Implementation of the Transparency Regulation
The new Transparency Regulation was published in the Official Journal on 6 September 2019. It entered into force 20 days after publication and became applicable as of 27 March 2021.
The Commission and the European Food Safety Authority (EFSA) have closely cooperated to ensure the proper implementation of the new Regulation.
To that end and to ensure full transparency on the stakeholder engagement process during the implementation phase of the Transparency Regulation, DG SANTE and EFSA agreed on common principles for interaction with stakeholders.
This page lists the deliverables of the Transparency Regulation implementation process, the Practical Arrangements, Implementing Acts, Guidance documents, as well as, the meetings organised by DG SANTE in the context of the implementation of the Transparency Regulation, and all input and documents sent by stakeholders and stakeholder associations to DG SANTE.
Details on documents received, meetings organised by EFSA on the implementation of the Regulation and EFSA deliverables can be found on EFSA’s website.
Celebratory event for the entry into application of the Transparency Regulation
To mark the upcoming entry into application of the Transparency Regulation, the European Commission and the Portuguese Presidency, in collaboration with the European Food Safety Authority (EFSA), jointly organised a celebratory virtual event on Tuesday 30 March 2021, from 10:00 until 12:30 CET.
More information:
- Dedicated Event page
- Event programme
- Opening remarks - Stella Kyriakides, European Commissioner for Health and Food Safety
- Opening remarks - Maria do Céu Antunes, Minister of Agriculture of Portugal
- Opening remarks - Bernhard Url, Executive Director of the European Food Safety Authority
- EFSA video “Open and accessible: a new window on food safety”
- Recording of the event
For further information, please check:
Practical arrangements
The Practical Arrangements are binding means to interpret and implement the legal framework provided by the Transparency Regulation.
By specifying the details for the implementation of required processes, they commit to how the Transparency Regulation will be applied by EFSA.
The Practical Arrangements can be found on EFSA’s dedicated webpage.
Commission Implementing acts
To align the existing Commission Implementing acts to the new requirements of the Regulation, the Commission has revised the following Commission Implementing acts.
- Commission Implementing Regulation 429/2008 on the assessment and the authorisation of feed additives
- Commission Implementing Regulation 2017/2468 concerning traditional foods from non-EU countries
- Commission Implementing Regulation 2017/2469 for applications referred to in Article 10 on novel foods
- Commission Implementing Regulation 234/2011 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Commission Implementing Regulation 844/2012 for the implementation of the renewal procedure for active substances
- Commission Implementing Regulation 257/2010 for the re-evaluation of approved food additives
Guidance documents
- The Commission published the following new guidance document:COMMISSION NOTICE on the submission of notifications under Articles 13 and 17 of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC and under the relevant provisions of Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 (2021/C 80/01)
To align the existing Commission guidance documents to the new requirements of the Transparency Regulation, the Commission has revised the following:
- WORKING DOCUMENT on the procedure for application of basic substances to be approved in compliance with Article 23 of Regulation (EC) No 1107/2009
- Practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings
EFSA’s updated scientific and administrative guidances reflecting the new provisions of the Transparency Regulation are available here.
Feedback mechanism - Have your say!
All contributions from stakeholders or stakeholder associations can be found on the dedicated Commission webpage of published initiatives. Contributions received through other channels are published here:
- Input from Safe Food Advocacy Europe A.S.B.L. (SAFE) on the Draft Implementing Regulation amending Regulation (EU) No 234/2011 on EU Transparency on risk assessment in the food chain
E-Submission Food Chain Platform
From 27 March 2021, any new dossier relating to authorisation procedures in the area of the food chain (except for Plant Protection Products and MRL) should be submitted electronically in the updated version of FSCAP, called "E-Submission Food Chain" Platform, which has been operational as of Monday 29 March 2021 at 08:00 CET.
All of the materials as well as the calendar of activities is listed on this dedicated page. The Transparency Regulation introduces new processes and tools affecting, in particular, stakeholders and business operators involved in the assessment of applications.
Training and support
On 11 January 2021, EFSA published the Practical Arrangements, which specify the details for the implementation of required processes.
To help stakeholders better understand and prepare for the new arrangements, SANTE and EFSA will be producing a range of supporting materials such as video tutorials and holding a series of training sessions which will be taking place as from January 2021.
More information on SANTE training and support will be made available on a dedicated webpage.
All details on EFSA’s training material as well as the calendar of training activities will be made available here.
Meetings
List of meetings - 2020
18 November 2020:
Ad hoc Advisory Group meeting on the Implementation of the Transparency Regulation
- Agenda
- Minutes
- SANTE – Implementing acts
- EFSA – Draft practical arrangements
- EFSA – Guidances
- EFSA – Notification of studies database
- SANTE – FSCAP
- EFSA – IUCLID
16 November 2020:
Expert Group on General Food Law - State of play on the implementation of the Transparency Regulation
- Agenda
- Minutes
- Annex
- SANTE – Implementing acts
- EFSA – Draft practical arrangements
- EFSA – Guidances
- EFSA – Notification of studies database
- SANTE – FSCAP
- EFSA – IUCLID
26 June 2020:
Expert Group on General Food Law - State of play on the implementation of the Transparency Regulation
- Agenda
- Minutes
- Annex
- EFSA – Practical arrangements
- SANTE – Implementing acts
- SANTE – FSCAP
- EFSA – IUCLID
5 June 2020:
Ad hoc working group of the Advisory Group on the food chain, animal and plant health
- Agenda
- Minutes
- Timeline – engagement with stakeholders
- EFSA – Practical arrangements
- SANTE – Implementing acts
3 March 2020:
Expert Group on General Food Law - State of play on the implementation of the Transparency Regulation and Farm to Fork Strategy
- Agenda
- Minutes
- EFSA – Working document on practical arrangements on Articles 38 and 39
- SANTE - Fact-finding missions and international aspects
- SANTE – Update on IT-related aspects of the Transparency Regulation
- SANTE – Farm to Fork Strategy
17 February:
DG SANTE information session to the European Parliament on the implementation of Regulation (EU) 2019/1381 on the transparency and the sustainability of the EU risk assessment in the food chain – “Transparency Regulation”
21 January:
Expert Group on General Food Law – IT implementation of Transparency Regulation
- Agenda
- Minutes
- Introduction to the implementation of the Transparency Regulation
- FSCAP – e-submission
- Demo
- Notification of studies project
Input by stakeholders and stakeholder associations
- POLLINIS, received on 23 September 2020, POLLINIS comments on the EFSA Practical Arrangements implementing Regulation (EU) 2019/1381
- European Crop Protection Association (E.C.P.A.), received on 8 September 2020, ECPA questions on the implementation of the Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain
- European Crop Protection Association (E.C.P.A.), received on 23 March 2020, LAEG analysis of EFSA working document on practical arrangements for confidentiality requests
- European Crop Protection Association (E.C.P.A.), received on 3 March 2020, LAEG questions to DG SANTE legislative officers (3 March 2020) – General Food Law
Contact
Directorate E (Food safety, sustainability and innovation), unit E1: Farm to Fork
SANTE-CONSULT-E1
ec [dot] europa [dot] eu (SANTE-CONSULT-E1[at]ec[dot]europa[dot]eu)