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2. Working safely with chemicals Janssen Pharmaceutica NV Erik Vanbriel December 2010

3. Contents General introductionSlide 3-9 Properties of substances and mixturesSlide 10-57 GHSSlide 58-80 Safety Data Sheet & Safety CardSlide 81-85 SummarySlide 86-88 Questions and contact personsSlide 89 2

4. Legislation 3

5. Essential regulations for chemicals 4

6. EH&S department 5

7. Dangerous chemicals 6

8. Procedures 7

9. 8

10. Inventory available Annual review Site EH&S department  departments (examples) 9

11. Properties of substances/mixtures 10

12. Aggregation states 11

13. Properties of substances/mixtures 12

14. Properties of substances/mixtures 13

15. Properties of substances/mixtures 14

16. Properties of substances/mixtures 15

17. Properties of substances/mixtures 16

18. Properties of substances/mixtures 17

19. Properties of substances/mixtures 18

20. Properties of substances/mixtures 19

21. Hydrophobic substances 20

22. 21 Oral (swallowing) Dermal (skin) subcutaneous (SC) Inhalation (breathing) Ocular (eyes) intramuscular (IM) intravenous (IV) intraperitoneal (IP)

23. Properties of substances/mixtures 22 - Acute (LD50, LC50, dermal,…) - Chronic (cancer) - Specific (mutagenic, sensitization,…) - Activity (narcotics, hormonal,..)

24. Limit values 23

25. PPM 24

26. OEL 25

27. PbOEL 26

28. PbOEL 27

29. Odor 28

30. Classification for labeling I.Physical chemical properties II.Environmental toxicity properties III.Toxicological health properties 29 SYMBOLS

31. Physical chemical properties 30

32. Physical chemical properties 31

33. Environmental toxicity properties 32

34. Toxicological health properties 33

35. Toxicological health properties 34

36. Toxicological health properties 35

37. Labeling 36

38. Labeling 37

39. Filling level recipients About 80% of container volume Mixtures, process samples, solutions, etc. T° fluctuations  build-up of pressure in container 38

40. Solvents 39

41. Solvents 40

42. Storage of chemicals – cooling Cold storage required for: –List intranet > gev. stoffen –See label/VFC/MSDS: – always follow the instructions –Risks: Pressure build-up, explosion, etc. Due to decomposition of products –Incident: Release/spillage of benzyl chloroformate Carcinogenic product stored with carcinogens, not cold storage 41

43. Procedure SWP-VEI-17 Working with carcinogenic and mutagenic agents Recognized in Europe Compliance with Belgian legislation Compliance with J&J IARC 42

44. Avoid health risks 43

45. Eyes 44

46. Skin 45

47. Breathing protection 46

48. Breathing protection 47

49. Breathing protection 48

50. Cleaning chemical spills 49

51. Cleaning chemical spills 50

52. Cleaning chemical spills 51

53. Cleaning chemical spills 52

54. Contractors 53 Contractors should dispose of the safety data sheets of the products they are handling.

55. External transportation 54

56. Emergency situations 55

57. 56

58. 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 57

59. General introduction Why GHS? Substance with LD50 oral rat = 257 mg/kg EUHarmful USToxic CanadaToxic AustraliaHarmful IndiaNot-toxic JapanToxic ThailandHarmful ChinaNot dangerous KoreaToxic 58

60. 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 59

61. General introduction Implementation in different countries 60 CountryImplementation Deadline SubstancesMixtures EU20 jan. 20091 Dec. 20101 June 2015 Switzerland??? Canada2001??? USA2007-2012?? Brazil27 Feb. 2011 China1 May 201030 April 2011 JapanLabel: 1 Dec 2006 SDS: 31 Dec 2010 Label: 30 Nov 2008 SDS: 31 Dec 2010 ? India20092010 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

62. 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. 61

63. General introduction Comparable? 62

64. General introduction What is new or different? Saint-Andrew’s cross no longer used under GHS 63 Current systemGHS Xn, Xi (harmful, irritating) Warning or Danger or

65. 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 64

66. General introduction What is new or different? New pictogram for gases: 65

67. 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 … 66

68. 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##) 67

69. 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 68

70. 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 69

71. 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 70

72. General introduction What is new or different? Change in criteria e.g. toxicity, acute, oral 71 LD50 (mg / kg) 12 300505 345 2.000 5.000 EU T+TXn 252002.000 GHS No pictogram

73. General introduction Example – Acetone Directive 67/548/EEC CLP 72 Acetone Highly flammable R11 R36 R66 R67 Harmful S-phrases Acetone Danger H225 H319 H336 EUH066 P-phrases

74. General introduction Example – Ketoconazole Directive 67/548/EEC CLP 73 Ketoconazole Toxic R60 R25 R48/22 R50/53 Dangerous for the Environment S-phrases Ketoconazole Danger H360F H301 H373 H410 P-phrases

75. Labeling 74

76. 75 Symbol R-phrases PbOEL HHCDanger diamond S-phrases Labeling Product label (existing)

77. 76 Pictogram Signal word H-phrasesP-phrasesNarcotics PbOEL HHC Labeling Product label (NEW)

78. 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 +3214602111 + –P phrases (maximum 6) PbOEL 3B/4 or narcotic: –Name user + date +PbOEL-class –Narcotic: Ministerial code and bone head on orange background 77

79. Labeling Example Alims label – contents < 125 ml 78

80. Examples MedChem 79

81. 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. 80

82. Safety Data Sheet Example

83. Safety Card For every hazardous substance; Created by EHS department; Summary of Safety Data Sheet; Available on Prevention site. 82

84. 83 Safety Card Example

85. 84 Web Viewer UNITY Bv. T003101 rechtstreeks bij “number” ofwel *3101 Beperkingen mogelijk op site, type naam, nummer, rapport, taal

86. 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: 85

87. 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. 86

88. 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. 87

89. Questions and contact persons GHS Site contact BeerseGriet De Cock - (SDS) GHS Site contact BeerseErik Vanbriel - (Transport/Labels) http://gpsgglobal.jnj.com/Organization/EHS/Pages/Discipline _Productveiligheidsinformatie.aspx 88

90. Thank you! Janssen Pharmaceutica NV Erik Vanbriel