Innovation, food safety and regulation.

by Desmarchelier, Patricia M.^Szabo, Elizabeth A.

Innovation: Management, Policy, & Practice • July, 2008 •

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ABSTRACT

The food chain from producer, processor, retailer and consumer is highly interconnected and dynamic. In the midst of this environment, cooperative linkages between government, industry and the consumer are critical to ensure the delivery of safe, healthy and nutritious food. Robust safety assessment of products is a proven system that helps keep our foods safe and enhances international trade. While advances in science and technology offer food production many potential benefits, developments must be guided by appropriate safety assessments and regulation (as appropriate) if risks are to be minimised and technologies developed in a socially acceptable way.

Keywords: food safety, innovation, regulation

INTRODUCTION

Participants along the food chain continuum, whether primary producers, manufacturers, retailers or caterers, are continually challenged to remain competitive either in the global and/or their local marketplace(s). Innovation is considered a key element to success in this endeavour through the development of new products, processes, services and markets.

The food industry has a long history of innovation that often is linked with or a consequence of the prevailing social and economic trends of the day. For example, in western countries since the Second World War there have been some significant changes in the foods we eat and the way food is delivered (See http://www.eatwell.gov.uk/ healthydiet/seasonsandcelebrations/howweusedtoeat/ 21stfood/ for a summary of food history in the United Kingdom). This is a result of the dynamic interactions between changes in society such as food availability, demographics, economy, migration and travel, work and leisure patterns, married together with the food and related industries making the most of innovation opportunities to meet societies evolving needs and desires. This is achieved by applying developments in disciplines such as medical science, food science and technology, various disciplines of engineering, information technology and transportation.

Post World War II, consumers in western countries emerged from years where the food supply consisted mainly of rationed staple foods that were locally produced and available seasonally. Until all households had refrigerators for food storage, food was procured daily. Since then, the availability and variety of food in the marketplace has changed with increased family income, acquisition of facilities for chilled and frozen food storage, the emergence of the self-service supermarket and super store retailers with multi-level car-parks, globalisation of the supply chain, and now internet shopping. Underpinning these changes are innovations that provide product diversity and differentiation and those that enhance food stability and extend shelf life, provide new packaging shapes and functions, and more sophisticated refrigeration engineering.

Changes in the traditional family structure, a baby boom, greater liberty for women and economic demands during this time have contributed to increasing single person households; both parents or house partners spending most of the day away from their residence at work and travelling to and from work. This has resulted in a need for easier to prepare and convenient so-called ready-to-cook or ready-to-eat and eat-on-the-go meals and snacks. The innovations that have been applied in response to this are endless. These includes developments in technologies for rapid cooking (microwave), food formulation, food preservation and packaging, and the introduction of systematic food safety management systems to name a few.

Consumers at the same time have become more diverse in their tastes, more conscious of the health implications of food consumption, more aware of the composition and origins of their food, and express concern about environmental impacts of food production and packaging. The food industry has been rapid to respond to a desire for 'fresher' and less processed foods, to re-formulate food to have lower levels of sugar, salt and fat and to find innovative ways to increase the nutrient value, the functionality of foods, and the pleasure of eating.

The above provides some examples of the innovation that has taken place in the food supply over the last sixty years in developed countries. Some of the innovation is obvious to the consumer (the microwave oven, a biodegradable package, bread fortified with omega 3 fatty acid, genetically modified soy), much is not (processing methods, food safety management systems based on risk). While food is our major source of nutrients it can also be a major source of exposure to health hazards such as chemicals, microorganisms and pharmacological agents. Food safety is compromised and human illness occurs when four essential elements come together:

* a susceptible consumer

* a hazard in a form able to cause illness and in sufficient concentration

* a food substrate that will support the transmission and in some cases amplification of the hazard, and

* an environment (eg temperature or atmosphere) that supports the specific hazard's transmission and in some cases amplification

Given the amount of food consumed globally and the number of cases of food-borne illness reported these factors do not coalesce so often. However, the incidence is unacceptably high in some communities (WHO 2007). In other countries, despite efforts to control food-borne illness there are reports that some specific illnesses remain static in incidence or continue to rise (Anon 2008). While the outcome of food-borne illness following consumption of a food is determined by the interaction of the above key elements, the epidemiology of food-borne illness is further influenced by prevailing socioeconomic influences, food production practices and technological developments, public health infrastructure and environmental factors that shape these key factors at any point in time. In all communities the risk can be minimised by attention to the major contributing elements listed above (WHO 2007).

