Call for EOIs: EFSA’s Advice for Novel Food SMEs 2025 (Europe)

Objectives 

• This initiative aims to raise awareness of and facilitate SME access to the General Pre-Submission Advice (GPSA) service. This service can be requested at any time before the submission of an application. However, this call focuses on two key stages that may be particularly relevant for SMEs with limited or no experience in preparing and submitting a novel food application:
  • Early development stage, even before initiating the studies that will be part of the application.
  • Final preparation stages, when most of the information that will be included in the application is available.

Eligibility Criteria 

• This initiative is open to all SME business operators working in the area of novel foods/traditional foods. SMEs that have previously received advice through the 2024 edition are also welcome to apply now as long as their request concerns a different novel food.
• Common eligibility requirements (each must be met)
  • The potential applicant is a business operator aiming to submit to EC an application for pre-market authorisation of a novel food/traditional food in the near future
  • The potential applicant qualifies as an SME, according to the EU definition.
  • The potential applicant has no or limited experience in submitting novel food applications.
  • The questions submitted by the potential applicant are in the scope of the GPSA service as defined by Article 6 of EFSA’s Practical arrangements on Pre-submission phase and public consultations. In this context, it should be noted that:
  • The GPSA is limited to the rules applicable to, and the content required for, an application. Aspects going beyond the information available in the rules and guidance documents or guidelines applicable to applications are out of the scope.
  • Questions related to design of studies, unless the advice concerns guidance documents developed by EFSA in which study design is addressed, and questions related to hypotheses to be tested or risk management are out of the scope.
• Specific requirements for each of the services
  • Early advice meetings: the potential applicant is still working on the development of the product, and few or no studies supporting the future application have already been performed. The submission of the application is not foreseen in the next 12 months.
  • Pre-submission meetings: the application is almost complete, and the potential applicant is planning to have it submitted in the next 12 months.

For more information, visit EFSA.