Introduction
Allergen labelling is one of the most critical elements of food packaging in the European Union. For consumers with food allergies or intolerances, accurate allergen information is essential to their health and safety. For businesses, getting allergen labelling wrong can result in serious legal consequences, product recalls, reputational damage, and loss of consumer trust.
EU allergen labelling laws are designed to ensure consistency and transparency across all member states, allowing consumers to identify allergens easily wherever they shop. However, while the rules themselves are clear, applying them correctly across complex product ranges, multiple markets, and fast-moving packaging workflows is often challenging. This article explains which regulations govern allergen labelling in the EU, what they require in practice, and how businesses can stay compliant.
What Is Allergen Labelling?
Allergen labelling refers to the legal requirement to declare certain ingredients that are known to cause allergic or intolerance reactions in some individuals. This information must be presented clearly and accurately so that consumers can make safe and informed choices.
In the EU, allergen labelling applies not only to packaged food sold in supermarkets, but also to food sold loose, food served in restaurants, and products prepared for direct sale. The obligation to provide correct allergen information follows the product throughout the supply chain, from formulation and packaging design to the point of sale.
What Counts as a Food Allergen?
A food allergen is a substance that triggers an immune response in susceptible individuals. This is distinct from food intolerance, which does not involve the immune system but can still cause unpleasant or harmful symptoms. EU legislation focuses on allergens that pose the greatest public health risk due to their prevalence and the severity of reactions they can cause.
Only allergens specifically listed in EU law must be declared, even though other foods may cause reactions in some people. This creates a harmonised approach across the EU, ensuring consumers receive consistent information regardless of where a product is sold.
The Legal Framework for Allergen Labelling in the EU
Regulation (EU) No 1169/2011 (The FIC Regulation)
The cornerstone of allergen labelling law in the EU is Regulation (EU) No 1169/2011, known as the Food Information to Consumers (FIC) Regulation. This regulation sets out the general principles for food labelling, including which allergens must be declared and how that information must be presented.
The FIC Regulation aims to protect consumers while also ensuring fair competition between food businesses. By harmonising rules across all member states, it reduces confusion for both consumers and operators, particularly those trading across borders.
Who Must Comply With the FIC Regulation?
Responsibility for allergen labelling does not sit with a single party. Food manufacturers are responsible for ensuring recipes and ingredient lists are accurate, while brand owners remain accountable for the information presented on packaging. Importers must ensure products brought into the EU meet all labelling requirements, and retailers and food service operators also have obligations, particularly when selling non-prepacked food.
Because allergen compliance spans multiple roles and departments, failures often occur when information is fragmented or poorly controlled.
The 14 Mandatory Allergens Under EU Law
EU legislation identifies fourteen allergens that must always be declared when used in food products. These include common ingredients such as cereals containing gluten, milk, eggs, fish, peanuts, soybeans, and nuts, as well as less obvious allergens like celery, mustard, lupin, molluscs, and sulphites above specified thresholds.
These allergens must be declared regardless of how small the quantity is and even when they appear as part of compound ingredients. The list is based on scientific evidence and is intended to cover substances most likely to cause serious allergic reactions across the European population.
How Allergens Must Be Declared on Food Packaging
Emphasis and Formatting Requirements
One of the most important requirements under the FIC Regulation is that allergens must be clearly emphasised within the ingredient list. This emphasis helps consumers identify allergens quickly without having to scan dense blocks of text.
Businesses may choose how to emphasise allergens, using methods such as bold text, capital letters, underlining, or a contrasting colour. However, whichever method is chosen must be applied consistently throughout the ingredient list. Inconsistent formatting is a common reason labels are deemed non-compliant during inspections.
Ingredient Lists and “Contains” Statements
The legal requirement is that allergens are emphasised within the ingredient list itself. While additional “contains” statements are allowed and can be helpful for consumers, they do not replace the obligation to highlight allergens in the ingredients. Relying solely on a “contains” statement is a frequent and avoidable compliance error.
Language and Legibility Rules
Allergen information must be presented in a language that consumers in the country of sale can easily understand. It must also meet minimum font size requirements and remain clearly legible. Poor contrast, overcrowded layouts, or low-quality printing can all undermine compliance, even if the correct wording is technically present.
Allergen Labelling for Prepacked Foods
What Is Considered Prepacked Food?
Prepacked food refers to any food placed into packaging before being offered for sale, where the packaging encloses the food completely or partially and cannot be altered without opening it. This includes most branded and retail food products sold through supermarkets and online channels.
