Food Product Recall: Procedure, Mock Recall and Traceability Exercise

In the UK, the duty is set out in retained Regulation (EC) 178/2002, Article 19(1). An operator who "considers or has reason to believe" that a food it has imported, produced, processed, manufactured or distributed is not compliant with food safety requirements "shall immediately initiate procedures to withdraw the food ... and inform the competent authorities thereof". Where the food may have reached consumers, the operator must inform them and, "if necessary, recall". Under Article 19(3), an operator "shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health".

In the US, 21 CFR 117.139 requires a written recall plan "for food with a hazard requiring a preventive control". It does not apply to every facility, so check whether your products fall within that scope.

The two terms are often used interchangeably on site, but regulators separate them clearly.

In the US, FDA assigns each recall a class under 21 CFR 7.3(m):

• Class I: a "reasonable probability" that the product "will cause serious adverse health consequences or death".
• Class II: temporary or medically reversible health consequences, or a remote probability of serious ones.
• Class III: "not likely to cause adverse health consequences".

Neither term is defined in UK or US regulation. They come from the standard owners, and IFS Food treats them as two separate tests: a traceability test (clause 4.18) and a recall and withdrawal test (clause 5.9).

In IFS Food Version 8, both the traceability system (4.18.1) and the recall and withdrawal procedure (5.9.1) are KO requirements. BRCGS Food Safety Issue 9 also requires an annual traceability test (3.9.3) and an annual recall and withdrawal test (3.11.3). If you are audited against another standard, check its current version for test frequency and timing. Customer timeframes also apply where they are shorter.

1. Choose the scenario. Pick a real batch and a plausible cause, for example an undeclared allergen or a supplier alert on a raw material.
2. Start the clock. Record the time the scenario is issued to the recall team.
3. Trace back. Identify every raw material lot, packaging lot and supplier linked to the batch.
4. Trace forward. Identify every customer and quantity shipped, plus stock still on site.
5. Reconcile quantities. Compare quantity produced with quantity shipped, held and used. Record any gap.
6. Walk through notification. Confirm who would be contacted, in what order and with what information. Do not contact real customers or regulators unless your test plan says so.
7. Stop the clock and record. Note the total time, the reconciliation result and every problem found.
8. Review and act. Raise corrective actions for each weakness and set a date to retest.

Your test timings and frequency should follow your certification standard and customer requirements. Under IFS Food Version 8, traceability from finished product to raw materials and customers must be achievable within four hours (4.18.3), and the outcome of the recall test "shall be reviewed for continuous improvement" (5.9.2).

A robust procedure usually covers:

• Scope, and the roles and deputies of the recall team, with out of hours contacts
• Criteria for deciding between withdrawal and recall
• How affected product is identified, using batch and date codes
• Who notifies the authorities, customers and consumers, and when
• Consumer recall notice content
• Stock retrieval, quarantine and disposal
• Effectiveness checks
• Root cause analysis and review after the incident

IFS Food 5.9.1 sets minimum content for the procedure: responsibilities, training, decision making, a permanently available authorized person, an alert contact list and a communication plan.

UK Notes

• Notify the competent authority: your local authority, or the port health authority for imports.
• Contact the FSA directly if the food went outside the UK, or if the incident is serious and the product has reached customers. GOV.UK lists what a report must include.
• Do not build a fixed number of hours into your procedure for UK notification. The legal wording is "immediately".
• Consumer recall notices should give product details, batch and date codes, an image, the reason for the recall, what to do, disposal advice and where to get more information. The FSA provides template recall documents.
• The FSA publishes detailed Guidance on Food Traceability, Withdrawals and Recalls, plus a quick reference guide, and advises root cause analysis after an incident.
• Scotland: Food Standards Scotland says a food business operator is "legally required to: inform their local authority; inform Food Standards Scotland where relevant; withdraw ... recall ... notify their local authority when a product is withdrawn or recalled". FSS issues product recall information notices (PRINs), allergy alerts and food alerts for action (FAFAs). See the FSS food and feed incidents guidance and the joint FSA and FSS withdrawals and recalls guidance, which covers all four UK nations and includes editable recall and allergy alert templates.

US Notes

• Under 21 CFR 117.139, the written recall plan must cover notifying direct consignees, notifying the public when appropriate, effectiveness checks and disposal of the recalled food.
• For a recall the firm starts itself, 21 CFR 7.46 says the firm is "requested to notify immediately" FDA, providing the product identity, reason, risk evaluation, amounts produced and in distribution, distribution list, communications, recall strategy and a contact.
• The Reportable Food Registry covers food where there is a "reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death". It was set up under the Food and Drug Administration Amendments Act 2007. It applies to all FDA regulated food and feed except dietary supplements and infant formula.
• Under 21 USC 350f, "as soon as practicable, but in no case later than 24 hours after a responsible party determines that an article of food is a reportable food", the responsible party must submit a report to FDA.
• If you export to the US, our FSMA 204 guide explains the additional traceability records FDA expects for certain foods.

Every test and every live incident should leave a record an auditor can follow:

Treat each weakness as a nonconformance with a root cause and a corrective action, then verify the fix at the next test. Many recalls start with a signal elsewhere, such as a customer complaint or a supplier issue, so link this procedure to your complaint handling procedure, your supplier audit checklist and, for undeclared allergens, your allergen risk assessment.