This case study aims to analyse how the public institutions in the UK and the EU investigate and control cases of food sale that fail the food safety standards and requirements. The starting point of this case study is the recent inspection of a local health-bar manufacturing company. The producer uses nuts, tree-nuts and dried fruits as ingredients, which have been imported from other countries, both EU and non-EU members. Recently the company launched a peanut butter product. However, while inspecting the samples it was found that the aflatoxin level exceeded accepted limits.
This essay will cover the microbiological background of aflatoxins and their occurrence. Testing for aflatoxins and levels of acceptance will be discussed as well as their impact on health. EU law and corresponding UK laws relating to aflatoxins are also defined and described. Furthermore, the major problems related to the case study are stated and a proposed course of action is discussed in relation to procedures provided by UK law and EU regulations, for national and international incidence. Finally, conclusions are drawn.
The fungi Aspergillus flavus, A.parasiticus and the rarer strains A.nomius and A.niger produce secondary metabolites known as Aflatoxins . Aflatoxins are a major concern as they are carcinogenic, mutagenic and immunosuppressive agents found in a large variety of agricultural commodities such as nuts/seeds, fruit and spices , Commodities at maximum risk of contamination are corn, peanuts, and cottonseed. While 20 different types of Aflatoxins have been identified, only 4 are essential contaminants of food stocks . All aflatoxins are difuranocoumarins  classified into two broad groups: B1, and B2, G1 and G2 depending whether the compound is blue (B) or green-yellow (G) under the UV light. B2 and G2 are dihydroxylated derivatives of B1 and G1 respectively. Two further aflatoxins, known as M1 and M2, are hydroxylated derivatives of aflatoxins found in milk products (both wet and dry) from animals fed on contaminated feedstock, which places dairy produce in the risk category .
Aflatoxin poses risks in both developed and developing countries, however, developing nations where subsistence farming is common, especially warm countries are at highest risk. Microbial growth conditions for Aspergillus involve high temperature (52-105F) and high humidity and moisture content. Aspergillus is not an aggressive pathogen however, plants weakened by for example long-lasting drought, can become susceptible to mould inoculation. Developing countries higher levels of contamination, which dramatically increase during storage.
Testing for aflatoxin
Aflatoxins are heat–stable, highly toxic compounds that can survive several food-processing steps, thus their toxicity poses a serious health risk, which means that exposure needs to be limited. Ultraviolet or “black” light testing can indicate contamination as the mycotoxin glows green or blue under UV light at 365nm, but this a non-conclusive, qualitative test. Quantitative testing for aflatoxin include techniques such as thin-layer chromatography (TLC), enzyme-linked immunosorbent assay (ELISA) and fluorometeric methods. However, aflatoxin testing in food is usually by liquid chromatography coupled with mass spectrometry, which is sensitive enough to detect contaminate levels in the part per billion . In the case of human exposure to aflatoxins, rapid tests are now available to determine the presence of mycotoxins in urine or blood serum .
Impact of aflatoxin on health
Aflatoxin B1, (AFB1) is the most common bioactive agent causing acute or chronic diseases. B1, is genotoxic, which means it can intercalate with the DNA. The main site of intoxication in both humans and other animals is the liver. Aflatoxicosis exposure is associated with necrosis and cirrhosis . Long exposure to aflatoxins increases risk of liver cancer, as the compounds undergo metabolism to form epoxides, which then bond covalently to proteins and DNA. Furthermore, exposure to aflatoxins plays a key role in mutations in the TP53 gene in hepatocellular carcinomas. Research on chemo-preventive drugs is the subject of research however; no direct cure has yet been found . Therefore, it is of high importance to provide appropriate food analysis and relevant legislation to avoid food contamination with aflatoxins.
Legislation in the EU and in the UK
Legislation of the case study requires an appropriate choice of legal acts. In the EU, the European Commission (EC) regulations are a primary legislation acts introduced in the member countries of the EU. The main regulation determining food hygiene standards is regulation (EC) No.852/2004, which states manufacturers must comply with microbiological criteria for foodstuffs (EC) No.852/2004, chapter 4, article 3a .
