize existing...

          3. 3.2.3. Classification criteria for mixtures

            1. 3.2.3.1. Classification of mixtures when data are available for the complete...

              1. 3.2.3.1.1. The mixture shall be classified using the criteria for substances,...

              2. 3.2.3.1.2. When considering testing of the mixture, classifiers are encouraged to...

            2. 3.2.3.2. Classification of mixtures when data are not available for the...

              1. 3.2.3.2.1. Where the mixture itself has not been tested to determine...

            3. 3.2.3.3. Classification of mixtures when data are available for all ingredients...

              1. 3.2.3.3.1. In order to make use of all available data for...

              2. 3.2.3.3.2. In general, the approach to classification of mixtures as corrosive...

              3. 3.2.3.3.3. Table 3.2.3 provides the generic concentration limits to be used to...

              4. 3.2.3.3.4.1. Particular care must be taken when classifying certain types of...

              5. 3.2.3.3.4.2. For mixtures containing strong acids or bases the pH shall...

              6. 3.2.3.3.4.3. A mixture containing ingredients that are corrosive or irritant to...

              7. 3.2.3.3.5. On occasion, reliable data may show that the skin corrosion/irritation...

              8. 3.2.3.3.6. If there are data showing that (an) ingredient(s) is/are corrosive...

                1. Note:

          4. 3.2.4. Hazard Communication

            1. 3.2.4.1. Label elements shall be used for substances or mixtures meeting...

        3. 3.3. Serious eye damage/eye irritation

          1. 3.3.1. Definitions and general considerations

            1. 3.3.1.1. Serious eye damage means the production of tissue damage in...

            2. 3.3.1.2. In a tiered approach, emphasis shall be placed upon existing...

          2. 3.3.2. Classification criteria for substances

            1. 3.3.2.1. Classification based on standard animal test data

              1. 3.3.2.1.1. Serious eye damage (Category 1)

                1. 3.3.2.1.1.1. A single hazard category (Category 1) is adopted for substances...

                2. 3.3.2.1.1.2. The use of human data is discussed in Section 3.3.2.2 and...

              2. 3.3.2.1.2. Eye irritation (Category 2)

                1. 3.3.2.1.2.1. Substances that have the potential to induce reversible eye irritation...

                2. 3.3.2.1.2.2. For those substances where there is pronounced variability among animal...

                3. 3.3.2.1.2.3. The use of human data is addressed in Sections 3.3.2.2, and...

            2. 3.3.2.2. Classification in a tiered approach

              1. 3.3.2.2.1. A tiered approach to the evaluation of initial information shall...

              2. 3.3.2.2.2. Existing human and animal data shall be the first line...

              3. 3.3.2.2.3. In vitro alternatives that have been validated and accepted shall be...

              4. 3.3.2.2.4. Likewise, pH extremes like ≤ 2 and ≥ 11,5, may indicate serious...

              5. 3.3.2.2.5. In some cases sufficient information may be available from structurally...

              6. 3.3.2.2.6. The tiered approach provides guidance on how to organize existing...

          3. 3.3.3. Classification criteria for mixtures

            1. 3.3.3.1. Classification of mixtures when data are available for the complete...

              1. 3.3.3.1.1. The mixture shall be classified using the criteria for substances,...

              2. 3.3.3.1.2. When considering testing of the mixture classifiers are encouraged to...

            2. 3.3.3.2. Classification of mixtures when data are not available for the...

              1. 3.3.3.2.1. Where the mixture itself has not been tested to determine...

            3. 3.3.3.3. Classification of mixtures when data are available for all ingredients...

              1. 3.3.3.3.1. In order to make use of all available data for...

              2. 3.3.3.3.2. In general, the approach to classification of mixtures as seriously...

              3. 3.3.3.3.3. Table 3.3.3 provides the generic concentration limits to be used to...

              4. 3.3.3.3.4.1. Particular care must be taken when classifying certain types of...

              5. 3.3.3.3.4.2. For mixtures containing strong acids or bases the pH shall...

              6. 3.3.3.3.4.3. A mixture containing skin corrosive or serious eye damaging/eye irritating...

              7. 3.3.3.3.5. On occasion, reliable data may show that the effects of...

              8. 3.3.3.3.6. If there are data showing that (an) ingredient(s) may be...

          4. 3.3.4. Hazard Communication

            1. 3.3.4.1. Label elements shall be used for substances or mixtures meeting...

        4. 3.4. Respiratory or skin sensitisation

          1. 3.4.1. Definitions and general considerations

            1. 3.4.1.1. Respiratory sensitisation means hypersensitivity of the airways occurring after inhalation...

            2. 3.4.1.2. Skin sensitisation means an allergic response occurring after skin contact...

            3. 3.4.1.3. For the purpose of section 3.4, sensitisation includes two phases:...

            4. 3.4.1.4. For respiratory sensitisation, the pattern of induction followed by elicitation...

            5. 3.4.1.5. Usually, for both skin and respiratory sensitisation, lower levels are...

            6. 3.4.1.6. The hazard class Respiratory or Skin Sensitisation is differentiated into:...

          2. 3.4.2. Classification criteria for substances

            1. 3.4.2.1. Respiratory sensitisers

              1. 3.4.2.1.1. Hazard categories

                1. 3.4.2.1.1.1. Respiratory sensitisers shall be classified in Category 1 where data...

                2. 3.4.2.1.1.2. Where data are sufficient a refined evaluation according to 3.4.2.1.1.3...

                3. 3.4.2.1.1.3. Effects seen in either humans or animals will normally justify...

                4. 3.4.2.1.1.4. Substances shall be classified as respiratory sensitisers in accordance with...

