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Department of Food Safety and Food Quality – Ghent University - Food Safety

Food Safety

Introduction (part 0)Microbiological hazards (part 1)

Chemical hazards (part 2)

Physical hazards (part 3)Quality Assurance Systems (part 4)Risk Analysis (part 5)

AJ 2010 - 2011

Prof. Dr. Ir. Mieke UyttendaeleProf. Dr. IR. Bruno De Meulenaer

Dr. Ir. Liesbeth Jacxsens

Department of Food Safety and Food QualityFaculty of Bio Science Engineering

Ghent University




Overview of Food Safety :

0. Introduction

1. Microbiological and hygienic aspects of food safety

1.1. Introduction

1.2. Bacteria - foodborne illness

1.2.1. Bacteria causing food infections

Salmonella

Campylobacter

Escherichia coli O157

Listeria monocytogenes Others

1.2.2. Food intoxicating bacteria

Staphylococcus aureus

Bacillus cereus

Clostridium perfringens

Clostridium botulinum

1.3. Viruses

1.4. Fungi

1.5. Protozoa and parasites

2. Chemical aspects of food safety

2.1. Basic principles about human toxicology

2.2. Food sensitivities

2.3. Food intoxications

2.3.1. Food additives

2.3.2. Residues

Veterinary drugs

Crop protection agents

Desinfectants

Migration from food contact materials

2.3.3. Contaminants

Environmental contaminants

Process contaminants

Mycotoxins

Marine and related toxins

2.3.4. Endogenous components

3. Physical aspects of food safety3.1 Definitions




3.2 Preventive measures and detection of foreign bodies

4. Quality assurance systems assuring food safety

4.1. Principles of Codex Alimentarius

4.2 Key elements of quality

4.3. Integrated approach4.4 ISO 9000: 2008

4.5. Quality assurance standards in the agricultural sector

4.6. Quality assurance standards in the food industry

5. Risk analysis in relation to food

5.1. Definitions

5.2. Risk assessment

5.2.1. Chemical risk assessment in foods

5.2.2. Microbial risk assessment in foods

5.3. Risk management and communication




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0. Introduction

0.1. Definition of food safety

Food safety became last decades very important for both governments, producers of foodproducts and consumers as well. These issues are playing on international, European and

national level.

Food safety is considering different types of hazards:

a) (Micro)biological hazards (see part 1): only these (micro)-organisms which are

pathogenic will be considered, which are causing a food infection or an intoxication.

The spoilage causing micro-organisms are not related to food safety but to food

quality.

b) Physical hazards (see part 3) : hard, sharp foreign objects which are not expected to be

present in the food product can provoke injuries in the mouth, teeth, pharynx, throat or

can lead to asphyxiation.

c) Chemical hazards (see part 2) : chemical products or contaminants can be of different

nature e.g. residues of pesticides or other phyto-products applied during the

production of crops, fruits and vegetables, antibiotics applied in the animal production,

environmental contaminants such as heavy metals or dioxins. The chemical hazards

are mostly inducing long term health problems for consumers of food products. In this

group as well the allergens are considered. This are mostly natural food components

e.g. proteins, which are provoking an allergic reaction with sensitive persons.

Examples of allergens are gluten (in wheat products), milk, egg, fish, nuts, mustard.

Problems with food safety can be very divers and in Europe an inventory is made by the

European Commission via the Rapid Alert System. See :

http://ec.europa.eu/food/food/rapidalert/index_en.htm

Food safety must be differentiated from food quality. Food safety is the basic requirement fora food product. Consumers may not become ill from eating a food product. Food quality on

the other hand, is more as food safety alone, secondary issues are playing here a role:

1) legally demanded quality aspects e.g. composition of bread, composition of chocolate,

nutritive value of milk,… : not for all types of food products these compositions or nutritive

values are described by international documents or on national level – this can impose

differences in the same type of a food product placed on the market by different suppliers or

in different countries. Some names of products are protected and can only be applied if the

composition or the region of production is respected e.g. chocolate (max. 5% of other plantfats as cacao butter), e.g. champagne (sparkling wine from a specific region in France). Also




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the application of genetically modified organisms for producing foodstuffs must be seen as a

legally organised quality aspect (in Europe only a very strict application of the GGO’s in

foodstuffs is possible).

2) sensorial quality aspects e.g. taste, odour, visual quality, texture,… : are important becausefood is associated with a nice feeling, consumers are judging food products severe when

buying them. Discolorations, abnormal proportions, abnormal visual aspect, … will influence

the behaviour of the consumer

3) commercial quality aspects : customers can have more demands regarding food products

e.g. packaging design, labelling,… . These are extra quality demands.

Figure 1. Relation food safety and food quality of a food product

The complete agro-food chain need to consider and need to take responsibility towards food

safety : agricultural sector – transformation and distribution as well. This will be further

discussed in the part of the legislation. But also the consumer can play an important role in

contributing towards food safety by respecting refrigerating temperatures during storage,

respecting shelf-life, preventing cross contamination during preparation of the food and

provided no undercooking of raw meat, fish, vegetables,… .

Food safey

Legal quality

Sensorial quality

Commercial quality




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0.2. The basic document: ‘General principles of food hygiene’

(CAC/RCP 1-1969) of the Codex Alimentarius

The Codex Alimentarius Commission is an international organisation that is responsible forthe elaboration of food standards. All these food standards together, are the Codex

Alimentarius. The Codex Alimentarius was formed in 1962 by the Food and Agricultural

Organisation (FAO) and the World Health Organisation (WHO) to protect public health and

to promote international trade of foodstuffs.

The Codex Alimentarius contains general standards (e.g. ‘General principles of food hygiene’

(CAC/RCP 1-1969)) and commodity standards (that are specific for a certain product). The

general standards have across-the board application to all foods and are not product-specific.

There are general standards or recommendations for:

• food labelling;

• food additives;

• contaminants;

• methods of analysing and sampling;

• food hygiene;

• nutrition and foods for special dietary uses;

• food import and export inspection and certification systems;

• residues of veterinary drugs in foods;

• pesticide residues in foods.

Besides the general standards, there are also product-specific standards (Codex Commodity

Standards). They can be very product specific e.g. production of dates, production of honey,

specific types of fresh fruits and vegetables,… or more industrialized processes e.g.

production of frozen vegetables, fermented product, canned thuna, canned pineapple, … .

Both food safety, food quality and international trading aspects are considered.

See as well for Appendix A.

These standards include the following categories of information:

• Scope – including the name of the standard;

• Description, essential composition and quality factors – defining the minimum

standard for the food;

• Food additives – only those cleared by FAO and WHO may be used;

• Contaminants;

• Hygiene and weights and measures;




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• Labelling – in accordance with the Codex General Standard for the Labelling of Pre-

packaged Foods;

• Methods of analysis and sampling.

The structure of the Codex Alimentarius can be found on the websitewww.codexalimentarius.net.

The document ‘General principles of food hygiene’ of the Codex Alimentarius is the basic

document for the production of safe food. The document was made in 1969 and was extended

with a part on HACCP (Hazard Analysis Critical Control Point) in 1993, further revisions

were made in 1997, 1999 and 2003. The document includes a part on GMP (Good

Manufacturing Practices) and hygiene rules on one hand and a part on HACCP on the other

hand (see further in part 4).

Before a Codex document is finished a long discussion is proceeding with both scientists,

experts, governments,…

Figure 2. The Codex Standard Process (see : www.codexalimentarius.net >> about Codex >>

understanding Codex)




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0.3. Legislation

In a many countries food safety issues are described in the (national) legislation. There is a

steady increase in the involvement of regulatory and advisory bodies in the area of food

safety.

There are a number of reasons for this, especially highly published incidents such as BSE,

Foot and Mouth outbreaks in Europe, and a myriad of problems with individual products.

Examples include benzene in water, insecticide in soft drinks, dioxins in olive oil, spent

lubricant oil in animal feeding resulting in the dioxin crisis in Belgium and deaths and

hospitalisation caused by food poisoning. Another factor can be the political fallout as nation

states impose import bans. The use of pesticides, antibiotics, genetically modified organisms

and hormones in farming has also been causing concern amongst consumers and experts.

In recent years food policy at international level has been moving in a new direction, towards

industry taking the responsibility for the control of the foodstuffs it produces, backed up by

official control systems.

The Codex Alimentarius is on international level seen as the basic instrument to make

legislation regarding food safety. This is resulting in the fact that much of the new legislation

and supporting instruments are based on the internationally developed Codex Alimentarius by

the WHO/FAO, contributing to a national and international trend towards harmonisation. (see

part 0.2).

In Europe, an European food legislation is existing, sometimes further translated into national

legislation by the member states. On the level of the European Union, the EU Regulation

178/2002 is a basic act and is called ‘the general food law’. This law lays down the general

principles and requirements of a food law and it is demanding from all actors in the agro-food

chain (primary production, transformation and distribution but as well all suppliers towards

the food chain e.g. supply of animal feeds) their contribution towards food safety, traceability

and notification when a potential risk is existing for a food product placed on the market. Thisapproach is as well defined as the ‘farm to fork’ approach.

The horizontal legislation has a more general scope and counts for all sectors. There are

horizontal legislation for hygiene, additives, contaminants, labelling, etc. The European

hygiene regulation has been revised and harmonised in 2004. The EU Regulation 852/2004

on general food hygiene requires hygiene rules for all actors in the food chain (Good

Agricultural Practices, Good Hygienic Practices, Good Manufacturing Practices and Good

Distribution Practices) and the implementation of a HACCP system (Hazard Analysis Critical

Control Point (see part 4)) for the transformation and the distribution sector. Food hygiene isdefined as the measures and conditions necessary to control hazards and to ensure fitness for




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human consumption of a foodstuff taking into account its intended use. In the annex of the

EU Regulation specific demands towards infrastructure, constructions of the building,

transportation, temperature control, water quality, pest control, cleaning and disinfection,

personnel hygiene and training of the personnel, control of waste,…. are defined.

Vertical legislation is specific for a certain food sector. For example hygiene requirements for

the dairy industry, meat industry,… . The vertical regulation regarding food hygiene in the

animal sector in nowadays in Europe the EU Regulation 853/2004 regarding food hygiene

for animal products. In total 15 sections are defined for a very specific type of animal product

(e.g. slaughterhouses, production of meat product, production of dairy products, egg

products,…). This vertical hygiene regulation is primarily aimed at controlling hygiene but

include as well other rules that target the control of quality and the provision of information to

a purchaser through labelling. Also for the production of animal feed there is a hygiene

regulation EU Regulation 854/2004.

More information : http://ec.europa.eu/food/food/

http://www.efsa.europa.eu/

In the United States the USDA is making food legislation. The USA has a long tradition in

organisation of food safety and has a very vertical legislation. It means that for specific type

of products a specific legislation is published. The plant inspections and product controls are

conducted by the FDA.

More information : http://www.ba.ars.usda.gov/

http://www.cfsan.fda.gov/




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1. Microbiological and hygienic aspects of foodsafety (prof. M. Uyttendaele)

The presence of pathogens in food products may cause food poisoning.There are two kinds of food poisoning: food intoxications and food infections.

1.1. FOOD INTOXICATIONS

Food intoxications are caused by consumption of food containing a microbial pre-formed toxin

as a result of a prior growth of a pathogen. Food intoxication does not require growth of the

organism in the host. The major food intoxications are caused by Staphylococcus aureus,

Clostridium perfringens, Clostridium botulinum, Bacillus cereus. Table 1 presents an overview

of the characteristics of the toxins. A summary of the growth conditions of these bacteria is given

in table 2.

1.1.1. STAPHYLOCOCCUS AUREUS

A. Classification

Staphylococcus aureus is a nonmotile, non-sporeforming Gram positive, spherical bacterium

(coccus) which occurs in pairs, short chains or bunched, grape-like clusters. They are catalasepositive and facultative anaerobe. They were placed in the family of the Micrococcaceae despite

their distinct difference in their mol% G+C content of DNA (65-75% for micrococci and 30-39%

for staphylococci). The genus Staphylococcus currently involves 32 species (including 6

subspecies).

Although several species have the potential to produce enterotoxin that causes gastroenteritis ,

nearly all cases of staphylococcus food poisoning can be attributed to coagulase positive St.

aureus and led to the use of coagulase-positive St. aureus in specifications in food.

B. Staphylococcus aureus enterotoxins (SE)

Staphylococcus aureus is capable of producing enterotoxins. These toxins are proteinaceous and

have a M.W. between 26.000 and 34.000 Da. By serology they can be divided into seven

antigenic types SEA, SEB, SEC, SED, SEE and recently discovered G and H Several SECs have

been identified (SEC1, SEC2, SEC3). Most food poisoning outbreaks involve enterotoxins A

and D.

The enterotoxins are single polypeptide chains. Protein sequencing have resulted in the current

detailed knowledge of the primary sequences of all the classical SEs.




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The enterotoxin production depends on a series of factors summed up in table 1.1.

TABLE 1.1. Factors that influence enterotoxin production

Factor Optimum Limits

aw

pH

t°

O2

0,98

7-8

40-45

aerobic

0,87-0,99(1)

4,5-9,6(2)

10-45

aerobic-anaerobic

(1) Aerobic (anaerobic aw 0.92 - 0.99)

(2) Aerobic (anaerobic lower pH limit is 5.0)

In food products containing glucose, the production of enterotoxins will be inhibited by growth

of lactic acid bacteria, which lower the pH of food products as a result of acid formation (pH <

5.0).

The St. aureus enterotoxins are in many respects more stable than other proteins. They are

resistant to proteolytic enzymes such as trypsin, chymotrypsin, renin and pepsin. Irradiation

doses applied for pasteurization and sterilization of food are not sufficient to inactivate SE.

Enterotoxins are remarkably resistant to heat-inactivation (resistant to heating for 100 min at

100°C and 20 min at 121°C. Common boiling processes do not suffice to destroy toxicity. The

time/temperature combinations that are applied for treatment of canned food are sufficient to

denaturize the amounts of toxin usually present with food intoxication (< 1 to 50ng/g).

A number of ELISA methods are commercially available for detection of the enterotoxins in

foods.

1.1.2. CLOSTRIDIUM PERFRINGENS

A. Classification

Clostridium perfringens is a Gram-positive, rod-shaped, encapsulated, nonmotile, spore-forming

(subterminal) bacterium occurring in couples or in chains. It is an anaerobic bacterium although

it tolerates some exposure to air. They are usually catalase negative. Hydrogen sulphide is

produced.

While at least 13 different toxins are known to be expressed by Cl. perfringens, individual Cl.

perfringens cells will produce only a defined subset of these toxins. Cl. perfringens is classified

into 5 types, namely A,B,C,D,E, according to each isolate's ability to express 4 (alpha, beta,

epsilon and iota) of the 13 Cl. perfringens toxins. All strains produce alpha toxin (lecithinase or

phospholipase C and also responsible for hemolytic activity).




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Food poisoning is almost always associated with type A isolates. The isolates produce an

enterotoxin which is a spore-specific protein (its production occurs together with that of

sporulation).

Clostridium perfringens type A is responsible both for "gas gangrene" as for food poisoning.

However, there is a substantial difference between strains causing "gas gangrene" and strainscausing food intoxications (table 1.2).

TABLE 1.2. Difference between Clostridium perfringens type A causing "gas gangrene"

and that causing food intoxiation

"Gas-gangrene" Food intoxication

High alpha-toxin production (a)Always epsilon-toxin production (b)

Always iota-toxin production (c)

Heat-sensitive spores

Low alpha-toxin productionSeldom epsilon-toxin production

Variable iota-toxin production

Thermoresistant spores (5h/100°C)

B. Clostridium perfringens enterotoxin (CPE)

CPE is a protein with a molecular weight of 36.000 Da. CPE is inactivated by pronase and

protease (produced by Bacillus subtilis) but not by chymotrypsine or carboxypeptidase.

CPE is thermolabile.

CPE has an antigen structure, which means that a specific antibody can be formed, that will not

react with other toxins produced by Clostridium perfringens type A. CPE usually is produced inthe intestines, seldom in food products. This is explained by the fact that CPE production takes

place at the moment of sporulation. However sporulation in food products and in laboratory

media is extremely difficult, if not impossible whereas Clostridium perfringens sporulates easily

in the intestine. Duncan and Strong medium was optimized to promote sporulation of Cl.

perfringens strains. The sporulated culture is centrifuged and the cell-free culture supernatant is

tested for the presence of enterotoxin by using reversed passive latex agglutination (RPLA). The

RPLA technique involves the use of sensitized (antiserum to enterotoxin treated) latex beads that

are exposed to serial dilutions of enterotoxin. The agglutination titer is determined after

overnight incubation. Several ELISA techniques have been proposed for the detection of the Cl.

perfringens enterotoxin (sensitivity of ELISA is 5-500 ng/g in faeces samples)

1.1.3. CLOSTRIDIUM BOTULINUM

Botulism is rare compared to many other foodborne microbial diseases but has a relatively high

fatality rate.

