Published: 8 April 2026
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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https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_alimentaria/evaluacion_riesgos/informes_cc_ingles/GUIDELINES_PROCESSING_AIDS.pdf
Original title:Líneas directrices del Comité Científico de la Agencia Española de Seguridad Alimentaria y Nutrición (AESAN) sobre la información requerida para realizar la evaluación de coadyuvantes tecnológicos que se pretenden emplear en la elaboración y obtención de alimentos
Food Domain: Other;Processing aids
Abstract/Summary:The processing aids used in food preparation and production processes are regulated in Spain by Royal Decree 773/2023, which also defines them. There is also a specific regulation for the processing aids used in the production process of edible oils, which are regulated by Royal Decree 640/2015. As established in said Royal Decrees, the processing aids that do not appear in Annex I, and that are not referred to in sections 2 and 3 of Article 3, of Royal Decree 773/2023, and the processing aids used in the production process of edible oils that do not appear in Annex I of Royal Decree 640/2015 must be subject, for their approval and inclusion in said annexes, to a risk assessment by the Scientific Committee of the Spanish Agency for Food Safety and Nutrition (AESAN) that establishes the safety of the intended use. In this regard, and in order to specify what information is necessary to evaluate the safety of the use of said processing aids and thus facilitate the submission of the assessment application dossiers, the AESAN Scientific Committee has developed these guidelines that are an amendment of those approved by the AESAN Scientific Committee in 2010, which they replace. They establish a series of guidelines regarding the submission of processing aid assessment applications, in addition to the documentation that must accompany said applications, in the form of a dossier, which will include information regarding: administrative details and general presentation; detailed composition and specifications; stability and reactivity; authorised uses in human food; technological function; toxicological reference values; allergenicity; efficacy; residues and environmental impact.
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.