1,133 results on '"Herman, Lieve"'
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2. Modification of the terms of authorisation regarding the additive consisting of liquid l‐lysine base produced with Corynebacterium glutamicum NRRL B‐67439 and NRRL B‐67535 for all animal species (ADM specialty ingredients (Europe) B.V.)
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Villa, Roberto Edoardo, Azimonti, Giovanna, Bonos, Eleftherios, Christensen, Henrik, Durjava, Mojca, Dusemund, Birgit, Gehring, Ronette, Glandorf, Boet, Kouba, Maryline, López‐Alonso, Marta, Marcon, Francesca, Nebbia, Carlo, Pechová, Alena, Prieto‐Maradona, Miguel, Röhe, Ilen, Theodoridou, Katerina, Herman, Lieve, Anguita, Montserrat, Innocenti, Matteo L., and Pettenati, Elisa
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ESSENTIAL amino acids ,ALLERGENS ,CORYNEBACTERIUM glutamicum ,ANIMAL species ,ANIMAL feeds - Abstract
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of liquid l‐lysine base produced with a genetically modified strain of Corynebacterium glutamicum as a nutritional feed additive for all animal species. The l‐lysine base liquid produced with C. glutamicum NRRL B‐67535 and NRRL B‐67439 is currently authorised as a nutritional additive for all animal species. The present application is aimed at modifying the current authorisation to include C. glutamicum NRRL B‐68248 as a production strain. The new production strain qualifies for the qualified presumption of safety approach when used for production purposes. It was unambiguously identified as C. glutamicum and was shown not to harbour acquired antimicrobial resistance determinants for antibiotics of human and veterinary importance. All the introduced sequences or mutations were considered to be safe, and no viable cells or DNA of the NRRL B‐68248 strain was detected in the final product. Therefore, the final product does not pose any safety concern associated with the production strain. l‐Lysine base produced using C. glutamicum NRRL B‐68248 does not represent a risk for the target species, the consumer or the environment. The additive was considered to be neither irritant to skin or the eyes, nor a dermal sensitiser. l‐Lysine base produced with C. glutamicum NRRL B‐68248 is considered to be an efficacious source of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Public health aspects of Vibrio spp. related to the consumption of seafood in the EU.
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Koutsoumanis, Konstantinos, Allende, Ana, Alvarez‐Ordóñez, Avelino, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Baker‐Austin, Craig, Hervio‐Heath, Dominique, Martinez‐Urtaza, Jaime, and Caro, Eva Sanjuán
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VIBRIO vulnificus ,EXTREME weather ,VIBRIO cholerae ,MOBILE genetic elements ,HEALTH risk assessment - Abstract
Vibrio parahaemolyticus, Vibrio vulnificus and non‐O1/non‐O139 Vibrio cholerae are the Vibrio spp. of highest relevance for public health in the EU through seafood consumption. Infection with V. parahaemolyticus is associated with the haemolysins thermostable direct haemolysin (TDH) and TDH‐related haemolysin (TRH) and mainly leads to acute gastroenteritis. V. vulnificus infections can lead to sepsis and death in susceptible individuals. V. cholerae non‐O1/non‐O139 can cause mild gastroenteritis or lead to severe infections, including sepsis, in susceptible individuals. The pooled prevalence estimate in seafood is 19.6% (95% CI 13.7–27.4), 6.1% (95% CI 3.0–11.8) and 4.1% (95% CI 2.4–6.9) for V. parahaemolyticus, V. vulnificus and non‐choleragenic V. cholerae, respectively. Approximately one out of five V. parahaemolyticus‐positive samples contain pathogenic strains. A large spectrum of antimicrobial resistances, some of which are intrinsic, has been found in vibrios isolated from seafood or food‐borne infections in Europe. Genes conferring resistance to medically important antimicrobials and associated with mobile genetic elements are increasingly detected in vibrios. Temperature and salinity are the most relevant drivers for Vibrio abundance in the aquatic environment. It is anticipated that the occurrence and levels of the relevant Vibrio spp. in seafood will increase in response to coastal warming and extreme weather events, especially in low‐salinity/brackish waters. While some measures, like high‐pressure processing, irradiation or depuration reduce the levels of Vibrio spp. in seafood, maintaining the cold chain is important to prevent their growth. Available risk assessments addressed V. parahaemolyticus in various types of seafood and V. vulnificus in raw oysters and octopus. A quantitative microbiological risk assessment relevant in an EU context would be V. parahaemolyticus in bivalve molluscs (oysters), evaluating the effect of mitigations, especially in a climate change scenario. Knowledge gaps related to Vibrio spp. in seafood and aquatic environments are identified and future research needs are prioritised. [ABSTRACT FROM AUTHOR]
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- 2024
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4. New developments in biotechnology applied to microorganisms.
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Mullins, Ewen, Bresson, Jean‐Louis, Dewhurst, Ian Crawford, Epstein, Michelle M., Firbank, Leslie George, Guerche, Philippe, Hejatko, Jan, Moreno, Francisco Javier, Naegeli, Hanspeter, Nogué, Fabien, Rostoks, Nils, Sánchez Serrano, Jose Juan, Savoini, Giovanni, Veromann, Eve, Veronesi, Fabio, Cocconcelli, Pier Sandro, Glandorf, Debora, Herman, Lieve, Jimenez Saiz, Rodrigo, and Ruiz Garcia, Lorena
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MICROBIAL biotechnology ,PHENOTYPIC plasticity ,PLACE marketing ,MUTAGENESIS ,GENOTYPES - 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. [ABSTRACT FROM AUTHOR]
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- 2024
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5. BSE risk posed by ruminant collagen and gelatine derived from bones.
