In many regulatory frameworks, a transgenic organism is one that contains deliberately altered genetic material which does not occur “naturally” through breeding or selection (EFSA, 2024). This inconsistency becomes more evident when considering that the same trait can be obtained both by genetic engineering techniques and by conventional breeding, creating different regulatory thresholds for products with the same traits.
Focusing on the characteristics and potential risks of the final product ensures regulatory coherence and risk assessment proportionality, avoiding inconsistencies where crops with similar traits are subject to different oversight. Not all GMOs pose the same level of risk; some have well-characterized, low-risk profiles; just as not all conventionally bred crops are inherently safe. Conventional methods such as wide crosses, mutagenesis, or spontaneous mutations can also result in traits with biosafety implications, including increased toxicity, allergenicity, or invasiveness.
While these products are generally not subject to a complete risk assessment, they are often regulated at various stages of the production chain (registration for the crop, safety assessment for the byproducts).A product-based approach enables regulators to focus their efforts on the actual risk presented by a crop rather than presuming risk based on the technique employed.
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In process-based systems, any genetic modification technique may mean that the organism is subject to biosafety assessment, which may result in the same product being classified as transgenic in some countries and not in others, hindering regulatory harmonization.
The existence of nGM plants highlights the need for a product-based regulatory approach, where the biosafety assessment focuses on the traits and phenotype of the final organism, rather than the process by which it was obtained. This approach would allow for more consistent biosafety regulation, eliminating arbitrary distinctions between genetically engineered plants and those obtained by conventional methods, which share many similarities in their genetic makeup and phenotypic properties.
