- What is the new Transparency Regulation about?
- Which food-related areas are concerned by the new Transparency Regulation?
- How will the new rules increase the transparency of the EU risk assessment in the food chain and the objectivity and independence of the scientific studies submitted by the industry?
- Are sanctions or penalties foreseen for non-compliance with the notification obligation of commissioned studies?
- Will confidential information be disclosed?
- How are the studies to be disclosed and how will confidential information be processed in practice?
- How have the concerned stakeholders, and in particular the food operators, been preparing for this legislation?
- Does the proposal protect personal data?
- Is the agreement reinforcing EFSA?
- What do the new rules foresee on risk communication?
- For more information
Transparency and sustainability of the EU risk assessment model in the food chain
What is the new Transparency Regulation about?
The Transparency Regulation, which was adopted by the European Parliament and the Council in 2019 following a proposal by the European Commission in April 2018, becomes applicable on 27 March. The new Regulation increases the transparency of the EU risk assessment in the food chain, strengthens the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and ensures the long-term sustainability of EFSA by revisiting its governance.
The Regulation is also a response to a successful European Citizens' Initiative and builds upon the findings of the fitness check of the General Food Law Regulation, a comprehensive evaluation, completed in January 2018.
Which food-related areas are concerned by the new Transparency Regulation?
The new Transparency Regulation amends theGeneral Food Law Regulation and eight other legislative acts dealing with specific sectors of the food chain: GMOs (cultivation and for Food/Feed uses), feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods[i]. However, it also concerns other areas in the food chain, underpinned by the General Food Law Regulation, such as the area of health claims.
How will the new rules increase the transparency of the EU risk assessment in the food chain and the objectivity and independence of the scientific studies submitted by the industry?
The Regulation stipulates that all studies and information supporting a request for a scientific output by EFSA, including applications, are to be made public automatically and proactively on EFSA’s website in an easily accessible electronic format with the possibility to search, download and print the studies. This will be done at the very early stage of the risk assessment process, e.g. in the case of an application when this is validated or found admissible. Duly justified confidential information will be protected.
Other measures which will ensure a more robust, independent and transparent risk assessment process are:
- A notification obligation for applicants and laboratories when studies are commissioned and the creation of a database of commissioned studies: This will provide a mechanism by which EFSA will be able to double-check whether all studies commissioned by an applicant, in the context of its application for an authorisation, have been submitted;
- Consultation of stakeholders and of the general public on submitted studies to ensure EFSA's comprehensive access to existing evidence underpinning its risk assessment;
- General pre-submission advice on the applicable rules and the required content of an application dossier, to be provided by EFSA upon request to potential applicants;
- Specific pre-submission advice in the case of renewals of already authorised substances, following a notification of planned studies and a public consultation;
- Fact-finding missions by the Commission to ensure the compliance of laboratories/studies with applicable standards;
- Possibility for the Commission to ask EFSA to commission studies in exceptional circumstances of serious controversies or conflicting results to verify evidence used in its risk assessment process.
Existing intellectual property rights and data exclusivity rules will be guaranteed in line with the existing Union and national rules concerning intellectual property rights, which set out limitations on certain uses of the publicly disclosed documents or their content and other Union law rules protecting the investment made by innovators respectively. The proactive public disclosure of scientific studies and other information does not provide any permission for further exploitation of the disclosed documents in breach of intellectual property rights or data exclusivity rules. EFSA will ensure that clear undertakings or signed statements are obtained to that effect by those who access the documents, prior to their disclosure out, however, jeopardizing the proactive character of, or the easy access to the disclosed information.
Are sanctions or penalties foreseen for non-compliance with the notification obligation of commissioned studies?
The legislation must be enforceable, therefore certain procedural consequences (delays) are foreseen for applicants who have not complied with the notification obligation of commissioned studies at pre-submission stage and in the absence of a valid justification.
Will confidential information be disclosed?
All scientific data, studies and other information supporting applications would be made public proactively, with the exception of duly justified confidential information. Confidentiality requests may only be submitted with respect to information falling within the closed positive lists of confidential items, set out in the Transparency Regulation. Applicants will have to substantiate their requests and provide verifiable justification that public disclosure of the relevant information would potentially harm their interests to a significant degree. Confidentiality requests will be mainly assessed by EFSA in the different sectoral authorisation processes, in accordance with the applicable Union provisions.
