This is appendix 2 for the Information Statement on Food Allergy.
European and UK food allergens subject to labelling law
Food allergens prioritised for legislative control, as regards food labelling in Europe and the UK, are contained in Annex II of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers. The following table was derived on 13th August 2021 from the then latest consolidated version of Reg. 1169/2011, that of 01.01.2018. The fully searchable European Commission law website, https://eur-lex.europa.eu/homepage.html should be consulted for the current Annex II at any future date.
*See Allergen Bureau VITAL® voluntary reference doses below https://allergenbureau.net/industry-guidance/
*Please note: ED01 is the eliciting dose that is protective of 99% of the population with the relevant food allergy. An ad hoc Joint FAO/WHO[1] Expert Consultation on Risk Assessment of Food Allergens in August 2021 published ED05 thresholds for nine allergens noting that ‘all symptoms up to ED05 fell into a mild or moderate category, while analysis of clinical data indicated that up to 5% of reactions at both ED01 and ED05 could be classed as anaphylaxis, although none were severe, based on the World Allergy Organisation definition. Furthermore, the Committee noted the extreme rarity of fatal food anaphylaxis (1 per 100000 person-years in the allergic population) and observed that no fatal reactions had been observed following exposure to doses at or below those considered for RfD (i.e. the ED01 and the ED05)’.
Annex II Substances or Products Causing Allergies or Intolerances |
IFST comments |
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*Voluntary reference doses: |
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1 |
Cereals containing gluten, namely: wheat (such as spelt and Khorasan wheat), rye, barley, oats or their hybridised strains, and products thereof, except[4]: (a) wheat based glucose syrups including dextrose (Note 1); (b) wheat based maltodextrins (Note 1); (c) glucose syrups based on barley; |
Wheat allergy should be distinguished in practice from Coeliac disease. To protect people with Coeliac disease, gluten-free foods are regulated (EU No.828/2014) and should contain no more than 20 mg/kg (ppm) gluten. The statement ‘very low gluten’ may only be made where the food, consists of or contains one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content, and contains no more than 100 mg/kg gluten in the food as sold to the final consumer. These limits may not be protective for people with wheat allergy. |
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VITAL® 3.0 ED01 Wheat: 0.7 mg as protein
FAO/WHO ED05 Wheat: 5.0 mg as protein |
2 |
Crustaceans and products thereof; |
e.g. shrimp/prawn, crab, lobster, crayfish, … tropomyosin is the major (but not the only) allergen protein in most crustaceans[5],[6] |
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VITAL® 3.0 ED01 Shrimp: 25 mg as protein
FAO/WHO ED05 Shrimp: 200 mg as protein
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3 |
Eggs and products thereof; |
Allergens are primarily in the egg white although some can be present in the yolk. Generally cooking reduces allergenic activity but not adequately for all those at risk |
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VITAL® 3.0 ED01 Egg: 0.2 mg as protein
FAO/WHO ED05 Egg: 2.0 mg as protein |
4 |
Fish and products thereof, except2: (a) fish gelatine used as carrier for vitamin or carotenoid preparations; (b) fish gelatine or Isinglass used as fining agent in beer and wine |
The major (but not the only) fish allergen is parvalbumin. Adverse reactions to fish also include the rapid onset Scombroid, or histamine, poisoning caused by bacterial production of free histamine following poor temperature control4 |
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VITAL® 3.0 ED01 Fish (finfish): 1.3 mg as protein
FAO/WHO ED05 Fish: 5.0 mg as protein |
5 |
Peanuts and products thereof; |
Peanut allergy affects about 1 in 50 children in UK. Cold pressed peanut oil (not highly refined) can cause reactions, but fully refined peanut oil may be safely consumed, in most cases. There is no legislative exception for highly refined peanut oil as a dossier has not at the time of writing been submitted to EFSA |
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VITAL® 3.0 ED01 Peanut: 0.2 mg as protein
FAO/WHO ED05 Peanut: 2.0 mg as protein |
6 |
Soybeans and products thereof, except2: (a) fully refined soybean oil and fat (15); (b) natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, and natural D-alpha tocopherol succinate from soybean sources; (c) vegetable oils derived phytosterols and phytosterol esters from soybean sources; (d) plant stanol ester produced from vegetable oil sterols from soybean sources |
Includes (soy) flour, derived from soya beans that can also be used to make textured vegetable protein (TVP) which is used as a meat replacer. The beans are fermented producing bean curd (tofu) and soy sauce. Soya milk contains allergenic proteins but the processing of soya oil and lecithin (E322), used as an emulsifier or stabiliser, reduces allergenicity significantly |
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VITAL® 3.0 ED01 Soy (milk and flour): 0.5 mg as protein
FAO/WHO ED05 No datum reported |
7 |
Milk and products thereof (including lactose), except: (a) whey used for making alcoholic distillates including ethyl alcohol of agricultural origin; (b) lactitol
