Allergens: risk management and communication obligations

Food allergies affect a limited but growing percentage of the population. The harmful and potentially fatal effects on the consumer make the issue of cross-contact central.

Regulation (EU) no. 1169/2011 and subsequent amendments and additions has identified foods and substances as responsible for food allergies and intolerances.

Annex II of the aforementioned Regulation specifies that there are 14 causes of adverse reactions to foods, including cereals containing gluten, shellfish, eggs, fish products, peanuts, soya, milk, nuts, celery, mustard, sesame seeds, lupins, molluscs and sulphites (in concentrations above 10 mg/kg or 10 mg/l).

For the correct prevention of this danger, both in the production phase and in the administration and sale phase of pre-packaged and non-packaged products, the rigorous application of good hygiene standards (GHP) and good production standards (GMP) is essential to mitigate the risk of cross-contamination.

To allow a complete and effective risk assessment, the manufacturer must identify allergens within its plant at three levels, namely:

those definitely present because in the production recipe;
those potentially present because foods containing different allergens were produced on the same production line and/or environment which could remain on the processing surfaces;
those present in the warehouse of your factory.
From a communication point of view, there are different provisions depending on the method of display and destination of the product, i.e. whether it is pre-packed, non-pre-packed or intended for the B2B market.

In pre-packaged products, particularly for unattended sales, allergens must be clearly highlighted in the list of ingredients, for example using bold or underlined characters to allow adequate communication to consumers. Furthermore, as specified by Commission n.2017/C 428/01, a document which delves into all the exceptions and particular cases, this information, or any repetition thereof, cannot be reported outside this list. Instead, if the product does not require a list of ingredients, perhaps because it is single-ingredient or included in the cases of derogation provided for in Article 19, as in the case of wine, the declaration relating to the presence of allergens is still mandatory and must be indicated preceded by the expression «Contains: [name of the substance present in Annex II]».

While in the case of foods served in restaurants, this indication must be provided appropriately before the same dish is served. It is therefore necessary that the information is clearly reported on menus, signs or other equivalent systems, including digital ones.

For food and semi-finished products not intended for the final consumer but for industry, intermediate commercial operators and artisans for their professional uses, the indication of allergens can be reported both physically, i.e. on the packaging or commercial documents, and in electronic method, provided that such documentation accompanies the food product to which it refers or is sent before or at the same time as delivery.

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