Text Food Safety Feb 2011

Department of Food Safety and Food Quality Ghent University - Food Safety
Department of Food Safety and Food Quality Faculty of Bio Science Engineering Ghent University
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 Uyttendaele Prof. Dr. IR. Bruno De Meulenaer Dr. Ir. Liesbeth Jacxsens
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 safety 3.1 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 approach 4.4 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
0. Introduction
0.1. Definition of food safety
Food safety became last decades very important for both governments, producers of food products 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 for a 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 plant fats 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 GGOs in foodstuffs is possible). 2) sensorial quality aspects e.g. taste, odour, visual quality, texture, : are important because food 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.
Commercial quality
Sensorial quality
Legal quality
Food safey
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, .
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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 for the 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 Prepackaged Foods; Methods of analysis and sampling. Alimentarius can be found on the website
The structure of the Codex www.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)
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. This approach 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 is defined 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/
1. Microbiological and hygienic aspects of food safety (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 catalase positive 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 aw pH t O2
(1) Aerobic (anaerobic aw 0.92 - 0.99)
Optimum 0,98 7-8 40-45 aerobic
Limits 0,87-0,99(1) 4,5-9,6(2) 10-45 aerobic-anaerobic
(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 100C and 20 min at 121C. 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 strains causing food intoxications (table 1.2). TABLE 1.2. Difference between Clostridium perfringens type A causing "gas gangrene" and that causing food intoxiation "Gas-gangrene" High alpha-toxin production (a) Always epsilon-toxin production (b) Always iota-toxin production (c) Heat-sensitive spores 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 in the 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 Food intoxication Low alpha-toxin production Seldom epsilon-toxin production Variable iota-toxin production Thermoresistant spores (5h/100C)
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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 nonproteolytic, 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 g 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 80C (during 10 minutes is sufficient to inactivate the botulinal toxins present in food products. A similar effect is obtained by treating at 86C (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 the enormous 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 m. The other largecelled 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 cyclic comprimising 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 most sensitive 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 (102-104 cfu/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 105-106/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. Classification Campylobacter 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 42C) 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 Gramnegative, oxidase-negative, motile (peritrichous) or sometimes nonmotile, non-spore-forming rod. 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 44C. 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 VT17
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 often studied 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 25C showing a characteristic 'tumbling' motility, but non-motile at 35C. 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 most frequently 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 highly heterogenous 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.
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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 between serotype 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.
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TABLE A Characteristics of toxins produced by Staphylococcus aureus, Bacillus cereus, Clostridium perfringens and Cl. botulinum Staphylococcus aureus Bacillus cereus Bacillus cereus Clostridium perfringens emetic toxin emetic toxin diarrhea toxin diarrhea toxin Toxin type Enterotoxin Enterotoxin Enterotoxin Enterotoxin (single chain polypeptide, Cereulide (cyclic a) Haemolysin BL: tripartite Single chain protein with MW with cystine-lus) dodecapsipeptide) protein complex B, L1, L2 36 kDa MW 26-34 kDa b) Non-haemolytic tripartite protein complex Formation of toxin In the food, during In the food during the late During vegetative growth in the food In the intestines after ingestion vegetative growth exponential or stationary or in the intestines after ingestion of of high number of cells Toxin phase high numbers of cells formed during sporulation Effect of proteolysis Resistent Resistent Activity loss Increased activity after treatment with trypsin Heat stability Resistent to 100-120C Resistent to 90 min at Inactivation by 5 min at 56C Inactivation by 15 min at 60C 121C Symptoms Nausea, vomiting Nausea, vomiting Cramps, diarrhea Cramps, diarrhea e (sometimes diarrhea) Incubation period 1-5h 1-5h 8-16 h 8-24 h (recovery after 24-48h) (recovery after 6-24h) (recovery after 12-24h) (recovery after 24-48h) Toxicity (LD50) LD50 (monkeys): 25 g/kg unknown 100 x more toxic than Cl.perfr. 1.5 g for a 20 g mouse dose causing symptoms in humans: 100-200 ng Detection methods - immunological detection - no immunological - Oxod BCET RPLA ( L2 component RPLA en ELISA (Oxod BCET RPLA, Vidas detection method Haemolysin BL) (Biomrieux), Tecria - cytotoxicity - Tecra immunoassay (Nonimmunoassay,..) - animal feed trials haemolytic protein complex) - cytotoxicity
Clostridium botulinum neurotoxin Neurotoxin Protein with MW 150-170 kDa in a complex with nontoxic proteins In the food during vegetative growth Activation Inactivation by a few minutes at 75-80C Gastro-enteritis, trouble vision and finally paralysis 12-36h (decease after 3-6 days) 25 pg for a 20 g mouse