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Koutsoumanis, Konstantinos, Allende, Ana, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Adkin, Amie, Andreoletti, Olivier, Griffin, John, and Lanfranchi, Barbara
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SPINE ,GELATIN ,RUMINANTS ,SPINAL cord ,RISK exposure - Abstract
The European Commission requested an estimation of the BSE risk (C‐, L‐ and H‐BSE) from gelatine and collagen derived from ovine, caprine or bovine bones, and produced in accordance with Regulation (EC) No 853/2004, or Regulation (EC) No 1069/2009 and its implementing Regulation (EU) No 142/2011. A quantitative risk assessment was developed to estimate the BSE infectivity, measured in cattle oral infectious dose 50 (CoID50), in a small size batch of gelatine including one BSE‐infected bovine or ovine animal at the clinical stage. The model was built on a scenario where all ruminant bones could be used for the production of gelatine and high‐infectivity tissues remained attached to the skull (brain) and vertebral column (spinal cord). The risk and exposure pathways defined for humans and animals, respectively, were identified. Exposure routes other than oral via food and feed were considered and discussed but not assessed quantitatively. Other aspects were also considered as integrating evidence, like the epidemiological situation of the disease, the species barrier, the susceptibility of species to BSE and the assumption of an exponential dose–response relationship to determine the probability of BSE infection in ruminants. Exposure to infectivity in humans cannot be directly translated to risk of disease because the transmission barrier has not yet been quantified, although it is considered to be substantial, i.e. much greater amounts of infectivity would be needed to successfully infect a human and greater in the oral than in the parenteral route of exposure. The probability that no new case of BSE in the cattle or small ruminant population would be generated through oral exposure to gelatine made of ruminant bones is 99%–100% (almost certain) This conclusion is based on the current state of knowledge, the epidemiological situation of the disease and the current practices, and is also valid for collagen. [ABSTRACT FROM AUTHOR]
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- 2024
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6. Safety evaluation of the food enzyme triacylglycerol lipase from the non‐genetically modified Penicillium caseifulvum strain AE‐LRF.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Herman, Lieve, Roos, Yrjö, and Aguilera, Jaime
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AMINO acid sequence ,MANUFACTURING processes ,ORGANIC foods ,ALLERGIES ,BODY weight - Abstract
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non‐genetically modified Penicillium caseifulvum strain AE‐LRF by Amano Enzyme Inc. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.013 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 69 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 5308. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. However, the Panel noted that traces of ■■■■■, used in the manufacture of the triacylglycerol lipase, may be found in the food enzyme. The Panel considered that the risk of allergic reactions upon dietary exposure could not be excluded, particularly in individuals sensitised to fish. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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7. Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus niger strain ASP.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Aguilera, Jaime, Andryszkiewicz, Magdalena, and Cavanna, Daniele
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AMINO acid sequence ,ASPERGILLUS niger ,GENETICALLY modified foods ,ASPARAGINASE ,ORGANIC foods - Abstract
The food enzyme asparaginase (l‐asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified Aspergillus niger strain ASP by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the prevention of acrylamide formation in foods and in the processing of yeast and yeast products. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.792 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level at the highest dose tested of 1038 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1311. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Safety evaluation of the food enzyme β‐glucosidase from the non‐genetically modified Penicillium guanacastense strain AE‐GLY.
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Silano, Vittorio, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lambré, Claude, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Herman, Lieve, and Roos, Yrjö
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AMINO acid sequence ,MANUFACTURING processes ,ORGANIC foods ,ALLERGIES ,BODY weight - Abstract
The food enzyme β‐glucosidase (β‐D‐glucoside glucohydrolase; EC 3.2.1.21) is produced with the non‐genetically modified Penicillium guanacastense strain AE‐GLY by Amano Enzyme Inc. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 4.054 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 943 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 233. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Scientific opinion on the characterisation of Ensifer adhaerens CGMCC 19596 used in the production of the feed additive consisting of vitamin B12 (cyanocobalamin) for all animal species (Hebei Huarong Pharmaceutical Co., ltd.).
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Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Durjava, Mojca, Dusemund, Birgit, Kouba, Maryline, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Villa, Roberto Edoardo, Woutersen, Ruud, Cocconcelli, Pier Sandro, Herman, Lieve, Innocenti, Matteo L., and Anguita, Montserrat
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VITAMIN B12 ,ANIMAL species ,FEED additives ,VITAMINS ,FERMENTATION - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation of the feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens (CGMCC 19596). The additive is intended to be used as a nutritional additive for all animal species. In a previous opinion, the FEEDAP Panel could not conclude on the characterisation of the production strain, due to uncertainties on whether the production strain E. adhaerens CGMCC 19596 was genetically modified. However, since viable cells and DNA were not detected in the product, the FEEDAP Panel concluded that vitamin B12 (cyanocobalamin), produced with E. adhaerens CGMCC 19596 would not raise safety concerns as regards the production strain. In the present submission, the applicant provided supplementary information regarding the origin and history of modifications of the strain. Based on the data provided, the FEEDAP Panel concluded on the characterisation of the production strain E. adhaerens CGMCC 19596, which can be considered not to be genetically modified. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Catalogue of Antimicrobial Resistance Genes in Species of Bacillus used to Produce Food Enzymes and Feed Additives.
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Peluso, Silvia, Aguilera‐Gómez, Margarita, Bortolaia, Valeria, Catania, Francesco, Cocconcelli, Pier Sandro, Herman, Lieve, Moxon, Simon, Vernis, Laurence, Iacono, Giovanni, Lunardi, Simone, Pettenati, Elisa, Gallo, Arianna, and Aguilera, Jaime
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DRUG resistance in microorganisms ,FEED additives ,FOOD chains - Abstract
A key step in the characterisation of bacterial strains used in the food and feed chain is the identification of antimicrobial resistance (AMR) genes in their genomes. The presence of acquired AMR genes influences important aspects of the risk assessment, such as the applicability of the qualified presumption of safety (QPS) approach, which can have a direct impact on the data requirements. Aiming to implement the EFSA approach to discriminate between 'intrinsic' and 'acquired' AMR genes, a bioinformatics pipeline was developed and applied to the species of the genus Bacillus that are most frequently subjects of applications for regulated products submitted to EFSA. The results are presented as a catalogue of genes indicating their abundance and distribution among complete and confirmed genomes publicly available for each species. The results of this work are aimed to support the evaluation of AMR genes in a consistent and harmonised way. [ABSTRACT FROM AUTHOR]
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- 2024
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11. Evaluation of additions related to “vacuum preparation” to the generic self‐checking guide G‐044 for the B2C sector
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Feys, Kim, primary, Iglesias, Yvan Diaz, additional, Ameryckx, Annemie Geeraerd, additional, Herman, Lieve, additional, Van Hoorde, Koenraad, additional, Devlieghere, Frank, additional, Houf, Kurt, additional, Veys, Pascal, additional, and De Zutter, Lieven, additional
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- 2024
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12. Safety of soy leghemoglobin from genetically modified Komagataella phaffii as a food additive.
