Suzanne Callander reports on the compliance challenges facing bakeries today when it comes to ensuring accurate labelling of products.  

According to the World Allergy Organization (WAO), the global prevalence of food allergies is estimated to affect up to 520 million people. It estimates that 3 – 10% of children have food allergies, with 40% of children with food allergies being allergic to multiple foods, while up to 10% of adults also have food allergies. 

Undeclared allergens are the leading cause of food recalls. In the US, for example, FDA food recalls for all but one quarter since Q2 2017 were as a result of undeclared allergens, including 52 recalls in Q3 2023 alone. Further, the volume of overall food recalls is increasing – there were a total of 506 FDA recalls across 2023, a five-year high for the industry.  

In an era where food allergies seem to be becoming increasingly prevalent, stringent allergen labelling regulations have been put in place across the globe to protect consumers. For bakery manufacturers, navigating this complex web of European and global allergen labelling requirements is challenging, but essential. Compliance is not just a legal obligation but is also a way to build trust with consumers and avoid costly recalls. 

The World Health Organization lists its ‘big 8’ food allergens as: 

• Cereals containing gluten 

• Crustacea and products of these 

• Eggs and egg products 

• Fish and fish products 

• Peanuts and products of these 

• Soybeans and products of these 

• Milk and milk products 

• Tree nuts and nut products. 

In 2023 the US expanded this list, positioning sesame as the ninth allergen. 

In the European Union, food allergens are strictly regulated under Regulation (EU) No 1169/2011, which governs the provision of food information to consumers. This legislation requires food manufacturers, including bakeries, to highlight 14 allergens in the ingredients list if present in their products. These allergens include gluten-containing cereals (like wheat and rye), milk, eggs, peanuts, soy, mustard, sesame and more. The legislation requires allergens to be emphasised on labels using bold, italics, or other distinguishable typesets within the ingredients list. 

Globally, food allergen regulations vary, but generally follow similar guidelines. In the US, the Food Allergen Labelling and Consumer Protection Act (FALCPA) mandates the labelling of nine major allergens – milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame – which together account for 90% of food allergies – while Canada’s regulations require the declaration of priority allergens, such as gluten, mustard, and sulphites, among others. Australia, New Zealand, and other regions also have specific guidelines regarding allergen declaration on food labels. 

Staying compliant with ever-evolving allergen regulations can be challenging for bakeries, particularly those with complex supply chains or a wide range of products. Fortunately, several technologies are now available to simplify allergen management and labelling helping ensure regulatory compliance. 

Helpful tools 
Automated food labelling systems allow for seamless integration of allergen information into product labels, ensuring that all allergenic ingredients are clearly and consistently highlighted. Many solutions available today can be updated in real-time to reflect changes in recipes, ingredients, or regulatory requirements, helping to reduce human error and potential non-compliance. 

Ingredient and allergen tracking software solutions can help manufacturers keep track of allergens in their supply chains. These systems track ingredients from suppliers, monitor recipe changes, and generate allergen risk assessments. When integrated with enterprise resource planning (ERP) software, these tools can help ensure that allergenic ingredients are flagged at each stage of production, automatically triggering alerts for any necessary labelling updates. 

For bakeries handling multiple products on the same production line, the risk of cross-contamination is high. Recent advances in allergen detection technology – such as on-site testing kits – allow manufacturers to quickly and accurately identify the presence of allergens in both raw materials and finished products. These kits will mostly utilise enzyme-linked immunosorbent assays (ELISA) and lateral flow devices, providing results in minutes to ensure allergen-free products or to trigger cleaning protocols. 

Blockchain technology is also emerging as a powerful tool for supply chain transparency, particularly in allergen management. By using a blockchain system, bakery manufacturers can trace every ingredient back to its origin, ensuring that all suppliers meet allergen handling standards. This can be especially helpful in regions with stricter allergen labelling requirements or where suppliers’ allergen-handling procedures vary. Blockchain allows manufacturers to prove due diligence in the event of regulatory inspections or product recalls. 

Artificial intelligence (AI), which is invading all areas of our lives today, is also being integrated into food safety systems to help predict potential allergen risks. AI can analyse historical data, ingredient substitution patterns, and allergen incident trends, helping bakery manufacturers anticipate allergen risks before they become a problem. AI solutions can be integrated into production processes to minimise human error, ensure compliance, and prevent allergen cross-contact. 

