Labelling, claims and in-house printed materials
Plain-language summary
Labels must be legal in the country of sale, every claim must be provable, and anyone printing their own labels needs artwork and print controls.
What the clause is really asking
A safe product with the wrong label is still a recall. The clause requires finished products to be labelled to the statutory and regulatory requirements of the country where they will be sold — allergen and customer requirements included — and, where product is unlabelled, that the information needed for safe use still reaches the customer. Any claim on the pack (allergen, nutritional, method of production, chain of custody, raw-material status) must be validated and then verified, with traceability and mass balance to prove the claim holds. If you print labels or printed materials yourself, you need artwork management and print control: master approval, change control including obsolete artwork, approval of each print run, error detection during the run, segregation of variants, and accounting for unused printed product.
What auditors look for
Auditors take an export product and check the label against that country's rules, not yours. They pick a claim — 'gluten free', 'organic', 'RSPO' — and ask for the validation and the mass-balance reconciliation. On an in-house print line they ask for the master, the run approval and what happened to the leftover labels.
Typical evidence
Label legality review per country of sale; claim validation and verification records incl. mass balance; artwork master approvals; print-run sign-offs; artwork change control and obsolete-artwork disposal records; unused-label reconciliation
How to comply — recommendations
Keep a label register per market with the regulatory review date. Treat every claim as a control: define what proves it, how often, and who reconciles the mass balance. On the print line, make the master sample physical and signed, and count labels out and back — the reconciliation is what stops a mixed-variant recall.
Common nonconformities
Labels checked against home-country rules only; claims with no validation or mass balance; no master sample or run approval on in-house printing; unused or obsolete labels not accounted for
Related clauses
ISO 22000 8.5.1.3 (characteristics of end products), 8.3 (traceability); FSSC 22000 2.5.9 (line clearance of labels), 2.5.1
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