Indication of certain ingredients present in foodstuffs (allergens)

Commission Directive 2007/68/EC amends Annex IIIa to Directive 2000/13/EC,and aims in particular to ensure that consumers suffering from food allergies or who wish to avoid eating certain ingredients are informed. Directive 2000/13/EC provides for the possibility of excluding from the labelling requirement ingredients or substances derived from ingredients listed in Annex IIIa for which it has been scientifically established that they are not likely, under specific circumstances, to trigger adverse reactions. Directive 2007/68/EC contains a list of those substances that must be indicated on the label as well those substances that may be excluded from the 'allergen' labelling requirement.

The following ingredients must be indicated on the label if they present in a food product:

  • Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof, except:
    • wheat-based glucose syrups including dextrose*
    • wheat-based maltodextrins*;
    • glucose syrups based on barley;
    • cereals used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages.
  • Crustaceans and products thereof
  • Eggs and products thereof
  • Fish and products thereof, except:
    • fish gelatine used as carrier for vitamin or carotenoid preparations;
    • fish gelatine or Isinglass used as fining agent in beer and wine
  • Peanuts and products thereof
  • Soybeans and products thereof, except:
    • fully refined soybean oil and fat*;
    • natural mixed tocopherols (E306), natural D-alpha tocopherol, natural D-alpha 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
  • Milk and products thereof (including lactose), except:
    • whey used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages;
    • lactitol
  • 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 (Macadamia ternifolia), and products thereof, except:
    • nuts used for making distillates or ethyl alcohol of agricultural origin for spirit drinks and other alcoholic beverages
  • Celery and products thereof
  • Mustard and products thereof
  • Sesame seeds and products thereof
  • Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2.

Mandatory since December 2008:

  • Lupin and products thereof
  • Molluscs and products thereof.

(*) And products thereof, insofar 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

Any ingredient from the above list used in the production of a food and still present in the finished product even if in an altered form must be indicated on the label with a clear reference to the name of the ingredient from which it originates. Alcoholic beverages (i.e. beverages containing more than 1.2% by volume of alcohol) will also have to declare allergens on their labels.

However, please note the transitory period granted in relation to lupin and molluscs and products thereof which were added to the list by Directive 2006/142/EC. It is transposed into Irish legislation by S.I. No. 808 of 2007. The Regulations came into operation on the 23 December 2008 and state that products complying with Directive 2006/142/EC may be placed on the market from 23 December 2007, and products labelled prior to 23 December 2008 may be sold while stocks last.

The Commission has published guidelines relating to Article 6 & 10 of Directive 2003/89/EC relating to the indication of the ingredients listed in Annex IIIa of the Directive.

Directive 2003/89/EC also established a procedure allowing for a temporary labelling exemption of relevant derivatives and to obtain a provisional labelling exemption for these ingredients or substances. The Commission issuedGuidelines for the contents of the notifications requested by new paragraph 11 of Directive 2000/13/EC,as amended by Directive 2003/89/EC to ensure that the submissions pursuant to Paragraph 11 were properly introduced and contained all the necessary information.Those applications concerned substances for which provisional exemptions were granted byCommission Directive 2005/26/EC as corrected by Commission Directive 2005/63/EC. On the basis of the EFSA opinions and other available information, it has now been concluded that certain ingredients or substances derived from those ingredients listed in Annex IIIa toDirective 2000/13/EC are not likely, under specific circumstances, to cause adverse reactions in susceptible individuals and a list now includes those substances were have been granted a permanent exemption. Commission Directive 2007/68/EC has applied since the 26 November 2007 and it repealed Directive 2005/26/EC on that date. S.I. No. 424 of 2008 transposes Commission Directive 2007/68/EC and allows foodstuffs placed on the market or labelled before 31 May 2009 that comply with the provisions of Directive 2005/26/EC as corrected to be marketed until stocks are exhausted.

Last reviewed: 24/8/2009

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