Part II Appendices2.3.2All relevant information needed to conduct the hazard analysis shall be collected,
2.7 List all potential hazards associated with each process step, conduct a hazard analysis and consider any measures to control identified hazards (equivalent to
Codex Alimentarius Step 6, Principle 1)
Clause Requirements
2.7.1 The HACCP food safety team shall identify and record all the potential hazards that are reasonably expected to occur at each step in relation to product, process and facilities.
This shall include hazards present in raw materials, those introduced during the process or surviving the process steps, and consideration of the following types of hazard:
• microbiological
• physical contamination
• chemical and radiological contamination
• fraud (e.g. substitution or deliberate/intentional adulteration) (see section 5.4)
• malicious contamination of products (see section 4.2)
• allergen risks (see section 5.3).
It shall also take account of the preceding and following steps in the process chain.
Part II Appendic es
Interpretation List of potential hazards
It is expected that the list will include specific hazards. The Standard provides examples of those that should be considered, including:
• specific micro-organisms (e.g. E. coli or Salmonella)
• specific chemicals (e.g. veterinary residues, pesticides or radiological contaminants)
• cleaning chemicals
• machinery lubricants
• specific foreign bodies (e.g. glass, metal or plastic)
• specific allergens (e.g. peanuts or egg); i.e. those identified by the company, materials that are considered allergens in the country of intended sale and any customer requirements
• the potential for fraud and/or adulteration
• malicious tampering with the product or processes.
It is important that the company considers all relevant potential hazards from all relevant sources. These could include raw materials, processes and the factory environment. The process flow diagram is a useful tool in considering the potential risks at each stage of production. Some sites find it useful to consider each hazard, at each step, in terms of:
• whether the hazard is likely to be present in, for example, the raw material or the processing environment
• whether there is the potential to introduce or create a specific hazard at the step in the process being considered
• if there is the potential for growth of micro-organisms
• whether the hazard will survive the processing step; for example, whether a pathogen can survive in the product, or whether the contaminant is stable to the process being completed (e.g. heat stable).
There must be a description of each hazard and its sources – one hazard may have several potential sources and occur at more than one point in the process. This is important to ensure that effective controls for each source of hazard are established in the subsequent steps of the process.
The Standard has referenced food fraud and malicious contamination (food defence) in the list of hazards in this clause to draw attention to the need to include these within site assessments. However, later sections of the Standard (sections 4.2 and 5.4) provide greater detail on the expected activity in these areas. This clause does not require those assessments to be repeated or duplicated (as part of the HACCP plan, and then in compliance with sections 4.2 and 5.4) – separate assessment processes are acceptable and the site can reference the additional assessment within the HACCP plan. However, the outputs from those separate assessments must be considered as part of this process, to ensure that the correct controls, monitoring, verification, etc. are in place.
The aim of including radiological hazards within the clause is to consider potential contamination by radioactive isotopes (a legal requirement in some countries) which may be present in water or soil (either from a naturally occurring source or resulting from contamination caused by humans). A number of authorities produce reports on known radiological hazards; for example:
Interpretation
continued In the UK:
• FSA: Radioactivity in Food and the Environment (RIFE)
• UK Health Security Agency:
Three Steps to Manage Radon in Buildings – Check, Measure, Act
• UK government: Radioactivity in Food and the Environment (RIFE) Reports.
In the US:
• FDA: FDA Response to the Fukushima Daiichi Nuclear Power Facility Incident.
In Ireland:
• EPA: National Radiation Monitoring Network
2.7.2 The HACCP food safety team shall conduct a hazard analysis to identify the significant hazards (i.e. those hazards that are reasonably likely to occur at an unacceptable level), which need to be prevented, eliminated or reduced to acceptable levels. Consideration shall be given to the following:
• likely occurrence of hazard
• severity of the effects on consumer safety
• vulnerability of those exposed
• survival and multiplication of micro-organisms of specific concern to the product
• presence or production of toxins, chemicals or foreign bodies
• contamination of raw materials, intermediate/semi-processed product, or finished product.
Where elimination of the hazard is not practical, justification for acceptable levels of the hazard in the finished product shall be determined and documented.