              2. 3.4.2.1.2. Human evidence

                1. 3.4.2.1.2.1. Evidence that a substance can lead to specific respiratory hypersensitivity...

                2. 3.4.2.1.2.2. When considering the human evidence, it is necessary for a...

                3. 3.4.2.1.2.3. The evidence referred to above could be:

                4. 3.4.2.1.2.4. Clinical history shall include both medical and occupational history to...

                5. 3.4.2.1.2.5. The results of positive bronchial challenge tests are considered to...

              3. 3.4.2.1.3. Animal studies

                1. 3.4.2.1.3.1. Data from appropriate animal studies which may be indicative of...

            2. 3.4.2.2. Skin sensitisers

              1. 3.4.2.2.1. Hazard categories

                1. 3.4.2.2.1.1. Skin sensitisers shall be classified in Category 1 where data...

                2. 3.4.2.2.1.2. Where data are sufficient a refined evaluation according to section...

                3. 3.4.2.2.1.3. Effects seen in either humans or animals will normally justify...

                4. 3.4.2.2.1.4. Substances shall be classified as skin sensitisers in accordance with...

              2. 3.4.2.2.2. Human evidence

                1. 3.4.2.2.2.1. Human evidence for sub-category 1A can include:

                2. 3.4.2.2.2.2. Human evidence for sub-category 1B can include:

              3. 3.4.2.2.3. Animal studies

                1. 3.4.2.2.3.1. For Category 1, when an adjuvant type test method for...

                2. 3.4.2.2.3.2. Animal test results for sub-category 1A can include data with...

                3. 3.4.2.2.3.3. Animal test results for sub-category 1B can include data with...

              4. 3.4.2.2.4. Specific considerations

                1. 3.4.2.2.4.1. For classification of a substance, evidence should include any or...

                2. 3.4.2.2.4.2. Evidence from animal studies is usually much more reliable than...

                3. 3.4.2.2.4.3. If none of the abovementioned conditions are met, the substance...

                4. 3.4.2.2.4.4. Immunological contact urticaria

          3. 3.4.3. Classification criteria for mixtures

            1. 3.4.3.1. Classification of mixtures when data are available for the complete...

              1. 3.4.3.1.1. When reliable and good quality evidence from human experience or...

            2. 3.4.3.2. Classification of mixtures when data are not available for the...

              1. 3.4.3.2.1. Where the mixture itself has not been tested to determine...

            3. 3.4.3.3. Classification of mixtures when data are available for all ingredients...

              1. 3.4.3.3.1. The mixture shall be classified as a respiratory or skin...

              2. 3.4.3.3.2. Some substances that are classified as sensitisers may elicit a...

              3. Note 1:

          4. 3.4.4. Hazard communication

            1. 3.4.4.1. Label elements shall be used for substances or mixtures meeting...

        5. 3.5. Germ cell mutagenicity

          1. 3.5.1. Definitions and general considerations

            1. 3.5.1.1. Germ cell mutagenicity means heritable gene mutations, including heritable structural...

            2. 3.5.1.2. A mutation means a permanent change in the amount or...

            3. 3.5.1.3. The more general terms ‘ genotoxic ’ and ‘ genotoxicity...

          2. 3.5.2. Classification criteria for substances

            1. 3.5.2.1. This hazard class is primarily concerned with substances that may...

            2. 3.5.2.2. For the purpose of classification for germ cell mutagenicity, substances...

            3. 3.5.2.3. Specific considerations for classification of substances as germ cell mutagens...

              1. 3.5.2.3.1. To arrive at a classification, test results are considered from...

              2. 3.5.2.3.2. The system is hazard based, classifying substances on the basis...

              3. 3.5.2.3.3. Classification for heritable effects in human germ cells is made...

              4. 3.5.2.3.4. In vivo heritable germ cell mutagenicity tests, such as:

              5. 3.5.2.3.5. In vivo somatic cell mutagenicity tests, such as:

              6. 3.5.2.3.6. Mutagenicity/genotoxicity tests in germ cells, such as:

              7. 3.5.2.3.7. Genotoxicity tests in somatic cells such as:

              8. 3.5.2.3.8. In vitro mutagenicity tests such as:

              9. 3.5.2.3.9. The classification of individual substances shall be based on the...

          3. 3.5.3. Classification criteria for mixtures

            1. 3.5.3.1. Classification of mixtures when data are available for all ingredients...

              1. 3.5.3.1.1. The mixture shall be classified as a mutagen when at...

                1. Note

            2. 3.5.3.2. Classification of mixtures when data are available for the complete...

              1. 3.5.3.2.1. Classification of mixtures will be based on the available test...

            3. 3.5.3.3. Classification of mixtures when data are not available for the...

              1. 3.5.3.3.1. Where the mixture itself has not been tested to determine...

          4. 3.5.4. Hazard communication

            1. 3.5.4.1. Label elements shall be used in accordance with Table 3.5.3,...

          5. 3.5.5. Additional classification considerations

        6. 3.6. Carcinogenicity

          1. 3.6.1. Definition

            1. 3.6.1.1. Carcinogenicity means the induction of cancer or an increase in...

          2. 3.6.2. Classification criteria for substances

            1. 3.6.2.1. For the purpose of classification for carcinogenicity, substances are allocated...

            2. 3.6.2.2. Specific considerations for classification of substances as carcinogens

              1. 3.6.2.2.1. Classification as a carcinogen is made on the basis of...

              2. 3.6.2.2.2. Classification of a substance as a carcinogen is a process...

              3. 3.6.2.2.3. Strength of evidence involves the enumeration of tumours in human...