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Gott, David, and Herman, Lieve
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FOOD additives ,MEAT alternatives ,PEPTIDES ,MEAT ,HEME - Abstract
The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of soy leghemoglobin from genetically modified Komagataella phaffii as a food additive in accordance with Regulation (EC) No 1331/2008. The proposed food additive, LegH Prep, is intended to be used as a colour in meat analogue products. The yeast Komagataella phaffii strain MXY0541 has been genetically modified to produce soy leghemoglobin; the safety of the genetic modification is under assessment by the EFSA GMO Panel (EFSA‐GMO‐NL‐2019‐162). The amount of haem iron provided by soy leghemoglobin from its proposed uses in meat analogue products is comparable to that provided by similar amounts of different types of meat. The exposure to iron from the proposed food additive, both at the mean and 95th percentile exposure, will be below the 'safe levels of intake' established by the NDA Panel for all population groups. Considering that the components of the proposed food additive will be digested to small peptide, amino acids and haem B; the recipient (non GM) strain qualifies for qualified presumption of safety status; no genotoxicity concern has been identified and no adverse effects have been identified at the highest dose tested in the available toxicological studies, the Panel concluded that there was no need to set a numerical acceptable daily intake (ADI) and that the food additive does not raise a safety concern at the proposed use in food category 12.9 and maximum use level. The Panel concluded that the use of soy leghemoglobin from genetically modified Komagataella phaffii MXY0541 as a new food additive does not raise a safety concern at the proposed use and use level. This safety evaluation of the proposed food additive remains provisional subject to the ongoing safety assessment of the genetic modification of the production strain by the GMO Panel (EFSA‐GMO‐NL‐2019‐162). [ABSTRACT FROM AUTHOR]
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- 2024
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13. Taxonomic identity of the Bacillus licheniformis strains used to produce food enzymes evaluated in published EFSA opinions.
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Barat Baviera, José Manuel, Bolognesi, Claudia, Chesson, Andrew, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lambré, Claude, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Aguilera, Jaime, and Gomes, Ana
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BACILLUS licheniformis ,WHOLE genome sequencing ,BACILLUS (Bacteria) ,SEQUENCE analysis ,ENZYMES - Abstract
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. [ABSTRACT FROM AUTHOR]
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- 2024
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14. Evaluation of alternative methods of tunnel composting (submitted by the European Composting Network) II.
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Koutsoumanis, Konstantinos, Allende, Ana, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Skandamis, Panagiotis, Ru, Giuseppe, Simmons, Marion, De Cesare, Alessandra, Escamez, Pablo Fernandez, Suffredini, Elisabetta, Ortiz‐Pelaez, Angel, and Ordonez, Avelino Alvarez
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COMPOSTING ,CANINE parvovirus ,EVALUATION methodology ,ENTEROCOCCUS faecalis ,RAILROAD tunnels ,PARVOVIRUSES - Abstract
Two alternative methods for producing compost in a tunnel, from certain category (Cat.) 3 animal by‐products (ABP) and other non‐ABP material, were assessed. The first method proposed a minimum temperature of 55°C for 72 h and the second 60°C for 48 h, both with a maximum particle size of 200 mm. The assessment of the Panel on Biological Hazards (BIOHAZ) exclusively focused on Cat. 3 ABP materials (catering waste and processed foodstuffs of animal origin no longer intended for human consumption). The proposed composting processes were evaluated for their efficacy to achieve a reduction of at least 5 log10 of Enterococcus faecalis and Salmonella Senftenberg (775W, H2S negative) and at least 3 log10 of relevant thermoresistant viruses. The applicant provided a list of biological hazards that may enter the composting process and selected parvoviruses as the indicator of the thermoresistant viruses. The evidence provided by the applicant included: (a) literature data on thermal inactivation of biological hazards; (b) results from validation studies on the reduction of E. faecalis, Salmonella Senftenberg 775W H2S negative and canine parvovirus carried out in composting plants across Europe; (c) and experimental data from direct measurements of reduction of infectivity of murine parvovirus in compost material applying the time/temperature conditions of the two alternative methods. The evidence provided showed the capacity of the proposed alternative methods to reduce E. faecalis and Salmonella Senftenberg 775W H2S negative by at least 5 log10, and parvoviruses by at least 3 log10. The BIOHAZ Panel concluded that the two alternative methods under assessment can be considered to be equivalent to the processing method currently approved in the Commission Regulation (EU) No 142/2011. [ABSTRACT FROM AUTHOR]
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- 2024
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15. Re‐evaluation of certain aspects of the EFSA Scientific Opinion of April 2010 on risk assessment of parasites in fishery products, based on new scientific data. Part 1: ToRs1–3.
