Food and environmental safety assessment of new plant varieties after the European Court decision: Process-triggered or product-based?

Background: For the safety assessment of new plant varieties most countries have adopted a basically process triggered legislation where the techniques applied in the plant breeding strategy determine the procedure for market approval. In other countries, there is a more product-based legislation where the characteristics of new plant varieties determine the procedure for market approval. Scope and approach: In the present paper it is investigated whether the knowledge on current plant breeding strategies warrants the current distinction in safety assessment between the different types of techniques applied. Related to this it is assessed whether it is feasible to enforce any future legislation of plants obtained by new plant breeding techniques, based on traceability aspects related to the different gene editing strategies. Key findings and conclusions: It is concluded that unintended side effects can be related to any of the current plant breeding techniques, but the effects and associated frequencies of the mutations cannot be predicted and insufficient data are available to relate them to specific techniques. As a consequence, there is no scientific basis to state that the breeding technique applied should determine the nature and extent of the pre-market safety assessment of any new plant variety. Furthermore, it will not be feasible to analytically distinguish many of the varieties obtained by new plant breeding techniques from conventionally bred varieties. This study shows that only a truly product-based approach, assessing each new plant variety on its own merits in terms of altered characteristics and related hazards, will guarantee the safety of our food supply as well as the environmental safety.