7 Principles of HACCP HAZARD A biological chemical

7 Principles of HACCP

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).

Principle 1: Hazard analysis n 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.

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

Microbial Hazards n Dangerous microorganisms that cause food-borne disease (FBD): – Bacteria – Moulds – Viruses – Parasites

Patogenic microorganisms are the MAJOR SOURCES of food contamination!!!

Major bacteria causing FBD • • 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

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

Mycotoxins

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

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

Bacterial growth curve

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

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 (70 o. C for 2 min) is sufficient to kill Salmonella in high moisture foods.

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).

Minimum infective dose L. monocytogenes High (100/g of food) Salmonella (excluding 106 S. typhi) Salmonella typhi 10 – 100 Camphylobacter About 500

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

Temperature range for the growth of patogenic bacteria

Temperature range for the growth of toxigenic moulds

Prevention of FBD

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

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

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

Menentukan signifikansi bahaya Matrix Risk (UNEP, 2002)

Matriks Risiko Boevee (Hermawan, 2005) Risk ranking scheme based upon severity of risk (S) and probability of hazard (P) Probability of occurrence (P) Severity of Unlikely Occasionally Probable Common hazard (S) (1) (2) (3) (4) Very High (4) High (3) 5 6 7 8 4 5 6 7 Medium (2) 3 4 5 6 Low (1) 2 3 4 5

Mikroorganisme Patogen Bahaya Tinggi Clostridium botulinum • Shigella dysenteriae • Salmonella typhy • Salmonella paratyphy • Trichinella spiralis • Vibrio cholerae • Bahaya Sedang Bahaya Rendah Listeria monocytogenes • Camphylobacter jejuni • Salmonella spp. • Shigella spp. • Streptococcus pyrogenes • Yersinia enterolytica • Hepatitis A dan E • Aeromonas spp. • Rotavirus Norwalk • Vibrio parahaemolyticus • Bacillus cereus • Clostridium perfringens • Staphylococcus aureus • Taenia saginata • Sumber: Winarno & Suroto (2002)

Contoh Produk dengan Berbagai Tingkat Risiko Tinggi • Daging • Ikan mentah • Produk-produk olahan susu. • Produk dengan nilai p. H 4. 6 atau diatasnya • Produk-produk yang mengandung ikan, daging, telur, sayur, serealia. Risiko Sedang • Produk-produk kering dan produk beku (ikan, daging, telur, sayuran, serealia) • Sandwich, pie daging • Produk berbasis lemak (margarine, coklat, mayonaise, salad dressing) Risiko Rendah • Produk dengan p. H di bawah 4. 6 (asam) • Produk dengan kadar gula tinggi (selai, sirup, dll) • Produk – produk konfeksioneri • Minyak

Principle 2: determine the CCPs n 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). n CCPs relate to control of significant food safety hazards only.

2. Determination of CCPs Critical control point decision tree n Questions to be asked for each raw material used Q 1. Is it likely that the raw material contains the hazard under study at unacceptable levels? YES NO Not CCP Q 2. Will processing, including expected consumer use, eliminate the hazard or reduce it to an acceptable level? CCP for the raw materials for this hazard NO YES Not CCP

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

Control Measure n Any factor or activity which can be used to prevent, eliminate, or reduce food safety hazards to an acceptable level. n Control measures are specific for each hazard and can be either process or activities.

Control Measures Biological Hazards Control Measures Vegetative pathogens: - Heat stable pre-formed toxins: S. aureus, B. cereus - Salmonella, Listeria monocytogenes, E. coli. Lethal heat treatment during packaging - Temperature control - Intrinsic factors: p. H, aw - Intact packaging - Secure building, etc. effective supplier process and testing - hand wash procedures - control of time

Control Measures Chemical Hazards Cleaning chemicals Chemical additives Control Measures Use of non-toxic, food compatible cleaning compounds - separate storage - covered containers - -Safe operating practices - written additive instructions - validation of levels through usage rates, sampling and testing

Control Measures Physical Hazards Control Measures Glass, wood, metal, etc in raw materials. - inspection – electronic or human - Washing - Air separation - X-ray detection - Metal detector, etc. Physical process crosscontaminants: pests - Pest control - Extermination (electric pest killers, poisoning, bait boxes, etc).

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

Critical Limit(s) n Critical § § § § limits can be: Values of p. H, 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

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

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

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

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”.

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.

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

Monitoring n The be: equipment used for monitoring must § 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.

Monitoring n People be: assigned monitoring duties should § 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

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)

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

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

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. n Monitoring records, deviation files, raw material &end-product test results, customer complaints etc. need to be reviewed regularly. n Records should be kept of all activities n