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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.

Highlights

28 August 2023

The Questions and Answers on EFSA’s Practical Arrangements - update August 2023. This new version concerns the arrangements of the pre-submission phase and introduces important updates relevant to the Notification of Studies. Check the Annex 1 with the list of main changes introduced, based on the experience gathered after more than two years of implementation: https://www.efsa.europa.eu/en/corporate-pubs/questions-and-answers-efsa-practical-arrangements

18 August 2023

IUCLID for pesticides filtering rule proposal for April 2024!

Have your say on amendments to the filtering rules for IUCLID dossiers. The proposal is made by EFSA with the endorsement of the IUCLID PSN sub-group and is due for implementation as from April 2024.

You can find the proposed filtering rule changes here.

Take part in our quick survey and provide your feedback by 20 September 2023.

29 June 2023

A note for all Portalino users!

Due to the maintenance and the release of new functionalities, Portalino will remain offline in the period from 6 July 2023, 9.00 UTC until 7 July 2023, 09.00 UTC. During this period, it will not be possible to send any new submissions.
 
In addition, please note that all the existing DRAFT submissions will be deleted from the system as they will, no longer be in line with the requirements introduced by the new functionalities. Therefore, make sure to send your submissions before the start of maintenance window or alternatively, after 7 July.

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

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

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

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

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

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

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 14 September 2023):
  • User Guide on Confidentiality: 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.