New rules on transparency and sustainability will transform the way the European Food Safety Authority (EFSA) carries out its role as a risk assessor in the EU food safety system. A new regulation adopted by the European Parliament and the Council of the EU, which will apply from 27 March, will strengthen the Authority’s ability to carry out its risk assessments in accordance with the highest standards of transparency.
The regulation will reinforce the reliability and transparency of scientific studies submitted to EFSA and strengthen the governance of the Authority to ensure its long-term sustainability.
Bernhard Url, Executive Director of EFSA, said: “This is a crucial moment for risk assessment in the food chain in the EU. EFSA is grateful to the European Parliament, the European Commission and the EU Member States for giving us this opportunity to bring citizens and stakeholders closer to our work and to benefit from increased scrutiny of our processes and working practices.”
Among other initiatives to support the implementation of the Regulation, EFSA has launched new tools and a dedicated web portal to help stakeholders adapt to the new provisions. The new portal will be available from 30 March.
A series of training sessions and webinars have also been organised. The implementation process has been carried out in collaboration with stakeholders and EFSA’s partners, such as the European Chemicals Agency (ECHA) and Member States.
The new provisions will apply to new mandates and applications and cannot be applied retroactively. This means that there will be an adjustment period during which much of EFSA’s ongoing work will continue to be carried out under the previous rules and legal provisions.
Mr Url said: “This is a major logistical challenge, and we have committed significant resources to ensure that the transition to the new system is as smooth and inclusive as possible for our stakeholders.”
The main elements of the Regulation aim at:
- Allows citizens access to scientific studies and information submitted to EFSA by industry early in the process of risk assessment.
- Embeds public consultations in the process for assessing applications for approval of regulated products.
- Ensures that EFSA is notified of all commissioned studies in a particular area to guarantee that companies applying for authorisations submit all relevant information.
- Gives the European Commission the option of asking EFSA to procure additional studies.
- Ensuring more transparency: Citizens will have automatic access to all studies and information submitted by industry in the risk assessment process. Stakeholders and the general public will also be consulted on submitted studies. At the same time, the Regulation will guarantee confidentiality, in duly justified circumstances, by setting out the type of information that may be considered significantly harmful for commercial interests and therefore cannot be disclosed
- Increasing the independence of studies: The European Food Safety Authority will be notified of all commissioned studies to guarantee that companies applying for authorisations submit all relevant information and do not hold back unfavourable studies. The Authority will also provide general advice to applicants, in particular SMEs, prior to the submission of the dossier. Commission may ask the Authority to commission additional studies for verification purposes and may perform fact-finding missions to verify the compliance of laboratories/studies with standards
- Strengthening the governance and the scientific cooperation: Member States, civil society and European Parliament will be involved in the governance of the Authority by being duly represented in its Management Board. Member States will foster the Authority’s scientific capacity and engage the best independent experts into its work
- Developing comprehensive risk communication: A general plan for risk communication will be adopted and will ensure a coherent risk communication strategy throughout the risk analysis process, combined with open dialogue amongst all interested parties.
Further down the line, the regulation will also transform the way EFSA is governed by adding Member State representatives to its Management Board. Work is also under way to make assessment and management of risks in the food chain more accessible to EU citizens by improving communication and engagement tools and practices.
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