What might the future hold? 

The future of allergen labelling looks set to move towards greater transparency, with global food safety bodies pushing for more standardised labelling practices. In the coming years, several trends are expected to shape allergen labelling requirements: 

• Expansion of allergen lists: As more allergens emerge – particularly in regions where certain ingredients are more common – regulators are expanding the list of allergens that require mandatory declaration. Bakeries need to keep themselves updated on international trends to ensure continued compliance in different markets. 

• Digital food labelling: With the rise of digital food information platforms, some countries are experimenting with QR codes that provide extended information about food products, including allergens. This trend could soon become a global standard, offering an opportunity for bakery manufacturers to provide consumers with detailed product information in real-time. 

• Stricter cross-contamination labelling: ‘May contain’ statements have long been used to warn consumers of potential cross-contamination. However, as regulatory bodies focus on improving consumer clarity, more prescriptive guidelines on when and how these statements should be used are expected. This may result in the need for more rigorous testing and record-keeping within bakery production lines to substantiate any claims made on labels. 

Clarity on the ‘may contain’ issue appears to be overdue. For example, when the US added sesame to its list of allergens that need to be listed on food labels it resulted in many more brands actually listing the ingredient. Food industry experts argued that the requirements are so stringent that many manufacturers, especially bakers, find it simpler and less expensive to add sesame to a product – and to label it – than to try to keep it the product away from other foods or equipment with sesame. 

An example of this can be seen in the reaction of Bimbo Bakeries in the US – which produces brands such as Sara Lee, Entenmann’s and Ball Park buns and rolls. It has defied a warning sent to it by the FDA saying that it considered several of the company’s products are ‘misbranded’ because the labels list sesame or tree nuts even though those ingredients aren’t in the foods. In a response to the FDA, Bimbo officials said they wouldn’t change their sesame labelling. The company said it has plants where some products are made with sesame and some are not. But when it came to labelling, the company said it declares sesame as an ingredient and uses the same packaging for all of the products to prevent people from inadvertently eating foods that can trigger potentially life-threatening reactions. 

Making allergen labelling easier  

When it comes to allergen labelling it is clear that bakery businesses face a unique mix of regulation challenges. Whether it’s flour, eggs, milk, nuts or sesame, keeping track of allergens is not easy – especially as there is no global standard for how these allergens should be labelled.  

As we have discussed, each country or region has its own rules, so it’s crucial to understand the specific regulations where your products are sold. If you don’t, the consequences can range from expensive recalls and fines to serious harm for customers, or even death. A major labelling mistake could also cause serious damage to a brands reputation.  

Fortunately, there are technologies available that can help simplify allergen management. For example, TraceGain enterprise solutions are powered by NutriCalc nutrition calculation software, which has been an industry leader in nutrition, allergen, and labelling software for over 30 years, helping ensure that all necessary allergen information is accurate and compliant in each country or region. 

For bakery ingredients such as wheat flour, which can vary in composition, the software allows custom ingredients to be added to the system using detailed supplier data. This helps ensure full traceability of allergens like gluten, so nothing gets missed.  

While NutriCalc makes allergen management much simpler, TraceGains does advise that it is still a good idea to manually check the ingredients list as a final safeguard. Supplier specification sheets can sometimes miss key details, and a quick review can help avoid any unintentional oversights.  

TraceGains highlighted another important aspect of allergen labelling in bakery production – the risk of cross-contamination. Even after production equipment has been cleaned traces of allergens can still linger. That’s why many UK and EU businesses use voluntary advisory labels like ‘may contain’ or ‘produced in a factory’ warnings. These labels help keep customers informed about the possibility of accidental cross-contact with allergens.  

TraceGains enterprise solutions are able to digitise and centralise product development and compliance on a unified, integrated platform. This end-to-end solution now also supports ESG Sustainability reporting, helping businesses to align with environmental goals and regulations. 

For bakery manufacturers, ensuring compliance with both current and future food allergen labelling requirements is non-negotiable. While staying up to date on regulatory changes is a challenge, modern technologies are available and can provide significant support. 

By embracing these technologies, bakeries can not only ensure regulatory compliance but also demonstrate a commitment to consumer safety, which is increasingly important in today’s allergen-conscious marketplace. 

Editorial contact:
Editor: Kiran Grewal kgrewal@kennedys.co.uk