Food allergen labelling: Legislative requirements and guidance

Posted: 24 April 2015 | Barbara Gallani and Alex Turtle, Food and Drink Federation (FDF) | No comments yet

The Food Information to Consumers (FIC) Regulation (No 1169/2011, as amended)1 has introduced new rules for the provision of information on allergens. This Regulation, which came into force across the entire EU on 13th December 2014, combines general and nutrition labelling provisions together into a single regulation to simplify and consolidate existing labelling legislation. Its aim is to help consumers make better and more informed choices about the food they buy and to update and harmonise current industry practice. The Food and Drink Federation (FDF) welcomes the new Regulation, but looks to EU institutions to ensure it fulfils its original objective of improving the information available to consumers.

Food allergen labelling: Legislative requirements and guidance

Allergen information presented to consumers was one of the major changes brought in. The FIC Regulation requires allergen labelling on pre-packed foods to be made clearer and given more emphasis. It also introduces a new mandatory requirement for allergen information to be provided for non pre-packed foods, including those sold in restaurants and cafés.

From a consumer perspective, ingredient lists will now look very different as allergenic ingredients will be given more prominence on the label compared to other ingredients. Under the new rules, allergens must be emphasised in the ingredients list to help consumers identify them. Food businesses can choose the method of emphasis that they would like to use (Figure 1, page 13), for example, by listing them in bold, however other types of emphasis are allowed.

Some companies are also using voluntary allergy advice statements on their products to direct consumers to the relevant part of the label (Figure 2), for example: ‘Allergy Advice: for allergens, including cereals containing gluten, see ingredients in bold’ or ‘Allergy Advice: for allergens, see ingredients in bold’. Where previously many labels would use voluntary ‘Contains statements/boxes’, where the names of the specific allergens would be duplicated in a box under the ingredients list (e.g. ‘Contains: milk and nuts’), this is no longer allowed as the repetition of allergen information is no longer permitted under the new EU rules. Therefore the sole use of the new voluntary allergy advice statements is to direct consumers to read the ingredients list. It is important to note that the only exception to this is for products that do not have an ingredients list, such as wine where a ‘Contains: sulphites’ may be used.

Labelling guidance

In November 2013, FDF published a resource for healthcare professionals about food and drink labelling as a tool to encourage healthier eating: ‘Food and Drink Labelling: A tool to encourage healthier eating’2. This tool helps to explain the changes to food and drink labels brought in under the FIC Regulation, including the important changes to allergen labelling. Currently the FDF’s Allergen Steering Group is working on supplementary guidance of the labelling of gluten containing cereals in order to provide best practice advice to the food industry on the implementation of the new labelling rules for this specific allergen.

Information provided on the potential risk of cross contamination with other allergens is not affected by the new rules. It can appear on labels in the same manner as it did before. Precautionary allergen labelling should only be used by food businesses where there is a demonstrable and significant risk of unintended allergenic ingredients being present in the finished product3. These warnings should therefore always be taken seriously by consumers.

Some consumers might be asking why there is a mix of old and new style labels available in store. It is important to note that in addition to a three year transition period from the entry into force of the new FIC Regulation on 13th December 2011, food products in the old style could still be labelled and placed on the market up until the 13th December 2014 enforcement deadline and then sold until stocks were used up. Some products (such as tinned or dried food) have a long shelf life; therefore it is possible that consumers could see old and new style labelling being used on these types of products for a couple of years to come. Echoing the consistent messaging of allergy charities, such as Coeliac UK, FDF cannot stress enough that consumers should always check the ingredients list for allergen information, as it will not be emphasised (e.g. in bold) on old style ingredients lists, however reference to the allergens will still be there.

One of the most significant changes the new legislation brought in was in relation to loose/non-prepacked foods and foods sold at catering establishments. From 13th December 2014 information on allergens used as ingredients must be provided for foods sold loose without packaging and for foods wrapped on site. These rules only cover information about the allergens intentionally used as ingredients. They do not cover allergens present as a result of cross contamination. However, food businesses should consider the risk of allergen cross contamination and communicate the risk to customers accordingly.

In partnership with the FDF, the British Retail Consortium (BRC) produced guidance to help the food industry understand and implement the new allergen labelling requirements for prepacked foods. The guidance document is available on the BRC website4. The FDF and BRC also worked with Allergy UK, the Anaphylaxis Campaign, the British Dietetics Association, British Nutrition Foundation, Coeliac UK and Food Standards Agency (FSA) to update the FSA’s leaflet: ‘Buying food when you have a food allergy or food intolerance’ to ensure timely communication of allergen labelling changes to consumers.