A. Classification




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Clostridium botulinum is a Gram-positive motile (peritrichous flagella), spore-forming

(subterminal) rod, that occurs alone, in couples or in chains. The spores swell the rod giving the

characteristic 'tennis-racket' shaped cells. Spores of most pathogenic species can be produced in

complex laboratory media.

They are usually catalase negative and strictly anaerobic.Cl. botulinum is a very diverse species comprising organisms differing widely in physiological

properties and genetic relatedness. They all share the ability to produce botulinum neurotoxin

(BoNT).

The strains of Cl.botulinum are classified into 7 serological types, deducted from the different

antigen structures of the formed neurotoxins and designated as types A,B,C,D,E,F and G. Types

A,B and E most commonly cause botulism in humans. The incidence varies according to

geographic region.

Cl. botulinum consists of four physiological groups (I to IV) with diverse physiological and

genetic characteristics. Group IV is the only group that has not been demonstrated to cause

botulism and has been assigned to the species Cl. argense. Groups I and II are the cause of

human botulism whereas group III causes botulism in various animals. Properties of Cl.

botulinum group I and II are given in table 2. Organisms in group I are proteolytic and may

produce type A, B, or F BoNT. Organisms in group II are commonly referred to as non-

proteolytic, require sugars for growth, and may produce either type B, E, or F BoNT.

B. Botulinal toxins

Cl. botulinum produces the moist poisonous substance known; it is estimated that 0.1-1.0 µg of

BoNT is sufficient to kill a human and the lethal dose for most animals is ca. 1 ng/kg body

weight.

Botulinal toxins consist of two components, one of them being toxic.

The toxic component is a neurotoxin. The nontoxic component of the complexes have been

shown to impart stability to the neurotoxin and to prevent inactivation by digestive enzymes in

the gut. Since in most food products pH < 7.0, the botulinal toxin will be present in its most

stable form. Moreover, there are no substances that influence toxicity in food products. Salts and

acid pH do not influence stability. Yet, botulinal toxins are thermolabile. Heating at 80°C (during

10 minutes is sufficient to inactivate the botulinal toxins present in food products. A similar

effect is obtained by treating at 86°C (during 1 minute).

BoNT is preferably detected using a bioassay (the mouse bioassay). Immunological methods

have been developed but are not as sensitive as the mouse bioassay.

1.1.4. BACILLUS CEREUS




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A. Classification

Bacillus cereus is a Gram-positive, motile, spore-forming (central, ellipsoid) rod with a granular

internal structure. At present the genus Bacillus encompasses more than 60 species. Owing to theenormous genetic diversity of this genus, it is difficult to define it concisely. Based on the wide

variation of G+C % and variation in rRNA sequences Bacillus encompasses more than one

genus. Bacilli are defined into groups based on spore and sporangium morphology. Group I

bacilli (which includes B. cereus) are defined as having a sporangium that is not swollen by the

spore. Within the group, subdivision of the species may be made on the basis of cell diameter.

The large-celled species (including B. cereus) have cell diameters > 0.9 µm. The other large-

celled Group I bacilli are B. anthracis (non-motile), B. mycoides (rhizoid growth) and B.

thuringiensis (parasporal crystal). On the basis of both phenotypic and genetic properties, the

latter three species should be considered as subspecies of B. cereus. Psychrotolerant strains of B.

cereus have been assigned to a new species, B. weihenstephanensis. Strains of this species may

also produce toxins and will be identified as B. cereus in the standard microbiological tests.

The inherent diversity within the B. cereus group raises the question on the presence of similar, if

not identical, toxin genes in a number of other members of the B. cereus group, especially B.

thuringiensis and their implication in food intoxications.

B. toxins

Two forms of clinical symptoms are raised by B. cereus: one is a diarrheal version while the

other is an emetic version.

A number of toxins are responsible for the diarrheal response including a haemolysin and a

cereolysin. The haemolysin designated haemolysin BL comprises three distinct peptides B, L1

and L2. Each of the genes coding for the three components has been cloned and the sequences

determined. A RPLA test for the detection of the L2 component of the enterotoxin complex is

available. Cereolysin is also a three-component enterotoxin,however non-hemolytic. One of the

components of the complex is recognized by an ELISA kit. The enteroxins are thermolabile

The emetic toxin (cerreulide) has been isolated and is a small dodecadepsipeptide. It is cycliccomprimising a three repeat of D-O-Leu-D-Ala-L-O-Val-L-Ala. No genes coding for cereulide

have been identified. No commercial kit for detection of the emetic toxin is available. The emetic

toxin is thermostable.

In a survey of B. cereus strains, a significant proportion (74%) were enterotoxin producers, but

only 5% produced the emetic toxin. Strains of the H1-serovar were most likely to produce

cereulide.

1.1.5. Mycotoxins




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Numerous molds are capable of producing toxic metabolites in food products. The major group

is the aflatoxin-group, produced by some strains of Aspergillus flavus and Aspergillus

parasiticus. Each food product on which Aspergillus flavus and Aspergillus parasiticus can grow

and produce toxin is suitable substrate. Especially dry food products (still having aw > 0.85) are

qualified. One strain can only form 2 or 3 aflatoxins, at least one of them being B1. The mostsensitive food products are cereals and nuts. In milk B1 and B2, that may be present in feed as a

result of mold growth, are converted into M1 and M2.

Information on aflatoxins and other mycotoxins is summarized in table 5

Differentiation of aflatoxin-producing and non-producing strains of the Aspergillus flavus group

is possible using a multiplex PCR.




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1.2. FOOD INFECTIONS

Food infection is caused by consumption of food contaminated with the ethological agent, in

other words, the pathogenic microorganism. The pathogen develops in the gastro-intestinal

system, accompanied or not by toxin production, causing food infection. Food infection can be

caused by low numbers of the pathogen. Low numbers can be expected in foods that are

correctly processed for safety and not recontaminated or recolonised subsequently. Virtually all

pathogens in foods are sublethally stressed. Therefore the detection method of infectious agents

encompasses four subsequent steps:

- A resuscitation procedure lasting between 0.5 and > 8h in a non or half selective medium to

enable recovery and limited outgrowth (102-10

4cfu/ml) of the stressed target organism.

- A period of enrichment in a selective medium to suppress the competitive flora and enabling

multiplication of the target organism to attain detectable levels of the order 105-10

6 /ml

- Isolation of the pathogen on a selective differential agar medium

- Purification of suspected colonies and identification using a number of biochemical/

physiological tests

The growth conditions of the most important foodborne bacterial infectious agents are

summarized in table 6.

1.2.1. SALMONELLA

A. Classification

Salmonella are facultatively anaerobic gram-negative, non-sporeforming rods belonging to the

family Enterobacteriaceae. Although members of this genus are motile, nonflagellated variants,

such as S. Pullorum and S. Gallinarum do occur. Salmonellae are oxidase-negative and catalase

positive.

Nomenclature of the Salmonella group has progressed through a succession of taxonomical

schemes based on biochemical and serological characteristics and on principles of numerical

taxonomy and DNA homology. The present situation is that Salmonella contains 2 species, S.

bongori and S. enterica, the latter being divided in 6 subspecies . S. enterica subspecies enterica

is the most important subspecies containing most of the > 2300 serovars. These serovars should

not be considered as species and should be designated as S. enterica subsp. enterica ser.

Enteritidis or (more practically) S. Enteritidis.

The biochemical identification of foodborne and clinical Salmonella spp. isolates is generally

coupled to serological information, a complex and labour-intensive technique involving the

agglutination of bacterial surface antigens with Salmonella-specific antibodies. These include O

lipopolysaccharides (LPS) on the external surface of the bacterial outer membrane, H antigens

associated with the peritrichous flagella, and the capsular (Vi) antigen, which occurs only in S.typhi, S. paratyphi C and S. dublin.




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1.2.2 CAMPYLOBACTER

A. ClassificationCampylobacter is a small non-spore-forming, Gram-negative rod, curved or spiral

shaped bacterium. They may form spherical or coccoid bodies in old cultures or cultures exposed

to air for prolonged periods. They are motile by a typically cork-screw motion. They are

microaerophilic (5% O2 - 10% CO2 - 85% N2) and oxidase-positive.

The genus Campylobacter belongs to the family of the Campylobacteriaceae and the taxonomy

has recently been reviewed. The family includes 20 species and subspecies within the genus

Campylobacter and four species in the genus Arcobacter (aerotolerant campylobacters). Former

species in the genus Campylobacter are now classified in the genus Helicobacter.

The thermotolerant species of Campylobacter spp. (optimum temperature 42°C) may cause food

infections: predominantly C. jejuni, C. coli and C. lari (to a smaller degree) and C. upsaliensis

(sporadic).

1.2.3. ESCHERICHIA COLI O157

A. Classification

The genus Escherichia is classified in the family Enterobacteriaceae. Escherichia coli is a Gram-

negative, oxidase-negative, motile (peritrichous) or sometimes nonmotile, non-spore-formingrod. It is a lactose-fermenting fecal microorganism. Isolates are serologically differentiated on

the basis of three major surface antigens: the O (somatic), H (flagella), and K (capsule) antigens.

At present, a total of 174 O antigens, 56 H antigens, and 80 K antigens have been identified.

Typical E. coli O157 possess several characteristics uncommon to most other E. coli: inability to

ferment sorbitol, inability to produce beta-glucuronidase and inability to grow well at 44°C.

Escherichia coli strains are a common part of the normal facultative anaerobic microflora of the

intestinal tract . E. coli strains that cause diarrheal illness are categorized into specific groups

based on virulence properties, mechanisms of pathogenicity, clinical syndromes and distint O:H

serogroups. These categories include:- enteropathogenic E. coli (EPEC): induce attaching and effacing (AE) lesions, some produce

one or more toxins.

- enterotoxigenic E. coli (ETEC): produce a heat-labile or heat-stable enterotoxin

- enteroinvasive E. coli (EIEC): invasive capacity related to a large plasmid (cfr. Shigella)

- diffuse-adhering E. coli (DAEC)

- entero-aggregative E. coli (EaggEC)

- enterohemorrhagic E. coli (EHEC): associated with hemorrhagic colitis. All EHEC produce

the following virulence factors: verotoxins (VTs) or Shiga-like toxins (STs). Many serotypes

of E. coli have been subsequently shown to produce VTs, hence they have been named VT-




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producing E. coli (VTEC) or SLT-producing E. coli (SLTEC). However, only strains that

cause hemorrhagic colitis are considered to be EHEC. Other virulence factors of EHEC are

the attaching and effacing (eae) gene and a 60 MDa plasmid. Since E. coli O157:H7 is the

most common serotype of the EHEC associated with large foodborne outbreaks and being

the single serotype to be differentiated by classical methodology this serotype is most oftenstudied in food microbiology. E. coli O157 is an example of a new emerging pathogen.

1.2.4. LISTERIA MONOCYTOGENES

A. Classification

L. monocytogenes is a small, short Gram-positive non-spore-forming rod, catalase-positive and

facultatively anaerobic. They are motile at 25°C showing a characteristic 'tumbling' motility, but

non-motile at 35°C.

The genus Listeria belongs to the Clostridium subbranch together with Staphylococcus,

Streptococcus, Lactobacillus, and Brochothrix. The genus Listeria presently comprises six

species (1) L. monocytogenes and the closely related species L. innocua, L. ivanovii, L.

welshimeri and L. seeligeri and (2) L. grayi (including the formerly L. murrayi). Within the

genus Listeria, only L. monocytogenes and L. ivanovii are considered virulent. Only one species,

L. monocytogenes is of public health concern.

The identification of Listeria species is based on a limited number of biochemical markers,

among which hemolysis is used to differentiate between L. monocytogenes and the mostfrequently encounterd nonpathogenic Listeria species, L. innocua.

1.2.5. LESS FREQUENTLY OCCURING FOOD INFECTIONS

Other bacteria may cause food infections, e.g. Yersinia enterocolitica (a zoonoses), Vibrio

cholerae and Vibrio parahaemolyticus (aquatic organisms, marine environment)

A Yersinia enterocolitica

Yersinia enterocolitica belongs to the family of the Enterobacteriaceae. It is a highlyheterogenous species, being divisible into a large number of subgroups, chiefly according to

biochemical activity (biotypes) and lipopolysaccharide (LPS) O antigens (serotypes). The

virulence determinants are classified into those which are chromosomally encoded (inv-gene

(invasion), ail-locus (attachment-ivasion), yst -gene (heat-stable enterotoxin)) and those specified

by a 70-75 kb virulence plasmid termed pYV (plasmid for Yersinia virulence)

B Vibrio cholerae and Vibrio parahaemolyticus

Phenotypic traits are routinely used for the species differentiation of vibrios. However, strain

variation is common and phenotypic testing is often insufficient for identification of species.




19

Vibrio cholera is well defined on the basis of biochemical tests and DNA homology studies but

this species is not homogenous with regard to pathogenic potential. Distinction is made on the

basis of production of cholera toxin (CT), encoded by the ctx-genes, and the serogroup (O1 and

O139 have been associated with epidemic disease).

V. parahaemolyticus can be serotyped, however, there appears to be no correlation betweenserotype and virulence. The ability of some strains to produce a hemolysin termed TDH

(thermostable direct hemolysin) or Kanagawa hemolysin, is correlated with virulence in this

species and can be determined now by in vitro DNA amplification.



Department of Food Safety and Foo

20

TABLE A Characteristics of toxins produced by Staphylococcus aureus, Bacillus cereus, Clostridium perfringens and Cl. botu

Staphylococcus aureus

emetic toxin

Bacillus cereus

emetic toxin

Bacillus cereus

diarrhea toxin

Clost

diarr

Toxin type Enterotoxin

(single chain polypeptide,

with cystine-lus)

MW 26-34 kDa

Enterotoxin

Cereulide (cyclic

dodecapsipeptide)

Enterotoxin

a) Haemolysin BL: tripartite

protein complex B, L1, L2

b) Non-haemolytic tripartite proteincomplex

Enter

Singl

36 kD

Formation of toxin In the food, during

vegetative growth

In the food during the late

exponential or stationary

phase

During vegetative growth in the food

or in the intestines after ingestion of

high numbers of cells

In the

of hig

form

Effect of proteolysis Resistent Resistent Activity loss Incretreatm

Heat stability Resistent to 100-120°C Resistent to 90 min at

121°C

Inactivation by 5 min at 56°C Inact

Symptoms Nausea, vomiting

(sometimes diarrhea)

Nausea, vomiting Cramps, diarrhea Cram

Incubation period 1-5h(recovery after 24-48h)

1-5h(recovery after 6-24h)

8-16 h(recovery after 12-24h)

8-24 (reco

Toxicity (LD50) LD50 (monkeys): 25 µg/kgdose causing symptoms in

humans: 100-200 ng

unknown 100 x more toxic than Cl.perfr. 1.5 µ

Detection methods - immunological detection

(Oxoïd BCET RPLA, Vidas(Biomérieux), Tecria

immunoassay,..)

- no immunological

detection method- cytotoxicity

- animal feed trials

- Oxoïd BCET RPLA ( L2 component

Haemolysin BL)- Tecra immunoassay (Non-

haemolytic protein complex)

- cytotoxicity

RPLA




TABLE B Growth conditions of Staphylococcus aureus, Bacillus cereus, Clostridium perfringens and Cl. botulinum

Staphylococcus aureus Bacillus cereus Clostridium perfringens

morphology G+, non-motile coc

non sporeforming

G+, motile rod

sporeforming

G+, nonmotile rod

sporeforming

toxin-producing types Type A, B, C1, C2, C3, D, E

Type A en D cause food

intoxication

- Type A, B, C, D, E

Type A responsible for food

intoxicationtemperatuur 10-45°C

optimum 35-37°C

10-50°C

optimum 28-35°C

rem: psychrotrophic strains,

growth at 4-10°C

15-55°C

optimum: 37-45°C

pH 4.5-9.3 4.9-9.3 5.0-8.3

Aw 0.83 0.91 0.95

atmosphere facultative anaerobe facultative anaerobe anaerobe (microaerophilic)

thermoresistent spores only vegetative cells, destroyed

by pasteurisation

D100= 2-8 min variable

heat resistant (5h-100°C) linke

to intoxication

conditions for toxin production min. Aw = 0.87

pH 5.1-9.0

optimum temp. 25-30°C during sporulation in the

intestines




22

TABLE C. Mycotoxin producing molds in foods

Mycotoxin Mold Clinical aspects Toxicity

Aflatoxin B1 en B2

Aflatoxin B1, B2, G1

and G2

Aspergillus flavus

Aspergillus parasiticus

- acute toxicity

- liver cancer

- Carcinogenic

- Mutagenic

- Terratogenic

- Toxic (AflatoxineLD50 7.2 mg/kg)

Ochratoxin A Aspergillus ochraceus

Penicillium verrucosum

- kidney disease 'Balkan

endemic nephropathy'

- Nephrotoxic

- Carcinogenic for

animals (possibly fo

humans)

- LD50 22 mg/kg)

Zearalenone Fusarium graminearum

F. culmorum, F. crookwellense

-reproduction system of

pigs

- breast cancer?

