New developments in biotechnology applied to microorganisms
Abstract 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 relea...
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| Format: | Article |
| Language: | English |
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Wiley
2024-07-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2024.8895 |
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| author | EFSA Panel on Genetically Modified Organisms (GMO) Ewen Mullins Jean‐Louis Bresson Ian Crawford Dewhurst Michelle M. Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Francisco Javier Moreno Hanspeter Naegeli Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Pier Sandro Cocconcelli Debora Glandorf Lieve Herman Rodrigo Jimenez Saiz Lorena Ruiz Garcia Jaime Aguilera Entrena Andrea Gennaro Reinhilde Schoonjans Dafni Maria Kagkli Tamas Dalmay |
| author_facet | EFSA Panel on Genetically Modified Organisms (GMO) Ewen Mullins Jean‐Louis Bresson Ian Crawford Dewhurst Michelle M. Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Francisco Javier Moreno Hanspeter Naegeli Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Pier Sandro Cocconcelli Debora Glandorf Lieve Herman Rodrigo Jimenez Saiz Lorena Ruiz Garcia Jaime Aguilera Entrena Andrea Gennaro Reinhilde Schoonjans Dafni Maria Kagkli Tamas Dalmay |
| author_sort | EFSA Panel on Genetically Modified Organisms (GMO) |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-6e0e1c43ae4e4d3a8039c5e17d0a8857 |
| institution | Matheson Library |
| issn | 1831-4732 |
| language | English |
| publishDate | 2024-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-6e0e1c43ae4e4d3a8039c5e17d0a88572025-07-15T09:06:43ZengWileyEFSA Journal1831-47322024-07-01227n/an/a10.2903/j.efsa.2024.8895New developments in biotechnology applied to microorganismsEFSA Panel on Genetically Modified Organisms (GMO)Ewen MullinsJean‐Louis BressonIan Crawford DewhurstMichelle M. EpsteinLeslie George FirbankPhilippe GuercheJan HejatkoFrancisco Javier MorenoHanspeter NaegeliFabien NoguéNils RostoksJose Juan Sánchez SerranoGiovanni SavoiniEve VeromannFabio VeronesiPier Sandro CocconcelliDebora GlandorfLieve HermanRodrigo Jimenez SaizLorena Ruiz GarciaJaime Aguilera EntrenaAndrea GennaroReinhilde SchoonjansDafni Maria KagkliTamas DalmayAbstract 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://doi.org/10.2903/j.efsa.2024.8895CRISPRgenetically modified microorganism(s)GMMnew genomic techniquesNGT |
| spellingShingle | EFSA Panel on Genetically Modified Organisms (GMO) Ewen Mullins Jean‐Louis Bresson Ian Crawford Dewhurst Michelle M. Epstein Leslie George Firbank Philippe Guerche Jan Hejatko Francisco Javier Moreno Hanspeter Naegeli Fabien Nogué Nils Rostoks Jose Juan Sánchez Serrano Giovanni Savoini Eve Veromann Fabio Veronesi Pier Sandro Cocconcelli Debora Glandorf Lieve Herman Rodrigo Jimenez Saiz Lorena Ruiz Garcia Jaime Aguilera Entrena Andrea Gennaro Reinhilde Schoonjans Dafni Maria Kagkli Tamas Dalmay New developments in biotechnology applied to microorganisms EFSA Journal CRISPR genetically modified microorganism(s) GMM new genomic techniques NGT |
| title | New developments in biotechnology applied to microorganisms |
| title_full | New developments in biotechnology applied to microorganisms |
| title_fullStr | New developments in biotechnology applied to microorganisms |
| title_full_unstemmed | New developments in biotechnology applied to microorganisms |
| title_short | New developments in biotechnology applied to microorganisms |
| title_sort | new developments in biotechnology applied to microorganisms |
| topic | CRISPR genetically modified microorganism(s) GMM new genomic techniques NGT |
| url | https://doi.org/10.2903/j.efsa.2024.8895 |
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