The requirement that applies today
The organization acts to keep potentially unsafe product out of the food chain unless it can show the hazard is reduced to the acceptable level, will be reduced before the product enters the chain, or the product still meets the acceptable level despite the nonconformity. Product identified as potentially unsafe stays under control until it is evaluated and a disposition is decided. If product that has left the organization is later found unsafe, the organization notifies relevant parties and starts a withdrawal or recall. The controls, the responses and the authorisation are documented. Each affected lot is evaluated. CCP failures are not released. OPRP failures are released as safe only on evidence that the controls were effective, that the combination meets the intended performance, or that sampling and analysis show conformity. Product not acceptable for release is reprocessed, redirected to a use that does not affect food safety, or destroyed, with the disposition and the approving person recorded.
ISO 22000:2018, 8.9.4 Control of product and process nonconformities: potentially unsafe products; ISO/DIS 22000:2026, 8.9.4.
What the draft does
Unchanged title: The public contents keep 8.9.4 at the same number and title. No structural change is shown.
Source: public contents and foreword at 8.9.4, retrieved 2026-10-19.
Why this clause matters
This is the clause that stands between a bad batch and a public incident. It is long because the decisions are consequential. The site needs the authority, the evaluation method and the disposition options ready before the event, and the records have to show who approved what.
Suggested evidence to discuss with your auditor
For 8.9.4, these are the artefacts we suggest discussing with your auditor. The standard publishes no evidence list, so this is our reading, not a requirement.
- A hold and release procedure with named authorities
- A worked lot evaluation showing the evidence used for the decision
- Disposition records with the approving person identified
Where systems usually fall short
- Product released on assurance with no evidence
- A hold that exists in practice but is not recorded
How to prepare
Write the release decision for a hypothetical OPRP failure, naming the evidence you would accept. Then check whether the site can actually produce that evidence. If not, the release route is a hope.
Dates
Cross-references
Source
Clause 8.9.4. Current edition: ISO 22000:2018. Draft: ISO/DIS 22000:2026. Retrieved 2026-10-19. The full DIS text for 8.9.4 is sold by ISO and not held here; the sources page lists what is.
Not legal advice; does not certify; our words, not the standard's, and the planning date is an estimate.