Oestrogenic activity

Deoxynivalenol (=

DON, vomitoxin)

(trichoticeen)

Fusarium graminearum

F. culmorum, F. crookwellense

- gastro-intestinal

- immune-system

domestic animals

Not carcinogenic fo

humans

T-2 toxin

(trichoticeen)

Fusarium spp. - alimentary toxic aleukia

(Russia WWII)

Not carcinogenic fo

humans

Fumonisins Fusarium moniliforme

F. proliferatum, F. subglutinans

- oesophageal cancer Carcinogenic for

animals (possibly fo

humans)

Patulin Penicillium expansum, other

Penicillium sp., some Aspergillus sp

no toxicity,

spoilage

Cyclopiazonic acid Aspergillus flavus and other species

Penicillium sp. e.g. P. camemberti

- anorexia, diarrhea

- muscural breakdownMoniliformin Fusarium proliferatum,

F. subglutinans - heart diseases




TABLE D : GROWTH CONDITIONS AND HEAT RESISTANCE OF THE MOST

IMPORTANT FOODBORNE BACTERIAL INFECTIOUS AGENTS

minimum atmosphere Heat-resistance

temp. pH aw

Salmonella sp. 7°C 4.0 0.94 Fac. anaerobe D58 0.63 minCampylobacter jejuni 32°C 4.9 0.99 Microaerophilel D55 0.6-2.3min

Escherichia coli 7-8°C 4.4 0.95 Fac. anaerobe D60 0.75min

Yersinia

enterocolitica

-1.3°C 4.2 0.96

5% NaCl

Fac. anaerobe D60 0.4-05 min

Listeria

monocytogenes

0°C 4.4 0.92 Fac.anaerobec D60 2.54min

D65 0.75min

Vibrio cholerae 10°C 5.0 0.97

4% NaCl

Fac. anaerobe D49 8.15 min

D60 2.65 min

Vibrio

parahaemolyticus

5°C 4.8 0.94

8-10 %NaCl

Fac. anaerobe D49 0.35-0.72 min

D55 0.02-0.29 min

Shigella sp. 6-8°C 4.8-5.0 3.8-5.2% NaCl Fac. anaerobe Rapid inactivation

(2-5min) at 60°C

Aeromonas sp. 0-4°C 4.5 6% NaCl Fac. anaerobe D45 29.5 min

D51 2.3 min




24

2. Chemical aspects of food safety

See lectures by prof dr ir Bruno De Meulenaer




3. Physical hazards related to food safety

3.1 Definition

Physical hazards can be defined as hard, sharp foreign objects which are not expected to be

present in the food product. Physical dangers can provoke injuries in the mouth, teeth,pharynx, throat or can lead to asphyxiation in worse case.

Foreign bodies are the biggest single source of customer complaints for many food

manufacturers, retailers and enforcement authorities. The accidental inclusion of unwanted

items can sometimes occur in even the best-managed processes. The perception of the

consumer is important, since not all foreign bodies are in fact alien to the food, though all

have the potential to give rise to a consumer complaint.

A study of the USDA demonstrated that a difference must be made between hard, sharp

foreign objects with a certain size range and others:

The U.S. FDA concluded a study that evaluated a) 190 reports of foreign objects in food

received by FDA’s Health Hazard Evaluation Board over a period of 25 years; and b) a

review of the scientific literature concerning physical hazards in food products.

A product should be considered adulterated if it contains:

- a hard or sharp foreign object that measures 7 to 25 mm in length and the product is

ready-to-eat or requires only minimal preparation steps that would not eliminate,

invalidate or neutralize the hazard prior to consumption.

A product may be considered adulterated, after review of the hazard by FDA, if it contains:

- a hard or sharp foreign object that measures 7 to 25 mm in length and the product

requires preparation or processing that may have an effect on the presence of the

foreign object in the finished food;

- a hard or sharp foreign object less than 7 mm in length and a special risk group such as

infants, surgery patients or the elderly is among the intended consumers of the

product;

- a hard or sharp foreign object over 25 mm in length.

A difference can be made between food product related foreign objects (intrinsic foreign

bodies) or product strange objects (extrinsic foreign bodies).




26

The first category can be present by the nature of the raw material which is applied for

producing the food product. These are typically stones in dried stone fruits as dates, plums or

a bone from fish, bone in meat products, crystals in sugar or salt which are mistaken for glass.

The second category will occur in the food product due to presence in raw material or duringthe production process. Materials are glass, metal, hard plastic, wood,… . Typical examples

are:

a) related to the production environment: e.g. wood, glass, small animals (insects),

stones,…

b) related to machines/apparatus e.g. metal, pins, other parts from machines

c) related to materials/packaging materials applied e.g. metal from cans, rope, elastic,…

d) due to technical interventions during processing e.g. metal sliver, electricity cable,

rope,…

e) due to contamination by the personnel e.g. jewellery, personal possessions,…

3.2 Preventive measures and detection of foreign objects

Methods involved in controlling physical hazards include raw material specifications and

inspections. Even for products on the field, a visual field control can prevent already a high

amount of foreign objects to enter the production of the food product. Also inspections of the

food product when entering the storage device or the production site can prevent the presence

of foreign objects.

For the environmental contaminations, preventions can be made by the food processor :

a) pest control in other to avoid insects and rodents in the production or storage area

b) preventive maintenance programmes for machines, conveyor belts and visual

inspection of the production and storage areas

c) guidelines regarding personal hygiene in order to avoid that personal possessions are

entering the food product e.g. no jewellery can be carried, hair must be in a net,…

d) strict working procedures in order to avoid errors that can be made (e.g. packaginginstructions to avoid that packaging material is in the food product)

Next to these general, preventive measures also in some production processes detection steps

can be introduced. Approaches to the technical methods of combating foreign bodies on the

food production line fall into two main categories:

a) detection and removal systems : are systems designed specifically to detect the

presence of a foreign body and remove it as a consequence of having discovered it.

The oldest method is manual sorting, while the newest methods included verysophisticated electronic technology. However, all rely on some physical difference




between the food and the foreign body, be it colour, shape, density, electrical

properties or another characteristic. Many of the more established techniques such as

sieving or magnets or metal detectors (used to locate ferrous and non ferrous metals)

use physical differences that are relatively obvious. Some of the more advance

methods, such as colour sorters have been devised to allow a machine to make judgements regarding a sample that may be obvious to human eye but to do so

extremely quickly. These methods have relied upon microprocessors to process the

information at speeds suitable for a modern production or packaging line. The most

recent method is scanning by X-rays. Overview of the most common techniques : e.g.

metal detection (both ferrous and non ferrous metals), magnets (only ferrous metals),

optical sorting machines. Future techniques are microwave reflectance, Nuclear

magnetic resonance imaging, X-ray scanning.

The basic principle of metal detection is based on the transmission and reception of

electrical impulses much like radio waves. All metals have characteristics that will cause

an alteration in a transmitted signal, because of their conductivity and magnetic properties.

What metal detectors do in food processing lines is to compare the signal received with

the expected signal and identify the presence of a contaminant if a variation is observed.

Magnetic separators are applied in wide range of industries. Magnets provide a simple and

inexpensive method of removing the unwanted ferrous particles. At the same time, the

removal by magnetic separators of ferrous contaminants reduces potential damage and

wear to the subsequent processing machines. Tube magnets can be applied which is

constructed of cylindrical permanent magnets contained within a thin stainless steel tube,

generally 25 mm, the length depends on the application. The tube magnet can be installed

single or in multiples within the process. Plate magnets are a rectangular box that contains

a permanent magnet. Plate magnets are installed above conveyors or in pipelines etc.

Drum magnetic separator comprises a rotating drum that contains a fixed permanent

magnet unit inside. These are applied for dry free flowing ingredients or products such as

grain, tea, rice and sugar. Magnetic pulleys comprises on a shaft to which permanent

magnets have been fixed and surround the entire periphery. As the material approachesthe magnetic pulley any items of ferrous contamination are attached to it.

b) separation systems : are mechanical methods such as sieving and flotation and

filtering that aim to separate foreign bodies from the food as a result of basic physical

differences. In many cases these methods are intrinsic to the production system itself.

Possibly the most ancient is the process of winnowing to separate wheat from chaff.




28

These techniques can be applied in homogenous liquid processes (e.g. fruit juice,

milk,…) or for powder systems (e.g. grains, flours,…).

Air separation systems are dry cleaning methods that are rarely used in isolation but

normally being combined with other removal systems. Air separation methods arerelatively cheap and convenient but care must be taken that they do not generated

excessive levels of dust that might cause a fire or explosion. They are 2 main types:

Aspirators : usually have specific applications for the separation of materials

with different densities or weights such as the separation of the chaff from

wheat or the shell fragments from nuts. A strong current of air passing though

the product carries lighter materials off, separating it from the heavier material.

Abraders and graders are useful for removing surface contaminants of food

materials such as soil or husk. Dry scouring by friction or impaction using

tumblers, vibrators and rotating brushes are all variants of this general type.

They are usually in conjunction with aspirators to remove the loosened

material.

Liquid separation systems involve a wide range of wet cleaning methods, which are

usually used in conjunction with other separation techniques. The washing of food is

frequently one of the first stages of processing particularly on agricultural crops.

Common methods include:

Washers and sprayers : in which the product is carried in or through clean

water to remove light or surface contamination e.g. soil. It can be both batch or

a continuous system.

Centrifuges work by separating food material with different phases and

different densities by centrifugal force. By clarifiers the content s rotates in a

rotating drum, and hydrocyclones, in which the rotation is achieved by a

tangential supply to the stationary status.

Sieves and filters remove foreign bodies on the basis of size and are equally applicable

to both wet and dry systems, to the full spectrum of food materials and to all levels of manufacturing output. They range from simple mobile hand-operated systems to

integrated in-line installations. The simplest sieves are static grids with meshes of any

size, depending on the separation required. Other systems include perforated plates

with square or round holes, which can be made from materials such as steel, copper,...

. More complex systems can be built up, consisting of a series of meshes arranged

vertically, horizontally or inclined. The sieving efficiency can be assisted by any

combination of rotary movement, aeration,… .

However, wet sieving or filtering can give rise to bacteriological and/or corrosion

problems whilst dry sieving or filtering can present a fire and explosion hazard.




Some foreign bodies are difficult to detect, generally because of a lack of a readily detectable

physical difference between them and the food product itself. Examples are stones and dirt or

small insects related to field crops, while fragments of bones are sometimes found in meat

products. However, some overall pattern can be detected, plastic fragments of packagingmaterials and insects are one of the greatest challenges to developers of detection equipment.

In the framework of the legal aspect of food safety and the responsibility of the food producer

it is necessary that a food producer can demonstrate that is has :

considered what foreign boy hazards might arise;

judged the likelihood of the occurrence, the risk, the concern and the potential danger

to the consumer;

selected and installed controls which are demonstrably effective;

integrated the controls into a whole plan;

set up a review system for continuous improvement;

maintained a full record above.

3.3. References for part 3

Edwards, M. 2004. Detecting foreign bodies in food. CRC Press, Boca Raton, USA, 306p.

ISBN 0-8493-2546-3

Lelieveld, H, Mostert,M., Holah, J. and White, B. 2003. Hygiene in food processing –

EHEDG. CRC Press, Boca Rotaon, USA, 392p. ISBN 0-8493-1212-4




30




4. Quality assurance systems assuring food safety

4.1 Principles of Codex Alimentarius

The document ‘General principles of food hygiene’ of the Codex Alimentarius is the basicdocument for the production of safe food. The document was made in 1969 and was extended

with a part on HACCP (Hazard Analysis Critical Control Point) in 1993, further revisions

were made in 1997, 1999 and 2003. The document includes a part on GMP (Good

Manufacturing Practices) and hygiene rules on one hand and a part on HACCP on the other

hand.

Important to note is that also hygiene measures are demanded on the agricultural level.

4.1.1. Good Manufacturing Practices (GMP)

GMP (Good Manufacturing Practices) can be defined as a package of requirements and

procedures by which the work methodology takes place under controlled conditions and by

which surrounding conditions are created that allow the production of hygienic and safe

products. The objective of GMP is controlling the different hazards for food safety

(microbiological, physical, chemical and the allergens) and must be seen as the basic

requirements in the food producing chain. Sometimes ‘GHP or Good Hygienic Practices’ are

applied. In the primary sector ‘GAP or Good Agricultural Practices’ are used.

GMP-measures are implemented on different levels in a food company:

• the environment;

• the process and product;

• the personnel.

Since the aim of the GMP regulations is to prevent or reduce the contamination to a

minimum, the application of these regulations is very important. When these regulations

are known and observed by everybody, hygienic working has a central place on every level inthe company (see part 0.3 legislation).

The most important GMP’s that need to be elaborated en implemented are (according to the

Codex Alimentarius on food hygiene):

GMP 1: cleaning and disinfection;

GMP 2: pest control;

GMP 3: water and air quality;

GMP 4: temperature control;




32

GMP 5: personnel (facilities, hygienic way of working, health, education);

GMP 6: structure and infrastructure (surrounding area, building, materials, equipment)

GMP 7: technical maintenance ;

GMP 8: waste management ;

GMP 9: control of raw material;GMP 10: work methodology;

GMP 11 : management and supervision

GMP 12 : Documentation and registration

GMP 13 : Recall procedures

4.1.2. PreRequisite Program (PRP)

Recently, the term ‘Pre-Requisite Program (PRP)’ is more used. PRP can be defined as every

specific and documented activity or facility that is implemented corresponding to the ‘Codex

General Requirements of Food Hygiene’, the ‘Good Manufacturing Practices’ and the

legislation, with the purpose to create basic requirements that are necessary for the

production and processing of safe foods in all stages of the food chain.

With other words PRP covers GHP (Good Hygienic Practices), GMP, GAP and the

legislation. The term ‘program’ refers to the fact that PRP’s are more than a working

instruction, a plan or a regulation. They are general control measures, which need to be

verified on their effectiveness on a regular base. The word ‘program’ indicates that in a PRP

there is more than an instruction, scheme or procedure that needs to be followed. The plan-do-

check-act circle or Deming circle should be present.

The PRP’s are divided into 14 groups:

PRP 1: cleaning and disinfection;

PRP 2: pest control;

PRP 3: water and air quality;

PRP 4: temperature control and registration;

PRP 5: personnel (facilities, hygienic way of working, health, education);

PRP 6: structure and infrastructure (surrounding area, building, materials, equipment);PRP 7: technical maintenance and calibration;

PRP 8: waste management;

PRP 9: control of raw material;

PRP 10: traceability, recall, goods returned, rejections/non-conform products;

PRP 11: allergens;

PRP 12: physical and chemical contamination;

PRP 13: management of product information;

PRP 14: work methodology.




4.1.3. Hazard Analysis Critical Control Point (HACCP)

4.1.3.1. Definition

HACCP is a methodology that identifies, evaluates, and controls hazards that are significant

for food safety.

4.1.3.2. History

The HACCP system arose in 1960 through the efforts of The Pillsbury Co., the Army Natick

Research and Development Laboratories and the National Aeronautics and Space

Administration (NASA) to develop a completely safe diet for astronauts. Pillsbury presented

the HACCP-concept on the first conference for Food Protection in 1971 and organised the

next year a workshop for inspectors of the FDA. This resulted in the use of the HACCP-

principles when drafting the Low Acid Canned Foods regulation in 1974.

In the seventies and in the beginning of the eighties, other important food companies adopted

the HACCP-approach. Reports of the International Commission on Microbiological

Specifications for Foods (ICMSF) created an international interest for the HACCP-concept

and for its usefulness in the production of safe food products. A sub commission of the

National Academy of Sciences proclaimed in 1985 that the HACCP-concept was accepted by

controlling authorities, resulting in 1987 to the National Advisory Committee on

Microbiological criteria for Foods. This committee extended the HACCP-protocol from 3 to

7 principles. In 1993 HACCP was included in the Codex Alimentarius and in 1997 and 1999

some adaptations were made. In 2003 some changes were made for small and/or less

developed businesses.

4.1.3.3. Objective of the HACCP system

The HACCP concept is a systematic approach to hazard identification, assessment and

control. From the moment something goes wrong, it is possible to act and react quickly

and efficiently. This prevents that large sets of products are rejected and public health isendangered. This system eliminates disadvantages inherent to control by inspectors and

microbial end product control. By concentrating only on these factors, which have a direct

effect on the safety of the food product, no energy and money should be spent on less

important factors. This system is cheaper and more effective compared to the traditional

control systems.




34

By focussing on the critical points, which influence the safety and quality of food products

over the complete production line, producers now can show that they are controlling the

production conditions and that safe products are provided. Moreover, inspectors are now

able to check the effect of the measures on the long term, where earlier inspections gave a

picture at a given moment.

