0 Info session Globally Harmonized System of Classification
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Info session Globally Harmonized System of Classification and Labelling of chemicals October 2010 Janssen Pharmaceutica NV
Contents • General introduction Slide 1 -19 • Labeling Slide 20 -24 • Safety Data Sheet Slide 25 -26 • Safety card Slide 27 -28 • Signalisation on site Slide 29 • Summary Slide 30 -32 • Questions and contact persons Slide 33 2
General introduction Background • Why “Globally Harmonized System of Classification and labelling of chemicals” (GHS)? • Implementation in different countries • What is “Classification, Labelling and Packaging” (CLP)? • GHS: what’s new or different? • Examples 3
General introduction Why GHS? • Substance with LD 50 oral rat = 257 mg/kg • • • EU US Canada Australia India Japan Thailand China Korea Harmful Toxic Harmful Not-toxic Toxic Harmful Not dangerous Toxic 4
General introduction GHS basics • GHS – new global UN guidance on hazard communication • Classification is based on symbols, hazard (H) phrases, precautionary (P) phrases and signal words • World wide implementation by regulatory authorities 5
General introduction Implementation in different countries Country Implementation EU Deadline Substances Mixtures 20 jan. 2009 1 Dec. 2010 1 June 2015 Switzerland ? ? ? Canada 2001? ? ? USA 2007 -2012 ? ? Brazil 27 Feb. 2011 China 1 May 2010 30 April 2011 Japan Label: 1 Dec 2006 SDS: 31 Dec 2010 Label: 30 Nov 2008 SDS: 31 Dec 2010 ? India 2009 2010 Russia 2010 ? ? Australia Expected 2012 – 2015 Expected 2012 Expected 2015 New Zealand 2 July 2006 Label: 31 Dec 2010 SDS: 30 June 2011 Label: 31 Dec 2010 SDS: 30 June 2011 6
General introduction What is CLP? • GHS implemented in EU = CLP (law); • 31/12/2008: Publicatie van Verordening (EG) 1272/2008 betreffende de indeling, etikettering en verpakking van stoffen en mengsels (Classification, Labelling & Packaging of substances and mixtures = CLP); • Is a law and no guidance; • Transition period foreseen. 7
General introduction Comparable? 8
General introduction What is new or different? • Saint-Andrew’s cross no longer used under GHS Current system GHS or or Xn, Xi (harmful, irritating) Warning or Danger 9
General introduction What is new or different? • CMR (carcinogenic, mutagenic and reprotoxic) • Respiratory sensitiser, Category 1 • Systemic toxicity (for the entire body): after single and repeated exposure(s), Category 1, 2 • Aspiration hazard (can cause pulmonary injuries if swallowed), Category 1 10
General introduction What is new or different? • New pictogram for gases: 11
General introduction What is new or different? • Indication of danger is ‘replaced’ by signal words • Extremely flammable • Highly flammable • Very toxic Danger Warning • Toxic • Corrosive • … • Flammable • Irritating • … 12
General introduction What is new or different? • Risk (R)-phrases Hazard (H)-statements • Safety (S)-phrases Precautionary (P)-statements • Subdivision of H-statements into various hazards – Physical hazards (H 2##) – Health hazards (H 3##) – Environmental hazards (H 4##) • Subdivision of P-statements into various precautionary statements – – – General precautionary statements(P 1##) Precautionary statements in relation to prevention (P 2##) Precautionary statements in relation to response (P 3##) Precautionary statements in relation to storage (P 4##) Precautionary statements in relation to disposal (P 5##) 13
General introduction What is new or different? Examples of H-statements (Hazard) • R 40: limited evidence of a carcinogenic effect • H 351: suspected of causing cancer • R 41: risk of serious damage to eyes • H 318: causes serious eye damage • R 43: may cause sensitisation by skin contact • H 317: may cause an allergic skin reaction 14
