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HACCP and ISO 9000

The European Commission trying to improve safety of food has published two documents "Consumer Health and Food Safety" and "The General Principles of Food Law in the European Union".
These papers have three general principles:
1. The responsibility for legislation should be separate from that for scientific consultation.
2. The responsibility for legislation should be separate from that for inspection.
3. There should be more clarity and easier access to information throughout the decision-making process and inspection measures.

The USDA is requiring that all meat and poultry plants design and implement HACCP systems. Plants are required to develop HACCP plans to monitor and control production operations. [1]

12.01.2011: Failing HACCP, GMP, farm to fork politics and unsafe concepts of European food industry

A never ending common threat can be followed through the last decades of European food industry. European food authorities and food industry are incompetent to repair the rotten food safety systems. An endless sequence of scandals of dioxin in eggs, poultry, cattle contaminating Mayonnais, sausages, cakes and others go on despite extensive warnings of scientific articles focussing on dioxin in ingredients of feed such as extensive warnings of Kamphues and Schulz 2006. [2]

Dioxin contamination spreads to pigs

[3] The dioxin scandal in eggs, poultry and pork in January 2011 is the latest scandal of European food industry. High levels of dioxin in German pork has been found in pigs. EU officials have confirmed that the tainted animal feed was also exported to France and Denmark in late 2010.

Organic eggs with high levels of dioxin because of tainted maize from Ukraine

[4] Dioxins in organic eggs were found in May 2010. The source has been identified as maize from the Ukraine, which was used by a Dutch feed producer and then exported to Germany poultry farms. These organic eggs were sold all over Germany. The Netherlands should now explain how the tainted maize could get through food safety systems and why certifiers of the food companies did not look at the loophole of their HACCP, GMP and farm to fork safety systems.

BSE crisis linked to infectious feed

[5] The BSE was one big feed scandal and increased the risk of human infection with Creutzfeldt-Jakobs Disease. Feed with the infected ruminant proteins was the primary cause of the epidemic. The feed industry, in an attempt to keep prices competitive, reduced the the sterilisation temperature of the feed produced from the corpses of animals which had died died of the disease. The feed ban of animal proteins to cattle, sheep and goats 2001 was the key animal health protection measure against BSE.

Misconceptions of German food groups management

[6] [7] Alain Caparros, CEO of the REWE food retailing group, criticizes the consumer saying " Germans bear the Aldi-gen, they spare on food to spend a bit more in vacation or other recreation areas." Caparros should be aware that foods must be safe and must comply with food laws. Dioxins and other hazards are independent of any pressure on prices which are generated by competition between REWE, Aldi and others. Camparros must learn that food safety is not endangered by the consumers choice, but the scandals are caused by failures of the safety and quality systems of the food chain, which includes retailers.

Self-comittment to food safety is necessary

Europe does not need more laws which may always be broken. Europe needs a self-commitment to food safety of the food industry and a new awareness of the principles of food safety systems. Every producer and every certifier must look at their flow charts and fill the gaps which made all these scandals possible. For the time being HACCP, GMP, ISO 9000 certification, quality stickers like "Organic" or "Controled Quality" are discredited.

Risk communication for the consumer

[8] The risk communication activities undertaken by authorities should be available to the consumer and organisations of industry and NGOs. Basic terms which are used in the field of national and international risk communication were analysed by Ulbig, Hertel and Böl 2010 as follow:

"Hazard" describes the inherent potential of a substance or situation to cause an adverse effect. "Risk" by contrast describes the probability of an adverse effect on exposure to a substance or situation under specific conditions. The difference between "hazard" and "risk" is, therefore, exposure. There is a "risk" when there is exposure to a "hazard". Consequently, risk information places information about the possible adverse effects centre stage, the occurrence or scale of which depends on the degree of exposure.

Limitations of hazard communication

According to Ulbig, Hertel and Böl hazard information is often sufficient for a purchasing decision. Frequently, a hazard becomes a risk because of incorrect use of the product. In these cases it is important to provide information about the proper handling of a product in hazard communication. The hazard communication suffices when it can lead to the avoidance of exposure.

Hazard designations like "genotoxic" or "carcinogenic" do not say anything about the actual risk as they do not provide any information about actual exposure. Whether the risk in a concrete case is very high or low cannot be determined from the hazard information. Hazard information does not suffice as an aid for the correct assessment by an individual of how it affects him/her or for the choosing the right course of action.

Public communication of hazard and risk

The authors stress that information should be provided primarily about the risk. Hazard information is only then sufficient when no data are available about exposure. Communication in press and media risk assessment should play a central and hazard information a secondary role.

Other definitions used in international literature

Hazard the International Programme on Chemical Safety (IPCS) defines a "hazard" as the inherent property of an agent or situation having the potential to cause adverse effects when an organism, system, or (sub) population is exposed to that agent. [9]

Risk, a mathematical concept Generally speaking "risk" is deemed to be the possibility of the occurrence of a harmful event. Kaplan and Garrick have formalised the general risk concept and their definition stresses the three main elements of risk. They have defined risk (R) as a set of triplets (Kaplan and Garrick 1981:

R = (si, pi, xi), i = 1,2,...,N.
Whereby si describes a scenario;
pi indicates the likelihood of the scenario;
xi indicates the scale of damage in this scenario.
In this concept the risk is described as the sum of consequences examined along with their likelihood and scale. Kaplanquantitative

Risk in the health sector In the health sector different variants of the risk concept are used depending on the scientific fields. For cancer research Williams and Paustenbach (2002) use the following definition "Risk is a unitless probability of an individual developing cancer". The IPCS definition of risk is broader. [10]

Food chain steps

There are different steps in the food chain: Agrarian origin, transportation, storage, industrial processing and handling by the consumer.

Every step must be covered by specific standards to ensure a high level of food safety. The whole food chain must be monitored. This includes also the environment as there is no seafood in a poisoned sea and there are no crops in a dead landscape.

The aim is to link failed productions with their causes so auditing can find failures of the existing food safety systems and avoid harm.

The different steps in the food chain are:

Agrarian origin,
Industrial processing,
handling by the consumer.

Every step must be covered by specific standards to ensure a high level of food safety. The whole food chain must be monitored. This includes also the environment as there is no seafood in a poisoned sea and there are no crops in a dead landscape. The aim is to link failed productions with their causes so auditing can find failures of the existing food safety systems and avoid harm.

The World Health Organisation Department of Food Safety quotes at : "...access to nutritional adequate and SAFE FOOD is a right of each individual" This right does not come from itself.

Controls, inspections and auditing standards are necessary to look after safety in food. Do not believe one single thing. Check it by yourself. How to do it, that is why we are here.

Food safety depends on:
1. Basic knowledge in farming, industrial know-how, transport and storage.
2. Ethical behaviour
3. Controls: HACCP, ISO 9001:2000, GMP, HALAL

Help for small food businesses: Guide to Inspections of Foods

[11] These guide are valuable instruments of food safety from farm to the end-consumer. The were made for investigators, however may also be used by food processors to check their own work or to revise the current HACCP system. This is very useful for small business which cannot afford expensive certifications. Applying these guides to inspection, a high level of safety may be achieved.

The FDA Guides to Inspections are reference material to investigators and other FDA personnel. They are not binding, and an alternative may be used if such an approach satisfies the applicable statutes, regulations of both.

The Guides include topics like allergen contamination, aseptic packaging, nutritional labelling, grain products, farm investigation, dairy products, low acid canned foods, acidified food, traceback of food risks in fresh fruits, vegetables, eggs and poultry.

Unlicensed medical equipment suppliers urged to register at the Saudi Food And Drug Authority (SFDA) [12]

Approximately half of importers and distributors of medical equipment in the Kingdom are unlicensed, according to a Saudi Food and Drug Authority (SFDA) official. According to Saleh Al-Tayar, a member of the SFDA, the Saudi medical market was a testing ground for various medical products as there was no system to regulate it until four years ago.

The Authority says that more than 1,300 importing and distributing agencies in the local market are registered. Saleh Al-Tayyar, urged all importers of medical equipment to acquire proper licenses to avoid penal measures..

Saudi Food And Drug Authority (SFDA)[13]

The Saudi Food and Drug Authority (SFDA) was established in 2002. The Authority's objective is to ensure the safety of food and drugs for man and animal; and the safety and effectiveness of medical devices, by developing and enforcing an appropriate regulatory system.

The main activities of the Saudi Food And Drug Authority

The control and/or testing activities can be conducted in the SFDA or other agency's laboratories. Moreover, the SFDA is in charge of consumers awareness on all matters related to food, drug and medical devices and all other products and supplies. The main objectives of SFDA are:

Observe the safety, security, and effectiveness of food and drug for humans and animal, of complementary biological and chemical substances, cosmetics and pesticides, of medical devices, Launch clear policies and procedures for food and drug, and plan to achieve and implement these policies, and conduct research and applied studies.

Launch rules, procedures and requirements for control and inspection of animals' slaughtering places, organize slaughterhouses, butcheries and meat sale outlets.

Control and supervise licenses procedures for food, drugs and medical devices factories in coordination with Ministry of Health and Saudi Arabian Standards and Specifications Organization (SASCO).

Propose legal rules relative to application of penalties on violators of food and drugs laws, and get them isued from the competent party.

The European Food Safety Authority (EFSA)

EFSA was established by the European Parliament with the regulation 2002 following a series of food scares in the 1990s (BSE, dioxins…) which undermined consumer confidence in the safety of the food chain.

The EFSA with seat in Parma, Italy and has the following tasks:

- Provision of independent scientific advice to support EU action on food safety, including all stages of food production and supply.

- Scientific evaluation of risks to the food chain, and any matter that may have a direct or indirect effect on the safety of the food supply.

- Safety evaluations of dossiers put forward by industry for EU level approval of substances or processes.

- Identification of emerging risks.

- Scientific support to the Commission, particularly in the case of a food safety crisis.

- Direct communication to the public on issues coming within its responsibility.

- EFSA is included in the rapid alert system managed by the Commission.

EFSA will assess risks to the food chain and advise the Commission, which is responsible for managing those risks.

What to take care of in order to ensure food safety

a - Biological hazards

Bacterial infections (Salmonella, Shigella, Campylobacter, Aspergillus), virus infections (Hepatitis, Creuzfeld-Jacobs-Disease)

b - Parasites

Such as nematodes in herring and other relevant worms.

c - Chemical contaminants

Herbicides, pest control substances and other chemicals such as mercury in Japan.

d - Bacterial poisoning

Natural toxins can harm people even after the agent has been removed or killed. (Staphyloccocine, botulism and other poisons)

e - Physical hazards

Ground Glass, metal or plastic fragments.

f - Radioactive contaminants

Radioactive fall-out of nuclear tests such as Brazil nuts with Strontium 90 due to fall-out of nuclear tests coming down in the rain forest of the Amazon region, or fall-out from the catastrophe of Chernobyl.

g - Wrong industrial food processing and bad kitchen habits

High Temperature on backing and frying. Just to mention acrylamid in french fries, crisp bread and breakfast cereals.

h - Wrong nutritional habits

Under- or oversupply of vitamins and trace elements, insufficient supply of dietary fiber.

History of HACCP

The HACCP concept had its origin in the USA and stands for "Hazard Analysis Critical Control Point".

Chronology of its development

1958- Foundation of the NASA (National Aeronautics and Space Administration)
1959- Development of the HACCP concept to assure one hundred percent safety of food to be used in space.
1971- The HACCP system was published and documented in the USA.
1985- The National Academy of Science (NAS) recommended the use of the system. Worldwide the system became used and the FAO/WHO Codex Alimentarius (Food and Agriculture Organisation/World Health Organisation) cited the system in the Codex.
1993- The European regulation 93/43 EG from 14.7.93 provides the use of the system for the production of food.
1998- With coming into force on the august the 8th of 1998 the Hygiene Verordnung (German hygiene Rule) demands the use of the HACCP system in Germany.

The HACCP-concept

The European hygiene rule defined in the paper 94/356/EG demands for an HACCP-concept which can be integrated in a quality management system
This HACCP concept has to be developed for all products of every factory. The five basic ideas of HACCP-concept are:
  1. Make a hazard analysis
  2. Determine the critical points (CPs) which might be of hazard in the production of the food.
  3. Determine the CPs which may be CCPs being of high importance to the safety of the food and which may be controlled safely using simple checks named "Controlling".
    For the controlling define the specifications of the product.
  4. Define a control system of the critical points, using tests which can be carried out during production in order to interfere in case of wrong production. "Monitoring".
    Introduce a documentation in order to record every happening.
    Define the corrections to be made in case of critical point being out of control.
  5. Define the way of verification to confirm that the HACCP-system works."Verification"

Timetable to install an HACCP System

  1. The head of the enterprise names the QS Manager who is responsible for the installation of the HACCP System
  2. The QS Manager names the members of the team which shall work out the HACCP system.
    The team should be composed of members of the production line, members of the bacteriological control, members of the quality control, members of the development. There should be persons with knowledge of food bacteriology, food hygiene, food technology. If there are not such persons in the factory, external aid should be taken in the phase of installing the system.
  3. The team determines what products can be handled together "Valid for.."
  4. Come together of the team to make a "Description of the Products".
    It should contain:
    A short description of the product,
    List of regulations and laws which regulate the food
    The list of the ingredients
    Important specifications of the product such as chemical and bacteriological limits
    Packaging of glass, tin can, PP, PE, paper or aluminium wrapping
    Shelf life
    Instructions of use
    and storage conditions.
  5. Come together of the team to make the "Flow Diagrams of the Products".
  6. The team checks all documents to make corrections of possible errors.
  7. The team marks all CPs on the flow diagrams.
    CPs are all points were a hazard for health of the consumer might occur.
  8. The team identifies and marks all CCPs on the flow diagrams, trying to have a low number of critical control points.
    CCP is a Critical Point were the hazard can be avoided, eliminated or reduced to an acceptable level.