The HACCP system is a preventive, company specific, quality system starting at the

selection and purchase of raw materials, ingredients and packaging materials, following the

complete production process and ending at the final product, ready for consumption.

4.1.3.4. The 7 principles of the HACCP-concept

The HACCP system consists of the following 7 basic principles:

Principle 1: Conduct a hazard analysis

Principle 2: Determine the Critical Control Points (CCP's)

Principle 3: Establish critical limit(s)

Principle 4: Establish a system to monitor control of the CCP

Principle 5: Establish the corrective action to be taken when monitoring indicates that a

particular CCP is not under control

Principle 6: Establish procedures for verification to confirm that the HACCP system is

working effectively

Principle 7: Establish documentation concerning all procedures and records appropriate to

these principles and their application

4.1.3.5. The fourteen stages of HACCP

To establish a HACCP plan, it is recommended to follow a logically structured sequence of

steps. In several books and articles, different types of plans with 12 or 14 stages can be

found. However, most of them are based on the internationally accepted system as described

in the Codex Alimentarius, which includes 12 stages (appendix B).

The plan that will be used in this course consists of 14 stages and is based on the FLAIR-document (Food Linked Agro Industrial Research):

Step 0: Policy statement

Step 1: Assemble a HACCP team

Step 2: Define the scope of the study

Step 3 Describe the product

Step 4 Identify the intended use of product

Step 5 Construct a flow diagram

Step 6 Confirm flow diagram on site

Step 7 Identify and list all relevant hazards and preventive measuresStep 8 Identify the CCP's




Step 9 Establish critical limits for the CCP's

Step 10 Establish a monitoring system for the CCP's

Step 11 Establish a corrective action plan

Step 12 Establish a documentation system

Step 13 Verify the HACCP planStep 14 Review the HACCP plan

4.1.4. Relation GMP, PRP and HACCP

GMP, PRP and HACCP are different systems but are closely related. GMP’s are general

hygiene measures, not specific for a sector or a type of production process (e.g. meat –

vegetable - … type of industry). While the PRP’s are programs in which these general

hygiene measures are translated into an effective, practical and company specific monitoring

system. Next to this, HACCP analysis very specific the company hazards which are

monitored by the CCP’s.

GMP and PRP are the required and necessary fundaments for the HACCP system.

Figure 3 : Relation between PRP and HACCP in a Food Safety Management System of a

company in the agri-food chain.




36

4.2. The key elements of quality

4.2.1 Definitions

QualityQuality has been defined in many ways. Some link quality as superiority or innate

excellence, whereas others view it as a lack of manufacturing or service defects. Today

most managers agree that the main reason to pursue quality is to satisfy customer

demands. A common definition of quality is “the total of features and characteristics

of a product or service that bears on its ability to satisfy given needs”. The view of

quality as the satisfaction of customer needs is often called fitness for use. In highly

competitive markets, merely satisfying the needs of customer expectations. Most

progressive organisations now define quality as follows “quality is meeting or

exceeding customer expectations”.

Quality policy

The intentions of the organisation with regard to quality and the ways to reach this,

formal expressed in a statement from the top management. The quality policy has to

be in accordance with the global policy of the organisation and has to be a basis for the

formulation of the quality objectives.

Quality control (QC)

Quality control refers to the operational techniques and activities, which are used to

fulfil the requirements for quality, e.g. monitoring of a process, control steps in the

process, weighing the final weight of a food in a package,…

Quality assurance (QA)

All the planned and systematic activities implemented within the quality system, and

demonstrated as needed, to provide adequate confidence that an entity will fulfil

requirements for quality. Examples are training, instrument maintenance and auditing.

Quality management (QA+QC)

All activities of the overall management function that determine the quality policy,

objectives and responsibilities and that implement them by means such as quality

planning, quality control, quality assurance and quality improvement within the

quality system.

Total quality management (TQM)

An organisation’s management approach centred on quality, based on the participation

of all the members and aimed at long-term success through customer satisfaction andbenefits to the members of the organisation and the society.




Quality management system (QMS) – food safety management system (FSMS)

The system (the organisational structure, competences, responsibilities, procedures,

processes and provisions) necessary for the arrangement of the quality policy and the

quality objectives and to reach the objectives. A management system is translated andimplemented into a company own setting (eg. Procedures, instructions, registrations

are followed by the personal). If the system is only focussed on food safety

(microbiological – chemical – physical hazards and allergens) we use the term ‘food

safety management system’. If the system is as well taking into account quality, we

use the term ‘quality management system’.

Quality Assurance standard

A Quality Assurance (QA) standard is defining requirements to which a quality

management or food safety management system in a company needs to attend. It can

be developed by different stakeholders e.g. retail organisations, governments. A

company can obtain a certificate after a positive audit.

Quality Assurance guideline

A quality Assurance guideline is explaining different aspects of required legislation or

quality assurance standards. Companies can use these guidelines to implement the

requirements in their company own management system. No certification is possible.

4.2.2. The Deming cycle

Deming emphasised that everyone learned a common method of describing and attacking

problems. This commonality is an absolute requirement if personnel from different parts of

the company must work together on company-wide quality improvement. Deming therefore

introduced a framework: the Deming cycle, where all parties can discuss problems and

suggest improvements.

The plan-do-check-act (PDCA) cycle, also referred to as either Stewart cycle or Deming

wheel, is the conceptual basis for continuous improvement activities. Representing theprocess with a cycle underscores its continuing nature. The use of the PDCA cycle is to co-

ordinate continual improvement efforts. It both emphasises and demonstrates that

improvement programs must start with careful planning, must result in effective action, and

must move on again to careful planning in a continuous cycle. The activities, which can be

developed in each stage, are explained below:




38

Figure 4 : The Deming cycle

Plan: Begin by studying the current process and document that process. Then collect data to

identify problems. Next, survey data and develop a plan for improvement. Specify measures

for evaluating the plan.

Do: Implement the plan, on a small scale if possible. Document changes made during this

phase. Collect data systematically for evaluation.

Check (study): Evaluate the data collected during the ‘do’ phase. Check how closely the

results match original goals of the plan phase.

Act: If the results are successful, standardise the new method and communicate the new

method to all people associated with the process. Implement training for the new method. If

results are unsuccessful, revise the plan and repeat the process or cease the project.

In replicating successful results elsewhere in the organisation, the cycle is repeated. Similarly,

if the plan was unsuccessful and you still wish to make further modifications, repeat the cycle.

Employing this sequence of steps provides, according to Deming, a systematic approach to

continuous improvement.

PLAN DO

CHECKACT




4.3. Integrated approach

In chapter 4.5 and 4.6, an overview is given of the different quality systems that have been

developed over the years in the primary production and in the food industry. During this

development there is a clear evolution to an integrated approach where 3 aspects are always

present:• Good Hygienic Practices (GHP) / Good Manufacturing Practices (GMP) / Good

Agricultural Practices (GAP) as a basis for a hygienic work methodology and a

foundation for HACCP;

• the HACCP methodology to guarantee food safety; (not for the primary sector !)

• a quality management system based on the principles of ISO 9000:2008 (see chapter 4.4).

Depending on the scope of the quality system a distinction can be made between systems that

focus only on food safety and hygiene and systems that guarantee general quality aspects or

that are a combination of other management systems than those for quality.

Different levels can be distinguished:

1. A limited number of quality management elements to support the HACCP plan. The scope

is limited to food safety and hygiene.

2. The elaboration of a quality management system with an extended scope to general

product quality.

3. Elaboration of a quality management system that is focussed on general customer

satisfaction. The scope is extended to deliver quality on the level of customer

expectations.

4. The elaboration of a global management strategy, by which the participation of all the

collaborators of the organisation is necessary in order to achieve continuous improvement.

5. Besides quality concern, there is also concern for working conditions, environment and

safety. Such a system is described as Total Quality Management (TQM).




40

Figure 5: Integrated approach of several quality systems

Food Safety Assurance plan(product/processpecific)

= HACCP-plan

Long-term manageralstrategy

e.g. TQM, ISO 9004

Quality ManagementSystem

e.g. BRC, ISO 9001Food Safety Management System

GMP/GHP= basic requirement

Quality ManagementSystem

General requirements Specific requirements

Legal requirements related to quality and product quality,

all quality aspects and all customer expectations

All quality aspects +

environment, safety and well-being of the personnel




4.4 ISO 9000:2008

ISO standards are international standards in order to achieve uniformity and to prevent

technical barriers to trade throughout the world. The essence of an ISO-based quality system

is that all activities and handlings must be established in procedures, which must be followedby ensuring clear assignment of responsibilities and authority.

The international Quality Assurance (QA) standards are developed by the technical

committees. Most used and probably best known of all ISO standards is the ISO 9000 series

for quality.

4.4.1. History

During World War II, approximately 200 thousand soldiers were killed simply because their

ammunition malfunctioned. This problem plagued the armed forces of many countries until a

military tribunal authorized the adoption of military standards for all ammunition

manufacturers. Since then, these military standards have spread to most applications of

products and services for both military and government agencies. The North American Treaty

Organization (NATO) was the first group of countries to adopt shared standards in 1945;

these quality assurance standards continued to evolve, with a global organization of standards

issuers. In 1975 the British Standard Organization developed the British Standard (BS) 5750

which became known as the “mother document” for the ISO 9000 series.

In 1987, the Technical Committee TC/176 developed the 9000 series, which provided a

framework for quality management and quality assurance. These standards were generic and

independent on any specific industry or economic sector. The ISO 9000 family comprises

standards providing requirements, guidance, terminology and vocabulary for quality

management systems (QMS), and supporting standards addressing specific issues, such as

auditing.

• ISO 9000:2000 Quality Management Systems - Fundamentals and vocabulary

• ISO 9001:2000 Quality Management Systems – Requirements• ISO 9004:2000 Quality Management Systems - Guidelines for Performance

Improvements

In 2008 a small revision is made regarding the audit protocols and now ISO 9001:2008 is

available. ISO 9001:2008 has been developed in order to introduce clarifications to the

existing requirements of ISO 9001:2000 and to improve compatibility with ISO

14001:2004 (environmental system). ISO 9001:2008 does not introduce additional




42

requirements nor does it change the intent of the ISO 9001:2000 standard. No new

requirements were introduced in ISO 9001:2008 edition but, in order to benefit from the

clarifications of ISO 9001:2008, users of the former version will need to take into

consideration whether the clarifications introduced have an impact on their current

interpretation of ISO 9001:2000, as changes may be necessary to their QMS.

Important remark: ISO 9000 family can be applied in all (industrial) sector, not only for

companies/organization in the agri-food chain.

More information is available on www.iso.org.

4.4.2. Objectives and principles of the ISO 9000 series

The primary objectives of ISO 9001:2008 are to achieve customer satisfaction by meeting

customer requirements through application of the system, continuous improvement of the

system and prevention of non-conformity. To achieve these goals, all activities are described

in procedures that have to be executed and controlled by assignment of responsibilities and

competences.

The international standards of the ISO 9000 family describe which elements should be part of

quality systems, but they do not describe how a specific organization can implement these

elements. The company or organization has to ‘translate’ the standard to the own

organization, since every organization is unique.

4.4.3. Structure

The revised ISO 9001 is structured and organized according to the process model. A process

is considered as any activity or operation, which receives inputs and converts it to outputs.

Characteristics of the model are shown in Figure 6:

Managementresponsibility

Productrealisation

Measurement,analysis, improvement

Resource

management

Product

Customer Customer

Satis-faction

Require-ments




Figure 6 : Model of a Process-Based Quality Management System

Characteristics of the model are:

• The four major topics of the QMS are represented:

- Management responsibility

- Resource management

- Product and/or service realization- Measurement, analysis and improvement

• The continuous improvement aspect and measuring of customer satisfaction are

clearly expressed.

• The model shows interaction between processes, and processes are closed loops. For

example, the input for product realization is customer-driven. Subsequently, the output

is measured by customer satisfaction measurements. This information is used as a

feedback to evaluate and validate whether customer requirements are achieved. The

management on its turn shall ensure that customer requirements are fully understood

and met.

ISO 9001:2008 starts with requirements with respect to the quality management system.

The organization must define and manage processes that are necessary to ensure that products

and/or service conform to customer requirements. For implementation and demonstration of

such processes, the organization must develop, document and maintain a quality management

system according to the international standard.

In the topic management responsibility (1), requirements are set on commitment and

responsibility of (top) management.

In the topic resource management (2), requirements are set with respect to

• human resources, such as assignment of appropriate personnel, development of

procedures to determine training needs and evaluate its effectiveness;

• information, like procedures for managing information on e.g. process, product,

suppliers etc.;

Value adding activities

Information flux




44

• infrastructure, like workspace, associated facilities, equipment, but also supporting

services;

• work environment , such as health and safety conditions, work methods and ethics.

The topic product and/or service realization (3) consists of general requirements and fivesubtopics. The general requirements refer to determination, planning and implementation of

realization processes (e.g. criteria and methods to control processes, arrangements of

measuring, monitoring and corrective actions, and maintenance of quality records). The five

subtopics are:

1. customer-related processes;

2. design and development;

3. purchasing;

4. product and service operations;

5. control of measuring and monitoring devices.

In the topic measurement, analysis and improvement (4) general requirements refer to

planning and implementation of these measuring, analysis and improvement processes to

ensure that the quality management system, processes and products and/or services comply

with requirements.

4.4.4. Benefits of ISO 9000

Pursuing ISO certification helps a company to standardize its processes and provides a better

platform for productivity analysis. Thus, companies should gain better control of their quality

virtue of applying the discipline required for ISO 9000 certification, even if they later decide

not to register. Another important reason for considering ISO 9000 certification is that more

and more companies worldwide are requiring their suppliers to become ISO 9000 registered,

as the whole world is moving toward standards. ISO 9000 is fast becoming an admission

ticket to compete in the global marketplace. ISO standards also provide a universally accepted

method to communicate an organization’s quality concepts and its processes for serving the

customer. Once this system is accepted and certified by ISO representatives during an ISO

audit, company adherence to those standards provides a sense of confidence and assurance toboth the company’s management and personnel and the company’s customers. Finally, one

important reason for adopting ISO standards is the potential impact that it has from a

marketing standpoint. Most companies that are ISO certified today use that certification as an

image-building tool.

4.4.5. Drawbacks of ISO 9000

The cost of implementing and maintaining ISO 9000 is significant. Smaller companies may

not be able to justify the investment in this award. This is a particularly acute problem for new

firms struggling to create a customer base; without ISO 9000 certification they may not winbusiness away from established competitors. In addition, ISO 9000 is costly to obtain and




maintain, lengthy time-scale to obtain certification, time-consuming to develop, difficult to

implement, organizational resistant to change, staff resistant to change, it is hard to maintain

enthusiasm for the system and more documentation is needed.

4.4.6. HACCP System and ISO 9000ISO 9000 is a QMS aimed primarily at preventing and detecting any non-conform product

during production and distribution to the customer, and by taking corrective action to ensure

that the non-conformance does not occur again. ISO 9000 means that the product meets its

specification 100% of the time. There is obviously the danger here in that if an unsafe product

is specified, the QMS will ensure that you make an unsafe product every time.

ISO 9000 standards are constraint to describe the elements of the organization that have to be

taken into account to guarantee obtaining the expected quality, establishing requirements or

recommendations in relation with each of them, meaning that the organizations should define

their own standards and demonstrate that they observe them. One of the methodologies

proposed for these aims is that of the HACCP system.

Each of the requirements of the ISO 9000 standard has relevance to HACCP and in many

instances it is vital that HACCP is supported by such procedures. For example, HACCP can

be very effective but only if:

- calibrated equipment is used;

- people are properly trained;

- documentation is controlled;

- the system is verified through audits and so on.

This does not mean that the organization needs to have a complete company quality system,

certified to ISO 9001 before starting with HACCP, but there is a relationship between the two

of them and how to use ISO 9000 as a guideline for installing the procedures which will make

the HACCP system secure.

4.5. Overview of different quality assurance standards in primaryproduction

The primary production is as well included in the Codex Alimentarius documents (e.g.

‘general principles of food hygiene ‘) where Good Agricultural Practices and registrations are

demanded for this sector (see part 0.2 and 4.1). Next to this, the primary production is more

and more taken into consideration as well in legislation regarding food safety and food

hygiene (see part 0.3), where a ‘farm to fork’ approach is included. So food safety is starting




46

actually already in the primary sector where contaminations with micro-organisms, chemical

agents or physical foreign bodies can happen.

Therefore, also on the level of the primary sector quality management systems are demanded

by government or customers. The retail has again played an important role in the developmentof quality assurance standards and is requiring often the certification against these standards

as a basic demand for delivering to the retail facilities of both fresh plant crops or fresh

meat/fish/animal products. Not only the retail is demanding on its fresh delivered products but

also the food industry is demanding requirements of food safety, food hygiene and food

quality to the primary sector, which is supplying them from raw materials.

In this part several important standards on international level are discussed.

