The EU Library gathers guidance documents related to food safety and produced by EU national competent organisations and risk assessors.
The EU Library includes entries collected by members of EFSA’s Advisory Forum with the support of the national Focal Points. It will be updated at least annually to ensure the inclusion of any new guidance and updates of existing ones.
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Food Domain: Other; Allergens
Abstract/Summary:Food allergens are substances (often proteins) that commonly cause allergic reactions or other hypersensitivity issues. In food safety risk communication, as in this report, food that contains allergenic proteins (e.g., milk) are described as ‘allergens’ even though the specific food actually contains a number of different allergenic proteins. Allergens such as milk, peanut, or egg protein can go undeclared in food products due to mislabelling or contamination. Undeclared allergens can cause severe allergic reactions and a dose–response relationship exists, meaning that more allergic consumers will react if they are exposed to higher doses of the allergen. The symptoms of an allergic reaction vary from mild to severe and can involve one or several organs including the skin, the stomach, and the airways. The most severe symptom is anaphylactic shock, which can be fatal. Globally, peanuts, tree nuts, milk and crustaceans are the most common causes of anaphylaxis, including fatal anaphylactic shock.
Double blind placebo-controlled food challenges (DBPCFC) are the standard method for testing whether an individual is allergic to a food and can also be performed to test at which dose an allergic individual reacts. Data from individual DBPCFC can be used to calculate eliciting doses at the population level. Doses that elicit reactions in one to fifty percent of individuals allergic to milk, peanuts, hazelnuts, eggs, cashew nuts, walnuts, soy, wheat, shrimp, fish or celery, are described in this guide. The interval is collected from scientific publications.
Labelling of allergenic ingredients is regulated in the Food Information Regulation (EU) No 1169/2011. Food allergens are considered hazards in Hygiene regulation (EC) No 852/20049 and food business operators therefore need to assess the risk of allergens and allergen crosscontamination in order to make risk-based decisions and take risk-based measures.
This risk assessment guide offers comprehensive information regarding how the Swedish Food Agency will assess the risk of allergic reactions in a population when the concentration of an undeclared allergen is identified. Food business operators and control authorities may also use the guide to calculate the risk undeclared allergens might constitute. The focus of the guide is on deterministic risk assessment, which offers a point estimate based on analytical results (mg/kg), food consumption data, and eliciting doses. Aspects to consider regarding analytical data, measurement uncertainty, food consumption data (portion sizes), and eliciting doses for different food allergens are included. In addition, the reference doses for food allergens proposed by FAO/WHO expert consultation on reference doses for food allergens (FAO/WHO, 2021) are included. This report does not give advice as per which doses require actions, nor does it advise as to which risk management decision would be most appropriate in any given situation.
OPINION of the French Agency for Food, Environmental and Occupational Health Safety regarding the update of the guidelines for the evaluation of guides to good hygiene practices and the application of HACCP principles
Original title:AVIS de l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail relatif à l’actualisation des lignes directrices pour l’évaluation des guides de bonnes pratiques d’hygiène et d’application des principes HACCP (GBPH)
Food Domain: Biological Hazards; Contaminants; Allergens
Abstract/Summary:This ANSES guidance document updates the evaluation framework for guides to good hygiene practices and the application of HACCP principles in the food sector. It aims to ensure that these guides remain aligned with current scientific knowledge, regulatory requirements, and practical realities in food production. The document outlines criteria for assessing the relevance, clarity, and effectiveness of hygiene guides, emphasizing their role in supporting food business operators in managing risks and complying with food safety regulations. It also provides methodological recommendations for drafting and reviewing the guides.