- Mouse bio-assay - ELISA
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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 G+, motile rod G+, nonmotile rod non sporeforming sporeforming sporeforming toxin-producing types Type A, B, C1, C2, C3, D, E Type A, B, C, D, E Type A en D cause food Type A responsible for food intoxication intoxication temperatuur 10-45C 10-50C 15-55C optimum: 37-45C optimum 35-37C optimum 28-35C rem: psychrotrophic strains, growth at 4-10C 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 D100= 2-8 min variable by pasteurisation heat resistant (5h-100C) linked to intoxication conditions for toxin production min. Aw = 0.87 optimum temp. 25-30C during sporulation in the pH 5.1-9.0 intestines
Clostridium botulinum G+, motile rod sporeforming Type A, B, C, D, E, F, G Type A, B, E and to a lesser extent Type F responsible for food intoxication Groep I (A, B, F) Groep II (B, E, F) 10-50C 3.3-45C optimum: 35-40C optimum: 18-25C proteolytic non-proteolytic min. pH = 4.6 min. pH = 5.0 0.94 (10% NaCl) 0.97 (5% NaCl) strictly anaerobic D80 = 0.6-1.25 min D100 = 30 min D121 = 0.03-0.3 min min pH = 5.2
TABLE C. Mycotoxin producing molds in foods Mycotoxin Mold Aflatoxin B1 en B2 Aspergillus flavus Aflatoxin B1, B2, G1 Aspergillus parasiticus and G2
Clinical aspects - acute toxicity - liver cancer
Ochratoxin A
Aspergillus ochraceus Penicillium verrucosum
- kidney disease 'Balkan endemic nephropathy'
Zearalenone
Fusarium graminearum F. culmorum, F. crookwellense Fusarium graminearum F. culmorum, F. crookwellense Fusarium spp. Fusarium moniliforme F. proliferatum, F. subglutinans Penicillium expansum, other Penicillium sp., some Aspergillus sp Aspergillus flavus and other species Penicillium sp. e.g. P. camemberti Fusarium proliferatum, F. subglutinans
Deoxynivalenol (= DON, vomitoxin) (trichoticeen) T-2 toxin (trichoticeen) Fumonisins
-reproduction system of pigs - breast cancer? - gastro-intestinal - immune-system domestic animals - alimentary toxic aleukia (Russia WWII) - oesophageal cancer
Toxicity - Carcinogenic - Mutagenic - Terratogenic - Toxic (Aflatoxine B1 LD50 7.2 mg/kg) - Nephrotoxic - Carcinogenic for animals (possibly for humans) - LD50 22 mg/kg) Oestrogenic activity
Foods implicated nuts, grains, figs cotton seed, maize milk and cheese
grains, nuts, figs, beans, coffee, cheese porc meat and poultry
maize, grains, feeds, hay
Not carcinogenic for humans Not carcinogenic for humans Carcinogenic for animals (possibly for humans) no toxicity, spoilage
grains, feeds
grains, feeds grains, maize, rice, peulvruchten - fruits (apples, grapes, strawberries) and juices
Patulin Cyclopiazonic acid Moniliformin
- anorexia, diarrhea - muscural breakdown - heart diseases
grains
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TABLE D : GROWTH CONDITIONS AND HEAT RESISTANCE OF THE MOST IMPORTANT FOODBORNE BACTERIAL INFECTIOUS AGENTS minimum atmosphere Heat-resistance temp. pH aw Salmonella sp. 7C 4.0 0.94 Fac. anaerobe D58 0.63 min Campylobacter jejuni 32C 4.9 0.99 Microaerophilel D55 0.6-2.3min Escherichia coli 7-8C 4.4 0.95 Fac. anaerobe D60 0.75min Yersinia -1.3C 4.2 0.96 Fac. anaerobe D60 0.4-05 min enterocolitica 5% NaCl Listeria 0C 4.4 0.92 Fac.anaerobec D60 2.54min monocytogenes D65 0.75min Vibrio cholerae 10C 5.0 0.97 Fac. anaerobe D49 8.15 min 4% NaCl D60 2.65 min Vibrio 5C 4.8 0.94 Fac. anaerobe D49 0.35-0.72 min parahaemolyticus 8-10 %NaCl D55 0.02-0.29 min Shigella sp. 6-8C 4.8-5.0 3.8-5.2% NaCl Fac. anaerobe Rapid inactivation (2-5min) at 60C Aeromonas sp. 0-4C 4.5 6% NaCl Fac. anaerobe D45 29.5 min D51 2.3 min
2.
Chemical
aspects
of
food
safety
See lectures by prof dr ir Bruno De Meulenaer
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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 FDAs 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).
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 during the 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. packaging instructions 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 very sophisticated electronic technology. However, all rely on some physical difference
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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 approaches the 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.
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 are relatively 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.
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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 packaging materials 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
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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 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. 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 in the company (see part 0.3 legislation). The most important GMPs 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;
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 PRPs 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-docheck-act circle or Deming circle should be present. The PRPs 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.
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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 HACCPprinciples 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 is endangered. 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.
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 FLAIRdocument (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 measures Step 8 Identify the CCP's
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Step 9 Step 10 Step 11 Step 12 Step 13 Step 14
Establish critical limits for the CCP's Establish a monitoring system for the CCP's Establish a corrective action plan Establish a documentation system Verify the HACCP plan Review the HACCP plan
4.1.4. Relation GMP, PRP and HACCP GMP, PRP and HACCP are different systems but are closely related. GMPs are general hygiene measures, not specific for a sector or a type of production process (e.g. meat vegetable - type of industry). While the PRPs 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 CCPs. 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.
4.2. The key elements of quality

