1. Labeling and identification of hazardous substances and preparations Level 2 Leo Sneyders - GPSG Beerse, October 2007 - Information provided subject to the 'Conditions for Sharing Materials and Advice' - Remark December 2010: will need update later to align with GHS

2. 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)

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

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

5. 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

6. 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

7. 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)

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

9. 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

10. LABELLING 10 3. 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

11. LABELLING 11 6. Sensitization (Xi)allergic reactions (via skin and inhalation) symbol: 4. Harmful (Xn)criteria acute: LD50/LC50 5. Irritant (Xi)a weak form of corrosive

12. 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

13. LABELLING 13 1. 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) 1 2 6 3 4 5

14. LABELLING 14

15. 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).

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

17. 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

18. 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 105 50 liter up to 500 liter105 x 148 >500 liter148 x 210

19. LABELLING 19