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7/31/2019 General Requirements for Managing Food Safety in the Context of HACCP Based Controls and Regulation 2073 2005 - P. Raspor
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Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Workshop on microbiological
criteria for foodstuffsAGR 33429
organised in co-operation withCroatian Ministry of Agriculture,Fisheries and Rural Development
Hotel InternationalMiramarska 24
HR-10000 Zagreb
Zagreb,8th July in 2009
Biotehnika fakulteta
Univerza v Ljubljani,
Slovenija
Peter RasporGeneral requirements for managing food safety
in the context of HACCP based controls andRegulation (EC) 2073/2005
Zagreb, 8. 7. 2009
*Profesor Dr., DDr.H.C.Predstojnik Katedre za Biotehnologijo, Mikrobiologijo in varnost ivil
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
AGENDA
INTRODUCTION
LEGISLATION Regulation (EC) 2073/2005
Microbiological Criteria HACCP based controls
Good Practices
What alse?
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
AGENDA
INTRODUCTION LEGISLATION
Regulation (EC) 2073/2005
Microbiological Criteria
HACCP based controls Good Practices
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What is The food?Bender, A. E. / Bender, D. A. 1995. Dictionary of food & nutrition. Oxford, Oxford University Press, p. 152.
Food any solid orliquid materialconsumed by livingorganism to supplyenergy, build andreplace tissue, orparticipate in suchreactions.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
The FoodBender, A. E. / Bender, D. A. 1995. Dictionary of food & nutrition. Oxford, Oxford University Press, p. 152.
FAO/WHO Codex Alimentarius Commission defines food as asubstance, whether processed, semi-processed, or raw,which is intended for human consumption and includes drink,chewing gum, and any substance that has been used in themanufacture, preparation, or treatment of food but does notinclude cosmetics, tobacco, or substances used only as drugs.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
The food law in EU(http://europa.eu.int/comm/dgs/health_consumer/library/press/press82_en.html)
Definition of the term "food in EU legislation":Food means any substance or product intended tobe, or expected to be ingested by humans.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Definition of food chain Very simple pathway of nutrient flow. Ex.
Carnivore > herbivore > plant .www.alken-murray.com/glossarybug.html
Food chains and food webs describe thefeeding relationships between species in abiotic community. In other words, they showthe transfer of material and energy from onespecies to another within an ecosystem.en.wikipedia.org/wiki/Food_chain
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Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Definition of food chain
A food supply chain, logistics network, or supply network is acoordinated system of entities, activities, information andresources involved in moving a product or service from supplierto customer.
The entities of a supply chain consist of primaryproducers,secondury production, manufacturers, serviceproviders, distributors, and retail outlets. Food supply chainactivities transform raw materials and components into afinished product.
The primary objective of food supply chain management is tofulfill customer demands through the most efficient use ofresources.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
AGRICULTURE
Farm AssuranceSchemes
PRODUCTION
HACCP basedProduction QA
Food
RETAIL
In storeHACCP
DISTRIBUTION
Chill Chain andHandling
Traceability and Control
Food (supply) chain
CONSUMPTION
Home?
EU REG. 178/2002
Definition: the ability to trace and follow a product through all stages ofproduction, processing and distribution
Objective: to facilitate targeted individual withdrawals and/or to provideappropriate information to consumers or control officials
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Estimation of food illnesses annually(extracted from Redmond E, GriffithCJ; 2003, WHO reports
130 million Europeans
(480 million population)
27%
76 million Americans
(277 million population) 27%
4,7 million Australians
(20 million population)
24%
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Food is a risk and food is concern
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Systemic tools to reduce risk
Technological tools
Regulatory tools
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
In EU member states sinceJanuary 1st 2006
In EU member states sinceJanuary 1st 2006
In Slovenia sinceJanuary 1st 2003In Slovenia sinceJanuary 1st 2003
HACCPHACCP
In USA sinceJuly 1996
In USA sinceJuly 1996
HACCP system is mandatoryHACCP system is mandatory
In Australia since
January 1st
2002
In Australia sinceJanuary 1st 2002
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Livestock
Seafood
Storage
Trasport
Processing Retail Cattering/CookingEatingCrops
Vehicleemission
Agriculturalpractices
Landfills
Industrialemissions
Where hazards arise in the foodsupply?
