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Transparency Regulation Implementation Training Programme

A new regulation on the transparency and sustainability of the EU risk assessment in the food chain becomes applicable on 27 March 2021.

The regulation aims to increase the transparency of risk assessment in the food chain, to strengthen the reliability, objectivity and independence of the studies submitted to EFSA, and reinforce the governance of EFSA to ensure its long-term sustainability.

To help stakeholders better understand and prepare for the new arrangements, we will be producing a range of supporting materials such as animated tutorials and holding a series of training sessions.

All the materials as well as the calendar of activities will be available on this dedicated page, which will be updated over the coming weeks.

As a first step, we held an information session on 19 November to give an overview of the processes and administrative requirements introduced by the new regulation. The first training sessions will follow in January 2021.

The Transparency Regulation will introduce new processes and tools affecting - in particular - stakeholders and business operators involved in the assessment of applications.

To promote a better understanding of the new tools and processes that will be implemented after the entry into application of the Transparency Regulation on 27 March 2021, and to ensure a smooth transition for all parties affected by the related changes, EFSA and the European Commission have been developing a series of webinars and video tutorials.

You can find below a provisional calendar, which will be kept regularly updated (please note that the schedule may be subject to changes).

Topic Date Title Target audience Material

Transparency Regulation 

20/11/2020 

Implementing the Transparency Regulation: Requirements, tools and services 

All 

Webinar 
 

Transparency Regulation 

20/11/2020 

Transparency Regulation: What’s new for business operators and applicants? 

Business Operators 

Video Introduction 
 

Transparency Regulation 

20/11/2020 

Table of Contents (TOC) for application submission 

Business Operators 

Video Introduction 
 

Account Registration / Ask a Question 

13/01/2021 

Account registration / AskAQuestion 

All 

Video Introduction 
Video Tutorial 

Public Access to Documents (PAD) 

22/01/2021 

Public Access to Document (PAD) 

All 

Video Tutorial 

Guidance Documents 

30/03/2021 

Update of sectoral and administrative Guidance Documents to address the Transparency Regulation provisions 

All 

Video Introduction 

OpenEFSA portal 

30/03/2021 

OpenEFSA Portal: Features implementing the Transparency Regulation 

All 

Video Introduction 

Notification of Study / Pre-submission Advice 

 

16/02/2021 

Notification of Study and Pre-submission Advice 

Business Operators 

Webinar (recording and supporting material) 

Notification of Study / Pre-submission Advice 

25/03/2021 

Notification of Study and Pre-submission Advice 

Business Operators 

Webinar (recording and supporting material) 

Notification of Study / Pre-submission Advice 

01/07/2021 

Notification of Studies Database user guides version June 2021 

Business Operators 

User Guide - Notification of Studies
User Guide - Pre-application ID

Notification of Study / Pre-submission Advice 

Q2 2021 

Notification of Study check for pesticides 

Competent Authorities 

Webinar 

Confidentiality 

14/04/2021 

Confidentiality for Applicants/Business Operators 

Business Operators 

Webinar 

Confidentiality 

18/05/2021 

IT tool for submission of confidentiality request 

Business operators 

Quick Guide 

IUCLID 

18/12/2020 

IUCLID: From mixture dataset to dossier creation 

Business Operators 

Video Tutorial 
 

IUCLID 

 
29/03/2021 (9:30-12:30 and 14:00-17:00) 

31/03/2021 (9:30-12:00) 

IUCLID Metapath: how to complete MSS composers for pesticides plant metabolism studies – 2 sessions 

Business operators/ Member States/ All interested parties  

Webinar 

IUCLID 

18/03/2021 (10:00-12:00) 

22/03/2021 (10:00–12:00) 

IUCLID for applicants (2 sessions) 

Business Operators 

Recording and supporting material 

IUCLID 

20/04/2021 (14:00 – 18:00) 

IUCLID MetaPath: how to complete DER composers for pesticides mammalian metabolism studies.  

Business operators/ Member States/ All interested parties 

 

Webinar 

IUCLID 

11/05/2021 (10:00 – 12:00) 

20/05/2021 (10:00 – 12:00) 

IUCLID for regulators 

Rapporteur  Member States performing substance and MRL evaluations 

 

Webinar (registration) 

IUCLID 

Q1 2022 

IUCLID for the general public 

General Public 

Webinar 

ESFC 

20/01/2021 

 e-submission food chain platform: Introduction to the system 

All 

Video Introduction 

ESFC 

05/02/2021 

 e-submission food chain platform: How to create, submit and follow up on my application/notification 

Business Operators 

Video Tutorial (Part 1Part 2Part 3Part 4

ESFC 

25/02/2021 

 e-submission food chain platform: How to follow up/manage a dossier from its submission to the end of the authorisation procedure 

European Commission 

Video Tutorial 

ESFC 

25/02/2021 

  e-submission food chain platform: Member States Competent Authority tutorial for : Food Contact Materials, Smoke, flavouring new and modification , Health claims and GMO Food and Feed new and modification. 

 Member States / Competent authorities 

Video Tutorial 

ESFC 

25/02/2021 

e-submission food chain platform: Member States Competent Authority tutorial for : GMO directive 2001/18/EC on deliberate release into the environment (Part C) 

Member States / Competent authorities 

Video tutorial 

ESFC 

09/03/2021 

How to create my EU login to access the platform 

All 

Quick guide 

Portalino 

18/05/2021 

Portalino - How to submit confidentiality requests 

Business operators 

Quick Guide 

Application procedure 

04/06/2021 

Application procedure for food enzymes, food flavourings and food additives 

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar 

 

Application procedure 

08/07/2021 

Application procedure for feed additives 

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar 

Application procedure 

23/09/2021 

Application procedure for novel food 

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar 

Application procedure 

28/10/2021 

Application procedure for pesticides active substances and MRL 

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar 

Application procedure 

Nov 2021 

Application procedure for Food Contact Materials 

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar 

Application procedure 

Dec 2021 

Application procedure for smoke flavourings 

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar 

Application procedure 

Jan 2022 

Application procedure for health claims 

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar 

Application procedure 

Feb 2022 

Application procedure for GMO

Business operators, small and medium-sized enterprises, laboratory/testing facilities 

Webinar