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Is your company’s allergen control plan recall-proof?

March 2014

A food recall is a high-impact event that could potentially cripple a company. Apart from the health risks and exorbitant costs associated with such an incident, the ensuing brand and reputational damages may be severe and long-lasting. In spite of a company’s best efforts to produce safe foods that comply with applicable legislative requirements, errors can occur, production processes can fail, and controls can falter, meaning that an immediate recall can become a real and daunting eventuality. Although multiple factors may lead to recalls in today’s globalised and complex food supply chains, evidence from several countries suggests that many more products are recalled due to labelling errors than from any other cause, including microbial and foreign-object contamination.

But did you know…
Among these labelling errors, undeclared allergens continue to be a major cause of food recalls in recent times.

Over the previous decade, the food industry has been hard-pressed to gain improved knowledge of the impacts of food allergens in the supply chain and to consumers. This has largely been attributed to the reported increase in the incidence of food allergies, and the associated passing of legislation in many countries (including South Africa) stipulating the declaration of specific ‘common allergens’ on food product labels.** These ‘common allergens’ typically include the ‘Big 8’ believed to cause ca. 90% of food-allergic reactions, namely cow’s milk, egg, soya, peanuts, tree nuts, fish, shellfish, and gluten-containing cereals. In accordance with such legislation, failure to indicate these is both unlawful and potentially hazardous to consumer health, thus compelling recalls in many cases.

How common exactly? Allergen recall statistics are severely lacking in South Africa; and since government does not maintain such data or make it publicly available, ‘silent recalls’ are bound to have occurred. With allergen labelling now being a legal entity, related recalls are expected to increase. This has already been exemplified by the 2011 Class I recall by General Mills of a muffin mix that potentially contained undeclared nuts.


What is a food recall?
A food recall is any corrective action taken to remove a product from the market to protect consumers from the potentially adverse effects of misbranding, contamination or adulteration. Recalls are often initiated on the manufacturer’s initiative (voluntary recall), but may also be ordered by statutory authorities (official recall).

Why are food recalls initiated?
- Product is in violation of applicable regulations
- Legal action could be taken against manufacturer
- Product could lead to health hazard or brand damage

What are the types of food recalls?
Trade/industry recall: recovery of products from distribution centres, wholesalers, catering institutes or outlets selling food for immediate consumption.
Consumer recall: extensive recovery of products from all points of production, distribution and retail, as well as from consumers.

What are the classes of food recalls?
Class I recall: an emergency situation involving a health hazard where there is a reasonable probability that ingestion will cause serious adverse health problems or death.
Class II recall: involves a potential health hazard, where there is a remote probability that ingestion will cause a temporary or reversible health problem.
Class III recall: involves a situation in which ingestion is unlikely to cause a health problem.

On the international front, allergen recalls in the US, Canada and Australia/New Zealand (ANZ) more or less doubled in number between fiscal years 2007 and 2012 (Fig. 1). During this period, a total of 732 allergen recalls were recorded by the US Food and Drug Administration (FDA), of which 63% were Class I and 35% were Class II recalls. Although recalls have recently been initiated due to all of the ‘Big 8’, the frequency for some allergens is higher than for others. Data from the US and ANZ (2007-2012) indicate that milk has been the chief offender, trailed by wheat, soya, peanut, tree nuts and egg, while fish has been implicated to a lesser extent (Fig. 2). US allergen recalls for bakery goods, snacks and confectioneries have outpaced those for all other food categories, with the root causes being primarily labelling omissions, incorrect packaging, unclear terminology, and cross-contact.
Recent international allergen recalls

US, 19 Jan 2014: A Kentucky company, Truitt Brothers Inc., recalled 1.77 million pounds of Kraft Velveeta cheese macaroni products that contained undeclared hydrolysed soya protein and dried soya sauce. The root cause appeared to lie with a label supplier who had mixed product labels listing different allergens.

US, 4 Feb 2014: ConAgra recalled ca. 27 tons of chicken noodle soup that contained egg and wheat which were not declared on the label. The company was alerted to the problem via consumer complaints.

UK, 26 Feb 2014: Sainsbury’s recalled chestnut, hazelnut and thyme stuffing mix due to undeclared peanuts.

Canada, 8 March 2014: Altra Foods Inc. recalled Chocolat Alprose brand 52% Cacao Premium Dark Chocolate, since the product contained milk that was not declared on the label.

Following persistent trends, allergens continued to be the single largest cause of food recalls in the US in 2013, accounting for a staggering 60% of FDA and 65% of US Department of Agriculture (USDA) recalls in the second quarter of this year. Undeclared allergens were also the basis of 35% of food recalls in the UK in 2011, with prominent supermarket chains such as ASDA, Tesco and Morrisons being involved in these incidents. Clearly it is not only small manufacturers, but also the biggest and the best that have struggled to ensure compliance with prevailing legislation and have fallen victim to allergen recalls. Such findings serve as a wake-up call for all members of the food industry to tighten manufacturing protocols and controls.


Building a recall-proof allergen control plan
The hazards that give rise to allergen recalls exist in almost every food-manufacturing facility, but their effects can largely be mitigated through the implementation of a robust and verifiable allergen control plan. Risk assessments and applicable operating procedures form the basis of such a plan, and include – among other actions – the identification of potentially allergenic raw materials; the segregation of allergens during receiving, storage and production; validated cleaning procedures; and the accurate labelling of products according to legislation. In addition, the efficacy of these measures should periodically be substantiated by allergen residue-testing by appropriate analytical methods (e.g. the Enzyme-Linked ImmunoSorbent Assay [ELISA] or Polymerase Chain Reaction [PCR]).

Even with a state-of-the-art control plan, however, a food manufacturer had best be prepared to take a proactive stance in protecting individuals – and their brand – with a thorough and critically-evaluated recall plan. This plan should detail the step-by-step procedures to be taken from that formidable moment when undeclared allergens are discovered in consumer-facing products. The most vital element of a successful recall is timing. The company needs to respond immediately and complete the process rapidly to reduce negative public and financial impact; which will only be made possible through pre-planning, the involvement of the correct individuals, and clear communication.

An effective recall plan should include:
• Key personnel and accountabilities: a recall team should be pre-determined and the responsibility of each member should be defined, as should the designation of a recall co-ordinator and spokesperson.
• Contact and notification measures: emergency contact lists and notification procedures should be drawn up to permit communication with recall team members, authorities, distributors, retailers and consumers.
• Records: Current and effective traceability records should be available for tracking where each consignment of effected product has gone, as well as measures for reconciling the amount recalled with that distributed.
• Procedures for food retrieval and disposal.
• Review: Post-crisis root-cause analysis, and corrective actions needed to prevent reoccurrence.

Additional local guidelines to assist with food recalls:
• Department of Health Policy Guidelines: National Food Safety Alerts and Official Product Recalls in South Africa.
• The Food Safety Initiative Food Industry Recall Guideline, compiled by the Consumer Goods Council of South Africa.

**While allergen-labelling regulations in most countries currently relate to pre-packaged foods, new legislation is set to come into effect in the EU at the end of 2014 which will require food companies to provide allergen information for unpackaged foods (e.g. in bakeries, delis and catering establishments). Modifications to existing requirements for labelling pre-packaged foodstuffs will also be part of this legislation.