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.
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Food Domain: Pesticides
Abstract/Summary:This is a guidance document developed by the Danish EPA for higher tier risk assessment of pesticides for birds and mammals. It has been revised to meet the need for a common strategy within the Northern Zone. The guidance describes species to be included, and the focal species to be used in higher tier risk assessment for each combination of crop and growth stage. The exposure scenarios, particularly the composition of diet to be used for all relevant combinations of focal species, crop and growth stage has been specified in more detail. A calculator tool (Excel spreadsheet) was developed for use in connection with the guidance. The calculator tool is a flexible tool, which complements the EFSA Calculator Tool for Tier 1 risk assessment, providing a range of refinement options for many species required for higher tier risk assessment. It supports regulatory evaluations within the Northern Zone framework, which includes several European countries collaborating on plant protection product authorizations. The template facilitates detailed modeling of exposure scenarios by integrating species-specific data such as body weight, diet composition, and application intervals. It calculates predicted environmental concentrations and compares them with toxicological endpoints like LD50 values to determine risk quotients. It is primarily used by applicants and evaluators to demonstrate compliance with EU Regulation No. 1107/2009, promoting safer pesticide use and protecting wildlife.