7 Principles of HACCP

1. 7 Principles of HACCP

2. HAZARD ??? A biological, chemical, or physical agent in food with the potential to cause an adverse health effect (Codex, 1997). Hazard: • Microbiological • Chemical • Physical Food-borne disease (FBD): penyakit menular atau keracunan yang oleh mikroba atau agen yang masuk ke dalam tubuh melalui makanan yang di konsumsi (WHO).

3. Principle 1: Hazard analysis • The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and should be addressed in the HACCP plan.

4. Information needed for hazard analysis • the agents that could be present in the food under study • the severity of the effects and the likelihood of their occurrence • the levels that could cause adverse health effects • the conditions that could lead to unacceptable levels

6. Microbial Hazards • Dangerous microorganisms that cause food-borne disease (FBD): • Bacteria • Moulds • Viruses • Parasites

7. Patogenic microorganismsare theMAJOR SOURCESof food contamination!!!

8. Aeromonas spp Bacillus cereus Brucella spp. Camphylobacter jejuni Clostridium botulinum Clostridium perfringens Escherichia coli Listeria monocytogenes Mycobacterium bovis Salmonella spp. Shigella spp. Staphylococcus aureus Vibrio cholerae Vibrio parahaemolyticus Vibrio vulcanificus Yersinia enterolitica Major bacteria causing FBD

9. Some toxigenic moulds causing FBD • Aspergillus spp • Fusarium spp. • Penicilium spp Producing mycotoxins, such as aflatoxin, ochratoxin, etc. Main sources: fruits, nuts and grains

10. Mycotoxins

11. Major viruses causing FBD • Hepatitis A and E viruses • Small round structured viruses (e.g. Norwalk) • Rotavirus • Polio virus

12. Anisakis Ascaris Clonorchis sinensis Cryptosporodium Cyclospora catetanensis Diphyllobothorium Echinococcus Entamoeba histolytica Fasciola hepatica Giardia Opisthorcis felineus Opisthorcis viverrini Sarcosporodium Taenia Toxoplasma Trichinella Major parasites causing FBD

13. Bacterial growth curve

14. Food-Borne Disease Bacteria • Infection • Invasion of bacteria and theirs multiplication within the body. • E.g.: Salmonella, Campylobacter, E. coli, V. parahaemolyticus, V. cholerae, Y. enterolitica, L monocytogenes • Intoxication • Caused by consuming toxin produced in food. • E.g.: Bacillus cereus, C. botulinum, S. aureus, E. coli

15. Example:1. Salmonella • Causing Salmonellosis • Main symptoms: diarrhea, fever, vomiting, abdominal cramps. • Persons at high risk: young, old, pregnant woman, underlying disease states. • Incubation period: 12 – 36 h • Sources: meat, poultry, milk, eggs, vegetables, shellfish, spices and herbs, untreated water. • Salmonella is heat sensitive • Pasteurization (70oC for 2 min) is sufficient to kill Salmonella in high moisture foods.

16. 2. Camphylobacter • Causing camphylobacteriosis • Symptoms: fever, nausea, diarrhea, abdominal cramp • Person at high risks: babies, debilitated people • Incubation: 2-5 days • Heat sensitive • Major sources: frozen foods (meats and poultry).

17. Minimum infective dose

18. Minimum toxic doses of bacterial toxins • S. aureus : 106 (cells/g) • C. botulinum : 104 - 105 • B. cereus : 107 – 108

19. Temperature range for the growth of patogenic bacteria

20. Temperature range for the growth of toxigenic moulds

21. Prevention of FBD

22. Chemical Hazards • Pesticides: PCBs, organochlorin • Dioxins • Heavy metals: Cd, Hg, Pb • Metals: Al, Se, etc. • Food additives • Natural contaminants • Desinfectants • Mycotoxins • Etc.

23. Hazard Determination Is the presence of agent in raw material probable? Is the presence of agent in line or environment probable? YES NO NO YES No Hazard Is an unacceptable survival, persistence or increase at this step probable? YES Is an unacceptable contamination at this step probable? NO YES No Hazard NO YES NO Is reduction, if any at a further step adequate? HAZARD

24. Menentukan signifikansi bahaya • Tingkat keseriusan bahaya (severity): • Severity dapat ditetapkan dengan melihat seberapa jauh dampaknya terhadap kesehatan konsumen dan dampak terhadap pencitraan industri. • Frekuensi terjadinya bahaya: • Risiko tinggi: cenderung terjadi • Risiko sedang: dapat terjadi • Risiko rendah: cenderung tidak terjadi

25. Menentukan signifikansi bahaya Matrix Risk (UNEP, 2002)

26. Matriks Risiko Boevee (Hermawan, 2005)

27. Mikroorganisme Patogen Sumber: Winarno & Suroto (2002)

28. Contoh Produk dengan Berbagai Tingkat Risiko

29. Principle 2: determine the CCPs • CCP: a step at which control can be applied and the step is essential to prevent and eliminate a food safety hazard or reduce it to an acceptable level (Codex 1997). • CCPs relate to control of significant food safety hazards only.

