It is widely accepted that a sufficient food and water consumption is an integral part of living and health promotion. Food safety and quality are therefore considered to be a major concern for food manufacturers, policy makers and general public. Although there is a significant progress in advisory labelling practice, undeclared allergens can sometimes be added into food as a result of a manufacturing process. Allergens can be defined as a substance capable of triggering immediate hypersensitivity (AAAAI, 2014). Food Standards Agency (FSA) (2014) has calculated that each year approximately 10 people die from food-induced anaphylaxis. Poorly controlled production of food also damages socioeconomic status of a country as it strains its healthcare system and depresses trade and tourism sections (WHO, 2014). Food safety and quality is an international issue especially considering that nowadays food is widely imported and exported between the countries. This is recognized by the EU White Paper on food quality and safety (Commissions of the European Communities, 1999). Food producers including manufacturers, importers, and businesses are responsible for advising customers on potential risks, monitoring the safety of food, and taking actions if the product has been recognized as harmful (Department for Business, Innovation and Skills, 2012). According to FSA (2007) food must be safe for the consumers and if the harmful product has already been sold, it should be withdrawn from sale or recalled. For the purpose of this assignment several recalls across Europe will be analysed in order to identify the categories, understand possible reasons, and give recommendations on how to minimize the risk and prevent such situations in the future.
According to Borjanovic (2008), risk assessment is a systematic approach to recognizing potential health hazards, determining the degree of exposure and evaluating the effectiveness of risk control measures. Broadly speaking, there are two notions associated with the risk assessment – hazard and risk. Hazard can be defined as a potential harm source, whereas risk refers to the probability of hazard exposure to cause an illness, injury or death. Risk assessment measures these two variables and mathematically can be viewed as a ‘ likelihood x severity’ function. However, Rasko and Bledsoe (2000) argue that there is an increased chance of uncertainty in measurements. Risk assessment includes the following steps: hazard identification, exposure assessment and risk characterization (Borjanovic, 2008). Hazard identification includes the collection of the necessary evidence for adverse health consequences. Exposure assessment measures the level of exposure that causes a certain effect in people. Risk categorization is the last step of the risk assessment process that can be reflected by a risk rating matrix (see Appendix 1). According to this matrix, low, medium and high levels of likelihood and severity should be assigned and multiplied. It is important to reduce unacceptable levels of risk that include high likelihood and high severity (Newslow, 2013). In this essay high severity will refer to adverse health outcomes, medium severity will include temporary health problems and low severity will consist of the situations where serious health problems are unlikely to happen.
FDA (2009) has assigned numerical designation (I, II or III) in order to identify the degree of health harm displayed by the recalled products. It can be difficult to identify the recall category and each recall case should be treated individually (Michigan Department of Agriculture, 2008).
In the most severe cases a person can develop anaphylaxis (Allergy UK, 2012). Anaphylaxis usually involves respiratory system and/or cardiovascular system and occurs due to the release of mast cell or basophil mediators in a response to allergens (Ellis and Day, 2003). It is not known why some people develop anaphylaxis and not just common mild symptoms, making it more difficult to predict. Anaphylaxis requires immediate medical assistance and if not treated in time, a person might die due to cardiovascular collapse or airway obstruction (Ellis and Day, 2003).
The risk probability is also found to be relatively high as the product has been initially marked as ‘ lactose-free’ and, therefore, there is an exceptionally increased chance of its consumption by lactose-intolerant and milk-allergic people. Thus, it can be suggested that this case is classified as Class I since it involves high severity (due to the possibility of developing anaphylaxis, which can lead to lethal consequences) and high likelihood (as the undeclared allergens were found in the previously declared ‘ lactose-free’ product affecting more allergic people than usual).
According to FDA (2009), Class II recalls refer to exposure to food that can cause temporary or medically reversible adverse health problems. A Class II recall has been identified from the provided list of cases. On the 5th of December, 2014 an undeclared sulphite was discovered in frozen shrimps (Parapenaeus longirostris) from Cyprus, with raw material from Greece. The severity is believed to be high as sulphite is an allergen. Sulphites are used as preservatives and/or antioxidants in some foods. According to Allergy UK (2012) allergy to sulphites is very rare but might affect people suffering from asthma. The incidence of such allergy is less than 2%. Sulphites-induced anaphylaxis has been reported, but it occurs very rarely. Based on the fact that severe allergic reaction is still possible, the severity is believed to be high in this case. However, when analysing the likelihood, it can be concluded that the risk probability is slightly lower than in previous case considering the mitigating circumstances that slightly reduce consumer risk. FDA has released the list of foods that may contain sulphites and advices those with sulphite allergies against their consumption. At least the intake of such foods should be limited. The list includes alcoholic beverages, confections, nuts, fish and shellfish (whether it is fresh, frozen, or dried) (EXTOXNET, n. d). Additionally, there is a sufficient amount of research that confirms the fact that the content of sulphite often breaches legislative limits (Hardisson, et al., 2002). Therefore, it might be suggested that the risk likelihood is slightly lower considering that those with sulphite allergies or intolerance might be aware of the fact that frozen shrimps may contain sulphites. Thus, the number of affected people is suggested to be relatively lower compared to the previous case.
