As part of EFSA’s ongoing commitment to engage with its stakeholders and to increase understanding of its scientific risk assessment work, EFSA has developed a customer-oriented approach to stakeholders in the area of applications for regulated products. Aiming at an interactive and responsive evaluation process, this approach is centred around a catalogue of services offered to business operators and applicants.
The catalogue provides a list of harmonised support initiatives targeted at applicants. It covers the entire application life-cycle for regulated products, from the preparation of the application (pre-submission phase) to the adoption and publication of EFSA’s scientific output.
As new possibilities of interaction with EFSA, the catalogue includes general pre-submission advice and renewal pre-submission advice, which were introduced by the Transparency Regulation, as well as tailored services for small and medium-sized enterprises.
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Webform for submitting queries to EFSA
EFSA is at your disposal to answer questions about applications for regulated products, public access to documents, job applications, the EFSA website and many other aspects related to our work.
Please note that EFSA is not responsible for establishing food safety legislation, for its enforcement or food trade matters. The European Commission, the European Parliament, the Council of the European Union, and the national authorities in each Member State are responsible for establishing and/or enforcing EU food safety legislation. EFSA’s role as risk assessor is to provide independent scientific advice on risks linked to food and feed safety to help EU risk managers make decisions.
General Pre-Submission Advice (GPSA)
Questions on a single application arising during the pre-submission phase should be conveyed via the GPSA service.
EFSA cannot provide advice on the design of studies, specific requests on how to develop and manage a study and hypotheses to be tested. Neither can EFSA comment on any proposed design, nor validate any protocol, as these aspects remain the applicant's responsibility.
When to request: anytime, preferably at least 6 months before submission
How to request: by filling in the dedicated GPSA form available on the Connect.EFSA portal
Renewal Pre-Submission Advice (RPSA)
Unlike general pre-submission advice, specific pre-submission advice for renewals focuses not only on the content of the intended application but also on the design of studies proposed by the potential applicant. The working procedures are similar to those for the provision of general pre-submission advice, with written advice being the default option, while meetings (preferably by tele- or video-conference) are organised only if EFSA considers them necessary.
To a limited extent, EFSA may provide general explanations regarding the design of studies, but only if and insofar as the study design is addressed in general guidance documents developed by EFSA.
When to request: RPSA is systematically provided following notification of intended studies for renewal and related public consultation. EFSA recommends that intended studies for renewal be notified at least 5 months before the date of the intended commission of the studies.
How to request: RPSA is a mandatory step provided to all potential applicants/notifiers who have notified intended studies for renewal in EFSA’s database of study notifications, which is available on the Connect.EFSA portal.
Submission and completeness/suitability check phase
Clarification teleconference during completeness/suitability check
A clarification teleconference is a virtual session between EFSA and the applicant. It is organised following a communication from EFSA requesting missing information or to clarify any outstanding issues during the completeness/suitability check phase.
When to request: upon receipt of an EFSA communication requesting missing information or at any time during the completeness/suitability check phase
How to request: via email to FDP [at] efsa.europa.eu (a maximum of two requests may be submitted for the same application)
Risk assessment phase
Clarification teleconference during risk assessment
A clarification teleconference during risk assessment is organised in case a request for additional/supplementary information by EFSA is not clear to the applicant. Such a teleconference can be requested to clarify the scientific rationale of individual questions raised during the risk assessment and/or to ensure a better understanding of the question to be answered by the applicant.
If a teleconference is organised upon withdrawal of an application, the discussion between EFSA and the applicant is limited to the content of the application that has been withdrawn before the adoption of an EFSA scientific output, with the aim of clarifying the sources of evidence and the issues identified regarding the application.
Clarification teleconferences, including those organised upon withdrawal of an application, do not provide a pre-assessment of responses to be submitted by the applicant in reply to EFSA’s request. If organised upon withdrawal of an application, they are neither meant to provide applicants with scientific advice for future submissions.
When to request: upon receipt of an EFSA communication requesting additional/supplementary information during the risk assessment of an application
How to request: contact the person responsible for the application in the relevant scientific unit
Clarification teleconference during Pesticide Peer Review and assessment of MRL application
This type of clarification teleconference is organised to clarify the scientific rationale of individual questions raised during the peer review process and when the additional information requested by EFSA is not clear to the applicant. Such a teleconference can be requested to clarify the scientific rationale of individual questions raised and additional information requested during the peer review and/or to ensure a better understanding of the questions and additional information requested. The meeting does not provide a pre-assessment of responses to be submitted by the applicant in reply to EFSA’s request.
When to request: upon receipt of an EFSA communication requesting additional information during the peer review phase
How to request: contact the Pesticides Peer Review Unit or the Pesticides Residues & Plant Health Unit, keeping the Rapporteur Member State (RMS)/Evaluation Member State (EMS) informed
Post adoption phase
A post-adoption teleconference can be organised between the applicant and EFSA following the publication of an EFSA scientific output regarding a regulated product. It is organised upon request by the applicant, and EFSA reserves all rights to decide on such request. In exceptional circumstances, the post-adoption teleconference may be organised in person, and ad-hoc participation of experts of EFSA Working Groups/Panels may be considered by EFSA.
This type of teleconference aims at establishing a dialogue between applicants and EFSA to explain the scientific rationale of the final Panel/EFSA output, to clarify the recommendations of the scientific output (if applicable), and/or to clarify the sources of evidence and the factors that influenced the outcome. Post-adoption teleconferences/meetings are not meant to provide applicants with scientific advice for future submission. The aim of the discussion is limited to the content of the final scientific output, as expressed by the Panel and/or EFSA.
When to request: after publication of an EFSA scientific output regarding an application
How to request: via email to the relevant Head of Unit (see EFSA directory)