ECHA - Guidance of the application of CLP criteria [November 2012]

Guidance on the Application of the CLP Criteria Version 3.0 - November 2012TABLE OF CONTENTS1 PART 1: GENERAL PRINCIPLES FOR CLASSIFICATION AND LABELLING.........................321.1 INTRODUCTION...............................................................................................................................321.1.1 The objective of the guidance document ................................................................................321.1.2 Background.............................................................................................................................331.1.3 Hazard classification...............................................................................................................331.1.4 Who is responsible for the hazard classification and what is the timetable............................341.1.5 Which substances and mixtures should be classified (the scope)...........................................351.1.6 What information is needed for classification ........................................................................361.1.6.1 Information for the classification of substances......................................................361.1.6.2 Information relevant for the classification of mixtures ...........................................371.1.7 Data evaluation and reaching a decision on classification......................................................371.1.7.1 Classification of substances ....................................................................................371.1.7.2 Influence of impurities, additives or individual constituents on theclassification of a substance ....................................................................................381.1.8 Updating of hazard classifications..........................................................................................381.1.9 The interface between hazard classification and hazard communication...............................381.1.10 The interface between self-classification and harmonised classification, and the list ofharmonised classifications......................................................................................................391.1.11 The Classification and Labelling Inventory (C&L Inventory) ...............................................401.1.12 Relation of classification to other EU legislation ...................................................................401.1.12.1 REACH ...................................................................................................................401.1.12.2 Plant Protection Products and Biocides ..................................................................401.1.12.3 Transport legislation................................................................................................411.2 THE SIGNIFICANCE OF THE TERMS 'FORM OR PHYSICAL STATE’ AND'REASONABLY EXPECTED USE’ WITH RESPECT TO CLASSIFICATIONACCORDING TO CLP.......................................................................................................................411.2.1 'Form or physical state’ and 'reasonably expected use’ ..........................................................411.2.2 The term 'reasonably expected use’ in relation to hazard classification.................................421.2.3 The term ‘form or physical state’ in relation to hazard classification ....................................421.2.3.1 Physical hazards ......................................................................................................421.2.3.2 Human health hazards .............................................................................................431.2.3.3 Environmental hazards............................................................................................431.3 SPECIFIC CASES REQUIRING FURTHER EVALUATION – LACK OFBIOAVAILABILITY..........................................................................................................................441.3.1 Definition................................................................................................................................441.3.2 Bioavailability ........................................................................................................................441.3.2.1 Human health hazards .............................................................................................451.3.2.2 Environmental hazards............................................................................................461.4 USE OF SUBSTANCE CATEGORISATION (READ ACROSS AND GROUPING) AND(Q)SARS FOR CLASSIFICATION AND LABELLING ..................................................................461.4.1 (Q)SAR...................................................................................................................................471.4.2 Grouping.................................................................................................................................481.4.3 Read across.............................................................................................................................481.5 SPECIFIC CONCENTRATION LIMITS AND M-FACTORS .........................................................491.5.1 Specific concentration limits ..................................................................................................491.5.2 Multiplying factors (M-factors)..............................................................................................501.6 MIXTURES.........................................................................................................................................511.6.1 How to classify a mixture.......................................................................................................516