Labeling and identification of hazardous substances and preparations Level 2 Leo Sneyders - GPSG Beerse, October Information provided subject to the 'Conditions for Sharing Materials and Advice' - Remark December 2010: will need update later to align with GHS

LABELLING 2 APPLICABLE TO: - YES: hazardous substances and preparations (incl. API’s and IPI’s) - NO:- Chemical waste - Radioactive substances - Biohazard compounds - Pharmaceutical end products (the drugs we sell)

LABELLING 3 Legislation EU Compounds: 67/548/EEC and all adaptations Mixtures, solutions: 1999/45/EC, 2001/60/EC and 2006/8/EC

LABELLING 4 I.Physico-chemical properties II.Ecotoxicological properties III.Toxicological properties Classification for labelling } SYMBOLS

LABELLING 5 OXIDIZING EXPLOSIVE HARMFUL/ IRRITATING/ SENSITIZER HIGHLY FLAMMABLE/ EXTREMELY FLAMMABLE VERY TOXIC / TOXIC DANGEROUS TO THE ENVIRONMENT CORROSIVE F+, F O E Xn, Xi C T+, T N OVERVIEW OF EU SYMBOLS

LABELLING 6 1. VHI (extremely flammable) criteria: bp  35 °C, fp < 0 °C 2. HI (highly flammable) criteria: bp > 35 °C, fp < 21 °C 3. I (flammable) criteria: fp  21 °C and  55 °C Flash point, flammability,….  NEVER store flammable compounds near oxidizing compounds

LABELLING 7 Oxidizing (O) symbol: Examples: potassium chlorate, benzoyl peroxide Must not be stored with flammable, toxic, harmful and environmentally hazardous substances. Explosive (E) Substances requiring a license symbol: Examples: 1-hydroxybenzotriazole, 2,4,6-trinitrofenol (picric acid)

LABELLING 8 Ecotoxicity effects (N) Criteria: toxicity in fish, daphnia, algae biological degradability partition coefficient oct/water (log P) symbol: Daphnia (water flea):

LABELLING 9 1. Highly toxic (T+)criteria acute: LD50/LC50 2. Toxic (T)criteria acute: LD50/LC50 symbol: Examples: sodium cyanide, benzene, chlorine Acute and chronic toxicity

LABELLING Corrosive (C) symbol: Chemical burns - Chemical burns on skin and eyes: sulfuric acid, sodium hydroxide - Chemical burns of lungs: trifluoro acetic anhydride, hydrogen chloride gas

LABELLING Sensitization (Xi)allergic reactions (via skin and inhalation) symbol: 4. Harmful (Xn)criteria acute: LD50/LC50 5. Irritant (Xi)a weak form of corrosive

LABELLING 12 Risk-phrases (R-phrases) Describe the risks related to: - health - flammability - physico-chemical risks - environmental hazard - other specific risks (hydrophobic,…) Safety recommendations (S-phrases) Provide appropriate measures for: - protection - fire prevention - storage - extinguishment - empty packages SPECIFIC EU LEGISLATION

LABELLING Name of the substance 2. Hazard symbols (10% of the label) + specification 3. Risk phrases 4. Safety recommendations 5. Name, address and phone number of supplier 6. Hazard diamond symbol (not required by law)

LABELLING 14

LABELLING 15 HAZARD DIAMOND (NFPA) Blue: health hazard Red: flammability Yellow: reactivity or instability White: additional information Numbers from 0 to 4 indicate the degree of hazard, where 4 indicates the greatest danger for that particular component. For R &T-numbers: the PbOEL-class in the white section (specific J&J).

LABELLING 16 Labeling in EU of: - Carcinogenic substances - Mutagenic substances - Reprotoxic substances

LABELLING 17 Carcinogenic Mutagenic Reprotoxic (cancer) (heredity) (fertility) Cat. 1 Cat 2 R 45, R 49 R 46 R 60, R 61 Cat. 3 R 40 R 68 R 62, R 63 R 45: May cause cancer R 46 May cause heritable genetic R 60: May impair fertility. R 49: May cause cancer by damage. R 61: May cause harm to the unborn child. inhalation R 40: Limited evidence of R 68: Possible risk of irreversible R 62: Possible risk of impaired fertility carcinogenic effect effects R 63: Possible risk of harm to the unborn child Cat. 1 Cat 2 Cat. 3

LABELLING 18 When is a label applicable? - on all packages (inner and outer) - format of the label is depending on the package content Content packageFormat in mm max 3 liter52 x 74 3 liter up to 50 liter74 x liter up to 500 liter105 x 148 >500 liter148 x 210

LABELLING 19