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Types of hazards
Three type of hazards :
Biological Chemical
Physical
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BIOLOGICAL HAZARDS
micro-organisms means
bacteria,
viruses,
yeasts,
moulds,
algae,
parasitic protozoa, microscopic parasitichelminths,
and their toxins andmetabolites
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
BIOLOGICAL HAZARDS
Factor contributing tothe occurrence:
improperstorage/holdingtemperature
in-adequate cookingprocess
improper hygiene
practices by foodhandlers
cross contamination incorrect reheating
process
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
BIOLOGICAL HAZARDS
3 ways of controllingmicrobiologicalhazards in food:
Eliminate, prevent or
reduce thehazards
Avoid contamination
Avoid bacteria growthand toxin
production
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
BIOLOGICAL HAZARDS
Eliminate, prevent or reducethe hazards
proper cooking and heatingprocess
freezing- to destroy
parasite in fish andmeat
Avoid food contamination
proper personnel hygiene
proper handling andstorage
proper cleaning andsanitation
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BIOLOGICAL HAZARDS
Avoid microbial growth
use preservatives
proper storage andpreparation
use chilling or freezingmethod
reduce pH and water
activity hold at the right
temperature - out ofthe danger zone (> 63C)
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
List and Sequence of steps during the
HACCP building
1. Management Commitment
2. Assemble HACCP Team
3. Describe Product
4. Identify Intended use
5. Construct process flow diagram
6. On-site verification of flow diagram
7. List all potential hazards associated with each step (Principle 1)
8. Determine CCPs (Principle 2)9. Establish Critical Limit for each CCP (Principle 3)
10. Establish a Monitoring System for each CCP (Principle 4)
11. Establish Corrective Action for deviations that may occur(Principle 5)
12. Establish Verification procedures (Principle 6)
13. Establish Document Control Procedure (Principle 7)
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
What is HACCP?
Hazard Analysis and Critical Control Point
Food safety system:Internationally recognized
Science-based
Preventative in nature
When developing a HACCP program:Identify hazards to food safety
Implement control measures to prevent,eliminate or reduce hazards
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Critical elements in food safetyJevnik M., Hlebec V., Raspor P. 2006. Meta-analysis as a tool for barriersidentification during HACCP implementation to improve food safety. Acta
Alimentaria, 35(3), 319-353.
47%
of barriers
Human
factor
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HACCP system working method
advantages HACCP is a systematical approach that includes every point
of food suitability view, from the production phase, growth,harvest and storing of the raw material to differentproductions. The production phases where the final productis remade from the raw material to distribution through thestore and cattering industry to consumers.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
HACCP system working method
advantages Traditional retrospective control, where we
analyze the final product, places the HACCPsystem in the preventive concept of following thesuitability.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
HACCP system working methodadvantages
The HACCP system ascertains the hazardelements, also those that can in reality only bepredicted
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
HACCP system working methodadvantages
The HACCP system is focusing on the technicalmeans and critical points in production process
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HACCP system working method
advantages The HACCP system is compatible with other
systematic solutions, that have a goal to buildsystems for quality assurance
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
HACCP system working method
advantages The HACCP systems assures economical control
for food suitability
Preventive of the HACCP system has aconsequence for direct product reduction loss
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
HACCP system working methodadvantages
HACCP is valued by FAO/WHO & CodexAlimentarius as the most successful method forpreventing the diseases transferred with food.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good practicesGood practices
Good practices supports development in the last 50 years,with constant rate, enabling integration into all activities,which are important in food industries specific for eachindividual branch.
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Good practices
Good Practice means activity of the qualityassurance which ensures that food products andfood related processes are consistent andcontrolled to assure quality procedures in foodsystems.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good practices
If we analyse goodpractices we can find threecategories of goodpractices:
Directly connected withfood
(i.e.: GMP good manufacturingpractice)
Indirectly connected with
food issues(i.e.: GRP good research
practice)
Needed but not existing inreality
(i.e.: GKP good housekeepingpractice)
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Today we manage food safety alsowith the help of Good Practiceslike: Good Agricultural Practice (GAP), Good Manufacturing
Practice (GMP), Good Transport Practice (GTP), GoodStorage Practice (GSP), Good Retail Practice (GRP),Good Catering Practice (GCP) as well as GoodLaboratory Practice (GLP) and Good Hygiene Practice(GHP) which can be applied independently.
In all of them are HACCP elements that compose
HACCP system as main system in food practice today.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good practices are directlyconected to food issues
1. good agricultural practice (GAP)2. good manufacturing practice (GMP)3. good transport practice (GTP)4. good storage practice (GSP)5. good retail practice (GRP)6. good catering practice (GCP)7. good laboratory practice (GLP)
8. good hygiene practice (GHP)
good housekeeping practice (GKP)
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Good practices
GKP
Good housekeeping practice is selection ofthe principles and techniques of foodstorage and preparation at home done byconsumer directly.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good practices
GAP
Good agricultural practice is selection of themethods of land use which can best achieve theobjectives of agronomic and environmentalsustainability.
