Reinforcing trust in scientific studies on food products: new rules for more transparency and independence
On 27 March 2021, the Regulation on the transparency and sustainability of the EU risk assessment in the food chain becomes applicable. The Commission’s proposal for this Regulation was adopted in 2019, following a European Citizens’ Initiative. The Regulation’s entry into force does not only mark an important step forward in the modernisation of the EU food safety policy, it is also a great example of the direct political impact of a European Citizens’ Initiative.
The new rules will improve the transparency of the EU risk assessment regarding food and cover a wide range of products of great concern for citizens. The Regulation will strengthen the reliability, objectivity and independence of studies submitted to the European Food Safety Authority (EFSA) and give a greater role to Member States in EFSA’s governance.
Commissioner Stella Kyriakides, in charge of Health and Food Safety, said: “More transparency on EU scientific work in the area of food will reinforce consumer trust. These new transparency rules directly respond to calls from our citizens. We are putting them in place at a time when the Commission has taken a strong commitment, through our Farm to Fork Strategy, in ensuring greater sustainability so that that the way we produce and consume our food is healthy not just for us, but also for our planet.”
Bernhard Url, EFSA’s Executive Director, said: “This is a pivotal moment for the food safety system in the EU. EFSA is grateful to legislators for giving us this exciting opportunity to bring citizens and stakeholders closer to our work and to benefit from greater scrutiny of our working processes and practices. Over the past couple of years we have committed significant resources to ensuring that the transition to the new system is as smooth and inclusive as possible for all our stakeholders.”
Early on in the EU risk assessment process all submitted scientific studies and data will proactively be disclosed to the public. This will happen in an easily accessible format on a dedicated section of EFSA’s website (unless this is not possible for duly justified reasons of confidentiality).
In addition, and to identify whether other relevant scientific data or studies are available, EFSA will consult the public and all other partners involved before preparing its scientific output.
A series of measures will ensure the quality, robustness and independence of the studies submitted by industry.
When studies have been commissioned to support a future EU-wide authorisation application or notification, the concerned business operators and laboratories must notify these studies to EFSA at pre-submission phase. This measure is to guarantee that companies applying for authorisations submit all relevant information and do not hold back unfavourable studies.
In the next four years, the Commission will also do fact-finding missions at laboratories to assess whether the latter apply the relevant standards for tests and studies submitted to EFSA in the context of an application process. These missions will allow the Commission to identify, and, if necessary, to correct any non-compliance or weaknesses.
In recent months, EFSA has been helping its partners to better understand and prepare for the new arrangements. It produced a range of supporting materials such as animated tutorials, frequently asked questions and it held a series of training sessions.
The Member States will play a bigger role to improve EFSA’s governance and scientific cooperation, and to ensure its long-term operational sustainability.
Representatives of all Member States, the European Commission, the European Parliament, civil society and food chain interest groups, will be involved in the governance of EFSA. They will be represented in its Management Board, as of 1st July 2022.
In addition, the legislation provides for a more active involvement of Member States in fostering EFSA’s scientific capacity, by engaging the best independent experts for EFSA.
The European Commission, EFSA and the EU Member States are now working to achieve the last step of the Regulation: the development of a general plan to ensure a coherent risk communication throughout the risk analysis process.
To mark the upcoming entry into application of the Transparency Regulation, the European Commission and the Portuguese Presidency, in collaboration with EFSA, will organise a joint celebratory virtual event on Tuesday 30 March 2021, from 10:00 till 12:30 CET. The event will be web-streamed here.
The Commission proposal was tabled on 11 April 2018, following a reply by the European Commission to the European Citizens’ Initiative: ‘Ban glyphosate and protect people and the environment from toxic pesticides’ and the completion of a Fitness Check of the General Food Law Regulation, in accordance with the Better Regulation agenda. It was adopted by the two co-legislators, the Council and the European Parliament, in less than 15 months, in June 2019.
Frequently Asked Questions – SANTE website
Implementation of the Transparency Regulation