How to identify a CCP ?

At any point of the production line ask the question:
- Is this point a hazard to the health of the consumer ?
IF NO go to the next point. IT IS NOT A CP
IF YES . The hazard is put under control at this point and it is reduced to an insignificant tolerable danger with the correct activity or it is totally eliminated.It IS A CCP and is put under control
- Are the control activities sufficient to avoid, eliminate or reduce the danger to an acceptable level?
NO, the technology of the production should be changed. YES, the CCP is marked in the flow diagram. and the controls are enumerated how often they have to be done and what specifications have to be observed.

For every CCP there should be made a list containing the following informations:
The place were the CCCP is situated (heater, packing line, Storage
What kind of controls should be made ( chemical bacteriological) What kind of instruments are necessary (thermometers, culture agar, microscope)
Instructions how to handle the instruments and detailed description of the laboratory methods
How often shall the controls be made?
Who makes the controls ? (Name the personal and the substitutes who have to make the controls)

The team determines the tests to be made at the CCPs (temperature, pH, acidity, filter, metal detector etc. The team marks the intervals between these tests. The team determines the corrections to be made in case of fail production. The team determines who is responsible to execute the corrections The team determines the methods used to control the CPs The QS Manager verifies if the system works or not and if the internal audits are made in time HACCP is a living system. After installing the system it should be rechecked periodic. The work on the basic documents will never end. Don't forget to answer in your documents the following questions:
Who controls? When? How the controls are made? Where the controls are made?

The Hygiene Rule 93/43 EWG demands quality controls which should be recorded in an appropriate documentation.
Basic documentation should contain [14]

  1. Make a drawing of the building enumerating the rooms
  2. Make a drawing of the machines enumerating them
  3. Make a diagram of the production line with including the material flow
  4. Make a drawing of the rooms containing all water tabs, enumerating them
  5. Make a drawing of the way the personal has to walk, starting from the entrance to the room where they may change clothes, the way to their working place, the way they have to go during work and the way back to change clothes.
    Image P8270013
  6. Make a drawing of the sewage system
  7. Make a plan of progressive education of the personal. This plan should include informations about new machines, new products, hand washing and disinfection, informations about shelf life of the products.
    Fingernail colours make an inspection of clean nails difficult. Therefore it should not be allowed.
    Image P7230041
  8. Make a cleaning and disinfection plan
  9. Make a plan to control the cleaning and disinfection
  10. Plan of the controls of water used in production
  11. Plan of pest control
Industrial hygiene is teamwork. Everyone engaged in production of food must cooperate.
There must be a detailed description of every work. The procedural rules should be available at the place where work takes place.

The quality and the safety of the end product depends on interventions at all stages of agricultural production or

harvesting through manufacture, processing,storage and transport to the final consumer.

The main concern is to avoid contaminations originated from:

All handling and controlling of the production of food should be conform to the system of "Good Manufacturing Practice ( GMP ).

X-Ray Inspection Systems

X-Ray inspection detects metal, bone fragments, glass, shell, stone and many types of plastic and rubber contamination in food products such as meat, poultry and fish, and it can pinpoint the location of the contaminating particle.

X-ray inspection system can penetrate aluminium foil and metal cans, to reveal foreign particles as small as 0.5mm diameter and, depending on the specifications of the equipment, ignore metal or other artefacts that form part of the packaging, such as clips.

German court undermines consumer safety and fundamental principles of HACCP

[16] A consumer eating a pastry with cherries baked into, broke a tooth biting on a cherry pit. The land court of Hagen ruled that the pastry with a cherry pit was unsafe violating the to article 3 of the directive on general product safety 2001/95/EC. [17]

The Judges stressed that despite the fact that the consumer might reason that any product might have certain numbers of runaways it does not justify that fact that the product was unsafe. Specifically for such a case, the Directive foresees a strict liability. [18]

The federal supreme court was asked to clear the case. It ruled that the harmed claimant had no right of compensation of his lost tooth. The court wrote that the pastry with cherries is a natural product which cannot be expected to be completely safe. According to the court the producer must take all objective measures to avoid hazards, however these measures must be objectively reasonable. [19]

The verdict waters the intention of the directive to protect the consumer. It undermines the principles of the HACCP system. Following the verdict of the federal supreme court there is no warranty for broken teeth resulting from pits of stone fruits, or splinters from pits of peaches or plums. The consumer must be aware of splinters of broken chicken bones or fish bones. Even stones in the stomach of kings crabs must be considered, because they are of natural origin.

The compensation for a broken tooth of Elizabeth Taylor due to a stone in a crab in a NY restaurant must now be revised. The verdict legalises careless production methods and endangers the consumer

Risks which might endanger the health of consumer

The health of the consumer may be endangered by following factors:

HACCP= Hazard Analysis and Critical Control Point

The HACCP - Concept is now introduced by the Hygiene Rules 93/43/EWG in the production line of food in Europe. It bears the main ideas from the worldwide accepted HACCP-System of the FAO/WHO Codex Alimentarius
The HACCP is a system demanded by the EG Hygiene Directives and avoids the hazards to the health of the consumer. Everything which is not a hazard to the health of the consumer is not covered by the system.

Hygiene regulations in Germany

The main regulations concerning hygiene in the production of food in Germany are based on the Hygiene Rules 93/43/EWG and are found under the 3 of the Lebensmittel Hygiene Regulations ( Food hygiene Regulations LMHV.
This regulation says that food is to be produced in a way so that there are no negative modifications possible during the production, handling, storage and transport.Supervision should be made with an HACCP concept.

HACCP may be integrated in the ISO 9000 Quality Assurance System
Other demands related to food safety are made by :

The ISO 9000 System controls the characteristics of quality of the production covering all aspects of quality.


With hazard every risk of the health of the consumer are meant.
Excluded are all events which are not related to health. This is the difference of the Quality Management of ISO 9.000 which covers every events of quality.

Critical Point

It is every point in the production of Food where risks of the health of the consumer can be present.

Critical Control Point

A Critical Control Point ( "CCP" ) is a point in the production line where a risk of hygiene may be put under control or eliminated.
With appropriate measures at that point the risk can be: Examples of critical control Points (CCPs) are:

In case of deviations of the specifications it is proceeded as follows:

Planing HACCP

To plan HACCP proceed as follow: Prepare the following tables:

Detailed description of every product

A detailed schematic description for every product should contain:

Description of processing

Prepare a table with a complete information about the production containing: The description of processing must be completed with a process flow diagram of the whole proceeding with the marked CCPs, the target values and tolerances and the corrective action should the product fall out of specification.

Static hygiene conditions:Building

The building where food is being handled according to hygiene rules must be in a condition to avoid negative influence during processing.
Cleaning and disinfection of the rooms must be possible.
Necessary temperatures for handling,processing and storage must be available.
The building must be clean and the maintenance must have been done.
The floor must be easy to clean and to disinfect. It should be watertight.
The walls are to be covered with watertight material, easy to clean and to disinfect.
The ceiling should be covered wit watertight material avoiding condensation water, dirt and molds.
There must be a sufficient number of hand washers with spender of liquid soap and disinfection based on alcohol.
There must be a sufficient natural and artificial illumination of all rooms.
There must be a facility for the personal to change cloth. Windows must have fly screens.
The rooms are not to be used for other activities.
The surface of tables and other surfaces which come in contact with food must be easy to clean and to disinfection.
To wipe there should be used only one-way towels ,not using it more then a day.
Buckets and other cleaning utensils should be of different colour in order do avoid cross contamination from one place to another.

Machines and other utensils for processing of food

: All surfaces must be easy to clean and to disinfect.
Everything should be of stainless steel.
Plastic parts should be made of polyester heat resistant to 130° .
The wire used to hold brushes together should be of stainless steel.Brushes should be made of polyester. They should be of different colour in order to avoid toilet brushes or highly contaminated places be used in the kitchen.
All parts and utensils should be free of cadmium.


: There must be a sufficient number of toilets with water flushing. Toilets should not have a direct communication with the processing rooms. The hand washers in the toilet room should provide liquid soap an disinfection based on alcohol being operated automatically or by arm, (not by hand !)
One way paper towels should be used.
There must be cold and warm water.
The toilet room must have an air exhauster

Dynamic hygiene conditions; Cleaning, disinfection and maintenance of the building,hygienic handling of food

The building must be cleaned and disinfected properly.
Maintenance of the building includes painting of walls and ceilings to avoid molds. Change broken coverings of walls and close all unnecessary holes.
Control the handling through all phases of the production, from income control, from production to storage and transportation.

Incoming control

Raw products and ingredients should not be accepted when there is evidence for the presence of pest,pathogen microorganism or there is evidence that the products are spoiled.
If necessary the products must be changed to adequate containers, or changed from wood pallets over to plastic pallets.
Image pallets
All products should be labelled with:
Name of the producer,
Date of delivery,
Expiration date.

Storage and handling of raw materials

Raw materials must be stored and handled under well defined conditions.
As Salmonellae were mainly transmitted by contaminated eggs,minced meat and related products great attention was paid to these topics.
1.- Eggs and egg products
In the late 1980s the importance of the storage conditions was shown in Germany by an increase of salmonella diseases. To reduced this hazard the following rules were established by the German Hünerei Verordnung (Hen's Egg Regulation) should be observed: in 2-4:

Food prepared with raw eggs which are being pasteurised

They demand no special precautionary measures.

Food prepared with raw eggs without heating

They must be eaten immediately after production.They are not allowed to be carried away. If they are heated right before eating this should not happen after two hours after production.

Food prepared with raw eggs without heating to be chilled consumed such as desserts

They have to be cooled down to +7°. They have to be maintained at this temperature or below and be eaten within 24 Hours after production.They also can be deep frozen and consumed 24 hours after defrosting its temperature not rising over +7°.

Production units preparing food for old or sick people and children

Food containing eggs or egg components must be heated properly by these units.

Charitable units which prepare food shortly before distribution

They have to proceed as described for production units for food for old or sick people and children added with the written information "to be consumed immediately".

Other production units cited above

They are allowed to produce food containing eggs or egg components when these ingredients were heated.No further special precautionary measures. If there is no thermal treatment the food must be cooled down to +7° within two hours after production and maintained at this temperature or below and consumed within 24 hours or deep frozen.After defrosting it must be maintained at +7° or below and consumed within 24 hours.

Production units with more than 30 meals with unheated eggs or egg components

These units have to keep samples of these meals at +4° for 96 hours after distribution. These samples have to be marked with day and time of production.
Minced, chopped and cut to small pieces meat such as kebab should only be served in heated form when there are no good hygienic conditions.
Unheated minced meat or kebab should be kept by +4°. For an immediate selling the meat can be kept be +7°.
Minced meat is allowed to be sold only at the day of preparation. Sausages and kebab can be sold on the day after production according to the Hackfleisch Verordnung (German minced meat regulation).

Production, improve the technical processing

Use good manufacturing practice principles handling food during processing.Make a separation of "dirty" and "clean" areas making sure that the routes of transportation of "dirty" and "clean" material does not cross each other (For example: keeping cooked meat and uncooked meat together in one refrigerator or one cooling room. this must be avoided)Avoid crossing unpacked food with already packed food. Avoid people working in "dirty areas" to get to "clean areas". This can be controlled by different hair coverings: Red for dirty areas and green or white for clean areas.
Wood utilities should be avoided as they bear pathogen moulds, bacteria and virus.This includes Tables, doors and environment:
Image table

Health condition or the staff which comes in contact with food

Medical inspection of all people handling food is to be periodic repeated and documented. This includes clinical inspection, bacteriological examination of faeces with regard to Salmonella bacteria, daily control of the personal to avoid purulent wounds, persons with diarrhoea and other problems to come in contact with food. These persons should be engaged in areas were they cannot come in contact with open unpacked food.

Pest control

The European rules related to hygiene in handling with food demands to avoid any negative affecting of food.
Pest[20] and their excrement affects food in this way. The measures to control the affecting should be integrated in the HACCP system.

Hazard analysis of pest control

Possible Pest in a food factory

Dissemination of pest

Dissemination of pest can happen through:

There are many ways of affecting food by pest:

Determination of critical points in relation to Pest control (CCPS)

There should be made a flow diagram, of the product to be analysed and a diagram of the building where the production and the storage of the raw material, packing material and end product is taken place.In this diagram the CCPS should be marked.

Factors which can facilitate pest dissemination

Neglected or abandoned rooms or environment can act as biotope for pests which can migrate to other parts of the building used for the actual production.
The whole building and his environment should be considered as one.
The best place is as good as the worst place is.