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Koutsoumanis, Konstantinos, Allende, Ana, Alvarez‐Ordóñez, Avelino, Bover‐Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Buchmann, Kurt, Careche, Mercedes, Levsen, Arne, and Mattiucci, Simonetta
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FISHERY products ,EUROPEAN seabass ,FISH parasites ,PULSED power systems ,PARASITES ,SPARUS aurata - Abstract
Surveillance data published since 2010, although limited, showed that there is no evidence of zoonotic parasite infection in market quality Atlantic salmon, marine rainbow trout, gilthead seabream, turbot, meagre, Atlantic halibut, common carp and European catfish. No studies were found for greater amberjack, brown trout, African catfish, European eel and pikeperch. Anisakis pegreffii, A. simplex (s. s.) and Cryptocotyle lingua were found in European seabass, Atlantic bluefin tuna and/or cod, and Pseudamphistomum truncatum and Paracoenogonimus ovatus in tench, produced in open offshore cages or flow‐through ponds or tanks. It is almost certain that fish produced in closed recirculating aquaculture systems (RAS) or flow‐through facilities with filtered water intake and exclusively fed heat‐treated feed are free of zoonotic parasites. Since the last EFSA opinion, the UV‐press and artificial digestion methods have been developed into ISO standards to detect parasites in fish, while new UV‐scanning, optical, molecular and OMICs technologies and methodologies have been developed for the detection, visualisation, isolation and/or identification of zoonotic parasites in fish. Freezing and heating continue to be the most efficient methods to kill parasites in fishery products. High‐pressure processing may be suitable for some specific products. Pulsed electric field is a promising technology although further development is needed. Ultrasound treatments were not effective. Traditional dry salting of anchovies successfully inactivated Anisakis. Studies on other traditional processes – air‐drying and double salting (brine salting plus dry salting) – suggest that anisakids are successfully inactivated, but more data covering these and other parasites in more fish species and products is required to determine if these processes are always effective. Marinade combinations with anchovies have not effectively inactivated anisakids. Natural products, essential oils and plant extracts, may kill parasites but safety and organoleptic data are lacking. Advanced processing techniques for intelligent gutting and trimming are being developed to remove parasites from fish. [ABSTRACT FROM AUTHOR]
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- 2024
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16. Safety evaluation of the food enzyme AMP deaminase from non‐genetically modified Aspergillus sp. strain DEA 56‐111.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Cavanna, Daniele
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AMINO acid sequence ,ASPERGILLUS ,FOOD safety ,ENZYMES ,ORGANIC foods - Abstract
The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the non‐genetically modified microorganism Aspergillus sp. strain DEA 56‐111 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.005 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The Panel identified a no observed adverse effect level of 1984 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 396,800. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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17. Safety and efficacy of a feed additive consisting of l‐tryptophan (produced with Escherichia coliCGMCC 7.460) for all animal species (Kempex Holland B.V.).
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Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Durjava, Mojca, Dusemund, Birgit, Kouba, Maryline, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Villa, Roberto Edoardo, Woutersen, Ruud, Herman, Lieve, Anguita, Montserrat, Innocenti, Matteo Lorenzo, and Tarrés‐Call, Jordi
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TRYPTOPHAN ,ANIMAL species ,FEED additives ,ALLERGENS ,ESCHERICHIA coli - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.460 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. The use of l‐tryptophan (≥ 98%) produced with E. coli CGMCC 7.460 to supplement feed is safe for non‐ruminant species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns on the safety of the simultaneous oral administration of l‐tryptophan via water for drinking and feed due to possible amino acid imbalances and hygienic reasons. The use of l‐tryptophan produced with E. coli CGMCC 7.460 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive in combination with the high dusting potential may represent a risk of exposure by inhalation to endotoxins for users. The additive l‐tryptophan is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. To be as efficacious in ruminants as in non‐ruminants, it should be protected from ruminal degradation. [ABSTRACT FROM AUTHOR]
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- 2024
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18. Safety and efficacy of a feed additive consisting of inactivated selenised yeast (Saccharomyces cerevisiae CCTCC M 2022402) for all animal species (Phytobiotics Futterzusatzstoffe GmbH).
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Bampidis, Vasileios, Azimonti, Giovanna, Bastos, Maria de Lourdes, Christensen, Henrik, Dusemund, Birgit, Durjava, Mojca, Kouba, Maryline, López‐Alonso, Marta, López Puente, Secundino, Marcon, Francesca, Mayo, Baltasar, Pechová, Alena, Petkova, Mariana, Ramos, Fernando, Villa, Roberto Edoardo, Woutersen, Ruud, Herman, Lieve, Galobart, Jaume, Holczknecht, Orsolya, and Innocenti, Matteo
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ANIMAL species ,FEED additives ,SACCHAROMYCES cerevisiae ,ALLERGENS ,YEAST - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: 'granules' and 'micro') as a nutritional feed additive for all animal species. Based on a tolerance–efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust‐free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium in feedingstuffs for all animal species. [ABSTRACT FROM AUTHOR]
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- 2024
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19. Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain LP‐N836.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Aguilera, Jaime, and Andryszkiewicz, Magdalena
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AMINO acid sequence ,FOOD safety ,ENZYMES ,DAIRY processing ,ALLERGIES - Abstract
The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non‐genetically modified Rhizomucor miehei strain LP‐N836 by Meito Sangyo Co., Ltd. The native enzyme can be chemically modified to produce a more thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in the processing of dairy products for the production of cheese and fermented dairy products. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.108 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 95 mg TOS/kg bw per day, the mid‐dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 880. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens and one with a food allergen (mustard) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to mustard proteins, cannot be excluded. Based on the data provided, the Panel concluded that both the native and thermolabile forms of this food enzyme do not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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20. Safety evaluation of the food enzyme microbial collagenase from the genetically modified Streptomyces violaceoruber strain pCol.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Aguilera, Jaime, and Andryszkiewicz, Magdalena
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MICROBIAL enzymes ,COLLAGENASES ,STREPTOMYCES ,AMINO acid sequence ,FOOD safety ,ANIMAL products - Abstract
The food enzyme microbial collagenase (EC 3.4.24.3) is produced with the genetically modified Streptomyces violaceoruber strain pCol by Nagase (Europa) GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in two food manufacturing processes: the production of modified meat and fish products and the production of protein hydrolysates from meat and fish proteins. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.098 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 940 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 856. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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21. Safety evaluation of the food enzyme thermolysin from the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Liu, Yi
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AMINO acid sequence ,ENZYMES ,FOOD safety ,ALLERGIES ,MANUFACTURING processes ,TRANSFER pricing - Abstract
The food enzyme thermolysin (EC. 3.4.24.27) is produced with the non‐genetically modified Anoxybacillus caldiproteolyticus strain AE‐TP by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes. Dietary exposure was estimated to be up to 0.973 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 700 mg TOS/kg bw per day, the mid‐dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 719. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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22. Safety evaluation of the food enzyme β‐fructofuranosidase from the non‐genetically modified Saccharomyces cerevisiae strain NCYC R693.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Aguilera, Jaime, and Andryszkiewicz, Magdalena
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SACCHAROMYCES cerevisiae ,AMINO acid sequence ,FOOD safety ,ENZYMES ,ALLERGIES - Abstract
The food enzyme β‐fructofuranosidase (β‐d‐fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the non‐genetically modified Saccharomyces cerevisiae strain NCYC R693 by Kerry Ingredients & Flavours Ltd. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in four food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.485 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach of safety assessment and no issue of concern arising from the production process of the food enzyme were identified, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a tomato allergen was found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to tomato, cannot be excluded. However, the likelihood of allergic reactions is expected not to exceed the likelihood of allergic reactions to tomato. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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23. Safety evaluation of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain NZYM‐NB.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Cavanna, Daniele
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BACILLUS amyloliquefaciens ,AMINO acid sequence ,ENZYMES ,FOOD safety ,MANUFACTURING processes - Abstract
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain NZYM‐NB by Novozymes A/S. The production strain meets the requirements for qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in eleven food manufacturing processes. Since residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was estimated only for the remaining nine food manufacturing processes. Exposure was estimated to be up to 1.327 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arising from the production process of the food enzyme was identified, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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24. Safety evaluation of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain DP‐Cyb74.