General introduction What is new or different? Examples of P-statements (Precautionary) • S 2: Keep out of the reach of children • P 102: Keep out of reach of children • S 7: Keep container tightly closed • P 404: Store in a closed container • S 46: If swallowed, seek medical advice immediately and show this container or label • P 301/310: IF SWALLOWED: immediately call a poison centre or doctor/physician 15
General introduction What is new or different? Additional hazard information (CLP) EUH 001 EUH 006 EUH 014 EUH 019 EUH 029 EUH 032 EUH 204 Explosive when dry. Explosive with or without contact with air. Reacts violently with water. May form explosive peroxides. Contact with water liberates toxic gas. Contact with acids liberates very toxic gas. Contains isocyanates. May produce an allergic reaction 16
General introduction What is new or different? Change in criteria e. g. toxicity, acute, oral GHS 1 2 5 3 4 50 300 25 T+ 5. 000 200 T 5 2. 000 LD 50 (mg / kg) Xn No pictogram EU 17
General introduction Example – Acetone Directive 67/548/EEC CLP Acetone Danger Highly flammable R 11 R 36 R 67 H 225 H 319 H 336 EUH 066 Harmful S-phrases P-phrases 18
General introduction Example – Ketoconazole Directive 67/548/EEC CLP Ketoconazole Danger Toxic R 60 R 25 R 48/22 R 50/53 Dangerous for the Environment H 360 F H 301 H 373 H 410 P-phrases S-phrases 19
Labeling 20
Labeling Product label (existing) Symbol Danger diamond R-phrases 21 S-phrases Pb. OEL HHC
Labeling Product label (NEW) Pb. OEL HHC 22 Pictogram Signal word H-phrases P-phrases Narcotics
Labeling Contents < 125 ml (Labo’s) • Always: product-, preparation name or code • If stored for a longer period of time: – Symbol and signal word + hazard classifications (most critical ones) + Pb. OEL • External: – Address: Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse +3214602111 + – P phrases (maximum 6) • Pb. OEL 3 B/4 or narcotic: – Name user + date +Pb. OEL-class – Narcotic: Ministerial code and bone head on orange background 23
Labeling Example Alims label – contents < 125 ml 24
Examples Med. Chem 25
Safety Data Sheet • Structured document; • Contains information on risks of a hazardous substance or mixture. • Contains recommendations for safe use. • SDS contains 16 chapters a. o. : – H 2: Hazard identification – H 4: First aid measures – H 14: Transportation. • Safety Data Sheets can be found on the Prevention site. 26
Safety Data Sheet Example
Safety Card • For every hazardous substance; • Created by EHS department; • Summary of Safety Data Sheet; • Available on Prevention site. 28
Safety Card Example 29
Web Viewer UNITY Bv. T 003101 rechtstreeks bij “number” ofwel *3101 Beperkingen mogelijk op site, type naam, nummer, rapport, taal 30
Next steps Signalisation on site 31
Summary • Changes due to GHS: – – H(azard)-statements replace R(isk)-phrases P(recautionary)-statements replace S(afety)-phrases New: signal word “Danger” or “Warning” New symbols in the shape of a diamond: 32
Summary • From December 1, 2010 products placed on the EU market have to be labeled with a CLP compliant label • 2 Year transition period (until December 1, 2012) for products already in stock or in labo • From mid November 2010 onwards, Safety Cards will contain both “old” and CLP information. From January 1, 2011 only CLP information on Safety Cards. • From December 1, 2010 until June 1, 2015, Safety Data Sheets contain both “old” and CLP information. From June 1, 2015 onwards, only CLP information available on SDS. 33
Summary • Regulation regarding storage of dangerous goods has not been revised yet. • CLP Signalisation on site to be executed in the beginning of 2011. • Transport regulation remains unchanged. 34
Questions and contact persons Questions? • GHS Site contact Beerse Griet De Cock - (SDS) Erik Vanbriel - (Transport/Labels) • http: //gpsgglobal. jnj. com/Organization/EHS/Pages/Discipline _Productveiligheidsinformatie. aspx 35
Thank You!
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