              4. 3.6.2.2.4. Additional considerations (as part of the weight of evidence approach...

              5. 3.6.2.2.5. The factors can be viewed as either increasing or decreasing...

              6. 3.6.2.2.6. Some important factors which may be taken into consideration, when...

              7. 3.6.2.2.7. A substance that has not been tested for carcinogenicity may...

              8. 3.6.2.2.8. The classification shall take into consideration whether or not the...

              9. 3.6.2.2.9. It is important that whatever is known of the physico-chemical,...

          3. 3.6.3. Classification criteria for mixtures

            1. 3.6.3.1. Classification of mixtures when data are available for all ingredients...

              1. 3.6.3.1.1. The mixture will be classified as a carcinogen when at...

                1. Note

                2. Note 1

            2. 3.6.3.2. Classification of mixtures when data are available for the complete...

              1. 3.6.3.2.1. Classification of mixtures will be based on the available test...

            3. 3.6.3.3. Classification of mixtures when data are not available for the...

              1. 3.6.3.3.1. Where the mixture itself has not been tested to determine...

          4. 3.6.4. Hazard Communication

            1. 3.6.4.1. Label elements shall be used in accordance with Table 3.6.3,...

        7. 3.7. Reproductive toxicity

          1. 3.7.1. Definitions and general considerations

            1. 3.7.1.1. Reproductive toxicity means adverse effects on sexual function and fertility...

            2. 3.7.1.2. For the purpose of classification the hazard class Reproductive Toxicity...

            3. 3.7.1.3. Adverse effects on sexual function and fertility

            4. 3.7.1.4. Adverse effects on development of the offspring

            5. 3.7.1.5. Adverse effects on or via lactation are also included in...

          2. 3.7.2. Classification criteria for substances

            1. 3.7.2.1. Hazard categories

              1. 3.7.2.1.1. For the purpose of classification for reproductive toxicity, substances are...

            2. 3.7.2.2. Basis of classification

              1. 3.7.2.2.1. Classification is made on the basis of the appropriate criteria,...

              2. 3.7.2.2.2. In the evaluation of toxic effects on the developing offspring,...

              3. 3.7.2.2.3. For human evidence to provide the primary basis for a...

            3. 3.7.2.3. Weight of evidence

              1. 3.7.2.3.1. Classification as a reproductive toxicant is made on the basis...

              2. 3.7.2.3.2. Toxicokinetic studies in animals and humans, site of action and...

              3. 3.7.2.3.3. If, in some reproductive toxicity studies in experimental animals the...

              4. 3.7.2.3.4. Data from animal studies ideally shall provide clear evidence of...

              5. 3.7.2.3.5. If appropriate information is available it is important to try...

            4. 3.7.2.4. Maternal toxicity

              1. 3.7.2.4.1. Development of the offspring throughout gestation and during the early...

              2. 3.7.2.4.2. Based on pragmatic observation, maternal toxicity may, depending on severity,...

              3. 3.7.2.4.3. Classification shall not automatically be discounted for substances that produce...

              4. 3.7.2.4.4. Some of the end points used to assess maternal effects...

            5. 3.7.2.5. Animal and experimental data

              1. 3.7.2.5.1. A number of internationally accepted test methods are available; these...

              2. 3.7.2.5.2. Results obtained from Screening Tests (e.g. OECD Guidelines 421 —...

              3. 3.7.2.5.3. Adverse effects or changes, seen in short- or long-term repeated...

              4. 3.7.2.5.4. Evidence from in vitro assays, or non-mammalian tests, and from...

              5. 3.7.2.5.5. It is preferable that animal studies are conducted using appropriate...

              6. 3.7.2.5.6. Studies involving routes of administration such as intravenous or intraperitoneal...

              7. 3.7.2.5.7. There is general agreement about the concept of a limit...

              8. 3.7.2.5.8. In principle, adverse effects on reproduction seen only at very...

              9. 3.7.2.5.9. However, specification of the actual ‘limit dose’ will depend upon...

          3. 3.7.3. Classification criteria for mixtures

            1. 3.7.3.1. Classification of mixtures when data are available for all ingredients...

              1. 3.7.3.1.1. The mixture shall be classified as a reproductive toxicant when...

              2. 3.7.3.1.2. The mixture shall be classified for effects on or via...

            2. 3.7.3.2. Classification of mixtures when data are available for the complete...

              1. 3.7.3.2.1. Classification of mixtures will be based on the available test...

            3. 3.7.3.3. Classification of mixtures when data are not available for the...

              1. 3.7.3.3.1. Subject to paragraph 3.7.3.2.1, where the mixture itself has not...

          4. 3.7.4. Hazard Communication

            1. 3.7.4.1. Label elements shall be used for substances or mixtures meeting...

        8. 3.8. Specific target organ toxicity — single exposure

          1. 3.8.1. Definitions and general considerations

            1. 3.8.1.1. Specific target organ toxicity – single exposure means specific, non-lethal...

            2. 3.8.1.2. Classification identifies the substance or mixture as being a specific...

            3. 3.8.1.3. These adverse health effects produced by a single exposure include...

            4. 3.8.1.4. Assessment shall take into consideration not only significant changes in...

            5. 3.8.1.5. Specific target organ toxicity can occur by any route that...

            6. 3.8.1.6. Specific target organ toxicity following a repeated exposure is classified...

            7. 3.8.1.7. The hazard class Specific Target Organ Toxicity — Single Exposure...

          2. 3.8.2. Classification criteria for substances

            1. 3.8.2.1. Substances of Category 1 and Category 2

              1. 3.8.2.1.1. Substances are classified for immediate or delayed effects separately, by...