- Author
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Apergi, Kyriaki
- Subjects
BACILLUS amyloliquefaciens ,AMINO acid sequence ,ENZYMES ,FOOD safety - Abstract
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain DP‐Cyb74 by Genencor International B.V. The production strain met all requirements for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in six food manufacturing processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.536 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arose from the production process of the food enzyme, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2024
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25. Persistence of microbiological hazards in food and feed production and processing environments.
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Koutsoumanis, Konstantinos, Allende, Ana, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Fox, Edward, Gosling, Rebecca, Gil, Beatriz Melero, and Møretrø, Trond
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FOOD production ,FOOD safety ,FOOD industry ,MANUFACTURING processes ,SALMONELLA enterica ,SEAFOOD industry ,ANIMAL industry - Abstract
Listeria monocytogenes (in the meat, fish and seafood, dairy and fruit and vegetable sectors), Salmonella enterica (in the feed, meat, egg and low moisture food sectors) and Cronobacter sakazakii (in the low moisture food sector) were identified as the bacterial food safety hazards most relevant to public health that are associated with persistence in the food and feed processing environment (FFPE). There is a wide range of subtypes of these hazards involved in persistence in the FFPE. While some specific subtypes are more commonly reported as persistent, it is currently not possible to identify universal markers (i.e. genetic determinants) for this trait. Common risk factors for persistence in the FFPE are inadequate zoning and hygiene barriers; lack of hygienic design of equipment and machines; and inadequate cleaning and disinfection. A well‐designed environmental sampling and testing programme is the most effective strategy to identify contamination sources and detect potentially persistent hazards. The establishment of hygienic barriers and measures within the food safety management system, during implementation of hazard analysis and critical control points, is key to prevent and/or control bacterial persistence in the FFPE. Once persistence is suspected in a plant, a 'seek‐and‐destroy' approach is frequently recommended, including intensified monitoring, the introduction of control measures and the continuation of the intensified monitoring. Successful actions triggered by persistence of L. monocytogenes are described, as well as interventions with direct bactericidal activity. These interventions could be efficient if properly validated, correctly applied and verified under industrial conditions. Perspectives are provided for performing a risk assessment for relevant combinations of hazard and food sector to assess the relative public health risk that can be associated with persistence, based on bottom‐up and top‐down approaches. Knowledge gaps related to bacterial food safety hazards associated with persistence in the FFPE and priorities for future research are provided. [ABSTRACT FROM AUTHOR]
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- 2024
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26. Safety evaluation of the food enzyme 3‐phytase from the genetically modified Aspergillus niger strain NPH.
- Author
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Liu, Yi
- Subjects
ASPERGILLUS niger ,AMINO acid sequence ,FOOD safety ,ENZYMES ,MILK substitutes - Abstract
The food enzyme 3‐phytase (myo‐inositol‐hexakisphosphate 3‐phosphohydrolase EC 3.1.3.8) is produced with the genetically modified Aspergillus niger strain NPH by DSM Food Specialties. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in three food manufacturing processes: processing of cereals and other grains for the production of (1) baked products and (2) distilled alcohol, and the processing of plant‐ and fungal‐derived products for the production of (3) plant‐based analogues of milk and milk products. Since no residual amounts of total organic solids (TOS) are carried over into distilled alcohol, dietary exposure was calculated only for the remaining two food manufacturing processes. It was estimated to be up to 0.553 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 833 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1506. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
- View/download PDF
27. Safety evaluation of the food enzyme mucorpepsin from the non‐genetically modified Rhizomucor miehei strain FRO.
- Author
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Apergy, Kyriaki, and Andryszkiewicz, Magdalena
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AMINO acid sequence ,FOOD safety ,ENZYMES ,RENNET ,ORGANIC foods - Abstract
The food enzyme mucorpepsin (EC 3.4.23.23) is produced with the non‐genetically modified Rhizomucor miehei strain FRO by DSM Food Specialties B.V. The enzyme can be chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in three food manufacturing processes: processing of dairy products for the production of (1) cheese, (2) edible rennet casein, (3) fermented dairy products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to about 0.072 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 27,778. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but is considered low, except for individuals sensitised to mustard proteins, for whom the risk will not exceed that of mustard consumption. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2024
- Full Text
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28. Safety evaluation of the food enzyme protein–glutamine γ‐glutamyltransferase from the non‐genetically modified Streptomyces mobaraensis strain M2020197.
