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Clause 8.5.1.2ISO 22000:2018 · Build a reliable basis for hazard analysis

ISO 22000 clause 8.5.1.2: understand materials before assessing hazards

ISO 22000 clause 8.5.1.2 requires the organisation to identify applicable statutory and regulatory food safety requirements for raw materials, ingredients and product-contact materials. It must also maintain information about their characteristics to the extent needed for hazard analysis. A purchasing description may identify what to order without explaining the food safety questions the team needs to assess.

What clause 8.5.1.2 requires in practice

Clause 8.5.1.2 deals with what goes into the product. It asks the organisation to find every statutory and regulatory food safety requirement that governs its raw materials, ingredients and the materials that touch product. It then requires documented information on each of these items, to the extent needed to carry out the hazard analysis.

The standard lists what that information can include, as appropriate: biological, chemical and physical characteristics; what formulated ingredients are made of, additives and processing aids included; the source, whether animal, mineral or vegetable; the place of origin; the method of production; how the item is packaged and delivered; storage conditions and shelf life; preparation or handling before use; and food safety acceptance criteria or specifications suited to the intended use.

The phrase to the extent needed means the detail is driven by what the analysis requires. Product contact materials are included alongside ingredients.

Describe characteristics that affect the analysis

Consider relevant biological, chemical and physical characteristics. For formulated ingredients, understand the composition sufficiently, including relevant additives and processing aids. The necessary detail depends on the material and its intended use in the organisation's product or process.

Source, provenance and production method can inform the analysis. Packaging and delivery, storage conditions, shelf life and preparation before use may also affect the assumptions being made. These topics should be addressed where appropriate, rather than completed mechanically with information that nobody evaluates.

Product-contact materials belong in the review. Their intended application and relevant characteristics can affect food safety even though they are not consumed as ingredients. Obtain information suitable for the actual contact conditions and applicable requirements.

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Connect specifications with intended use

Define food safety acceptance criteria or specifications appropriate to the intended use. A supplier's general specification may need clarification where the organisation uses the material differently from the supplier's usual application.

Check consistency between the information used by the food safety team and the information used for purchasing and receipt. If the analysis assumes a particular characteristic, procurement should not treat a materially different alternative as interchangeable without evaluation.

Use suitable supplier communication to resolve uncertainty. A declaration is useful only to the extent that it addresses the relevant material and question. Do not interpret a missing statement as evidence of absence.

Maintain the information when materials change

Identify which changes need review, including formulation, source, production method, packaging or handling arrangements where relevant. Connect notifications with external communication and the food safety team's updating process.

Group genuinely comparable materials where appropriate, but preserve differences that can affect hazard identification or control. Convenience in the document system should not determine whether two materials are technically equivalent.

Why understanding materials matters to the business

Many food safety hazards enter with the materials. An allergen in a compound ingredient, a contaminant linked to a growing region or a packaging material unsuited to the product can all undermine controls inside the factory. Knowing what you receive, and why it is acceptable for your use, protects both consumers and your reputation.

There are procurement benefits as well. Clear acceptance criteria give purchasing a basis to compare alternatives on safety as well as price, and avoid disputes with suppliers about what was agreed. When a supplier changes a formulation, the team can immediately see which hazards are affected. In an audit or customer review, well-organised material information shows that purchasing and food safety work together rather than separately.

How to implement clause 8.5.1.2

Gather information by material group and keep it linked to how each material is used. The steps below are one practical approach.

  1. List every raw material, ingredient, processing aid and product contact material in scope, including packaging.
  2. Identify the legal food safety requirements that apply to each, such as limits, permitted use or labelling constraints.
  3. Request supplier information that answers the questions the analysis will ask, including composition, origin, production method and storage needs.
  4. Record the acceptance criteria that matter for food safety, matched to how you intend to use the material.
  5. Check that purchasing specifications and receiving checks align with the information the food safety team is using, and resolve any differences between them.
  6. Group materials only where they are genuinely equivalent for hazard purposes, and note the differences that remain.
  7. Tell the team whenever a source, formulation or handling arrangement changes, and review the information when it does, before the changed material is accepted into routine use.

Illustrative food-manufacturing example

Illustrative example 1

A manufacturer proposes a substitute ingredient with the same commercial function. The team compares relevant composition, processing and handling information before accepting it as equivalent. It identifies a difference that affects the preliminary information and requires reconsideration in hazard analysis.

Illustrative example 2

The purchasing team records the approved basis so a future substitution is not judged only by price and product name. No universal acceptance value is invented; the criteria need a suitable technical and requirement basis.

Automate™ on Effivity · included in every Sterling engagement

Keep clause 8.5.1.2 alive in Effivity

Record what you decided under clause 8.5.1.2, 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 food-packaging example

A food producer changes a product-contact packaging material. The team checks whether the supplier information addresses the intended food and conditions of use. It seeks clarification where the proposed use differs from the information provided.

The evaluation links the material decision with the end-product characteristics and process. A generic statement that the material is suitable for food contact is not automatically enough for every application.

Evidence and common failures

What counts as evidence

Maintain the relevant material information, applicable requirements and food safety acceptance basis. A structured specification can help, but the standard does not prescribe one fixed layout. Evidence should be sufficient for the decisions in hazard identification.

Common weaknesses

Common failures include omitting processing aids or contact materials, using supplier documents without checking applicability and allowing approved alternatives to accumulate without review. Another is maintaining detailed technical files that receiving personnel cannot connect to the material actually delivered.

Frequently asked questions

Does this cover packaging?

It covers product-contact materials. Evaluate the relevant characteristics and requirements for the actual application rather than treating packaging only as a commercial item.

Must every material have the same amount of detail?

No. Maintain information to the extent needed for hazard analysis, addressing relevant characteristics and requirements.

Can materials be grouped?

Yes where the grouping is technically justified and meaningful differences remain visible. Reassess when a material changes.

Close the gap between purchasing and hazard analysis

Discuss a material or supplier-information review with Sterling. Support can connect specifications, team learning and agreed evidence workflows through Effivity ISO & GRC automation software. Review HACCP Awareness, with the preliminary-steps guide and hub for context.

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.