              2. 3.8.2.1.2. The relevant route or routes of exposure by which the...

              3. 3.8.2.1.3. Classification is determined by expert judgement (see section 1.1.1), on...

              4. 3.8.2.1.4. Weight of evidence of all data (see section 1.1.1), including...

              5. 3.8.2.1.5. The information required to evaluate specific target organ toxicity comes...

              6. 3.8.2.1.6. In exceptional cases, based on expert judgement, it is appropriate...

              7. 3.8.2.1.7. Effects considered to support classification for Category 1 and 2...

                1. 3.8.2.1.7.1. Classification is supported by evidence associating single exposure to the...

                2. 3.8.2.1.7.2. Evidence from human experience/incidents is usually restricted to reports of...

                3. 3.8.2.1.7.3. Evidence from appropriate studies in experimental animals can furnish much...

              8. 3.8.2.1.8. Effects considered not to support classification for Category 1 and...

              9. 3.8.2.1.9. Guidance values to assist with classification based on the results...

                1. 3.8.2.1.9.1. In order to help reach a decision about whether a...

                2. 3.8.2.1.9.2. Thus, in animal studies, when significant toxic effects are observed...

                3. 3.8.2.1.9.3. The guidance value (C) ranges for single-dose exposure which has...

                  1. Note

              10. 3.8.2.1.10. Other considerations

                1. 3.8.2.1.10.1. When a substance is characterised only by use of animal...

                2. 3.8.2.1.10.2. When well-substantiated human data are available showing a specific target...

                3. 3.8.2.1.10.3. A substance that has not been tested for specific target...

                4. 3.8.2.1.10.4. Saturated vapour concentration shall be considered, where appropriate, as an...

            2. 3.8.2.2. Substances of Category 3: Transient target organ effects

              1. 3.8.2.2.1. Criteria for respiratory tract irritation

              2. 3.8.2.2.2 Criteria for narcotic effects

          3. 3.8.3. Classification criteria for mixtures

            1. 3.8.3.1. Mixtures are classified using the same criteria as for substances,...

            2. 3.8.3.2. Classification of mixtures when data are available for the complete...

              1. 3.8.3.2.1. When reliable and good quality evidence from human experience or...

            3. 3.8.3.3. Classification of mixtures when data are not available for the...

              1. 3.8.3.3.1. Where the mixture itself has not been tested to determine...

            4. 3.8.3.4. Classification of mixtures when data are available for all components...

              1. 3.8.3.4.1. Where there is no reliable evidence or test data for...

              2. 3.8.3.4.2. These generic concentration limits and consequent classifications shall be applied...

              3. 3.8.3.4.3. Mixtures shall be classified for either or both single- and...

                1. Note 1

              4. 3.8.3.4.4. Care shall be exercised when toxicants affecting more than one...

              5. 3.8.3.4.5. Care shall be exercised when extrapolating toxicity of a mixture...

              6. 3.8.3.4.6. In cases where the additivity approach is used for Category...

          4. 3.8.4. Hazard Communication

            1. 3.8.4.1 Label elements shall be used in accordance with Table 3.8.4.,...

        9. 3.9. Specific target organ toxicity — repeated exposure

          1. 3.9.1. Definitions and general considerations

            1. 3.9.1.1. Specific target organ toxicity-repeated exposure means specific toxic effects on...

            2. 3.9.1.2. Classification for target organ toxicity (repeated exposure) identifies the substance...

            3. 3.9.1.3. These adverse health effects include consistent and identifiable toxic effects...

            4. 3.9.1.4. Assessment shall take into consideration not only significant changes in...

            5. 3.9.1.5. Specific target organ toxicity can occur by any route that...

            6. 3.9.1.6. Non-lethal toxic effects observed after a single-event exposure are classified...

          2. 3.9.2. Classification criteria for substances

            1. 3.9.2.1. Substances are classified as specific target organ toxicants following repeated...

              1. Note

            2. 3.9.2.2. The relevant route or routes of exposure by which the...

            3. 3.9.2.3. Classification is determined by expert judgement (see section 1.1.1), on...

            4. 3.9.2.4. Weight of evidence of all data (see section 1.1.1), including...

            5. 3.9.2.5. The information required to evaluate specific target organ toxicity comes...

            6. 3.9.2.6. In exceptional cases, based on expert judgement, it is appropriate...

            7. 3.9.2.7. Effects considered to support classification for specific target organ toxicity...

              1. 3.9.2.7.1. Reliable evidence associating repeated exposure to the substance with a...

              2. 3.9.2.7.2. Evidence from human experience/incidents is usually restricted to reports of...

              3. 3.9.2.7.3. Evidence from appropriate studies in experimental animals can furnish much...

            8. 3.9.2.8. Effects considered not to support classification for specific target organ...

              1. 3.9.2.8.1. It is recognised that effects may be seen in humans...

            9. 3.9.2.9. Guidance values to assist with classification based on the results...

              1. 3.9.2.9.1. In studies conducted in experimental animals, reliance on observation of...

              2. 3.9.2.9.2. In order to help reach a decision about whether a...

              3. 3.9.2.9.3. Thus, in animal studies, when significant toxic effects are observed...

              4. 3.9.2.9.4. The decision to classify at all can be influenced by...

              5. 3.9.2.9.5. The guidance values refer to effects seen in a standard...

              6. 3.9.2.9.6. Thus classification in Category 1 is applicable, when significant toxic...

              7. 3.9.2.9.7. Classification in Category 2 is applicable, when significant toxic effects...

              8. 3.9.2.9.8. The guidance values and ranges mentioned in paragraphs 3.9.2.9.6 and...