How are the studies to be disclosed and how will confidential information be processed in practice?
When the applicant submits a dossier, it may request certain parts of the submitted studies and other information (that are included in the positive lists of confidential items) to be kept confidential, with the condition that verifiable justification for this request is provided demonstrating that disclosure of the relevant information would potentially harm its interests to a significant degree. To this end, it should submit a non-confidential version and a confidential version of the submitted studies and other information.
When the application is validated or found admissible, EFSA will make the non-confidential version public, as submitted by the application, of the submitted studies and information. In parallel, within 10 weeks from the date of receipt, EFSA would assess the confidentiality claim. Once this assessment is completed, any additional data and information for which confidentiality requests has been considered as unjustified would also be made public.
Further details are set out in EFSA’s Practical Arrangements on transparency and confidentiality. For the specific sector of plant protection products, additional details are also set out in EFSA’s Practical Arrangements concerning confidentiality in accordance with Articles 7(3) and 16 of Regulation (EC) No 1107/2009.
How have the concerned stakeholders, and in particular the food operators, been preparing for this legislation?
Since the Transparency Regulation does indeed introduce new processes and tools affecting - in particular - stakeholders and business operators involved in the assessment of applications, proper training has been going on for months.
To promote a better understanding of the new tools and processes and to ensure a smooth transition for all parties affected by the related changes, EFSA and the European Commission have been developing a series of materials, notably webinars and video tutorials, to explain the new rules. Guidance documents have also been published.
Does the proposal protect personal data?
Any processing of personal data would be carried out in accordance with the applicable Union legislative framework. On this basis, no personal data will be made publicly available unless it is necessary and proportionate for the purposes of ensuring the transparency, independence and the reliability of the risk assessment process, and preventing conflicts of interests.
Is the agreement reinforcing EFSA?
Since it is crucial to strengthen the EU risk assessment model which includes EFSA but also EU national scientific bodies contributing to EFSA's work, the new Regulation will lead to greater transparency of the risk assessment process by:
- contributing to EFSA acquiring greater legitimacy in pursuing its mission and
- increasing citizens' confidence in EFSA's work.
The EFSA model, as it is also the case for the other EU scientific agencies (EMA, ECHA), is dependent on its capacity to pool expertise from Member States. In particular, national scientific organisations contribute to EFSA's work by allowing their experts to work in EFSA as experts in its Scientific Panels and by providing EFSA with scientific data and studies. These contributions should be further supported to avoid increasing current difficulties in attracting sufficient candidates for EFSA's Scientific Panels.
The Regulation addresses these limitations by reinforcing EFSA's own scientific capacity and by strengthening the scientific cooperation with national scientific organisations.
The key elements concern:
EFSA remains an independent European agency funded by the European Union that operates independently of the European legislative and executive institutions (i.e. Commission, Council, and European Parliament) as well as the Member States. The rules whereby members of the Management Board and members of the Panels have to act independently and - publicly - make an annual declaration of interest are maintained and reinforced. EFSA Management Board will also continue to hold its meetings in public.
Role of Member States
The new EFSA Management Board will be operational on 1 July 2022. It will consist of representatives of all EU Member States, the Commission, the European Parliament as well as representatives of civil society and food chain interests.
In the coming months, each Member State would need to nominate a representative to the EFSA Management Board, on the basis of relevant experience and expertise in the field of the food chain legislation and policy, including risk assessment. Strict criteria of independence will have to be fulfilled. Member States will thus assume more responsibility for supporting EFSA and ensure an increased scientific cooperation.
What do the new rules foresee on risk communication?
Ensuring a coherent communication throughout the risk assessment process is key for two reasons. First, it enables to avoid divergences that could have an adverse impact on public perception as regards safety in the agri-food chain. Second, it guarantees a more comprehensive and continuous process throughout the risk analysis process, by actively involving all the relevant parties (i.e. the Commission, EFSA, Members States, stakeholders and the public). Both elements are very relevant for European citizens.
To this end, the Regulation sets out objectives and general principles of risk communication. Based on these objectives and general principles, the Commission is empowered to set out a general plan on risk communication by means of an implementing act. Its objective will be to promote an integrated risk communication framework for all risk assessors and risk managers on all matters relating to the food chain. Work on the preparation of this act is on-going.
The Commission is currently preparing this act with EFSA and the Member States.