They are described in several different Codes ofPractice designed by producers organizations (egCOLEACP), importers and retailers consortia (e.g. BRC,FPC, CIMO, EUREP) and Government bodies representingconsumers (e.g. UK Food Standards Agency).
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Agricultural Practice (GAP),
In that case a suitable use of manure, storage ofmanure, use of pesticides and herbicydes, suitableuse of feed supplements, a need to control theheavy metal content in the soil and a need to avoidany possibility for contamination with pathogenmicroorganisms is important.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Goodmanufacturingpractice
Good manufacturing practice shall mean a system forensuring quality, providing for the consistent
manufacture and control of products by qualitativecriteria and conformity assessing criteria with intendedpurpose as required by the marketing authorisation andspecification of the product;
Good Manufacturing Practice means the part of the quality assurance whichensures that food products are consistently produced and controlled to thequality standards appropriate to their intended use.
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Good Manufacturing Practice
(GMP) GMP is based on good hygiene practices and well
organised labour. Good manufacturing practice is sometimes
referred to as current good manufacturingpractice (cGMP current Good ManufacturingPractice), which reminds manufacturers to keeptheir equipment up to date.
In order for the requirements of goodmanufacturing practice to be realised,manufacturers have to take into considerationthe layout and construction of the plant,personnel training, hygiene practice, sanitaryprecautions, supervision of operations, theprocess itself and the control of goodmanufacturing practice.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Manufacturing Practice
(GMP) Food, produced under the requirements of good
manufacturing practice can contain naturallypresent undesired substances, which are notharmful for human health in small quantities.
Good manufacturing practice contributes to thesuccessful economy of a company. Goodmanufacturing practice will allow companies toproduce quality products and it will constantly beimproved.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Manufacturing Practices(GMPs)
Good Manufacturing Practices (GMPs) provideimportant guidelines for the production of safeand quality foods.
GMP-Food Safety Audit contains more categorieslike:
Food Safety Systems Quality Systems Grounds, Building and Equipment Pest Control Employee Practices Receiving, Storage and Shipping Plant sanitation Processing
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
How do GMPs of differentcountries compare?
At a high level, GMPs of various nations arevery similar; most require things like: equipment and facilities being properly
designed, maintained, and cleaned
Standard Operating Procedures (SOPs) bewritten and approved
an independent Quality unit (like QualityControl and/or Quality Assurance)
well trained personnel and management
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Good transport practice
Good transport practice shall mean aqualitative system governing theorganisation, implementation and control oftransport of food products from theproducer to the final user;
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Transport Practice
In the food industry, the food transport becomesan important part of the food chain which leadsfrom producer to consumer.
Good food transport practice is the way oftransport where food in transport chain remainssafe, non-contaminated and suitable forconsumers.
Beside the transport of food good transport
practice also includes preparing and pre-transportstorage of food, preparing of vehicle andtransport boxes, preparing of loading andunloading place and documentation of environmentin which the food exist during transport.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Transport Practice
With good transport practice, one tries toexclude every biological, chemical,microbiological and physical hazard.
In every part of transport chain it isnecessary to perform basic hygienicpractice but, there are some procedures,developed for transport practice only.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Prducer
Storage beforetransport
loading
Selection andpreparation oftransporters
Selection andpreparation oftransports and
packaging tor transport
Change/replacement of transporters
Downloading
Selection of the placefor loading
Receiver
Selection ofparmeteers and
condition (temp, time),
Hygiene
Staff Training,
Control anddocumentation of all
procedures
Delivery to carrier,transportee
Suitable locationfor downloading
Good Transport Practice
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Good StoragePractice
good storage practice shall mean aqualitative system governing theorganisation, implementation andcontrol of product storage inaccordance with a defined regimeprior to their further use;
Good storage practice is codex ofruels to assure best handling of foods,basic legislation, persons, conditionsfor wholesalers of food items. Itshould be established on theprinciples to ensure quality and saftyof stored products or row materials
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Storage Practice (GSP)
Good Storage PracticeGuidelines
Pre-requisite forlicensing : importers,wholesalers andretailers
Key elements :Premises, Personnel,
Documentation, Recalls Inspection -
collaboration with -
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good RetailPractice
Good retail practice is ensureing that quality system operated bydistributors (wholesalers) of food products are:
Food products that they distribute are authorisedin accordance with Community legislation, thatstorage conditions are observed at all times,including during transportation, that contaminationfrom or of other products is avoided, that anadequate turnover of the stored food productstakes place and that products are stored inappropriately safe and secure areas.
