Consequences of application of the CLP Regulation criteria to the classification of Seveso II chemicals Tatjana Humar-Jurič; M.Sc, Subsecretary Ministry i of Health - Chemicals Office of the Republic of Slovenia Semira Hajrlahović Meehić, LL.M., B.Sc.Chemicals Inspector Ministry of Health -Chemicals Office of Republic of Slovenia TA Project: Chemical Safety in Croatia Workshop 16-17 June 2011 1
Old Current EU Legislation/ Criteria for classification DSD*: 67/548/EEC, Annex VI DPD**: 99/45/EC, Annex I, II, III New CLP Regulation 1272/2008/EC, Annex I * Dangerous Substances Directive ** Dangerous Preparations Directive 2
Criteria for Classification HAZARD BASED! Hazard identification of intrinsic properties: Physical hazards Health hazards Environmental hazards Criteria for classification Regulation 1272/2008/EC, Annex I 3
What to Classify Substances /mixtures meeting hazard criteria in parts 2-5 of Annex I Physical: Human Health: Environment: Hazardous to the Ozone Layer: 4
New CLP Classification Criteria Physical expanded number and type of hazard classes/categories Human Health new Hazard Classes with categories Specific Target Organ Toxicity Serious Eye Damage/Eye Irritation Aspiration Environment Acute and Chronic categories Hazardous to the Ozone Layer 5
Physical hazards under CLP 2.1 Explosives 2.9. Pyrophoric liquids 2.2 Flammable gases 2.10 Pyrophoric solids 2.3 Flammable aerosoles 2.11 Self-heating substances and mixtures 2.4 Oxidizing ggases 2.12. Substances and mixtures which in contact 2.5 Gases under pressure with water emit flammable gases 2.6 Flammable liquids 2.13 Oxidizing liquids 2.7 Flammable solids 2.14 Oxidizing solids 2.8 Self-reactive substances 2.15 Organic peroxides and mixtures 2.16 Corrosive to metals There are 1-8 Categories (Types/Divisions) for each Hazard Class 6
Health hazards under CLP Hazard class Hazard category Acute oral toxicity 1 2 3 4 Acute dermal toxicity 1 2 3 4 Acute inhalation toxicity 1 2 3 4 Corrosive Irritation Skin corrosion/irritation 1A 1B 1C 2 Severe eye damage/eye irritation 1 2 Sensitisation: respiratory 1A 1B Sensitisation: skin 1A 1B Germ cell mutagenicity Carcinogenicity Reproductive toxicity 1A 1B 2 1A 1B 2 1A 1B 2 Lactation STOT single exposure 1 2 STOT repeated exposure 1 2 Aspiration hazard 1 3 7
Environmental hazards under CLP Hazard Class Hazard Category Hazardous to the aquatic environment - Acute (short-term) hazard - Chronic (long-term) hazard 1 2 3 + 4 1 Hazardous to the ozone layer 1 8
New Criteria for Environmental Hazards Hazard a Cat. Criteria Chronic aquatic 1 L(E)C50 1 mg/l and the substance is not rapidly degradable and/or Bioconcentration Factor (BCF) 500 (or, if absent, the Partition coefficient (Log Kow) 4) Hazardous to the ozone layer Environmental fate and behaviour evidence may present a danger to stratospheric ozone layer 9
CLP classification Summary Physical, HH and ENV endpoints to be classified Hazard Classes and Categories have changed from DPD/DSD Classification Harmonised C&L Self classification Translation with Annex VII 10
SEVESO II Directive Directive 96/82/EC Annex I Part 1: Named substances Part 2 :Categories of substances and preparations not specifically named in Part 1 11
SEVESO II Revision Reasons To align its Annex I to CLP Regulation CLP amends and repeals Dir. 67/548/EEC and 1999/45/EC to which the Seveso II Dir. currently refers The CLP rules become definitive with effect from 1 June 2015 After the entire transition period for substances & mixtures CLP is obligatory and Existing system loses its legal status 12