Categories of effects of pest attack,according to Voigt

General considerations about pest control

Contamination caused by rodents and insects produces loss of material and is a way of transmission of diseases. The European Hygiene rules demand to keep food free of influence of pest and pesticides and repulsive modifications as well all hazards for the health of the consumer.


Rats and mice

They generally live near garbage and drainpipes.As these animals live in places with high contamination with bacteria they bear on the hairs of their coat dirt and pathogen bacteria and contaminate the food with which they come in contact.
Rats and mice feed themselves with garbage and deteriorated food contaminating itself with bacteria which are eliminated in their faeces and urine.
When rats and mice die the fleas abandon the corps an can attack human transmitting diseases or cause allergies.
The teeth of rodents grow continuously. In order to keep them short they have to gnaw hard objects such as electrical wires, causing electrical shorts and fire.
Rats and mice should therefor be exterminated.

Extermination of rats and mice

Combat of rats and mice are made with anticoagulants. In the surroundings of food only products of the list of the BBA (Biologische Bundesanstalt,Germany) are allowed.
As babies of rats and mice can feed by itself after 17 days of lactation it is necessary to proceed with the lay out of poison for at least 14 days after the death of adult animals. The new generation can leave their nest in that time.
Rats and mice are reservoir of Borrelia, which is transmitted to humans by ticks.
Bacteria transmitted by rodents, according Hoffmann 1986

Bacteria transmitted by rodents

according to Hoffmann 1986

Viruses transmitted by rodents

Molds transmitted by rodents

Nematodes transmitted by rodents


They like damp and hot places eating all kind of food, including spoiled garbage.They make therefore the transport of bacteria. They contaminate food with their legs, faeces and vomits.

Bacteria transmitted by cockroaches.According to Hoffmann, 1985

Viruses transmitted by cockroaches. According to Hoffmann, 1985

Yeast and molds transmitted by cockroaches. According to Hoffmann, 1985

Protozoa and nematodes transmitted by cockroaches. According to Hoffmann, 1985


Flies like the house fly Musca domesticaand Fannia canicularis make the transport of bacteria like Salmonella.


The genus Calliphora sp. and Lucilia sp. inhabit contaminated places such as latrines garbage etc.They enter buildings carrying diseases and putrefaction agents.
Contact of food with bluebottle can be avoided keeping food in refrigerator or covering food with a covering bell or plastic coverings, the doors and windows should be closed with fly lattice. Indoor electrical devices with blue light should be used which kill insects using high voltage.
Larvae should be killed with insecticides and keeping the environment clean and free of garbage, deteriorated meat and carcases. Interior and surroundings of the buildings should be free of garbage and carcases.
Insecticides should not come in to drain pipes as they may kill small animals which are part of the food chain for other animals.

Bacteria transmitted by flies. According to Hoffmann 1985,Steinbrink 1989

Bird control

Interior and surroundings of food storage, market halls and stores, food processing buildings the presence of birds are not acceptable. Common bird which try to built their nests in the interior of buildings are pigeons, starlings and sparrows.
Bird control should be done by removing their nests and avoid reinvasion.
Shooting is not always effective and should not collide with rules of animal protection.
Pest control tries to avoid pests, early detection and control.
Important are tight doors, smooth surface of walls and floors and good air conditioning.

Fumigation, Methyl bromide

Methyl bromide is being used as a method of fumigation for raw materials such as wheat, semolina and flour to ensure effective eradication of insect pests. Chemical fumigation however is to be banned by 2005. Natural solutions are therefore being searched, such as heat and controlled humidity.

Canadian IPM without methyl bromide

[21] The Canadian Pest Management Regulatory Agency Canada developed the Integrated Pest Management in Food Processing: Working Without Methyl Bromide Series to the phaseout of methyl bromide. This IPM acquires increasing importance facing the high number of containers being fumigated with all kid of toxics.

Methyl bromide is identified under the Montreal Protocol on Substances that Deplete the Ozone it was used in in large space fumigation, for example, in flour and oat mills, and in food processing operations.

A number of pest management products and techniques exist or are under development for use in food processing facilities. It is clear, however, that there will not be a single treatment or practice that will suffice to replace methyl bromide.

A combination of preventative and treatment practices will be necessary for effective pest management. The Integrated Pest Management in Food Processing gives instructions for pest management without methyl bromide. Consistent and effective sanitation is the most important component of an IPM plan.

In some areas alternative treatments to methyl bromide are not available. Procedures and criteria are being developed in Canada and under the Montreal Protocol for emergency and critical use exemptions where no technically and economically feasible alternatives exist.
The highlights of the IPM are:

IPM Strategy

1. Assessment

The first step of the IPM strategy is an assessment of the actual or potential pest problem.

2. Development of Pest Management Plan

The next stage is to develop a pest management plan for implementation, based on the assessment findings.

3. Plan Implementation

Implementation of the pest management plan starts with a facility's management and decision makers. The leadership shown by the management of a facility and a company, indeed by the industry as a whole, may be the most important step in adoption of IPM.

4. Evaluation of Plan

The effectiveness of the pest management plan must be reviewed based on monitoring of pests and inspection reports.

5. Adjustments

Changes to the pest management plan are designed and implemented based on the analysis of the plans effectiveness.

A variety of techniques are in use or under development for treatment of stored grain and other products, such as the use of phosphine gas, irradiation, malathion, diatomaceous earth, carbon dioxide and high energy non-ionizing microwave and millimetrewave radiation.


Phosphine is the most frequently used alternative to methyl bromide for durable commodities. It is widely used to kill pests in cereals, legumes, dried fruits, nuts and other commodities. Phosphine requires a long exposure period (5 to 15 days) and usually temperatures of over 15° to release phosphine from its tablet form, making its use not practicable in cold climate. It can be used in transit.

Phosphine gas is generated by the reaction of metallic phosphide such as aluminium phosphide or magnesium phosphide granules and tablets with atmospheric moisture.

Other systems use compressed gas cylinders mixed with carbon dioxide, or by reacting phosphide granules with water and carbon dioxide (Horn Generator). Used on its own initial dosages of 900 to 1200 ppm and final concentrations of 200 to 400 ppm for 36 to 48 hours.

Corrosion, however, should be kept in mind as it endangers electrical equipment. Resistance of pests to phosphine develop under frequent use with poor sealing of structures.

Heat, phosphine, Carbon dioxide treatment

Combination of heat(30 to 38°), phosphine (150 to 500 ppm) and carbon dioxide (3 to 7%) increase respiration in insects, allowing reduced concentration of phosphine and reduces the potential for corrosion. These values compare to temperatures over 50° for a heat treatment alone, or an initial dosage of phosphine of 900 ppm or more when used on its own.


Irradiation can be used to disinfect packaged or bulk products. In Canada irradiation is allowed only for wheat and wheat flower, spices, herbs and vegetable seasonings.

High-speed centrifugal impact

High-speed centrifugal impact machines (Entoleters) are useful to destroy any insects that may be in flour. This procedure is less useful for semolina as it tends to break up the larger particles.

Diatomaceous earth (DE)

The fossilized diatoms are amorphous silicon dioxide which works as an insecticide by adsorbing to the wax coatings on insect bodies, leading to death by drying.

It is used on grain, in grain storage and transport containers, and in food processing plants and flour mills. It is primarily used in specific areas as a spot treatment or surface treatment of containers. It can also be applied inside electrical and control panels and in dead spaces behind walls before they are closed up.

Personnel items

A separate area should be provided for personal items such as coats, shoes and lunches that are brought into the plant as they might be a root of pests.

Good Sanitation Practices

The importance of cleaning and sanitation must be emphasized to all staff. In particular, cooperation among cleaning crews, quality control officials, and a pest control service will be beneficial. In case of faulty food injured people have rights of recourse.If the producer of the faulty food has a valid HACCP concept with written results of his controls the injured person must provide the evidences that the failure was originated during during handling and treatment of a specific producer.
If the produce does not have the written results of his controls or the frequency of the controls are not sufficient he has to prove that the failure has not been originated under his responsibility.
The HACCP system is therefore a practical instrument of protection against unjustified accusations.
However if he fails to proof that the failure could not be originated during his responsibility the producer has to assume the liability.

HACCP for supermarkets

Supermarkets have a complex system of storage,distribution and selling of their goods.
Many hazards which may be present are identical with those described above. The structure of a supermarket includes the head of the organisation with
the main delivery of food, their storage and the distribution to the branch stores.
Supermarkets deal with stabilised food like tin cans and dried foods as well as frozen food and perishable food like salads, dairy products cheese, yoghurt, butter, meat and meat products as well as fish and derivate.
This means all efforts concerning distribution, storage, handling and processing have to be made related to cooling and freezing, in relation to cleaning of the machines and utensils, disinfection and hygiene of the personal, Pest control, good condition of the building, hand washing facilities, toilets with no direct access to the area where food is stored,handled or sold.

How to install an HACCP system for supermarkets

Timetable to install an HACCP system for supermarkets

See "Timetable to install an HACCP system"for details:

Basic documentation

For detailed informations see "Basic Documentation"31.4.3.
The basis of a HACCP system is the documentation. Everything must be written and all results of checks must be recorded.

Head of documents and forms

All documents and all forms should have a head containing:
Name of the enterprise
Name and address of the branch office
Name of the document or form
Identification number of the document or form
The number of the version
The date of the version
The number of pages of the document or form

SUPER CHEAP MARKET Name of the document or Form Number of the document version, date, number of pages
Basic documents are

Distribution of ware from the main ware house to the branch stores

Transport should be made according a document with following informations:
Name of the ware or group of related wares
Delivery documents
Temperature to be maintained during transport
Special care needed, such as "Don't throw, protect against sunlight, rain and humidity, use no hooks ".

Waste control

There should be a document with informations about:
Type of waste
Place where waste and garbage is collected.
How the waste is transported and to where it should go.
Date and signature.
Garbage and waste cannot be collected and stored in the store where food is being sold, stored or handled.
Containers should have a lid and they should always be closed
Pest control should avoid rats and insects to get to the garbage.

HACCP for cheese dairies

To start an HACCP concept for cheese dairies please get the basic informations which were given before.

Flow Diagram

Start the flow diagram beginning with the collection of the milk at the farms and end it with the delivery of the product. During the flow diagram special attention should be payed on pipelines, fittings and taps. They need special care.
The high pressure which is used with the CIP systems causes erosion. After a short time automatic valves get leaking and leek. Gaskets can lift from their seat, hiding traces of products which get spoiled after a short time.
In old cleaning procedures heat in form of steam was used as disinfectant. Heating the pipeline systems with steam was good as it sterilised also product particles hidden under gaskets or left in dead zones. The new way using low temperature and sterilising with chemical disinfectants bear the risk to leave bacteria acting as focal contamination.
As the production of cheese needs long storages to ripe, low bacterial count can turn out to get dangerous.

Pipeline Diagrams for cheese dairies

In addition to the flow diagram for cheese dairies a diagram of all pipelines should be made enumerating all valves so they can be disassembled and the gaskets be changed in preset times.
Don't trust your engineers saying the new generation of valves are safe, they are not and do need periodic care and maintenance.
Image P8120011
Own experiences with pipelines have shown leaking valves between product line and pipes being cleaned in place, so that CIP solutions got into the product.
Don't underestimate the value of pipeline diagram. Engineers like to talk it down because of the trouble to make the initial drawing and to keep it update.
Only with complete diagrams hazards like lealing valves placed between product and CIP lines operated simultaneously can be made visible.
Due to failure of the CIP program in a production line of the dairy company SNOW BRAND in Japan 14.000 peoplewere intoxicated by Staphylococcus aureus bacteria. These bacteria were located on a valve of a storage tank of skimmed milk of "Delicious Milk" brand which had not been cleaned for three weeks.
AS a result of this production failure the company closes their factories in Tokyo, Osaka, Sendai, Niigata and Takamatsu[22].
Failure of CIP systems such as the break down of Snow Brand can only be avoided by visual control of all dead ends, of fittings and gaskets. Visual checks should be done with a strong spot light and additional bacteriological controls.

Water in cheese dairies

Water leaving the main pipe reduces its velocity and often comes to a total stop.
Only few meters after the main stream water can be highly contaminated. Pipelines with low flow tend to develop a biofilm of bacteria rising up bacterial count.
If such water is used to rinse equipments and pipelines after disinfection all hygienic efforts are useless.
Water should be controlled as a CP.
In case of rising bacterial count in Water bacterial filters such as those from Sartorius should be installed at all points entering a CIP equipment and entering the product.
Another point of concern in cheese dairies are the gutters and sewage as they bear Listeria monocytogenes. Gutters should be easily to access , be cleaned every day and sterilised. /paragraphBiofilms protect bacteria from predators [23]
Carsten Matz and colleagues 2008 studied the ecology of bacterial biofilms. Marine bacteria produce biofilms in water pipes.

Sessile bacterial communities such as Pseudoalteromonas tunicata are organized as biofilms which serve as bacterial refuge from bacterivorous nanoflagellates such as Cafeteria roenbergensis. The authors identified a violet antiprotozoal compound, the alcaloid violacein, secreted by the biofilm cells. Violacein inhibits protozoan feeding by inducing a conserved eukaryotic cell death program.

