general requirements for managing food safety in the context of haccp based controls and regulation...

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


AGENDA

INTRODUCTION

LEGISLATION Regulation (EC) 2073/2005

Microbiological Criteria HACCP based controls

Good Practices

What alse?


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.


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.


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.


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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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.


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


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%


Food is a risk and food is concern


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Systemic tools to reduce risk

Technological tools

Regulatory tools


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


Livestock

Seafood

Storage

Trasport

Processing Retail Cattering/CookingEatingCrops

Vehicleemission

Agriculturalpractices

Landfills

Industrialemissions

Where hazards arise in the foodsupply?


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


BIOLOGICAL HAZARDS

Factor contributing tothe occurrence:

improperstorage/holdingtemperature

in-adequate cookingprocess

improper hygiene

practices by foodhandlers

cross contamination incorrect reheating

process


BIOLOGICAL HAZARDS

3 ways of controllingmicrobiologicalhazards in food:

Eliminate, prevent or

reduce thehazards

Avoid contamination

Avoid bacteria growthand toxin

production


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)


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)


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


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.



advantages Traditional retrospective control, where we

analyze the final product, places the HACCPsystem in the preventive concept of following thesuitability.


HACCP system working methodadvantages

The HACCP system ascertains the hazardelements, also those that can in reality only bepredicted



The HACCP system is focusing on the technicalmeans and critical points in production process


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advantages The HACCP system is compatible with other

systematic solutions, that have a goal to buildsystems for quality assurance



advantages The HACCP systems assures economical control

for food suitability

Preventive of the HACCP system has aconsequence for direct product reduction loss



HACCP is valued by FAO/WHO & CodexAlimentarius as the most successful method forpreventing the diseases transferred with food.


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.


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)


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.


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.


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).


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.


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.


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.


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


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;


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.



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.


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



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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


Good Storage Practice (GSP)

Good Storage PracticeGuidelines

Pre-requisite forlicensing : importers,wholesalers andretailers

Key elements :Premises, Personnel,

Documentation, Recalls Inspection -

collaboration with -


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.


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.


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


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)


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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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/


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



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.



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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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


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


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.



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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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.


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.


How Does Everything Fit?

PrerequisitePrograms

ManagementCommitment

HACCPPlan

TheHACCP


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


AGENDA

INTRODUCTION


Microbiological Criteria HACCP based controls

Good Practices


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


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


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.



(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.



(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.


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.


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.


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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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.



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.


AGENDA

INTRODUCTION



HACCP based controls

Good Practices


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



Regulation (EC) No 852/2004 on the hygiene offoodstuffspoint 11,12,13,14 15; CHpI art1,5,7,9,13; ChpVII



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.



(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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(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.



(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.



(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.



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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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.



Regulation (EC) No 853/2004 laying down specifichygiene rules for food of animal originponit 7; and chpIV art 10; and sect 2



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.


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.



Regulation (EC) No 854/2004 laying down specificrules for the organisation of official controls onproducts of animal origin intended for humanconsumptionart4 and anex 1



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;



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



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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


AGENDA

INTRODUCTION



HACCP based controls

Good Practices

What alse?



Food Safety standards: ie.:ISO 22000


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


Purpose of the Microbiological criteria

validation and verification of HACCP andGHP

acceptability of batches


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


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


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)


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


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


The food


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/

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


Microbiological criteria for foodstuffs


Microbiological criteria for foodstuffs




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 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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general requirements for managing food safety in the context of haccp based controls and regulation...

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