Food allergen labelling and information requirements technical guidance
Food allergen labelling and information requirements technical guidance: Part 1: Guidance for businesses providing prepacked food
Guidance for any businesses that provide packed food
26. The following section provides guidance and examples of compliance with the FIC provisions specific to allergen labelling for prepacked foods. This is based on the following articles:
- Article 9 on the listing of mandatory particulars
- Article 13 on the presentation of mandatory particulars
- Article 19 on foods that do not require an ingredients list
- Article 21 on labelling of certain substances or products causing allergies or intolerances
- Article 36 on applicable requirements relating to the provision of voluntary food information
List of mandatory particulars (Article 9)
27. Below, you will find guidance on the scope of each allergenic ingredient captured in Annex II of the FIC and how the allergens must be emphasised in the ingredients list (see pages 10 to 12 for exemptions).
Cereals containing gluten
28. Annex II to the FIC lists these as: wheat (such as spelt and Khorasan wheat), rye, barley and oats or their hybridised strains. Spelt and Khorasan are types of wheat, which are not suitable substitutes for people with coeliac disease and/or wheat allergy.
29. Cereals containing gluten must be declared in the ingredients list using the specific name of the cereal, i.e., wheat (such as spelt, Khorasan or Kamut), rye, barley or oats. Where ‘spelt’, ‘Khorasan’ and ‘Kamut’ have been used; the inclusion of a specific reference to wheat would be required; for example, ‘spelt (wheat)’ or ‘Khorasan wheat’ and ‘Kamut (wheat)’.
30. Ingredients which are or have been derived from cereals containing gluten will need to be emphasised within the ingredients list. This will make clear for those with an allergy to specific cereals to avoid such food; for example: ‘wheat starch’; ‘barley malt extract’. The voluntary inclusion of the word ‘gluten’ within the ingredients list following the mandatory declaration of a specific cereal (containing gluten) is permitted however the FIC requires the cereal to be emphasised, rather than the gluten; for example, ‘barley (gluten)’.
Best practice
31. Where foods have been voluntarily labelled as ‘gluten-free’ they must meet the requirements set out in Regulation (EU) No. 828/2014 (footnote 1). This legislation sets out the conditions under which foods may be labelled as ‘gluten-free’ (no more than 20 mg/Kg in the food as sold to the final consumer) or ‘very-low gluten’ (no more than 100 mg/Kg gluten in the food as sold to the final consumer). When a product containing one of the cereals mentioned in Annex II (e.g., oats specially produced, prepared, or processed to reduce gluten) meets the relevant requirements of Regulation (EU) No. 828/2014, then the statement ‘gluten free’ or ‘very low gluten’ can be used on the product. However, the cereal mentioned in Annex II must still be indicated and emphasised in the list of ingredients. These rules surrounding use of the terms ‘gluten-free’ and ‘very-low gluten’ apply to all foods including non-prepacked foods such as those served in restaurants. No other statements to describe the absence or reduced presence of gluten are permitted. When gluten-free oats are used in a gluten-free product, the word ‘oats’ would still need to be emphasised and declared in accordance with Article 21 and 9 (1) (c) of the FIC.
Crustaceans
32. The rules do not name any specific species of crustaceans which means all types of crustaceans are included (for example lobster, prawns, and langoustines).
33. Labelling of crustaceans and products made from them need to have a clear reference to the Annex II food: for example, ‘prawns (crustaceans)’, ‘crayfish (crustaceans)’, ‘lobster (crustaceans)’, ‘shrimp paste (crustaceans)’.
Eggs
34. The rules do not name any species of eggs, because ‘eggs’ refers to eggs from all birds, for example from laying hens as well as eggs from ducks, quails, geese, gulls, and guinea fowl. Therefore, all eggs need to be declared when used as an ingredient or a processing aid.
Fish
35. The rules do not name any species of fish because ‘fish’ means all species of fish and fish products. The generic terms provisions allow the generic name fish to be used in an ingredient list only where there is no specific reference to a common fish species name on the label, for example fish stock.
36. Labelling of fish ingredients or products need to have a clear reference to the Annex II food; for example, ‘cod (fish)’, ‘salmon (fish)’, ‘tilapia (fish)’ unless exempt.
Peanuts
37. While peanuts may also be commonly referred to as groundnuts (which can be confused with ground/powdered nuts such as almonds or a mix of nuts and peanuts) or monkey nuts, the term peanuts must be used for products or ingredients made from them for allergen labelling purposes, as this is the term specified in Annex II of the FIC.
38. Both refined and unrefined peanut oil must be labelled with reference to peanut.
Best practice
Soyabeans
39. Terms such as ‘soya’ or ‘soy’ are sufficient to indicate the soybean origin. However, less common terms such as tofu or edamame may not be recognised as originating from soya and its clear presence needs to be indicated for soya products or derivatives. e.g., tofu (soya) or edamame (soya) unless exempt.
