‘‘Contains‘ or ‘May contain‘ – ‘traces of‘ (?) – ‘allergens‘ or ‘allergenic ingredients‘. What substances and where, on what single food product or food of sorts? The ABCs of so-called ‘Precautionary Allergen Labeling‘ (PAL) to follow.
Allergens, the duty to inform
The Allergens Directive introduced, 15 years ago, a duty to disclose the presence of certain substances capable of stimulating allergic reactions or intolerances on the labels of all prepackaged food products. (1)
The regulation ‘
Food Information to’ Consumers
‘ resumed and strengthened the information regime to protect patients with allergies and celiac disease, providing the following.
1) The ingredient list, on the labels of prepackaged food products, must include graphic evidence of keywords related to allergenic ingredients (e.g. wheat flour),
2) Food sold in bulk or pre-wrapped for the purpose of direct sale must always indicate the allergens present, with specific regard to each of the products for sale,
3) Food given or served by communities to final consumers, even free of charge, must in turn be dutifully accompanied by accurate information on the presence of allergens.
Allergenic ingredients subject to specific mandatory information are those listed in the exhaustive list in Reg. EU 1169/11, Annex II. (2) Which must come precisely identified.
The following should therefore be mentioned, for example, ‘wheat, barley, rye‘ instead of ‘cereals containing gluten‘. ‘Almonds and walnuts‘ instead of ‘nuts‘.
The European Commission updated its allergen guidelines in 2017, where confirmation of the aforementioned requirements can be found. (3)
‘Contains.‘ o ‘May contain‘, a matter of PAL
Ironically, the acronym PAL stands for ‘Protect a Life fromFood Allergy’ in food allergy education campaigns. As well as ‘Precautionary Allergen Labeling’ from the perspective of labeling.
In the only case in which – as a result of the timely application of good hygienic practices and HACCP – the operator is unable to exclude the risk of accidental contamination of the food with allergens not foreseen in the recipe, the use of the words ‘Contains‘, or ‘May Contain‘, is permitted.
‘Contains,’ or ‘May contain‘
This wording, in the margin of the ingredient list, must be followed by the specific name of the allergenic ingredients (referred to in Annex II of EU Reg. 1169/11) that may remain in the food due to ‘cross-contamination.’
With the caution to specify the name of each, when even individual shell fruits which cannot be designated by the name of their category alone.
The reference to ‘
traces of.
‘ is intended to be prohibited in the absence of scientific consensus on contamination thresholds below which the risk of immune reactions by allergic consumers can be excluded. (4)
Indeed, EU Regulation 1169/11 requires clear, precise and unambiguous information to be provided to consumers.
All the more so where the news has health significance, as precisely in the present case. (5)
The real risk of providing ambiguous allergen news is to make less educated allergic consumers believe the hypothetical harmlessness of ‘traces,’ which instead can trigger an immune reaction with even very serious consequences for their health. (6)
Dario Dongo
Notes
(1) See EC dir. 2003/89/EC as amended, repealed by reg. EU 1169/11 which incorporated and strengthened its prescriptive contents.
(2) This list was developed in agreement between European scientific authorities and national experts, based on work already shared at the Codex Alimentarius level.
(3) The European Commission Guidelines also specify the duty to specify the cereal from which the ingredient ‘gluten‘ is derived. Ex. ‘gluten (
barley
)‘.
(4) EU Regulation 1169/11 – like already the Allergens Directive (dir. 2003/89/EC) – does not, moreover, provide either for the possibility of referring to ‘traces of …’,nor for the meaning and conditions of use of this locution. Which therefore, a fortiori, must be understood to be prohibited.
(5) It is worth mentioning in this regard that-according to Reg. EC 178/02, Article 14 – food must also be safe for vulnerable groups of consumers. Which ones are allergic and celiac. The aforementioned standard also requires that the food safety risk analysis be carried out taking into account the information accompanying the product. It follows that food lacking the required information on the presence of the ingredients in Annex II to reg. EU 1269/11 qualifies as hazardous, and must therefore be subjected to corrective action under the ‘General Food Law’ (EC Reg. 178/02, Article 19). That is, immediate commercial recall with notification to the competent health authority, consumer information, commercial recall when any other measure is found to be inadequate to ensure a high level of food safety and public health assurance.
(6) The reference to the possible presence of ‘traces of‘ allergenic ingredients must therefore be sanctioned for violation of the criteria of fairness of consumer information, set out in Articles 7 and 36 of EU Regulation 1169/11 (with regard to mandatory and optional label information, respectively).
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.