Transparency

Openness and transparency have been key values for EFSA since it was established in 2002. As a public body, EFSA is accountable to the people it was set up to serve – the citizens of the European Union, without whose trust and confidence the Authority cannot function effectively.

A new regulation on the transparency and sustainability of the EU risk assessment in the food chain, which has been in application since 27 March 2021, strengthens the Authority’s ability to carry out its risk assessment functions in accordance with the highest transparency standards.

During the main implementation phase of the regulation leading up to its entry into application, EFSA liaised closely with stakeholders via a dedicated Sounding Board and several technical groups. You can find more information here.

EFSA communicates proactively about relevant change, updates and news related to the Transparency Regulation. Upcoming meetings and training opportunities are published in the EFSA calendar.

EFSA works continually to improve the digital tools available to applicants and other stakeholders. Information on upcoming digital enhancements is available here.

EFSA is also committed to ensuring that business operators and applicants have all the information and support they need to make a smooth transition to the new environment. Advice and supporting materials are available at the Applicants’ Toolkit section of the EFSA website, And a dedicated LinkedIn group to support applicants.

The regulation was introduced with the aim of increasing 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 in order to ensure its long-term sustainability. In particular it stipulates that:

• Citizens will have access to studies and information submitted by industry in the risk assessment process. Stakeholders and the general public will also be consulted on submitted studies.
• EFSA will be made aware of all commissioned studies to guarantee that companies applying for authorisations submit all relevant information. The Authority will also offer advice to applicants prior to the submission of dossiers.
• The European Commission may ask EFSA to commission additional studies and may carry out fact-finding missions to verify that laboratories/studies comply with quality standards.

In line with transparency requirements, EFSA has developed Open EFSA, a dedicated portal that provides comprehensive information on our risk assessment process. This includes everything from the receipt of a mandate or dossier to the adoption of an output. In the event that EFSA rejects a request for scientific advice because it fails to fulfil the necessary requirements or falls outside its remit, the Authority will outline the reasons for such non-acceptance. 

Public access to documents

Article 15 of the Treaty on the Functioning of the European Union (“TFEU”) sets the principle of transparency which includes the right of any citizen of the Union, and any natural or legal person residing or having its registered office in a Member State a right of access to documents of the EU institutions, bodies, offices and agencies according to the principles and conditions as defined in Regulation (EC) No 1049/2001. This right of access is also enshrined in Article 42 of the Charter of Fundamental rights of the European Union.

In order to give the fullest possible effect to the right of public access to documents, Regulation (EC) No 1049/2001 was adopted to implement the principle of transparency by setting up the procedure for addressing applications for access to documents. This Regulation also lists the exceptions to disclosure for protecting certain public and private interests. Regulation (EC) No 1049/2001 applies to EFSA as per Article 41 of Regulation (EC) No 178/2002. In addition, EFSA has adopted practical arrangements implementing Regulation (EC) No 1049/2001 and Articles 6 and 7 of Regulation (EC) No 1367/2006 and an internal operating procedure for handling applications for access to documents. Moreover, EFSA has adopted a Guidance for applicants to inform the public of their rights under Regulation (EC) No 1049/2001.

The right of public access to documents held by the EU institutions, bodies, offices and agencies embodies the principles of openness and transparency which constitute core values in the European legal order, contributing to a more transparent functioning of the European Union in a democratic system.

You can access EFSA’s Practical Arrangements  for the implementation of Regulation (EC) No 1049/2001 and Articles 6 and 7 of Regulation (EC) No 1367/2006here.

A Guidance for applicants for access to documentsis also available.

The process is also detailed in SOP 36 here.

For submitting applications for access to documents, please use the online form available in Connect.EFSA. By choosing in the “area” section “public access to documents” your request will be handled in accordance with Regulation (EC) No 1049/2001.

In order to explain the process, EFSA has organised a webinar.