4.5.1. GLOBALG.A.P. as retail initiative

4.5.1.1. Objective and history

Eurep-GAP started in 1997 as an initiative of a group of European retailers, the Euro-Retailer

Produce Working Group (EUREP). The goal was to elaborate standards and procedures for

the development of Good Agricultural Practices (GAP), in other words a quality management

system for primary production. The following sectors are included: fruit and vegetables,

flower and ornamentals, integrated farm assurance, integrated aquaculture assurance, green

coffee.

In 2007 the EUREP-GAP standard was extended both in scope and became internationally

recognised by the retailers. The name changed into GlobalGap. The GlobalGap standard is

primarily designed to reassure consumers about how food is produced on the farm by

minimising detrimental environmental impacts of farming operations, reducing the use of

chemical inputs and ensuring a responsible approach to worker health and safety as well as

animal welfare.

The most important point of interest of the standards that are developed within GlobalGap isfood safety, closely related to traceability. The starting point is legislation. However, it is not

enough to focus on food safety, the consumer has also other demands towards food quality.

Aspects that are related to sustainable agriculture are also included. Therefore, attention is

given to environment and well-being and safety of the workers. Also technical aspects of the

cultivation are included in the standards. Elements of quality management systems are limited

and include registrations, training of the personnel and forms for complaints.

4.5.1.2. Structure of GlobalGap




The new GlobalGap standard version integrates all agricultural products into a single farm

audit. Producers of different crops and livestock can now avoid multiple audits to meet

various market and consumer requirements.

There are modular applications (see Figure 7) for the different product groups, ranging fromplant and livestock production to plant propagation materials and compound feed

manufacturing.

I n t e g r a t e d

f a r m a

s s u r a n c e s t a n d

a r d

Crops base Fruit & vegetables

Flowers &

ornamentals

Combinable crops

Green coffee

Tea

Cotton

Others

Livestock base Cattle & sheep

Dairy

Pigs

Poultry

Others

Aquaculture base Salmon & troutPangasius

Shrimp

Tilapia

Others

Figure 7. Structure of GlobalGap

4.5.1.3. Content of GlobalGap

The documentation of the system is organised in major blocks, which is available for each

type of activity, giving:

a) system rules referred as General Regulations (GR) : in this chapter rules for

auditing and combination of audits are given. There are recommendations, major

must and minor must. The major and minor musts must be fulfilled for obtained

the certification.




48

b) global G.A.P. requirements referred to as Control Points and Compliance

Criteria (CPCC) : in here we can find the actual requirements for the specific

activity in the primary sector.

These are including e.g. (see further in figure 8)

i) all farm base: (section AF)

o record keeping and internal self-assessment/internal

inspection

o site history and site management

o workers health, safety and welfare

o waste and pollution management, recycling and re-use

o environment

o complaints

o traceability

ii) crops base (section CB)

o traceability

o propagation material

o site history and site management

o soil management

o fertiliser use

o irrigation

o integrated pest management

o plant protection products

iii) fruit and vegetables (section FV)

o propagation material

o soil and substrate management

o irrigation

o is there a written justification for the use of soil

fumigants ?

o product handling (post harvest)iv) continuing for the other activities

Important to note is that there is always a general starting point for all activities ‘section AF’ ,

followed by a general part for crops ‘section CB’ or livestock ‘section LB’ or aquaculture

‘section AB’, and finally the activity specific requirements ‘section FV, CC, CO, TE, FO, CS,

DY, PG, PY, SN (see figure 8).

c) Inspection documents referred as checklists (CL) : which are applied during

the audit, to check whether all requirements or CPCC are fulfilled




AF

All farms base

CB

Crops base

FV Fruit & vegetables

FO Flowers & ornamentals

CC Combinable crops

CO Green coffee

TE Tea

Cotton

Others

LB

Livestock base

CS Cattle & sheep

DY Dairy

PG Pigs

PY Poultry

Others

AB

Aquaculture base

SN Salmon & troutPangasius

Shrimp

Tilapia

Others

Figure 8: structure of the documentation and requirements of Global Gap

More information : www.globalgap.org

4.5.2. Qualität und Sicherheid für Lebensmittel vom Erzeuger bis zum

Verbraucher (QS)

The QS standard was developed in Germany by all those that are involved in the production

and marketing of meat/meat products and fruit, vegetables and potatoes. It is a quality

assurance standard (with possibility of certification) to ensure the quality and origin of food

products. In the mean time this standard became more important in Europe and over the world

because of the strength of the German retailers and the fact that it was the first standard that

was combining both plant production and livestock production.

Moreover, the QS standard combined as well primary production with further food production

(e.g. slaughterhouse, …) and retail/distribution (full agro-food chain approach).

In order to achieve this goal QS:




50

• installed a system for quality management and control which covers all stages from

birth through to (slaughtering), cutting and processing and including transportation

and storage;

• creates transparency at all stages of production, from birth through to point of sale;

• makes it possible to trace the origins of the raw materials;• takes account the consumer interests to a degree which exceeds legal stipulations as

early as the specification stage when laying down requirements for QS-approved

products;

• pays due attention to considerations of animal welfare.

The QS standard apply to both domestic and imported products. Within QS, professional

associations and organisations from the feedstuff industry, the farming industry, the meat

industry, the meat production industry, the fruit/vegetable and potato retailing, the food

retailing industry and CMA (Centrale Marketing Gesellschaft der deutschen Agrarwirtschaft

mbH – the central association for marketing for the German agriculture).

Additional information can be found on http://www.q-s.info/

4.5.4. Other international quality assurance standards for primary production

Two standards are developed both for the primary sector and for further

processing/distribution of food products. These standards will be discussed in detail in part

4.6.

ISO22000:2005 is aiming to the complete agro-food chain including primary production and

even suppliers to the agro-food chain (e.g. producers of fertilizers, producers of

pesticides,….).

SQF 1000 is a standard from USA/Australia as well aiming at the complete agro-food sector.

4.5.5. Other national quality assurance standards for primary production

Besides these GlobalGAP and QS standards there are also a lot of other quality assurance

standards, that are used more on national level (e.g. Integrated quality assurance milk (IKM,

Belgium), environmental project ornamental plant cultivation (MPS, the Netherlands),

Integrated chain quality control system (IKKB, Belgium), etc.). Most of these standards are

based on the international ones (e.g. GlobalGap or QS) and are combining national practices

or legislation.

Mostly a benchmarking is conducted towards these international standards so that a combinedaudit can take place.




51

4.6. Overview of the different quality assurance standards in the

food industry

In this chapter an overview is given of the most relevant standards with respect to quality,hygiene and safety of foods in the transformation and or distribution of foodstuffs. See as well

appendix C.

4.6.1. Global Food Safety Initiative (GFSI)

In April 2000, a group of international retailers, international manufacturers and food service

companies identified the need to enhance food safety, ensure consumer protection, strengthen

consumer confidence, to set requirements for food safety schemes and to improve cost

efficiency throughout the food supply chain. Following their lead, the Global Food Safety

Initiative was launched in May 2000. The initiative is facilitated by CIES – The Food

Business Forum. CIES is the organization of the 200 biggest retailers in the world. The

initiative is based on the principle that food safety is a non-competitive issue, as any potential

problem arising may cause problems in the whole sector.

GFSI has developed a Guidance Document (Fifth Edition) (see http://www.mygfsi.com/),

against which quality assurance standards focussing on food safety for food processing

companies can be benchmarked. The benchmark requirements in the Guidance Document are

made up of three key elements:

• Food Safety Management Systems;

• Good Practices for Agriculture, Manufacturing

and Distribution (GAP, GMP, GDP);

• HACCP.

Compliance with all components of the key elements will lead to endorsement of a submitted

QA standard through the Initiative framework and subsequent acceptance by retailers. Once a

QA standard has been benchmarked successfully, the standard is “acknowledged”. Theconforming benchmarked QA standard can be applied by food suppliers throughout the whole

supply chain, upon agreement with retailers, when defining contracts for sourcing of products.

GFSI does not undertake any certification or accreditation activities. Instead, GFSI

encourages the use of third-party audits for benchmarked QA standards, with the goal of

enabling suppliers to work more effectively through less audits and reducing travel costs for

retailers, so that resources can be redirected to continually ensure the quality of food produced

and sold worldwide.




52

More information is available on www.ciesnet.com en www.mygfsi.com.

4.6.2. BRC

4.6.2.1. History In supermarkets in the United Kingdom, about 50% of all foods are sold as private label. This

implies that the retailers are responsible for these products. In the Food Safety Act 1990

concerning product responsibility, a new principle was introduced: the “Due Diligence”

principle.

“It shall …. be a defence for the person charged to prove that he took all reasonable

precautions and exercised all due diligence to avoid the commission of the offence by himself

or by the person under his control”

A consequence of this principle was that for every private label the technical execution like

production methods of all suppliers has to be verified demonstrably. During the period 1990-

1995 this resulted in a situation where every retailer made his own standard and had an

extensive quality department with a lot of auditors to audit their suppliers. Consequently,

there were high costs for the producer (specific requirements for every retailer, for every

retailer an audit, …) and for the retailer (extended quality department to make the standards

and to audit the suppliers).

To resolve these problems the BRC standard was developed in 1998. BRC stands for British

Retail Consortium and represents the biggest British retailers (e.g. Tesco, Safeway,

Somerfield, Sainsbury,…). Together they compiled the requirements that the suppliers have to

meet in the BRC-technical standard. As a consequence the supplier can comply with the

requirements of the different retailers with only one certificate and limit the audits. The BRC-

technical standard is made by the retailers themselves, without involvement of the

government, consumers or experts. In 2000 a first revision of the BRC standard was executed

(=2nd

version).

The development of GFSI and the need for continuous improvement and a number of

problems that occurred in the first version of 2000, leaded to a revision of the BRC-technical

standard (=3th

version). In December 2004 the 4th

version was lanced with changes regarding

the new hygiene demands by EU legislation and a chapter regarding allergen policy of a food

company. At the beginning of 2008 the latest version is published (version 5), which will be

implemented from 1st

of July 2008. This contains 326 very detailed requirements.

Although it was a British initiative, other countries, particularly Belgium and the Netherlands,

also wanted to use the system. Some retailers in the Netherlands and Belgium demand an




53

audit report of the suppliers of their private labels. Moreover, it is expected that the suppliers

can demonstrate a continuous improvement.

4.6.2.2. Objective

The aim of the BRC-technical standard is twofold.1. For the retailers:

• limit the costs concerning supplier control;

• the objective report gives the retailer insight in the way on which the suppliers

controls food safety and quality;

• meet the due diligence principle.

2. For the producers:

• limit the costs: 1 report for several retailers;

• the result of the BRC inspection can motivate the producer to improve

continuously and in this way shift from the basic level to the higher level.

4.6.2.3. Structure

The BRC standard consists of a technical standard for companies supplying retailer branded

food products and an evaluation protocol. The evaluation protocol provides the specific

requirements for the certification bodies that will evaluate against the BRC technical standard.

The technical standard is an enumeration of more than 300 requirements that the suppliers

have to meet.

The BRC-technical standard requires:

• the adoption and implementation of HACCP;

• a documented and effective quality management system;

• control of product, process, personnel and the factory environment.

The BRC-technical standard is divided in 7 chapters;

1. Senior management requirements

2. the food safety plan : HACCP system;

3. Management commitment and continual improvement : quality management system;4. Factory environment standards;

5. Product control;

6. Process control;

7. Personnel.

Each section of the Technical standard begins with a highlighted paragraph in bold text,

which is the statement of intent, which all suppliers must comply with in order to gain

certification.




54

Below the statement of intent, there are specific criteria regarding this subject. With the latest

version of BRC there is no difference made anymore between higher or lower level, all

demands are on the same level.

There are as well some FUNDAMENTALS defined (since version 4) which are important,when a critical or major non conformity is defined during auditing, no certificate will be

delivered. Examples of fundamentals are:

• chapter 1: HACCP-system

• chapter 2.1 : Quality Management System

• chapter 2.9 : internal auditing

• chapter 2.12 : corrective actions

• chapter 2.13 : traceability

• chapter 3.2.1 : lay out, product flow, cross contamination

• chapter 3.8 : cleaning and disinfection

• chapter 4.2 : measures for specific materials (e.g. allergens)

• chapter 5.1 : process control

• chapter 6.1 : training

4.6.3. International Featured Standard-FOOD (IFS)

4.6.3.1. History

In 1999 the German retailers, united by the ‘Bundesvereinigung Deutscher Handelsverbände

(BDH)’, started with the development of a quality assurance standard to check their suppliers

of private labels. The bases and aims were:

• Develop one standard with a uniform rating system, by which the interpretation of the

auditor is limited.

• The control of the standard should be carried out by qualified certification bodies and

auditors.

• The audit report should give a truthful view on the company and the used food safety

systems.• The audit should be a part of a continuous process of improvement and problems that

occurred during the audit as non conform should be handled.

• Critical non-conformities should be known.

• The standard and the audit protocol should be in accordance with GFSI.

The Germans came to the conclusion that they did not want to make a national, German

standard, but an international standard. A working group was elaborated and started with the

making of the first draft in October 2001. The content of the BRC standard was used as a base

and the structure was derived from ISO 9001:2008.




55

In the beginning it was a German initiative, but in the meanwhile the French retailers also got

involved and German and French retailers support the standard now. Therefore, it is becoming

more important in Continental Europe. From the 1st

of January 2007 the latest version 5 is

effective where also the Italian retailers have been working on and new European legislation

(e.g. legislation regarding food contact materials) is included.

4.6.3.2. Structure and content

The IFS standard is an enumeration of requirements on 3 levels: foundation level, higher level

and recommendations on good practice. The standard contains 5 chapters:

1. Management of the quality system;

2. Management responsibility;

3. Resource Management;

4. Product realisation;

5. Measurements, analyses, improvements.

4.6.3.3. Rating system

In order to determine whether compliance with a clause in the International Food Standard

has been met, the auditor has to check every item in the standard. The auditor can rank his

finding as follows:

A: In full compliance with the criteria of the standard.

B: Almost full compliance with the criteria in the standard but a small deviation was

found.

C: Only a small part of the criteria is implemented.

D: The criteria in the standard are not implemented.

The auditor has to explain all B, C, and D non-conformities in the audit report.

For each rating a number of points are assigned depending on the level. The total number of

points will determine whether or not a certificate will be gained. With the version 5 > 95%

must be obtained before a certificate is obtained. Moreover, no difference is made anymore

between the different demands (all demands are on 1 level in version 5).

Besides the ranking, the auditor can decide to give the auditee a “KO” (knock-out) or a

“major non-conformance” that will subtract points from the total amount. The KO criteria in

the standard are e.g.:

1.2.3 HACCP analysis;

2.2.2 Management commitment;

4.18 General traceability;

5.11 Corrective actions.

More information : http://www.ifs-certification.com/




56

4.6.4. SQF 2000

In 1995 the Australian government and some farmer organisations developed a system to

control the complete chain with 1 system. This system was based on a chain scan: SQF (Safe

Quality Food). Later this system was translated to a standard; SQF 2000. The bases for thisstandard are the HACCP requirements, of the Codex Alimentarius, and the requirements of

the ISO 9000 series. Since, representatives of agriculture were involved in the development of

the standard, it is directly applicable in primary production. Since the summer of 2003, SQF is

managed by the Food and Marketing Institute (FMI) in Washington.

Because of the big diversity in size, processes and products, it was not possible to use 1

standard for all the companies of the food chain. Therefore, 3 different standards were

developed:

• SQF 1000: for primary production and small-scaled processors and service providers (so

called “low-risk” companies).

• SQF 2000: for bigger industry (so called “high risk” companies).

• SQF 3000 is still in development and is focussed on retail.

More information: http://www.sqfi.com/

4.6.5. Approval by GFSI

Five quality assurance standards from retailers are approved by GFSI:

• BRC Technical standard;

• Dutch HACCP code;

• EFSIS standard;

• IFS food;

• SQF 2000 code.

This means that the standards can use the GFSI logo and that the certificates for these

standards are considered as equal by 65% of the retailers over the world.

Benchmarking of farm assurance standards for agricultural produce started in 2004.

4.6.6. ISO 22000:2005

Since national initiatives for HACCP-certification (e.g. the Netherlands, Denmark) did not

have international success, Denmark launched the proposition for an international food

standard. Therefore, ISO started in 2001 with the elaboration of a standard with requirements

for a management system for food safety based on HACCP.




57

The international standard specifies the requirements for a food safety management system

that combines the following generally recognized key elements to ensure food safety along

the food chain, up to the point of final consumption:

• interactive communication;

• system management;• process control;

• HACCP principles;

• Prerequisite programs.

The first version is from September 2005. The difference with the retailer and GFSI approved

standards are – and are as well the reason why ISO 22000 is not GFSI approved and not

accepted by the retailers in Europe:

• No explicit demands regarding pre requisite programs

• Quality is not in the scope only food safety

Positive regarding this standard is the international acceptance and the application in the

whole food chain (not restricted to food transformation as the ones approved by GFSI).