              9. 3.9.2.9.9. Thus it is feasible that a specific profile of toxicity...

            10. 3.9.2.10. Other considerations

              1. 3.9.2.10.1. When a substance is characterised only by use of animal...

              2. 3.9.2.10.2. When well-substantiated human data are available showing a specific target...

              3. 3.9.2.10.3. A substance that has not been tested for specific target...

              4. 3.9.2.10.4. Saturated vapour concentration shall be considered, where appropriate, as an...

          3. 3.9.3. Classification criteria for mixtures

            1. 3.9.3.1. Mixtures are classified using the same criteria as for substances,...

            2. 3.9.3.2. Classification of mixtures when data are available for the complete...

              1. 3.9.3.2.1. When reliable and good quality evidence from human experience or...

            3. 3.9.3.3. Classification of mixtures when data are not available for the...

              1. 3.9.3.3.1. Where the mixture itself has not been tested to determine...

            4. 3.9.3.4. Classification of mixtures when data are available for all components...

              1. 3.9.3.4.1. Where there is no reliable evidence or test data for...

                1. Note 1

              2. 3.9.3.4.2. These generic concentration limits and consequent classifications apply to repeated-dose...

              3. 3.9.3.4.3. Mixtures shall be classified for either or both single- and...

              4. 3.9.3.4.4. Care shall be exercised when toxicants affecting more than one...

          4. 3.9.4. Hazard Communication

            1. 3.9.4.1. Label elements shall be used in accordance with Table 3.9.5...

        10. 3.10. Aspiration hazard

          1. 3.10.1. Definitions and general considerations

            1. 3.10.1.1. These criteria provide a means of classifying substances or mixtures...

            2. 3.10.1.2. ‘Aspiration’ means the entry of a liquid or solid substance...

            3. 3.10.1.3. Aspiration hazard means severe acute effects such as chemical pneumonia,...

            4. 3.10.1.4. Aspiration is initiated at the moment of inspiration, in the...

            5. 3.10.1.5. Aspiration of a substance or mixture can occur as it...

            6. 3.10.1.6. Specific considerations

              1. 3.10.1.6.1. A review of the medical literature on chemical aspiration revealed...

              2. 3.10.1.6.2. The classification criteria refer to kinematic viscosity. The following provides...

              3. 3.10.1.6.2a Although the definition of aspiration in section 3.10.1.2 includes the...

              4. 3.10.1.6.3. Classification of aerosol/mist products

          2. 3.10.2. Classification criteria for substances

            1. Note:

          3. 3.10.3. Classification criteria for mixtures

            1. 3.10.3.1. Classification when data are available for the complete mixture

            2. 3.10.3.2. Classification when data are not available for the complete mixture:...

              1. 3.10.3.2.1. Where the mixture itself has not been tested to determine...

            3. 3.10.3.3. Classification when data are available for all components or only...

              1. 3.10.3.3.1. Category 1

                1. 3.10.3.3.1.1. The ‘ relevant ingredients ’ of a mixture are those...

                2. 3.10.3.3.1.2. A mixture is classified as Category 1 when the sum...

                3. 3.10.3.3.1.3. In the case of a mixture which separates into two...

          4. 3.10.4. Hazard Communication

            1. 3.10.4.1. Label elements shall be used for substances or mixtures meeting...

      5. 4. PART 4: ENVIRONMENTAL HAZARDS

        1. 4.1. Hazardous to the aquatic environment

          1. 4.1.1. Definitions and general considerations

            1. 4.1.1.1. Definitions

            2. 4.1.1.2. Basic elements

              1. 4.1.1.2.0. Hazardous to the aquatic environment is differentiated into:

              2. 4.1.1.2.1. The basic elements used for classification for aquatic environmental hazards...

              3. 4.1.1.2.2. Preferably data shall be derived using the standardised test methods...

            3. 4.1.1.3. Other considerations

              1. 4.1.1.3.1. Classification of substances and mixtures for environmental hazards requires the...

              2. 4.1.1.3.2. While the classification system applies to all substances and mixtures,...

          2. 4.1.2. Classification criteria for substances

            1. 4.1.2.1. The system for classification recognises that the intrinsic hazard to...

            2. 4.1.2.2. The core classification system for substances consists of one short-term...

            3. 4.1.2.3. The criteria for classification of a substance in Acute 1...

            4. 4.1.2.4. The system also introduces a ‘ safety net ’ classification...

            5. 4.1.2.5. Substances with acute toxicities below 1 mg/l or chronic toxicities below...

            6. 4.1.2.6. The criteria for classifying and categorising substances as ‘ hazardous...

              1. Note 1:

              2. Note 2:

              3. Note 3:

              4. Note 4:

            7. 4.1.2.7. Aquatic toxicity

              1. 4.1.2.7.1. Acute aquatic toxicity is normally determined using a fish 96-hour...

              2. 4.1.2.7.2. For determining chronic aquatic toxicity for classification purposes data generated...

            8. 4.1.2.8. Bioaccumulation

              1. 4.1.2.8.1. Bioaccumulation of substances within aquatic organisms can give rise to...

            9. 4.1.2.9. Rapid degradability of organic substances

              1. 4.1.2.9.1. Substances that rapidly degrade can be quickly removed from the...

              2. 4.1.2.9.2. One way of demonstrating rapid degradation utilises the biodegradation screening...

              3. 4.1.2.9.3. Many degradation data are available in the form of degradation...

              4. 4.1.2.9.4. The criteria used reflect the fact that environmental degradation may...

              5. 4.1.2.9.5. Substances are considered rapidly degradable in the environment if one...