In food producing factories and hospitals biofilms with spoilage or pathogen bacteria are a serious problem. Protected by the mucus of the biofilm, the bacteria are protected from antibiotics and desinfection.

The HACCP system is concerned only with hazards which might endanger health of the consumer. It is part of sanitary regulations of some countries. It does not bother with quality control which is being covered by the standard ISO 900031.15.3.
Companies which do not need certified according the ISO 9000 use to add quality control to the HACCP system. It is that why many parts of some HACCP systems include quality checks which are no hazard points. It would not make any sense to produce or sell healthy products which do no maintain a certain quality standard.
HACCP should be the first step in safety and quality control of the production, handling and merchandise of food.
ISO 9.000 is a wide concept of quality control beyond the hygiene and safety rules determined by the HACCP system.This system can be certified by certifying enterprises.ISO 9000 is not always necessary.

Total Quality Management

Total Quality Management TQM can be installed after ISO 9000. The system tries to unite all the different phases of the activities of a company beginning from the financial control down to production and technical details.
With growing international business [24]the enterprises have to integrate modifications in the basic structure concerning the rapid changing international market. ISO 9000 is the basic activity which supports Total Management.

Characteristics and ability of the Total Management staff

The staff according A.Borning should have: In the past quality control and quality improvement was considered as being in the responsibility of one department or a part of an enterprise.
In Total Management Quality has to concern every part of the enterprise. The whole personal staff is responsible for the quality management of the enterprise.
To coordinate internal processes and external demands of customers Business Process Management BMP can be used. It is a structured, methodical enterprise specific handling of the transaction. The relation from supplier to customer is in BMP of great importance.
The different goals of the TQM should be: The integration of manager and the way of thinking of different continents and cultures must be kept always in mind to solve international problems.Therefore are opinions and conferences with a multinational staff extremely important.
The main question which rules all activities of Total Quality Management is:
What can be improved ?
The target of the Total Quality Management is:
The most important targets are:
High capital rentability
Team spirit, culture of the enterprise directed to Total Quality Management resulting in success on long terms.
Targets must be arranged according to their priority in order not to create conflict situations between employees responsible for the execution of the different sections. In case of necessary changes in the structure of the organisation the international manager staff should have flexibility to overcome difficulties related to: Rotation of the Management between branches inland as well as branches from abroad with the main head is very useful to create a common feeling and fortify the unit of the enterprise.


The career of managers with many changes of jobs between enterprises should be analysed very skeptical.They show little care about the flag they serve and the destiny of the enterprises. Their goal is their own career. They have no identification with the history and with the future of the enterprise. In bad times they go and take the know how and company secrets to bargain with it for a new job.

Hyperlinked Management

Hyperlinked Management is a system covering all other systems.
Hyperlinked Management establishes the link of the enterprise with his costumers All phases of the technical activities, financial control and all activities of the branch stores.
Hyperlink is the management of the Global administration of raw ware, production and retail from technology, distribution and trade.
Its main concern is to create an information flow and centralise all data making them accessible to the head of the enterprise. Decisions can be made on the base of the latest data. Delays caused by long data researches, lost documents are avoided.

Introduction of the Hyperlinked Management

Phase one: Educational work

1.-Conference of the head and the manager of the enterprise.Not more than fifty participants should be present. Introduction of the Hyperlinked Management System has to overcome a natural resistance of the different sections of the enterprise trying to protect their autonomy.
The main message of this conference should be to explain the System giving confidence that there will be no detriment to the autonomy of the different sections of the enterprise.
The conference should be held by the head of the enterprise comprising :

Hyperlinked Management Structure

Image Hyperlinked_Management_Structure

There are countless advantages for the customer.

Software to handle Global Hyperlinked Management

There are countless software systems.Most of them are inadequate to handle the tasks.For instance from the point of view of the author of this home page is the LIMS System integrated in the program "Collier" slow in its flow path, rigid in the design of reports and is not user friendly.
Integrated data gathering systems such as ERP and more advanced global links should avoid ready systems.
Software engineers should provide their isolated programs with standardised interfaces so that the user can assemble different modules according the demands of the market.Central managed master data like Product numbers, specifications, prices etc must be located in every subunit. Interchange or updating can be handled online or be made once a day according demands of the system.
In this way short programs loops and resulting waiting time are achievable. Adaptation to actual circumstances concerning reports and flexibility relating the change some isolated modules is at any time possible. A gradual upgrading is unlimited possible such as the link to intranet, internet ERP Enterprise Resource Planning and Hyperlinked Management.
Small simple programs are to be favourized in maintenance, they are less susceptible to system crashes and are visible at a glance. Remember: " Small is beautiful ".
Complete systems create dependency, the user turns out to be open to blackmail by the software engineer. This can cost fortunes.

Marcam Software Solutions

[25] Marcam Software Solutions supplies ERP software for food and drink industries. It is one of three suppliers being considered by Nestlé to link and manage the whole global enterprise.
Weak areas in ERP systems are production planning and scheduling, costing and warehouse management. In food production throughput time is the time of production measured in shifts or days. Variability and availability of raw materials changes of prices must also be considered. To overcome these difficulties it is almost impossible to handle with one stiff giant system. Only linked modules working independent of a central program can avoid system crashes. These problems bring Nestlé to the conclusion that there will be no decision concerning the introduction of a worldwide system before 2000.

Wilab LIMS

[26] The Wilab LIMS is a LIMS System which can be used in a global system. But using this system on one platform may not be a good solution for the future. To globalize the data would turn the program to great to be handled in future links.Small working units with data exchange should be used.

ISO 9000

The standard ISO 9000 dates at the year 1989 an was accepted in Europe under the Number EN 29000 as European norm.The different standardisation organisations have integrated the ISO series under different denomination. The European standardisation organisation CEN C=Comité E=Européen N=Normalisation has created the denomination "DIN EN ISO 9000 ff" published in English, German,and French.
This standard contains the norms and the procedure to obtain the Certificate ISO 9000. There are many organisation which are accredited to give out certificates, such as DGS (Deutsche Gesellschaft zur Zertifizierung von Qualitäts managementsystemen], TÜV (Technischer Überwachungs Verein).
The interested company makes a contract with a certifying.It takes approximately 1 to 2 years to obtain the certificate depending on how complex the company is.
In this period the company writes the ISO 9000 documentation which is finally audited by the certifier. This documentation is generally written with the help of external advisors.
The centre of all organisation is the Quality Management Manual.

Quality Management Manual

The Quality Management Manual contains all topics concerning Quality Management QM having a description of all standards of the QM system.All other documents are subordinated to the Quality Management Manual.
When the whole enterprise is organised according to the principles of ISO 9000 it is certified during a period of 3 years.
During this period the certifying company makes audits each year

External audits

index Audits, external The external audits are made by the company which had certified the enterprise.
The external audit controls the actual work to be accord to the established rule of the Quality Management Manual.The duration of an external audit is approximately one day.The external auditor may negate the certificate when serious faults are found.

ISO norms dealing with quality management

A Quality Management system can integrate the rules of Good Manufacturing Practice (GMP), the HACCP and the Good Laboratory Practice (GLP).A QM System is made of three basic parts:
  1. Quality Management Handbook (QMH) This Manual is a Presentation of the System. It has a short description of the complete system. It contains the main activities of the different parts of the enterprise,the responsibilities, the competences and refers to the Instructions of Procedures. The instruction of Procedures contains the normal procedures of production, Plans such as Hygiene Plans of the personal, Cleaning and Disinfection Plan and Flow Diagrams where the whole production is schematically represented and the CCPs are marked, defining the responsibilities. Are detailed instructions for every specific work.

DIN EN 9001 norm

The DIN EN 9001 norm will here be more detailed described. It is built up of different parts:
  1. Responsibility of the highest direction The highest direction of the enterprise has the responsibility to determine a person responsible for the documentation of quality has the responsibility to verify the working of the system. The execution of all activities concerning the quality system is under responsibility of the chief of each department.
    The highest direction defines the quality politics and makes it public.
    Quality politics may be for instance the concentration on quality,chose ingredients of superior quality, the continuous improving of the technical equipment and improving continuously the education of the personal,define new aims such as to reduce complaints, reduce accidents at work, improve the communication between the different departments, to improve motivation of the personal.
    Define the organisation of the enterprise making a schematic diagram of the organisation.
  2. Basis of the QM-System The basis of the Q'S is the documentation.
  3. Contract control The contracts are controlled concerning its practicability. It is to be controlled that every specification mentioned in the contracts can be complied with. Therefore checks must be determined to be used to control these specifications. The verification of the purchase contracts is to make sure that the supplier has the same demands concerning the quality of the product as the client has. All contracts like purchase contracts or selling contracts must be controlled. Verification or contracts

Model SA 8000 (Social Accountability)

In Brazil due to the great demand of orange juice great plantations of orange trees were created.
About 100.000 peoples are working to harvest the oranges. Their pay is so small that they are unable to feed the family, so the children must help to increase income of the family. 30 to 35 % of the workers are children ,many of them are only 10 years old, working up to 14 hours a day. They cannot go to school and are endangered by pesticides.
UNICEF and other organisations make efforts to avoid the work of children and to give them the opportunity to go to a school. Some enterprises already have agreed to avoid or to reduce the work of children. There is still a need of external organisation to control the promise of not having children work.
The CEPAA (Council on Economic Priorities Accreditation Agency)has developed the Model SA 8000 (Social Accountability) which is a new international norm similar to ISO 9000.
The Model SA 8000 describes Standards in nine sectors of daily work, the health protection, the security during work and children work.
The control in the different enterprises is to be made from external free certificating companies.
The model SA 8000 certifying the working condition of a producer similar to certify the quality of the product according to ISO 9000 can make life difficult for people engaged in the harvest of oranges in Brazil.
It is important to rise the pay of the farm workers in a way to make it possible for a head of a family to feed his children.In order to attain this it is important to rise the price of orange juice in Germany an other consuming countries.
Another certification norm should survive the overpay to come to better pay of the farm worker.

The British Retail Consortium ( BRC)

The introduction of the UK Food Safety Act in 1990, the statutory of "due diligence" made necessary to formalise food inspection by the retailer. The retailer could no longer rely on a warranty defence in case of any complaint.

HACCP and small businesses

Since 1995, all proprietors of food businesses in the UK have been required to carry out a hazard analysis to identify the food safety hazards within their businesses. This covers five of the seven HACCP principles. The businesses are not required by legislation to document or formally verify their controls.

However, larger food businesses have already included all seven principles in their control system for their own advantage. In the future this will be a legislative requirement in the whole EU.

A study on the implementation conclude that it has become increasingly apparent that without a requirement for food businesses to perform the latter two steps of HACCP, recording and verification, enforcement officers have difficulty in proving non-compliance with the existing hazard analysis requirement in UK legislation. They have found that over half of all premises surveyed in the UK, were not cleaning and disinfecting correctly.

Situation in Australia

The same situation is found in Australia. The School of Leisure, Hospitality and Food Management at the University of Salford, notes that change in larger companies has been primarily customer driven (the large supermarket chains) but this has had little impact on smaller operations where the customer is often the end-user. The typical owner/manager has yet to be convinced that HACCP is either practical or effective in the context of his business.
Small food businesses face special problems when trying to implement HACCP. This is possibly even more pronounced in catering rather than processing or retail situations. A strong support system will need to be in place for an extended period if HACCP is to be successfully implemented in this type of business. Small businesses dealing directly with the public account for a significant part of the food industry and must be supported accordingly.

HACCP in the feed chain: HACCP concept should be implemented in the feed chain as this industry has been on the headlines in food scandals. The Third International Conference on Mycotoxins, which took place in Tunisia in March 1999, issued general recommendations to implement HACCP principles taking special attention in the control of risks associated with mycotoxin contamination of feed. Other hazards include dioxin, nitrofen, MPA in feed in Netherlands (MPA -Medroxy Progesterone Acetate- could affect a woman's ability to conceive), and BSE prions.


"The Codex Guidelines" has published several guidelines regarding feedstuffs such as, the Code of Practice for the Reduction of Aflatoxin B1 in Raw Materials and supplemental Feedingstuffs for Milkproducing Animals CAC/RCP 45-1997 1, The Proposed Draft Code of Practice for the Prevention of Mycotoxin Contamination in Cereals CX/FAC 02/21 November 2001.HACCP can help to reduce aflatoxins in crops. Critical control points often do not exist in the field because, many factors which influence the mycotoxin contamination of cereals are environmentally related, such as weather and insects. A HACCP system should be built on sound GAPs and GMPs.

Regional Programmes for Food Security (RPFS)

FAO broadened its partnership with 12 Regional Economic Organisations in Africa, the Caribbean and South Pacific, providing assistance to:
- identify regional issues/constraints affecting food security, agriculture and rural development; - prepare RPFS, including a plan of operation to address regional constraints; - prepare detailed projects for submission to donors, and facilitate resource mobilisation for their implementation. The RPFS projects incorporated a combination of production and productivity increases at the level of small farmers, development of domestic markets and of regional and international trade.