- Author
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Aguilera, Jaime, and Andryszkiewicz, Magdalena
- Subjects
FOOD of animal origin ,FOOD safety ,STREPTOMYCES ,AMINO acid sequence ,MEAT alternatives ,BAKED products - Abstract
The food enzyme protein–glutamine γ‐glutamyltransferase (protein–glutamine: amine γ‐glutamyltransferase; EC 2.3.2.13) is produced with the non‐genetically modified Streptomyces mobaraensis strain M2020197 by Taixing Dongsheng Bio‐Tech Co. Ltd. The identity of the production strain and the absence of viable cells could not be established. The food enzyme is intended to be used in eight food manufacturing processes: processing of cereals and other grains for the production of (1) baked products, (2) cereal‐based products other than baked; processing of dairy products for the production of (3) fermented dairy products, (4) cheese, (5) dairy desserts; processing of plant‐ and fungal‐derived products for the production of (6) meat analogues, (7) plant‐based analogues of milk and milk products; processing of meat and fish products for the production of (8) modified meat and fish products. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 3.498 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 91 mg TOS/kg bw per day. The calculated margin of exposure for each age group was 36 (infants), 26 (toddlers), 50 (children), 99 (adolescents), 115 (adults) and 133 (the elderly). A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is low. The safety of the food enzyme could not be established given the derived margins of exposure. Therefore, the Panel concluded that the food enzyme could not be considered safe under the intended conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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29. Update of the list of qualified presumption of safety (QPS) recommended microbiological agents intentionally added to food or feed as notified to EFSA 17: suitability of taxonomic units notified to EFSA until September 2022
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Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luísa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Escámez, Pablo Salvador Fernández, Maradona, Miguel Prieto, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barizzone, Fulvio, Correia, Sandra, Herman, Lieve, Koutsoumanis, Konstantino, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luísa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagioti, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Escámez, Pablo Salvador Fernández, Maradona, Miguel Prieto, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barizzone, Fulvio, Correia, Sandra, and Herman, Lieve
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Streptococcus orali ,Geobacillus thermodenitrifican ,Ogataea polymorpha ,Xanthobacter ,Lactiplantibacillus argentoratensi ,QPS - Abstract
The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by 'qualifications'. In the period covered by this Statement, new information was found leading to the withdrawal of the qualification 'absence of aminoglycoside production ability' for Bacillus velezensis. The qualification for Bacillus paralicheniformis was changed to 'absence of bacitracin production ability'. For the other TUs, no new information was found that would change the status of previously recommended QPS TUs. Of 52 microorganisms notified to EFSA between April and September 2022 (inclusive), 48 were not evaluated because: 7 were filamentous fungi, 3 were Enterococcus faecium, 2 were Escherichia coli, 1 was Streptomyces spp., and 35 were taxonomic units (TUs) that already have a QPS status. The other four TUs notified within this period, and one notified previously as a different species, which was recently reclassified, were evaluated for the first time for a possible QPS status: Xanthobacter spp. could not be assessed because it was not identified to the species level; Geobacillus thermodenitrificans is recommended for QPS status with the qualification 'absence of toxigenic activity'. Streptoccus oralis is not recommended for QPS status. Ogataea polymorpha is proposed for QPS status with the qualification 'for production purposes only'. Lactiplantibacillus argentoratensis (new species) is included in the QPS list.
- Published
- 2023
30. Safety evaluation of the food enzyme leucyl aminopeptidase from non‐genetically modified Aspergillus oryzae strain NZYM‐EX.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Glandorf, Boet, Herman, Lieve, Roos, Yrjö, and Andryszkiewicz, Magdalena
- Subjects
KOJI ,AMINO acid sequence ,FOOD safety ,MILK proteins ,PROTEIN hydrolysates ,FOOD of animal origin - Abstract
The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non‐genetically modified microorganism Aspergillus oryzae strain NZYM‐EX by Novozymes A/S. The food enzyme is free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes: processing of dairy products for the production of (1) flavouring preparations, (2) modified milk proteins; processing of plant‐ and fungal‐derived products for the production of (3) protein hydrolysates, (4) soy sauce; processing of meat and fish products for the production of (5) protein hydrolysates; processing of cereals and other grains for the production of (6) baked products, (7) brewed products; (8) processing of yeast and yeast products. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.577 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 440 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 763. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2023
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31. Safety evaluation of synthesised DNA oligonucleotides as a food additive.
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Gott, David, and Herman, Lieve
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FOOD additives ,OLIGONUCLEOTIDES ,ARTIFICIAL chromosomes ,DNA ,TECHNICAL specifications - Abstract
The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of synthesised DNA oligonucleotides as a new food additive, in accordance with Regulation (EC) No 1331/2008. Considering that the additional information requested by the Panel during the risk assessment was not provided by the applicant, the assessment was concluded on the basis of the sole information available in the application. The proposed food additive consists of purified synthetic DNA sequences intended to be used for traceability purposes, alone or combined with carriers. Information provided by the applicant on the identity, characterisation and production process of the proposed food additive was considered insufficient. The Panel considered that the product specifications as proposed by the applicant do not adequately define and characterise the proposed food additive. The applicant proposed for the food additive the maximum use levels of 0.001 mg/kg for a variety of food categories. The food additive was also proposed as a Group I additive at a specific maximum level of quantum satis. The applicant did not provide exposure estimates according to the EFSA ANS Panel guidance (2012). No biological or toxicological data were provided by the applicant for the proposed food additive. Considering the inadequate information available and the uncertainty introduced by the proposal at quantum satis, along with the insufficient specifications, the Panel could not conclude on the safety of the food additive as proposed and described by the applicant. [ABSTRACT FROM AUTHOR]
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- 2023
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32. Safety evaluation of the food enzyme rennet containing chymosin and pepsin A from the abomasum of suckling calves, goats and lambs.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Kovalkovičová, Natália, and Liu, Yi
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RENNET ,PEPSIN ,CALVES ,GOATS ,LAMBS - Abstract
The food enzyme rennet containing chymosin (EC 3.4.23.4) and pepsin A (EC 3.4.23.1) is prepared from the abomasum of suckling calves, goats and lambs by GENENCOR INTERNATIONAL B.V. The food enzyme is intended to be used in milk processing for cheese production. As no concerns arise from the animal source of the food enzyme or from its manufacture and based on the history of safe use and consumption, the Panel considered that toxicological data and the estimation of dietary exposure were not required. On the basis of literature data, the Panel considered that the risk of allergic reactions by dietary exposure could not be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2023
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33. Safety evaluation of the food additive steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Yarrowia lipolyticaVRM.