REACH CPL: Transitional Period CLP HPV etc. > 100 t/a 1 Dec 2010 1 June 2015 > 1 t/a Substances Mixtures For substances and mixtures: Exist. system: binding CLP: optional; Label: CLP if class. For substances: CLP: obligatory* SDS must contain exist. and CLP classification For mixtures: EU-System: binding CLP: optional; Label: CLP if class. After the entire transition period: For substances & mixtures: CLP: obligatory* Exist. system: loses its legal status * *derogation for already placed on the market: - substances until 1.12.2012 - mixtures until 1.6.2017 13
Revision Problems An alignment of Annex I to the CLP Reg. The impact on the scope of the Directive was the key issue Nature and extent of the changes compared with the current Directive amending, recast???? New directive was proposed 14
Alignment of Annex I to the CLP Reg.I Other technical amendments to Annex I and the procedures for adapting Annex I in the future were possible Simple change of reference or one-to-one translation from the old classification system to the CLP Reg.is not possible old odhazard aadcass classification cao 'toxic' cad and 'very eyo toxic cdo not correspond to the new CLP 'Acute Toxicity' 1 to 3 categories are moreover divided into different exposure routes (oral, dermal and inhalation) 15
Alignment of Annex I to the CLP Reg. II A further complication when substances are classified or re-classified under the CLP Reg. over time Automatically impact on the scope of the Seveso II 16
Alignment of Annex I to the CLP CION proposal: Reg. II maintains a high level of protection taking into account the most likely and relevant exposure routes nature and extent of the changes compared with the current Directive, a revision of that in the form of an amending Directive or recast would not be appropriate a new directive is therefore proposed. 17
Consequences Article 2 defines the scope of the Directive Where dangerous substances listed in Annex I are present above prescribed thresholds The provisions of Article 2 are essentially unchanged from Directive 96/82/EC Order of Parts 1 and 2 of Annex I has been reversed 18
Consequences Part 1 of Annex I lists categories of dangerous substances according to their generic hazard classification (in accordance with the CLP Reg.) Part 2 lists named dangerous substances or groups of substances, notwithstanding their generic hazard classification 19
Consequences : differences in terms of content of the Annex I Part 1 Main change concerns health hazards Former category: "Very Toxic" has been aligned to the CLP category "Acute Toxic 1" "Toxic" to "Acute Toxic 2 (all exposure routes) and "Acute Toxic 3" (dermal and inhalation routes). 20
Consequences : differences in terms of content of the Annex I Part 1 Several more specific CLP categories for physical hazards that did not exist before replace the more general old categories for: Oxidizing Explosive flammable hazards 21
Consequences : differences in terms of content of the Annex I Part 1 For the new category of flammable aerosols, the thresholds have been adapted proportionately to those that apply currently based on their flammable properties and components For reasons of consistency, the group of pyrophoric substances has been completed by the inclusion of pyrophoric solids 22
Consequences : differences in terms of content of the Annex I Part 2 The new Annex I Part 2 retains the old Part 1 largely unchanged OLD PART 1 NEW PART 2 But some changes 23
Consequences : differences in terms of content of the Annex I Part 2 Changes are: updated reference to the CLP Reg.for liquefied flammable gases, inclusion of anhydrous ammonia, boron triflouride, and dhydrogen sulphide as named substances, bt previously covered by their hazard categories, to keep their threshold unchanged, inclusion of heavy fuel oil in the entry for petroleum products update of the toxic equivalency factors for dioxins. 24
