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Application procedures

Many food and feed related products – so-called regulated products – require a scientific assessment to evaluate their safety before risk managers can authorise them for the EU market. EFSA carries out these assessments to support EU risk managers in their decision-making.

Regulated products include substances used in food and feed (such as additives, enzymes, flavourings, and nutrient sources), food contact materials and pesticides, genetically modified organisms, food-related processes and processing aids. EFSA’s mandate in the area of regulated products also includes evaluating the scientific substantiation of nutrition and health claims.

Organisations or companies set to profit from regulated substances or products must provide the evidence to prove that these substances are safe or, in the case of health claims, that these are backed by sound science.

The below links provide more detailed information regarding the general and area-specific application procedures for regulated products, claims and processes, as well as on related transparency aspects.

Applications and transparency

Since 27 March 2021 a regulation on the transparency and sustainability of the EU risk assessment in the food chain (Transparency Regulation) has been in application. It strengthens EFSA’s ability to carry out its risk assessment functions in accordance with the highest transparency standards.

EFSA is committed to ensuring that business operators and applicants have all the information and support they need to make a smooth transition to the new environment.

As part of the implementation process, EFSA has published detailed arrangements for how the new rules and measures specified in the Transparency Regulation operate in practice.

E-submission of regulated product applications through internet-based software (submitted before 27 March 2021)

Decision of the Executive Director concerning the electronic submission of applications for regulated products during COVID-19 outbreak