            10. 4.1.2.10. Inorganic compounds and metals

              1. 4.1.2.10.1. For inorganic compounds and metals, the concept of degradability as...

              2. 4.1.2.10.2. Poorly soluble inorganic compounds and metals may be acutely or...

          3. 4.1.3. Classification criteria for mixtures

            1. 4.1.3.1. The classification system for mixtures covers all classification categories which...

            2. 4.1.3.2. The approach for classification of aquatic environmental hazards is tiered,...

              2. Figure 4.1.2 Tiered approach to classification of mixtures for short-term (acute) and...

            3. 4.1.3.3. Classification of mixtures when toxicity data are available for the...

              1. 4.1.3.3.1. When the mixture as a whole has been tested to...

              2. 4.1.3.3.2. The long-term (chronic) hazard classification of mixtures requires additional information...

              3. 4.1.3.3.3. Classification for category Acute 1

              4. 4.1.3.3.4. Classification for categories Chronic 1, 2 and 3

              5. 4.1.3.3.5. Classification for category Chronic 4

            4. 4.1.3.4. Classification of mixtures when toxicity data are not available for...

              1. 4.1.3.4.1. Where the mixture itself has not been tested to determine...

              2. 4.1.3.4.2. Dilution: if a mixture is formed by diluting another tested...

              3. 4.1.3.4.3. If a mixture is formed by diluting another tested mixture...

            5. 4.1.3.5. Classification of mixtures when toxicity data are available for some...

              1. 4.1.3.5.1. The classification of a mixture is based on summation of...

              2. 4.1.3.5.2. Mixtures can be made of a combination of both components...

              3. 4.1.3.5.3. When applying the additivity formula for part of the mixture,...

              4. 4.1.3.5.4. If a mixture is classified in more than one way,...

              5. 4.1.3.5.5. Summation method

                1. 4.1.3.5.5.1. Rationale

                  1. 4.1.3.5.5.1.1. In case of the substance classification categories Chronic 1 to...

                  2. 4.1.3.5.5.1.2. When a mixture contains components classified as Acute 1 or...

                2. 4.1.3.5.5.2. Classification procedure

                  1. 4.1.3.5.5.2.1. In general a more severe classification for mixtures overrides a...

                3. 4.1.3.5.5.3. Classification for category Acute 1

                  1. 4.1.3.5.5.3.1. First, all components classified as Acute 1 are considered. If...

                  2. 4.1.3.5.5.3.2. The classification of mixtures for short-term (acute) hazards based on...

                4. 4.1.3.5.5.4. Classification for the categories Chronic 1, 2, 3 and 4...

                  1. 4.1.3.5.5.4.1. First all components classified as Chronic 1 are considered. If...

                  2. 4.1.3.5.5.4.2. In cases where the mixture is not classified as Chronic...

                  3. 4.1.3.5.5.4.3. In cases where the mixture is not classified either as...

                  4. 4.1.3.5.5.4.4. If the mixture is still not classified in Chronic 1,...

                  5. 4.1.3.5.5.4.5. The classification of mixtures for long-term (chronic) hazards, based on...

                5. 4.1.3.5.5.5. Mixtures with highly toxic components

                  1. 4.1.3.5.5.5.1. Acute 1 and Chronic 1 components with toxicities below 1 mg/l...

            6. 4.1.3.6. Classification of mixtures with components without any useable information

              1. 4.1.3.6.1. In the event that no useable information on short-term (acute)...

          4. 4.1.4. Hazard communication

            1. 4.1.4.1. Label elements shall be used for substances or mixtures meeting...

      6. 5. PART 5: ADDITIONAL HAZARDS

        1. 5.1. Hazardous to the ozone layer

          1. 5.1.1. Definitions and general considerations

            1. 5.1.1.1. Ozone depleting potential (ODP) is an integrative quantity, distinct for...

          2. 5.1.2. Classification criteria for substances

            1. 5.1.2.1. A substance shall be classified as hazardous to the ozone...

          3. 5.1.3. Classification criteria for mixtures

            1. 5.1.3.1. Mixtures shall be classified as hazardous to the ozone layer...

          4. 5.1.4. Hazard communication

            1. 5.1.4.1. Label elements shall be used for substances or mixtures meeting...

    2. ANNEX II

      SPECIAL RULES FOR LABELLING AND PACKAGING OF CERTAIN SUBSTANCES AND MIXTURES

      1. This Annex consists of 5 parts:

      2. Part 1 contains special rules for the labelling of certain...

      3. 1. PART 1: SUPPLEMENTAL HAZARD INFORMATION

        1. 1.1. Physical properties

          1. 1.1.1. EUH001 — ‘Explosive when dry’

          2. 1.1.2. EUH006 — ‘Explosive with or without contact with air’

          3. 1.1.1. EUH014 — ‘Reacts violently with water’

          4. 1.1.2. EUH018 — ‘In use, may form flammable/explosive vapour-air mixture’

          5. 1.1.3. EUH019 — ‘May form explosive peroxides’

          6. 1.1.4. EUH044 — ‘Risk of explosion if heated under confinement’

        2. 1.2. Health properties

          1. 1.2.1. EUH029 — ‘Contact with water liberates toxic gas’

          2. 1.2.2. EUH031 — ‘Contact with acids liberates toxic gas’

          3. 1.2.3. EUH032 — ‘Contact with acids liberates very toxic gas’

          4. 1.2.4. EUH066 — ‘Repeated exposure may cause skin dryness or cracking’...