4.2.1 Definitions Quality Quality 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 organisations management approach centred on quality, based on the participation of all the members and aimed at long-term success through customer satisfaction and benefits to the members of the organisation and the society.
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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 and implemented 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 the process with a cycle underscores its continuing nature. The use of the PDCA cycle is to coordinate 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:
PLAN
DO
ACT
CHECK
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.
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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).
Food Safety Management System
Quality Management System e.g. BRC, ISO 9001
Long-term manageral strategy e.g. TQM, ISO 9004
General requirements
Legal requirements related All quality aspects + to quality and product quality, environment, safety and all quality aspects and all Specific requirements well-being of the personnel customer expectations
GMP/GHP = basic requirement
Food Safety Assurance plan (product/processpecific) = HACCP-plan
Quality Management System
Figure 5: Integrated approach of several quality systems
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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 followed by 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
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:
Customer
Management responsibility
Customer
Resource management
Measurement, analysis, improvement
Satisfaction
Require -ments
Product realisation
Product
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Value adding activities Information flux
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.;
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 five subtopics. 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 organizations 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 to both the companys management and personnel and the companys 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 win business away from established competitors. In addition, ISO 9000 is costly to obtain and
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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 9000 ISO 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 primary production

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
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 development of 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 is food 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
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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 from plant and livestock production to plant propagation materials and compound feed manufacturing. Crops base Fruit & vegetables Flowers & ornamentals Combinable crops Green coffee Tea Cotton Others Cattle & sheep Dairy Pigs Poultry Others Salmon & trout Pangasius Shrimp Tilapia Others
Integrated farm assurance standard
Livestock base
Aquaculture base
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.
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
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AF
FV Fruit & vegetables FO Flowers & ornamentals CC Combinable crops Crops base CO Green coffee TE Tea Cotton Others All farms base LB CS Cattle & sheep DY Dairy Livestock base PG Pigs PY Poultry Others AB SN Salmon & trout Pangasius Aquaculture base Shrimp Tilapia Others Figure 8: structure of the documentation and requirements of Global Gap More information : www.globalgap.org
CB
4.5.2. Qualitt und Sicherheid fr 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:
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 combined audit can take place.
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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. The conforming 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.
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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 19901995 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 BRCtechnical 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
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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.
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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 Handelsverbnde (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.
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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/
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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 this standard 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.
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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 PRPs 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.
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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 N7, 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 technomanagerial approach, Wageningen Pers, Wageningen, 323 p. Mortimore S. & Wallace C. 1994. HACCP a practical approach, Chapman & Hall, London, 296 p.
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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.
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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
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Appendix B The 12 stages of the Codex Alimentarius
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Appendix C An overview of the different standards in food industry

