RQA Group’s Top Ten Weakest Links in Allergen Management

Allergen-related recalls are always in the headlines and with some recent serious and tragic cases where allergic reactions have proven fatal, they are very much in focus with the authorities and auditors too.  So, what do the recall numbers tell us in Europe, Australia and the US?

The number of alerts relating to allergens issued by RASFF has increased steadily over the last 4 years. So far in 2019 (until end of November) there have already been 153 alerts (the most serious category of notification in  RASFF), which is more than 2018 total for the full year, which was 138.


Undeclared allergens have triggered the highest total number of recalls in Australia in the last ten years (266 recalls or 39% of all recalls during this period). The numbers have increased steadily and since 2013 allergens have consistently been the main reason for recall in the country.


Conversely, in the US recall events have been steadily declining over the last few years. These numbers do not include labelling or packaging errors that mean an allergen is not declared.

Why are allergen recalls still so commonplace?

With so much focus on Allergen Management in the Global Food Safety Initiative (GFSI) endorsed standards such as BRC and SQF as well as in retailer standards, why are there still so many allergen recalls?  Allergen management is multifaceted and requires numerous controls to be implemented effectively throughout the supply chain – from raw material suppliers to final labelling and packing and distribution. Any system is only as robust as its’ weakest link and failure of any one of these controls at any point in the supply chain can result in undeclared allergens and a recall or withdrawal.

The following are 10 potential “weakest links”:

1. Training

• Allergen training should be provided to all new employees at induction and repeated regularly, and visitors and contractors should receive training appropriate to their site activities before entering production areas.

• All staff involved in the commercialisation, production and distribution of foods should receive training in the implications of the presence of undeclared food allergens. This should include the need to manage the risk and the role individuals play in reducing the risk of cross-contact such as using dedicated workwear and the good personal hygiene practices.

• Senior management, marketing, product developers, engineers, operators, production schedulers should all receive general allergen training in addition to specific training related to their allergen management responsibilities.

2. Supplier Management

• Allergen risk assessments are only effective if the information about the allergen status of the raw materials and ingredients is correct and complete.

• Always clarify information from suppliers – query anything unusual, don’t accept generic terms and don’t make assumptions. Keep asking questions until you are satisfied with the response – data gaps should not be accepted.

• Ensure that information in raw material specifications, on packaging, and on labelling matches.

• Make sure a change notification process is in place with every supplier so that newly identified allergen risks for ingredients that are already being supplied are notified and can be acted upon.

• Look out for hidden allergens – they are not always obvious.

• Only accept ingredients from approved suppliers.

3. Manufacturing Premises and Equipment

• Allergens should be physically segregated in storage areas, preferably under locked control to prevent inadvertent or malicious use.

• Adequate space between production lines and around equipment ensures that cleaning and inspection of cleaning is effective to minimise the risk of allergen cross contact.

• Where practically possible production areas or lines and equipment should be dedicated to specific allergen profiles. This includes weighing equipment, and colour coded scoops and other hand-held utensils.

• Where specific allergen free claims are being made equipment, personnel, vehicles and maintenance tools should be dedicated to the area and staff should wear visibly distinguishable hygienic workwear.

• Consider the risk of airborne contamination. Dedicated air handling units with controlled pressure between areas or dust extraction systems may be required.

• Other potential sources of allergenic materials should be risk-assessed. Some examples include peanut oil in lubricants, wheat flour in cardboard packaging release agents, and peanuts in non-toxic internal rodent indicator baits.

4. Process Controls

• Using the wrong ingredient in a recipe should be a “Never Event” and there are a number of control systems that can be employed to avoid mistakes, including manual verification with supervisory cross checks at the point of both weighing up and addition, or more sophisticated software systems utilising barcode generation and scanning that alerts if incorrect ingredients are scanned at any point in the weighing up and addition process. Long sentence, break up into smaller sentences • Rework should be considered as an “ingredient” which these systems also need to consider, and controls must be in place for the labelling of semi-finished goods and work in progress.

• Where physical separation is not possible, cross-contact can be avoided using temporal segregation through production scheduling. Production runs should be scheduled so that products without allergenic materials are produced first after the last full clean, and product produced subsequently have must have increasingly complex but compatible allergen profiles.

• This method of management introduces different risks, and the temptation to change the production schedule, for example when packaging materials have not arrived, must be closely managed.

5. Changeovers

Changeovers between products are frequently seen as production downtime or as a non-value adding activity. Management pressure to minimise the amount of time between production runs can result in failures of changeover processes leading to wrong packaging being used with incorrect allergen declarations (another Never Event), or cross-contamination through inadequate cleaning.  Thorough and effective changeovers. are fundamental to allergen management and an investment in product safety.