In the following chapters the demands are formulated:

Chapter 4 : management system for food safety

Chapter 5 : responsibility of the management

Chapter 6 : Measure of resources

Chapter 7 : Planning and realisation of safe products (e.g. demands regarding PRP’s and

HACCP)

Chapter 8 : validation, verification and improvement of the management system for food

safety

The difference with the retailer standards are

• No explicit demands regarding pre requisite programs• Quality is not in the scope only food safety

In order to overcome the problem of non acceptance by retailers, a technical document (PAS

220) is worked out to explain the PRPs (prerequisite programs) by the British Food

Association. This document is detailed explaining which PRPs need to be established in the

food chain. GFSI and the retailers accept now ISO 22000 and the PAS 220 document. The

ISO22000 requirements combined with PAS 220 requirements is called FSSC (FOOD

SAFETY SYSTEM CERTIFICATION) 22000. This latest standard is recognised last year by

GFSI and consequently, as well by the retailers.




58

Positive regarding this standard is the international acceptance and the application in the

whole food chain (not restricted to food transformation/processing as the other ones approved

by GFSI).

4.7. References for part 4

British retail consortium. 2007. Technical standard. Technical standard and protocol for

companies supplying retailer branded food products, issue 5.

Codex Alimentarius. 1969. Recommended international code of practice – General principles

of food hygiene, CAC/RCP 1-1969, Rev.4-2003, 31 p.

Flair Linked Agro Industrial Research (FLAIR). 1993. HACCP user guide, concerted action

N°7, 53 p.

International Commission on Microbiological Specifications for Foods (ICMSF). 1990.

HACCP in microbiological safety and quality, Blackwell Scientific Publications, Oxford, 357

p.

International Food Standard; 2007. International Food Standard. Standard for auditing retailer

and wholesaler branded food products, version 5

International Standards Organization. 2000. ISO 9000. Quality management systems –

Requirements, 34 p.

International Standards Organization. 2008. ISO 9001. Quality management systems –

Fundamentals and vocabulary, 35 p.

International Standards Organization. 2004. ISO/CD 22000. Food safety management systems

– requirements for organizations throughout the food chain, draft, 43 p.

Jouve J.L., Stringer M.F. & Baird-Parker A.C. 1998. Food safety management tools, ILSI

Europe, Brussels, 20 p.

Luning P.A., Marcelis W.J. & Jongen W.M.F. 2002. Food quality management. A techno-

managerial approach, Wageningen Pers, Wageningen, 323 p.

Mortimore S. & Wallace C. 1994. HACCP a practical approach, Chapman & Hall, London,

296 p.




59

Mortimore S. & Wallace C. 2001. HACCP, Blackwell Science, Oxford, 136 p.

Pierson M.D. & Corlett D.A. 1992. HACCP principles and applications, Van Nostrand

Reinhold, New York, 212 p.

Postmus E. & Guldemeester H.P. 1995. Handboek HACCP, Kluwer, Deventer, 270p.

The Global Food Safety Initiative. 2004. GFSI Guidance document, Fourth edition, 28 p.

van den Berg M.G. 1993. Kwaliteit van levensmiddelen, Kluwer, Deventer, 360p.




60

Appendix A Structure of the Codex Alimentarius

• Volume 1A – General requirements

• Volume 1B – General requirements (food hygiene)

• Volume 2A – Pesticide residues in foods (general texts)• Volume 2B – Pesticide residues in foods (maximum residue limits)

• Volume 3 – Residues of veterinary drugs in foods

• Volume 4 – Foods for special dietary uses (including foods for infants and children)

• Volume 5A – Processed and quick-frozen fruits and vegetables

• Volume 5B – Fresh fruits and vegetables

• Volume 6 – Fruit juices

• Volume 7 – Cereals, pulses (legumes) and derived products and vegetable proteins

• Volume 8 – Fats and oils and related products

• Volume 9 – Fish and fishery products

• Volume 10 – Meat and meat products; soups and broths

• Volume 11 – Sugars, cocoa products and chocolate and miscellaneous products

• Volume 12 – Milk and milk products

• Volume 13 – Methods of analysis and sampling

Volume 1A – General requirements

1. General principles of the Codex Alimentarius

2. Definitions for the purpose of Codex Alimentarius

3. Code of ethics for international trade in foods

4. Food labelling

5. Food additives – including the General Standard for Food Additives

6. Contaminants in food – including the General Standard for Contaminants and Toxins

in Foods

7. Irradiated foods

8. Food import and export food inspection and certification systems




61

Appendix B The 12 stages of the Codex Alimentarius




Appendix C An overview of the different standards in food indFeatures Codex principles ISO

9001:2008

ISO

15161:2001

ISO

22000:2005

+ PAS 220

BRC GL

GAPRP HACCP

Focus Food safety Food safety Product or

service quality

&

organisational

quality

Food safety

& organisat-

ional quality

Food safety Food safety,

food quality

& organisat-

ional quality

Fo

&

qu

Scope Whole agri-food chain

Processing &distribution

stages

Whole chain(i.e. food and

non-food

products)

Processing &distribution

stages

Whole agri-food chain

Processingstages

Aglev

an

aq

Legislative

Status

Compulsory Compulsory Voluntary Voluntary Voluntary Voluntary

(retailers’

demand)

Vo

(re

de




Features Codex principles ISO 9001:2008 ISO

15161:2001

ISO

22000:2005 +

PAS 220

BRC G

GPRP HACCP

Combined –key

elements I GMP, II

HACCP , III

management

system

I (PRP) II (HACCP) III

(Management

system)

I, II, & III I, II, & III I, II, & III I

GFSI status Not

benchmarked

but PRPs are

used in GFSI

Not

benchmarked

but its

principles are

used in GFSI

Not

benchmarked

but its

principles are

used in GFSI

Not

benchmarked

Not (yet?) Yes N

Acknowledgement Worldwide Worldwide Worldwide Worldwide Worldwide Europe W




Features Codex principles ISO

9001:2000

ISO

15161:2001

ISO

22000:2005

+ PAS 220

BRC Global

GAP

IFS

PRP HACCP

Certification? No No Yes No Yes Yes Yes Yes

Scope of

certification

Not

applic-

able

(NA)

NA ISO/IEC

17021:2006

(company’s

certification)

NA ISO/IEC

17021:2006

EN 45011 (food and

non-food or service

certification)

EN

45011

EN 4

Gradation in

certification

NA NA No gradation NA No

gradation

Three gradations:

• A

• B

• C

No

gradation

Two

Frequency of

audit

NA NA Annual NA Every 3

years

• Annually for

grade A & B

certificates

• 6 months for

grade C

certificate

Annual Ann




65

5. Risk analysis in relation to food

5.1. Definitions

Risks can have different sources and can be from different nature. In the past, the mainattention was given to the direct risks for human but more and more people are realizing

that ecological consequences of pollution needs more quantitative attention. At this time,

people are aware that ecological effects provoked by e.g. intensive agriculture, high use of

energy or production and application of chemical products can interact with the biological

diversity and the integrity of ecosystems and like this threat the continuation of humans. The

scope and the type of risk assessments are very divers, from broad scientific based

assessments regarding air pollution which are interacting the whole population towards site

specific studies regarding the presence of specific chemicals in the local water resources.

Some assessments are retrospective and are looking at the consequences of a specific incident,

e.g. the consequence of illegal dumping of chemical waste. While others are more related to

the future and try to measure the damage in the future for human welfare or the environment

e.g. evaluation of authorization of a new pesticide.

In this lectures we will focus on risks associated with food safety e.g. microbiological, chemical

agents.




66

The following definitions are important in risk analysis :

Hazard: the inherent capacity of a biological, chemical or physical agent to cause,

under the conditions of the exposure, an adverse health effect on human or negative

effects on environment.

Risk: a function of the probability of an adverse health effect and the severity of that

effect, consequential to a hazard.

Risk-analysis: the process of 3 distinct but closely connected components : risk

assessment, risk management and risk communication.

Risk assessment: is an independent, scientific process, consisting of the following 4

steps : hazard identification, hazard characterization, exposure assessment and risk

characterization

Risk management: is the process, distinct from risk assessment, of weighing policy

alternatives, in consultation with all interested parties, considering risk assessment

and other factors relevant for the health protection of environmental protection and if

needed selecting appropriate prevention and control options.

Risk communication: an interactive exchange of information and opinions throughout

the risk analysis process concerning risk , risk related factors and risk perceptions

among risk assessors, risk managers, consumers, industry, the academic community

and other interested parties, including the explanation of risk assessment findings

and the basis of risk management decisions.

Hazard identification: During the hazard identification, biological, chemical, and

physical agents that may cause adverse health effects and which may be present

in a particular food or group of foods, are identified.

Exposure assessment: Exposure assessment is defined as the qualitative and/or

quantitative evaluation of the likely intake of the hazard via food or environment

as well as exposure from other sources, if relevant

Hazard characterization: in the process of the hazard characterization, the natureof the adverse health effects or negative effects on the environment associated

with the hazard is evaluated in a qualitative and/or quantitative way (dose-

response relationship)

Risk characterization: During the risk characterization, all the evidence from the

previous three steps is combined in order to obtain a risk estimate (i.e. an

estimate of the likelihood and severity of the adverse health effects / negative

effect on the environment that would occur in a given population with associated

uncertainties) and respond to the questions posed by the risk managers




67

Risk analysis is containing three essential parts : the risk assessment, the risk management

and the risk communication.

Figure 9 : risk analysis and its three essential parts

5.2. Risk assessment

A risk can be defined as a function of the probability of an adverse health effect and the

severity of that effect, consequential to a hazard in food [Codex Alimentarius, 1999]. During a

risk assessment an estimate of the risk is obtained. The goal is to estimate the likelihood and

the extent of adverse effects occurring to humans due to possible exposure(s) to hazards. Risk

assessment is a scientifically based process consisting of the following steps : (i) hazard

identification, (ii) hazard characterisation, (iii) exposure assessment, (iv) and risk

characterisation [Codex Alimentarius, 1999].

Risk assessment is a scientific process, conducted by scientific experts, which may begin with

a statement of purpose intended to define the reasons that the risk assessment is required and

support the aims of the subsequent stages of risk management.

Risk Assessment:

-Hazard Identification;

-Hazard Characterization;

-Exposure Assessment;-Risk Characterization.

Risk Management:

- Evaluation of the

different policy

scenarios- selection and

implementation of themost suited policy

measures.

Risk Communication:

Interactive exchange ofinformation and opinions.

Risk Assessment:

-Hazard Identification;

-Hazard Characterization;

-Exposure Assessment;-Risk Characterization.

Risk Management:

- Evaluation of the

different policy

scenarios- selection and

implementation of themost suited policy

measures.

Risk Communication:

Interactive exchange ofinformation and opinions.




68

Figure 10 : Elements of risk assessment and risk management

During the hazard identification, biological, chemical, and physical agents that arecapable of causing adverse health effects and which may be present in a particular food or

group of foods, are identified [Codex Alimentarius, 1999].

Therefore, the aim of chemical hazard identification is to evaluate whether the chemical has

the potential to cause adverse effects in humans by reviewing all available data on toxicity

and the biological mechanism that leads to toxicity (Barlow et al., 2002).

In contrast, not all micro-organisms are pathogenic, but even a very small number of

pathogens has the potential to cause disease. Therefore, microbiological hazardidentification aims to identify the likelihood of the presence of known pathogenic micro-

organisms or microbial toxins in a certain food product, and to evaluate whether they have the

potential to cause harm when present in food or water (Benford, 2001).




69

To carry out a hazard identification different sources of information can be used:

Epidemiological data

Well-conducted epidemiologic studies that show a positive association between an agent and

a disease are accepted as the most convincing evidence about human risk. However this

evidence is often difficult to accumulate. The evidence is low, the number of persons exposed

is small, the latent period between exposure and disease is long, and exposures are mixed and

multiple. Thus, epidemiologic data require careful interpretation.

Animal-Bioassay data

The most commonly available data in hazard identification are those obtained from animal

bioassays. The inference that results from animal experiments are applicable to humans is

fundamental to toxicological research; this premise underlies much of experimental biology

and medicine and is logically extended to the experimental observation of carcinogenic

effects. Despite the apparent validity of such inferences and their acceptability by most cancer

researchers, there are no doubt occasions in which observations in animals may be of highly

uncertain relevance to humans.

Short-Term studies

Sometimes tests are used which indicate certain negative effects. A typical example is the

mutagenicity assay. These tests need to be considered as indicative and need to be

supplemented with bioassays.

Comparison of molecular structure

Comparison of an agent’s chemical or physical properties with those of known carcinogens

provides some evidence of potential carcinogenicity. Experimental data support such

associations for a few structural classes; however, such studies are best used to identify

potential carcinogens for further investigation and may be useful in priority setting for

carcinogenicity testing.

Case studies

Case studies are also an important source of information for hazard identification. Data of

outbreaks and accidents can identify the cause of an outbreak or the necessary exposure to

cause negative effects.

In the second step, the hazard characterisation, the nature of the adverse health effects

associated with the hazards are evaluated in a qualitative and/or quantitative way [Codex

Alimentarius, 1999]. Therefore a dose-response assessment should be performed. The dose-

response assessment is the determination of the relationship between the magnitude of

exposure (dose) to a chemical, biological or physical agent and the severity and/or frequency

of associated adverse health effects (response). The overall aim is to estimate the nature,

severity and duration of the adverse effects resulting from ingestion of the agent in question




70

[Benford, 2001]. Whereas in hazard identification, the emphasis differs for microbiological

and chemical agents, the processes of chemical risk assessment (CRA) and microbiological

risk assessment (MRA) are much more closely aligned for the hazard characterisation stage.

The aim of both chemical and microbiological hazard characterisation is to determine the

dose-response relationship.

Figure 11. A typical dose-response curve

Exposure assessment is defined as the qualitative and/or quantitative evaluation of

the likely intake of the hazard via food as well as exposure from other sources, if relevant

[Codex Alimentarius, 1999]. For food, the level ingested will be determined by the levels of the agent in the food and the consumed amount.

When the exposure is determined it is necessary to take into account that the (sub)population

is not always equally exposed and that the exposure can vary in time. When for example the

risk of fumonisins via the consumption of maize containing foods is estimated the eating

habits of the population at research have to be taken into account. These eating habits can

differ from person to person. Also when the level of an agent in a food can be determined, the

storage conditions, the preparation, frequency and the amount of the consumed product will

lead to a high variation in the intake of the agent. This is also be the case for the applicationof a solvent in a consumer product that is applied in a bad ventilated room or in the open air.

Another important aspect of exposure assessment is the determination of which groups in the

population may be exposed to a chemical agent; some groups may be especially susceptible to

adverse health effects. Pregnant women, very young and very old people and persons with

impaired health may be particularly important in exposure assessment. The importance of

exposures to a mixture of carcinogens is another factor that needs to be considered in

assessing human exposures.

For example, exposure to cigarette smoke and asbestos gives an incidence of cancer that ismuch greater than anticipated from carcinogenicity data on each substance individually.




71

Because data detecting such synergistic effects are often unavailable, they are often ignored or

accounted for by the use of various safety factors.

The last step, risk characterisation, integrates the information collected in thepreceding three steps. It interprets the qualitative and quantitative information on the

toxicological properties of a chemical with the extent to which individuals (parts of the

population, or the population at large) are exposed to it [Kroes et al, 2002]. In other words,

estimating how likely it is that harm will be done and how severe the effects will be. The

outcome may be referred to as a risk estimate, or the probability of harm at given or expected

exposure levels [Benford, 2001].

Quantitative risk assessment (QRA) is characterised by assigning a numerical value to the

risk, in contrast with qualitative risk analysis, that is typified by risk ranking or separationinto descriptive categories of risk [Codex Alimentarius, 1999]. During QRA a model is used

to calculate (estimate) the risk based on the exposure and the dose-response. Besides the

QRA model, the exposure and the dose-response can also be described by a model. To

calculate the exposure to a microbiological hazard for example, a model can be used that

predicts the growth during storage. Several methods can be used to estimate the risk, namely :

(i) point estimates or deterministic modelling; (ii) simple distributions and (iii) probabilistic

analysis [Kroes et al, 2002]. In a deterministic framework inputs to the exposure and effect

prediction models are single values. In a probabilistic framework, inputs are treated as random

variables coming from probability distributions. The outcome is a risk distribution [Verdonck et al, 2001]. The method chosen will usually depend on a number of factors, including the

degree of required accuracy and the availability of data [Parmar et al, 1997]. No single

method can meet all the choice criteria that refer to cost, accuracy, time frame, etc. Therefore,

the methods have to be selected and combined on a case-by-case basis [Kroes et al, 2002].

Chemical and microbiological hazards are fundamentally different and demand a

different risk assessment approach. Allergens, as a special group within the chemical

hazards, will not be discussed in the presented text.