Milk
40. The rules do not name the animal origin of milk because the word ‘milk’ includes milk from mammals such as cow, sheep, goat, and buffalo etc. It should be noted that all mammalian milk proteins have a similar structure and if someone has an allergy or intolerance to cows’ milk, they are likely to be allergic or intolerant to other mammalian milk. Therefore, all milk and milk products (including lactose) need to be declared when used as an ingredient or a processing aid unless exempt.
41. Milk products such as cheese, butter, fermented milk, and cream do not have to have an ingredients list where no other ingredients have been added other than lactic acid, food enzymes and microbiological cultures and (in the case of cheese) salt. In order to ensure that consumers still receive the information they need to clearly identify the presence of milk in such cases, the following advice may be applied. The use of sales names such as ‘cheese’, ‘butter’ ‘cream’ and ‘yoghurt’ is considered to refer clearly to the milk because legally these products can only be made from mammalian milk (Regulation (EU) No. 1308/2013 on common organisation of the markets in agricultural products including dairy designations). In such cases, further reference to milk is not necessary because the dairy designations protect such products. Therefore, cheese, and cream (footnote 2) can be emphasised within the ingredients to demonstrate the presence of a milk product.
Best practice
42. However, the information must make a clear reference to milk in the case of less familiar milk products used as ingredients (e.g., fromage frais, Mascarpone, Cantal, Quark) or products being sold under a name which does not clearly refer to milk. Components derived from milk, such as lactose, casein, and whey, must be declared with a clear reference to milk e.g., ‘whey (milk)’.
Nuts
43. The rules list these as: almond, hazelnut, walnut, cashew nut, pecan nut, Brazil nut, pistachio nut, Macadamia nut or Queensland nut and products made from these nuts. The type of nut must be listed and emphasised in the ingredients panel. Other types of nuts, and other foods which are not nuts (even though they are called nuts i.e., chestnuts, pine nuts and coconut), are not named in the rules. Chestnuts, pine nuts, and coconut are also known to cause allergy in some people but must not be emphasised within the ingredients.
44. Where ingredients or processing aids derived from nuts have been used, the ingredient must be indicated with a clear reference to the nut; for example, ‘flavourings (almond)’ unless exempt.
Celery
45. This term is used generically in the FIC to refer to stick celery and celery root/tuber (also often known as celeriac). However, the term refers to any part of the celery plant and other forms that originate from it, such as celery leaf, celery root, celery seeds, celery oil, celery salt, celery spice, celery seed oil and celery seed oleoresin (an oil / resin extract from celery).
Mustard
46. This term refers to the mustard plant and other products which originate from it, such as leaves, sprouted seeds, mustard flour, table mustard, mustard oils, mustard seed oils and mustard oleoresins. The appropriate terms must be used in labelling. The rules do not name any particular species of mustards and therefore must be applied to all types of mustard.
Sesame
47. This term refers to sesame seeds, ground sesame powder and sesame oil. Products derived from sesame seeds, such as tahini, must be clearly labelled with a reference to sesame e.g., ‘tahini (sesame)’. The rules do not name any particular species of sesame seeds and therefore must be applied to all.
Sulphur dioxide and / or sulphites at levels above 10 mg/Kg or 10 mg/litre
48. The labelling rules apply to sulphur dioxide and/or sulphites that have been deliberately added for example when it has been used as a preservative or have been added to an ingredient used in a preparation of the food. The rules require sulphur dioxide and/or sulphites to be labelled when present above 10 mg/Kg or 10 mg/litre (calculated in terms of the total sulphur dioxide (SO2)) in the finished product as consumed, i.e., prepared according to the manufacturer’s instructions. The method of analysis for sulphur dioxide sulphites cannot differentiate between those naturally present in the food or added as a preservative. Where sulphur dioxide and/ or sulphite-based preservatives (even as carryover in an ingredient) have been used and the levels in the finished product are above 10 mg/Kg or 10 mg/litre, it will need to be declared on the label.
49. Under general food additives legislation, where sulphur dioxide and/or sulphites have been added and have a technological function in the finished product, the function and the name and/or e number of the additive must be included - for example: ‘Dried Apple, (Preservative: sulphur dioxide)’ – however, if only the E number is provided, a clear reference to the allergen must be provided so it is easily understood by the consumer. Under allergen labelling legislation, when sulphites are present at above 10 mg/Kg/litre in the finished product, whether or not they have a technological function, a clear declaration of sulphites and/or sulphur dioxide is always required.
