Recombinant DNA in fermentation products is of no regulatory relevance

(Alexandra Lensch, Elke Duwenig, Hans-Georg Dederer, Sirpa O. K¨arenlampi, Ren´e Custers, Agnes Borg, Markus Wyss)

ABSTRACT

A large variety of fermentation products are used in food and feed production, but also in other industries, and many of these products are produced with genetically modified microorganisms (GMMs).

In food and feed production, prominent examples are amino acids, vitamins, food and feed enzymes, colorants, non-caloric sweeteners, human milk oligosaccharides, or vegan alternatives of dairy, egg and meat products.

From a regulatory perspective, fermentation products are typically produced under containment. This means that premises, equipment and work processes need to be designed to prevent or at least minimize release of GMMs into the environment. The fermentation products themselves should not contain any live cells of the GMM.

Over the past years, there have been concerning developments, particularly in the European Union, stipulating that also absence of recombinant DNA might be interpreted as a regulatory requirement for fermentation products produced with GMMs.

In this paper, we attempt to place these developments into the historical context, sketch the potential negative repercussions for the food and feed industries, elaborate on the safety of recombinant DNA, and postulate that recombinant DNA should remain an integral part of the safety assessment of fermentation products but should not be misconstrued as a criterion for regulatory classification of products of biotechnology.

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