Scientific uncertainty surrounds biotech foods. To regulate such foods and to ensure consumer choice and safety, the EU has adopted a precautionary approach based on premarket authorisation and mandatory labelling. Despite these regulatory requirements, the controversial concept of substantial equivalence is still present within the existing regimes for GM and cloned foods. The concept uses a comparative analysis of conventional and biotech foods to assess their safety. If substantial equivalence is present, biotech foods are regulated in the same manner as conventional foods. The concept restricts consumer choice and calls into question the safety of such foods because it requires no specific mandatory labelling or traceability and only minimal premarket authorisation. The dynamic between substantial equivalence and the precautionary principle is problematic as the two concepts seem contradictory. This situation prevents the existence of an adequate and efficient regulatory environment for EU biotech foods regulation and undermines a comprehensive precautionary approach towards such foods and the EU food system in general.
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