What is the legislation concerning the labelling of allergens on foodstuffs?
Directive 2000/13/EC on the labelling, presentation and advertising of foodstuffs was amended by Directive 2003/89/EC as regards the indication of ingredients present in foodstuffs, which required that certain allergenic ingredients and products thereof must be indicated on the label of a foodstuff. This Directive amended Directive 2000/13/EC through the addition of Annex IIIa which lists these allergens. This Annex has subsequently been updated by Directive 2006/142/EC (addition of lupin and molluscs to the list of allergens) and Directive 2007/68/EC.
How has this legislation changed the way pre-packaged foodstuffs are labelled?
With few exceptions, this legislation requires that all ingredients must now be listed on pre-packaged foodstuffs and that the presence of recognised allergens must be clearly labelled.
What are the allergens referred to in this legislation?
Annex IIIa of Directive 2000/13/EC lists the allergens as:
- Cereals containing gluten and products thereof
- Crustaceans and products thereof
- Eggs and products thereof
- Fish and products thereof
- Peanuts and products thereof
- Soybeans and products thereof
- Milk and products thereof (including lactose)
- Nuts i.e. almond, hazelnut, walnut, cashew, pecan nut, brazil nut, pistachio nut, macademia nut and queensland nut and products thereof
- Celery and products thereof
- Mustard and products thereof
- Sesame seeds and products thereof
- Sulphur dioxide and sulphites at concentrations of more than 10mg/kg or 10 mg/litre expressed as SO2
- Lupin and products thereof
- Molluscs and products thereof
Are there any exemptions from having to declare any of the ingredients listed in Annex IIIa?
Since it is possible that some ingredients or substances derived from allergens are not likely to pose a threat for consumers with allergies, Directive 2003/89/EC provides for the possibility of excluding from the labelling requirements ingredients or substances derived from ingredients in Annex IIIa for which it has been scientifically established that they are not likely, under specific circumstances, to trigger adverse reactions.
Following assessment by the European Food Safety Authority (EFSA) Commission Directive 2005/26/EC, as corrected by Commission Directive 2005/63/EC, listed the food ingredients and substances provisionally excluded from Annex IIIa of Directive 2000/13/EC until 25 November 2007.
Directive 2005/26/EC was repealed on 26 November 2007 by Directive 2007/68/EC amending Annex IIIa to Directive 2000/13/EC as regards certain food ingredients. On the basis of EFSA opinions and other available information, certain ingredients or substances derived from these ingredients can now be permanently excluded from Annex IIIa, as they are not considered likely to cause adverse reactions in susceptible individuals. Table 1 lists these excluded food ingredients and derived substances.
Table 1: List of food ingredients and derived substances excluded from Annex IIIa of Directive 2000/13/EC
Products thereof excluded
Cereals containing gluten
(a) Wheat based glucose syrup including dextrose 1;
(b) Wheat based maltodextrins 1;
(c) Glucose syrups based on barley;
(d) Cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
(a) Fish gelatine used as carrier for vitamins or carotenoid preparations
(b) Fish gelatine or Isinglass used as fining agent in beer and wine.
(a) Fully refined soybean oil and fat 1.
(b) Natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha tocopherol acetate, natural D-alpha tocopherol succinate from soybean sources;
(c) Vegetable oils derived phytosterols and phytosterol esters from soybean sources;
(d) Plant stanol ester products produced from vegetable oil sterols from soybean sources.
(a) Whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;
(a) Nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;
(1) And products thereof, in so far as the process that they have undergone is not likely to increase the level of allergenicity assessed by the EFSA for the relevant product from which they originated
Will the list of allergens in Annex IIIa be reviewed in the future?
Directive 2003/89/EC required that the first re-examination of Annex IIIa take place by 25 November 2005 at the latest. This has been carried out and the Annex was updated by Directive 2007/68/EC. It is expected that the list of allergens be systematically re-examined and where necessary updated on the basis of the most recent scientific knowledge.
Where on the label must the declaration of allergens be made?
The legislation does not specify where on the label the allergen information must appear, however, it must be clear to the consumer that the allergen is present. So, for example, if milk powder is listed in the list of ingredients it is clear to the consumer that the food contains milk. However, if casein is listed the consumer may not be aware that this is a milk protein. In this instance the word ‘milk’ in brackets could be inserted beside casein in the list of ingredients and/or a ‘contains box’ may be used. This would also apply to other unusual names such as lysozym (egg), unusual fish species or other uncommon names that may not be understood by the consumer as being allergenic.
Alcoholic beverages with an alcohol content of more than 1.2% by volume and other foodstuffs not requiring a list of ingredients under Directive 2000/13/EC, must read ‘contains’ on the label e.g. contains egg, contains wheat, unless it is clear from the name of the product that the allergen is present e.g. wheat beer.
Manufacturers may in addition voluntarily provide a ‘contains’ list on the label whether it is necessary or not.
What about the labelling of carry over processing aids, additives and solvents that originate from the listed allergenic ingredients?
Allergenic ingredients, as part of carry-over processing aids, additives and solvents are considered ingredients and must be clearly indicated on the label with a clear reference to the name of the ingredient from which they originate e.g. 'Additive (from wheat)'.
However, if there are multiple carry over substances, or a carry-over substance and other ingredients, that originate from the same allergenic ingredient, multiple references to this allergen do not need to be made on the label. It would suffice to present the information as follows, for example:
(1) from wheat
When and how should sulphites be declared on a food label?
Sulphur dioxide and sulphites must appear on the label under their chemical names e.g. sodium metabisulphite, where present at levels exceeding 10mg/kg or 10mg/l, expressed as SO2. Labelling the category and the additive number is not sufficient. Therefore, it is not enough to label as preservative: E223.
Does the legislation apply to food sold loose?
No. Under the current legislation the indication of the presence of allergens does not apply to foods sold loose. However, under the new Food Information Regulation (Regulation 1169/2011/EU), from 13 December 2014, all foods, whether packaged or sold loose, must indicate the presence of allergens. For foods sold loose the information will have to be available and easily accessible for consumers. It will not be sufficient to just provide the information on demand.
Do deli counters and serve-over counters at retail level have to list the ingredients in Annex IIIa?
No, where food is sold loose to the final consumer such as a deli counter or a salad bar, the only labelling required is the name of the food on a notice or sign near the food. There is no obligation to list ingredient or allergen information. However, under the new Food Information Regulation (Regulation 1169/2011/EU), from 13 December 2014, all foods, whether packaged or sold loose, must indicate the presence of allergens. For foods sold loose the information will have to be available and easily accessible for consumers. It will not be sufficient to just provide the information on demand.
What about pre-packaged foods which do not intentionally contain allergens but are made on a site which handles allergens?
The legislation does not apply to unintentional cross contamination of foods with allergenic ingredients which are used on a manufacturing site for foods which are known to contain allergens. However, the use of a ‘may contain’ statement should not be used as a substitute for Good Manufacturing Practice (GMP).
Are there any additional allergens that would be required be labelled on children’s products?
No. The allergenic ingredients listed in Annex IIIa apply to all foods whether for adults or children and so would need to be labelled accordingly.
Are pine nuts considered as allergens?
No. Pine nuts are not considered as being part of the category ‘peanuts and products thereof’ and so will not have to be listed as an allergen. However, when used in a food product, pine nuts will have to be labelled in the list of ingredients.
Last reviewed: 5/9/2013