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Info session Globally Harmonized System of Classification and Labelling of chemicals Janssen Pharmaceutica NV October 2010

Contents General introductionSlide 1-19 LabelingSlide Safety Data SheetSlide Safety cardSlide Signalisation on siteSlide 29 SummarySlide Questions and contact personsSlide 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 LD50 oral rat = 257 mg/kg EUHarmful USToxic CanadaToxic AustraliaHarmful IndiaNot-toxic JapanToxic ThailandHarmful ChinaNot dangerous KoreaToxic 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 6 CountryImplementation Deadline SubstancesMixtures EU20 jan Dec June 2015 Switzerland??? Canada2001??? USA ?? Brazil27 Feb China1 May April 2011 JapanLabel: 1 Dec 2006 SDS: 31 Dec 2010 Label: 30 Nov 2008 SDS: 31 Dec 2010 ? India Russia2010?? AustraliaExpected 2012 – 2015 Expected 2012Expected 2015 New Zealand2 July 2006Label: 31 Dec 2010 SDS: 30 June 2011 Label: 31 Dec 2010 SDS: 30June 2011

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 9 Current systemGHS Xn, Xi (harmful, irritating) Warning or Danger or

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 Toxic Corrosive … Flammable Irritating  Warning … 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 (H2##) –Health hazards (H3##) –Environmental hazards (H4##) Subdivision of P-statements into various precautionary statements –General precautionary statements(P1##) –Precautionary statements in relation to prevention (P2##) –Precautionary statements in relation to response (P3##) –Precautionary statements in relation to storage (P4##) –Precautionary statements in relation to disposal (P5##) 13

General introduction What is new or different? Examples of H-statements (Hazard) R40: limited evidence of a carcinogenic effect H351: suspected of causing cancer R41: risk of serious damage to eyes H318: causes serious eye damage R43: may cause sensitisation by skin contact H317: may cause an allergic skin reaction 14

General introduction What is new or different? Examples of P-statements (Precautionary) S2: Keep out of the reach of children P102: Keep out of reach of children S7: Keep container tightly closed P404: Store in a closed container S46: If swallowed, seek medical advice immediately and show this container or label P301/310: IF SWALLOWED: immediately call a poison centre or doctor/physician 15

General introduction What is new or different? Additional hazard information (CLP) EUH001Explosive when dry. EUH006Explosive with or without contact with air. EUH014Reacts violently with water. EUH019May form explosive peroxides. EUH029Contact with water liberates toxic gas. EUH032Contact with acids liberates very toxic gas. EUH204Contains isocyanates. May produce an allergic reaction 16

General introduction What is new or different? Change in criteria e.g. toxicity, acute, oral 17 LD50 (mg / kg) EU T+TXn GHS No pictogram

General introduction Example – Acetone Directive 67/548/EEC CLP 18 Acetone Highly flammable R11 R36 R66 R67 Harmful S-phrases Acetone Danger H225 H319 H336 EUH066 P-phrases

General introduction Example – Ketoconazole Directive 67/548/EEC CLP 19 Ketoconazole Toxic R60 R25 R48/22 R50/53 Dangerous for the Environment S-phrases Ketoconazole Danger H360F H301 H373 H410 P-phrases

Labeling 20

21 Symbol R-phrases PbOEL HHCDanger diamond S-phrases Labeling Product label (existing)

22 Pictogram Signal word H-phrasesP-phrasesNarcotics PbOEL HHC Labeling Product label (NEW)

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) + PbOEL External: –Address: Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse –P phrases (maximum 6) PbOEL 3B/4 or narcotic: –Name user + date +PbOEL-class –Narcotic: Ministerial code and bone head on orange background 23

Labeling Example Alims label – contents < 125 ml 24

Examples MedChem 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.: –H2: Hazard identification –H4: First aid measures –H14: 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

29 Safety Card Example

30 Web Viewer UNITY Bv. T rechtstreeks bij “number” ofwel *3101 Beperkingen mogelijk op site, type naam, nummer, rapport, taal

31 Next steps Signalisation on site

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 Transport regulation remains unchanged. 34

Questions and contact persons Questions? GHS Site contact BeerseGriet De Cock - (SDS) GHS Site contact BeerseErik Vanbriel - (Transport/Labels) _Productveiligheidsinformatie.aspx 35

Thank You!