Introduction of hazard and risk analysis into the new EU food legislation  

After a number of food crisis with Salmonella in eggs, Listeria in diaries, and the severe impacts of BSE at the beginning of the 1990’s, the EU marked a shift to a more pro-active food policy with the release of a White Paper on Food Safety in January 2000. With emphasis on the precautionary principle, The White Paper led to the development of a new legislation, which was epitomised by a package of legislative acts, the Hygiene Package, which was accompanied by the withdrawal of 17 existing directives. The overall goal was to create a framework of harmonised standards, based on the Hazard Analysis and Critical Control Points system (HACCP). The HACCP represents the key element for an early warning system at the production site and enables manufacturers to take preventive measures based on real data and hazard analysis. This system was already part of a Council Directive in 1993, but became now enforced for all sectors dealing with food and feed.

The HACCP principles have been developed by the Codex Alimentarius Commission, a joint commission of The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organisation (WHO), which had accepted the HACCP as an official standard in 1997. Hence, HACCP is a globally used safety philosophy to ensure the safety of foodstuffs.

Origin of the new EU food policy - Council Directive 93/43/EC

The Council Directive 93/43/EC on the hygiene of foodstuffs emphasised the importance of the use of hazard analysis, risk assessment, and management techniques. This directive laid down general rules on the hygiene for foodstuffs and the procedures to be used for the verification of compliance with these rules. It states that

offering for sale and supply of foods shall be carried out in a hygienic way. One of the main purposes with this Directive was to set a food safety standard throughout Europe including the HACCP as a requirement for all food companies. The Directive established that “food business operators shall identify any step in their activities which is critical to ensure food safety and that adequate safe procedures are identified, implemented, maintained and reviewed on the basis of the HACCP principles”.

The hygiene package

The hygiene package, one of the key elements in the new EU legislation is composed of five parts covering common rules of hygiene in the food industry (Regulation (EC) No 852/2004), hygiene of foodstuffs of animal origin (Regulation (EC) No 853/2004), official controls and animal health rules for products of animal origin intended for human consumption (Regulation (EC) No 854/2004), veterinary certification (Council Directive 2002/99/EC), and a directive repealing previously existing regulation (Council Directive 2004/41/EC). The hygiene package endorsed the HACCP principles, laid down in the directive 93/43/EC for all sectors of the food business except for primary production on farms. Regulation 852/2004 gives the common rules for any production of food, while in Regulation 853/2004, specific rules are laid down for

Special requirements on the hygiene for production and marketing of fresh meat

The Commission Decision on the general hygiene in slaughter houses and cutting plants (Commission Decision 2001/471/EC) stipulated pre-operational hygiene controls (bacteriological sampling) of cleaned and disinfected utensils, fittings and machinery, e.g. transport conveyor belts, cutting tables, flab doors, etc. It also laid down the acceptable levels of bacteria to be found on surfaces after cleaning and disinfection, mainly the numbers of a certain group of bacteria, the Enterobacteriaceae, and the total number of bacteria. Causes of unsatisfactory results should be clarified by consultation with the cleaning staff. The decision also mentions possible factors involved in failure of the disinfection, in particular

Hence, cleaning and disinfection measures are part of the stipulated quality assurance system applying the principles of HACCP. An example for the application of HACCP in food production is the introduction of critical control points in slaughterhouses is the prevention of faecal contamination of carcasses and ensuring the correct temperature of carcasses during storage.

Microbial criteria for foodstuffs

The microbial criteria on different foodstuffs are laid down in the Commission Regulation (EC) No 2073/2005, and the Commission Regulation (EC) 1441/2007, respectively. In general, the foodstuffs delivered should be free from pathogenic bacteria and bacterial toxins. Depending on the type of foodstuffs, it will be tested for Salmonella, Listeria, Staphylococcus, or other organisms.

Other contaminants in foodstuffs

Apart from microbial contamination, the Regulations (EC) 1881/2006 and Commission Decision 2008/629/EC set maximum levels for certain contaminants in foodstuffs (nitrate, fungal toxins, dioxin, as well as heavy metals.

Risk analysis

To achieve the common goal of protection of the consumer’s health, the European food law employs risk analysis. In contrast to hazard, the word risk stands for the probability for a certain (negative) event to take place. Elimination or avoidance of risk should be undertaken in an independent, objective and transparent manner on the basis of the available scientific information and data. The European Food Safety Authority (EFSA) was established provide a systematic methodology and to collect scientific evidence on targeted measures or other actions to protect health. The EFSA will provide expertise on risk analysis and the precautionary principle. Risk analysis is here based on the components of risk assessment, risk management, and risk communication.

Definitions according to Regulation (EC) No 178/2002:

Hazard: means a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect

Risk: means a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard

Risk analysis: means a process consisting of three interconnected components: risk assessment, risk management and risk communication

Risk assessment: means a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation

Risk management: means the process of weighing policy alternatives considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options

Risk communication: means the exchange of information and opinions throughout the risk analysis process among risk assessors, risk managers, and consumers, including the explanation of risk assessment findings and the basis of risk management decisions


The EU has applied HACCP based hazard analysis as a key element in it’s legislation on the hygiene of foodstuffs. This Codex Alimentarius standard on food safety is part of the core legislation on the hygiene of foodstuffs, mainly the Regulations (EC) No 852/2004, 853/2004, and 854/2004. The HACCP principles have to be applied by all food producers and may be integrated into other already existing QM-Systems. There are special requirements on the general hygiene of meat producing facilities which include a regular check of the success of cleaning and disinfection prior to start of the production. HACCP implies the use of trained personnel following proper instructions and the use of suitable chemicals.