Almost every day, in one of the countries that have food allergen lists and labelling requirements, a product is recalled because an allergen was not declared on the packaging but was found in the product.

January 2015 in the US saw recalls on undeclared peanuts in ground cumin, seasoning blends, bakery products, soups, salsa, sauces, veggie burgers and hummus. There were also recalls related to the presence of food allergens including shellfish in ravioli, tree nuts in cookies and almonds in snack items and cereals.1 Seventeen of the first 25 US Food and Drug Administration (US FDA) food recalls in 2015 were because of undeclared allergens, a figure that does not include a coconut pie that was labelled as lemon pie. For 2014, the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) reported that 43 of the 94 recalls were because of undeclared allergens.2

This year, to date, most of the recalls have been made because of an undeclared peanut protein in ground cumin, which had been contaminated by a peanut protein. Of course, this was not declared on the ingredient statement. The contaminated ground cumin was used by seasoning companies as part of seasoning in a wide range of products. The initial recall started in November and is still continuing because this raw material was used in other raw materials and finished products.

If the US FDA and the USDA FSIS didn’t have a zero tolerance on the big eight allergens (peanuts, tree nuts, wheat, eggs, milk, shellfish, fish and soy) then some of these recalls might not be taking place. At this time, the cumin supplier and provider states that no peanuts or peanut materials are in their facility, so it is not known if this issue was caused by unintentional or intentional contamination.

The reasons for undeclared allergen recalls vary, but have some common factors such as contamination during production, an undeclared allergen in a raw material because of product change or incorrect labelling.

Undeclared Allergen in a Raw Material Because of Product Change

The starting point for any food safety plan is knowledge of the raw material suppliers and the products/ingredients that are being provided. One must know what is in the ingredient provided, what changes have been made to it, and those that are to be made. Provision must also be made for prompt notification if/when the ingredient is no longer in compliance with the regulations or food safety standards.

When changes are made, or are going to be made, the ingredient company must ensure that any change resulting in an ingredient being added or even removed, especially an allergen, are notified to companies using the altered ingredient. Simply changing the ingredient statement on the packaging/ label may not be sufficient, because the receiver of this material may not have a proper programme to review labels and check that they match what they were expecting to receive. Without this detail, they cannot make the appropriate changes in their product. Alternatively, they may be rushed and skip this crucial step either because they have been waiting for the ingredient, or because it is holding up production and their customer is waiting for the product they produce.

These changes must be conveyed to the customer in a manner indicating that a change has been made, such as, “new formula now contains peanut allergen” on the container. This message must be conveyed to the company receiving the product in advance of its receipt. On the receiving side, no product should ever be used without verification that it is in compliance with the specifications, and that the ingredients are as listed on the specification, no matter how urgently the product is needed. Similarly, the receiver must make sure that any changes are also made on their own labelling and that the information is conveyed to their customer.

Incorrect Labelling

Product labelling and label control is an inadequately addressed area in the food business. The business needs to start addressing labelling as if the product is a drug or drug ingredient. All ingredients must be declared, even incidental additives, when they are allergens. Competent personnel must review labelling against the control (specification or control label). Labelling control must be rigorous to ensure that the correct and current packaging is being used.

This needs to be done either manually, or better still, by a computerised control system such as bar code scanning. There must also be control in the form of destruction of the old labelling, to prevent it being used by mistake. In addition, all labelling that is used, unused and destroyed must be accounted for. There must be control of any labeling returned to the inventory system and access to the packaging inventory controlled, whether it is inbound or outbound.

Contamination During Production

In production, there is the risk of unintentional contamination as well as intentional contamination for economic gain, or even to create harm. It is possible to put processes in place to reduce the impact, or risk, of unintentional contamination. There are some simple processes that need to be put into place to prevent this type of contamination. The most important being the control of rework, making sure that rework with allergens only goes into those products that it is designed to be in. Marking and recording is essential for the control of rework. Of course, if there is no rework, then it is important to ensure that the production lines or schedules are designed to separate allergen products from non-allergen product or other allergen products. This goes hand in hand with storage and handling processes at all points, from receiving through to shipping. This includes all equipment, clothing/ uniforms, gloves and personnel that can cross contaminate products. Air flow, along with process flow, must be designed to prevent cross contamination. Validate cleaning programmes and verify that cleaning is performed according to the validated programme. Allergen testing is required for validation and it can be useful for verification too. Testing of the finished product for potential allergen contamination may be useful, as a pass/fail release, but should not be relied on for replacement of allergen process controls.

Intentional contamination is harder to prevent and may be impossible to prevent if key management and personnel are involved. There are ways to reduce these risks by assessing the systems, facility and procedures for those vulnerable points and to then establish programmes to reduce the risk of contamination at those points. This can be as simple as locks and key controls and in certain operations or in certain countries.

This can be achieved through in-process inspection by a third party, which may aid in mitigating these risks. Regulatory agencies and standard holders are asking the industry to start developing systems to reduce these risks. Unfortunately, this is a growing area of concern, and must now be addressed by processing facilities.

Mistakes will happen, but having an atmosphere in the operation that allows an employee to state that a mistake has been made, without repercussion, will prevent mistakes from being hidden, only to be discovered when the product is no longer under the control of the facility. Additionally, the way a mistake is handled afterwards is essential to the continuous improvement of a food safety plan. Root cause analysis can identify why these mistakes happen. Corrective action and preventative actions must then be developed to prevent any recurrence. Continuous improvement is essential and requires internal and external audits to review operations and procedures.

For more information, please visit SGS Food Safety website or contact:

Jim Cook
Food Scientific and Regulatory Affairs Manager
SGS North America, Inc.
t: +1 973 461 1493
SGS Agriculture & Food


1 FDA - Recalls, Market Withdrawals, & Safety Alerts
2 USDA - Summary of Recall Cases in Calendar Year 2014