The European Food Safety Authority (EFSA) is the main regulatory authority responsible for risk assessments related to food and feed safety in the EU. If a company wishes to commercialize a novel food, food additive, or make a nutrition or health claim, the submission of a dossier to the EFSA must be followed precisely as it relates to the submission process. Understanding these submission requirements is integral to regulatory compliance, delays, and market authorization. The EFSA provides independent scientific risk assessments related to the understanding of currently and emerging food safety concerns, which underpin the European legislation and policies that protect consumers throughout the food supply chain. [1]
The EFSA manages a range of submission categories, each of which has scientific and regulatory requirements, including:
Each submission type requires tailored dossiers demonstrating safety, efficacy, and compliance with EFSA’s scientific standards. [2]
The EFSA application process for regulated products will involve several key stages:
Pre-submission: The applicant can request General Pre-Submission Advice (GPSA) via the Connect. EFSA portal. This advice can provide clarity on the regulatory requirements for the relevant dossiers before they are commenced.
Dossier preparation and submission: Applicants prepare and submit their dossiers via EFSA’s e-submission systems e.g. the e-Submission Food Chain (ESFC) platform or IUCLID for chemical substances. The e-submission systems provide a standardized pathway for submissions and tracking of their application.
Scientific evaluation: EFSA will then undertake a thorough risk assessment of the application dossiers. This includes reviewing science data, and, in most cases, public consultations and expert peer reviews.
Outcomes: After evaluating the data, EFSA issues a scientific opinion based on the contents of the data submitted which subsequently will be incorporated into the European Commission’s approval decision processes.
EFSA have issued comprehensive administrative guidance for each of the protocols on how to prepare for all the steps taken in an application submission e.g. food contact materials, feed additives, pesticides etc. These guidance documents will explain the procedures to apply for each application type, timeframes and requirements. [3] [4]
EFSA’s submissions are primarily governed by Regulation (EU) No 2015/2283 (Novel Foods) and other related EU legislation. EFSA does publish guidance documents that count on the format and content of dossiers, data to provide in submissions, and how EFSA is going to assess final submissions. When following legislation or guidance, being able to indicate evidence of reliability of the submissions will elevate the science based on submission and assessment. [5]
Applicants commonly experience hurdles from missing data, missing standardized testing or unexplained scientific rationale. Examples of best practice to combat these challenges are:
Being prepared and proactive will enhance the chances of success in an EFSA submission.
Successfully navigating EFSA submissions requires complex scientific writing ability, understanding the regulatory requirements, and completing the dossier. Our research writing services are here to help clients prepare compliant, effective, high-quality dossiers based on EFSA’s expectations. We will support clients from analysing and documenting data, through to final submission, while being regulatory ready and simplifying the route to market.
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