Interpretation Hazard analysis
Any hazards identified in clause 2.7.1 must be evaluated against the criteria detailed in this clause to identify those which are significant. For the purposes of the Standard a significant hazard is a hazard identified by the hazard analysis, which is reasonably likely to occur in the absence of a control, at an unacceptable level (i.e. a level that would be considered unsafe or illegal), and therefore control is essential for the production of a safe product. The HACCP food safety team must therefore take into account:
• the likely occurrence of the hazard, taking into consideration existing prerequisite programmes, the nature of the facility and the equipment used
• the severity of the effects on consumer safety
• the vulnerability of those exposed
• the survival and growth of micro-organisms (i.e. those of concern to the product(s) within the scope of the HACCP or food safety plan)
• the presence or production of toxins, chemicals or foreign bodies
• contamination of raw materials, intermediates, semi-processed product or finished product.
Evidence of the decisions, along with the justification for the decision and the decision- making process, must be kept within the HACCP or food safety plan.
Part II Appendic es
Interpretation
continued There are a range of tools that may assist with the evaluation of hazards (e.g. quadrant graphs, scoring systems, logic tables or decision trees). The team may choose to use these tools but should keep a record of any that are deployed. Such tools may also help in establishing CCPs.
It is useful to remember that the quality of the output from the assessment depends on the quality of the data or evidence used. The hazard analysis should, wherever possible, be based on demonstrable evidence such as documented validation studies, trend analysis and science-based literature. Where this information is not available at the site, it may be necessary for the site to obtain it from suppliers or reputable external sources to establish the likelihood or severity of the specific hazards.
Where elimination of a hazard is not possible, acceptable levels need to be defined.
Reference should be made to legal requirements or scientific evidence to justify the acceptable levels (e.g. microbiological standards or presence of mycotoxins).
2.7.3 The HACCP food safety team shall consider the control measures necessary to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Consideration may be given to using more than one control measure.
Interpretation Control measures
Control measures required to reduce or eliminate the specific hazards (i.e. each hazard identified in clause 2.7.1) must be established. Any hazard that cannot be eliminated must have control measures designed to reduce it to an acceptable level of presence. This acceptable level (e.g. setting a target of <100 cfu/g of Staphylococcus aureus in finished product) needs to be justified; in other words the site should understand the potential consequences of the hazard and be able to demonstrate that the acceptable level will adequately protect the consumer.
Industry guidelines, codes of practice, legislation etc. can help to establish and justify these levels.
2.7.4 Where the control of a specific food safety hazard is achieved through prerequisite programmes (see section 2.2) or control measures other than critical control points (CCPs;
see clause 2.8.1), this shall be stated and the adequacy of the programme to control the specific hazard validated.
Interpretation Validation of prerequisites
It is important that all controls are effective and consistently prevent identified hazards from occurring. Therefore where specific hazards are controlled by mechanisms other than CCPs (e.g. by prerequisite programmes or other control measures) these also need to be validated.
It is not a requirement that a documented validation of every prerequisite is undertaken, as prerequisite programmes typically cover a wide range of general environmental controls, often with results that are not quantifiable. However, where a prerequisite programme is used to manage a specific hazard (e.g. cleaning regimes used to prevent allergen cross- contamination), there needs to be a documented validation that the prerequisite controls
Interpretation
continued the identified hazard. Some companies prefer to differentiate these prerequisites that manage specific hazards from other prerequisites, by referring to them as operational prerequisites (oPRPs).
Examples of prerequisites that require validation include:
• control of allergen cross-contamination by cleaning the production equipment. Evidence is required that the cleaning regime can effectively and consistently remove the allergen (examples of how this might be achieved are given in the guidance to clause 5.3.8).
• chilled storage conditions for product safety. The defined storage temperature must be validated by reference to technical literature, confirming the control of growth of relevant spoilage or food poisoning organisms. The storage facility must be validated as being capable of consistently delivering the defined temperature.
Prerequisites used to control specific hazards must also be subject to routine verification and monitoring, and records should detail the control measures and monitoring procedures used (see clause 2.12.2 for full details of this requirement).