Allergens labeling and warnings in EU: what it will be from 13th December 2014? This year, with the application of the EU Reg. 1169/2011 on the provision of food information to consumers1, major labeling changes will be put in place by the food business operators. One of the most worrying aspects is for sure the allergens labeling, especially due to the severe consequences to consumer’s health which a non compliant behavior could bring. Art. 9, par. 1, lett. c) of the Regulation establishes the mandatory indication of any “ingredient or processing aid listed in Annex II or derived from a substance or product listed in Annex II causing allergies or intolerances used in the manufacture or preparation of a food and still present in the finished product, even if in an altered form”. The Annex II provides 14 categories of substances, such as cereals containing glutens, crustaceans, eggs, fish, milk, peanuts and nuts, soybeans, mustard, celery, sesame seeds, lupine, molluscs and Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre in terms of the total SO. About the way of expression of this indication, the first important aspect to stress is that the allergens should be indicated in the list of ingredients. The indication “Contain: …. [allergen]” it is permitted only where an ingredient list is not present (i.e. wine “Contain: sulphites”), to maintain the label clear and avoid too many repetitions. Is also fundamental to remember that allergens should be indicated “with a clear reference to the name of the substance or product as listed in Annex II” (art. 21, par. 1, lett. a). This is of utmost importance, because it will be better to avoid ingredient’s name different from the 14 listed and their specification. An exemption to the indication of the allergens will be provided in cases where the name of the food clearly refers to the substance or product concerned (art.21, par. 4). About this point there are ongoing discussions, especially for products like cheese. Despite is legally and traditionally not possible to do cheese without milk it will be possible to avoid the “milk” indication in the ingredient list as an allergen? The most cautious answer should be no, since the term cheese is not provided by the Annex II of the Regulation, but the final answer to this question probably will follow only with the practical application of the Regulation. Anyway, most of the more influent Guidelines about the Regulation (i.e. DEFRA in UK, FoodDrinkEurope/Eurocommerce), opted for the most permissive solution (i.e. don’t declare milk as an allergen in cheese, butter, etc.) “Where several ingredients or processing aids of a food originate from a single substance or product listed in Annex II, the labeling shall make it clear for each ingredient or processing aid concerned” (art. 21, par. 3). This principle, called “repetition principle”, clearly established that each time an allergen is present in an ingredient it should be declared. Finally the name of the substance or product as listed in Annex II “shall be emphasised through a typeset that clearly distinguishes it from the rest of the list of ingredients, for example by means of the font, style or background colour”. The way to emphasise the allergen is given to the choice of the food business operator, but for practical reason the most adopted solution is to write the name of the substance in bold. 1
REGULATION (EU) No 1169/2011 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (http://eurlex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011R1169&rid=1 )
The Regulation does not cover possible allergen cross contamination or “free from” claims, so they could be put on labels like any other voluntary information, unless they are misleading for consumers. According to Article 36, par. 3, let. a), the European Commission must adopt implementing measures detailing the application of the requirements related to voluntary information on “may contain” labeling (i.e. the possible and unintentional presence in food of substances or products causing allergies or intolerances). At this stage it is not sure if and when the Commission will provide, but surely a position could be useful. In the actual context we find too many products with long list of “may contain…. [allergen]” and often this is done as an excess of precaution by food business operators. This phenomenon limits the choice of the consumers, as well as the availability of company’s products to allergic subjects. It is significant that also the allergic consumers are asking for review regulations about this sort of indication (i.e. whether it is possible its use, what are considered “traces” etc…). The increasing awareness about allergens and the possible outcomes of non-compliance on public health suggest to the food business operators not only to be well acquainted with this new provision, but also to implement strong allergen management programs to avoid (or limit at the lowest level possible) crosscontaminations and unintentional presence of allergens in their products. Cesare Varallo Food lawyer and founder at www.foodlawlatest.com