Applications for regulated products, claims and processes

EFSA has implemented a number of provisional measures – such as all staff being required to work from home – in order to comply with the restrictions in place to control the spread of COVID-19. To ensure business continuity on regulated product applications in these circumstances, EFSA will allow companies and institutions to share documentation with the Authority through their chosen internet-based software. For more information, including contact details, consult the Services for applicants page.

Many food and feed related products require a scientific assessment to evaluate their safety before risk managers can authorise them for the EU market.

These so-called 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 regulated products mandate 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.

EFSA carries out these assessments to support EU risk managers in their decision-making.

Who does what in the applications process?

The Applications Helpdesk

We are the first point of call for all applications. We provide support to applicants and other stakeholders on all applications evaluated by EFSA. We carry out the initial administrative steps of all applications. These include the registration of all received applications and a completeness check of the information received with the submitted application.

There are three types of applications:

  • Review at EU level of products already on the market or authorised for use at national level
  • First-time evaluation of new products, prior to their introduction on the market
  • Re-evaluation of products due to the expiry of their authorisation or subsequent changes in technology or development of new scientific knowledge.