Lastly, Class III recalls typically involve the situations where the products are unlikely to cause detrimental health outcomes (FDA, 2009). However, it can be argued that the presence of undeclared allergens cannot be classified as Class III recalls as all the undeclared allergens have a potential to cause adverse health consequences (Michigan Department of Agriculture, 2008). From the provided recall cases in Europe, one has been identified as Class III. This included altered organoleptic characteristics (possible presence of solvents). Organoleptic characteristics of food include both appearance and sensory quality (D’Souza, 2007). Consequently, it can be suggested that the severity of this recall is relatively low, as it does not cause severely adverse health outcomes. The likelihood is also suggested to be lower than in previous recall cases.
It is now important to analyse the possible reasons for the failures described above and to make recommendations based on the findings. There are a great variety of possible causes. Food Drink Europe (2013) in their Guidance on Food Allergen Management for Food Manufacturers suggest that failures could happen at different stages of production, including Training, Personal Hygiene, Supplier Management, Raw Materials Handling, Equipment and Factory Design, Production Process and Food Labelling. One of the possible reasons why the abovementioned products were recalled is the lack of training, where employees were not aware of the potential hazards of allergens and/or other dangerous substances, storage and risk identification procedures. It is, therefore, recommended to educate every employee involved in the process of food manufacturing and distribution on the effects of presence of allergenic ingredients.
Another possible reason as stated by Food Drink Europe (2013) is personal hygiene, which is vital in food production process as cross-contamination or cross-contact could occur due to the personnel inadvertent transfer of the allergens to foods. According to Schaefer (2011), in cross-contamination (the process of contamination of food with the microorganisms such as viruses or bacteria) proper cooking can reduce or eliminate the risk of foodborne illnesses, whereas in cross-contact (situation where allergens are inadvertently added into foods) cooking does not reduce the chance of adverse health outcomes for allergic people.
Grifiths (2009) seconds this statement and recommends the development of stricter clothing requirements, frequent hand washing, special policies on food and drink consumption on site. Lack of cleaning could also lead to the presence of undeclared allergens. Cleaning provides a separation between allergen- and non-allergen containing manufacturing processes (Cochrane and Skrypec, 2014). It is recommended to assess the effectiveness of cleaning process in order to identify if the objectives are met. Food Drink Europe (2013) suggests avoiding the crossover of production lines and implementing effective cleaning practices. Additionally, it is essential to keep records of cleaning.
Another possible problem could be that the raw materials have not been clearly identified and/or stored in an inappropriate way. Cross-contamination of other raw ingredients can occur due to raw materials storage issues. Both Food Drink Europe (2013) and Grifiths (2009) agree that segregation of allergens from other raw materials is vital in food industry. It is recommended to store allergenic materials in designated areas. For instance, colour codes could be used (Food Drink Europe, 2013). It is also vital to check the deliveries and use marked packaging.
The next possible cause for the failures described above is incorrect use or incorrect selection of equipment and/or inappropriate production process where cross-contact between raw materials could have occurred. Food Drink Europe (2013) suggests avoiding cross-contact between allergenic and other types of materials by allowing sufficient space between production lines. Additionally, special areas on production lines should be dedicated to separate allergenic materials. Such areas should be designated. It is also important to control the movement of equipment, employees and vehicles.
Additionally, failures could have occurred during the production process including lack of recipe verification, non-separation of products, and incorrect packaging or labeling. FSA (2006) believes that the most common reason for product recall is incorrect labeling and suggests that policies regarding labeling and packaging should be developed, implemented and frequently monitored. Food manufacturers are obliged to list the allergenic ingredients. In pre-packed foods the list of ingredients should be attached to the package. However, businesses selling non-pre-packed foods are not legally obliged to indicate allergenic ingredients yet.
It is preferable for food businesses to use Hazard Analysis and Critical Control Point (HACCP) principles in the process of assessment, management, and communication. HACCP addresses food safety using systematic approach to control of biological, chemical and physical hazards in the process of production, procurement, manufacturing, distribution, and consumption of a food product (Schaefer, 2011). According to Institute of Food Research (2014), HACCP programme involves different stages: identification of the hazards, identification of the control points, development and implementation of monitoring policies, development of corrective actions, development of the procedures to ensure the effectiveness of the programme and documentation of the work. Critical points of control of the allergen hazards should include the abovementioned points such as employee training, product design, raw material supply chain, manufacturing process, facilities and equipment, cleaning, packaging and labelling. Broadly speaking, these are the points at which control process is enabled in order to prevent, eliminate or reduce the chances of risk. Some people argue that HACCP should not be applied towards allergen management as allergens are different from microorganisms and are more difficult to be controlled. However, these views are somewhat purist as it is difficult to develop a more flexible approach (Griffiths, 2009).
Currently, there are two management systems in food industry: HACCP and ISO 9001: 2000 (Rotaru and Borda, 2007). A new ISO standard ISO 22000: 2005 was published in 2005 that uses ISO 9001: 2000 as a tool for HACCP procedure implementation. It has been suggested that the quality and safety issues are interrelated resulting in an increased application of ISO 22000: 2005 to manage both safety and quality issues. ISO 9001: 2000 is a management system of quality and can be complemented by HACCP, which is associated with the safety issues. It is important to note that HACCP is different from prerequisite requirements. Prerequisite requirements include basic food operating conditions and are required to be implemented before HACCP procedures are developed (FSA, 2008). An example of prerequisite requirements can be Good Manufacturing Practice (GMP).
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