Version 1
: Received: 16 May 2022 / Approved: 19 May 2022 / Online: 19 May 2022 (04:55:19 CEST)
How to cite:
Lensch, A.; Duwenig, E.; Dederer, H.; Kärenlampi, S.; Custers, R.; Borg, A.; Wyss, M. Recombinant DNA in Fermentation Products is of No Regulatory Relevance . Preprints2022, 2022050251. https://doi.org/10.20944/preprints202205.0251.v1.
Lensch, A.; Duwenig, E.; Dederer, H.; Kärenlampi, S.; Custers, R.; Borg, A.; Wyss, M. Recombinant DNA in Fermentation Products is of No Regulatory Relevance . Preprints 2022, 2022050251. https://doi.org/10.20944/preprints202205.0251.v1.
Cite as:
Lensch, A.; Duwenig, E.; Dederer, H.; Kärenlampi, S.; Custers, R.; Borg, A.; Wyss, M. Recombinant DNA in Fermentation Products is of No Regulatory Relevance . Preprints2022, 2022050251. https://doi.org/10.20944/preprints202205.0251.v1.
Lensch, A.; Duwenig, E.; Dederer, H.; Kärenlampi, S.; Custers, R.; Borg, A.; Wyss, M. Recombinant DNA in Fermentation Products is of No Regulatory Relevance . Preprints 2022, 2022050251. https://doi.org/10.20944/preprints202205.0251.v1.
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 and human milk oligosaccharides. 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 (i) attempt to place these developments into the historical context, (ii) sketch the potential negative repercussions for the food and feed industries, (iii) elaborate on the safety of recombinant DNA, and (iv) 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.
Keywords
Recombinant DNA; scope of legislation; regulatory compliance; analytical capabilities; safety; global harmonization
Subject
LIFE SCIENCES, Biotechnology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
