ISO 22000 clause 8.5.2.2: identify hazards and justify acceptable levels

What clause 8.5.2.2 requires in practice

This sub-clause has two linked tasks. The first is to identify and document the food safety hazards that can reasonably be expected for the product, process and environment. Identification draws on the preliminary information, experience, internal and external data including scientific and historical material, information from elsewhere in the food chain, and statutory, regulatory and customer requirements. The organisation also works out the step or steps where each hazard can be present, be introduced, grow or persist, looking before and after its own activities and at every step in the flow diagram, equipment, utilities, environment and people. The second task is to determine, wherever possible, the acceptable level of each hazard in the end product, and to keep the justification as documented information.

Use several relevant sources

Begin with preliminary product and process information, then bring in experience and relevant internal and external information. Scientific, epidemiological and historical data can contribute where available. Food-chain information and applicable statutory, regulatory and customer requirements also matter.

Evaluate relevance rather than collecting sources indiscriminately. Information about a different product or process may offer a useful question but not a directly transferable conclusion. Competent personnel need to judge the connection with the operation being analysed.

Describe hazards sufficiently specifically to support assessment and selection of measures. A broad biological, chemical or physical category may be a starting point, but the team needs to understand the actual hazard under consideration. Relevant allergen hazards also require appropriate consideration within the food safety analysis.

Locate the hazard through the process

Consider every step in the flow diagram, stages before and after the organisation's own work, and relevant equipment, utilities, environment and people. Ask whether the hazard can already be present, enter at that stage, increase or persist.

Do not restrict the exercise to where a control currently exists. Identification precedes the judgment about whether existing control is sufficient. A missing control should not cause a hazard to disappear from the analysis.

Link the hazard to the stage and circumstances that matter. This gives the later assessment a meaningful basis and helps the team identify appropriate points of control.

Establish an acceptable end-product basis

Determine the acceptable level for each identified hazard whenever possible. Identify applicable requirements, consider intended use and use other relevant information. Maintain both the determination and its justification so a reviewer can understand the basis.

An acceptable level describes the food safety outcome for the hazard in the end product. A critical limit or action criterion is used to manage a selected control measure. These concepts connect, but they are not interchangeable.

Do not invent a numerical level merely to complete a table. Where the available basis is uncertain or requires specialist interpretation, obtain appropriate expertise and document the conclusion and limitations. The wording “whenever possible” does not excuse avoiding relevant available requirements.

Why clause 8.5.2.2 matters to the business

A hazard that was never named cannot be controlled, and a hazard named too vaguely produces controls that miss it. Acceptable levels matter equally: without a stated target outcome, nobody can judge whether a control is strong enough or a limit is set sensibly. Getting this right protects consumers and reduces the cost of over-cautious or under-cautious controls. It also makes customer conversations simpler, because specifications, limits and test results can be tied to a documented basis instead of being argued from memory.

How to implement clause 8.5.2.2

Build the hazard list from evidence and process knowledge, then give each hazard a defined outcome. Where evidence is thin, say so in the record and involve a competent specialist, because an accurate statement of limits is more defensible than a confident number with nothing behind it.

1. Gather inputs: product and process information, complaint and incident history, supplier information, scientific references and applicable requirements.
2. Go step by step through the confirmed diagram and ask, for each hazard, whether it can be present, enter, increase or persist there.
3. Include steps upstream and downstream of your own site, and consider equipment, utilities, environment and people.
4. Describe each hazard specifically enough to support assessment, rather than using only broad headings.
5. For each hazard, find the acceptable end-product level from requirements, intended use and other relevant information.
6. Record the justification, and where no level can be set, record why and what expert advice was taken.
7. Keep the identification table linked to its sources so it can be reviewed when new information appears.

Illustrative ingredient-production example

Illustrative catering example

A caterer analyses an off-site meal route and considers hazards at preparation, transport and service. It includes relevant consumer and intended-use information rather than assessing only the condition when food leaves the kitchen.

The team identifies which assumptions depend on the receiving operation and checks the communication arrangement. The acceptable-outcome decision is therefore linked to the actual food-chain use.

Evidence and common mistakes