Regulation (EC) No.1881/2006 with amended 165/2010 determines the acceptable aflatoxin levels depending on the type of food or feed [9, 10]. General requirements for the processed food levels are 2µg/kg for aflatoxin B1 and 4µg/kg for the total concentration of aflatoxins. (EC) No.1152/2009  determines the control norms for aflatoxin contamination that have to be carried out with regard to the country of origin. Import of aflatoxin-prone commodities has to be especially thorough in exports from the following countries: India, Nigeria, Pakistan, Peru, South Africa and Ghana, due to their climates being ideal for microbial growth, as it is stated in the (EC) No.669/2009. (EC) No. 669/2009 was amended with (EC) No.178/2010, which regulates analysis methods required to be used during investigations into the control of foodstuffs [12, 13].
In the United Kingdom, Food Safety Act from 1990 serves as a main source of domestic legislation . The following case study violates the food safety requirements noted in part II, article 8. To implement the course of action, Food Law: Code of Practice is a main source of detailed information on how to deal with the hazardous food [15, chapter 1.7].
Analysis of the problems
The course of action and a food incident flow diagram are provided in the Food Law: Code of Practice . The level of aflatoxins found within the peanut butter are classified as a biological and chemical food hazard, which is defined as an incident with the potential to cause an effect on human health and safety . The company should provide the Food Authority with information about the extent and scale of hazard. Increased levels of aflatoxins in peanut butter are regarded as a serious localised food hazard. A major problem associated with the case scenario is that the contaminated products might have already entered the market. Responsibility for public health lie with both the Food Authority and the manufacturer and efforts to prevent the poisoned food from being consumed should be foremost. Additionally, other products processed by the company have to be sampled and analysed as well as all machines used for food production. There exists a possibility that other products have been contaminated in the factory, and the contamination does not come from the imported sub-products. The manufacturer should be able to provide documentation on safety and hygienic standards, and also the list of suppliers used for the raw ingredients. Samples from all foodstuffs within the factory will be sent for analysis in order to determine the source of aflatoxins.
Course of action
As a member of the EU, it is essential to perform a risk assessment as soon as the aflatoxin levels were found to be exceeded. The following statements will define the course of action necessary to reduce the public contact with the hazardous substance. Firstly, the affected product must be recalled from the market, and edia sources used to prevent public consumption of purchased food from the affected manufacturer. The source of the contamination must be determined, and examination of other products manufactured by the company – in this case: health-bars will be performed to ensure there is no further contamination. Microbiological control has to be carried out by taking several samples from different series, as the aflatoxin distribution within the products may vary. The variation of toxicity is caused because some peanuts may have higher levels of contamination than others, and homogeneity of aflatoxin is rare in contamination cases. It is important to clearly identify which commodity was the source of aflatoxins in order to limit possible further outbreaks by preventing sale from the particular grower/distributer. The stage of the process at which the foods were contaminated will be investigated to check whether the imported produce was the contaminant. In cases where the raw produce was not the contaminant source, the company’s facilities would undergo inspection to determine at which stage contamination appeared. Another important aspect is to determine the scale and extent of contamination. If the products from this series were already available to consumers, the Food Authority must use an Outbreak Control Plan. The Public Analyst and Food Examiner would be contacted and informed directly after the microbiological contamination was found. Part of the risk assessment is to investigate the consumer demographics at risk of consuming the product, for both the peanut butter and, as a preventative measure, the health-bars too. Cases where the product has been exported to other EU countries will be discussed fully in the next section. It is however of primary importance to contact the place in which the product has entered the EU, whether it is a shipping port or the airport. As a Food Authority inspector, it is also part of the duty to evaluate whether the manufacturer has the ability to cope with the removal of the products from the market. In order to assure the proper flow of information, it is essential to inform the media to spread the news to the customers about the danger .
