According to the World Allergy Association, it’s estimated that food allergy affects approximately 2-4% of children and adults globally, and the figure is rising.

If you’re a food and beverage manufacturer supplying locally or exporting overseas, it’s vital that your products comply with these countries’ official food allergen labeling laws.

If you don’t, whether it’s intentionally or due to a genuine error, it could cost your business a huge expense if a product recall is required to replace the packaging, and hefty fines can be involved. Far worse, it could cause serious harm or even death for some consumers of your product. It could also damage your business’s reputation if the error is serious enough to attract high-profile negative media publicity.

Recalls heard around the world

Whether you’re part of a startup or lead an experienced professional team, allergen labeling can be confusing. There is no global standard regarding which foods need to be highlighted as allergens, standardized naming of like-for-like allergens, or how to highlight these allergens on food labeling. As a result, there’s no single, global label that fits all countries / regions. The stakes, however, are high. In the US, allergen-related issues were the leading cause of FDA food recalls in 2023 for the sixth year in a row.  

It’s therefore vital to thoroughly understand the official food labeling legislation for each country or regional market in which you offer (or plan to offer) products. For everyone involved, it’s critical to ensure that you are both complying with local labeling legislation and making your products safe for all consumers.

There are of course many similarities as well as some key differences between the legislations, so here some key takeaways when it comes to food allergen labeling around the world, with a particular eye toward the United States, UK/EU, and Canada. 

Avoid a bad reaction from customers

Let’s start by defining what an allergen is. Strictly, it’s something that causes an allergic reaction or an intolerance in some people when their body’s immune system reacts to proteins in certain foods. Depending on the person’s level of food allergy or intolerance, their reaction can range from very mild to severe, or even life-threatening. Although it’s rare, there are cases of highly susceptible individuals suffering a fatal anaphylactic shock. According to the United States’ Food Allergen Labeling and Consumer Protection Act, there are nine major food allergens, eight of which account for 90% of allergic reactions.

Most countries agree with this list of allergens:

1. Crustacean shellfish (including hard shell crayfish, prawn, lobster, crab, etc.).
2. Eggs.
3. Fish (mainly white finned species, such as cod).
4. Milk (from all mammalian animals and including dairy-based foods, such as cheese, butter, cream, and yoghurt).
5. Tree nuts (including almond, walnut, cashew, pecan, Brazil, pistachio, macadamia, etc.).
6. Peanut (separate from tree nuts as it’s a groundnut). 
7. Soy.
8. Wheat / cereals containing gluten (including wheat, rye, barley, etc). 

In addition, there are others which are only recognized in specific jurisdictions. As a result, the number of allergens varies geographically. The United States, for example, has nine, Canada has 12, and the UK/EU have 14. 

There are multiple variations to choose from. Sulphites are recognized as an allergen by many countries, though not all. Similarly, sesame is an allergen in North America, Europe, and Australia. Canada, the EU/UK, Australia, and New Zealand all classify lupin, celery, and mollusks as allergens. 

But more controversial examples exist. Less common food allergens only recognized by a few countries include bee pollen/propolis, and royal jelly, such as Australia and New Zealand. Plus, almost exclusively in Asia, countries include buckwheat, beef, chicken, pork, mango, peach, and tomato. 

Beyond these basic differences in allergen lists, it’s worth pointing out that the devil really is in the details. Especially when it comes to small differences that can exist between the definitions of supposedly like-for-like food allergens in different regions. For example, in Canada the official list of “tree nuts” contains almonds, Brazil nuts, cashews, macadamia nuts, pecans, pine nuts, pistachios and walnuts. Whereas in the UK/EU, the list also includes hazelnuts, but excludes pine nuts. Adding to the potential for confusion, seemingly similar allergens are sometimes classified differently. For example, wheat and gluten are sometimes classified as the same allergen, and sometimes separately.

And of course, there being exceptions to nearly every rule, exemptions exist for some ingredients that are derived from known allergens, but which will not cause an allergic reaction due to being heavily processed, such as fully refined soy oil or wheat glucose syrups.

