Opinion of the Scientific Panel on Dietetic products, nutrition and allergies [NDA]  on a request from the Commission relating to the evaluation of allergenic foods for labelling purposes

No abstract available

Amongst adverse reactions to food there are immune-mediated and non-immune mediated reactions. Food allergies comprise immune-mediated reactions to foods mediated either by IgE antibodies or other immunological pathways. Food intolerance comprises non-immune-mediated responses that are dependent on enzyme deficiencies, pharmacological reactions, or, as is true in the majority of cases, unknown mechanisms.

EU legislation has recently been modified regarding food labelling in order to ensure derogations to the obligatory declaration of food ingredients are not applicable to those ingredients which may induce food allergies and/or food intolerances (Annex IIIa of Directive 2003/89/EC ). This pertains to cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk and dairy products including lactose, nuts, sesame seeds, celery, mustard, and sulphite at concentration of 10 mg/kg and above.

In view of the recent scientific developments in this field and the earlier opinion of the Scientific Committee on Food (SCF) on “Adverse reactions to foods and food ingredients” expressed in 1995, the European Food Safety Authority is asked to advise the Commission on: 1) The scientific basis supporting the identification of foods, food components and food ingredients which induce food allergies and food intolerance for foodstuffs labelling purposes; and 2) The possibility of determining thresholds or of identifying other elements (including food processing) which would establish that a food component or a food ingredient is no longer susceptible of inducing adverse reactions.

In general terms, it can be stated that all allergens and products thereof mentioned in the list can cause adverse health effects, and in some cases exposure to these can be fatal. These are the most common food allergens which are generally resistant to food processing and they have the capacity to trigger an allergic reaction in an allergic consumer if they are added to foods. Some of these allergens are very widely distributed all throughout Europe, while others, such as mustard and celery, are more geographically restricted. This list should be kept under review in the light of changing food practices and emergence of new clinical observations and other kind of scientific information.

There is high variability in sensitivity between different sensitised individuals with respect to the dose of allergens required to trigger an adverse effect. In addition, for ethical reasons, highly sensitive individuals are often not tested in an appropriate way to establish thresholds. Hence, the information available is insufficient to draw firm conclusions regarding the highest dose that would not cause an adverse effect. Thus, a system of risk evaluation based on the assessment of no observed adverse effect levels (NOAEL) does not apply currently.

Processing can influence allergenicity of the foods, as does the food matrix in which the allergens are presented to the consumer. In addition, individuals who suffer from allergies to the same food may react to different components of that foodstuff. The data available do not indicate that food processing predictably influences allergenicity, and also the influence of the matrix cannot be predicted.

To minimise the risks to the consumer, analysis of foods for traces of potential food allergens is desirable. However, while sensitive test systems are coming into use and are commercially available for analysis of some allergens in foods, major problems remain with regard to factors such as: insufficient extraction, detection limits outside the range of clinical sensitivity, insufficient specificity due to cross-reaction and insufficient interlaboratory reproducibility.

The possibility that specific derivatives of the food allergens listed in Annex IIIa of the Directive are unlikely to trigger an allergic reaction needs to be evaluated on a case by case basis.

Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on a request from the Commission relating to the evaluation of allergenic foods for labelling purposes