It is not surprising then that the factors that lead to compromises in food safety have evolved together with the evolution of food history and society. In some cases our knowledge of food safety hazards and their control is acquired as a result of innovations along the food supply chain either because a hazard has been anticipated or it has been consequential to the incidence of food-borne illness in the community. A classic example is the introduction of pasteurisation of milk that was an innovation led by the food industry in response to increasing attribution of raw milk to the disease burden in the community at the time.

In the USA, before widespread adoption of milk pasteurisation, an estimated 25% of all food-borne and waterborne outbreaks of disease were associated with milk. By 2001, the percentage of such outbreaks associated with milk was estimated at <1% (CFSAN 2002). Similarly in Australia between 1920 and 1945 many health authorities reported enormous reductions in infant mortality from diseases caused by the consumption of cow's milk. The reduction was not due to a higher degree of 'purity' in the milk supplied, but directly attributed to the increasing practice of heating the milk prior to consumption either in the home or at the processing plant (Government of Victoria 1943). For these reasons, the introduction of pasteurisation is viewed as one of the most significant food safety management milestones of the past 100 years and is prescribed in regulation in many countries.

Innovations in the food chain, consensus on the potential food safety risks and acceptance of risk management approaches by all stakeholders is not always as clear cut. The pace of food innovation and related science may progress at a much faster rate than the food safety science required to underpin management of the possible risks and effective risk communication. A key example is the development of genetically modified plants, animals and microorganisms used in food production. The Institute of Food Science and Technology in a review of GM foods described the key concern in the GM food debate as 'the fundamental matter of the role of science and society in relation to new science based developments' (IFST 2004). In this paper we discuss food safety hazards from the perspective of the food industry and innovation, and approaches to risk mitigation and regulatory control.

FOOD SAFETY AND QUALITY

Food safety is defined by the Codex Alimentarius Commission as 'assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use' (FAO/WHO 2001a). Food safety is associated generally with hazards such as microorganisms, chemicals and toxins. Food quality on the other hand is a broad and ill defined term that may include the organoleptic characteristics, physical and functional properties, and nutrient composition of a food (Burlingame and Piniero 2007). Further it can encompass biosecurity and the social and political environment of the food chain and its links.

Recent innovations and evolution of the global food supply have resulted in a move to expand the concept of food safety and to include aspects of nutrition so that the two are seen as a continuum rather than separate (Burlingame and Pineiro 2007). Some current examples of innovations that raise human health concerns, rightly or wrongly, that have to be managed are the use of genetic modification to manipulate food production efficiency and food quality characteristics, the use of nanotechnology in agriculture, food processing and packaging, and trends to manipulate the functionality of foods. The food safety concept is increasingly seen as including these factors such as the nutrient components of food that are known to be risk factors associated with human chronic disease or nutrient components of food in the form of additives, functional food components or supplements.

MICROBIAL HAZARDS

Microbial hazards that are food-borne include bacteria, viruses, and parasites, bacterial and mycological toxins. There are numerous genera and species within these groups that have been implicated in food-borne disease (WHO 2007). The epidemiology of food-borne illness continues to evolve as descried above and various terms have been coined to describe microbial hazards such as 'well-recognised', 'emerging' and 're-emerging' (Braden and Tauxe 2006; WHO 2002; Desmarchelier 1996). Emerging pathogens include those previously not known as food-borne disease agents at the time of occurrence eg Campylobacter jejuni and Vibrio vulnificus in the 1970s, Listeria monocytogenes and enterohaemorrhagic Escherichia coli O157 in the 1980s (Altekruse et al 1997; Desmarchelier 1996). Re-emerging pathogens include those that are well recognised then increase in prevalence, increase in association with new food vehicles or increase with enhanced virulence traits, eg certain sub-types of serovars of Salmonella, viruses and parasites.