In addition to this, the quality system should ensure that the rightproducts are delivered to the right addressee within a satisfactorytime period. A tracing system should enable any faulty product tobe found and there should be an effective recall procedure.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Retail Practice (GRP)
GRP means a preventive measure thatincludes practices and procedures toeffectively control the introduction ofpathogens, chemicals, and physical objects
into food, that is prerequisite toinstituting a HACCP or Risk Control Plan,and is not addressed by a public healthintervention or risk factor.
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Good CateringPractice
Good catering practice consist of practicaladvices and assistance to managers ofcatering (food service) outlets and suppliersto caterers. The Guidelines concentrate onthe essential steps needed to ensure that
the food served is always safe andwholesome.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Catering Practice (GCP)
The Catering includes the following types of operation: Banqueting Clubs Contract & In-House Catering (in the work place, institutions,
schools,healthcare establishments, prisons, etc.) Delivered Catering and Meals on Wheels Fish & Chip Restaurants Food on the Move (Trains, Coaches, Boats*, Aeroplanes*) Hotels & Guest Houses Mobile Snack Vehicles, Market Stalls Outdoor & Event Catering Private Party Caterers (including catering operations conducted
from domestic premises) Public Houses Restaurants & Cafes of all types Sandwich Bars Takeaway & Fast Food Restaurants
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Hygiene Practices
good hygiene practices are concerned with:- processes that return the processing environment
to its original condition. These are usually
referred to as cleaning and disinfection orsanitation programmes.-practices that keep the building and equipment in
efficient operation. These are referred to as themaintenance programme.
-practices that relate to the control of cross-contamination during manufacture, usuallyrelated to people, surfaces, the air and thesegregation of raw and processed product.
Such control is generally referred to asGood Manufacturing Practice (GMP)
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Hygiene Practice (GHP)
It has many aspects: personal hygiene (proper living habits, cleanliness
of body and clothing, healthful diet, a balancedregimen of rest and exercise);
domestic hygiene (sanitary preparation of food,
cleanliness, and ventilation of the home); public hygiene (supervision of water and food
supply, containment of communicable disease,disposal of garbage and sewage, control of air andwater pollution);
industrial hygiene (measures that minimizeoccupational disease and accident); and
mental hygiene (recognition of mental andemotional factors in healthful living).
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Good Hygiene Practice (GHP)
Personal hygiene Daily washing of the body and hair More frequent washing of hands and/or face Cleaning of the clothes and living area General avoidance of bodily fluids Holding a hand in front of the mouth when
sneezing or coughing Suppression of habits such as spitting or nose-
picking Use of condoms in sexual relations Washing hands before eating Not licking fingers before picking up sheets of
paperBiotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Hygiene Practice (GHP)
Food preparation and consumption Cleaning of food preparation areas and equipment Washing of hands after touching uncooked food when
preparing meals Non-sharing of cutlery when eating Refrigeration of foods (and avoidance of certain foods in
environments where refrigeration is or was not feasible) The labeling of food to indicate when it was produced (or,
as food manufacturers prefer, to indicate its best before
date) Storage of food so as to prevent contamination by DDD
compounds Disposal of uneaten food and packaging Institutional dish sanitizing
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Hygiene Practice (GHP)
All practices regarding the conditions andmeasures necessary to ensure the safetyand suitability of food at all stages of thefood chain
Identify the essential principles of foodhygiene applicable throughout the foodchain, to achieve the goal of ensuring thatfood is safe and suitable for humanconsumption.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Hygiene Practice (GHP)
Identify the essential principles of foodhygiene applicable throughout the foodchain, to achieve the goal of ensuring thatfood is safe and suitable for human
consumption.
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Good Hygiene Practice (GHP)
Areas examined under GHP
1. Primary production
2. Establishment: design and facilities
3. Control of operation
4. Establishment: maintenance and sanitation
5. Establishment: personal hygiene
6. Transportation
7. Product information and consumer awareness
8. Training
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good laboratory
practice
Good laboratory practice shall mean aqualitative system governing organisationalprocesses and conditions of planning,implementing, controlling, recording andreporting on food related studies;
The Principles of good laboratory practice are intended toidentify the GLP requirements for test facilities(laboratories)which perform studies for regulatory purposes. Theseprinciples define a quality system concerned with theorganisational process and the conditions under which studiesare planned, performed, monitored, recorded, reported andarchived.
http://embryo.ib.amwaw.edu.pl/invittox/er/ER/ER%2037.pdf
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Laboratory Practice
Good Laboratory Practice (GLP) embodies a set ofprinciples that provides a framework within whichlaboratory studies are planned, performed,monitored, recorded, reported and archived.
