Toolkit

This page provides an overview of all EFSA portals and tools that may be of interest to applicants, including the pre-submission activities gateway, the e-submission system, and EFSA’s portal for information on its scientific assessment work. According to their needs and areas of interest, applicants will be able to access the tools via the dedicated links.

EFSA works continuously to improve the digital tools available to applicants and other stakeholders. Information on upcoming digital enhancements is available here.

For e-submission of regulated product applications through internet-based software (submitted before 27 March 2021), see: Decision of the Executive Director concerning the electronic submission of applications for regulated products during COVID-19 outbreak.

Below the main tools and platforms in a nutshell:

Connect EFSA

For all applications

This portal gives you the possibility to engage with EFSA on a variety of topics. You can perform pre-submission activities, take part in public consultations, request information or public access to documents, and browse frequently asked questions. By registering on the portal, you can:

• Obtain a pre-application identification number (see user guide and video tutorial)
• Notify studies in EFSA’s database of study notifications (see user guide)
• Define and submit the list of intended studies for renewal applications and obtain renewal pre-submission advice (see video tutorial)
• Request general pre-submission advice (see video tutorial)
• Indicate your topics of interest to receive tailored notifications (e.g. on the launch of a public consultation in a particular domain)

Resources

Practical Arrangements: pre-submission phase and public consultations

User Guide: pre-application ID (last update: 1 February 2023) for:

• Creating pre-application IDs in Connect.EFSA
• Creating study notifications from a pre-application ID
• Managing component(s) associated to a pre-application ID
• Requesting general pre-submission advice
• Conducting pre-submission activities for renewal applications
• Creating and submitting a list of intended studies and receiving renewal pre-submission advice
• Accessing reporting features

User Guide: notification of studies (last update: 1 February 2023) for:

• Being informed about the different roles business operators, consultants and laboratories may have in the process
• Notifying studies in Connect.EFSA, from study record creation to co-notification
• Managing component(s) associated to study records
• Managing relationships between the different actors involved in the process
• Accessing reporting features

See also

• Video: pre-application ID and list of intended studies
• Video: General Pre-submission Advice - GPSA

OpenEFSA portal

For all applications

This portal hosts information on scientific assessment work, allowing you to follow the lifecycle of the risk assessment process, from reception to adoption, and to access public documents related to it.

The portal provides information on:

• The status of assessments
• Dossiers, studies, and related notified information (non-confidential versions)
• Pre-submission advice
• Members of panels and working groups (and their declarations of interest)
• Public consultations and comments received
• Meeting agendas and minutes

See also

• Video: open and accessible – a new window on food safety
• Video: how to check the status of a question number in Open.EFSA

E-submission Food Chain platform – ESFC

For all applications

ESCF is a web-based application used by applicants to create, submit and manage their applications for the following regulated product areas:

• Feed additives
• Food contact materials
• Food improvement agents
• GMO
• Nutrition (health claims, infant formulae and follow-on formulae, food allergens, nutrient sources)
• Novel food (novel and traditional foods)
• Decontamination substances

Using this system, you can build and submit a dossier, track the progress of an application, reply to requests for additional information, provide additional data requested, request a deadline extension, comment on a confidentiality assessment clarification/decision, receive information about the adoption of opinions, comment on draft opinions, and withdraw an application.

To access the system, you need an EU Login account.

See also

• Quick guide: how to create my EU login to access the platform
• Video: e-submission food chain platform – introduction to the system
• Video: e-submission food chain platform – how to create, submit and follow up on my application/notification (part 1, part 2, part 3, part 4)
• Video: e-submission food chain platform – Member State Competent Authority tutorial for food contact materials, smoke flavourings (new and modification), health claims, and GMO (food and feed, new and modification)
• Video: e-submission food chain platform – Member State Competent Authority tutorial for GMO Directive 2001/18/EC on deliberate release into the environment (Part C)

IUCLID software

Only for pesticide-related applications

The International Uniform Chemical Information Database (IUCLID) is a software application for recording, storing, maintaining and exchanging data on intrinsic and hazard properties of chemical substances, and the standard data format agreed for pesticide applications.

