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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.

Highlights

16 November 2023

IUCLID for Evaluators! Get familiar with the dossier admissibility and/or evaluation of a pesticide IUCLID dossier through a self-paced, online course available on the EU Academy portal. If you are working within pesticides regulatory authorities in EU (Rapporteur/Evaluating Member States, European Commission), then this course is suitable for you!

By completing this course, you will be able to:

  • Know how to navigate within an IUCLID dossier and where to find key information;
  • Complete the steps for the Admissibility check;
  • Use the tools available in IUCLID to check, compare, review confidentiality claims and generate reports.

Enrol today and take first steps toward mastering IUCLID

https://academy.europa.eu/courses/iuclid-for-evaluators

17 October 2023

IUCLID for Applicants! Explore the world of IUCLID and unlock the secrets of dossier preparation with our brand new, self-paced online course available on the EU Academy portal. This course is intended for applicants or consultants working on regulatory dossiers in IUCLID format.

By the end of this course, you'll be equipped to:

  • Select the right tools for IUCLID dossier preparation,
  • Prepare dossiers ready for submission to regulatory authorities in Europe,
  • Skilfully use IUCLID tools for checking, comparing, summarizing, filtering for dissemination, and submission.

Enrol today and take the first step towards mastering IUCLID

https://academy.europa.eu/courses/iuclid-for-applicants   

17 October 2023

Important news for pesticides applicants related to the MetaPath and MSS composers for consolidation and management of metabolism data. The MetaPath platform is developed to collect, organize and analyse experimental data on metabolism or catabolism, observed biotransformation pathways and crucial supporting metadata. Please be informed that the latest versions of MetaPath (v. 5.4.2) and MSS Composers (v. 1.14) are now available at the following link https://oasis-lmc.org/products/software/metapath.aspx 

Below the main tools and platforms in a nutshell:

Connect

Bringing together EFSA and its stakeholders

Need to ask us about pre-submission advice, public consultations, public access to documents, notification of studies or other similar issues? The Connect platform is where you will find the answers.

OpenEFSA

All you need to know about our risk assessments

Dedicated portal hosting comprehensive information on our risk assessments, from receipt of a mandate or dossier to adoption of an output: check the status of assessments, browse data and studies, and details about experts.

ESFC

The e-submission food chain (ESFC) platform is a web-based application used by applicants to create, submit and manage their applications.

IUCLID

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.

Portalino

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.

Connect EFSA

For all applications

Access tool

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

Resources

User Guide: pre-application ID (last update: 14 September 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: 14 Semptember 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

OpenEFSA portal

For all applications

Access tool

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

See also

E-submission Food Chain platform – ESFC

For all food domains, excluding plant protection products and MRLs

Access tool

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

IUCLID software

Only for pesticide-related applications

Access tool

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:

Filter rules:

Crosswalks:

Report generator:

Training material:

Data protection notice:

Central submission system (ECHA Cloud Services)

Only for pesticide-related applications

Access tool

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

See also

Portalino

For specific cases not covered by ESFC or IUCLID

Access tool

Portalino is an e-submission system for the submission of food-chain related dossiers, documents, and datasets, including the corresponding confidentiality requests, for specific cases not covered by the E-Submission Food Chain platform (ESFC) and IUCLID workflows.

Resources

  • User guide: Portalino (last update 21 November 2023)
  • User Guide on Confidentiality: submission of confidentiality requests:
    • 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.