Risk-based approach

The FDF supports a risk-based approach to allergen control and has consistently urged that the use of precautionary labelling (e.g. ‘May contain’) should only be used where there is a real and demonstrable risk of significant traces of an allergen being present. The FDF is keen to improve allergen information and management within the whole food chain and encourages wider uptake of the principles set out in the FSA’s Guidance on Allergen Management and Consumer Information. It also supports development of training and awareness activities based upon it.

The FDF also supports progress towards agreement on allergen ‘action levels’ also known as ‘allergen thresholds’, to enable quantitative risk assessment. In 2011, the European Food Safety Authority (EFSA) was mandated by the Food Safety Authority of Ireland (FSAI) to perform a review of the state of play of the current knowledge in the field of food allergens5, specifically looking at: food allergy prevalence in Europe, recommendations for threshold concentrations of each allergen in food, and the suitability of analytical methods for detection/quantification of food allergens.

The resulting EFSA Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes6 was published on 27th November 2014. It concluded that the prevalence of each allergy is difficult to determine, due to the scattered studies available and different methodologies used to collect the data, however it estimated that the prevalence of food allergy was about 1% in both adults and children, when considering European studies only. The Opinion also summarised the approaches for risk assessment for determining the thresholds for specific allergenic foods. The EFSA Panel clearly stated that these approaches could assist in risk management decisions, such as exemption from labelling, but this falls outside of EFSA’s remit; as any decision on this matter would need to be taken by the European Commission, the body responsible for risk management in the EU.

Understanding and controlling the supply chain of a food product is an important tool when managing the risks to consumers of foodstuffs, both where allergens are intentionally added and those present adventitiously or as a result of adulteration. The production of safe and wholesome food is the upmost priority for the UK food industry and all matters relating to food safety are taken very seriously. The FDF works collaboratively with relevant Government bodies and other trade associations to effectively share information in a timely manner in order protect consumers.

This collaborative, timely and effective engagement of the food industry’s network of stakeholders has been recently demonstrated following a number of product recalls in the USA and Canada and, more recently, in the UK and other European countries, due to the presence of undeclared peanut or almond proteins in ground cumin and paprika. Members of the Seasoning and Spice Association (SSA) have been conducting in-depth investigations of their supply chains and have increased allergen testing where appropriate, in order to prevent affected products from reaching consumers.

Food companies have in place a series of process controls based on well-established good manufacturing practices (GMPs) and sound food safety management systems (FSMS). Furthermore all products are purchased from approved suppliers in order to ensure full traceability at all stages of production, processing and distribution.


  1. Regulation (EU) No. 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers (OJ L 304, 22.11.2011, p. 18–63) (as amended).
  1. Food and Drink Federation Food and Drink Labelling: A tool to encourage healthier eating. A resource for healthcare professionals (November 2013).
  2. Food Standards Agency Guidance on Allergen Management and Consumer Information (2006).
  3. BRC Guidance on Allergen Labelling and the Requirements in Regulation 1169/2011, in partnership with FDF (March 2013).
  4. EFSA Mandate (M-2011-0194 / EFSA-Q-2011-00760): Allergen Risk Assessment, request for advice from EFSA from FSAI Ireland.
  5. EFSA Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes (EFSA Journal 2014;12(11):3894).

About the authors

Barbara Gallani is Director of the Regulatory, Science and Health Division of the Food and Drink Federation (FDF). She is responsible for the development, implementation and promotion of FDF’s policy with respect to health and nutrition, food safety, incident management, food contact materials, novel foods, food labelling and many other technical and regulatory issues. Her team monitors and contributes to UK, European and international policies and legislation trying to ensure consistency of approaches, based on evidence and science. Before joining the FDF in 2008, she worked as Food Policy Executive at the British Retail Consortium (BRC), as Food Policy Advisor at the European Consumers Organisation (BEUC) in Brussels and as Senior Scientific Officer at the Food Standards Agency (FSA). She is a Fellow of the Institute of Food Science and Technology and was listed at the beginning of this year as one of the top 100 UK Scientists by the Science Council.

Alex Turtle works as Food Safety & Sectors Executive in the Regulatory, Science and Health Division of the FDF with responsibility for the area of allergens and the Allergens Steering Group. Alex represents FDF on the FoodDrinkEurope Expert Committee on allergens. He also provides a secretariat role for the FDF Biscuit, Cake, Chocolate and Confectionery Sector Group and FDF Ice Cream Sector Group, particularly in relation to regulatory and technical issues. Before joining the FDF, Alex worked as a Regulatory Affairs Advisor for both Leatherhead Food Research and Campden BRI.

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