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Regulatory status of non-GMO plant innovations under current EU law

A new article on the latest plant breeding methods has been published in the latest issue of Bio-Science Law Review.

The existing EU regulatory framework, when considered holistically, provides efficient guarantees that every stage of the agri-food supply chain, from lab to fork, is subject to constraints and obligations dictated by harmonised legislations, each providing various degrees of scrutiny, risk management and control, sanctions and remedial action.

Comparisons between the existing non-GMO legal framework with the GMO legislation or with any other authorization regime based on a full pre-market risk assessment are, by definition, of little practical relevance, since such regimes aim to address potentially serious risks, which, as the SAM Note clarifies, have not been identified in the case of Non-GMO NBT Products. In the absence of any such concrete, identifiable risk induced by (the use of NBTs for) Non-GMO NBT Products and in view of their non-distinguishability from CBT products, the protection of human/animal/plant health and the environment should thus be considered to be adequately ensured and Non-GMO NBT Products should not be treated differently from products resulting from CBT.

The opposite conclusion would not only raise serious concerns under the SPS Agreement but would essentially also mean that all non-GMO plant products on the market today must be considered inadequately regulated. Just as Advocate-General Bobek concluded in his Opinion in Case C–528/16,133 with regard to mutagenesis, that ‘one could hardly assume that a reasonable legislator could ever wish to state, en bloc and for the future, that something is safe to such a degree that it does not need regulating at all’, one can neither assume that all NBT-products should en bloc be considered to only yield products suspect of causing unacceptable risks. Against that backdrop, it is submitted that both the precautionary principle and the specific safeguard clauses in horizontal and sectoral legislation can justify and sufficiently guarantee the adoption of stricter risk management measures, if a previously unidentified risk arises.”

Publication date: 7/12/2018



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