Case: Export of products to other EU member states
For the purpose of emergency situations, such as contaminated produce being exported to other EU member states, the EC introduced a warning system called Rapid Alert System for Food and Feed (RASFF) . The system functions in two main areas: market notification and boarder rejection. The first requires removal of all contaminated products from the market and/or prevention of entry to the market. The border rejection emergencies have to be carried out if the product has not yet entered the EU, so that it can be rejected and sent back to the country of origin or destroyed. This is made easier by Regulation (EU) No 274/2012 , which ‘imposes special conditions governing the import of certain foodstuffs from certain non-EU countries due to contamination risk by aflatoxins’ which includes that certain produce may enter the UK only through ‘specific ports or airports approved as designated points of import’ and that consignments of these foodstuffs must be accompanied by a health certificate and results of sampling and analysis. The information gathered in that process are immediately placed in the internet database, allowing other companies to investigate which suppliers have been recorded to fail in the food hygiene standards, these suppliers are subsequently investigate and export of suspect food is stopped. All expenses connected with the emergency are to be paid by the company that brought the contaminated food to the EU market .
Aflatoxins are one of the most dangerous compounds found in food and feedstock. The economic impact of this mycotoxin is huge and the Food and Agriculture Organization estimates that 25% of food crops worldwide are affected. Eating food contaminated with aflatoxin can lead to serious health problems, including liver cancer and increased susceptibility to hepatitis B. Feedstock contamination can lead to dairy products contaminated with the M1 and M2 strains of aflatoxin. Therefore, vigilant monitoring for aflatoxin contamination in food and feedstock is essential for public health and safety. Uk and EU regulations seek to minimise health impact and spread of the contaminants by judicious use of boarder control and consumer access. Aflatoxin affects both human and livestock, ranging from server illness and cancer to death. As well as the terrible consequences to public health, it also affects business livelihood and thus has potentially economically dire consequences, therefore vigilant monitoring of this widespread toxin is imperative not just nationally but worldwide.
Lawley, R, Curtis, L and Davis, J (2008) The Food Safety Hazard Guidebook, RSC Publishing.
S., Selamat, J., and Lioe, H., (2010) Aflatoxin in Raw Peanut Kernels Marketed in Malaysia, Journal of Food and Drug Analysis, Vol. 18, No. 1, Pages 44-50
Wild, C.P. and Turner, P.C. 2002. The toxicology of aflatoxins as a basis for public health decisions. Mutagenesis. 17 (6): 471-481.
Finley, J.W.,Robinson, S.F. and Armstrong, D.J. (1992). Food Safety Assessment. American Chemical Society, Washington, D.C. pp261-275
Lu, F. C. (2003). Assessment of Safety/Risk vs. Public Health Concerns: Aflatoxins and Hepatocarcinoma. Environmental Health and Preventive Medicine. 7: 235-238.
Shuaib, F.M.B., Ehiri, J., Abdullahi, A., Williams, J.H. and Jolly, P.E. (2010). Reproductive health effects of aflatoxins: A review of the literature. Reproductive Toxicology. 29: 262-270.
Wild, C.P. and Turner, P.C. (2002). The toxicology of aflatoxins as a basis for public health decisions. Mutagenesis. 17 (6): 471-481.
EUROPEAN COMMISSION REGULATION (EC) No 852/2004.
EUROPEAN COMMISSION REGULATION (EC) No 1881/2006
EUROPEAN COMMISSION REGULATION (EC) No 165/2010
EUROPEAN COMMISSION REGULATION (EC) No 1152/2009
EUROPEAN COMMISSION REGULATION (EC) No 669/2009
EUROPEAN COMMISSION REGULATION (EC) No 178/2010
THE FOOD SAFETY ACT 1990 – A GUIDE FOR FOOD BUSINESSES (2009)
Food Law Code of Practice (England) (Issued April 2012)
Food Standards Agency. 2012. Food Law Code of Practice (England).
http://www.food.gov.uk/multimedia/pdfs/codeofpracticeeng.pdf , retrieved: 30.01.2013.
Rapid Alert System for Food and Feed, RASFF: EC Health and Consumers http://ec.europa.eu/food/food/rapidalert/index_en.htm. Retrieved 6/1/2013
EUROPEAN COMMISSION REGULATION (EC) No 274/2012
CBI Ministry of Foreign Affairs of Netherlands. 2012. EU legislation: Non-compilance with food safety legislation (cases). http://www.cbi.eu/marketintel/EU-legislation-Product-safety-for-food-products-cases-/159355 , retrieved: 30.01.2013.