Altekruse et al (1997) in a review of emerging food-borne diseases, considered technology and industry to be a contributing factor in the emergence of food-borne pathogens in the following examples: Hepatitis A and strawberries frozen and transported inter-continentally, Salmonella Enteritidis phage type 4 and egg containing foods and mass-distributed ice-cream, E. coli O157:H7 and fast food chain hamburgers and raw apple cider. These examples allow reflection on whether these outbreaks have been related to food chain innovations. While food innovations may have been involved, the incidents would not have occurred in the absence of other interacting factors. One trend among the outbreaks is an ongoing shift to large scale food production and distribution. We can now mass manufacture food and serve food to consumers though fast food chains modelled on production line principles; we can move foods and food ingredients including perishable products over global food chains from farm to retail and consumer. This has come about because of innovations in mechanisation in pre- and post-harvest production and food service, product development and packaging for minimum point of sale food preparation and longer shelf life, and high speed and temperature controlled long distance transport. At the same time diligence that was required and appears to have been overlooked was to provide barriers to raw material contamination on farm, to have knowledge of food-borne pathogen prevalence at source, to have control of process and storage parameters and equipment hygiene. Other contributing factors to these incidents were consumer food preferences (undercooked beef burgers and unpasteurised juices), demand for convenient, reasonably priced and year round food supplies.

More recently Enterobacter sakazakii has been the subject of increasing attention for powdered milk manufacturers and the community due to associated reports of life- threatening meningitis in neonates and product recalls (Iversen and Forsythe 2003). The bacterium is an occasional contaminant in powered infant formula; however, it appears to have been able to amplify in prepared infant formula incorrectly stored to provide an infective dose specifically for this at risk consumer group. This product has been formulated to be convenient and to provide essential nutrients mimicking natural mother's milk; however, an opportunistic pathogen has emerged due to a failure in food handling for a specific consumer group. E. coli O157, once 'emerging' and now 'well recognised' as a food-borne pathogen, is reported increasingly in association with fresh leafy green vegetables such as spinach and lettuce while meat and dairy products were formerly implicated (Herman et al 2008). The increased leafy green consumption is not considered to totally account for this increase and production factors along the entire food chain continuum are likely to be playing a significant role.

CHEMICAL HAZARDS

Chemical hazards can enter the food chain at any point--from primary production to the consumer--and can be accidentally or intentionally introduced (WHO 2008). Environmental pollution of air, water and soil with toxic metals, polychlorinated biphenyls (PCBs) and dioxin, and the intentional use of agrichemicals such as pesticides and veterinary drugs can all lead to contamination of foods and food ingredients. During food processing and preparation, food additives and contaminants can be introduced or formed and may have adverse health effects. The potential human health effects of chemical contaminants is as diverse as the variety of contaminants and can range from learning disabilities to birth defects, dementia or cancers to name a few (WHO 2008). The onset of health effects and association with a chemical food-borne contaminant may occur months to years after past or current exposure and this presents epidemiological challenges. Our knowledge of the potential health risks of chemicals has increased with developments in medical science and in the availability of analytical tools for their detection in increasingly minute amounts. Thus heath concerns are being raised about foods developed in the past and that have become part of modern diets. However, the evidence is inconclusive to date for some implicated chemicals and materials.

Compounds such as acrylamide and furans are additions to the chemicals of concern in the last decade (Stadler and Anklam 2007). Acrylamide is a potential carcinogen that is created when starchy foods are baked, roasted, fried or toasted. In 2002, scientists testing carbohydrate-rich food reported unexpectedly high levels of acrylamide that caused cancer in lab rats. The foods of concern include potato products, bread and bakery products, breakfast cereals, and coffee. In 2004, concerns were raised about the possible risk to health of furans in foods when they were shown to be present in many different products, especially those that are canned or jarred. Both compounds are produced during the thermal treatment of foods and therefore have been present in the human diet for thousands of years; however, their detection in these manufactured products that are now common to many diets raises questions of the total dietary exposure. While food innovation may be contributing to an increase in exposure, there is a large market for these products and there has been a global response for innovation in analytical methods, and alternative processing to reduce the levels and mitigate the risk (Mestdagh et al 2008).

Adapting 'traditional' food of other countries into 'western' style food can lead to the inadvertent exposure of consumers to potentially harmful, naturally occurring chemicals. For example, cassava is a hardy plant grown in many tropical countries where it is an important food source. Cassava-based products have been available to western consumers for many years and their profile has increased as manufacturers use the gluten-free nature of cassava to provide variety and choice for consumers with gluten intolerances, particularly in the snack food sector. Cassava contains, in its natural state, compounds called cyanogenic glycosides. A problem can occur with cassava-based products under certain circumstances (Cardoso et al 2005). If poorly processed, the plant, when eaten, can trigger the production of hydrocyanic acid (hydrogen cyanide) in the gut. In some developing countries where cassava is the primary source of carbohydrate for the population, long-term exposure to sub-lethal concentrations of cyanogenic glycosides present on-going health issues, such as Konzo, an irreversible motor neuron disease; clinical signs include the inability to walk, limited arm movement, and speech difficulties (Ernesto et al 2002; Oluwole 2008). While cassava products are not consumed to these levels in western countries, industry and government need to assess any potential health impact and manage accordingly.

