Workshop on hygiene requirements for milk and dairy production AGR organised in co-operation with The Palestine Standards Institution

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1 Workshop on hygiene requirements for milk and dairy production AGR organised in co-operation with The Palestine Standards Institution Venue: Ramallah, Palestine May, 19 th -20 th, 2014

2 Processing milk products Application of HACCP principles Dr. Conrad Maas, Germany

3 Traditional food production Shelf life ( keepability ) and organoleptic quality oriented Production methods based on experience Safety taken for granted, later reliance on end - product testing

4 Traditional regulatory measures Food Control Based on : observation and testing of samples detection of spoilage ( unhealthy ) and fraud The system was: retroactive, and provided little health protection, particularly regarding pathogenic organisms

5 Traditional food control "Snap-shot" inspection for compliance with GHP/GMP + End - product testing

6 Traditional food inspection Flash observation of hygiene Checking compliance with regulations Regulations on GMP used often vague terms such as: as appropriate when necessary Little distinction between trivial and important matters concerning safety

7 End - product testing not reliable costly waste of food cost of analysis time consuming

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9 Tools for Food Safety Food Safety Monitoring System Quality Monitoring Sysem e.g. ISO 9000, Long Term Quality Management Strategy e.g. TQM General Specific All Quality Elements Specifications Specifications GMP/GHP =Basic Condition Food Safety Management Plan (product/process specific) = HACCP-Plan Quality System

10 CCP Significant food hazard Decision tree may be useful Critical limit must be set Preferably only a few Critical Control Point versus Quality Control Point QCP Food quality Decision tree not applicable Critical limit not appropriate Likely to be every step or activity

11 European legislation Preambulum Reg. EC/852/2004 (Food Hygiene) The application of hazard analysis and critical control point (HACCP) principles to primary production is not yet generally feasible. The HACCP system is an instrument to help food business operators attain a higher standard of food safety. The HACCP requirements should take account of the principles contained in the Codex Alimentarius. They should provide sufficient flexibility to be applicable in all situations, including in small businesses.

12 HACCP systeme versa Hygiene management HACCP systeme Hygiene management means preventive food safety management is a precondition for the implementation of HACCP

13 HACCP CONCEPT Hazard analysis, risk assessment, determination of CCP s, control measures cleaning and disinfection pest control temperature measurement personal hygiene No cross contamination Proper layout and make up of building technical preconditions

14 conditions for a successful managing of the HACCP-concept not very complicated not involved into the quality system HACCP must be easily to manage simple handling effective control of relevant hazards

15 The company-specific HACCP plan must clearly specify the products covered by this study (scope, boundaries). They may use the legal name, its own product codes or other pertinent description. The HACCP team must identify a complete list of all the characteristics, ingredients and production techniques for this type of product(s). This information should allow the HACCP team to define the final specifications. product identification composition physico-chemical composition (e.g. water activity (aw), acidity) the main processing effect on microbial growth (e.g. type of heat treatment) the packaging (MAP, material) the date of minimum shelf life, the conditions for storage

16 Target group: Average consumers Young, Old, Pregnant and Immunodeficient Only people suffering from cows' milk allergy or lactose intolerance, should not consume these products Storage: Condition: ambient versus chilled Shelf life: 7 days, 30 days, 4 months, 6-9 months Usage Kitchen (bakery): cheese, cream

17 Example: UHT-LDP & UHT Cream Raw Milk Reception Storage Raw Milk Standardization Intermediate storage Cream Mixing ingredients Intermediate storage UHT-treatment + homogenisation Intermediate aseptic storage Aseptic filling Paletisation Storage Transport Distribution

18 risk assessment 3. detection of occurence of damages probability of occurence is to be estimated: a) conditions within the relevant environment b) crossing of organisms in the environment c) kind and quantity of the organisms

19 Risk terminology Risk terminology Negligible Very low So rare that it does not merit to be considered Very rare but cannot be excluded Low Medium High Very high Rare but does occur Occurs regularly Occurs very often Events occur almost certainly Examples from (OIE, 2004; EFSA, 2006):

20 Documentation as few as possible, as much as needed HACCP-plan responsabilities description of the product intended use of the product hazards to control flow diagram of CCP s critical limits corrective actions sampling plan documentation of results

21 Quality control A system for maintaining standards in production or in a product, especially by inspecting samples of the product

22 Number of reported cases Incidence of infectious enteritis and typhoid fever in Germany 250, , , ,000 50,000 Typhoid and paratyphoid fevers Infectious enteritis Years

23 Increased incidence of foodborne diseases in UK * * x 1000 Laboratory reports of gastrointestinal infections in England and Wales Campylobacters Salmonellae Rotavirus Shigellae Giardia Cryptosporidia

24 No. of Isolations Emergence of foodborne diseases.coli O157/H7 in UK gland & Wales Northern Ireland Laboratory Isolation of E.coli O157:H7 FBD surveillance DB Scotland England & Wales Northern Ireland

