March 27, 2021, is fast approaching and a date to note on your calendar. This day marks the implementation of the European Commission’s new regulation and update to the General Food Law Regulation, aimed at increasing the transparency of risk assessments for foods. This new regulation directly affects how the European Food Safety Authority (EFSA) performs their risk assessments and how stakeholders interact with EFSA, notify studies, and submit dossiers. While the goal of the initiative is to increase the transparency of the risk assessment by strengthening the reliability, objectivity, and independence of the scientific studies performed, it’s yet to be seen how smooth and effective the transition will be—this regulation is a complete re-design of the European Union’s previous review and submission process and is to be implemented in a short time.
ToxStrategies has been an active participant in the Transparency Regulation Implementation Training Program that EFSA launched in January of 2021 to help stakeholders better understand and prepare for the new requirements under this regulation. In parallel with the Training Program, EFSA has also published detailed Practical Arrangements to outline how the new rules will be put into practice. It is evident from reviewing these materials that the Transparency Regulation may pose additional challenges to applicants, particularly during the first year of implementation.
For example, when the new submission framework goes into effect on March 27, 2021, all scientific studies supporting an application must be notified through EFSA before they are commissioned or carried out (according to Article 32b or 32c1 of the Regulation). This process is complicated further by being different for new applicants than for applicants for re-authorization. Stakeholders already in the process of preparing applications (before March 27, 2021) may run into logistical issues with implementing the Transparency Regulation, especially if they need to complete studies in time to meet submission deadlines for application renewals. In addition to this example, ToxStrategies has identified multiple issues that an applicant might encounter during this transition period.
If you are interested in learning more, please contact Dr. Allison Franzen at afranzen@toxstrategies.com