Food packaging and other food contact materials have been an area of significant innovation in providing the diverse and convenient food supply we all expect. The risk of chemical migration and formation of hazards with food component from these materials is a key risk to be controlled. Bisphenol A is used to make polycarbonate plastic, a clear shatter-resistant material that is used to manufacture a range of everyday products from plastic baby bottles and water bottles to sports safety equipment and medical devices. It also is used to make durable epoxy resins for coatings in most food and beverage cans (Brotons et al 1995). Research on laboratory animals has been used to show that bisphenol A is an oestrogenic hormone disrupter that causes reproductive damage and may lead to prostate and breast cancer in adulthood. From risk assessments of this compound in foods, newborns and infants are suggested to be at the greatest risk resulting from boiling water poured into polycarbonate baby bottles and from can linings into liquid infant formula (Government of Canada 2008).

OTHER FOOD SAFETY CONCERNS

Genetic modification (GM) of food ie the intentional modification of plant, animal and microbial genomes by the modification of DNA in a way that does not occur naturally, has been practised in food biotechnology for some 30 years. However, debate continues over the safety of GM foods and questions remain (http://www.who.int/foodsafety/publications/b iotech/20questions/en/index.html). The three main issues for debate according to the World Health Organization are: tendencies to provoke an allergic reaction (allergenicity), gene transfer and out-crossing, ie the movement of GM plants into conventional crops or related species in the wild as well as the mixing of crops derived from conventional seeds with those grown using GM crops, that may have an indirect effect on food safety and food security). Many regulatory agencies and international organisations such as the World Health (WHO) and Food and Agriculture Organizations (FAO) have attempted risk assessments of GM food. An outcome of an Expert Consultation conducted by FAO/WHO was that, based on the knowledge available, the risk of GM foods is best evaluated using the concept of 'substantial equivalence' where GM food were considered 'safe' relative to traditional foods (IFST 2004; WHO 2000).

Nanotechnology offers the opportunity to manipulate matter at the smallest scale possible to date--100 nanometres or less (Service 2004). It has emerged over the last decade from the laboratories of chemists and physicists to diverse and multidisciplinary applications ranging from communications, construction and clothing materials, cosmetics, medicine and agriculture to name a few. This technology is expected to offer many benefits to the food and related industries with nanotechnology-derived food ingredients, food additives and food contact materials that are expected to bring new tastes, textures and sensations, reduced fat content, enhanced nutrient absorption, improved packaging, traceability and security of food products (Chaudhry et al 2008). Some of these applications are already available and an escalation in nanotechnology applications is underway (Service 2004). It has been estimated that by 2015 the global impact of products in which nanotechnology plays a key role will be approximately one trillion US dollars a year with significant increases in the food industry in food processing, ingredients, nutraceuticals delivery systems, packaging and food safety monitoring (Dingman 2008).

However, the interaction between nanosized materials at the molecular and physiological level is not clear and thus potential adverse effects on the consumer's health or impacts on the environment are not defined (Chaudhry et al 2008; Dingman 2008). It is not known whether our understanding of the health effects of conventional chemicals and materials will apply to nano-products. Concerns have been expressed that the very properties of nanoscale particles being exploited in certain applications such a drug delivery might also have negative health and environmental impacts. Almost all the concerns relate to the potential impacts of deliberately manufactured nanoparticles and nanotubes that are free rather than fixed to or within a material. Additionally, most knowledge to date is on inhalation of engineered nanoparticles and not those ingested. The size of nanoparticles may result in different interactions with biological systems and in different accumulations of the chemicals and material in the environment and in the food chain. Little too is known about potential exposure risks for the lifecycle of the product, ie release into the environment during degradation.