Effective changeovers require:

• Line Clearance: Removal of product previously manufactured on the line, ingredients and packaging and the line cleaning.

• Set Up: Bringing new ingredients or product and packaging to the line and re-setting equipment such as date-code printers, vision systems, online check weighers and metal detectors.

• Start Up: All activities from line clearance and set up should be checked, confirmed and signed off before the next production run begins.

Packing of products into incorrect packaging is one of the main reasons for UK FSA Allergen Alerts and RQA classes these recalls as “Never Events”.

6. Cleaning

Effective cleaning is one of the most important aspects of any allergen management strategy. A “visually and physically clean” standard requires that all potential hang ups or difficult to clean areas are identified and subject to a detailed and attentive inspection of the production line or area.

Cleaning procedures for food contact surfaces should be validated by analysis to ensure that they are effective at removing allergens. Validation should consider:

  • Which allergenic derivative is the most complicated / challenging to clean, e.g. sticky materials or particulates
  • Which recipes contain which allergens in highest proportions
  • Analytical validation methods are appropriate to the food matrix and allergen

Environmental cleaning should consider accumulations of settled allergenic material on flat surfaces, e.g. machine guards, windowsills, shelves and cleaning methods should prohibit the use of high-pressure hoses or air blowing that may create allergen containing aerosols or distribute powder or small particulates.

7. Labelling

Ingredient lists and allergen declarations on products must comply with Allergen Labelling Regulations for the country of consumption. For the EU, this is EU 1169/20111 but be aware that allergens that must be declared vary outside the EU. See point 8 below. Ensure that there are systems in place to ensure that following a recipe change to a product all old packaging is not only withdrawn from use but destroyed so it cannot be used in error.  It is good practice to design packaging to clearly differentiate between different varieties of similar products to minimise the chance of incorrect use.

8. Allergen labelling requirements outside of the EU

Allergen labelling regulations vary from country to country, and as well as the 14 main EU allergens there are another 10 allergens which may potentially need to be declared depending on your overseas market which are: Buckwheat, Beef, Bee Pollen / Propolis, Chicken, Royal Jelly, Pork, Mango, Tomato, Peach, Latex

In Japan, mandatory labelling is required for shrimps, crabs, wheat, buckwheat, eggs, milk, peanuts and walnuts, and voluntary labelling is recommended for Abalone, Mackerel, Squid, Salmon, Salmon Roe, Cashew, Matsutake Mushroom, Sesame, Soybean, Yam, Apple, Banana, Kiwifruit, Orange, Peach, Beef, Chicken, Gelatin, Pork and Almond.
In Australia, Section 1.2.3 of the Australia and New Zealand Food Standards Code requires mandatory allergen labelling for Peanut, Tree nuts, Milk, Eggs, Sesame, Fish, Shellfish, Soy, Wheat, Lupin & Royal Jelly3.In the US, under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) the list is smaller with only Crustacean Shellfish, Egg, Fish, Milk, Peanut, Soy, Tree Nuts, Wheat  required to be declared2.

You will find the  Food Allergens – International Regulatory Chart very useful as a resource to understand the varying allergen labelling requirements globally.

9. Food Prepacked for Direct Sale (PPDS)

From October 2021, the way food businesses in the EU must provide allergen labelling information for food that is Prepacked for Direct Sale (PPDS) will change4.

Foods will need to have a label with a full ingredients list with allergenic ingredients emphasised within it. These changes will provide essential information to help people with a food allergy or intolerance to make safe choices when buying food Prepacked for Direct Sale food.

10. Allergen Testing

Allergen testing and analysis is complex and to ensure that analysis undertaken provides the information you need to support your allergen management system there are some simple rules that should be followed:

• Analysis for cross contact allergens should consider the type of potential cross contact, and involve different time points within a batch, multiple batches, or possibly different
production runs.

• A stringent, risk-based ongoing sampling plan should be implemented where any pack claim is made.

• Composite samples dilute the true allergen concentration and report a value that does not represent the level in each individual sample.

• The choice of test kits for use on the manufacturing site or laboratory analysis depends on the required outcome – an unquantified check to verify cleaning or a quantified result to inform a risk assessment.


Through a better understanding of the risks, putting an allergen management plan in place to mitigate these weakest links, and carrying out regular allergen risk reviews, you should be able to avoid a costly and brand damaging product recall.

For more information on how RQA can help you with allergen management, such as planning, risk reviews and allergen training get in touch on contact@rqa-group.com or call us on +44 (0)118 935 7242.

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RQA Group – Allergen Management Weakest Links



2FDA Allergen labelling information     

3 Australian allergen labelling information

4 EU information on changes to labelling of Prepacked for Direct Sale

Further Reading:

RQA Group Never Events article

Allergen Bureau’s Allergen Risk Review website

Allergen statistics from Allergy UK