Looking below the surface

Supposedly allergen-free foods can accidentally come into contact with allergen proteins from foods produced in the same factory on the same equipment, even after the equipment in question has been cleaned.

In the UK/EU, United States, and Canada, food manufacturers can include a voluntary ‘may contain’ or ‘made in factory’ advisory statement on labels, to highlight this potential, unintentional cross-contamination during the manufacturing process. 

Putting a label on allergens

Nearly all regulatory bodies agree that consumers with an allergy need to be able to easily identify all ingredients which contain allergens on food products’ packaging, but just as with allergens themselves, the rules for highlighting allergens can vary from region to region.

For example, in the EU/UK, all ingredients containing allergens must be printed in bold text in the mandatory list of ingredients on the label. For ingredients where the food name matches the allergen name, the full ingredient must be presented in a bold typeface—e.g. celery, peanuts, lupins. Otherwise, just the allergen must be printed in bold, or shown in brackets—e.g. wheat flour, sesame seeds, double cream (milk), cod (fish), hazelnuts, etc.

However, in the USA and Canada, manufacturers can choose either to state the allergen within the ingredient list or use a separate ‘contains’ statement on the label to declare the presence of the allergen, such as “Contains Wheat, Milk, and Soy.” Ultimately, all of these labeling requirement are intended to achieve the same thing, but understanding regional variations in labeling formats is crucial for avoiding expensive headaches in those markets. 

Packaging up the regulations

So which foods and beverages do the food allergen labeling regulations apply to? In most countries the regulations apply to products which are prepacked before being supplied to a food outlet for sale.

In the UK/EU, the regulations also apply to what’s known as ‘prepacked for direct sale’ (PPDS) products, which are packaged at the same place they are sold, and before being selected by the consumer. For example, it might be food kept behind a counter or in a display unit, such as in a self-service food outlet. 

In addition, for foods sold through any type of retail outlet or restaurant, allergen information must be made available for any affected items being sold. It can be provided either in writing on display/menu, or by speaking to staff. 

With many aspects then to food allergen labeling legislation, and official documentation which is often written in a convoluted and confusing way, consulting experts on this subject can provide you with the peace of mind that there’s someone to speak to if you have any queries.

Be proactive with international solutions

Wherever you operate in the world, TraceGains Networked Product Development Suite can help to simplify your management of allergens. Powered by NutriCalc, the industry standard calculation and labeling software for over 30 years, Formula Management helps you keep track of allergens even as you iterate on new product development or formulation. Easily identify allergens required to be highlighted by law in key world regions, add your own custom allergens if legislation in the country you’re supplying to identifies different allergens, and be guided through vital ingredient allergen checks. The powerful NutriCalc platform is also available as a standalone solution with a cost-effective entry point for R&D teams. 

TraceGains NPD Suite is seamlessly integrated with the TraceGains Networked Ingredients Marketplace, letting teams pull in technical ingredient specifications instantly, and jump directly from sourcing to formulation and labeling.  Meanwhile, TraceGains Specification Management digitizes and centralizes your ingredient and finished goods specs, allowing error-free management of specs alongside seamless supplier and Co-manufacturer collaboration.  

Finally, TraceGains Regulatory Global provides an integrated data source for regulatory intelligence, new market entry data and up-to-the-minute restricted substance limits worldwide. Powered by SGS DigiComply,TraceGains Regulatory Global is a consolidated source of worldwide regulatory data powered by boots-on-the-ground expertise. 

In a complex and dynamic food industry, keeping consumers safe while managing regulatory compliance can be a challenge. TraceGains NutriCalc is here to help—reach out to learn more.  

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Sources: UK/EU Food Law Regulations | Food Standards Agency (FSA) | Food & Drug Administration (FDA) | United States Department of Agriculture (USDA) | Canadian Food Inspection Agency (CFIA) | World Allergy Association (WAO) | | Anaphylaxis UK | Allergy UK | University of Nebraska Food Allergy Research and Resource Program, US