          5. 1.2.5. EUH070 — ‘Toxic by eye contact’

          6. 1.2.6. EUH071 — ‘Corrosive to the respiratory tract’

      4. 2. PART 2: SPECIAL RULES FOR SUPPLEMENTAL LABEL ELEMENTS FOR CERTAIN...

        1. 2.1. Mixtures containing lead

        2. 2.2. Mixtures containing cyanoacrylates

        3. 2.3. Cements and cement mixtures

        4. 2.4. Mixtures containing isocyanates

        5. 2.5. Mixtures containing epoxy constituents with an average molecular weight ≤...

        6. 2.6. Mixtures sold to the general public which contain active chlorine...

        7. 2.7. Mixtures containing cadmium (alloys) and intended to be used for...

        8. 2.8. Mixtures containing at least one sensitising substance

        9. 2.9. Liquid mixtures containing halogenated hydrocarbons

        10. 2.10. Mixtures not intended for the general public

        11. 2.11 Aerosols

      5. 3. PART 3: SPECIAL RULES ON PACKAGING

        1. 3.1. Provisions relating to child-resistant fastenings

          1. 3.1.1. Packaging to be fitted with child-resistant fastenings

            1. 3.1.1.1. Packaging of whatever capacity containing a substance or mixture supplied...

            2. 3.1.1.2. Packaging of whatever capacity containing a substance or mixture supplied...

            3. 3.1.1.3 Where a substances or mixture has at least one of...

          2. 3.1.2 Reclosable packages

          3. 3.1.3 Non-reclosable packages

          4. 3.1.4 Notes

            1. 3.1.4.1. Evidence of conformity with the above standards may be certified...

            2. 3.1.4.2. Specific cases

        2. 3.2 Tactile Warnings

          1. 3.2.1. Packaging to be fitted with a tactile warning

            1. 3.2.1.1. Where substances or mixtures are supplied to the general public...

            2. 3.2.1.2. Section 3.2.1.1 does not apply to transportable gas receptacles. Aerosols...

          2. 3.2.2. Provisions relating to tactile warning

        3. 3.3 Liquid consumer laundry detergents in soluble packaging for single use...

      6. 4. PART 4: SPECIAL RULE FOR LABELLING OF PLANT PROTECTION PRODUCTS...

      7. 5. PART 5: LIST OF HAZARDOUS SUBSTANCES AND MIXTURES TO WHICH...

    3. ANNEX III

      LIST OF HAZARD STATEMENTS, SUPPLEMENTAL HAZARD INFORMATION AND SUPPLEMENTAL LABEL ELEMENTS

      1. 1. Part 1: hazard statements

      2. 2. Part 2: supplemental hazard information

      3. 3. Part 3: supplemental label elements/information on certain certain substances and...

    4. ANNEX IV

      LIST OF PRECAUTIONARY STATEMENTS

      1. This Annex sets out a matrix listing the recommended precautionary...

      2. To provide flexibility in the application of precautionary phrases, combinations...

      3. Notwithstanding Article 22 the precautionary statements that appear on labels...

      4. Where square brackets […] appear around some text in a...

      5. When a forward slash or diagonal mark [/] appears in...

      6. When three full stops […] appear in a precautionary statement...

      7. Where the text in column 5 indicates that a precautionary...

      8. 1. Part 1: Criteria for the selection of precautionary statements

      9. 2. Part 2: precautionary statements

    5. ANNEX V

      HAZARD PICTOGRAMS

      1. INTRODUCTION

        1. 1. PART 1: PHYSICAL HAZARDS

          1. 1.1. Symbol: exploding bomb

          2. 1.2. Symbol: flame

          3. 1.3. Symbol: flame over circle

          4. 1.4. Symbol: gas cylinder

          5. 1.5. Symbol: corrosion

          6. 1.6. A pictogram is not required for the following physical hazard...

        2. 2. PART 2: HEALTH HAZARDS

          1. 2.1. Symbol: skull and crossbones

          2. 2.2. Symbol: corrosion

          3. 2.3. Symbol: exclamation mark

          4. 2.4. Symbol: health hazard

          5. 2.5. A pictogram is not required for the following health hazard...

        3. 3. PART 3: ENVIRONMENTAL HAZARDS

          1. 3.1. Symbol: environment

        4. 4. PART 4: ADDITIONAL HAZARDS

          1. 4.1. Symbol: exclamation mark

    6. ANNEX VI

      Mandatory classification and labelling for certain hazardous substances

      1. Part 1 of this Annex provides an introduction to the...

      2. Part 2 of this Annex lays down general principles for...

      3. ...

      4. 1. PART 1: INTRODUCTION TO THE LIST OF MANDATORY CLASSIFICATIONS AND...

        1. 1.1. Information listed for each entry

          1. 1.1.1. Numbering of entries and identification of a substance

            1. 1.1.1.1. Index numbers

            2. 1.1.1.2. EC numbers

            3. 1.1.1.3. CAS number

            4. 1.1.1.4. Chemical name

            5. 1.1.1.5. Entries for groups of substances

          2. 1.1.2. Information related to the classification and labelling of each entry...

            1. 1.1.2.1. Classification codes

              1. 1.1.2.1.1. Hazard class and category codes

              2. 1.1.2.1.2. Hazard statement codes

            2. 1.1.2.2. Labelling codes

            3. 1.1.2.3. Specific concentration limits, M-factors and Acute Toxicity Estimates (ATE)

          3. 1.1.3. Notes assigned to an entry

            1. 1.1.3.1. Notes relating to the identification, classification and labelling of substances...