Applicants can use this tool to prepare their dossiers under Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005.

Rapporteur Member States (RMS) and Evaluating Member States (EMS) can access Agency IUCLID to view and evaluate submitted dossiers.

Interested parties can view the submitted dossiers by accessing Public IUCLID through links in OpenEFSA.

Resources

User manuals:

• Active substance manual​
• MRL manual​
• Microorganisms manual​
• Basic substance manual​
• IUCLID for PPP – validation and submission rules 
• User Guide: submission of confidentiality requests (last updated: 9 March 2022)
  • This user guide provides instructions on how to submit confidentiality requests in ESFC, Portalino or IUCLID. It explains the different standards to be complied with for the submission of a successful confidentiality request, as well as the procedural steps applicable to the assessment of the confidentiality requests and the legal remedies available to applicants. Please regularly check the latest version of this document as it may be subject to regular updates.

Filter rules:

• IUCLID for PPP – filter rules

Crosswalks:

• Crosswalks EU PPP Microorganisms - active substance application (product) to New Data Requirements Regulation (EU) 2022/1439 & Regulation (EU) 2022/1440 including useful clarifications about the transitional period in IUCLID
• Crosswalks IUCLID 6.6 EU PPP – Active substance application (product) to KCA & KCP

Report generator:

• Documents M EU PPP for IUCLID report generator
• Documents D (GAP) EU PPP for IUCLID report generator
• Confidentiality report EU PPP for IUCLID report generator
• Notification of Studies (NoS) extraction request EU PPP for IUCLID report generator
• Documents L (List of literature references) EU PPP for IUCLID6.6 report generator
• MRL application report EU PPP for IUCLID 6.6 report generator

Training material:

• Training course: IUCLID for applicants – pdf/zip files
• Training course: IUCLID for applicants – recording and supporting material
• Webinar: IUCLID for regulators
• Light check for personal data on pesticide dossiers in IUCLID
• Running the validation assistant tool on pesticide dossiers in IUCLID
• IUCLID tutorials
• Video: Table of Contents (ToC) for application submission
• Webinar on Metapath: how to complete MSS composers for pesticide metabolism studies – plants (primary and rotational crops) and livestock
• Webinar on Metapath: how to complete DER composers for pesticide mammalian toxicology metabolism studies
• Webinar: IUCLID training on common mistakes (part 1)
• Video: most common mistakes (part 1)
• Process and responsibilities for study notification of pesticide dossiers

Data protection notice:

• IUCLID data protection notice

Central submission system (ECHA Cloud Services)

Only for pesticide-related applications

ECHA Cloud Services is the secure online platform for submitting applications on pesticides.

To access this system you need to be a registered user (ECHA account).

Resources

• ECHA Cloud Services web page
• Q&A on ECHA Cloud Services

See also

• Pesticide evaluation: tools

Portalino

For all applications

This tool allows applicants to submit confidentiality requests related to applications, datasets and documents supporting the mandates that EFSA receives, or that are submitted in response to EFSA calls for data.

Data submitted through the E-Submission Food Chain (ESFC) platform or IUCLID are not covered by Portalino.

Resources

• Quick Guide: Portalino confidentiality requests
• User Guide: submission of confidentiality requests (last updated: 9 March 2022)
  • This user guide provides instructions on how to submit confidentiality requests in ESFC, Portalino or IUCLID. It explains the different standards to be complied with for the submission of a successful confidentiality request, as well as the procedural steps applicable to the assessment of the confidentiality requests and the legal remedies available to applicants. Please regularly check the latest version of this document as it may be subject to regular updates.
• Video: training on Portalino – how to submit confidentiality requests