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Clause 8.5.1.3ISO 22000:2018 · Build a reliable basis for hazard analysis

ISO 22000 clause 8.5.1.3: describe the end product the analysis must protect

ISO 22000 clause 8.5.1.3 requires applicable statutory and regulatory food safety requirements to be identified for intended end products. The organisation must maintain their characteristics as documented information to the extent needed for hazard analysis. The description should make clear what product is being assessed and the conditions on which its food safety assumptions depend.

What clause 8.5.1.3 requires in practice

Clause 8.5.1.3 turns attention to what the organisation intends to produce. It requires applicable statutory and regulatory food safety requirements to be identified for all end products, and it also requires documented information describing the end products, in as much detail as the hazard analysis needs.

The standard lists what that information includes where appropriate: the product name or other identification; its composition; biological, chemical and physical characteristics relevant to food safety; intended shelf life and storage conditions; packaging; labelling that relates to food safety or to handling, preparation and intended use; and the methods of distribution and delivery.

The reference to the extent needed again links detail to the hazard analysis. The aim is a clear, accurate definition of the product that the team is assessing, covering what the product is, how long and in what conditions it is expected to remain safe, and how it reaches the user.

Define the product beyond its commercial name

Use a product name or other clear identification, then describe relevant composition and biological, chemical and physical characteristics. A familiar brand or category name is not enough when products within it have materially different characteristics.

Consider intended shelf life and storage conditions together. They are part of the product description used for analysis and need a suitable basis. This guide does not prescribe a universal shelf life or storage value; those decisions depend on the product and applicable technical requirements.

Describe packaging and relevant food safety labelling or instructions for handling, preparation and intended use. Information given to the user can be part of the assumptions behind the analysis, so it must be accurate and consistent with the product.

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Include distribution and delivery

The end product does not become detached from its food-chain conditions when it leaves production. Describe relevant distribution and delivery methods so the team can consider where the product goes and what conditions are reasonably expected.

Check the interface with intended use. A product intended for further processing can require a different analysis from one presented for direct consumption. That distinction must be supported by actual arrangements and information, not merely by an internal label.

Where products are grouped, document the basis and identify differences that matter. A shared production line does not establish that every product has the same end-product characteristics.

Keep the description aligned with commercial changes

Changes to formulation, packaging, storage instructions, shelf life or distribution may affect the analysis. Ensure the food safety team receives relevant information before the organisation relies on a revised arrangement.

Compare the maintained description with current labels, specifications and customer information. A technically sound file can become disconnected from what customers actually receive. Use documented-information controls to manage the connection.

Why describing the end product matters to the business

The hazard analysis protects a specific product used in a specific way. If the description is vague, the team may assume conditions that are not true, for example a shelf life that has never been supported or storage that customers do not follow. The resulting controls may be mismatched to the real risk.

A clear product description also supports commercial decisions. Sales and marketing can see which claims and labels are consistent with the food safety basis, and customers receive information that matches what the product needs. When a pack format, recipe or distribution route changes, the team can quickly see which assumptions to re-examine. For audits and customer reviews, a precise description signals that the organisation knows its products rather than relying on trade names.

How to implement clause 8.5.1.3

Describe each product in enough technical detail for hazard analysis, and keep the description aligned with what customers actually receive. The following sequence is practical.

  1. List each end product or defined product group, using an identification that cannot be confused with a similar item.
  2. Identify the legal food safety requirements that apply to each product in each market served.
  3. Record composition and the biological, chemical and physical characteristics that bear on safety.
  4. Document intended shelf life and storage conditions, together with the basis on which they were set.
  5. Describe the packaging and the food safety labelling or handling and preparation instructions, and check they match the product.
  6. Describe how the product is distributed and delivered, including any conditions during transport and the information passed to the next party in the chain.
  7. Compare the description with current labels, specifications and customer information when anything changes, and tell the food safety team promptly so it can judge the effect.

Illustrative manufactured-food example

Illustrative example 1

A manufacturer proposes a different pack format for an established food. The team compares the relevant packaging characteristics and intended storage and distribution arrangements with the existing product description. It determines which assumptions need further evaluation before the revised product is approved.

Illustrative example 2

The review does not conclude that the product is unchanged simply because its recipe remains the same. Packaging and use conditions can be significant inputs to food safety analysis.

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Keep clause 8.5.1.3 alive in Effivity

Record what you decided under clause 8.5.1.3, link it to the records and controls it affects, and let the review date trigger the next look. Effivity is the ISO & GRC software used in 50+ countries — and part of every Sterling ISO 22000 programme.

Illustrative catering example

A caterer prepares a meal for supply to another organisation that will carry out a defined final preparation step. The team records the relevant product characteristics, delivery arrangement and information needed by the receiving operation.

When the customer proposes serving the meal through a different arrangement, the caterer evaluates whether the earlier description and intended-use assumptions still apply. Commercial acceptance follows the relevant food safety consideration.

Evidence and common mistakes

What counts as evidence

Maintain the product information needed for analysis and identify the applicable requirements. A product specification, dossier or connected set of documents can serve this purpose. The format should allow the team to find and interpret relevant facts.

Common weaknesses

Common mistakes include using marketing descriptions as technical specifications, grouping products too broadly and changing label information without checking the analysis. Another is documenting a desired shelf life as though it were already technically supported.

Connect this information with hazard identification and acceptable levels. The later decision needs to relate to the product that is actually intended to be produced.

Frequently asked questions

Does every product need a separate document?

Not necessarily. A justified grouping or connected information set can work if relevant characteristics and differences remain clear.

Is shelf life only a commercial decision?

No. Intended shelf life and storage conditions are relevant product information for food safety analysis and need an appropriate basis.

Does a label change always affect hazard analysis?

Evaluate the change. Food safety instructions or intended-use information may affect assumptions even when other label changes do not.

Check whether the product description matches the offer

Bring Sterling a product change or specification question to scope the relevant FSMS review. Documentation, learning and suitable Effivity ISO & GRC automation software support can accompany the work. Explore HACCP Awareness, then use the preliminary-information guide and hub.

Source basis and reading note. This is original practical guidance for ISO 22000. Use an authorised copy for definitive requirements. Illustrative examples describe hypothetical situations, not client results. Implementation methods are distinguished from requirements; independent bodies decide management-system certification outcomes. Issuer standard record: iso.org.
Disclaimer. This guide is provided for general information only. It is not the text of the standard, not legal or professional advice, and not a representation of how any certification body will assess your organisation. Sterling International Consulting accepts no liability for any loss arising from reliance on it. Requirements are applied to each organisation's own context through an engagement; contact us to implement ISO 22000 in your organisation.