SME support services

Last reviewed date:

EFSA provides services dedicated to Small and Medium-sized Enterprises (SMEs) preparing and submitting applications for regulated products, substances and claims. 

Fast-tracking of general pre-submission advice requests

EFSA provides general pre-submission advice (GPSA) on the rules and content for an application. This service is designed to support SMEs handle their GPSA requests, by reducing waiting times by up to 50% compared to the standard GPSA procedure. Upon receipt of a request, we aim to provide the advice within 20 working days preferably in the form of a meeting to allow direct interaction and ensure that SME queries are clarified faster. 

When to request: any time prior to submission of the application, preferably at least six months before submission.

How to request: following confirmation of their SME status, SMEs requesting a GPSA will automatically benefit from this service. 

Additional information: see section 2.1.2. of the Catalogue of support initiatives for regulated products.

Fast processing of web form queries

EFSA replies to questions about the application procedures via our Ask a Question service. We fast process queries from SMEs on these topics:

  • application procedures for products, substances or claims requiring EFSA's scientific assessment, and the status of applications
  • public consultations
  • the portals and tools used in our application procedures.

Through this initiative we aim to provide SMEs with an answer within 7 working days instead of the standard 15 days, so that doubts SMEs may have while navigating the application processes can be addressed faster.

Queries about the interpretation of EU legislation are outside EFSA’s remit and should be addressed to the European Commission or the competent authority of a Member State. 

When to request: at any time.

How to request: by filling in the web form available on the Connect.EFSA portal.

Additional information: see section 2.5.2. of the Catalogue of support initiatives for regulated products.

Support using IT tools for application

This service supports SMEs in mastering the tools all applicants have to use during the application process. With our help SMEs can speed up their pre-submission activities and enhance the quality of their submissions.

We offer both physical and virtual hands-on sessions designed to help SMEs solve issues experienced in using these IT tools. The sessions cover the different platforms involved: Connect.EFSA and e-submission systems like ESFC, Portalino, and IUCLID.

When to request: at any time before the submission of the application.

How to request: a request shall be submitted via the Ask a Question service indicating the tool(s) and specific difficulty(ies) that SMEs are facing. SMEs shall indicate their availability by proposing three possible timeslots for the session.

Additional information: see section 2.1.4. of the Catalogue of support initiatives for regulated products.

Teleconferences during completeness/suitability check

Following the submission of an application, EFSA checks its content and may request additional information from the applicant. A clarification teleconference involves EFSA and the applicant and aims to clarify the request for information or any outstanding issues identified at this stage. Both the applicant and/or EFSA can request such a meeting. 

As a rule, up to two requests may be submitted for the same application. When the applicant is an SME, EFSA may consider accepting more than two requests for the same application. The clarification teleconference helps SMEs to ensure a clear understanding of the questions EFSA may have about their application.

When to request: upon receipt of an EFSA request for missing information or at any time during the completeness/suitability check phase.

How to request: contact our FDP unit via e-mail: FDP [at] efsa.europa.eu. 

Additional information: see section 2.2.1. of the Catalogue of support initiatives for regulated products.