Hubert Deluyker

Is scientific assessment a scientific discipline

Abstract EFSA, the European Food Safety Authority, was established in 2002 as the EUs independent risk assessment body for food and feed safety. This paper takes stock of what has been achieved and what challenges lie ahead. To do so, it first reviews scientific assessments conducted by EFSA from the perspective of a scientific experiment. This includes a hypothesis that is examined by scientific experts using existing evidence and employing agreed‐upon assessment methods, the results of which are made public. Next, it considers a number of characteristics legitimising this work: quality, consistency, independence and impartiality, as well as transparency and openness. Other key considerations are relevance, evolving expectations and innovations, fitness‐for‐purpose and efficiency, along with sustainability of the system. By and large, the scientific assessment process in place at EFSA can be understood to mimic the conduct of a scientific experiment. However, being a regulatory support mechanism, it has some distinct characteristics. Therefore, its legitimising characteristics are not necessarily identical to those used in academic research. In conclusion, since its creation 15 years ago, EFSA has very much delivered on its mission. Whatever the achievements, the EU cannot rest on its laurels though.

Emerging technologies for food and drug safety

Emerging technologies are playing a major role in the generation of new approaches to assess the safety of both foods and drugs. However, the integration of emerging technologies in the regulatory decision-making process requires rigorous assessment and consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) in partnership with the Brazilian Health Surveillance Agency (ANVISA) hosted the seventh Global Summit on Regulatory Science (GSRS17) in Brasilia, Brazil on September 18-20, 2017 to discuss the role of new approaches in regulatory science with a specific emphasis on applications in food and medical product safety. The global regulatory landscape concerning the application of new technologies was assessed in several countries worldwide. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the development, application and review of emerging technologies. The need for advanced approaches to allow for faster, less expensive and more predictive methodologies was elaborated. In addition, the strengths and weaknesses of each new approach was discussed. And finally, the need for standards and reproducible approaches was reviewed to enhance the application of the emerging technologies to improve food and drug safety. The overarching goal of GSRS17 was to provide a venue where regulators and researchers meet to develop collaborations addressing the most pressing scientific challenges and facilitate the adoption of novel technical innovations to advance the field of regulatory science.