EFSA Press Release, 19 November 2004

LABELLING - EFSA provides scientific advice for labelling of food allergen derivatives: nine evaluations finalised

The European Food Safety Authority (EFSA) has published today further scientific advice on allergenic ingredients and their derivatives in order to underpin future measures related to food labelling. The Panel on Dietetic Products, Nutrition and Allergies (NDA) has finalised 9 evaluations concerning derivatives of food allergens for which temporary exemption from mandatory declaration on food labels has been requested. By taking into account all information available, including data provided by the applicants, the Panel was able to provide advice on the likelihood of adverse reactions for most of the derivatives evaluated. EFSA has received 25 requests for scientific opinions on allergen derivatives, the remainder of which will be completed in the coming months.

Directive 2000/13/EC on food labelling requires the mandatory labelling of ingredients present in foodstuffs, including all known allergens, in order to provide consumers with better information and to protect the health of those suffering from food allergies or intolerances. Given the possibility that certain derivatives of known food allergens may not trigger an allergic reaction, this same legislation also provides for possible exemption from their mandatory declaration in the ingredient lists of food labels (under Article 6, paragraph 11 of Directive 2000/13/EC of the European Parliament and of the Council on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs, as amended by Directive 2003/89/EC). A list of derivatives of allergenic ingredients for which mandatory labelling is not required is to be determined by the European Commission provided that it can be scientifically established that these do not cause adverse reactions. EFSA's NDA panel has previously advised that such applications would need to be considered on a case by case basis (See: NDA (2004). 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. The EFSA Journal 32.)

In order to allow the food industry sufficient time to provide evidence demonstrating that certain derivatives of allergenic ingredients do not trigger allergic reactions in sensitive individuals, the legislation allows for temporary labelling exemptions to be established based on current scientific knowledge. In this context, industry was requested to submit applications before 25 August 2004 for possible temporary exemption of allergen derivatives from mandatory labelling so as to give the European Commission the opportunity to establish such a list following scientific advice from EFSA. The allergen derivatives included in the list will then be temporarily excluded from mandatory declaration on food labels pending confirmation, based on results of research to be carried out by industry, that they indeed do not cause an allergic reaction.

The European Commission has requested that EFSA evaluate a number of applications received concerning allergen derivatives and provide scientific advice regarding the likelihood of their triggering adverse reactions following their consumption by susceptible individuals under the conditions specified by the applicant.

The majority of the requests were received by EFSA in September and October. In advance of receiving these requests, the NDA Panel carried out preparatory work related to this task, including a stakeholder consultation with industry experts.

The table below provides an overview of the ingredients evaluated to date and the Panel's conclusions on nine applications. Taking into account all scientific data available, including its previous opinion and data provided by the applicants, the Panel was able to provide advice for 8 of these 9 applications. For one application, related to milk, egg and fish products used in the manufacture of wine, the data submitted was insufficient to draw a conclusion.

The Panel will pursue the evaluation of the remaining applications and provide scientific opinions as requested by the European Commission in the coming months.

Opinions published by EFSA's NDA Panel on applications for temporary exemption of allergen derivatives from food labelling Allergen derivatives evaluated by EFSA

Panel's conclusions

Wheat-based glucose syrups including dextrose

• Not very likely to cause severe allergic reaction in the majority of cereal allergic individuals
• Unlikely to cause an adverse reaction in individuals with coeliac disease (Provided that gluten content does not exceed 200 mg/kg).

Wheat-based maltodextrins

• Not very likely to cause severe allergic reaction in the majority of cereal allergic individuals
• Unlikely to cause an adverse reaction in individuals with coeliac disease

Glucose syrups produced from barley starch

• Not very likely to cause severe allergic reactions in the majority of cereal allergic individuals
• Unlikely to cause an adverse reaction in individuals with coeliac disease

Distillates made from cereals

• Unlikely to cause an adverse reaction in cereal allergic individuals

Distillates made from whey

• Unlikely to cause an adverse reaction in whey (milk) allergic individuals

Distillates made from nuts

• Unlikely to cause an adverse reaction in nut allergic individuals

Acid hydrolysed vegetable protein from wheat

• The product could cause an allergic reaction in cereal allergic individuals
• Unlikely to cause an adverse reaction in individuals with coeliac disease

Fully refined peanut oil and fat

• The product could cause allergic reactions in peanut allergic individuals

Milk products, egg products and fish products used in the manufacture of wine

• Data submitted by the applicant did not allow the Panel to predict the likelihood of adverse reactions in allergic individuals