Example
The term ‘sulphites’ (or ‘sulfites’) may also be used as a generic term for this ingredient. Furthermore, depending on the particular sulphite present, the chemical name may be used with the sulphite element emphasised, for example, ‘sodium metabisulphite’
50. References to sulphur dioxide and/or sulphites, which are used and found present in the finished product (ready for consumption or reconstituted according to manufacturers’ instructions) at less than 10 mg/Kg or 10 mg/litre is not required.
Lupin
51. The term lupin is used generically in the FIC to refer to both lupin seed and products from it such as lupin flour. The appropriate terms must be used in labelling. The rules do not name any particular species of lupin and therefore must be applied to all.
Molluscs
52. The rules do not name any species because the term molluscs includes all types of molluscs (for example oyster, squid, cockles, mussels, winkles, and scallops as well as land molluscs like snails).
53. Labelling of mollusc ingredients and products derived from molluscs need to have a clear reference to the Annex II food: for example, ‘mussels (mollusc)’, ‘octopus (mollusc)’, ‘oyster (mollusc)’.
Presentation of mandatory particulars (Article 13)
54. The term “mandatory particulars” refers to the information that must be provided under Article 9 (1) of the FIC. All written mandatory allergen information must be easily visible, clearly legible, and not obscured in any way. Mandatory information must not be hidden for example under a flap or across a fold or crease, detracted from or interrupted by any other written or pictorial matter or any other intervening material.
55. When considering how the required labelling information is displayed, you should take into account the following:
- Is it sufficiently visible?
- Is it readable for those with visual impairments? For example, consider individuals with colour blindness when using contrasting colours.
- Have you used the required minimum font size where the x-height (as illustrated in Annex IV of the FIC) is 1.2 mm or more must be used where labelling surface is 80 cm2 or more. Figure 1 below illustrates how the x height of the font used is measured.
Figure 1: How to measure x-Height 1 (of your font)
56. Where the food packaging or container’s largest surface area is less than 10 cm2 (e.g., a single portion sachet of sauce), the ingredients list can be omitted, provided that the ingredients information is provided by other means or made available at the consumer’s request. In such cases, the presence of Annex II ingredients in the food must be declared on the packaging. This must be done using the word ‘Contains…’ followed by the name of substance or product (e.g., Contains: celery, fish). The minimum font size rules also apply to other mandatory information as listed in Article 9 (1) of the FIC. Please refer to Article 13 of the FIC for further details.
Omission of the list of ingredients (Article 19)
57. Where the name of the product consists of a single ingredient (e.g., bag of peanuts or a box of eggs) and clearly refers to the presence of a substance or product causing allergies, further indication of the presence of the Annex II substance or product is not required. Therefore, in these examples, a bag of peanuts and a box of eggs would not need to declare the presence of peanut and egg respectively. However, where the name of the food does not clearly refer to the substance as named in Annex II, information regarding the presence in the food of an Annex II substance must be provided in the manner required for those substances. For example, gingelly oil is sesame oil and must therefore be labelled ‘Contains: sesame’.
Labelling of certain substances or products causing allergies or intolerances (Article 21)
58. Article 21 specifies that mandatory information about the presence of the Annex II ingredients which cause allergies will need to be emphasised from the other ingredients within the ingredients lists by means of contrasting font, size, style or background colour. For example, ‘INGREDIENTS: Oatmeal, sunflower oil, prawn (crustacean)’.
59. The FBO has flexibility in deciding which mode of emphasis to use to declare the presence of allergens.
Example
An allergy advice statement could be used on the product label to explain how allergens are emphasised within the ingredients list. For example: ‘Allergy advice: for allergens, see ingredients in bold’ or ‘Allergy advice: for allergens, including cereals containing gluten, see ingredients highlighted in blue.’
60. The source of allergens for each ingredient needs to be declared even if there are several ingredients from the same allergenic food.
Example
Partially Reconstituted Skimmed Milk Concentrate, Sugar, Sunflower Oil, Whey Powder (milk), Dextrose, Emulsifier (Mono- and Di-Glycerides of Fatty Acids), Flavouring, Stabilisers (Guar Gum, Sodium Alginate), Colours (Beetroot Red, Beta-Carotene).
61. If the name of an ingredient partly includes the Annex II allergen in a single word, then the name of the ingredient corresponding to the Annex II food can be emphasised. (For example: ‘sodium metabisulphite’ can be emphasised as ‘sodium metabisulphite’).
62. Where an ingredient comprises of several words (such as ‘skimmed milk powder’ and ‘egg white’) then only the Annex II food must be emphasised (in these examples, ‘skimmed milk powder’ and ‘egg white’).
63. If individual ingredients used to make a food contain added sulphur dioxide and/or sulphites, their presence must be emphasised for those ingredients separately if, when added together, the level in the overall food is >10 mg/Kg.
