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Food Safety

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:

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.

Guidance documents

To align the existing Commission guidance documents to the new requirements of the Transparency Regulation, the Commission has revised the following:

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:

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

16 November 2020:

Expert Group on General Food Law - State of play on the implementation of the Transparency Regulation

26 June 2020:

Expert Group on General Food Law - State of play on the implementation of the Transparency Regulation

5 June 2020:

Ad hoc working group of the Advisory Group on the food chain, animal and plant health

3 March 2020:

Expert Group on General Food Law - State of play on the implementation of the Transparency Regulation and 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

Input by stakeholders and stakeholder associations

Contact

Directorate D (Food sustainability, international relations), unit D1: Farm to fork strategy

SANTE-SCIENCE-TRANSPARENCY@ec.europa.eu