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Younes, Maged, Aquilina, Gabriele, Degen, Gisela, Engel, Karl‐Heinz, Fowler, Paul, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert‐Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Passamonti, Sabina, Moldeus, Peter, Shah, Romina, Waalkens‐Berendsen, Ine, Wright, Matthew, Barat Baviera, José Manuel, Gott, David, and Herman, Lieve
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FOOD additives ,GLYCOSIDES ,BACTERIAL mutation ,FERMENTATION ,FOOD safety - Abstract
The EFSA Panel on Food Additive and Flavourings (FAF Panel) provides a scientific opinion on the safety of a new process to produce steviol glycosides by fermentation of simple sugars using a genetically modified strain of Yarrowia lipolytica (named Y. lipolytica VRM). The manufacturing process may result in impurities different from those that may be present in the other steviol glycosides E 960a‐d, therefore the Panel concluded that separate specifications are required for the food additive produced as described in the current application. Viable cells and DNA from the production strain are not present in the final product. The Panel considered that the demonstration of the absence of kaurenoic acid in the proposed food additive, using a method with a limit of detection (LOD) of 0.3 mg/kg, is adequate to dispel the concerns for potential genotoxicity. Given that all steviol glycosides follow the same metabolic pathways, the Panel considered that the current steviol glycosides would fall within the same group of substances. Therefore, the Panel considered that the already existing data on rebaudioside M and structurally related steviol glycosides are sufficient, and a similar metabolic fate and toxicity is expected for the food additive. The results from the bacterial reverse mutation assay and the in vitro micronucleus assay were negative and indicated absence of genotoxicity from the food additive. The existing acceptable daily intake (ADI) of 4 mg/kg body weight (bw) per day, expressed as steviol equivalents, was considered to be applicable to the proposed food additive. The Panel concluded that there is no safety concern for steviol glycosides, predominantly Rebaudioside M, produced by fermentation using Y. lipolytica VRM, to be used as a food additive at the proposed uses and use levels. [ABSTRACT FROM AUTHOR]
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- 2023
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34. Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the non‐genetically modified Trichoderma citrinoviride strain 278.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Aguilera, Jaime, Andryszkiewicz, Magdalena, and Boinowitz, Erik
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AMINO acid sequence ,TRICHODERMA ,FOOD safety ,BAKED products ,ENZYMES - Abstract
The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) is produced with the non‐genetically modified Trichoderma citrinoviride strain 278 by Kerry Ingredients & Flavours Ltd. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes: processing of cereals and other grains for the production of baked products; production of cereal‐based products other than baked, brewed products, starch and gluten fractions, distilled alcohol; processing of fruits and vegetables for the production of juices, wine and wine vinegar and processing of yeast and yeast products. Since residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was only calculated for the remaining six food manufacturing processes. Exposure was estimated to be up to 4.808 mg TOS/kg body weight (bw) per day in European populations. The Panel was unable to reach a conclusion on genotoxicity and systemic toxicity. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. In the absence of an acceptable full set of toxicological data, the Panel was unable to complete the safety assessment of the food enzyme. [ABSTRACT FROM AUTHOR]
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- 2023
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35. Safety evaluation of the food enzyme α‐amylase from the genetically modified Bacillus licheniformis strain NZYM‐AC.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Fernàndez‐Fraguas, Cristina
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BACILLUS licheniformis ,AMINO acid sequence ,FOOD safety ,ENZYMES ,FOOD industry - Abstract
The food enzyme α‐amylase (1,4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐AC by Novozymes A/S. The genetic modifications do not give rise to safety concerns and the production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates, cereal‐based products other than baked, brewed products and distilled alcohol; processing of fruits and vegetables for the production of juices and products other than juices; production of refined and unrefined sugars. Since the residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of concerns resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found with a respiratory allergen. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2023
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36. Safety evaluation of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain GNP.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Aguilera, Jaime, Andryszkiewicz, Magdalena, and Fernández‐Fraguas, Cristina
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BACILLUS amyloliquefaciens ,AMINO acid sequence ,FOOD safety ,MILK proteins ,PROTEIN hydrolysates ,FOOD of animal origin - Abstract
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain GNP by DSM Food Specialties B.V. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in nine food manufacturing processes: processing of cereals and other grains for the production of baked products, cereal‐based products other than baked, brewed products and distilled alcohol; processing of dairy products for the production of flavouring preparation and modified milk proteins; processing of meat and fish products for the production of protein hydrolysates; processing of plant‐ and fungal‐derived products for the production of protein hydrolysates and plant‐based analogues of milk and milk products. Since the food enzyme–total organic solids (TOS) is not carried into distilled alcohols, dietary exposure was estimated only to the remaining eight food processes. Exposure was estimated to be up to 17.934 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the QPS approach to safety assessment and no issue of concern arose from the production process, no toxicological studies other than the assessment of allergenicity were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2023
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37. Safety evaluation of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain AGS 430.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Aguilera, Jaime, Andryszkiewicz, Magdalena, and Fernàndez‐Fraguas, Cristina
- Subjects
BACILLUS amyloliquefaciens ,AMINO acid sequence ,FOOD safety ,MILK proteins ,PROTEIN hydrolysates ,FOOD of animal origin - Abstract
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain AGS 430 by Kerry Ingredients & Flavours Ltd. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme is intended to be used in 11 food manufacturing processes: processing of cereals and other grains for the production of baked products; cereal‐based products other than baked; brewed products; starch and gluten fractions; distilled alcohol; processing of dairy products for the production of flavouring preparations and modified milk proteins; processing of meat and fish products for the production of protein hydrolysates; processing of plant‐ and fungal‐derived products for the production of protein hydrolysates and plant‐based analogues of milk and milk products; processing of yeast and yeast products. Since residual amounts of the total organic solids (TOS) are removed during two processes, dietary exposure was estimated only for the remaining nine food manufacturing processes. Exposure was estimated up to 3.482 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualifies for the QPS approach and no issue of concern arose from the production process of the food enzyme, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions upon dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
