ISO 22000 - (Section 7 - Planning and realization of safe products)

7.4. Hazard analysis

7.4.1. General

The food safety team shall conduct a hazard analysis to determine which hazards need to be controlled, the degree of control required to ensure food safety, and which combination of control measures is required.

7.4.2. Hazard identification and determination of acceptable levels All food safety hazards that are reasonably expected to occur in relation to the type of product, type of process and actual processing facilities shall be identified and recorded. The identification shall be based on

  1. the preliminary information and data collected according to 7.3,
  2. experience,
  3. external information including, to the extent possible, epidemiological and other historical data, and
  4. information from the food chain on food safety hazards that may be of relevance for the safety of the end products, intermediate products and the food at consumption.

The step(s) (from raw materials, processing and distribution) at which each food safety hazard may be introduced shall be indicated. When identifying the hazards, consideration shall be given to

  1. the steps preceding and following the specified operation,
  2. the process equipment, utilities/services and surroundings, and
  3. the preceding and following links in the food chain. For each of the food safety hazards identified, the acceptable level of the food safety hazard in the end product shall be determined whenever possible. The determined level shall take into account established statutory and regulatory requirements, customer food safety requirements, the intended use by the customer and other relevant data. The justification for, and the result of, the determination shall be recorded.

7.4.3. Hazard assessment

A hazard assessment shall be conducted to determine, for each food safety hazard identified (see 7.4.2), whether its elimination or reduction to acceptable levels is essential to the production of a safe food, and whether its control is needed to enable the defined acceptable levels to be met.

Each food safety hazard shall be evaluated according to the possible severity of adverse health effects and the likelihood of their occurrence. The methodology used shall be described, and the results of the food safety hazard assessment shall be recorded.

7.4.4. Selection and assessment of control measures

Based on the hazard assessment of 7.4.3, an appropriate combination of control measures shall be selected which is capable of preventing, eliminating or reducing these food safety hazards to defined acceptable levels.

In this selection, each of the control measures as described in shall be reviewed with respect to its effectiveness against the identified food safety hazards.

The control measures selected shall be categorized as to whether they need to be managed through operational PRP(s) or by the HACCP plan.

The selection and categorization shall be carried out using a logical approach that includes assessments with regard to the following:

  1. its effect on identified food safety hazards relative to the strictness applied;
  2. its feasibility for monitoring (e.g. ability to be monitored in a timely manner to enable immediate corrections);
  3. its place within the system relative to other control measures;
  4. the likelihood of failure in the functioning of a control measure or significant processing variability;
  5. the severity of the consequence(s) in the case of failure in its functioning;
  6. whether the control measure is specifically established and applied to eliminate or significantly reduce the level of hazard(s);
  7. synergistic effects (i.e. interaction that occurs between two or more measures resulting in their combined effect being higher than the sum of their individual effects).

Control measures categorized as belonging to the HACCP plan shall be implemented in accordance with 7.6. Other control measures shall be implemented as operational PRPs according to 7.5.

The methodology and parameters used for this categorization shall be described in documents, and the results of the assessment shall be recorded.