28 May 2021
Helen Arrowsmith, Principal Food Law Adviser and Allergen Specialist
A brief summary of the requirements for allergen labelling in the EU and UK
In harmonised EU legislation (the Food Information to Consumers Regulation (EU) No. 1169/2011 - FIC), which has been retained
into UK law since EU exit at the end of 2020, there are 14 substances or products causing allergies or intolerances that must be labelled on food and
drink packages if they have been deliberately included as an ingredient or are contained as part of a compound ingredient or processing aid that is
deliberately added to a food. This requirement extends to all products and derivatives of these ingredients, with a few specific exceptions (listed
later in this briefing). The requirement is to make the presence of the material or ingredient clearly known.
Substances or products causing allergies or intolerances that must be labelled
- Cereals containing gluten, namely: wheat (such as spelt and khorasan wheat), rye, barley, oats or their hybridised strains*#
- Milk and products thereof (including lactose)#
- Nuts, i.e. almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts
(Carya illinoiesis (Wangenh.) K.Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia nuts and Queensland nuts
- Sesame seeds*
- Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/l expressed as SO2 in products ready for consumption
* and products thereof
# except exemptions
Allergen labelling requirements - The Food Information to Consumers Regulation
The Food Information to Consumers Regulation (EU) No. 1169/2011 details requirements for allergen labelling, among other
labelling provisions. The Regulation states that for prepacked food, allergens must be emphasised in the ingredients list through a typeset that
clearly distinguishes them from the rest of the ingredients. The Regulation also states that where several ingredients originate from a single
allergenic source, the labelling must make it clear for each ingredient. Where foods are offered for sale without prepackaging (including in the EU
where foods are pre-packed for direct sale), the provision of allergen information is also mandatory but can be provided any way the business
chooses, including orally. It is a requirement under UK national law (The Food Information Regulations, 2014 - FIR) that if allergen information is
provided orally, it must be indicated on a notice, menu, ticket or label that allergen information can be obtained by asking a member of staff.
In the UK an amendment to the FIR requires foods that are prepacked for direct sale (i.e. those foods prepacked prior to the
consumer selecting or ordering them, and that have been packaged at the same place from where they are sold) are labelled with the legally compliant
name of the food and a fully compliant ingredients list with the 14 allergens listed in the FIC (Annex II) emphasised, from 1 October 2021.
Following extensive scientific evaluation, it has been agreed that some ingredients derived from an allergenic starting material are unlikely to
trigger an allergic reaction in susceptible individuals under the proposed conditions of use and are therefore exempt from the requirement to label
them as allergens. These are:
- wheat-based glucose syrups including dextrose
- wheat-based maltodextrins
- glucose syrups based on barley
- cereals used for making alcoholic distillates including ethyl alcohol of agricultural origin.
- fish gelatine used as carrier for vitamin or carotenoid preparations;
- fish gelatine or isinglass used as fining agent in beer and wine.
- fully refined soybean oil and fat
- natural mixed tocopherols (E306), natural D-alpha tocopherol, natural Dalpha tocopherol acetate, natural D-alpha tocopherol succinate
from soybean sources
- vegetable oils derived phytosterols and phytosterol esters from soybean sources
- plant stanol ester produced from vegetable oil sterols from soybean sources.
- whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages
- nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
It should be noted that gluten itself is not included in the list of substances or products causing allergies or intolerances
that must be labelled. It is the cereal to which the legislation refers, as people can be allergic to proteins in these grains, including but not
limited to gluten. The name of the cereals (e.g. wheat, rye, barley or oats) should therefore be emphasised in the ingredients list of products that
contain them. Gluten can cause an autoimmune reaction in people with coeliac and related diseases; however this is not a ‘true’ IgE mediated allergic
reaction. The legislation does not therefore require the term ‘gluten’ to be emphasised. Please note that gluten-free foods and the limit of ≤20mg/kg
to make this claim refer to food suitable for people with coeliac disease (refer to Commission Implementing Regulation (EU) No. 828/2014 for
The only allergen in the legislation with a ‘limit’ (below which it does not need to be emphasised) is sulphur dioxide and
sulphites. It does not need to be emphasised if present below 10mg/kg or 10mg/l in the product ready for consumption. Therefore, unless an exempt
derivative is being used, the allergens must always be emphasised in the ingredients list. The level of 20mg/kg for making a gluten-free claim is
not related to the allergen labelling requirement but is a level below which it is safe for the majority of people with coeliac disease to consume
- see the section on gluten above.
Nuts and other allergens
The legislation specifies which nuts must be labelled as such. There are, however, some other nuts and related ingredients
to which people may be allergic, or which may result in allergic responses in nut allergy sufferers. Chestnuts and pine nuts, for example, are known
to cause allergy in some people. In addition, there are other substances to which people are allergic but that are not included in the legislation,
for example, kiwi. The Food Standards Agency advises that best practice would be to include these substances in allergen management systems, but
there is no need for these ingredients to be emphasised as allergens on the label of foods that contain them. The legislation and technical
information service at Campden BRI can offer advice on whether other ingredients are likely to fall into this category.
It is important to note that peanuts should not be labelled merely as nuts, but specifically as peanuts.
Precautionary ‘may contain’ allergen labelling
The above requirements relate only to ingredients that are part of the formulation of the food. They do not cover situations
where there is a risk of cross-contamination. Good Manufacturing Practices should eliminate or greatly reduce the risk of cross-contamination in most
cases. Current recommendations are that precautionary allergen labelling should only be used where there is a realistic risk of cross-contamination
occurring that, because of the nature of the product and its production environment, cannot be eliminated. Much work has been conducted on the use
of quantitative risk assessment and use of ‘action levels’ in determining the need for precautionary labelling, please contact us if you would like
to discuss this.
Helen Arrowsmith is currently a Principal Food Law Adviser and Allergen Specialist in the Regulatory Affairs Department at Campden BRI. Helen uses her
knowledge, gained over more than 17 years working with the food and drink industry, to provide advice on relevant UK and harmonised EU legislation,
to present on training courses, and to contribute to publications such as Food Law Alert.
Allergen labelling white paper
Click below to download a copy of the white paper in PDF format
For more information, please contact:
Allergen labelling and other legislation issues:
Preventing and monitoring allergen cross-contamination:
This is a revised version of the white paper originally published on 6 August 2014