These studies are undertaken to generate data bywhich the hazards and risks to users, consumersand third parties, including the environment, canbe assessed for pharmaceuticals, agrochemicals,cosmetics, food and feed additives andcontaminants, novel foods and biocides.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good Laboratory Practice
GLP helps assure regulatory authorities that thedata submitted are a true reflection of theresults obtained during the study and cantherefore be relied upon when making risk/safetyassessments.
The aims of Good laboratory practice are orientedtowards the establishment and insurance ofquality and integrity of study data andconsequently the facilitation of cooperationbetween laboratories in different countries.
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Good Laboratory Practice
The implementation of GLP requiresstrenuous approach of all the participantsas of all of the supervising authorities aswell.
The main task of the latter is to examinetesting laboratories and to asses whetherthey are GLP compliant or not.
The system is fully established indeveloped countries.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Good practicesGood practices
Precise analysis of good practices show that they areintroverted and they to be limited within their own frame ofactivity and they don not generally show intention to be fusedwith neighbouring or related good practice.
However it has to be stressed that all have intention ofproviding consumers with safe and quality products.
Each good practice has its own primary issues forming basis
for other elements, which together determine the extentof particular good practice.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
How Does Everything Fit?
PrerequisitePrograms
ManagementCommitment
HACCPPlan
TheHACCP
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
But respecting legislation along foodsupply chain!
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Representative ManufacturingSteps
Formula(Recipe)
FlexibleTesting
Components WarehouseBulk
ProductionPackaging Shipping
Market
SegregateMaterials
CountFill Container
Label
Mixer/Blender
Records
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
AGENDA
INTRODUCTION
LEGISLATION Regulation (EC) 2073/2005
Microbiological Criteria HACCP based controls
Good Practices
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
COMMISSION REGULATION (EC) No2073/2005 of 15 November 2005 onmicrobiological criteria for foodstuffs
30 statements and 12 articleslays down:
the microbiological criteriafor certain micro-organismsand
the implementing rules to becomplied with by foodbusiness operators whenimplementing the general andspecific hygiene measures
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
30 statements state with clearconnection to other relevant regulation
1. Protection of public health is one of the fundamental objectivesof food law
2. Foodstuffs should not contain micro-organisms or their toxinsor metabolites
3. General food safety requirement no unsafe food on the market4. Microbiological criteria is base for food safety5. Safety of foodstuffs is ensured by good hygiene practice and
hazard analysis and critical control point (HACCP) principles6. Food business operators are to comply with microbiologicalcriteria
7. Official controls performed to ensure the verification ofcompliance with feed and food law, animal health and animalwelfare rules
8. Setting microbiological criteria for foodstuffs describes thestrategy to lay down and revise the criteria
9. Microbiological criteria should be relevant and effective inrelation to consumer health protection
10. Objective to keep the concentration of Listeria monocytogenesin food below 100 cfu/g.
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Conection to HACCP in (EC) No2073/2005
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Statements 4,5 and 23 of (EC) No2073/2005 are connected to HACCP
1. Protection of public health is one of the fundamental objectives offood law
2. Foodstuffs should not contain micro-organisms or their toxins ormetabolites
3. General food safety requirement no unsafe food on the market
4. Microbiological criteria base for food safety5. safety of foodstuffs is ensured by good
hygiene practice and hazard analysis andcritical control point (HACCP) principles
6. food business operators are to comply with microbiological criteria7. official controls performed to ensure the verification of compliance with
feed and food law, animal health and animal welfare rules8. setting microbiological criteria for foodstuffs describes the strategy to
lay down and revise the criteria9. microbiological criteria should be relevant and effective in relation to
consumer health protection10. objective to keep the concentration of Listeria monocytogenesin food
below 100 cfu/g.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Statements 4,5 and 23 of (EC) No2073/2005 are connected to HACCP
(4) Microbiological criteria also give guidance on theacceptability of foodstuffs and theirmanufacturing, handling and distributionprocesses. The use of microbiological criteriashould form an integral part of the implementation
of HACCP-based procedures and other hygienecontrol measures.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Statements 4,5 and 23 of (EC) No2073/2005 are connected to HACCP
(5) The safety of foodstuffs is mainly ensured by a preventiveapproach, such as implementation of good hygiene practice andapplication of procedures based on hazard analysis and criticalcontrol point (HACCP) principles. Microbiological criteria can beused in validation and verification of HACCP procedures and otherhygiene control measures. It is therefore appropriate to setmicrobiological criteria defining the acceptability of the processes,and also food safety microbiological criteria setting a limit above
which a foodstuff should be considered unacceptably contaminatedwith the microorganisms for which the criteria are set.