Priority was given to structural reforms for sustainable growth, harmonisation of policies, reduction of barriers to trade and development of human resources at both the national and regional level. Strengthening the agrarian structure of developing countries open the way for a later introduction of safety systems and guidelines. Without a substantial aid, the implementation of these systems are not realistic.

The poor countries will not benefit from an international food market if the world community represented by the UN acting through the FAO and WHO do not give them the necessary to help to fulfil the heavy demands of food safety and quality emanating from different Agreements and Negotiations.

Good Agricultural Practices (GAP)

[27] A multiplicity of Good Agricultural Practices (GAP) codes, standards and regulations have been developed in recent years by the food industry and producers organizations but also governments and NGOs, aiming to codify agricultural practices at farm level for a range of commodities. Their purpose varies from fulfilment of trade and government regulatory requirements (in particular with regard to food safety and quality), to more specific requirements of speciality or niche markets. The objective of these GAP codes, standards and regulations include, to a varying degree: - ensuring safety and quality of produce in the food chain
- capturing new market advantages by modifying supply chain governance
- improving natural resources use, workers health and working conditions, and/or
- creating new market opportunities for farmers and exporters in developing countries.

Good Agricultural Practices related to soil

- Reducing erosion by wind and water through hedging and ditching
- Application of fertilizers at appropriate moments and in adequate doses (i.e., when the plant needs the fertilizer), to avoid run-off (see nitrogen balance method).
- Maintaining or restoring soil organic content, by manure application, use of grazing, crop rotation
- Reduce soil compaction issues (by avoiding using heavy mechanical devices)
- Maintain soil structure, by limiting heavy tillage practices
- In situ green manuring by growing pulse crops like cowpea, horse gram, sunhemp etc.

Good Agricultural Practices related to water

- Practice schedule irrigation, with monitoring of plant needs, and soil water reserve status to avoid water loss by drainage
- Prevent soil salinization by limiting water input to needs, and recycling water whenever possible
- Avoid crops with high water requirements in a low availability region
- Avoid drainage and fertilizer run-off
- Maintain permanent soil covering, in particular in winter to avoid nitrogen run-off
- Manage carefully water table, by limiting heavy output of water
- Restore or maintain wetlands (see marshlands)
- Provide good water points for livestock
- In situ water harvesting by digging catch pits, crescent bunds across slope

GAPs related to animal production, health and welfare

- Respect of animal well-being (freedom from hunger and thirst; freedom from discomfort; freedom from pain, injury or disease; freedom to express normal behaviour; and freedom from fear and distress)
- Avoid nontherapeutic mutilations, surgical or invasive procedures, such as tail docking and debeaking;
- Avoid negative impacts on landscape, environment and life: contamination of land for grazing, food, water and air - Check stocks and flows, maintain structure of systems
- Prevent chemical and medical residues from entering the food chain
- Minimize non-therapeutic use of antibiotics or hormones
- Avoid feeding animals with animal wastes or animal matter (reducing the risk of alien viral or transgenic genes, or prions such as mad cow disease),
- Minimize transport of live animals (by foot, rail or road) (reducing the risk of epidemics, e.g., foot and mouth disease)
- Prevent waste run-off (e.g. nitrate contamination of water tables from pigs), nutrient loss and greenhouse gas emissions (methane from cows)
- Prefer safety measures standards in manipulation of equipment
Apply traceability processes on the whole production chain (breeding, feed, medical treatment...) for consumer security and feedback possibility in case of a food crisis (e.g., dioxin)

The ultimate goal of FAO GAP activities is to assist developing countries in developing appropriate protocols and processes which fit the local context, with a special focus to ensure that small and medium-holders can participate in GAP-orientated markets, which will continue to be of major importance in the global food system [28].

The FAO published a series of GAP guidelines such as:
Good Agricultural Practices - a working concept. 2004 [29].
Good Agricultural Practices (GAP) on horticultural production for extension staff in Tanzania [30]

What certification system should be used?

There is not one universally used accreditation scheme used in North America, and there are a number of different audit programs in use. It is to certify on audit standard the buyer want for their sellers and which audit company they accept. For instance, big national retailer will probably require for their suppliers to utilize an audit scheme recognized by the Global Food Safety Initiative. This is very expensive and are not always applicable to small farms. Other retailers or food service companies allow to utilize any auditing organization from a list of approved companies, this gets more difficult with a growing number of buyers using different systems.

The USDA Good Agricultural Practices and/or Good Handling Practices [31]

The United States Department of Agriculture currently operates an audit/certification program to verify that farms use Good Agricultural Practices and/or Good Handling Practices. Unlike the FAO guidelines, the USDA guidelines focus on food safety, and do not address topics such as animal welfare, biodiversity, or the use of antibiotics and hormones. The USDA GAP/GHP guidelines and principles are based upon a 1998 Food and Drug Administration publication entitled, "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables."

The USDA's GAP/GHP Program is broken down into three major sections: Good Agricultural Practices (GAP) which examines farm practices; Good Handling Practices (GHP) which concentrates on packing facilities, storage facilities and wholesale distribution centres; and Food Defense protocols utilized throughout the food chain. USDA also provides oversight for commodity specific audits performed to satisfy the requirements of the Leafy Green Marketing Agreement, the California Tomato Growers Cooperative, the mushroom industry, government purchase and of many large retail organizations. USDA also performs audits utilizing the newly developed GAP Harmonized Standards. The USDA GAP/GHP program is a voluntary, user fee funded program and is not mandatory regulation [32].

Third-party certification [33]

Third-party certification is a scientific process by which a product, process or service is reviewed by a reputable and unbiased third party to verify that a set of criteria, claims or standards are being met. Third-party Certifications and Consensus Standardization can eliminate the need for government to create bureaucratic laws and regulations that may restrict market access and delay the introduction of new technologies. The Manual is focused on five areas of a third-party certification:
1) Farm Review
2) Field Harvest and Field Packing Activities
3) House Packing Facility
4) Storage and Transportation
5) Traceback

Other audit programs

EurepGAP: is a common standard for farm management practice created in the late 1990s by several European supermarket chains and their major suppliers. The aim was to bring conformity to different retailers' supplier standards, which had been creating problems for farmers. It is now the world's most widely implemented farm certification scheme. Most European customers for agricultural products now demand evidence of EurepGAP certification as a prerequisite for doing business. The standard was developed using the Hazard Analysis and Critical Control Points (HACCP) guidelines published by the United Nations Food and Agriculture Organization, and is governed according to the ISO Guide 65 for certifications schemes. Unlike other farm certification schemes, it has definitive rules for growers to follow, and each production unit is assessed by independent third party auditors. These auditors work for commercial certification companies who are licensed by the EurepGAP secretariat to conduct audits and award certificates where merited.

Global GAP: In September 2007, EurepGAP changed its name to GLOBALGAP. The decision was taken to reflect its expanding international role in establishing Good Agricultural Practices between multiple retailers and their suppliers. A series of the standards can be accessed online [34].

China GAP: In February 2009 China GAP was launched by Global GAP. It was backed by the Certification and Accreditation Administration of the People's Republic of China (CNCA) . The CNCA is authorized by the China State Council to perform unified management, supervision and overall coordination of certification and accreditation activities in China [35].

PrimusLabs GAP: The PrimusLabs GAP program addresses the food safety topics of site selection, adjacent land use, fertilizer usage, water sourcing and usage, pest control and pesticide monitoring, harvesting practices (including worker hygiene, packaging storage, field sanitation and product transportation) and food defence. Standard Operating Procedures (SOP) are developed and incorporated into the GAP program, providing guidance with respect to potential points for contamination and preventative or corrective measures to mitigate their effects.

Vendor Management Program: It is focused on wholesalers, distributors and retailers in ensuring that their vendors comply with internal company food safety policies, including HACCP, GAP and GMP checklists.

FPA: The Food Processors Association's FPA-SAFE program targets food processors and suppliers of food ingredients. The Food Products Association, USA (FPA) is the largest trade association serving the food and beverage industry worldwide. It is an audit composed of Food Safety and Quality criteria. It includes Hazard Analysis and Critical Control Point (HACCP) based food safety systems, production controls, quality management systems and regulatory considerations.

SQF-Safe Quality Food Institute: SQF is a certification program which includes safety and quality. by the Global Food Safe Initiative (GFSI) for primary production as well as manufacturing, food storage and distribution and agents/brokers.

TN10: Suppliers of produce to Tesco in the UK must comply with the Tesco Nurture (TN10) scheme , which is a set of safety, quality and environmental standards of production.

British Retail Consortium (BRC): In 1998 the British Retail Consortium (BRC) developed the BRC Food Technical Standard to be used to evaluate manufacturers of retailers own brand food products.

ISO 22000: It is based on ISO 9001 with the incorporation of the HACCP food safety concept.

Certification of Uganda Tea by the Rainforest Alliance

[36] Rainforest Alliance certification is one of the certifications that promote sustainable agriculture practices. The Rainforest Alliance works to conserve biodiversity and ensure sustainable livelihoods by transforming land-use and business practices, and consumer behaviour mainly focused on tea production spread along the Rwenzori mountain ranges (Uganda).

Rainforest Alliance certification uses the Sustainable Agriculture Network Standard principles controlling that Social and environmental management systems are in place, conserve existing ecosystems, wildlife protection, prohibit deforestation, exert water conservation, improve working conditions and operational health, no use of banned agrochemicals, prevention of erosion and fertilization based on crop requirements and soil characteristics and use of integrated waste management programs.

The Farm management standards, together with the traceability system ensure that all certified products have their origin in well-managed farms that protect workers and wildlife. Sustainable Agriculture Network and the Rainforest Alliance work together in the have upgraded the Rainforest Alliance Certified Chain of Custody system. [37]

Greenwashing [38]

Rain Forest is active in more than 64 countries. It is being blamed to be an industry friendly organisation. Its logo is said to be used by giant corporations to improve their image and simulate the appearance that the origin of the products are of ecological and fair trade origin, which are not included in the criteria of Rainforest Alliance.

Quality of teas of Uganda [39]

According to George Ssekitoleko of the Uganda Tea Association, the teas of Ugandan are of low quality they are mainly used for blending with other teas at Mombasa and it goes out as Kenyan tea. Ugandan teamakers, he says, is finding enough workers to pluck tea leaves by hand. There shortage of labour in Uganda this country, and teamakers must use machines instead of manual plucking, Machines do not select between ripe and unripe leaves, which affects quality of the product.

A report of the International Center for Tropical Agriculture says that the suitability within the current tea-growing areas in Uganda for tea production in general will decrease by 2050. The suitable areas will migrate up to altitudes which rarely exists in Uganda. There is not sufficient land at these altitudes and alternative crops such as maize, passion fruit, banana or citrus must be considered. The districts of Kyejojo, Bundibugyo, Bushenyi, Kanungu, Masaka, will become unsuitable by 2050, alternative crops will have to bee planted there. Kabarole and Kisoro will remain suitable for tea, but adaption of agronomic management will be necessary. Suitability of tea will increase in areas around Rwenzori National Park and the southwestern corner of Uganda. However, many of these areas are protected areas. [40]

Mabale Growers Tea Factory is located at an altitude of around 1,500 metres on the lower slopes of the Rwenzori Mountains near Fort Portal in the west of Uganda, the country's main tea growing area. Fairtrade buys a small part of the production, however, most of the tea is sold to international buyers via the Mombasa auction. [41]

FDA Juice HACCP Hazards and Controls Guidance to help safe juice production []Juicindfiredit2004

The FDA provides a HACCP guidance for juice producers. Here is a small summary. The guidance is available at Juice HACCP.

All juice (as defined in 21 CFR 120.1(a))[3] sold as juice or for use as an ingredient in other beverages is subject to the requirements of the juice HACCP regulation, with the exception of juice produced at a retail establishment (i.e., for sale directly to consumers only; see definition of "Retail Establishment") [42]

The Food and Drug Administration's (FDA) "Juice HACCP Hazards and Controls Guidance." FDA recommends that this guidance be used in conjunction with FDA's final regulation (21 CFR Part 120) that requires a processor of juice to evaluate its operations using Hazard Analysis Critical Control Point (HACCP) principles and, if necessary, to develop and implement HACCP systems (i.e., a system of preventive control measures based upon HACCP principles) for it's operations.. [43]

Pathogen Hazard Identification/Evaluation of juices: Such as Salmonella, E. coli O157:H7, protozoan parasite Cryptosporidium parvum and viruses. Contamination of food by viruses is most likely to be caused by an ill individual, such as a farm worker or food handler.

Chemical Hazards: Here are aflatoxins cited such as patulin. Available information indicates that high levels of patulin may occur in apple juice if controls are not carried out to prevent this occurrence.

Lead: Lead contamination of produce can occur as a result of past use of lead in agricultural settings. For example, past use of lead arsenate as a pesticide in what were apple orchards is believed to have caused persistent lead contamination of the soil causing carrots presently grown on these sites to contain elevated lead levels. Produce could also become contaminated with airborne lead if it is handled at sites where vehicles or equipment are operated that use leaded fuel, if the equipment is operated in a manner that exposes the produce to excessive emissions from the equipment. Codex Alimentarius Commission has established a maximum level of 50 ppb for lead in ready-to-drink fruit juices.