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Milk allergy mostly affects infants, though recently some fatal adult reactions have occurred in UK. Includes milk from cows, buffalo, sheep and goats; milk can be present in yogurt, cheese, butter, whey and in powdered form. Skimmed milk powder is widely used in the food industry. Lactose intolerance is not a food allergy but is due to the absence of lactase in the affected individual allowing fermentation of lactose in the bowels, giving rise to bloating, cramping, pain and diarrhoea |
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VITAL® 3.0 ED01 Milk: 0.2 mg as protein
FAO/WHO ED05 Decision pending based on further data analysis |
8 |
Nuts, namely: almonds (Amygdalus communis L.), hazelnuts (Corylus avellana), walnuts (Juglans regia), cashews (Anacardium occidentale), pecan nuts (Carya illinoinensis (Wangenh.) K. Koch), Brazil nuts (Bertholletia excelsa), pistachio nuts (Pistacia vera), macadamia or Queensland nuts (Macadamia ternifolia), and products thereof, except for nuts used for making alcoholic distillates including ethyl alcohol of agricultural origin |
Also known as tree nuts. Co-sensitisation and co-allergy) is relatively common among the tree nuts and with peanut (although the latter is botanically a legume rather than a nut) |
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VITAL® 3.0 ED01 Cashew: 0.05 mg Hazelnut: 0.1 mg Walnut: 0.03 mg All as protein
FAO/WHO ED05 Walnut, Pecan, Cashew and Pistachio: 1.0 mg as protein |
9 |
Celery and products thereof;
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e.g., celery sticks and celeriac which is the root of the plant and contains significant quantities of the allergen. Often an ingredient in savoury seasonings |
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VITAL® 3.0 ED01 Celery: 0.05 mg as protein
FAO/WHO ED05 No datum reported
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10 |
Mustard and products thereof; |
including leaves, seeds and oil |
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VITAL® 3.0 ED01 Mustard: 0.05 mg as protein
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11 |
Sesame seeds and products thereof; |
For example, in tahini paste, which is often used to make hummus. Sesame was added to the US FDA list of allergens in 2021 |
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VITAL® 3.0 ED01 Sesame: 0.1 mg as protein
FAO/WHO ED05 Decision pending based on further data analysis
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12 |
Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO2 which are to be calculated for products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers
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The generic term ‘sulphites’ describes a range of permitted food additives (with legislative limits in food additive law up to 2000 mg/kg (in dried vine fruit)) that consist of or can generate sulphur dioxide, the active compound, in food. Analytically sulphites are generally determined as ‘sulphur dioxide’, SO2, hence the additives may also be described by these terms and the quantitative threshold of 10 mg/kg or mg/L arises from the limit of detection of the reference method for SO2. Toxicological concerns arose in the 1980’s implicating sulphites as initiators of asthmatic reactions in a small subset of the asthmatic populations (and in smaller subsets of the non-asthmatic population) |
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13 |
Lupin and products thereof; |
Lupin flour is used to make bread, pastry and pasta; beans (seeds) are used in savoury snacks in parts of Europe, Middle East and South America |
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VITAL® 3.0 ED01 Lupin: 2.6 mg as protein
FAO/WHO ED05 No datum reported
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14 |
Molluscs and products thereof; |
Includes mussels, scallops, cockles, oyster, clam, snail, octopus (squid, calamari), abalone. Tropomyosin a significant (but not the only) allergen protein in most molluscs4, [7] |
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VITAL® 3.0 ED01
FAO/WHO ED05 No data reported |
Note 1: reference 15 in the Regulation 1169/2011 Annex II; reads ‘And the products thereof, in so far as the process that they have undergone is not likely to increase the level of allergenicity assessed by the [European Food Safety] Authority for the relevant product from which they originated’.
[1] FAO/WHO: The Food and Agriculture Organisation of the United Nations and the World Health Organisation of the United Nations
[2] Allergen Bureau, 2019: Summary of the 2019 VITAL® Scientific Expert Panel Recommendations https://vital.allergenbureau.net/wp-content/uploads/2021/03/VSEP-2019-Summary-Recommendations_FINAL_Sept2019.pdf
[3] FAO/WHO ad hoc Joint Expert Consultation on Risk Assessment of Food Allergens http://www.fao.org/3/cb6388en/cb6388en.pdf
[4] Exceptions must be established in European law by the European Commission, based on advice from the European Food Safety Authority (EFSA), generally following a request to the Commission, by an industry body, and submission of a dossier of evidence to EFSA, for a risk assessment.
[5] Tropomyosins from house dust mites and cockroaches share a high sequence homology to shellfish tropomyosins and the inhalation of dust mite fragments has been postulated as a sensitiser for shellfish allergy. There have been case reports of allergy triggered by flour that was in fact due to dust mite contamination.
[6] The presence of marine biotins may also cause adverse reactions
[7] Tropomyosins from house dust mites and cockroaches probably share sequence homology to molluscan tropomyosins.