25 Increased awareness of the economic consequences of foodborne diseases medical care costs loss of productivity loss of food reduced food trade decrease in tourism

26 Increase in the number of vulnerable people elderly immunocompromised individuals pregnant women infants and young children undernourished individuals

27 Urbanization A longer and more complex food chain; Agricultural production Processing & manufacturing thus greater opportunities for food contamination Food service & catering establishments Transport & serving Transport & distribution Household food preparation Consumption Street food vending operations

28 Changing lifestyles increase in food service and mass catering establishments (including street food vendors) travel role of women migration

29 Changing lifestyles increase in food service and mass catering establishments (including street food vendors) travel role of women migration

30 Objectives of application of the HACCP system Prevention of foodborne illness Reduction of costs of food analyses More efficient quality assurance system Reduction of losses due to product recall Protection of reputation

31 Control in space age Preventative Having control over something Ensuring safety and quality of products by building - in and engineering out Minimizing risks

32 HACCP concept Identifying potential food safety problems Determining how and where these can be controlled or prevented Describing what to do and training the personnel Implementation and recording

33 Traditional food safety assurance system GMP/GHP for safe food production + End- product testing for obtaining assurance of safety

34 Microbiological process control Having control over conditions which may lead to unacceptable or growth, survival, spread contamination with / of undesirable microorganism

35 Example of processing for safety Pasteurization Safety assured by adequate heating time & temperature Reliance on monitoring to detect deviations Timely adjustments and corrective actions

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37 This is Risk! Background for HACCP 37

38 Background for HACCP This is Risk Management! 38

39 Setting up of a HACCP system Food business operators (FBO s) equipment for maintaining a HACCP system experiences in registration and approval of establishments

40 H A C C P HACCP should help to identify, analyse and control severe health risks preventing security system for the production of safe food

41 7 principles of HACCP principle 1 principle 2 principle 3 principle 4 principle 5 principle 6 Hazard Analysis Critical Control Points (CCP) Critical Limits Monitoring Corrective Actions Verification principle 7 Documentation

42 prerequisites for the implementation of HACCP hygiene plan GHP must already be followed hygiene measures and testing should be documented after plan HACCP-Team microbiological, epidemiological knowledge chemical, toxicological knowledge technological knowledge description of production and processes

43 conditions for a successful managing of the HACCP-concept not complicated not involved into the quality system HACCP must be easy to manage simple handling effective control of relevant hazards

44 conditions for a successful managing of HACCP introduction of HACCP understanding of terminology personal and establishment conditions preparation of the staff training

45 further conditions for the implementation of a HACCP-system good hygiene practice cooperation, patience supported by management acceptance by the personnel involvement of the staff time/costs/benefit

46 What Is HACCP? Hazard Analysis and Critical Control Point The HACCP system is solely related to FOOD SAFETY and not PRODUCT QUALITY

47 HACCP based system HACCP does not replace GHP or existing documentation but it is more effective and aims at a better food safety

48 Example Guideline in cold stores: - unloading and acceptance - handling (e.g. freezing) - internal transport - storing - loading and delivery

49 freezing melting labelling quality check delivery unpack

50 food frozen cooled open meat/fish cooled packed meat/fish point of reception CP CCP cont. micro CCP cont. micro handling CP CCP cont. micro internal transport CCP CP CP CP storing CP CP CP cont. micro loading CP CP CP delivery CP CP CP

51 7 principles of HACCP principle 1 Hazard Analysis principle 2 principle 3 principle 4 principle 5 principle 6 principle 7

52 Prinzip 1: hazard analysis Hazard Identification Identify SIGNIFICANT biological, chemical or physical hazards and their causes at each step in the production process and their potential to damage consumers health Risk Assessment Probability of occurence importance for health

53 Principle I: Hazard analysis (and risk assessment) Chemical hazards Contaminants heavy metals PCB radio nuklides Residues animal drugs c + disinfection pesticides

54 Principle I: Hazard analysis (and risk assessment) biological hazards Bacteria Salmonella Staphylococcus aureus (toxin) E. coli Listeria monocytogenes Bacillus cereus (toxin)

55 Principle I: Hazard analysis (and risk assessment) biological hazards Bacteria Yersinia enterocolitica Vibrio cholerae Campylobacter jejuni Mycobacterium bovis Brucella spp.