5.2.1. Chemical risk assessment in foods

5.2.1.1. Hazard identification

The emphasis of hazard identification differs for chemical and biological agents, due to the

different nature of both hazards. In fact, any chemical substance is likely to produce some

form of adverse effect if taken in sufficient quantity and a single chemical substance may

be associated with several different adverse health effects (Benford, 2001).Therefore, the




72

aim of chemical hazard identification is to evaluate whether the chemical has the potential to

cause adverse effects in humans by reviewing all available data on toxicity and the biological

mechanism that leads to toxicity (Barlow et al., 2002).

The different chemical hazards will be discussed by prof Bruno De Meulenaer in part 2. Butwe are dealing with additives applied in food products, contaminants (heavy metals e.g. Pb,

Cd, Hg – nitrates in vegetables – residues of pesticides or medical treatment of animals –

group of dioxins – PCB), product which are formed during the production process (e.g. PAK

during drying process, nitrosamines, oxidation of fats, ….), migration from (plastic)

packaging material, natural toxins (e.g. mycotoxins), allergens.

5.2.1.2. Hazard characterisation

For chemical agents, hazard characterisation is closely linked to hazard identification and is

often based on the same studies. Hazard identification reveals the type(s) of toxicity

associated with a particular substance, while hazard characterisation determines the

relationship between dose and response and subsequent estimation of dose levels that may

cause that response in humans.

To summarize : hazard characterization is dealing with toxicological research to the

possible adverse effects in humans, by taking into consideration:

- the different toxic effects which can be provoked : this will be discussed in part 2 by

prof Bruno De Meulenaer

- the dose-response relations that are existing

A. Dose-response relations

In fact each chemical product is intrinsic toxic. The toxicity however, is depending on

different factors, by which concentration is probably one of the most important one. The

concentration-dependency of the toxicity is demonstrated in a dose-response curve. One of

the presentations of a dose-response curve is the cumulative frequence distribution curve, see

figure 12.




73

Figure 12. Dose-response curve (cumulative frequence distribution)

A distinction is made between threshold effects and nonthreshold effects.

Many of the non-carcinogenic adverse effects observed in animal or humans are characterised

by a threshold dose, below which no adverse effects are observed (Kuiper- Goodman, 2004).

For these effects, it is current practice to estimate the level of exposure without significant

adverse effect and to derive a health-based guidance value such as a tolerable daily intake

(TDI) or acceptable daily intake (ADI) (Barlow et al., 2006).

With regard to carcinogens, it is not possible to define a dose without a potential effect, unless

it can be clearly established that the mode of action involves an indirect mechanism that may

have a threshold (Kuiper-Goodman, 2004; Barlow et al., 2006). Both effects are treated in a

different way to extrapolate safe intake estimates as explained in the following paragraphs.

B. Chemicals with a threshold dose

Non-carcinogenic chemicals are usually characterised by a threshold dose, the no observed

adverse effect level (NOAEL), which is the highest dose that causes no toxic effects (Dybing

et al., 2002). This parameter can be derived from the dose-response curve (see figure 13).




74

Figure 13. Graphic presentation of NOAEL value

The NOAEL is divided by a safety or uncertainty factor of 100 or 1000 in order to calculatethe amount of a chemical, expressed on a body weight basis that can be ingested

daily over a lifetime without causing adverse health effects (Barlow, 2005). For food

chemicals, this is expressed as the ADI or TDI.

The term ADI is generally used for substances intentionally added to food, while TDI is

generally used for substances appearing in food but not intentionally added (Barlow, 2005).

The incorporation of a safety or uncertainty factor gives an additional margin of reassurance

to take account of the possibility that humans may be more sensitive than animals (inter-species variation) and that among humans some may be more sensitive than others (intra-

species variation) (Benford, 2000).

It can be stated that :

or safetyfact

NOAEL

daybodyweight

mgTDI of ADI =

•

With safety factor = 100 or 1000

For chemicals with cumulative properties (e.g. heavy metals) the tolerable weekly intake

(TWI) is calculated (Benford, 2001). The TWI is similar to the TDI, but is calculated on a

weekly base instead of a daily base.

Another measure, useful in risk assessment and management, is the acute reference dose

(RfDacute). This value is estimated to deal with situations where there is high short-term orsingle exposure with the possibility of subsequent adverse effects. The RfDacute is derived




75

from appropriate animal or human data and is generally 2 to 10-fold greater than the

TDI/ADI. In general, it should not be used for substances for which there is no threshold for

the observed toxic effects (Kuiper-Goodman, 2004).

C. Chemicals without a threshold dose

For carcinogenic agents, no threshold can be determined unless an indirect mechanism is

involved (Kuiper-Goodman, 2004). The mathematical analysis of the dose-response data from

an animal bioassay can be used to define the intake necessary to produce a given level of

response, such as 10% cancer incidence. The intakes of different compounds giving the same

level of response reflect the relative potencies of the compounds.

For these products or products where the toxicity is not enough know yet, the ‘threshold of

chemical concern’ is applied. This value can be defined as the maximal exposure where no

adverse effect for human can be expected. This values is based on a database of carcinogenic

products. A possibility, applied by the FDA in USA is that a cancer can be developed when

there is exposure to a carcinogenic product, is estimated to be less than 1/1.000.000 if the

concentration in the diet of that carcinogenic product is smaller than 0,5 ppb.

5.2.1.3. Exposure assessment

In chemical exposure assessment, the level of the chemical hazard is determined and together

with the consumption data, the intake of the chemical is calculated.

The low levels at which chemicals can be present in food and can cause toxicological effects,

have implications for the analytical performance of the analytical methods (O’Brien et al.,

2006). The number of samples below the limit of detection (LOD) and limit of quantification

(LOQ) and how such ‘non-detects’ are treated can have an important influence on the

exposure estimation (Kuiper-Goodman, 2004).

For certain groups of chemical hazards (e.g. additives, pesticide residues) it can be useful to

determine first if it is necessary to perform human exposure studies. In that case a tiered

approach can be used, which is a logical stepwise approach that uses available information to

the optimum extent while reducing unnecessary requirements for human exposure surveys.

The principle of the tiered approach will be explained by the methodology elaborated by the

European Commission to evaluate the dietary intake of food additives (Figure 14) (European

Commission, 2001). The tiered approach is only executed for food additives that are

authorised at a maximum permitted level and for which an ADI is specified. Additives that

are authorised in one or few specific food categories and new additives are excluded from the




76

scope. In Tier 1, the intake is calculated based on theoretical food consumption data and

maximum usage levels for additives. When the ADI is not exceeded in Tier 1, the additive in

question is eliminated from further considerations. Resources can then be focused on the

remaining additives for a more refined intake estimate. In the second and third tiers, the intake

is calculated by combining actual national food consumption data with the maximumpermitted usage levels for the additive (Tier 2) or with the actual usage levels of the additive

(Tier 3). This approach enables authorities to establish priorities for monitoring and to focus

on food additives for which the ADI is probably exceeded regularly (European Commission,

2001).

Figure 14. Dietary intake of food additives




77

In a small number of instances, these epidemiological data permit a dose-response relation to

be developed directly from observations of exposure and health effects in humans. If

epidemiological data are available, extrapolations from the exposures observed in the study to

lower exposures experienced by the general population are often necessary. Suchextrapolations introduce uncertainty into the estimates of risk for the general population.

Uncertainties also arise because the general population includes some people, such as

children, who may be more susceptible than people in the sample from which the

epidemiologic data were developed.

It is not always possible to perform human exposure studies. Therefore, other

techniques need to be applied for the exposure assessment. By the combination of the

consumption data and the data regarding the concentration of the chemical product in

the food product, an estimation can be made of the exposure of the population to thechemical product.

The extrapolation is carried out by fitting a mathematical model to dose-response data that

were collected during animal testing or outbreaks of food borne illnesses. At present, the true

shape of the dose-response curve at doses several orders of magnitude below the observation

range cannot be determined experimentally. However regulatory agencies are often concerned

about much lower risks (1 in 100,000 to 1 in 1,000). This problem is illustrated in Figure 15

for chemical risks e.g. the risk of benzo-pyrene for carcinogenese.

In extrapolating from animals to humans, the doses used in bioassays must be adjusted to

allow for differences in size and metabolic rates. Several methods currently are used for this

adjustment and assume that animal and human risks are equivalent when doses are measured

as milligrams per kilogram per day, as milligrams per square meter of body surface area, as

parts per million in air, diet, or water, or as milligrams per kilogram per lifetime.




78

Figure 15. Result of different extrapolation models for the same experimental datafor the dose-response relation for benzo-pyrene carcinogenese experiment with

animals (mouse)

Quantitative risk assessment (QRA) is characterized by assigning a numerical value to the

risk. This in contrast with qualitative risk analysis, which is typified by risk ranking or

separation into descriptive categories of risk. During QRA a model is used to calculate

(estimate) the risk based on the exposure and the dose-response. Besides the QRA model,

the exposure and the dose-response can also be described by a model. To calculate the

exposure to a microbiological hazard for example, a model can be used that predicts the

growth during storage. Several methods can be used to estimate the risk, namely : (i) point

estimates or deterministic modeling; (ii) simple distributions and (iii) probabilistic analysis.

In a deterministic framework inputs to the exposure and effect prediction models are single

values. In a probabilistic framework, inputs are treated as random variables coming from

probability distributions. The outcome is a risk distribution.

The method chosen will usually depend on a number of factors, including the degree of required accuracy and the availability of data.




79

Deterministic modeling (point estimates) uses a single ‘best guess’ estimate of each variable

within the model to determine the model’s outcome(s). A fixed value for food consumption

(such as the average or maximum consumption) is multiplied by a fixed value for the

concentration of the contaminant in that particular food (often the average level or permittedlevel according to the legislation) to calculate the exposure from one source (food). The

intakes from all sources are then summed to estimate the total exposure.

This method is illustrated with the calculation of the exposure to a contaminant, e.g. the

pesticide atrazine for fishes. The risk is defined by the relation between the exposure and the

adverse health effect. The exposure is defined by the concentration of the pesticide in the

rivers. This concentration will differ between different rivers, between different sampling

times, etc. In the case of a deterministic risk assessment a point estimation is applied for the

concentration of atrazine and mostly this is the average concentration. The same is used of the

adverse health effect. The adverse health effect is expressed as the concentration were no

effect is detected with animals in animal studies. This concentration differs from type of

animal and per individual animal. In the calculation of risk will also here a point estimation be

used, mostly the average.

In probabilistic analysis the variables are described in terms of distributions instead of point

estimates. In this way all possible values for each variable are taken into account and each

possible outcome is weighted by the probability of its occurrence. Therefore, the Monte Carlo

simulation can be applied. One random sample from each input distribution is selected, and

the set of samples is entered into the deterministic model. The model is then solved, as it

would be for any deterministic analysis and the result is stored. This process or iteration is

repeated several times until the specified number of iterations is completed. Instead of

obtaining a discrete number for model outputs (as in a deterministic simulation) a set of

output samples is obtained. This method is described as a first order Monte Carlo simulation

or a one - dimensional Monte Carlo simulation (Figure 16),




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Figure 16 illustration of the 1ste

order Monte Carlo simulation

Within the probalistic risk assessment, the distributions that are used as a model input can be

a distribution function (parametric approach) or the data as such (non-parametric

approach). For the parametric approach the data are fitted to a distribution function, like thenormal distribution, the gamma distribution, the binomial distribution, etc. The distribution

function that gives the best fit is used as a model input. For the non-parametric approach the

original data are used as an input of the model.

The third possibility, ‘simple distributions’ is a term used to describe a method that is

combination of the deterministic and probabilistic approach. It employs a distribution for the

food consumption, but it uses a fixed value for the level of the hazard. The results are more

informative than those of the point estimates, because they take account of the variability that

exists in food consumption patterns. Nonetheless, they usually retain several conservative

assumptions (e.g. all soft drinks that an individual consumes contain a particular sweetener at

the maximum permitted level; 100% of a crop has been treated with a particular pesticide,

etc.) and therefore usually can only be considered to give an upper bound estimate of

exposure. This method is applied when there are not enough values or information of a certain

parameter.

Data

Data

Data

modelll




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Both the deterministic and probabilistic methods have their pro and contras. Deterministic

models or point estimates are commonly used as a first step in exposure assessments

because they are relatively quick, simple and inexpensive to carry out. Inherent in the point

estimates models are the assumptions that all individuals consume the specified food(s) at the

same level, that the hazard (biological, chemical or physical) is always present in the food (s)and that it is always present at an average or high concentration. As a consequence, this

approach does not provide an insight into the range of possible exposures that may occur

within a population or the main factors influencing the results of the assessment. It provides

limited information for risk managers and public. The use of this method also tends to

significantly over- or under-estimate the actual exposure

An important advantage of probabilistic risk assessments (PRA) is that it permits to

consider the whole distribution of exposure, from minimum to maximum, with all modes and

percentiles. In this way more meaningful information is provided to risk managers and public.

A second important advantage is the possibility to carry out a sensitivity analysis. An

important disadvantage of the current PRA procedures is the need for accurate prediction of

the tails in a distribution (e.g. the 5- and 95-percentile). These tails are very important in

performing a PRA because the largest exposure concentrations (e.g. 95-percentile) will have

first effects on the most sensitive population (e.g. 5-percentile). Also the high degree of

complication and time-consumption are a disadvantage.

5.2.1.4. Chemical risk characterization

For chemical hazards, different approaches have been adopted for the risk characterisation of

chemicals with a threshold and without a threshold (Renwick et al., 2003). For chemicals with

a threshold effect, the results of the exposure assessment can be compared to the ADI or TDI,

in order to estimate the risk (Benford, 2001). For chemicals without a threshold, four different

approaches can be used (Barlow et al., 2006):

1. as low as reasonably achievable (ALARA);

2. low-dose extrapolation of data from rodent carcinogenicity bioassays;

3. threshold of toxicological concern (TTC);

4. margin of exposure (MOE).

The ALARA approach says that the intakes should be as low as reasonably achievable

(Barlow et al., 2006). Although the ALARA principle is an easy to understand concept, it

poses some major difficulties for the risk manager as it does not discriminate between very

potent and very weak carcinogens and does not take human exposure into account (O’Brien et

al., 2006). It does not give any estimate of risk and will not give risk managers sufficient

information to assess the degree of urgency and extent of risk reduction measures that may be

required (Barlow et al., 2006).




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An estimation of the risk associated with human exposure to a low dose of a certain

chemical,

can be derived by extrapolation of the animal dose-response data or by the use of the TD50,

T25 or BMDL10 as the point of departure for simple linear extrapolation (O’Brien et al.,2006). Estimation of the possible cancer risk at the levels of human intake is based on

empirical mathematical models that however do not reflect the complexity of the underlying

biology. Using the same dose-response data but different mathematical models, can result in

intakes associated with very low risks (e.g. one in a million), that differ by orders of

magnitude (O’Brien et al., 2006). Moreover, simple linear extrapolation methods probably

greatly overestimate the real risks (Ames & Gold, 1991). Therefore, it is not recommended to

use this approach (O’Brien et al., 2006).

The TTC approach is used for risk assessment of contaminants in food in cases where thebiological data are few but the chemical structure is known and good exposure data are

available (Kroes et al., 2005). The TTC is the daily intake estimated to give a lifetime risk of

less than one in a million. This value is derived from the dose-response data of all structurally

related compounds studied in rodent cancer bioassays (Barlow, 2005). A generic threshold of

0.15 µg/person/day (or 0.0025 µg/kg bw/day) is applied for all structural alerts4, except

genotoxic and high potency carcinogens (aflatoxin-like compounds, N-nitroso-compounds,

azoxy-compounds) (Kroes et al., 2004). It is advised to use this approach when no good

hazard characterisation data are available (Barlow et al., 2006; O’Brien et al., 2006).

A fourth approach is the margin of exposure (MOE): the ratio between a dose leading to

tumors in experimental animals and the human intake. The magnitude of the MOE reflects,

but does not attempt to define the possible magnitude of the risk: the larger the MOE, the

smaller the risk posed by exposure to the compound under consideration. Calculation of the

MOE requires two decisions; defining the point on the dose-response curve and the human

intake (O’Brien et al., 2006). The TD50, T25 or BMD are often taken as comparative

estimates of the potency of genotoxic carcinogens (Sanner et al., 2001). For the human intake,

different values can be used, providing risk managers with different information, for example

the median intake provides a general picture, while the intake by the 90th or 97.5th percentileprovides information about the high consumer (O’Brien et al., 2006). The European Food

Safety Authority (EFSA) Scientific Committee considered that an MOE of 10 000 or more,

based on animal cancer bioassay data, “would be of low concern from a public health point of

view and might reasonably be considered as a low priority for risk management actions”

(EFSA, 2005). The MOE is considered as the preferred approach to characterise risks without

a threshold, because it is based on the available animal dose-response data, without

extrapolation, and on human exposures. The MOE can be used for prioritisation of risk

management actions but it is recognised that the MOE is difficult to interpret in terms of

public health (Barlow et al., 2006).