64. Where foods are sold under a less common name, due to appellation, trade name, foreign cuisine etc., it could be difficult to tell whether they contain any of the Annex II products/ substances (e.g., ‘monkey nuts (peanuts)’, ‘gingelly oil (sesame)’, ‘ghee (milk)’, ‘edamame beans (soya)’). In such cases there must always be a clear reference to the name of the substance as listed in Annex II.
Presentation of Voluntary Information on Prepacked Foods
65. Precautionary Allergen Labelling statements should make specific reference to one or more of the 14 regulated allergens, that may be unintentionally present in the food, so that consumer food choice is not unnecessarily limited.
66. Where an Annex II allergen is a group of foods, for example cereals and nuts, to enable consumers to have the greatest range of food choice and avoid ambiguity and confusion, it is best practice to name the specific food(s) within that allergen group, for example: not suitable for consumers with nut (hazelnut) allergy.
67. Precautionary Allergen Labelling statements should not be used in conjunction with a ‘free from’ statement for the same allergen, because a ‘free-from’ claim is a guarantee that the food is suitable for all with a food hypersensitivity to that allergen.
68. Precautionary Allergen Labelling statements can be used in combination with a ‘vegan’ label, because a ‘vegan’ label communicates different information to a ‘free from’ claim and is aimed at different consumer groups. Only free-from allergen claims are guarantees that the specified allergen is absent; to use it, a food business must have implemented strict controls to eliminate any risk of cross-contamination. The Vegan Society advise that their Vegan Trademark can be used on food products carrying a precautionary allergen label for food(s) of animal origin, provided that the labelling decision is based on an assessment of the risk of cross-contamination.
69. 'Gluten-free’ statements differ from other ‘free-from’ statements in that they are not absolute claims but stipulate that levels of gluten in the food are below 20mg/kg. A ‘gluten-free’ statement can be used in combination with a PAL statement, for example ‘gluten-free’ and ‘may contain wheat (cereal)’. An example where this would be appropriate is if there were a risk of a food being cross-contaminated with barley, but testing has shown gluten presence below 20mg/kg. This product would be safe for those with coeliac disease, but is still a risk for those with an allergy to non-gluten barley proteins. The Food and Drink Federation have produced guidance for gluten labelling on prepacked food that provides further information for businesses.
Best practice
Food products without ingredients lists
70. Some foods do not require an ingredients list such as alcoholic drinks with more than 1.2% by volume of alcohol (see Article 16 (4) of the FIC). In this case the presence of any substances or products derived from the Annex II list which are present and not clear from the name of the food needs to be indicated. For example, a bottle of wine must have a statement such as: ‘Contains: sulphites, milk and egg’ if the finished product contains sulphites at more than 10 mg/litre and if milk or egg residues are detectable in the wine.
Example
Allergen(s) within a ‘Contains’ statement on products without an ingredients list do not need to be emphasised however, you can voluntarily choose to emphasise the allergens to make clear their presence in a product (e.g., ‘Contains: sulphites’),
Applicable requirements – voluntary information (Article 36)
71. Where an ingredients list is provided, the FIC does not permit the voluntary use of allergen advisory statements such as ‘Contains: wheat, egg and milk’ to repeat mandatory allergen ingredients information. Information about allergens as ingredients can only be presented in the mandatory format (i.e., emphasised within the ingredients list). This is to ensure that information is presented in a single and consistent format across food products.
Distance selling (Article 14)
72. FBOs selling prepacked foods through distance selling need to make the same level of information on allergens available to consumers, for example on their website or in their catalogue, as when the food is bought from a retail environment. (footnote 3) This is to ensure that the mandatory allergen information is available before the purchase is concluded and at the moment of delivery. Telephone numbers provided by FBOs which enable consumers to obtain oral allergen information over the telephone, must not be at an additional cost (in other words the calls must be free or non-chargeable within standard rate call plans).
73. The distance selling rule to provide information before the purchase is concluded does not apply to prepacked foods sold through vending machines.
Example
One method a business could use is to list the ingredients (with allergens emphasised in some way) on the website where the customer views the product prior to purchasing it. To make this information available to the customer at the moment of delivery, it could appear on the packaging of the food.
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Regulation (EU) No. 828/2014 enforced in Wales by The Food Information (Wales) (Amendment) Regulations 2016 and in Northern Ireland by The Food Information (Amendment) Regulations (Northern Ireland) 2016.
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Commission Notice on substances of products causing allergies or intolerances (2017/C 428/01).
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For distance sales of prepacked food, other mandatory information must be provided as listed in Article 9 with exception of Article 9 (1) (f)
Revision log
Published: 23 August 2023
Last updated: 23 August 2024