30. 2. Determination of CCPs Critical control point decision tree • Questions to be asked for each raw material used Q1. Is it likely that the raw material contains the hazard under study at unacceptable levels? YES NO Not CCP Q2. Will processing, including expected consumer use, eliminate the hazard or reduce it to an acceptable level? YES NO CCP for the raw materials for this hazard Not CCP

31. Questions to be asked for each process stage (SNI, 1998)

32. Control Measure • Any factor or activitywhich can be usedto prevent, eliminate, or reducefood safetyhazardsto an acceptable level. • Control measures are specific for each hazard and can be either process or activities.

33. Control Measures

34. Control Measures

35. Control Measures

36. Critical Limit(s) • CL are the criteria that differentiate between‘safe’and ‘unsafe’ safety boundaries. • Codex (1997):“a criterion which separates acceptability from unacceptability.” • Defined by regulations, safety standards and scientifically proven values. • Operational limits are often set a more stringent levels to provide a buffer or action zone for process management.

37. Critical Limit(s) • Critical limits can be: • Values of pH, aw, temperature, time • Absorbed radiation dose • Levels of disinfectant or antimicrobial agents • Level of cleanliness • Limits of residues • Limits of contaminants • Limits of microbiological criteria • Sensory parameters: visual appearance and texture

38. Critical Limit(s) • Buffer or action zone, for example: If in a heat process the critical limit is 72oC for 2 minutes, the operating limit of 75oC for 10 min may be set.

39. Critical Limit(s) • CL harus spesifik dan jelas baik batas maksimum maupun minimum. • Harus berkaitan dengan tindakan pengendalian (monitoring) dan mudah dipantau. • Perusahaan harus memastikan bahwa CL dapat diaplikasikan pada operasi atau produk secara spesifik. • CL harus terukur dan dapat divalidasi.

40. When is deviation from normality unacceptable? ( i.e. establishment of Critical Limits )

41. Monitoring • Observation or measurement required to ensure that the process is under control operating within the defined critical limit  ensuring that control measures are working. • Codex (1997) defined monitoring as “ the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control”.

42. Monitoring • Monitoring of the CCPs is carried through tests or observations • The frequency and responsibility for monitoring will be appropriate to the control measure. • The frequency of monitoring will depend on the nature of the CCP and must be determined as part of the control system. • All personnel responsible for monitoring must be trained and have a clear understanding of their role.

43. Monitoring • Equipment and methods: • Physical parameters:temperature, time, moisture levels, metal detection, X-ray detection, inspecting sifters, and sieves. • Chemical test:chlorine analysis, pH, aw, pesticide residue analysis, allergen residue testing, heavy metals analysis. • Sensory test:visual appearance, texture.

44. Monitoring • The equipment used for monitoring must be: • Accurate:needs to be calibrated. • Easy to use • Accessible:having the equipment close to the point of testing and must be quick in terms of providing results.

45. Monitoring • People assigned monitoring duties should be: • Familiar with the process • Trained in the monitoring techniques • Trained in HACCP awareness • Unbiased in monitoring and reporting • Trained in the corrective action procedures: what to do when monitoring indicates loss of control

46. Corrective Actions • The action should be taken when the result shows a deviation from the critical limit • Adjust the process to bring it back under control • Deal with the material produced under the deviation period • Hold on the product • Rework • Release product after sampling and testing • Direct into less sensitive products, e.g. animal feed • Clarify to all personnel involve (what to do and how to do it)

47. Verification • The application of methods, procedures, tests, and other evaluations, in addition to monitoring, to determine conformity with the HACCP plan. • Verification is on going activities (Codex, 1997)

48. Verification • Review of HACCP system and records • Review of unacceptable deviations and their follow up • Confirmation that CCPs are controlled • Review of consumer complaints • End-product testing • Review of validation data

49. Verification • Whenever a change from the existing situation is made a new Hazard Analysis needs to be carried out, the outcome verified and the effectiveness of changes in the HACCP plan, if any, validated. • Monitoring records, deviation files, raw material &end-product test results, customer complaints etc. need to be reviewed regularly. • Records should be kept of all activities