This article puts to the test what is explained in food traceability and connects with the requirements of GFSI schemes.
Table of contents
A plan written so you do not have to improvise
When an unsafe food has already left the plant, you need to know which lots are affected, where they are, whom to notify and who decides, and none of those questions is answered well for the first time in the middle of a crisis. That is why United States and European Union legislation, the Codex Alimentarius and GFSI-recognized schemes ask for the same thing in different words: a written procedure to remove product, traceability capable of supporting it and periodic tests that show both work.
Withdrawal and recall are not the same
The FAO and WHO guide on national food recall systems warns that the word withdrawal changes meaning from country to country: in some it refers to removing product that has not reached the consumer, in others to removal for quality rather than safety reasons.
In the European Union
Article 19 of Regulation (EC) No 178/2002 distinguishes two actions. If an operator considers or has reason to believe that a food it has imported, produced, processed, manufactured or distributed is not in compliance with food safety requirements, it must immediately initiate procedures to withdraw it from the market where the food has left its immediate control, and inform the competent authorities. Where the product may have reached consumers, it must effectively and accurately inform them and, if necessary, recall products already supplied to them when other measures are not sufficient to protect health. Retailers and distributors must withdraw the product within their own activities and provide the traceability information required by Article 18.
In GFSI schemes
FSSC 22000 version 6 adopts the GFSI definitions (2020.1): a product recall is the removal of an unsafe product that has already been sold to the end consumer or is available for sale at retailers or food service; a product withdrawal is the removal of an unsafe product that has not yet been placed on sale to the end consumer.
In the United States
21 CFR 7.3 uses other categories. A recall is the removal or correction of a marketed product that FDA considers to be in violation and against which the agency would initiate legal action. A market withdrawal is the removal or correction of a distributed product that involves a minor violation that would not be subject to legal action, or no violation. A stock recovery is the removal of a product that has not been marketed or has not left the direct control of the firm. A recall can be initiated by the firm on its own, at FDA's request or by order of the agency.
FDA recall classes
FDA assigns each recall a class according to the health hazard, as defined in 21 CFR 7.3:
- Class I. There is a reasonable probability that the use of, or exposure to, the product will cause serious adverse health consequences or death.
- Class II. The product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
- Class III. The product is not likely to cause adverse health consequences.
The class shapes the strategy. 21 CFR 7.42 requires each strategy to define three things: the depth (consumer or user level, retail level or wholesale level), the need for a public warning, reserved for urgent situations where other means are not enough to prevent use of a product that presents a serious hazard, and the level of effectiveness checks. The latter ranges from level A, which requires contacting 100% of consignees, to level B (more than 10% and less than 100%), C (10%), D (2%) and E (no effectiveness checks).
What a recall plan must contain
21 CFR 117.139 requires a written plan for foods whose hazard analysis identifies a hazard requiring a preventive control. It must describe how consignees are notified directly (including how to return or dispose of the product), how the public is notified when appropriate, how effectiveness is checked and how the recalled food is disposed of: reprocessed, diverted to a use that does not present a safety concern or destroyed. It must also assign responsibilities. Combined with the other frameworks, a complete plan includes:
- Team and authority. Who initiates, who manages and who investigates, with deputies. IFS Food version 8 (requirement 5.9.1, KO No. 9) also requires a person who is authorized and permanently available to initiate the process in a timely manner.
- Decision process. Written criteria to assess the risk and decide the scope (which lots), the depth and whether production is stopped.
- Up-to-date contact list. Customers, authorities, legal counsel and, in GFSI schemes, the certification body.
- Communication plan. Internal, with the authority, with customers and, if the product reached the consumer, with the public. FDA's 2022 guidance recommends having draft letters and press releases ready.
- Lot coding and distribution records. 21 CFR 7.59 calls for coding that allows positive lot identification and for distribution records to be kept beyond the shelf life and expected use of the product.
- Handling of recovered product. Codex (CXC 1-1969, section 13.5) requires it to be held under secure conditions until its disposition is decided, and the cause, extent and corrective actions of the recall to be documented.
Codex adds one idea: when a product is recalled because of a hazard posing an immediate health risk, other products produced under similar conditions must also be evaluated, because they may present the same hazard. The plan should be linked to the HACCP system, which is where hazards and corrective actions are defined.
The mock recall: test it before you need it
Codex requires recall procedures to be documented, maintained and modified based on the results of periodic tests. The FAO and WHO guide recommends that operators carry out regular simulation exercises to check that contact lists are up to date and that staff are trained. GFSI schemes turn that recommendation into auditable requirements, with differences worth knowing (see GFSI schemes and audits):
- IFS Food version 8. The traceability system, including mass balance, must be tested at least once every 12 months or whenever there are significant changes (4.18.2), in both directions. Traceability from the finished product to the raw materials and to the customers must be completed within four hours at most, or less if the customer requires it (4.18.3). Separately, the recall procedure must be tested end to end: the test is planned within a 12-month period and its execution may not exceed 15 months (5.9.2).
- SQF Food Manufacturing, edition 9. The recall system must be reviewed, tested and verified as effective at least annually, covering incoming materials (one step back) and finished product (one step forward). Tests must include products from different shifts and materials that are used in several products or reach many customers (2.6.3.2). Edition 10 was published in March 2026 and, according to SQFI, will not come into force before January 1, 2027.
- BRCGS Food Safety, issue 9. According to the BRCGS FAQs, incident management procedures, which include recall, must be tested at least once a year (3.11.3). The traceability test (3.9.3) includes a mass balance that also covers packaging and labels printed with legal or safety information.