In the past ten years, food allergy and intolerance has emerged from being a problem for the sensitive individual to one of general public health importance. It is estimated, in some countries that around 1-3% in adults and 4-8% in children experience food allergy and intolerance responses, resulting in conditions ranging from the very mild to potentially life threatening reactions (Rona et al 2007). The reasons for the prevalence of food allergy and intolerance are unclear. Avoidance of foods containing allergens is at present the only practical means available to consumers who have allergies or intolerances. Comprehensive labeling of foods containing allergenic ingredients has been adopted by many governments in order to provide consumers, and in particular sensitive individuals, with the information they require in selecting appropriate foodstuffs.

Such rules mostly apply to ingredients deliberately added to pre-packed food. Complex manufacturing processes might result in the adventitious presence of allergens in food and indeed the food supply chain extends beyond pre-packaged food and precautionary labeling or consumer advice is used by many businesses. This can result in frustration for the sensitive individual who either has to accept decreased food choices or take a risk that they cannot fully assess. Unfortunately the high variability in sensitivity between different sensitised individuals with respect to the dose of allergens required to trigger an adverse effect makes if difficult to establish a system of risk evaluation based on the assessment of a no observed adverse effect levels. Reliable knowledge of thresholds at both an individual and population would benefit all stakeholders.

NUTRIENT HAZARDS

Burlingame and Pineiro (2007), suggest that the concept of a nutrient is broadening over time in line with globalisation of the food supply and innovations in food nutrient composition. The Codex Alimentarius Commission considers a 'nutrient' to mean any substance normally consumed as a constituent of food which provides energy; or which is needed for growth and development and maintenance of healthy life; or a deficit of which will cause characteristic biochemical or physiological changes to occur (CAC 1991b). Further an essential nutrient is a nutrient which cannot be synthesised in adequate amounts by the body. On the other hand, a fortification or enrichment refers to the addition of one or more essential nutrients to a food whether or not it is normally contained in the food for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups.

There is an increasing trend in the innovation, development and consumption of foods and food additives which result in the food as consumed having a nutrient composition that is manipulated ie fortified foods, dietary supplements, specially formulated foods and so-called 'functional' foods (Korthals 2002). Substances such as polyphenols, isoflavines, coumestrol and phytochemicals may be characterised as nutrients or referred to as beneficial bioactive components when added to the diet yet as they are not necessary for life this confuses the definition (Burlingame and Pineiro 2007). Safe upper limits of intake of these food forticants or enrichments are not clear and are necessary so that these products resulting from innovative research and development can be made available in a safe form and consumers advised of appropriate usage. As a result, through an expert working group, the FAO and WHO developed a science-based international approach to nutrient risk assessment as it related to establishing upper levels of intake for nutrients and related substances for use by risk managers (FAO/WHO 2006).

Further, there is increasing challenge of well established processes such as pasteurisation by advocates claiming the process destroys beneficial nutrients. For example, some advocates claim health benefits from raw milk compared with pasteurised milk, including decreased risks for atherosclerosis, arthritis and lactose intolerance. Such claims are not supported by scientific evidence and unsubstantiated claims of health benefits of raw milk for infants and children are particularly concerning for caregivers because infants and children are dependent on their caregivers to make safe dietary decisions for them. This is not a perceived concern, it is a real concern. In 2005, as only one example, an outbreak of a particular E. coli serotype, O157:H7, resulted in the hospitalisation of five children, four of these had a potentially life-threatening condition called haemolytic uremic syndrome (Bhat et al 2007).

Emerging food science and technologies leading to innovation in the food supply have the potential to impact on consumers in ways unfamiliar to them and thus may challenge their trustworthiness in the safety of alternatively produced and prepared or 'new' foods. Consumers may be presented with influential yet conflicting information from various interested parties promoting their innovations or points of view. Food companies invest significant intellectual and financial resources into innovation to differentiate their products and remain competitive and it is in their interest to ensure safety to maintain consumer confidence and brand integrity. Thus food safety risk management programs and policy decisions for such foods need to be transparent, based on sound scientific analysis and evidence, and take into account relevant ethical factors for consumer health (FAO 2003).