              1. Note A:

              2. Note B:

              3. Note C:

              4. Note D:

              5. Note E (Table 3.2):

              6. Note F:

              7. Note G:

              8. Note H (Table 3.1):

              9. Note H (Table 3.2):

              10. Note J:

              11. Note K:

              12. Note L:

              13. Note M:

              14. Note N:

              15. Note P:

              16. Note Q:

              17. Note R:

              18. Note S:

              19. Note T:

              20. Note U (Table 3):

            2. 1.1.3.2. Notes relating to the classification and labelling of mixtures

              1. Note 1:

              2. Note 2:

              3. Note 3:

              4. Note 5:

              5. Note 7:

              6. Note 8:

              7. Note 9:

          4. 1.1.4. Information related to the classification and labelling of each entry...

            1. 1.1.4.1. Classification codes

            2. 1.1.4.2. Labelling codes

            3. 1.1.4.3. Specific Concentration Limits

            4. 1.1.4.4. Non-conformity with Table 3.1 for physical hazards

        2. 1.2. Classifications and hazard statements in Table 3 arising from translation...

          1. 1.2.1. Minimum classification

          2. 1.2.2. Route of exposure cannot be excluded

          3. 1.2.3. Hazard statements for reproductive toxicity

          4. 1.2.4. Correct classification for physical hazards could not be established

      5. 2. PART 2: DOSSIERS FOR HARMONISED CLASSIFICATION AND LABELLING

      6. 3. PART 3: HARMONISED CLASSIFICATION AND LABELLING TABLE

    7. ANNEX VII

      Translation table from classification under Directive 67/548/EEC to classification under this Regulation

      1. This Annex includes a table to assist translation of a...

      2. 1. Translation table

    8. ANNEX VIII

      HARMONISED INFORMATION RELATING TO EMERGENCY HEALTH RESPONSE AND PREVENTATIVE MEASURES

      1. PART A GENERAL REQUIREMENTS

        1. 1. APPLICATION

          1. 1.1. Importers and downstream users placing on the market mixtures for...

          2. 1.2. Importers and downstream users placing on the market mixtures for...

          3. 1.3. Importers and downstream users placing on the market mixtures for...

          4. 1.4. Importers and downstream users having submitted information relating to hazardous...

          5. 1.5. By way of derogation from Section 1.4, if one of...

        2. 2. PURPOSE, SCOPE AND DEFINITIONS

          1. 2.1. This Annex sets out the requirements that importers and downstream...

          2. 2.2. This Annex shall not apply to mixtures for scientific research...

          3. 2.2a. In the case of bespoke paints, submitters may, without prejudice...

          4. 2.3. In the case of mixtures with an end use not...

          5. 2.4. For the purposes of this Annex, the following definitions shall...

        3. 3. SUBMISSION REQUIREMENTS

          1. 3.1. Before placing mixtures on the market, submitters shall provide information...

          2. 3.2. Where following receipt of a submission under Section 3.1 an...

          3. 3.3. The submission shall be in the official language(s) of the...

          4. 3.4. The intended use of the mixture shall be described in...

          5. 3.5. A submission update shall be made without undue delay when...

        4. 4. GROUP SUBMISSION

          1. 4.1. A single submission may be provided for more than one...

          2. 4.2. A group submission shall only be permitted when all mixtures...

          3. 4.3. By way of derogation from Section 4.2, a group submission...

          4. 4.4. In the case of a group submission, the information required...

        5. 5. UNIQUE FORMULA IDENTIFIER (UFI)

          1. 5.1. The submitter shall create a Unique Formula Identifier (‘UFI’) by...

          2. 5.2. The UFI shall be preceded by the acronym ‘ UFI...

          3. 5.3. Instead of including the UFI in the supplemental information on...

        6. 6. FORMATS AND TECHNICAL SUPPORT FOR SUBMISSION OF INFORMATION

          1. 6.1. The Agency shall specify, maintain and update the UFI generator,...

          2. 6.2. The Agency shall provide technical and scientific guidance, technical support...

      2. PART B INFORMATION CONTAINED IN A SUBMISSION

        1. 1. IDENTIFICATION OF THE MIXTURE AND OF THE SUBMITTER

          1. 1.1. Product identifier of the mixture

          2. 1.2. Details of the submitter and contact point

          3. 1.3. Name, telephone number and email address for rapid access to...

        2. 2. HAZARDS IDENTIFICATION AND ADDITIONAL INFORMATION

        3. 3. INFORMATION ON MIXTURE COMPONENTS

          1. 3.1. General requirements

          2. 3.2. Identification of mixture components

            1. 3.2.1. Substances

            2. 3.2.2. Mixture in mixture

            3. 3.2.3. Identification by generic component identifiers

          3. 3.3. Mixture components subject to submission requirements

          4. 3.4. Concentration and concentration ranges of the mixture components

            1. 3.4.1. Hazardous components of major concern for emergency health response and...

            2. 3.4.2. Other hazardous components and components not classified as hazardous

          5. 3.5. Grouping of components in an interchangeable component group

            1. 3.5.1. Name of interchangeable component group and identification of grouped components...

            2. 3.5.2. Concentration and concentration ranges of grouped components

          6. 3.6. Mixtures complying with standard formulas

          7. 3.7. Fuels

          8. 3.8. Classification of mixture components

        4. 4. SUBMISSION UPDATE

          1. 4.1. Conditions for submission update

          2. 4.2. Content of the submission update

      3. PART C SUBMISSION FORMAT

        1. 1. SUBMISSION FORMAT

          1. 1.1. Submission Format

          2. 1.2. Identification of the mixture, submitter and contact point

          3. 1.3. Classification of the mixture, label elements and toxicology

          4. 1.4. Information on the mixture components and interchangeable component groups

      4. PART D STANDARD FORMULAS

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