Features Codex principles PRP Focus Food safety HACCP Food safety ISO 9001:2008 ISO 15161:2001 ISO 22000:2005 + PAS 220 BRC GLOBAL GAP IFS SQF
Product or Food safety Food safety service quality & organisational quality & organisational quality
Food safety, Food safety food quality & food & organisat- quality ional quality
Food safety, food quality & organisational quality
Food safety, food quality & organisational quality
Scope
Whole agri- Processing & Whole chain Processing & Whole agri- Processing food chain distribution (i.e. food and distribution food chain stages stages non-food stages products)
Agri-cultural Processing Agricultural level (crops, stages (SQF 1000) animal & & Processing aquaculture) (SQF 2000)
Legislative Status
Compulsory
Compulsory
Voluntary
Voluntary
Voluntary
Voluntary (retailers demand)
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Features
Codex principles PRP HACCP II (HACCP)
ISO 9001:2008 ISO 15161:2001 III (Management system) I, II, & III
ISO 22000:2005 + PAS 220 I, II, & III
BRC
GLOBAL GAP
IFS
SQF
Combined HACCP system GFSI status ,
key I (PRP) III
I, II, & III
I, II, & III
I, II, & III
I, II, & III
elements I GMP, II management Not Not
Not benchmarked its are its but used in GFSI
Not benchmarked
Not (yet?)
Yes
Not (yet?)
Yes
Yes
benchmarked benchmarked but PRPs are but
used in GFSI principles are principles used in GFSI
Acknowledgement Worldwide
Worldwide
Worldwide
Worldwide
Worldwide
Europe
Worldwide
Europe
Australia, Asia-Pacific, North South America &
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Features
Codex principles ISO PRP HACCP 9001:2000 No NA Yes ISO/IEC 17021:2006 (companys certification) NA
ISO
ISO + PAS 220
BRC
Global GAP
IFS
SQF
15161:2001 22000:2005 No NA Yes ISO/IEC Yes
Certification? No Scope certification of Not applicable (NA) Gradation in NA certification
Yes
Yes EN 45011
Yes ISO/IEC 65:1996 (food and nonfood or service certification)
EN 45011 (food and EN certification)
17021:2006 non-food or service 45011
No gradation NA
No gradation
Three gradations: A B C
No gradation
Two gradations: Foundation level Higher level
Three gradations: Level 1 Level 2 Level 3
Frequency of NA audit
NA
Annual
NA
Every years
Annually for Annual grade A & B certificates
Annual
Annual
6 months for grade certificate C
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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 main attention 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.
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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 nature of the adverse health effects or negative effects on the environment associated with the hazard is evaluated in a qualitative and/or quantitative way (doseresponse 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
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Risk analysis is containing three essential parts : the risk assessment, the risk management and the risk communication.
Risk Assessment: -Hazard Identification; -Hazard Characterization; -Exposure Assessment; -Risk Characterization.
Risk Management: - Evaluation of the different policy scenarios - selection and implementation of the most suited policy measures.
Risk Communication: Interactive exchange of information and opinions.
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.
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Figure 10 : Elements of risk assessment and risk management
During the hazard identification, biological, chemical, and physical agents that are capable 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 hazard identification aims to identify the likelihood of the presence of known pathogenic microorganisms 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).
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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 agents 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 doseresponse 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
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[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 application of 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 is much greater than anticipated from carcinogenicity data on each substance individually.
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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 the preceding 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 separation into 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
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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. But we 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.
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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).
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Figure 13. Graphic presentation of NOAEL value The NOAEL is divided by a safety or uncertainty factor of 100 or 1000 in order to calculate the 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 (interspecies variation) and that among humans some may be more sensitive than others (intraspecies variation) (Benford, 2000). It can be stated that :
mg NOAEL ADI of TDI = safetyfactor bodyweight day