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Article 4Testing against criteria
1. Food business operators shall perform testing asappropriate against the microbiological criteria setout in Annex I, when they are validating orverifying the correct functioning of theirprocedures based on HACCP principles and goodhygiene practice.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Article 4Testing against criteria
2. Food business operators shall decide the appropriate samplingfrequencies, except where Annex I provides for specific samplingfrequencies, in which case the sampling frequency shall be at leastthat provided for in Annex I. Food business operators shall makethis decision in the context of their procedures based onHACCP principles and good hygiene practice, taking into accountthe instructions for use of the foodstuff. The frequency ofsampling may be adapted to the nature and size of the foodbusinesses, provided that the safety of foodstuffs will not beendangered.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Article 5Specific rules for testing and sampling
3. The number of sample units of the sampling plansset out in Annex I may be reduced if the foodbusiness operator can demonstrate by historicaldocumentation that he has effective HACCP-basedprocedures.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Article 7Unsatisfactory results
1. When the results of testing against the criteriaset out in Annex I are unsatisfactory, the foodbusiness operators shall take the measures laiddown in paragraphs 2 to 4 of this Article togetherwith other corrective actions defined in their
HACCP-based procedures and other actionsnecessary to protect the health of consumers.
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Article 7Unsatisfactory results
1. In addition, they shall take measures to find thecause of the unsatisfactory results in order toprevent the recurrence of the unacceptablemicrobiological contamination. Those measures mayinclude modifications to the HACCP-basedprocedures or other food hygiene controlmeasures in place.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Article 7Unsatisfactory results
2. The food business operator may use the batch for purposesother than those for which it was originally intended,provided that this use does not pose a risk for public oranimal health and provided that this use has been decidedwithin the procedures based on HACCP principles and goodhygiene practice and authorised by the competent authority.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
AGENDA
INTRODUCTION
LEGISLATION Regulation (EC) 2073/2005
Microbiological Criteria
HACCP based controls
Good Practices
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Statements 5 and 11 of (EC) No2073/2005 are connected to HACCP
(5) The safety of foodstuffs is mainly ensured by a preventiveapproach, such as implementation of good hygiene practice andapplication of procedures based on hazard analysis and criticalcontrol point (HACCP) principles. Microbiological criteria can beused in validation and verification of HACCP procedures and otherhygiene control measures. It is therefore appropriate to setmicrobiological criteria defining the acceptability of the processes,and also food safety microbiological criteria setting a limit abovewhich a foodstuff should be considered unacceptably contaminatedwith the microorganisms for which the criteria are set.
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Indirect connection to other rlevantregulation linked in 2073
Regulation (EC) No 852/2004 on the hygiene of foodstuffs point 11,12,13,14 15; CHpI art1,5,7,9,13; ChpVII
Regulation (EC) No 853/2004 laying down specifichygiene rules for food of animal origin ponit 7; and chpIV art 10; and sect 2
Regulation (EC) No 854/2004laying down specific rules forthe organisation of official controls on products ofanimal origin intended for human consumptionart4 and anex 1
Regulation (EC) No 882/2004 on official controlsperformed to ensure the verification of compliance withfeed and food law,animal health and animal welfare rulespoint 12,13; art8; anex 2
link to HACCP and GP
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Indirect connection to other rlevantregulation linked in 2073
Regulation (EC) No 852/2004 on the hygiene offoodstuffspoint 11,12,13,14 15; CHpI art1,5,7,9,13; ChpVII
link to HACCP and GP
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 852/2004 on thehygiene of foodstuffs
11) The application of hazard analysis andcritical control point (HACCP) principles toprimary production is not yet generallyfeasible. However, guides to good practiceshould encourage the use of appropriatehygiene practices at farm level. Wherenecessary, specific hygiene rules forprimary production should supplementthese guides. It is appropriate for thehygiene requirements applicable to primaryproduction and associated operations todiffer from those for other operations.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 852/2004 on thehygiene of foodstuffs
(12) Food safety is a result of severalfactors: legislation should lay downminimum hygiene requirements; officialcontrols should be in place to check food
business operators compliance and foodbusiness operators should establish andoperate food safety programmes andprocedures based on the HACCP principles.
