How EFSA provides support during the safety assessment of regulated products
Applicants seeking authorisation to put a product on the EU market receive support from EFSA throughout the assessment process, particularly during: preparation and submission of an application; assessment and adoption; and publication of EFSA's final evaluation.
Guidance documents explain the procedures and requirements for the preparation and submission of applications. They include, for instance, data requirements and the list of scientific evidence to be submitted.
Technical meetings are arranged where EFSA scientists, EFSA experts and interested parties exchange views and discuss scientific issues related to applications for regulated products in specific areas.
Workshops and conferences provide a forum for dialogue to exchange views and information on broader scientific food and feed safety issues. The scientific topics are not strictly related to applications for regulated products.
Online form to submit administrative and scientific queries. EFSA replies within 15 working days.
EFSA keeps applicants and other stakeholders informed with:
- Details about the activities of relevant Scientific Panels and Working Groups (dates, agendas and minutes of meetings are published on the EFSA website)
- Updates on the status of applications (through the Register of Questions and correspondence)
Applicants submit technical dossiers and respond to requests for missing or additional information using electronic formats (CD-ROMs, DVDs or USB keys).
Applicants can request a teleconference to clarify a request from EFSA for missing information.
Applicants can request a teleconference to clarify a request from EFSA for additional information.
After submitting additional or supplementary information, applicants may be invited by EFSA to attend a meeting of an EFSA working group or scientific panel to clarify issues related to the newly submitted material.
24 hours before the publication on EFSA's website, applicants and other selected stakeholders receive the adopted scientific output under embargo.
Following the publication of an adopted scientific output, a teleconference can be requested by the applicant to clarify the rationale for the decision of the Scientific Panel or EFSA and explain the evidence and other factors that influenced the outcome.
EFSA informs the applicant that EFSA's Scientific Panel has adopted a scientific output on its application one day after adoption by the Panel.