56 Principle I: Hazard analysis (and risk assessment) biological hazards Yeasts/Moulds Mycotoxins esp. aflatoxins

57 Factors affecting growth of bacteria in food Temperature Time ph Water activity (a w ) Oxygen tension Preservatives Microbial interactions mh 35

58 Temperature range for growth of pathogenic bacteria Temperature C Min. Opt. Max. Salmonella Campylobacter E. coli S. aureus C. botulinum (proteolytic) C. botulinum (non-proteolytic) B. cereus = Mesophilic 2 = Psychrotrophic mh 36

59 Principle I: Hazard analysis (and risk assessment) Physical hazards Splinters metal glass wood other foreign bodies synthetic materials pieces of metal

60 risk of bacterial infections and intoxications of or by food Contamination Propagation source of contaminations ecology of micro-organisms way of contamination production of raw materials treatment / technology hygiene (personnel, plant etc.) intrinsic factors a w -value, ph-value extrinsic factors temperature atmospheric influences process factors influence of production technology on intrinsic and extrinsic factors implicit parameters interaction of micro-organisms

61 risk assessment 3. detection of occurence of damages probability of occurence is to be estimated: a) conditions within the relevant environment b) crossing of organisms in the environment c) kind and quantity of the organisms

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64 7 principles of HACCP principle 1 principle 2 principle 3 Hazard Analysis Critical Control Points (CCP) principle 4 principle 5 principle 6 principle 7

65 Decision tree

66 principle 2: implementing of CCP s CCP: step at which a hazard can be controlled in a process CCP must fulfill following criteria: specific for the hazard measures must eliminate the hazard elimination must be verifiable suitable corrective actions

67 principle 2: implementing of CCP s Microbiological testing is seldom an effective mean of monitoring CCPs (time to obtain results). Monitoring of CCPs can at best be accomplished through physical and chemical tests and through visual observations. Microbiological criteria may verify that the HACCP system is working.

68 7 principles of HACCP principle 1 principle 2 principle 3 Hazard Analysis Critical Control Points (CCP) Critical Limits principle 4 principle 5 principle 6 principle 7

69 principle 3: limits for CCP s limits: conditions allowing to control a process limits must not be exceeded or undergone by the results products can be devided into acceptable and unacceptable As an optimum limits can be measured or checked continuously and the keeping of the limits can be assured!

70 7 principles of HACCP principle 1 principle 2 principle 3 principle 4 Hazard Analysis Critical Control Points (CCP) Critical Limits Monitoring principle 5 principle 6 principle 7

71 principle 4: monitoring system of CCP s Monitoring plan scope: clarification, whether limits are kept z. B. check of temperature/time documentation in the control plan!

72 7 principles of HACCP principle 1 principle 2 principle 3 principle 4 principle 5 Hazard Analysis Critical Control Points (CCP) Critical Limits Monitoring Corrective Actions principle 6 principle 7

73 principle 5: corrective action In case of unsatisfaction of a CCP exceeding a certain limit Aim: Identification and elimination of the deviation Advice for managing of bad products correction/rework

74 principle 5: corrective action Purpose: to prevent foods which may be hazardous from reaching consumers. Therefore: determine and correct the cause of noncompliance determine the disposition of non-compliant product record the corrective actions that have been taken Specific corrective actions should be developed in advance for each CCP and included into the HACCP plan

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76 7 principles of HACCP principle 1 principle 2 principle 3 principle 4 principle 5 principle 6 Hazard Analysis Critical Control Points (CCP) Critical Limits Monitoring Corrective Actions Verification principle 7

77 principle 6: verification checking the suitibility of the HACCP-concept testing of end-products checking of the documentation intern and extern audits if needed revision of the systeme

78 principle 6: verification must be sufficient to for the confirmation of HACCP frequency of verification depends on the business

79 7 principles of HACCP principle 1 principle 2 principle 3 principle 4 principle 5 principle 6 principle 7 Hazard Analysis Critical Control Points (CCP) Critical Limits Monitoring Corrective Actions Verification Documentation

80 principle 7: documentation as few as possible, as much as needed HACCP-plan responsabilities description of the product intended use of the product hazards to control flow diagram of CCP s critical limits corrective actions testing systeme documentation of results

81 checking at CP in certain intervals suitable checking devices checking odour, colour, shape of food check of the packaging SOP for these checks documentation of these checks Controlled by responsible person

82 Example Milk : Brucellosis, Tuberculosis Is the hazard relevant? Hazard analysis Risk assessment Heat treatment Controlling, CCP On-line automatic Temperature measurement Monitoring C / sec. Automatic return of the milk (3-way valve) Phosphatase determination Critical limits Corrective measure Verification

83 documentation existing advices, production plans documentation of temperatures own checks (microbiolog. etc.) on-site-visits, audits

84 temperature temperature measurement devices documentation of temperature

85 Bacterial growth curve mh _ Toxic Time to spoilage Time Lag phase Log phase Spoils Stationary phase

86 obstacles for HACCP I production is not HACCP compatible too many CCPs too few CCPs

87 obstacles for HACCP II: wrong principles no control possible no correction possible

88 obstacles for HACCP III: HACCP-systeme too complicated GHP is insufficient

89 advantages of the HACCP-concept improved health protection common standards preparation of a chain of security transparency and traceability fulfilling FBO s responsibility

90 disadvantages of the HACCP-concept time and efforts for the introduction know how needed, as well for small businesses expenses for documentation documentation does not guarantee a living systeme checks by the competent authority ineffective

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92 Thank you for listening!