Aktuelles zur industriellen Biotechnologie und zur weißen Gentechnik

Fraiture M.-A., Gobbo A., Guillitte, C. Marchesi E., Verginelli D. et al. (2024): Pilot market surveillance of GMM contaminations in

 alpha-amylase food enzyme products: A detection strategy strengthened by a newly developed qPCR method targeting a GM Bacillus licheniformis producing alpha-amylase. Food Chemistry: Molecular Sciences 8 , 100186 | https://doi.org/10.1016/j.fochms.2023.100186

Using high-throughput metagenomics on commercial microbial fermentation products, DNA from a new unauthorized genetically modified microorganism (GMM), namely the GM B. licheniformis strain producing alpha-amylase (GMM alpha-amylase2), was recently discovered and characterized. On this basis, a new qPCR method targeting an unnatural association of sequences specific to the GMM alpha-amylase2 strain was designed and developed in this study, allowing to strengthen the current GMM detection strategy. The performance of the newly developed qPCR method was assessed for its specificity and sensitivity to comply with the minimum performance requirements established by the European Network of GMO Laboratories for GMO analysis. Moreover, the transferability of the in house validated qPCR method was demonstrated. Finally, its applicability was confirmed by a pilot market surveillance of GMM contaminations conducted for the first time on 40 alpha-amylase food enzyme products labelled as containing alpha-amylase. This pilot market surveillance allowed also to highlight numerous contaminations with GMM alpha-amylase2, including frequent cross-contaminations with other GMM strains previously characterized. In addition, the presence of full-length AMR genes, raising health concerns, was also reported.

https://www.sciencedirect.com/science/article/pii/S2666566223000266

BIOHAZ Panel (2024): Update of the list of qualified presumption of safety (QPS) recommended microbiological agents

intentionally added to food or feed as notified to EFSA 19:

Suitability of taxonomic units notified to EFSA until September 2023. EFSA Journal, 22(1), e8517        https://doi.org/10.2903/j.efsa.2024.8517

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8517

Ballester, A.R., Roqué, M., Ricci-Cabello, I., Rotger, A., Malih, N. (2023): Horizon scanning on microorganisms and their products

obtained by new developments in biotechnology. EFSA supporting publication 20 (12):EN-8503, 65 pp. doi:10.2903/sp.efsa.2023.EN-8503

Background: The aim of this horizon scanning is to map applications of new genomic techniques (NGTs) developed after Directive 2001/18/EC to obtain genetically modified microorganisms (GMMs) of categories 3 and 4, with an application to the agri-food and feed sectors; as well as understanding their relevant safety and risk assessment aspects.

Methods: The review comprised systematic comprehensive searches for the identification of relevant applications: i) structured electronic searches in Medline, EMBASE, and Web of Science, and ii) searches in on-line resources, including websites of companies, regulatory agencies, patents, and registries.

Results: we identified 35GMMs meeting the eligibility criteria. An evidence table (available in a separate file) offers a detailed description of their characteristics. Most of the GMMs were developed or commercialised by institutions in China or USA (14and 10cases, respectively). Of the 35GMMs identified, 11were bacteria, 22yeasts, one fungal endophyte, and one microalga. As for use, 30 GMMs were used as (or as a source of) food or food additives, three as (or as a source of) feed or feed additives, and two for agricultural purposes. Eight GMMs are already commercialized, 9 are published in patent applications, and 18 are under development. When considering the purpose o  the new traits introduced, 10GMMs modify flavours in food; 10 increase the bioproduction of compounds; seven improve food profile/composition; two boost immunity/reduce toxicity in feed additives; five optimize food production processes, and one increases nitrogen-fixation as fertiliser. Only three identified GMMs have been subjected to an authorisation process by national or international authorities, and risk assessment studies are scarcely available. The findings of this horizon scan illustrate the growing worldwide adoption of NGTs in producing GMMs for application in the food and feed sectors

https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2023.EN-8503

Das Problem des Vorkommens von Spuren rekombinanter DNA in Fermentationsprodukten, insbesondere bei Enzymen.

Deckers M. Strategies to control the presence of microbial impurities, including genetically modified microorganisms,

in food enzymes. Ghent University. Faculty of Pharmaceutical Sciences, Ghent, Belgium.

Enzymes have been used for decades in various food processes. They are increasingly being produced by fermentation using micro-organisms, including genetically modified micro-organisms (GMM). The (EC) No 1332/2008 regulation requires that food enzymes (FE) sold on the EU market follow a safety evaluation in order to be approved for sale and one of the investigated criteria during the evaluation is the absence of the producer organism, both viable cells and associated DNA. However, no detection methods were available to investigate FE preparations regarding the presence of microbial impurities, including FE producing micro-organisms. Additionally, most of the information needed for the development of appropriate detection methods is submitted confidentially. Lastly, since no investigations had been performed on EU commercialized FE, the competent authorities were not able to determine whether or not such microbial impurities could occur. This PhD thesis aimed to contribute to the development of a control strategy targeting microbial impurities related to producing organisms in FE preparations and to obtain an overview of these potential contaminations. First, public information, dispersed in many documents, was collected, structured and analyzed. The collected data was structured and gathered into an open-access web application. Second, generic methods were developed for the detection of FE producing organisms, including bacteria and fungi. Combined to a recently available GMM detection strategy, these generic methods were applied on a representative collection of FE sold on the EU market. This pilot monitoring allowed to verify the applicability of the detection strategies on FE and to provide a first picture of the current situation related to the contamination of FE with their producing organism. Furthermore, the generated results allowed to identify potential needs to guarantee the safety and traceability of the food chain.