Tin: Tin is used frequently as a coating in unlacquered metal cans used to pack light colored juices, such as pineapple juice. Typically, some tin plating leaches into the juice in small amounts that help retain the light color of the juice due to the antioxidant activity of tin. These small amounts generally do not pose any potential harm. The Codex Alimentarius Commission is considering establishing a maximum level of 200 ppm for tin in canned liquid foods for the protection of consumers.

Pesticide Residues: Agrarian fungicides and pesticides should to be considered as a chemical hazards.Pesticides are used widely to treat (e.g., for insect control) fruits, vegetables, grains, and other foods, and may be present in small amounts as residues on these foods. For pesticides used on foods, EPA also must establish a tolerance, which is the amount of residue legally permitted to remain in or on each treated food commodity, or an exemption from the requirement of a tolerance for the pesticide residue on the particular commodity.

Residues from unapproved pesticides, or residues in excess of pesticide tolerances, are illegal and could pose a potential hazard in juice warranting control in a HACCP plan if the residues occurred over a period of time at levels capable of causing health effects from repeated exposure, or if they occurred for only a brief period of time at levels capable of causing acute health effects. See additional information on pesticides in section IV. C. 2.

Undeclared Food Allergens in Juice due to Cross-Contact from Shared Processing Equipment: Peanuts, soybeans, milk, eggs, fish, crustacea, tree nuts, wheat, juice contamination using inadequately cleaned equipment previously used to produce other products.

Physical Hazards:These hazards are glass fragments, metal fragments.

How to control hazards of juices using the HACCP strategy

- Evaluate All Potential Hazards
- Determine Whether Potential Hazards Will Require Controls in Your HACCP Plan
- Potential Hazards "Reasonably Likely to Occur"
- Potential Hazards "Not Reasonably Likely to Occur"
- Hazards Related to Facility Sanitation
- Identify Control Measures and CCPs
- Make a CCP Decision Tree
- Location of CCPs

Activities Not Considered to be HACCP Control Measures

Some activities firms may undertake in processing juice and in related functions are not HACCP control measures. These include Good Agricultural Practices (GAPs) and Current Good Manufacturing Practices.


The HACCP regulation applies to firms engaged in the processing of juice. It does not apply to firms that conduct activities such as the growing, harvesting, and transporting of fruits and vegetables that will be processed into juice. Growers may voluntarily implement GAPs based upon FDA's GAPs guidance document [44] and by mail from the address given in section I. C above. Because growers and transporters of raw agricultural ingredients of juice are not subject to the requirements of the HACCP regulation, GAPs measures voluntarily undertaken by these parties are not HACCP controls. However, if a hazard originating from the agricultural environment is determined to be reasonably likely to occur on your incoming fruit, e.g., patulin on incoming apples, or pathogens on incoming raw fruit, pursuant to 21 CFR 120.8 (a), that hazard must be identified in your hazard analysis and controlled through your HACCP plan. If control of such a hazard involves actions that will be carried out by your grower, e.g., supplying you with only tree-picked fruit or fruit that does not include fallen fruit, your control measure could be based upon a supplier guarantee to this effect implemented as part of your HACCP plan.

Many small- and mid-scale growing operations do not have comprehensive GAPs or auditing programs on their farms. Rather, they tended to describe specific practices that they believed reduce risk of contamination (e.g., not using manure).

However, the FDA encourages to work with the suppliers to evaluate and modify agricultural practices in accordance with FDA's GAPs guidance document. [45]

Current Good Manufacturing Practices [44]

Juice processors are required to comply with the CGMPs requirements of 21 CFR Part 110. One common misconception about HACCP is that some hazards that are reasonably likely to occur may be controlled under a firm's CGMP programs under 21 CFR Part 110. Because programs to comply with 21 CFR Part 110 are general in nature and are not designed to control specific hazards, they are not HACCP control measures. Therefore, you cannot use CGMP programs to control a specific hazard that, based upon your hazard analysis, you have concluded is reasonably likely to occur in your juice. You must use HACCP controls for any such hazard.

Multilateral trade negotiations on agriculture

The basic concepts of the World Trade Organisation (WTO) agreements which affects directly agriculture are:

The Agreement on Agriculture (AoA)

The WTO's Agriculture Agreement was negotiated in the 1986-94 Uruguay Round and is a significant first step towards fairer competition and a less distorted sector. It includes specific commitments by WTO member governments to improve market access and reduce trade-distorting subsidies in agriculture. These commitments are being implemented over a six years period (10 years for developing countries) that began in 1995.

The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS)

An agreement on how governments can apply food safety and animal and plant health measures (sanitary and phytosanitary or SPS measures) sets out the basic rules in the WTO. It helps to ensure that strict health and safety regulations are not being used as an excuse for protecting domestic producers.

The Agreement on Technical Barriers to Trade (TBT)

Technical regulations and product standards may vary from country to country. Having many different regulations and standards makes life difficult for producers and exporters. If regulations are set arbitrarily, they could be used as an excuse for protectionism. The Agreement on Technical Barriers to Trade tries to ensure that regulations, standards, testing and certification procedures do not create unnecessary obstacles.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

The WTO Decision of the General Council of 30 August 2003 agrees on legal changes on TRIPS that will make it easier for poorer countries to import cheaper generics made under compulsory licensing, if they are unable to manufacture the medicines themselves. There is hope that likewise to the "Decision", in the future the benefits of food science will be shared with poorer countries, providing a more practical access to seeds and agrarian knowledge.

The treaties, agreements, guidelines are hurting sometimes even powerful nations, like recent problems of the food chain:

The bird flu outbreak in Texas in February 2004 is hurting poultry producers. Shares in a number of US chicken processors have already fallen.

According to the experts, it is not as virulent as the outbreak in Asia, but nevertheless its a highly contagious virus and therefore does require an immediate response from the EU.

The US exports about 15 per cent of its chicken, and the loss of these vital poultry export markets comes together with the first US case of mad cow disease in December resulting in a near-global ban on US beef loosing the export of about 10 per cent of its beef production. The US, on its turn, banned imports of French meat and poultry because of problems with French plants that have been certified to export.

ISO 15161:2001, Guidelines on the application of ISO 9001:2000 for the food and drink industry

ISO 15161:2002 combines ISO 9001:2000 and HACCP. It is a useful model for the business improvement in the food industry. It makes special reference to:

- A food safety risk assessment programme - Maintaining compliance with legal requirements - Maintaining emergency procedures and response - Maintaining operational risk control, monitoring and measurement - The continuous improvement of food safety management system performance - The effectiveness of corrective and preventative actions

Different aims of HACCP and ISO 9001

The Hazard Analysis Critical Control Point (HACCP) ensures the safety, whereas the ISO 9001 system is focused on ensuring the quality. The application of HACCP within an ISO 9001 quality management system can result in a food system that is more effective than the application of either ISO 9001 or HACCP alone, leading to enhanced customer satisfaction and improving organisational effectiveness. These guidelines give an interpretation of how ISO 9001 could be applied on a food organisation and are designed for organisations involved in all aspects of food industry.

ISO 15161:2001 includes sourcing, processing and packaging food and drink products and explains the possibility to link the common interests and the communication between the two systems. It is important to consider, that ISO 15161 is not a HACCP standard and cannot be a reference document at certification, but these guidelines are intended to provide a clear management system supporting HACCP controls for an effective food safety system, under the recognised framework of an ISO 9000 Quality Management System.

List of acceptable alternative standards to ISO 15161:2001

IRCA (International Register of Certified Auditors) has determined that, for the purposes of compliance with the food safety auditor certification criteria, the CAC/RCP 1 Code of Practice Food Hygiene is considered to be acceptable alternatives to ISO 15161:2001.
IRCA's evaluation of these standards consisted of a technical review for the purposes of validation of acceptability of an applicant's claim of experience "equivalent" to auditing to ISO 15161:2001.

ISO publishes the standard ISO 22000 "Food safety management systems- Requirements". These two standards are quite different. ISO 15161 deals with all aspects of food quality and shows how the HACCP system can be integrated into a quality management system. On the other hand, ISO 22000 concentrates exclusively on food safety and will instruct food producers how they can build up the food safety system itself.

ISO 22000: 200x Food Safety Management Standard

ISO 22000 will be international and will define the requirements of a food safety management system covering all organisations in the food chain from farmers to catering, including packaging. In recent times there has been a worldwide proliferation of third party HACCP and Food Safety Standards developed both by national standards organisations and industry groups including the UK's own BRC.

The idea of harmonising the relevant national standards on the international level was initiated by the Danish Standards Association (DS). ISO 22000 aims to harmonise all of these standards.

The standard has the following objectives: 1.Comply with the Codex HACCP principles.
2.Harmonise the voluntary international standards.
3.Provide an auditable standard that can be used either for internal audits, self-certification or third-party certification.
4.The structure is aligned with ISO 9001:2000 and ISO 14001:1996.
5.Provide communication of HACCP concepts internationally.

The ISO 22000 gives definitions on related terms, describes a food management system including:
1.General system requirements.
2.Definition of the management responsibility and commitment.
3.Documentation requirements.
4.Definition of responsibility and authority.
5.Calling for a food safety team, communication, contingency preparedness and response.
6.Gives a review on management, resource management, provision of resources, human resources, realization of safe products, product and process data, hazard analysis, design of the CCP plan, design of the SSM programmes, operation of the food safety management system, control of monitoring and measuring devices, measurement, analysis and updating of the FSM system.
7.System verification,validation and updating.
8.Correspondence between ISO 22000:200x and ISO 9001:2000.

The BRC/IoP Packaging Standard and ISO 22000:200x

Overview of the BRC/IoP Standard

The BRC/IoP Packaging Standard dates from 17 October 2001 and was developed by The British Retail Consortium and The Institute of Packaging , together with retailers, food producers, trade associations and packaging companies.

The suppliers of many UKś retailers such as Marks and Spencer, Sainsbury's, Safeway, Co-op, Tesco and Waitrose must achieve certification to the BRC/IoP Packaging Standard. EU Food Safety Directive 93/43/EECwas the response to the need to increase food safety. Under the terms of the UK Food Safety Act, retailers have an obligation to take all reasonable precautions and exercise all due diligence in the avoidance of failure, whether in the development, manufacture, distribution, advertising or sale of food products to the consumer.

The BRC/IoP Standard will probably become the benchmark by which audits are undertaken and it will likely supersede previous hygiene certification schemes.

Requirements of the BRC/IoP Standard
1.The adoption of a formal Hazard Analysis System.
2.A documented Technical Management System.
3.The control of factory standards, products, processes and personnel Benefits of certification.
1.Supported by most of the major UK Retailers.
2.A single standard and protocol, evaluations will be carried out by third party certification bodies accredited to European standard EN45011.
3.Packaging manufacturers can use the standard to ensure that their suppliers are following good hygiene practices and complete the 'due diligence' chain.

The standard has been translated into Swedish, Dutch, Italian, German, French and Spanish. UK hopes are that pressure will be achieve by the retailers to get the BRC/IoP Packaging Standard applied to all their suppliers.

The requirements of the standard differ depending on the risk of the food. The 'decision tree' in section 8 is intended to determine whether the category 'B' meeting higher level requirements of the standard is to be used, or category 'A' with less rigorous requirements is applied.

The standard is flexible and allows suppliers to operate both category A and B standards in separate 'risk areas' of the factory. In addition suppliers may apply for exemptions to certain clauses of the standard if they can be identified and confirmed through the hazard analysis.

Content of the BRC/IoP Standard

The standard consists of eight sections plus an associated protocol.

1. Scope

General overview of the standard, whom the standard applies to and what the requirements of the standard are.

2. Organisation

Covers the requirements for the organisation in terms of management responsibility, organisational structure and management review.

3. Hazard and risk management system

Covers the requirements for a formal hazard analysis of the production process considering foreign object, chemical and microbiological contamination as well as packaging defects that compromise consumer safety.

4. Technical management system

Covers the quality and hygiene policy, hygiene system documentation and control, specifications, management of incidents and product recall, traceability system, internal audits, complaints, supplier monitoring, subcontracting and product analysis.

5. Factory standards

Covers the requirements for the building infrastructure, facilities and fabric, product flow, maintenance of equipment, housekeeping, cleaning and waste management.

6. Contamination control

Covers the requirements for foreign object training, glass control, blade control, chemical and biological control, pest control and transport, storage and distribution.

7. Personnel

Covers the access and movement of personnel, staff facilities, toilets and hand washing, eating, drinking and smoking, illness and injury, jeweller and personal items, protective clothing and hygiene training.

8. Risk category determination

In this section the supplier uses the decision tree to determine whether they are a category A or B risk supplier.

Certification bodies

It is a requirement that the certification bodies evaluating against the standard are formally accredited to the European standard EN45011 (General requirements for bodies operating product certification systems).

Formal accreditation of a certification body can only be granted by a National accreditation body; in Great Britain this Body is The United Kingdom Accreditation Service (UKAS). In other countries this will include National accreditation bodies which are members or associate members of EA (European Co-operation for Accreditation) or subject to bi-lateral or multilateral agreements.

