Aktuelles zur industriellen Biotechnologie und zur weißen Gentechnik
EFSA (European Food Safety Authority), (2024). EFSA statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain. EFSA Journal 22 (8), e8912. https://doi.org/10.2903/j.efsa.2024.8912
Microorganisms, genetically modified or not, may be used in the food chain either as active agents, biomasses or as production organisms of substances of interest. The placement of such microorganisms or their derived substances/products in the European market may be subject to a premarket authorisation process. The authorisation process requires a risk assessment in order to establish the safety and/or the efficacy of the microorganism(s) when used in the food chain as such, as biomasses or as production strains. This includes a full molecular characterisation of the microorganism(s) under assessment. For certain regulated products, the use of whole genome sequence (WGS) data of the microorganism is established as a requirement for the risk assessment. In this regard, data obtained from WGS analysis can provide information on the unambiguous taxonomic identification of the strains, on the presence of genes of concern (e.g. those encoding virulence factors, resistance to antimicrobials of clinical relevance for humans and animals, production of harmful metabolites or of clinically relevant antimicrobials) and on the characterisation of genetic modification(s) (where relevant). This document provides recommendations to applicants on how to describe and report the results of WGS analyses in the context of an application for market authorisation of a regulated product. Indications are given on how to perform genome sequencing and the quality criteria/thresholds that should be reached, as well as the data and relevant information that need to be reported, if required. This updated document replaces the EFSA 2021 Statement and reflects the current knowledge in technologies and methodologies to be used to generate and analyse WGS data for the risk assessment of microorganisms.
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8912
GMO Panel (2024): New developments in biotechnology applied to microorganisms. EFSA Journal, 22 (7), e8895.
https://doi.org/10.2903/j.efsa.2024.8895
EFSA was requested by the European Commission (in accordance with Article 29 of Regulation (EC) No 178/2002) to provide a scientific opinion on the application of new developments in biotechnology (new genomic techniques, NGTs) to viable microorganisms and products of category 4 to be released into the environment or placed on the market as or in food and feed, and to non-viable products of category 3 to be placed on the market as or in food and feed. A horizon scanning exercise identified a variety of products containing microorganisms obtained with NGTs (NGT-Ms), falling within the remit of EFSA, that are expected to be placed on the (EU) market in the next 10 years. No novel potential hazards/risks from NGT-Ms were identified as compared to those obtained by established genomic techniques (EGTs), or by conventional mutagenesis. Due to the higher efficiency, specificity and predictability of NGTs, the hazards related to the changes in the genome are likely to be less frequent in NGT-Ms than those modified by EGTs and conventional mutagenesis. It is concluded that EFSA guidances are ‘partially applicable’, therefore on a case-by-case basis for specific NGT-Ms, fewer requirements may be needed. Some of the EFSA guidances are ‘not sufficient’ and updates are recommended. Because possible hazards relate to genotypic and phenotypic changes introduced and not to the method used for the modification, it is recommended that any new guidance should take a consistent risk assessment approach for strains/products derived from or produced with microorganisms obtained with conventional mutagenesis, EGTs or NGTs.
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8895
EFSA (2024): Peluso S, Aguilera-Gómez M, Bortolaia V, Catania F, Cocconcelli PS, Herman L, Moxon S, Vernis L, Iacono G, Lunardi S,
Pettenati E, Gallo A, Aguilera J, Catalogue of antimicrobial resistance genes in species of Bacillus used to produce food enzymes and feed additives. EFSA supporting publication 2024: 21 (7):EN-8931. 33 pp. doi:10.2903/sp.efsa.2024.EN-8931
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8931
EFSA (2024): EFSA launches new webtool to calculate dietary exposure to food enzymes
EFSA has released an innovative new webtool designed to support industry operators and consumers estimate exposure to food enzymes through the diet
https://www.efsa.europa.eu/de/news/efsa-launches-new-webtool-calculate-dietary-exposure-food-enzymes
Bossier H and Verbeke T, (2024): Software for Food Enzyme Intake Models. EFSA supporting publication 21 (7):EN-8957. 24 pp.
doi:10.2903/sp.efsa.2024.EN-8957
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8957
CEP Panel (2024): Taxonomic identity of the Bacillus licheniformis strains used to produce food enzymes evaluated in
published EFSA opinions. EFSA Journal 22 (5), e8770. https://doi.org/10.2903/j.efsa.2024.8770
Bacillus paralicheniformis, a species known to produce the antimicrobial bacitracin, could be misidentified as Bacillus licheniformis, depending on the identification method used. For this reason, the European Commission requested EFSA to review the taxonomic identification of formerly assessed B. licheniformis production strains. Following this request, EFSA retrieved the raw data from 27 technical dossiers submitted and found that the taxonomic identification was established by 16S rRNA gene analyses for 15 strains and by whole genome sequence analysis for 12 strains. As a conclusion, only these 12 strains could be unambiguously identified as B. licheniformis.
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8770
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 20: Suitability of taxonomic units notified to EFSA until March 2024. EFSA Journal, 22 (7), e8882. https://doi.org/10.2903/j.efsa.2024.8882
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8882
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.
► 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
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