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5.2.2. Microbial risk assessment in food

5.2.2.1. Hazard identification

The potential pathogenic micro-organisms are discussed with prof Mieke Uyttendaele in part

1.

Typical food related pathogens are Listeria monocytogenes, E. coli O157:H7, Salmonella,

Campylobacter ,….

5.2.2.2. Microbiological hazard characterization

Ingestion of a pathogen does not necessarily mean that a person will become infected, nor that

illness or death will occur. The likelihood that an individual becomes ill from ingesting a

micro-organism is dependent on the complex interaction among the host, the food and the

pathogen. This interaction is commonly known as the ‘infectious disease triangle’ or

‘epidemiologic triad’ (Dennis et al., 2002). The components of this triangle have an influence

on the dose-response relationship and it is therefore necessary to indicate which information

has been used (Forsythe, 2002).

Until relatively recently it has been assumed that there is a threshold level of pathogens that

must be ingested to cause an infection or disease (the minimum infectious dose). However,

this idea has been replaced by the proposal that infection may result from the survival of a

single, viable, infectious pathogenic organism (single-hit concept) (Forsythe, 2002). However,

the probability that a single Listeria monocytogenes cell would cause a food-borne disease is

estimated to be one on 1014 (Benford, 2001).

In this fase, an answer need to be found on questions as: what is the probability that a human

is getting ill from the consumption of 10 cells of Salmonella and what is the adverse effect on

the health of this disease ? Important herewith is the dependency in sensitivity by (1) the own

immuno-resistance by persons, (2) the virulence of the strain of micro-organism in concern,

(3) the type of food product which is related. The virulence is depending on the growth

conditions of the micro-organisms in the food product. The dependence of the strain is

illustrated in figure 17.




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Figure 17 : LD50-values for different strains of L. monocytogenes in normal mice

(USDA, 2001) (LD50 = dose by which 50% of the population died)




85

The dependence of the risk group of a population (= the sensitivity of an individual person) is

illustrated for L. monocytogenes. In this figure 18, the mortality (per portion food product) as

a function of the degree of contamination per portion for different sub populations

Figure 18 : Listeria monocytogenes dose-response with variable strain-virulence for

different subpopulations (A : an intermediate subpopulation, B : new born baby’s, C :

elderly > 60 years)

A

B

C




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De dose-response relation will also be very different for the different types of pathogens (see

figure 19).

bacterie Infection or intoxication MID (intake cells) or MTD

(intake toxin)

Bacillus cereus Infection or intoxication > 106

Campylobacter jejuni infection 500

Clostridium botulinum intoxication LD50 = 0,0005 µg/kg body

weight

Clostridium perfringens Infection and/or intoxication > 106

E. coli infection 105

- 108

E. coli O157:H7 infection 10 – 103

L. monocytogenes infection 10³ - 106

Salmonella infection 10 - 106

Shigella dysenteriae infection 10

Staphylococcus aureus Intoxication 1 – 25 µg (toxine can be

produced from 105

CFU/g)

Vibrio parahaemolyticus infection 105

Yersinia enterocolitica infection 109

Figure 19. The different pathogens and there possibility to be infective.

Besides infection, pathogens can also cause intoxication. Bacterial toxins may be formed in

food and may cause adverse health effect, when the dose is high enough. Risk assessment of

such toxins follows the same protocol as for chemicals with a threshold effect (Benford,

2001).

5.2.2.3. Microbiological exposure assessment

In microbiological exposure assessment the hazard is alive, which reorients the focus of the

exposure assessment significantly. The level of the pathogen in a food can change over time

due to growth and inactivation (FAO/WHO, 2005). Also cross and post contamination will

have an influence on the level and the prevalence of the pathogen. Moreover, a pathogen is

able to enter the food chain at many points. Therefore, it is necessary to include the complete

chain in the exposure assessment through a farm to fork approach (Figure 20) (Forsythe,

2002).

A large number of factors have an influence on the microbial population. These factors

include (modified from Forsythe, 2002):




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• the microbial ecology of the food;

• the growth requirements (intrinsic and extrinsic parameters) and their influence on the

growth/inactivation;

• the initial contamination of the raw materials;

• prevalence of infection in food animals;

• the effect of the production, processing, cooking, handling, sorting, distribution steps

and preparation by the final consumer on the microbial agent (i.e. the impact of each

step on the level of the pathogenic agent of concern, including the risk for cross or

post contamination);

• the variability in processes involved and the level of process control;

• the level of sanitation, slaughter practices, rates of animal-animal transmission;

• the methods or conditions of packaging, distribution and storage of the food (e.g.

temperature of storage, relative humidity of the environment, gaseous composition of

the atmosphere) and the characteristics of the food that may influence the potential for

growth of the pathogen (and/or toxin production) in the food (e.g. pH, water activity,

nutrient content, presence of antimicrobial substances) under various conditions,

including abuse.

Figure 20 : Framework of “farm to fork” modules for microbiological exposureassessment




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5.2.2.4. Risk characterization

In the microbiological risk characterisation, the output of the exposure assessment is used as

an input for the dose-response relationship and the result is the risk estimate, namely the

probability of an adverse effect (Forsythe, 2002).

It must be noted that the probability that a certain hazard is occurring never can be reduced to

zero. This has the consequence that there will be always a certain level of risk which need to

be accepted. This acceptation will depend on the resulting effect on the public health and the

considered economical problems and the legislation of concern.

5.2.2.5. Risk assessment of Salmonella enteritidis in eggs and egg products in

USA (http://www.fsis.usda.gov/OPHS/risk/index.htm#team)

The 'Food Safety and Inspection Service' started in December 1996 a very big risk assessment

of Salmonella enteritidis as an answer on the increase in illnesses duet o the consumption of

eggs.

In this quantitative risk assessment the whole agro food chain was included: from chicken to

the consumption of eggs or egg products. The objective was to develop a model of Salmonella

enteritidis, starting from the internal contaminated eggs until the consumption and the

infection disease.

Following results are obtained;

a) in total there are 65 billion eggs who are yearly produced, of which 47 billion are sold as

fresh eggs and are consumed and 18 billion eggs are on an industrial scale transformed to

egg products in the food industry.

b) The model estimates that of the 47 billion eggs who are consumed without an industrial

process, in average 2,3 million (0,05%) already internal are contaminated with S.

enteritidis.

c) Via dose-response curves it is estimated that out of the 2,3 million eggs which are

internal contaminated will result in average in 661.663 infections a year.

d) This means that 661.663 S. enteritidis infections a year on 207 billion individual prepared

meals (47 billion eggs who are consumed x 4,4 meals/egg). The predicted average risk is

3,1 S. enteritidis infections a year on 1 million mean containing eggs.




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e) The sensitive sub populations (YOPI’s; young, old, pregnant, immuno-deficient) are 20%

of the total population in USA. The model predict that 68% of the infections will occur

with the normal healthy group of the population and 32% in the YOPI group.

5.3. Risk management and communication

Risk management is the process, distinct from risk assessment, of weighing policy

alternatives, in consultation with all interested parties, considering risk assessment and other

factors relevant for the health protection of environmental protection and if needed selecting

appropriate prevention and control options. During risk management the results of the

conducted risk assessments are evaluated in order to select policy decisions. In principle, the

executers of the risk assessment are not consulted during the risk management in order towork objectively.

Risk communication is an interactive exchange of information and opinions throughout the

risk analysis process concerning risk, risk related factors and risk perceptions among risk

assessors, risk managers, consumers, industry, the academic community and other interested

parties, including the explanation of risk assessment findings and the basis of risk

management decisions.

Risk communication is set up because there is in the total process of risk analysis a clear

necessity to inform interested groups and to communicate the assembled information between

the risk assessment and the risk management. Risk communication recognizes the importance

of behaviour and sensitivity for risks and their perception. It is a very usefull instrument to let

understand the risks and their uncertainties but also to inform the risk manager regarding the

perception of the risks by the population.

5.3.1. The use of risk assessment outputs in risk management : Chemicalrisks

When the risk assessment indicates that the proportion of consumers with the potential to

exceed the TDI/ADI is zero, there is no need to take action in order to control the risk.

However, even in these circumstances other activities, such as risk communication, might be

appropriate (Tennant, 2001).

If during the risk characterisation, it is observed that the exposure poses a possible health risk,

recommendations for risk reduction need to be formulated. Priorities for risk reduction

depend on the extent and frequency that the TDI/ADI is exceeded, or on the size of the MOE




90

(Kuiper-Goodman, 2004).

When it concerns a chemical for which a threshold dose can be

defined, the simplest approach is to identify the level of contamination that would cause a

high-level consumer to exceed the TDI/ADI and to use this value as maximum level inlegislation (Tennant, 2001). The maximum level is also called MRL (maximum residue

level), typically used for phytosanitary products and residues of medicines for veterinary use

(Benford, 2001; CAC, 2003b)

For non-threshold carcinogens, some jurisdictions prefer to use an approach that keeps

residue levels ‘as low as reasonably achievable’ (ALARA), but it is then difficult to derive an

appropriate maximum permitted concentration (Kuiper-Goodman, 2004). Other jurisdictions

try to ensure that maximum levels for unavoidable non-threshold carcinogens pose a

‘negligible risk’, which corresponds to a MOE of 10 000 (EFSA, 2005).

5.3.2. The use of risk assessment outputs in risk management :Microbiological risks

5.3.2.1. Appropriate level of protection

The aim of a risk assessment is to provide risk managers with answers to one or more

questions that may enable them to make better informed decisions (Van Schothorst, 2002).

Government risk managers need to decide what in the WTO-SPS agreement (WTO, 1995) is

called an appropriate level of protection (ALOP).

ALOP is defined as the level of protection deemed appropriate by the member (state)

establishing a sanitary or phytosanitary measure to protect human, animal or plant life or

health within its territory (WTO, 1995).

ALOP is a way to express, on a population level, what level of risk a society is prepared to

tolerate or is considering to be achievable (Gorris, 2005). ALOP is also called the ‘acceptable

level of risk’(ALR) or ‘tolerable level of risk’ (TLR). The latter expression is preferred

because consumers may tolerate food safety risks but they are reluctant to accept them (VanSchothorst, 2002). Discussion is actively ongoing whether in addition to scientific insights,

other factors can be considered in the decision of an ALOP. Such factors could be for instance

technological and economical (e.g. the potential damage in terms of loss of production, the

cost of control) (de Swarte & Donker, 2005).

In comparison to microbial hazards, it is more difficult to set a meaningful ALOP for

chemical hazards. With chemical hazards, often there is no proof of causality between a

chemical hazard and an individual case of food-borne disease because impacts of chemical

hazards may be more chronic in nature. A second complication regarding ALOPs forchemicals is that most chemical hazards can be found in a variety of products, both food and




91

non-food, and in our direct living environment (de Swarte & Donker, 2005).

5.3.2.2. Food safety objective

An ALOP, expressed for instance as a number of illnesses in a population per annum, is not a

measure that is meaningful for food safety management in practice. The food safety

professionals responsible for controlling the specific hazards need more specific guidance. To

that end, and within the current risk analysis framework, competent authorities can formulate

a so-called food safety objective (FSO) (Gorris, 2005). FSO is defined by the Codex

Alimentarius Commission (CAC) as the maximum frequency and/or concentration of a

hazard in a food at the time of consumption that provides or contributes to the appropriate

level of protection (CAC, 2004). Some hypothetical examples of FSO values are given in

Table 5.1. Although the CAC considers FSOs only for microbial hazards, the concept could

also be applied to other types of hazards as well (de Swarte & Donker, 2005).

Table 5.1: Hypothetical examples of concepts used in food safety control (Gorris, 2005;

Stringer, 2005)




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Food safety on an operational level is primarily the responsibility of the food industry. The

national authorities however, are responsible for controlling the process of setting, achieving

and evaluating the level of a hazard that can be tolerated (de Swarte & Donker, 2005). Within

this framework, the FSO value is an important communication tool for the overall

management of the chain as it gives the expected level of control in the food chains in order tomake a product that can be considered as safe. It is a concept that bridges from a population’s

generic requirements for safe food to specific operational measures (Figure 21) (Gorris,

2005). The implementation of an FSO as a target at the end of the food chain, leaves the food

industry more freedom and flexibility to organize their quality management tools (e.g. hazard

analysis critical control points (HACCP), Prerequisite programs (PRP)) on the condition that

this target is achieved (de Swarte & Donker, 2005; Gorris, 2005).

Figure 21: Illustration of how food safety control at a country level can link into food

safety management at the operational level through a food safety objective set by a

governmental competent authority on the basis of a public health goal (ALOP)

established following the risk analysis framework (modified from Gorris, 2005)




93

Achieving the given FSO depends to a large extent on the efficiency of the control measures

along the food chain. It is necessary to establish whether PRP and HACCP systems can

provide the level of technical control needed to achieve the FSO. If not, the procedures should

be re-evaluated and adapted until the FSO is achieved (Stringer, 2005).

5.3.2.3. Other food safety management targets

In order to assure that an FSO is met at consumption, it can be relevant to specify one or more

targets earlier in the food chain. These targets are called performance objectives (PO) and are

defined as the maximum frequency and/or concentration of a hazard in a food at a specified

step in the food chain before the time of consumption that provides or contributes to an FSO

or ALOP, as applicable (CAC, 2004). POs are linked to the FSO and, when proposed by

governments, can be viewed as a kind of milestones that governments provide as guidance in

order to help to meet the FSO (Gorris, 2005). However, POs can also be established by

operational food safety managers as an integral part of the design of a food safety

management system.

To comply with a PO or an FSO, at the operational level, control measures (CM) need to be

established. A control measure is any action and activity that can be used to prevent or

eliminate a food safety hazard or to reduce it to an acceptable level (it can be microbiological

specifications, guidelines on pathogen control, hygiene codes, microbiological criteria,

specific information (e.g. labelling), training, education, and others) (ICMSF, 2002).

Examples of control measures are given in Table 1. At a particular step in the chain, one or

more control measures can be implemented as part of the product and process design to

control a hazard.

The overall effect of control measures on the hazard level at a particular step, is called

performance criterion (PC). The PC is defined as the effect in frequency and/or concentration

of a hazard in a food that must be achieved by the application of one or more control

measures to provide or contribute to a PO or an FSO (CAC, 2004). PCs are the specific

operational, supply chain measures at (a) specific step(s) that result in meeting the objective

for that step, the PO or FSO. The control parameters (e.g. time, temperature, flow rate) at a

step or a combination of steps that are applied to achieve a PC are called the process criteria

(Van Schothorst, 2002). Product criteria on the other hand are the parameters of the food that

are used to prevent unacceptable growth of micro-organisms (e.g. pH, aw) (Van Schothorst,

2002). PCs in general will be decided on by food safety managers as key points in the design

of a production flow that allows the production of safe foods (Gorris, 2005). Some

hypothetical examples of PC values are given in Table 1.

Although PO and PC like the FSO are not intended to be enforced, these concepts on occasion

could lend themselves to be verified by specific testing or could be linked to specific

microbiological criteria. Figure 22 gives an overview of how various guidance milestones

and control measures relate to each other in an imaginary food supply chain (Gorris, 2005).




94

Figure 22 : Schematic representation of how governmental or country guidance along an

imaginary food chain links in with operational level measures at relevant points. The

guidance is given in the form of FSO or PO values stipulated by the appropriate food

control function. The operational level measures are embedded in the food safety

management systems operated in the chain, such as PRP and HACCP (Gorris, 2005)

5.3.2.4. Microbiological criteria

Establishing microbiological criteria is another risk management option to guarantee food

safety. A microbiological criteria (MC) is defined as the acceptability of a product or a food

lot, based on the absence or presence, or number of micro-organisms including parasites,

and/or quantity of their toxins/metabolites, per unit(s) of mass, volume, area or lot (CAC,

1997).

In the establishment of MC’s, FSOs or PSs can be useful and an MC for a food should berelated to its FSO. An MC that is excessively stringent relative to an FSO may result in

rejection of food even though it has been produced under conditions that provide an

appropriate level of protection (Van Schothorst, 2002). However, microbiological criteria

differ in function and content from FSOs. An FSO will normally not prescribe a

sampling plan, while for MCs it is essential that such a plan is developed, because it will

assist in achieving transparency and equivalence as mentioned in the WTO/SPS agreement

(Van Schothorst, 2002).

A two-class attribute sampling plan is used, which is characterized bythe number of samples to be tested (n), the number of samples (c) that exceed the test criteria




(in microbial testing associated with pathogenic micro-organisms, c is usually zero), the lower

limit of detection for the test (m), the upper limit of detection for the test (M) and a

confidence level (e.g., 95%) that the test will identify an unacceptable lot (Whiting et al.,

2006). The European Commission has published in 2005 a new regulation concerning

microbiological criteria (European Commission, 2005).

Table 5.2: Characteristics of FSOs and microbiological criteria (Van Schothorst, 2002)

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Text Food Safety Feb 2011