https://biblio.ugent.be/publication/8753176

► Biosafe:   Mistakes to avoid when analysing recombinant DNA in food products

Lensch A., Duwenig E., Dederer H.-G., Kärenlampi S.O., Custers R., Borg A., Wyss M. (2022): Recombinant DNA in fermentation products is of no regulatory relevance. Food Control | https://doi.org/10.1016/j.foodcont.2022.109170

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 (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.

https://www.sciencedirect.com/science/article/pii/S0956713522003632

Dederer H.-G., Hamburger D. (2022): Are genome-edited micro-organisms covered by Directive 2009/41/EC?—Implications

 of the CJEU’s judgment in the case C-528/16 for the contained use of genome-edited micro-organisms.

Journal of Law and the Biosciences 9 (1), lsab033, | https://doi.org/10.1093/jlb/lsab033

In its judgement of July 25, 2018, the Court of Justice of the European Union (CJEU) in the case C-528/16, Confédération paysanne and Others, held that organisms obtained by techniques of mutagenesis are ‘genetically modified organisms’ (GMOs). It follows from the Court’s reasoning that genome-edited organisms, ie organisms resulting from techniques of directed mutagenesis, are GMOs as well and are fully regulated by Directive 2001/18/EC. However, Directive 2001/18/EC only stipulates rules for the deliberate release and placing on the market of GMOs. By contrast, the European Union (EU) has adopted a separate set of rules laid down in Directive 2009/41/EC, which apply to the so-called ‘contained use’ of ‘genetically modified micro-organisms’ (GMMs). Whether also genome-edited micro-organisms are GMMs and, thus, subject to Directive 2009/41/EC is of crucial importance since contained use activities with genome-edited micro-organisms are currently carried out extensively, eg in laboratories and research facilities. An in-depth legal analysis shows that the CJEU’s interpretation of Directive 2001/18/EC can be extended to Directive 2009/41/EC which means that, in the end, genome-edited micro-organisms are GMMs invariably subject to Directive 2009/41/EC.

https://academic.oup.com/jlb/article/9/1/lsab033/6513430

Jany Kl.-D:: Werden genom-editierte Pflanzen anders eingeordnet als genom-editierte Mikroorganismen?

https://www.biotech-gm-food.com/kommentare/eugh-urteil-mutagenese-geschlossene-systeme-rl-2009-49-EG 

Deckers M., Van Braeckel J., Vanneste K., Deforce D., Fraiture M.-A., Roosens N. (2021): Food Enzyme Database (FEDA): a web application gathering information about food enzyme preparations available on the European market .

Database, Volume 2021, 2021, baab060, | https://doi.org/10.1093/database/baab060

Following the European Commission No. 1332/2008 regulation and the consequent necessity of a scientific evaluation of food enzymes (FEs) for their approval for sale on the European Union market, many FE dossiers have been submitted to the European Commission and various documents currently co-exist. In order to centralize all relevant information in one structured location that is easily accessible to support enforcement laboratories and the competent authorities, we developed a web application, called Food Enzyme Database (FEDA). FEDA allows searching and collection of information originating from many different sources in one centralized portal. Queries can be performed using key information types, which include information on the producing company, production source (strain type, genetically modified microorganism status), type of enzyme protein and evaluation status with employed evaluation criteria. The database contains all current publicly available information. Centralizing all information coupled with intuitive searching functionality also allows the generation of general statistics regarding the current market situation. FEDA is open access and is freely available at the following location: https://feda.sciensano.be.

https://academic.oup.com/database/article/doi/10.1093/database/baab060/6385791

Energiewende - einmal anders

Fraunhofer: Pflanzliche Proteine ersetzen erdölbasierte Rohstoffe

Proteine gehören wie Cellulose, Lignin und Fette zu den nachwachsenden Rohstoffen. Ihr Potenzial für die chemische Industrie wird bisher kaum genutzt. Dies wollen Forscherteams des Fraunhofer-Instituts für Verfahrenstechnik und Verpackung IVV gemeinsam mit Partnern ändern und die vielversprechenden technofunktionellen Eigenschaften pflanzlicher Proteine für industrielle Anwendungen nutzen. Ziel des Projekts TeFuProt: die Abkehr vom Erdöl, hin zu nachwachsenden Rohstoffen.

Forschungszentrum Jülich: Stroh zu Gold spinnen

Jülicher Forschende haben nicht nur Plastikmüll als Rohstoffquelle im Blick. Ein weiterer riesiger Berg ungenutzter Ressourcen sind Pflanzenabfälle. Sie machen rund 50 Prozent der weltweiten Ernten aus. Hierfür haben sich der Mikrobiologe Prof. Jan Marienhagen und der Bioverfahrenstechniker Dr.-Ing. Stephan Noack zusammengetan. Ihr Ziel ist es, wertvolle Biobausteine aus Pflanzenabfällen zu gewinnen, die üblicherweise geschreddert und untergepflügt oder verbrannt werden.

CAC: CAC builds biofuel plant for OMV

05.03.2021