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 or single exposure with the possibility of subsequent adverse effects. The RfDacute is derived
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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 (OBrien 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
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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 maximum permitted 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
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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. Such extrapolations 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 the chemical 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.
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Figure 15. Result of different extrapolation models for the same experimental data for 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.
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Deterministic modeling (point estimates) uses a single best guess estimate of each variable within the model to determine the models 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 permitted level 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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Data
Data
modelll
Data
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 the normal 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.
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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 (OBrien 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 (OBrien 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 (OBrien 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 (OBrien et al., 2006). The TTC approach is used for risk assessment of contaminants in food in cases where the biological 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 g/person/day (or 0.0025 g/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; OBrien 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 (OBrien 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 percentile provides information about the high consumer (OBrien 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)
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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 babys, C : elderly > 60 years)
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De dose-response relation will also be very different for the different types of pathogens (see figure 19). bacterie MID (intake cells) or MTD (intake toxin) Bacillus cereus Infection or intoxication > 106 Campylobacter jejuni infection 500 Clostridium botulinum intoxication LD50 = 0,0005 g/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 10 - 106 Salmonella infection 10 - 106 Shigella dysenteriae infection 10 Staphylococcus aureus Intoxication 1 25 g (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. Infection or intoxication
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 exposure assessment

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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 (YOPIs; 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 to work 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 : Chemical

risks 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
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(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 in legislation (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 (Van Schothorst, 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 for chemicals is that most chemical hazards can be found in a variety of products, both food and
90
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 to make a product that can be considered as safe. It is a concept that bridges from a populations 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)
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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).
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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 MCs, FSOs or PSs can be useful and an MC for a food should be related 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 by the number of samples to be tested (n), the number of samples (c) that exceed the test criteria
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(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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Department of Food Safety and Food Quality Ghent University - Food Safety

Overview of Food Safety :

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

The structure of the Codex www.codexalimentarius.net.

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

1.1. FOOD INTOXICATIONS

Optimum 0,98 7-8 40-45 aerobic

Limits 0,87-0,99(1) 4,5-9,6(2) 10-45 aerobic-anaerobic

1.1.4. BACILLUS CEREUS

1.2. FOOD INFECTIONS

- Mouse bio-assay - ELISA

Clinical aspects - acute toxicity - liver cancer

Aspergillus ochraceus Penicillium verrucosum

- kidney disease 'Balkan endemic nephropathy'

Deoxynivalenol (= DON, vomitoxin) (trichoticeen) T-2 toxin (trichoticeen) Fumonisins

maize, grains, feeds, hay

Patulin Cyclopiazonic acid Moniliformin

- anorexia, diarrhea - muscural breakdown - heart diseases

See lectures by prof dr ir Bruno De Meulenaer

3.2 Preventive measures and detection of foreign objects

3.3. References for part 3

4. Quality assurance systems assuring food safety

Step 9 Step 10 Step 11 Step 12 Step 13 Step 14

4.2. The key elements of quality

4.3. Integrated approach

Food Safety Management System

Quality Management System e.g. BRC, ISO 9001

Long-term manageral strategy e.g. TQM, ISO 9004

GMP/GHP = basic requirement

Food Safety Assurance plan (product/processpecific) = HACCP-plan

Quality Management System

Figure 5: Integrated approach of several quality systems

4.4 ISO 9000:2008

Measurement, analysis, improvement

Value adding activities Information flux

4.5. Overview of different quality assurance standards in primary production

Integrated farm assurance standard

4.7. References for part 4

Appendix A Structure of the Codex Alimentarius

Appendix B The 12 stages of the Codex Alimentarius

Appendix C An overview of the different standards in food industry

Food safety, food quality & organisational quality

Food safety, food quality & organisational quality

Voluntary (retailers demand)

Voluntary (retailers demand)

Voluntary (retailers demand)

Voluntary (retailers demand)

Codex principles PRP HACCP II (HACCP)

ISO 22000:2005 + PAS 220 I, II, & III

Combined HACCP system GFSI status ,

key I (PRP) III

I, II, & III

I, II, & III

I, II, & III

I, II, & III

elements I GMP, II management Not Not

Not benchmarked its are its but used in GFSI

benchmarked benchmarked but PRPs are but

used in GFSI principles are principles used in GFSI

Australia, Asia-Pacific, North South America &

ISO + PAS 220

15161:2001 22000:2005 No NA Yes ISO/IEC Yes

Certification? No Scope certification of Not applicable (NA) Gradation in NA certification