A new regulation reinforcing trust in scientific studies on food products passed by the European Parliament (“Parliament”) and Council (“Council”) of the EU, which will be applicable as of 27 March, 2021. The new rules (“Regulation”) are aimed at bolstering the transparency of the EU risk assessment regarding food and covering a wide range of products of great concern for citizens. Within the rules, European Food Safety Authority (“Authority-EFSA”) grasps the chance to improve its ability to carry out its risk assessments in accordance with the highest transparency standards.
What does the Regulation bring?
The Regulation stipulates that food law should be based on risk analysis and therefore, aims to reinforce trust in scientific studies on food products. Risk analysis is defined as a process consisting of three interconnected components as (i) risk assessment, (ii) risk management, and (iii) risk communication under the Regulation. For the purposes of risk assessment throughout the Union, the Regulation introduces EFSA as the responsible Union risk assessment body in matters relating to food and feed safety.
Furthermore, the Regulation stipulates that risk communication operations should determine the cardinal factors to be taken into account when considering the type and level of risk communication activities needed, such as the different levels of risk, the nature of the risk and its potential impact on human health, animal health and the environment. Also, it sets forth that risk communication operations should examine, who and what are directly or indirectly affected by the risk, the levels of exposure to a hazard, the level of urgency and the ability to control risk, and other factors that influence risk perception, including the applicable legal framework and relevant market context.
Notwithstanding, the Regulation allows citizens access to scientific studies and information submitted to EFSA by industry early in the process of risk assessment. It lodges public consultations in the process for assessing applications for approval of regulated products. The Regulation aims to ensure that EFSA is notified of all commissioned studies in a particular area to guarantee that companies applying for authorizations submit all relevant information. Finally, it offers the European Commission (“Commission”) the option of asking EFSA to procure additional studies.
It should be noted that the new arrangements under the Regulation cannot be implemented retroactively, meaning that it will only be applicable to new mandates and applications. Relying on that there will be a period of adjustment for relevant bodies and authorities during which much of their ongoing work will continue to be carried out under the previous rules and legal provisions. Therefore, relevant authorities in particularly EFSA have started working on the implementation of the Regulation. Among other initiatives to support implementation of the Regulation, EFSA has presented new tools and a web portal which will be live as of March 30, 2021 in order to assist stakeholders’ adaptation to the new arrangements.
The Commission and EFSA are now closely cooperating to ensure the proper implementation of the Regulation. They are working to achieve the final step of the Regulation which is the development of a general plan to ensure a coherent risk communication throughout the risk analysis process. To that end, they are organizing joint celebratory events and online webinars to be clustered and working on the implementation process.
The Commission proposal for the Regulation was adopted in 2019, subsequent a proposal of the European Citizens’ Initiative (“ECI”). In point of fact, the Regulation was developed in response to a ECI’s initiative on pesticides.
On January 25, 2017, the ECI called on the Commission to propose to member states a ban on glyphosate, to reform the pesticide approval procedure, and to set EU-wide mandatory reduction targets for pesticide use. It has been claimed that glyphosate-based herbicides should be banned since it links to cancer in humans and has led to ecosystems degradation. Therefore, the ECI invited the Commission to take an action for achieving a pesticide-free future. This proposal was formally registered on October 6, 2017 and answered on December 12, 2017.
Overall, this Regulation on the transparency and sustainability of the EU risk assessment in the food chain is deemed as the example of the direct political impact of the European Citizens’ Initiative.
What is ECI?
ECI was introduced as a tool allowing citizens to participate in shaping EU policies. It was developed as an agenda-setting tool in the hands of citizens with the Lisbon Treaty in 2007. However, it was officially established in April 2012. Basically, ECI enables the EU member states to call on the Commission to directly propose legislative acts in areas where the Commission has the power to act. In other words, ECI gives citizens the right to directly participate in setting the legislative agenda of the EU in many subjects. If the Commission considers that the ECI is legally admissible, as it meets the necessary conditions, it decides to register its’ proposals.
There are certain conditions for a proposal to be found admissible by the Commission, as follows:
the proposed action should not manifestly fall outside the framework of the Commission's powers to submit a proposal,
the proposed action should not be manifestly abusive, frivolous, or vexatious and
the proposed action should not manifestly be contrary to the values of the Union.
Currently there are 76 successfully registered initiatives of ECI in relation to various issues.