EU Food allergen regulation and its impact on the industry

Product labeling is uneven in different countries and, even at the European level, legislation has gaps both for food producers and for consumers. Some countries, such as the UK, are moving to implement new national legislation.     Introduction  According to the final RASFF (Rapid Alert System for Food and Feed) report for 2018 (European Commission 2018), alert notifications related to food allergens in the European Union are on the rise. Last year 149 notifications were registered on the system (up by 31% compared to 2017). Overall, they account for just 4% of the total notifications of food safety related risks uploaded on the system (3699 for 2018). Despite the fact that such figures might seem meager compared to the US or Canada, the spike in the statistics cannot be ignored. Official controls and the attention of the public are plainly increasing. Milk, gluten and nuts are the most commonly reported allergens. Prepared dishes and snacks are the most affected categories, possibly due to the heavy processing and the increased risk of cross contamination. Typically, most food allergen-related incidents are prompted by labeling mistakes leading to undeclared allergens. It could be that several notifications about products with undeclared allergens can be traced back to the same labeling defect but this fact of course does not diminish the high level of risk in such cases.    PAL-Precautionary allergen labeling  It is important to remember that not all allergen-related issues are harmonised in EU legislation and covered by Regulation (EU) 1169/2011 (European Parliament and Council of Europe 2011) on the provision of food information to consumers. Quite often, on the RASFF system, traces of allergens are notified, occurring in foods due to cross-contamination. Such allergen occurrence is not regulated at the EU level, threshold levels have not been set to define the concept of “traces”, and reference doses have not been established. This situation leads to:  – uncertainty and inconsistency across the supply chain in the risk assessment process put in place by the food industry to determine the use of PAL (“Precautionary allergen labeling”) warnings;  – confusion for consumers, due to different wordings used for PAL warnings (e.g., “May contain”, “May contain traces”, “Produced in a facility …”) and a generic overuse of such statements without proper risk assessments, especially in the SME (small medium enterprises) sector;  – an inconsistent approach by the competent authorities, especially where local guidance about thresholds for the use of PALs where reference doses have been established.  Despite European Food Safety Authority (EFSA) efforts in defining the problem (see Scientific Opinion on the evaluation of allergenic foods and food ingredients for labeling purposes, 2014), such institutions have refrained from establishing specific reference doses because: “the purpose of the risk assessment (e.g., exemptions from labeling, labeling of allergens unintentionally present in food) and the level of risk that may be acceptable (e.g., the fraction of the allergic population that is intended to be protected and to what extent) are risk management decisions, which are outside EFSA’s remit.” Indeed the task is competence

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