- FSSC 22000 version 6. It takes traceability and the recall procedure from ISO 22000:2018 (clauses 8.3 and 8.9.5), includes traceability exercises within audit time and requires the certification body to be notified within 3 working days of public food safety events, such as a public recall (2.5.17).
How to set up a useful mock recall
A good exercise picks a real finished-product lot and a raw material lot shared by several lines, measures the time from the alert to having the complete list of consignees and reconciles quantities: what was produced must match what was shipped, what remains in stock and losses. It is worth actually calling some contacts, including another shift and recording deviations with their corrective actions. FDA's 2022 guidance suggests setting metrics and correcting procedures or training if a mock recall goes badly.
The laboratory should also take part: besides where the lot is, you need to know which tests were run on it, with what results and whether samples or enrichment broths remain for retesting.
The role of the laboratory before deciding
Many recalls start with an analytical result from the company itself, from official sampling or from environmental monitoring. Before deciding, the person in charge needs to know what type of result they have in hand.
Presumptive or confirmed
A positive from a screening method, such as PCR on the enrichment broth, is a presumptive result until it is confirmed by culture and identification according to the reference method. Why a presumptive result may not be confirmed is explained in presumptive vs. confirmed result. That difference guides the action, but does not always delay it:
- If the product is still under the company's control, the prudent course is to hold it until confirmation. USDA-FSIS has applied this logic to its own sampling since February 8, 2013: if it tests a product for adulterants, such as Listeria monocytogenes or Salmonella in ready-to-eat products, the establishment must maintain control of the product and not release it into commerce until negative results are received.
- If the product has already been distributed, FDA's 2022 guidance states that the firm does not need to wait until the investigation is complete to initiate a voluntary recall. The decision is made by a qualified person using established criteria.
In the European Union, Article 7 of Regulation (EC) No 2073/2005 establishes that, if testing against a food safety criterion gives an unsatisfactory result, the product or batch must be withdrawn or recalled in accordance with Article 19 of Regulation 178/2002. Products not yet at retail level may be subjected to a treatment that eliminates the hazard, carried out by operators other than retailers.
What the laboratory report should provide
- The status of the result (presumptive or confirmed), the method and the test portion analyzed.
- An unambiguous link between the sample and the lot, line and shift.
- Retention of the enrichment broth and the isolate, which allows confirmation, serotyping and strain comparison by whole genome sequencing.
Negative results in other lots do not prove they are free of the pathogen: sampling only bounds the probability of detecting it (see attribute sampling plans). The scope is defined by traceability and process boundaries, such as full cleanings between lots.
Which TAAG kits relate to this topic
A detection kit does not replace the recall plan, but it can shorten the time to a presumptive result and help decide what to hold. In the TAAG catalog, Ampliora 3.5 Salmonella spp., L. monocytogenes and Listeria spp. (V-SF59) is a multiplex real-time PCR that detects all three targets in one reaction, with declared validated matrices in cold cuts, cured meats, dairy products, frozen vegetables and surfaces, a declared sensitivity of 1 CFU/25 g in foods and 1 CFU/100 cm² on surfaces, and 100 minutes of PCR. Ampliora 1.1 Salmonella spp. (V-SF97) declares 1 CFU/25 g in raw chicken thigh, frozen beef burger, sausage (longanicilla), mortadella and surface. In both, the TxA software interprets the curves automatically. Their positives are presumptive and must be confirmed according to the reference method required by the applicable criterion; if the matrix is not among those declared, the scope must be confirmed with TAAG before using them to decide on a lot.
Conclusion
A recall plan works if it quickly answers three questions: which lots, where they are and who decides. FDA, the European Union and Codex agree on the essentials, with a written plan, identified lots, distribution records and communication with authorities and customers, even though they use different categories to name the removal. GFSI schemes add the requirement to test it at least once a year, with mass balance and, in IFS, a maximum time of four hours for traceability. The laboratory is part of the decision: distinguishing a presumptive from a confirmed result, retaining the isolate and having the records at hand determines whether product is held, withdrawn or recalled.
About TAAG
Ask TAAG whether Ampliora 3.5 Salmonella spp., L. monocytogenes and Listeria spp. covers your matrix to obtain presumptive results within the time your hold and recall plan requires.
Frequently asked questions
What is the difference between withdrawal and recall of a food?
In the European Union, withdrawal removes from the market a food that does not comply with food safety requirements once it has left the operator's immediate control; recall goes further and retrieves product that is already in consumers' hands. GFSI uses a similar distinction between withdrawal (product not yet placed on sale to the end consumer) and recall (product already sold or available for sale).
What do FDA recall Classes I, II and III mean?
Class I: reasonable probability of serious adverse health consequences or death. Class II: temporary or medically reversible consequences, or a remote probability of serious effects. Class III: not likely to cause adverse health effects. The class guides the depth of the recall, the public warning and the level of effectiveness checks.
How often should a mock recall be carried out?
It depends on the scheme. IFS Food version 8 requires traceability to be tested at least once every 12 months and the recall test to be planned within 12 months without exceeding 15; SQF edition 9 and BRCGS issue 9 require at least an annual test. FDA guidance suggests considering them, particularly for firms that anticipate complex recalls.
Do you have to wait for laboratory confirmation to start a recall?
Not necessarily. If the product is still under the company's control, the prudent course is to hold it until confirmation. If it has already been distributed, FDA states that the firm does not need to wait until the investigation is complete to initiate a voluntary recall; the decision depends on the hazard and the exposed population.
How quickly must a traceability test be completed?
IFS Food version 8 sets a maximum of four hours to trace from the finished product to the raw materials and to the customers, or less if the customer requires it. Other schemes require the test and the mass balance, but the target time is set by the company or its customer.