EN45011: The standard for the European Accreditation of bodies who are involved in certification

Certification body

Companies who have gained accreditation to EN 45011 for the scope of the BRC/IoP standard.


A systematic examination to measure compliance of practices with a pre-determined system, whether the system is implemented effectively and is suitable to achieve objectives, carried out by certified bodies. UKAS: The United Kingdom Accreditation Service, recognised by the British Government as the sole national body responsible for assessing and accrediting the competence of organisations in the fields of measurement, testing, inspection and certification of systems, products and personnel.

Types of standards

ISO has several types of standards:

Auditable standards

Auditable standards are developed in a manner that all elements are applicable (unless stated otherwise (exclusions)) and must be implemented. The ISO 9001:2000 is an auditable standard.

Guidance standards

Guidance standards are intended to be used by organisations to provide an interpretation of the auditable standard. ISO 22000:200x will be a guidance standard describing the requirements of a food safety management system, it will also be an auditable standard and can be used for certification and registration. The scope of the standard will be food safety. Food quality issues are to be addressed using ISO 9001:2000. ISO 9000:2000 and ISO 9004:2000 are guidance standards that are used to interpret ISO 9001:2000.

The BRC/IOP Packaging Standard does not completely separate the food safety issues and the quality issues, turning the Standard a good tool for the food industry.

Detail of the Standards

ISO 22000:200x appears to be less prescriptive than the BRC/IOP Packaging Standard, in that it does not address in detail the Good Manufacturing Programs (GMPs), (Good Hygiene Programs) or prerequisite programs.

Structure of the standards

ISO 22000:200x will be compliant with ISO GUIDE 72. ISO Guide 72 is a standard that describes the structure of management system standards. This will ensure that the ISO standard has a parallel structure to ISO 9001:20000. The structure of BRC/IOP Packaging Standard appears to be similar to ISO 9001:1994.


ISO 22000:200x is intended to be used by organisations throughout the food chain, while the BRC/IOP Packaging Standard is intended to be used by food packaging organisations. ISO22000 will probably turn out to be the auditable standard or a standard that can be used for registration / certification for the future, but it does require the implementation of relevant industry GMP's, Standards and prerequisite measures. The BRC/IOPI may therefore remain in Britain as a standard that could provide more guidance to the food packaging companies on the interpretation of the GMP or prerequisite programs.

Food industry organisations who trade solely within the UK may never be required to achieve certification to ISO 22000:200x, but global suppliers will have to get the ISO 22000 certificate.

Auditing Standard ISO 19011

This International Standard can be used by internal and external parties, including certification bodies, to assess the organisation's ability to meet customer, regulatory and the organisation's own requirements. The quality management principles stated in ISO 9004:2000 have been taken into consideration during the development of this International Standard.

Other special rules on food production to ensure food safety

Auditing for Bovine Spongiform Encepalopathy (BSE)

Australian system of certification applying to each country which wishes to export bovine products to Australia is intended to protect Australians from BSE and vCJD. Australia has announced a system of certification which will apply to each country which wishes to export bovine products to Australia. This will replace the current suspension of imports of beef and beef products from a number of countries.

ANZFA has categorised countries according to their BSE risk. Countries where BSE has been reported will have current import suspensions on beef products extended, while others will be required to provide official government certification of their BSE status based on their measures to protect against BSE, scientific assessment by specialist international bodies such as the Scientific Steering Committee of the European Union and the World Animal Health Organisation (OIE), and other informations. There will be four categories:

Category A (certification required) countries are regarded as posing a negligible risk to human health.
Category B (certification required) countries, while not reporting cases of BSE, may have been exposed to high risk factors such as the importation of high-risk meat and bone meal.
Category C (certification required) countries are known to have considerable exposure to BSE risk materials, but have not reported indigenous cases of BSE.
Category D countries, which have reported cases of indigenous BSE in their herds, pose the highest level of risk and their beef and beef products will be refused entry to Australia.

Products from category B and C countries can only be imported if the national authority can certify that the product is derived from animals not exposed to BSE risk and if specific risk materials have been excluded from the food chain. Belgium, the Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxemburg, the Netherlands, Portugal, Spain, Switzerland and the United Kingdom - where cases of BSE have been reported - will be deemed Category D and will have existing temporary import suspensions of beef and beef products extended.

Quality Control

Deming's Management-Program

W. Edwards Deming influenced worldwide quality control. He stressed the need to "drive out fear," to stop relying on inspection for insuring quality, and to focus on building cooperation and not competition within an organisation.[46]

The philosophy of Deming was successful in US. In Germany there are only weak responses to the ideas of Deming. The German site tries to bring these ideas to the German-speaking area. In Switzerland The Swiss Deming Institute and in Great Britain, however, The British Deming Association are propagating the philosophy based on Deming's fourteen points:[47]

1. Create constancy of purpose towards improvement of product and service, with the aim to become competitive, stay in business, and to provide jobs.
2. Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, must learn their responsibilities, and take on leadership for change.
3. Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by creating quality into the product in the first place.
4. End the practice of awarding business on the basis of price tag. Instead minimise total cost. Move towards a single supplier for any one item, on a long term relationship of loyalty and trust.
5. Improve constantly and forever the system of production and service, to improve quality and productivity, and thus constantly decrease costs.
6. Institute training on the job.
7. Institute leadership (see point 12.) The aim of leadership should be to help people and machines and gadgets to do a better job. Leadership of management is in need of overhaul, as well as leadership of production workers.
8. Drive out fear so that everyone may work effectively for the company.
9. Break down barriers between departments. People in research, design, sales, and production must work as a team, to foresee problems of production and in use that may be encountered with the product or service.
10. Eliminate slogans, exhortations, and targets for the work force that ask for zero defects and new levels of productivity.
11a. Eliminate work standards (quotas) on the factory floor. Substitute leadership.
11b. Eliminate management by objective. Eliminate management by numbers, numerical goals. Substitute leadership.
12. Remove barriers that rob the hourly worker of his right to pride of workmanship. The responsibility of supervisors must be changed from sheer numbers to quality.
12b. Remove barriers that rob people in management and in engineering of their right to pride in workmanship. This means, abolishment of the annual or merit rating and of management by objective, management by the numbers.
13. Institute a vigorous program of education and self-improvement.
14. Put everybody in the company to work to accomplish the transformation. The transformation is everybody's job.

The Seven Deadly Diseases

1. Lack of constancy of purpose to plan product and service that will have a market and keep the company in business, and provide jobs.
2. Emphasis on short-term profits: short-term thinking (just the opposite of constancy of purpose to stay in business), fed by fear of unfriendly takeover, and by push from bankers and owners for dividends.
3. Personal review systems, or evaluation of performance, merit rating, annual review, or annual appraisal, by whatever name, for people in management, the effects of which are devastating. Management by objective, on a go/no-go basis, without a method for accomplishment of the objective, is the same thing by another name. Management by fear would still be better.
4. Mobility of management; job hopping.
5. Use of visible figures only for management, with little or no consideration of figures that are unknown or unknowable.
6. Excessive medical costs.
7. Excessive costs of liability.

Deming's Chain Reaction

Deming developed what was called Demigś Chain Reaction: Improved quality → Improved productivity → Costs decrease → Greater market share → sollid company structure → Secure working places.[48]

Arman Feigenbaum

Armand Feigenbaum together with Deming created the basis of quality management and introduced the "Total Quality Control". The idea is that quality requires a "total" effort of management and not simply the inspection department. Feigenbaum defined four keys components of quality cost:
1 - Prevention costs including quality planning.
2 - Appraisal costs including inspection.
3 - Internal failure costs including scrap and rework.
4 - External failure costs including warranty costs, complaints etc.
Feigenbaum has summarised his ideas about Total Quality into ten key concepts. Feigenbaum called for a separate Quality Assurance Department to help coordinate the Total Quality effort.[46]

Kaoru Ishikawa

Kaoru Ishikawa developed many of the tools of quality management like the Quality Circles, the Cause-and-Effect Diagram (Fishbone Graph or Ishikawa Graph), and the Seven Tools of Quality Control. According to Ishikawa, workers alone should not be blamed poor quality, failures of the management system should be looked upon too. Worker attitudes would improve as the systems which are provided by management improve.[46]

Interoperability of Standards

The main producers of national standards

Western Europe

United Kingdom

British Standard Institution


Deutsches Institut fr Normung e.V.


Association Francais de Normalisation


European Committee for Electrotechnical Standardization
European Committee for Standardisation
Electronic Components Committee
European Standard Harmonized Document

Institutions Outside Europe


American National Standards Institute


Canadian Standards Association

International Standards

International Standards themselves are drawn up by international technical committees which have been approved by ISO or IEC member countries.

Where different national Standards persist they will do so as a reflection of different market preferences. Quality is today seen by a customer when a product always meets the quality standard that was initially offered and/or recommended.

Other countries such as Japan and Saudi Arabia develop their own Standards, but European and North American Standards are the most widely used ones. International trade has been hindered by the diversity of standards. Many suppliers do not have copies on the relevant standard of the country to which they want to export, or they do not find it cost-effective to retool their entire works in order to conform to the requirements of that particular standard.
For this reason international standards are becoming increasingly important.

International Organization for Standardisation

Industrial standards

International Electrotechnical Commission
Electrical equipment
International Telecommunications Union
Global telecom networks

Associating ISO 9001:2000 with complementary systems such as BS 8800 Health and Safety and the ISO 14001:1996, Environmental Management, increases the synergic effect of the systems. There is an overlap between 9001:2000 and 14001:1996 and there are some elements which differ:
ISO 9001:2000 aims to achieve customers satisfaction looking on competitive price. The ISO 14001:1996 aims to improve environmental impact on nature.

The 2000 revision is an attempt to harmonise ISO 9000 (quality) withe ISO 14001 (environment) and BS 8800 (health)so that an organisation can handle quality, environment, health and safety with one system.

ISO 9001:2000

The ISO 9000 series turnbed out to be the best international quality management system. The ISO-9001:2000 can be used for internal application by organisations, certification, or contractual purposes.

The ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 family of standards have been consolidated into a single revised ISO 9001:2000 which contains a single quality management requirements standard that is applicable to all organisations, products and services aiming to: Address customer satisfaction.
Meet customer and applicable regulatory requirements.
Enable internal and external parties to assess the organisation?s ability to meet these requirements.
The ISO-9001:2000 quality system aims to enhance customer satisfaction. This includes the processes for continual improvement of the quality system and the assurance of conformity to the customer and applicable regulatory requirements.
In global business the certification according ISO 9000 turned out to be an imperative duty.t The HACCP concept should be integrated in the quality system fulfilling hygiene regulations.

The ISO 9000 was first released in 1987, a first revision was published in 1994 and in 2000 the modification to ISO 9001:2000 was released. Since then only three main standards subsisted: ISO 9000:2000: Includes a description approach to quality Management as well a revised vocabulary. ISO 9001:2000: Includes the quality management system, requirements. ISO 9004:2000: Includes guidelines for performance improvement moving toward Total Quality Management. It is not intended for certification or contractual use.

They rely on the following eight principles:
1.Customer focused organisation
3.Involvement of people
4.Process approach
5.System approach to management
6.Continual improvement
7.Factual approach to decision making
8.Mutually beneficial supplier relationship

Documentation of the system should include:
1.Quality Manual.
2.Specific statement regarding quality policy and quality objectives.
3.Documented procedures that describe the sequence of processes necessary to ensure the conformity of the product.
4.Documented instructions to ensure the effective operation and control of the processes.
5.Quality records.

Control of documents: A procedure for the control of documents should include: 1.Controlled distribution of documents.
2.Approval of documents prior to issue.
3.Review and updating and re-approval of documents.
4.Identifying the current revision status of documents.
5.Ensuring that only relevant versions of applicable documents are available at points of use.
6.Insuring that documents remain legible, readily identifiable and retrievable.
7.Identifying, distributing and controlling documents from an external source.
8.Controlling obsolete documents.

Control of records should include:
5.Retention time
6.Disposition of all quality records.

Management commitment:
1.Conduct regular management reviews
2.Ensure the availability of necessary resources
3.Ensure that everyone is aware of the importance of meeting customer, regulatory and legal requirements.

Customer focus:
1.Customer needs and expectations must be determined.
2.They must be converted into requirements
3.The requirements must be fulfilled.

Quality policy:
The quality policy of the organisation should be communicated and understood by everyone. It should be capable of continual improvement and regularly reviewed.

Quality management system planning:
Quality planning should be documented including quality objectives and resource.

Responsibility, authority and communication:

The administration of the QMS covering the responsibilities and authorities, function, relationship and the internal communication must be documented.

Review input from:
1.Earlier management reviews such as follow-up actions.
2.Previous internal and external audits.
3.Customer feedback.
4.Process performance.
5.Product conformance.
6.Preventive and corrective actions.
7.Changes that could affect the QMS and recommendations for improvement.

Review output:
1.Improves the overall QMS and its process.
2.Improves the product.
3.Enhances customers satisfaction.
4.Confirmes the resources required.

Resource management includes:
1.Human resources on regard of competence, awareness and training.
2.Provision of resources.
3.Work environment.