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Regulation (EC) No 852/2004 on thehygiene of foodstuffs
(13) Successful implementation of theprocedures based on the HACCP principleswill require the full cooperation andcommitment of food business employees.To this end, employees should undergotraining. The HACCP system is aninstrument to help food business operators
attain a higher standard of food safety.The HACCP system should not be regardedas a method of self-regulation and shouldnot replace official controls.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 852/2004 on thehygiene of foodstuffs
(14) While the requirement of establishingprocedures based on the HACCP principlesshould not initially apply to primaryproduction, the feasibility of its extensionwill be one element of the review that theCommission will carry out followingimplementation of this Regulation. It is,
however, appropriate for Member Statesto encourage operators at the level ofprimary production to apply such principlesas far as possible.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 852/2004 on thehygiene of foodstuffs
(15) The HACCP requirements should take accountof the principles contained in the CodexAlimentarius. They should provide sufficientflexibility to be applicable in all situations,including in small businesses. In particular, it isnecessary to recognise that, in certain food
businesses, it is not possible to identify criticalcontrol points and that, in some cases, goodhygienic practices can replace the monitoring ofcritical control points. Similarly, the requirementof establishing "critical limits" does not imply thatit is necessary to fix a numerical limit in everycase. In addition, the requirement of retainingdocuments needs to be flexible in order to avoidundue burdens for very small businesses.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 852/2004 on thehygiene of foodstuffs
GENERAL PROVISIONS
Article 1
Scope
1. This Regulation lays down general rules for food
business operators on the hygiene of foodstuffs,taking particular account of the followingprinciples:
(e) guides to good practice are a valuable instrumentto aid food business operators at all levels of thefood chain with compliance with food hygiene rulesand with the application of the HACCP principles;
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Regulation (EC) No 852/2004 on thehygiene of foodstuffs
CHAPTER XIITRAININGFood business operators are to ensure:1. that food handlers are supervised and instructed and/or
trained in food hygiene matters commensurate with theirwork activity;
2. that those responsible for the development and maintenanceof the procedure referred to in Article 5(1) of thisRegulation or for the operation of relevant guides havereceived adequate training in the application of the HACCPprinciples; and
3. compliance with any requirements of national law concerningtraining programmes for persons working in certain foodsectors.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Indirect connection to other rlevantregulation linked in 2073
Regulation (EC) No 853/2004 laying down specifichygiene rules for food of animal originponit 7; and chpIV art 10; and sect 2
link to HACCP and GP
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 853/2004 layingdown specific hygiene rules for food ofanimal origin
(7) The requirement in Regulation (EC) No852/2004 whereby food businessoperators carrying out any stage ofproduction, processing and distribution of
food after primary production andassociated operations must put in place,implement and maintain procedures basedon hazard analysis and critical control point(HACCP) principles also permitssimplification.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 853/2004 layingdown specific hygiene rules for food ofanimal origin
Article 10Amendment and adaptation of Annexes II and III1. Annexes II and III may be adapted or updated in
accordancewith the procedure referred to in Article 12(2),
taking intoaccount:(a) the development of guides to good practice;(b) the experience gained from the implementation
of HACCP basedsystems pursuant to Article 5 of Regulation(EC) No 852/2004;
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Regulation (EC) No 853/2004 layingdown specific hygiene rules for food of
animal originSECTION II: OBJECTIVES OF HACCP-
BASED PROCEDURES
1. Food business operators operatingslaughterhouses must ensure that theprocedures that they have put in place inaccordance with the general requirementsof Article 5 of Regulation (EC) No
852/2004 meet the requirements that thehazard analysis shows to be necessary andthe specific requirements listed in point 2.
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Indirect connection to other rlevantregulation linked in 2073
Regulation (EC) No 854/2004 laying down specificrules for the organisation of official controls onproducts of animal origin intended for humanconsumptionart4 and anex 1
link to HACCP and GP
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Regulation (EC) No 854/2004 laying down specific rulesfor the organisation of official controls on products ofanimal origin intended for human consumption
3. The official controls referred to inparagraph 1 shall include:
(a) audits of good hygiene practices andhazard analysis and critical control point
(HACCP)-based procedures;
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Indirect connection to other rlevantregulation linked in 2073
Regulation (EC) No 882/2004 on official controlsperformed to ensure the verification ofcompliance with feed and food law,animal healthand animal welfare rules
point 12,13; art8, 10; anex 2
link to HACCP and GP
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Regulation (EC) No 882/2004 on official controlsperformed to ensure the verification of compliance withfeed and food law,animal health and animal welfare rules
ANNEX II
COMPETENT AUTHORITIES
CHAPTER I: SUBJECT MATTER FOR THETRAINING OF STAFF
PERFORMING OFFICIAL CONTROLS
7. The evaluation of the application of HACCP
procedures
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
AGENDA
INTRODUCTION
LEGISLATION Regulation (EC) 2073/2005
Microbiological Criteria
HACCP based controls
Good Practices
What alse?
