Allergens, declaration and risk management. Towards a harmonized European approach

EU regulation 1169/11 perfected the consumer information regime on the presence of allergenic ingredients in food products. The best (1) are yet to be discovered, in Italy, due to defects in updating national norms (2) and the sanction range. Meanwhile Brussels is trying to regulate use of the text “May contain…”.

The European Commission is obliged to define, with the appropriate implementing act, requirements for “information relating to the possible, unintended presence in food of substances or products causing allergies or intolerance”.(3)

The “Precautionary Allergen Labels” expert group, made up of Member States reps and Commission officials, DG Santé, last met on 18.1.2016 to understand the situation. Approach to so-called “May contain”, i.e. the precautionary label on the possible presence of allergenic ingredients in food due to cross contamination, should be based on actual risk analysis (HACCP) following right application of good hygiene practice (GMP) in every production plant.

Checks conducted in 2015, via a questionnaire circulated by Brussells, still reveal only some Member States are actually busy surveying right provision fulfilment. And not all yet consider “cross-contamination” equal to other contamination risks that can affect food safety. “Risk management” is in turn differentiated, where some Member States apply “tolerance zero” while others modulate intervention (relabelling, withdrawal, recall) in relation to contamination levels, limited to notifying some cases to the interested Associations.

General consensus is revealed on the opportunity to define uniform approach, starting from risk evaluation. JRC (“Joint Research Center”) suggests organizing a Work Group designed to identify harmonised sample and check methods, considering both PRC analyses (not always efficient, in the hypothesis of DNA remains lacking on analyzed materials) and methods based on antibodies (e.g. ELISA, sometimes in turn insufficient, in relation to transformation processes food undergoes).

The information really must be extended to non-packaged products, and follow uniform criteria designed to guarantee univocal indications to vulnerable consumers. Clarity is needed (4), mainly excluding uncertain text like “traces of…” (with no definition or measure of the “traces”, and their potential clinical effects), rather than references meaning nothing to the final user like “Produced on premises with …present” or “… worked too”.

Work continues and must certainly involve research centers as well as organizations (5) of patients suffering from allergies or food intolerance, imcluding celiac. For information, risk evaluation and good management.

Dario Dongo

(1) Progress is reported with regard to previous allergen directives, dir. 2003/89/CE and successive modifications.
(2) Reg. (EU) n. 1169/11 in particular provides that national legislators define “means by indications or their elements” must be made available in relation to un-packaged food “and, possibly, form of expression and presentation” (Art. 44)
(3) Reg. (EU) n. 1169/11, Title V (Voluntary information), Art. 36 (Applicable requisites), clause3

(4) Cfr.
(5) Cfr.