Specifications are essential technical requirements for items, material, or services, including the procedures to be used to determine wether the requirements have been met. Specifications may also include requirements for preservation, packaging, packing and marking.[49] Without proper specifications it is impossible to expect a manufacturer or supplier to produce an article, equipment or system that completely satisfies the customer.

Types of specifications

Three types of specifications can be used to settle product requirements:

1. General specifications

Are overall specifications of the product written by the purchaser. It requires a detailed description of the article. Suitable, appropriate, conventional harmless or healthy should not be used as they open loopholes in case of complaints. It should contain the whole formula for food, ingredients and packaging.
2. Overall performance specifications These Specifications have vague contents. They leave everything up to the manufacturer. Later complaints are almost impossible.

3. Standard specification

Here a detailed description of every ingredient is given. Lists of the National Standards Organisations NSOs of parts commonly used by manufacturers, or The British Standards Institution (BSI) lists such as BS 9000, CENELEC and IECQ and CECC as well as standards and regulations such as Codex Alimentarius and other organisations can be used.

Control of non-conforming products

This part of the System is to avoid:
1.Products which do not conform to requirements are prevented from unintended use or delivery.
2.Non-conforming products that have been corrected are re-verified to demonstrate conformity.

Economics of Quality

BS 6143-2:1990

This standard gives procedures in case of non- conformity products. BS 6143:Part 1:1992 Process cost model Control of quality costing of any process or service.
BS 6143:Part 2:1990 Prevention, appraisal and failure model (PAF).

Robot for food production reducing handling contamination

Robots may reduce human contact with food products during separating, dosing, packing, sealing and labelling, eliminating thus a major source of contamination. his may become an important step toward an improved aseptic production.

The Quickplacer robot of the Fatronik corporation can be used for quality control in the processing of vegetables or feeding various products such as fish or meat to flowpack machines, in positioning chocolates in individually-shaped slots or for packaging bars of chocolate, biscuits, peppers, lipstick bars and baby towelettes, either individually or in groups, work being done by workers.

Pork quality and pH

[51] Ken Prusa, a professor of food science of the Iowa State University, studied the correlation between pH levels and pork quality.

Prusa proposes pH testing as a new way to evaluate pork quality. He found that higher pH products are more tender, juicy and flavourful. On the contrary, acidity causes meat deterioration, discolouration and watery consistency.

According to Prusa pork pH is affected by
- Genetics: Geneticists are looking on pork quality related to pH factor.
Chilling procedure: Lowering the temperature of the carcass rapidly in order to avoid pH to drop too low before chilling can stabilize it.
Stress levels: Stress just before slaughter causes high adrenaline levels, resulting in a really rapid pH decline due to higher metabolism.

The work of Prusa will influence packers, processors and geneticists taking advantage of the pH factor. As a quality check, measuring pork pH ensures a carcass had been chilled rapidly and excessive animal stress before laughter had been avoided.


[52] The EU Eco-Management and Audit Scheme (EMAS) is a management tool for companies and other organisations to evaluate, report and improve their environmental performance. The scheme has been available for participation by companies since 1995 (Council Regulation (EEC) No 1836/93 of 29 June 1993) and was originally restricted to companies in industrial sectors.

Participation is voluntary and extends to public or private organisations operating in the European Union and the European Economic Area (EEA) - Iceland, Liechtenstein, and Norway. An increasing number of candidate countries are also implementing the scheme in preparation for their accession to the EU.

EMAS registration

To receive EMAS registration an organisation must comply with the following steps:
  1. conduct an environmental review considering all environmental aspects of the organisation's activities, products and services, methods to assess these, its legal and regulatory framework and existing environmental management practices and procedures.
  2. in the light of the results of the review, establish an effective environmental management system aimed at achieving the organisation's environmental policy defined by the top management. The management system needs to set responsibilities, objectives, means, operational procedures, training needs, monitoring and communication systems.
  3. carry out an environmental audit assessing in particular the management system in place and conformity with the organisation's policy and programme as well as compliance with relevant environmental regulatory requirements.
  4. provide a statement of its environmental performance which lays down the results achieved against the environmental objectives and the future steps to be undertaken in order to continuously improve the organisation's environmental performance.
The environmental review, EMS, audit procedure and the environmental statement must be approved by an accredited EMAS verifier and the validated statement needs to be sent to the EMAS Competent Body for registration and made publicly available before an organisation can use the EMAS logo.

The EMAS regulation

[53] Regulation (EC) No 761/2001 of the European Parliament and of the Council of 19 March 2001 allowing voluntary participation by organisations in a Community eco-management and audit scheme (EMAS).

The Eco-Management and Audit scheme (EMAS) evaluates and improves the environmental performance of organisations and the provision of relevant information to the public and other interested parties by :

(a) the establishment and implementation of environmental management systems by organisations as described in Annex I;
(b) the systematic, objective and periodic evaluation of the performance of such systems as described in Annex I;
(c) the provision of information on environmental performance and an open dialogue with the public and other interested parties;
(d) the active involvement of employees in the organisation and appropriate initial and advanced training that makes active participation in the tasks referred to under (a) possible. Where they so request, any employee representatives shall also be involved.

Environmental policy

Should be the overall aims and principles of action of an organisation with respect to the environment including compliance with all relevant regulatory requirements regarding the environment and also a commitment to continual improvement of environmental performance; the environmental policy provides the framework for setting and reviewing environmental objectives and targets. Annex I describes the environmental management system.

Annex II

describes the requirements concerning internal environmental auditing.

Annex III

describes the environmental statement. The aim of the environmental statement is to provide environmental information to the public and other interested parties regarding the environmental impact and performance and the continual improvement of environmental performance of the organisation. Environmental information shall be presented in a clear and coherent manner in printed form for those who have no other means of obtaining this information. Upon its first registration and every three years thereafter, the organisation is required to make available the information in a consolidated printed version.

Annex IV

describes the logo, bearing the registration of the organisation.

Annex V

describes the accreditation, supervision and function of the environmental verifiers.

Annex VI

describes the environmental aspects

Annex VII

describes the environmental review

Annex VIII

describes the registration information

Recognition of ISO 14001:2004

[54] The Commission Regulation (EC) No 196/2006 of 3 February 2006 amends Annex I to Regulation (EC) No 761/2001 of the European Parliament and of the Council taking account of the European Standard EN ISO 14001:2004.

Organisations participating in the eco-management and audit scheme (EMAS) shall implement the requirements of EN ISO 14001:2004, which are described in Section 4 of the European Standard (*) and are fully reproduced below:

ISO 14001

[55] The EMAS EC directive is exclusively applicable to industrial companies , and was transformed in 1995 into German law.

The ISO 14000 ff

The International Standard Organisation (ISO) developed at that time its ISO 14000 ff standards which regulates the implementation of environmental management systems and the performance of environmental audits. These standards have a wide scope and are suited for service companies. There is further integration work necessary for ISO 14000ff to correspond to the requirements of the EMACS EC directive

European food safety regulation activities in EU

UK FSA Guidance issued on preventing and responding to food incidents

[56] [57] The Food Standards Agency in a press release from 18. April 2007 announces that it has published a guidance to help businesses and enforcement authorities to prevent and better respond to food incidents.

According to the UK Food Standards Agency an incident is defined as any event where, there are concerns about actual or suspected threats to the safety or quality of food that could require intervention to protect consumers' interests. This includes Food and feed where it impacts on food safety or quality.

The guidance gives step-by-step advice about preventing food incidents, including how to identify potential hazards. It also gives practical advice about effective incident response from notification through to post-incident actions.

The guidance is designed to help anyone who is responsible for handling incidents in the food industry as well as those in local authorities. A summary version has been developed particularly for small businesses. According to FSA the food chain is complex and food incidents are difficult to eliminate altogether but the Agency hopes that providing clear, easy-to-follow information will help food businesses to reduce the likelihood of them happening. The FSA notes that the guidance also aims to improve the handling of incidents by providing easy-to-follow advice on the steps to follow if an incident does occur. The contents are voluntary in nature and do not replace to summarise current best practice in incident management.

Get the Factsheet and the Guidance Document: Principles for preventing and responding to food incidents.

EC General Food Law Regulation 178/2002


General principles of food law

Risk analysis

The Food Law is based on risk analysis.

Precautionary principle

In specific circumstances where the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure health protection may be adopted. These measures shall be proportionate and no more restrictive of trade than is required to achieve the health protection.

Protection of consumers' interests

The Food Law aims at the protection of the interests of consumers and provides a basis for consumers to make informed choices in relation to the foods they consume and prevents against:

Principles of transparency

Where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health Public consultation and public information public authorities shall take appropriate steps to inform the general public of the nature of the risk to health, identifying the food or feed, the risk that it may present, and the measures which are taken.


Confidential information shall not be divulged to third parties, except for information which must be made public to protect public health.
The conclusions of the scientific opinions relating to foreseeable health effects shall on no account be kept confidential.

Rapid alert system

A rapid alert system among the Member States for the notification of a risk to human health deriving from food or feed is established as a network under the responsibility of the Commission. The Member States notify the Commission under the rapid alert system of:

Emergency measures for food and feed of Community origin or imported from a third country

Where it is evident that food or feed originating in the Community or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, the Commission, acting on its own initiative or at the request of a Member State, acts as follow:

General plan for crisis management

The Commission sets up a crisis unit and provides scientific and technical assistance if necessary. The crisis unit is responsible for collect and evaluate informations and identify the options to prevent, eliminate or reduce the risk to human health.

Shelf life testing

Shelf life testing light and temperature effects

[59] Lara Manzocco and colleagues developed a new shelf life modeling of photosensitive foods such as beverages highly prone to oxidative photobleaching, considering different light levels at increasing temperatures. Bleaching rate, pigment content, and pigment degradation products were analysed.

The authors stress that shelf life testing of light-sensitive foods must take into proper account the effect of temperature and light to predicting shelf life of photosensitive foods under marketing conditions.

New Code of Responsible Practice (CORP)

[60] [61] This code is being developed by the International Fish meal and Fish Oil Organisation (IFFO), which represents the fish meal and fish oil industry worldwide, is developing a new Code of Responsible Practice (CORP). Fish meal and fish oil producers will be able to prove that their products are traceable, high quality marine products which are manufactured safely using fish from responsibly managed fisheries. Producers should be able to enter the audit process early in 2009.

The EU and Japan monitor fish meal to ensure it is free of land animal material.

HACCP shemes

HACCP schemes are usualy in place to control safety and quality of the production. This involves outside inspectors who ensure critical control points are correctly identified and controls carefully monitored and recorded e.g. product temperature, moisture, microbial count etc.

IFSA quality assurance scheme

Exporters to European Union should adopt the International Feed Standard Alliance (IFSA) quality assurance scheme. This covers quality assurance from raw material through the factory, storage and transport to the end user. It includes the Dutch GMP+ and UK Femas schemes and is expected to become the main quality assurance scheme for raw materials across Europe. [62]

Production and quality

The production and quality controls of fish meal and oil are described by FAO. [63] [64]

Serious lack of HACCP and quality control menaces veracity of forensic DNA evidences

[65] Contaminated cotton swabs had been used by the German police collecting evidences at crime scenes. The same DNA profile was found in 40 criminal cases.

The German newsmagazine Stern reported that the cotton swabs were probably contaminated, speculating that it could have been by a careless employee at the manufacturer.

16.000 hours of meticulous research had been spent tracking the "Phantom of Heilbronn" whose DNA was first noted during the researches concerning the killing attempt of two policeman at Heilbronn city 15 years ago. This profile was then found all over the country, with the exception of one State which used swabs of a different swab producer.

HACCP and quality control systems failed to avoid bad quality of the swabs, questioning the veracity of all forensic DNA evidences. This case reveals serious loopholes over all HACCP and quality control systems.

Bernd Carstensen of the German Union of Criminal Investigators (BDK) calls for a DNA quality seal which includes data about the DNA of the employees who handled the products in the packaging. Contamination could be ruled out.

Report of food outbreaks 2009 in Germany

[66] The German Federal Institute for Risk Assessment (BfR) published the report of food-borne outbreaks in Germany in 2009. A total of 78 food-borne outbreaks were reported, mainly caused by salmonella, together with other pathogens, toxins and amines. Meat, meat products and sausages dominated. Contaminated foods were primarily consumed in restaurants and private households.

Sources of contamination

The transmission of microorganisms from one (usually raw) food to another, referred to as cross-contamination, played an essential role in outbreaks. Other sources of contamination were the handling of foods by infected individuals, an insufficient sanitation plan as well as the processing of shell eggs or other contaminated ingredients.

Cooling or heating of food

Insufficient cooling or cooling-down of foods contributed to the increase of pathogens in contaminated food. Insufficient heating of foods was also reported often, which can lead to the survival of pathogens in foods.

Insufficient HAACCP concepts

Insufficient HACCP concepts (Hazard Analysis and Critical Control Point) of food companies were also a factor. The HACCP concepts are an essential aspect of self-monitoring plans in food companies.

The BfR concluded that many of the food-borne out-breaks were caused by hygiene deficiencies and mistakes in temperature management, which occurred both in private households and the commercial sec-tor. Suitable consumer information and regular trainings of kitchen personnel in restaurants and other community catering facilities can help prevent future outbreaks.


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See also: Related OurFood News
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