Consequences : differences in terms of content of the Annex I exclusions to the Directive previously listed in Article 4 of Directive 96/82/EC are listed in Part 3 to: to remove any possible doubts, the possibility to exclude substances for the purposes of fthe SEveso IIDi Dir.if ifthey do not present a major-accident hazard 25
NEW Annex I, Part 1 Categories of substances and mixtures Column 1 Column 2 Column 3 Categories of dangerous substances and mixtures Qualifying quantity (tonnes) of dangerous substances as delivered in Article 3 (9), for the application of Section H HEALTH HAZARDS Lower-tier requirements Upper-tier requirements H1 ACUTE TOXIC Category 1, all exposure routes 5 20 H2 ACUTE TOXIC 50 200 - Category 2, all exposure routes - Category 3, dermal and inhalation exposure routes H3 STOT SPECIFIC TARGET ORGAN TOXICITY SINGLE EXPOSURE STOT Category 1 50 200 26
NEW Annex I, Part 1 Categories of substances and mixtures Column 1 Column 2 Column 3 Categories of dangerous substances and mixtures Qualifying c (tonnes) of dangerous substances as delivered in Article 3 (9), for the application of Lower-tier requirements Upper-tier requirements Section P - PHYSICAL HAZARDS P1a EXPLOSIVES (see note 8) - Unstable explosives or - Explosives, Division i i 1.1, 1 1.2, 1.3, 1.5 or 1.6 P1b EXPLOSIVES (see note 8) Explosives, Division 1.4 (see note 10) P3a FLAMMABLE AEROSOLS (see note 11.1) Extremely flammable or Flammable aerosols, containing flammable gases Category 1 or 2 or flammable liquids Category 1 5 10 50 200 150 500 P3b FLAMMABLE AEROSOLS (see note 11.1) 1) Extremely flammable or Flammable aerosols, not containing flammable gases Category 1 or 2 nor flammable liquids category 1 (see note 11.2) 5.000 50.000 27
NEW Annex I, Part 1 Categories of substances and mixtures Column 1 Column 2 Column 3 Categories of dangerous substances and mixtures Qualifying quantity (tonnes) of dangerous substances as delivered in Article 3 (9), for the application of Section P -PHYSICAL PHYSICAL HAZARDS Lower-tier requirements Upper-tier requirements P5a FLAMMABLE LIQUIDS - Flammable liquids, Category 1, or - Flammable liquids Category 2 or 3 maintained at a temperature above their boiling point, or 10 50 P5b FLAMMABLE LIQUIDS - Flammable liquids Category 2 or 3 where particular processing conditions, such as high pressure or high temperature, may create major-accident hazards, or 50 200 P6a SELF-REACTIVE SUBSTANCES AND MIXTURES and ORGANIC PEROXIDES 10 50 Self-reactive substances and mixtures, Type A or B or organic peroxides, Type A or B 28
NEW Annex I, Part 1 Categories of substances and mixtures Column 1 Column 2 Column 3 Categories of dangerous substances and mixtures Qualifying quantity (tonnes) of dangerous substances as delivered in Article 3 (9), for the application of Section E ENVIRONMENTAL HAZARDS Lower-tier requirements Upper-tier requirements E1 Hazardous to the Aquatic Environment in Category Acute 1 or Chronic 1 100 200 E2 Hazardous to the Aquatic Environment in Category 200 500 Chronic 2 29
NEW Annex I, Part 1 Categories of substances and mixtures Column 1 Column 2 Column 3 Categories of dangerous substances and mixtures Qualifying quantity (tonnes) of dangerous substances as delivered in Article 3 (9), for the application of Lower-tier requirements Upper-tier requirements Section O OTHER HAZARDS O1 Substances or mixtures with hazard statement EUH014 (EUH 014: Reacts violently with water. ) O2 Substances and mixtures which in contact with water emit flammable gases, Category 1 O3 Substances or mixtures with hazard statement EUH029 (EUH 029: Contact with water liberates toxic gas. ) 100 500 100 500 50 200 30
Consequences New Proposal Changes in Annex I due to alignment to CLP Reg. Part 1 in line with CLP classification criteria Reversed Parts 1 and 2 Changes in Part 2 New Part 3 Quantities/trasholds unchanged 31
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