The EFSA manages a range of submission categories, each of which has scientific and regulatory requirements, including:

• Application for Novel Food: This concerns food or food ingredients that were not widely consumed within the European union before May 1997.
• Food Additives: which are chemical compounds added to food for preservation, flavoring, and appearance
• Feed Additives: which are used with an animal feedstuff
• Pesticide Residues: which are concerned with the residue from pesticides on food products
• Health and Nutrition Claims: which rely upon scientific evidence substantiation of claims made in labeling, or other marketing materials.

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:

• Consulting early with EFSA or regulatory professionals to clarify expectations.
• Providing clear, transparent through scientific evidence.
• Following EFSA’s dossier templates/guidance to avoid administrative difficulties.

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.