Labeling and identification of hazardous substances and preparations
Labeling and identification of hazardous substances and preparations Level 2 Leo Sneyders - GPSG Beerse, October 2007 Remark December 2010: will need update later to align with GHS - Information provided subject to the 'Conditions for Sharing Materials and Advice' -
LABELLING 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) 2
LABELLING Legislation EU Compounds: 67/548/EEC and all adaptations Mixtures, solutions: 1999/45/EC, 2001/60/EC and 2006/8/EC 3
LABELLING Classification for labelling I. Physico-chemical properties II. Ecotoxicological properties III. Toxicological properties } SYMBOLS 4
LABELLING O F+, F E OXIDIZING HIGHLY FLAMMABLE/ EXPLOSIVE EXTREMELY FLAMMABLE T+, T VERY TOXIC / TOXIC OVERVIEW OF EU SYMBOLS N C Xn, Xi HARMFUL/ IRRITATING/ SENSITIZER DANGEROUS TO THE ENVIRONMENT CORROSIVE 5
Fl as hp oi nt , f lam m ab i lit y , … . LABELLING 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 NEVER store flammable compounds near oxidizing compounds 6
LABELLING 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) 7
LABELLING Ecotoxicity effects (N) Criteria: • toxicity in fish, daphnia, algae • biological degradability • partition coefficient oct/water (log P) symbol: Daphnia (water flea): 8
LABELLING Acute and chronic toxicity 1. Highly toxic (T+) criteria acute: LD 50/LC 50 2. Toxic (T) criteria acute: LD 50/LC 50 symbol: Examples: sodium cyanide, benzene, chlorine 9
LABELLING s 3. Corrosive (C) l a c i n ur b m e h C symbol: - Chemical burns on skin and eyes: sulfuric acid, sodium hydroxide - Chemical burns of lungs: trifluoro acetic anhydride, hydrogen chloride gas 10
LABELLING 4. Harmful (Xn) criteria acute: LD 50/LC 50 5. Irritant (Xi) a weak form of corrosive 6. Sensitization (Xi) allergic reactions (via skin and inhalation) symbol: 11
• Risk-phrases (R-phrases) Describe the risks related to: - health - flammability - physico-chemical risks - environmental hazard - other specific risks (hydrophobic, …) SP EC I FI C EU LE G IS LA T IO N LABELLING • Safety recommendations (S-phrases) Provide appropriate measures for: - protection - fire prevention - storage - extinguishment - empty packages 12
LABELLING 1 2 6 5 3 4 4. Safety recommendations 1. Name of the substance 2. Hazard symbols (10% of the label) + specification 5. Name, address and phone number of supplier 6. Hazard diamond symbol (not required by law) 3. Risk phrases 13
LABELLING 14
LABELLING 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 Pb. OEL-class in the white section (specific J&J). 15
LABELLING Labeling in EU of: - Carcinogenic substances - Mutagenic substances - Reprotoxic substances 16
LABELLING Carcinogenic (cancer) Mutagenic (heredity) Reprotoxic (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 Cat. 1 Cat 2 Cat. 3 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. R 68: Possible risk of irreversible R 62: Possible risk of impaired fertility effects R 63: Possible risk of harm to the unborn child inhalation R 40: Limited evidence of carcinogenic effect 17
LABELLING When is a label applicable? - on all packages (inner and outer) - format of the label is depending on the package content Content package Format in mm max 3 liter 52 x 74 3 liter up to 50 liter 74 x 105 50 liter up to 500 liter 105 x 148 >500 liter 148 x 210 18
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