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Indirect connection to other rlevantregulation linked in 2073
Food Safety standards: ie.:ISO 22000
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Summary
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Commission egu ation C o2073/2005
microbiological criteria process hygiene criteriaindicates the acceptable functioning of the
production process
applicable during the process, not to productsplaced on the market
action: improvement of production hygiene,selection of raw materials
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Purpose of the Microbiological criteria
validation and verification of HACCP andGHP
acceptability of batches
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
food safety criteria examples
Listeria monocytogenes
- all ready-to-eatfoods
Salmonella
- certain ready-to-eat foods
- certain other products
Staphylococcal enterotoxins - certain dairyproducts
Enterobacter sakazakii- dried infant food
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
food safety criteria: Salmonella
minced meat and meat preparations
from poultry (intended to be cooked)
absence in 10 g until 1/1/2010
absence in 25 g thereafter
n=5, c=0
sampling once a week
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Transitional derogation (Art. 8)until 31-12-2009
n=5, c=1
notify Commission and MS
labellingonly for the domestic market
to be thoroughly cooked
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Process hygiene criteria:Salmonella
Carcasses of broilers and turkeys>15 carcasses once a week
10 g of neck skin
after chilling
absence in 25 g of pooled sample,
"rolling window" system(7 out of 50 samples can be positive)
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Flexibility
operator can choose frequency andmethodbased on risk
in the context of HACCP
fixed frequency of sampling (carcases,etc.)
once weekly fortnightly sampling
reduced frequency for smallestablishments
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Community criteria
unsatisfactory resultsactions laid down in Regulation 2073/2005
(Article 7)
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Absence of Community criteria
interpretation of resultsArticle 14 of the GFL:
unsafe food products must not be placed on themarket
enforcement actions by the CA should beproportionate and based on scientific
proof
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
The food
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Food safety issues-
How far we can go?
All consumers should have access to foodthat is safe, nutritious, of good qualityand good value, and should be able tomake healthy lifestyle choices.
Research and development has to supportthis with all means and technology and
society should also support thisactivity.
Technology changes our methods but notour problems in achieving better andsafer tomorrow.
Biotehnika fakulteta
Univerza v Ljubljani,
Slovenija
Peter Raspor
Thank You/Hvala!Thank You/Hvala!
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The second view
Have A Cup of Coffe and Pray
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/ Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Hvala lepa!
Univerza v LjubljaniBiotehnika fakulteta
Jamnikarjeva 1011001 LJUBLJANA
SLOVENIJA
Tel.: +386 (0)1 423 11 61Fax: +386 (0)1 256 57 82http://www.bf.uni-lj.si/
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Respecting ANNEX IMicrobiological criteria for foodstuffs
Chapter 1. Food safety criteria
Chapter 2. Process hygiene criteria2.1. Meat and products thereof2.2. Milk and dairy products2.3. Egg products2.4. Fishery products2.5. Vegetables, fruits and products thereof
Chapter 3. Rules for sampling and preparation of testsamples3.1. General rules for sampling and preparation of test
samples3.2. Bacteriological sampling in slaughterhouses and at
premises producing minced meat and meat preparations
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Microbiological criteria for foodstuffs
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Microbiological criteria for foodstuffs
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Respecting ANNEX IMicrobiological criteria for foodstuffs
Chapter 1. Food safety criteria
Chapter 2. Process hygiene criteria
2.1. Meat and products thereof
2.2. Milk and dairy products
2.3. Egg products2.4. Fishery products
2.5. Vegetables, fruits and products thereof
Chapter 3. Rules for sampling and preparation of test samples
3.1. General rules for sampling and preparation of test samples
3.2. Bacteriological sampling in slaughterhouses and at premises producingminced meat and meat preparations
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Chapter 2. Process hygiene criteria
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Chapter 2. Process hygiene criteria
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Chapter 2. Process hygiene criteria
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Chapter 2. Process hygiene criteria
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Chapter 2. Process hygiene criteria
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Chapter 2. Process hygiene criteria
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Chapter 2. Process hygiene criteria
Biotehnika fakulteta, Univerza v Ljubl jani http://www.bf.uni-lj.si/
Respecting ANNEX IMicrobiological criteria for foodstuffs
Chapter 1. Food safety criteria
Chapter 2. Process hygiene criteria2.1. Meat and products thereof2.2. Milk and dairy products2.3. Egg products2.4. Fishery products2.5. Vegetables, fruits and products thereof
Chapter 3. Rules for sampling and preparation oftest samples
3.1. General rules for sampling and preparation oftest samples
3.2. Bacteriological sampling in slaughterhousesand at premises producing minced meat andmeat preparations
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