Common Compliance Errors
Despite clear legal requirements, allergen labelling errors remain widespread. These often arise when recipes change but packaging artwork is not updated, when incorrect allergen terminology is used, or when older templates are reused across multiple markets. In many cases, these mistakes stem from manual processes and poor version control rather than a lack of regulatory knowledge.
Allergen Labelling for Non-Prepacked Foods
Food Sold Loose or Prepacked for Direct Sale
Allergen labelling requirements also apply to food sold loose or prepared on-site. This includes bakery items, deli counter products, takeaway meals, and restaurant food. In recent years, rules around food prepacked for direct sale (PPDS) have become stricter in several countries following fatal allergic reactions.
How Allergen Information Must Be Provided
For non-prepacked food, allergen information must still be available before purchase. This is increasingly expected to be provided in written form, supported by accurate internal documentation. While verbal communication may still be permitted in some cases, it must be reliable and backed by robust processes to avoid misinformation.
“May Contain” and Precautionary Allergen Statements
Are “May Contain” Statements Regulated?
Precautionary allergen labelling, such as “may contain nuts”, is not explicitly defined in EU legislation. However, regulators expect these statements to be used responsibly and based on documented risk assessments. They should not be applied as a blanket precaution where no genuine risk exists.
Best Practice for Cross-Contamination Warnings
Overuse of precautionary statements can undermine consumer trust and unnecessarily restrict food choices for people with allergies. Best practice involves assessing cross-contamination risks carefully and reviewing precautionary wording regularly to ensure it remains justified.
Country-Specific Variations Across the EU
National Enforcement and Interpretation
Although allergen labelling rules are harmonised at EU level, enforcement is carried out by national authorities. This can lead to differences in inspection focus, interpretation, and penalties between member states. Businesses operating across multiple markets must therefore remain aware of local guidance as well as EU-wide requirements.
The UK has retained allergen labelling requirements that closely mirror EU law. While regulatory divergence may occur over time, current rules remain largely aligned. This is particularly true for businesses selling products in both the UK and EU.
Penalties for Non-Compliance
- Regulatory Consequences: Non-compliance with allergen labelling laws is treated seriously by regulators. Consequences can include mandatory product recalls, withdrawal from the market, financial penalties, and increased regulatory scrutiny. Allergens are consistently viewed as a high-risk area due to their potential impact on consumer health.
- Commercial and Brand Impact: Beyond regulatory action, allergen labelling failures can severely damage a brand’s reputation. Loss of retailer confidence, negative media coverage, and erosion of consumer trust often have long-lasting commercial consequences that extend far beyond the initial incident.
Managing Allergen Labelling at Scale
Challenges for Complex Product Portfolios
As businesses expand their product ranges and enter new markets, allergen compliance becomes increasingly complex. Managing multiple recipes, frequent reformulations, and country-specific packaging requirements places significant strain on manual systems and disconnected workflows.
Many allergen issues arise during the artwork creation and approval process. When teams work in silos or rely on outdated files, errors can slip through and reach the market. Improving visibility and control at this stage is critical to reducing risk.
How 4Pack Helps You Stay Compliant with EU Allergen Labelling
4Pack is designed to help businesses manage packaging compliance with confidence, including allergen labelling across EU markets.
By centralising ingredient and allergen data, 4Pack creates a single source of truth that teams can rely on. Automated checks help ensure allergens are correctly declared and emphasised. Structured workflows reduce the risk of outdated or incorrect artwork being approved. Real-time collaboration between regulatory, quality, and design teams ensures everyone is working from the same information, with full audit trails to support inspections.
Why Book a Demo with 4Pack
By simplifying allergen labelling and reducing manual intervention, 4Pack helps businesses lower risk while moving faster to market. A demo allows you to see how the platform fits into your existing processes and how it can scale as your product portfolio grows.
If allergen compliance is creating bottlenecks or increasing risk in your organisation, booking a demo with 4Pack is the first step towards a more controlled and confident approach.
Final Thoughts
Allergen labelling in the EU is governed by clear and enforceable regulations designed to protect consumers and promote transparency. While the legal framework is well established, managing compliance in practice is increasingly complex, particularly for businesses operating at scale.
With the right systems and controls in place, allergen labelling can move from being a source of risk to a source of confidence. Solutions like 4Pack enable businesses to embed compliance into their packaging processes. This protects both consumers and brands in an increasingly regulated market.