At a national level the key decision making in the management of food safety lies with competent authorities designated to protect public health. Many nations form strategic links internationally through agencies such as the World Trade Organization (WTO), the Codex Alimentarius Commission (CAC) and the International Organization for Standardization (ISO), to make transparent the requirements for the safety of food traded on global markets (Szabo et al 2008). In addition to public oversight of food safety, private mechanisms for control of food safety are being implemented increasingly resulting in a more complex system for food suppliers (Martinez et al 2007). With globalisation of food supply chains compliance with private quality assurance schemes is often a pre-requisite to supply with major retailers becoming the main drivers of the development of food safety management and market participants, rather than government agencies are influencing the determination of acceptable standards of food safety (Manning 2007).

Management of food safety in the past has been based on end product testing and inspection with little focus on foods that pose the greatest risk to public health and controls that have the most impact on risk mitigation. More recently, the limitations of this approach are being addressed and the trend is away from prescriptive regulation and to an outcome-based approach (Szabo et al 2008; Martinez et al 2007). Risk managers are applying risk management using transparent and standardised methodologies, based on scientific and epidemiological evidence and objective evaluations. The aim is to prevent unsafe food at the point of consumption using a through chain approach focusing on points posing the most serious threats to public health risk and where the potential gains from risk reduction are greatest (FAO/WHO 2007; Burlingame and Pineiro 2007).

Our multicultural society encourages and promotes an extraordinary range of food and much processing and manufacturing takes place according to traditional practices, not always soundly based or correctly followed. One irresponsible or incompetent manufacturer can cause serious illness and devastate an industry. Public and private intervention in managing food safety can be conducted with varying levels of involvement from each party, eg no public intervention and private industry self-regulation, co-regulation, provision of information and education, incentive based structures and direct command and control (Martinez et al 2007). The introduction of risk analysis approaches, hazards analysis critical control point systems and pre-requisite good manufacturing, handling and agricultural practices has given greater responsibility to the private sector (Szabo et al 2008).

However, the public will always hold governments accountable, and legally accountable, if there are breakdowns in food safety. Public authorities acting on behalf of government are faced with the challenge of managing resources for regulatory effectiveness and economic efficiency. The use of risk analysis to set food safety objectives, priorities and options that guide flexible implementation by industry and then provide a regulatory role in checking compliance commensurate with the level of risk presented by the business sector. This lays the foundations for a partnership of primary regulation and self-regulation (or industry participation) resulting in a co-regulatory approach (Martinez et al 2007).

A co-regulatory approach provides the food industry with options in food innovation where there is no existing regulation. However as Szabo et al (2008) point out this approach has implementation challenges in their experience in Australia. The lack of prescription, eg specification of a maximum level of a microbiological or chemical hazard can lead to difficulties for industry to know when their product is safe or for regulators to measure compliance and the cost of determining these parameters can be prohibitive for small and medium size enterprises. Martinez et al (2007) examined this approach in the United Kingdom and North America and highlighted the challenges of balance between private and social benefit and between regulatory cost and consumer benefit, and perceived increasing power of private versus public interests. Mutual trust and informed debate between government, industry, consumers and other stakeholders is an essential element for success.

Food safety regulations and legislation remains varied between countries and some perceive regulatory measures and the global inconsistency can obstruct the introduction of novel food processes and call for global harmonisation (Lelieveld and Keener 2007). The concept of 'appropriate level of protection' or ALOP is aligned with an outcome based regulatory approach as this implies that food sanitary measures can vary yet be 'equivalent' if they achieve the same outcome or ALOP (WHO 1998). The Food Safety Objective (FSO) concept with associated performance and product criteria introduced by the International Commission for the Microbiological Specification for Foods is a further step to allow flexibility in achieving equivalence between alternate processes (Anon 2002). An FSO is a statement of the maximum frequency or concentration of a hazard in a food at the time of consumption that provides the ALOP for public health while the performance objective is a similar statement at a specific point in the food chain that must not be exceeded is the FSO is to be met.

CONCLUSIONS

The move towards an outcome based approach and demonstration of equivalence is a positive step in the acceptance of new or alternate food processes developed through innovation. At present the concepts are still evolving, they can be resource intensive, difficult to apply in practice and take significant time to complete for both industry and regulators (Szabo et al 2008). However, as the applications increase, pressure increases for food innovations that are of benefit to the community and where there is the willingness from government, industry and the consumers for a co-regulatory approach this challenge will be overcome.

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PATRICIA M DESMARCHELIER

Senior Principal Research Scientist, Food Science Australia, Cannon Hill QLD, Australia

ELIZABETH A SZABO

Chief Scientist, New South Wales Food Authority, Newington NSW, Australia