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- 2023
- Full Text
- View/download PDF
38. Safety evaluation of the food enzyme bacillolysin from the non‐genetically modified Bacillus amyloliquefaciens strain HPN 131.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Aguilera, Jaime, Andryszkiewicz, Magdalena, and Fernandez‐Fraguas, Cristina
- Subjects
BACILLUS amyloliquefaciens ,AMINO acid sequence ,FOOD safety ,PROTEIN hydrolysates ,MILK proteins ,FOOD of animal origin - Abstract
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non‐genetically modified Bacillus amyloliquefaciens strain HPN 131 by ENMEX SA de CV. The production strain qualifies for the qualified presumption of safety (QPS) approach to safety assessment. The food enzyme under assessment is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of baked products, brewed products and distilled alcohol; processing of dairy products for the production of modified milk proteins; processing of meat and fish products for the production of protein hydrolysates; processing of plant‐ and fungal‐derived products for the production of protein hydrolysates; processing of yeasts and yeast products. Since residual amounts of total organic solids (TOS) are not carried over to distilled alcohol, a dietary exposure was estimated only for the remaining six food manufacturing processes. Exposure was estimated to be up to 8.302 mg TOS/kg body weight (bw) per day in European populations. As the production strain qualifies for the QPS status and no issue of concern arose from the production process of the food enzyme, the Panel considered that no toxicological studies other than the assessment of allergenicity were necessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no matches were found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
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39. Safety evaluation of the food enzyme catalase from the non‐genetically modified Aspergillus tubingensis strain AE‐CN.
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Criado, Ana
- Subjects
AMINO acid sequence ,FISH eggs ,FOOD safety ,CATALASE ,ENZYMES - Abstract
The food enzyme catalase (hydrogen‐peroxide:hydrogen‐peroxide oxidoreductase; EC 1.11.1.6) is produced with the non‐genetically modified Aspergillus tubingensis strain AE‐CN by Amano Enzyme Inc. The absence of viable cells of the production organism in the food enzyme was not demonstrated. The food enzyme is intended to be used in five food manufacturing processes: production of baked products, processing of egg and egg products, production of fruit and vegetable products other than juices, production of cheese and production of fish roes. The dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.325 mg TOS/kg body weight (bw) per day in European populations. The results of the in vitro genotoxicity studies indicated the presence of a clastogenic agent in the food enzyme which could not be dismissed due to limitations in the in vivo studies. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 323 mg TOS/kg bw per day, the highest dose tested. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Because of the results of the genotoxicity studies, and as the absence of viable cells from the production strain was not demonstrated, the Panel was unable to establish the safety of the food enzyme. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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- View/download PDF
40. Safety evaluation of the food enzyme endo‐polygalacturonase from the non‐genetically modified Aspergillus tubingensis strain MUCL 55013.
- Author
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Fernàndez‐Fraguas, Cristina
- Subjects
FOOD safety ,AMINO acid sequence ,GRAPE seed extract ,ASPERGILLUS ,COFFEE beans ,ENZYMES - Abstract
The food enzyme endo‐polygalacturonase ((1→4)‐α‐D‐galacturonan glycanohydrolase (endo‐cleaving); EC 3.2.1.15)) is produced with the non‐genetically modified Aspergillus tubingensis strain MUCL 55013 by Soufflet Biotechnologies. The food enzyme is free from viable cells of the production organism. It is intended to be used in 10 food manufacturing processes: processing of fruits and vegetables for the production of juices, other fruit and vegetable products, wine, distilled spirits from wine, alcoholic beverages other than grape wine; processing of plant‐derived products for the production of refined and unrefined sugar, edible oils from plants, green coffee beans by demucilation, coffee extracts and tea and other herbal and fruit infusions. Since residual amounts of total organic solids (TOS) are removed in three processes, dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 7.834 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2,097 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 268. A search for the similarity of the amino acid sequence of the food enzyme to known allergens found 14 matches, one of which was to a food allergen. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen‐sensitised individuals. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
41. Safety evaluation of the food enzyme glucan 1,4‐α‐maltohydrolase from the genetically modified Bacillus subtilis strain AR‐513.
- Author
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Liu, Yi
- Subjects
BACILLUS subtilis ,AMINO acid sequence ,FOOD safety ,ENZYMES ,MILK substitutes - Abstract
The food enzyme glucan 1,4‐α‐maltohydrolase (4‐α‐D‐glucan α‐maltohydrolase EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐513 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in four food manufacturing processes: processing of cereals and other grains for the production of baked products, other cereal‐based products and glucose syrups and other starch hydrolysates; processing of plant‐ and fungal‐derived products for the production of plant‐based analogues of milk and milk products. Since residual amounts of total organic solids (TOS) are removed in the production of glucose syrups and other starch hydrolysates, dietary exposure was not calculated for this process. For the remaining three food processes, exposure to the food enzyme‐TOS was estimated to be up to 0.2 μg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐513 meets the requirements for the qualified presumption of safety (QPS) approach and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and five matches with respiratory allergens and one with a mosquito allergen were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
42. Microbiological hazards associated with the use of water in the post‐harvest handling and processing operations of fresh and frozen fruits, vegetables and herbs (ffFVHs). Part 1 (outbreak data analysis, literature review and stakeholder questionnaire)
- Author
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Koutsoumanis, Konstantinos, Ordóñez, Avelino Alvarez, Bolton, Declan, Bover‐Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Nonno, Romolo, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Banach, Jen, Ottoson, Jakob, Zhou, Bin, and da Silva Felício, Maria Teresa
- Subjects
WATER use ,LITERATURE reviews ,FROZEN fruit ,WATER disinfection ,WATER management ,ORCHARDS ,WATER shortages - Abstract
The contamination of water used in post‐harvest handling and processing operations of fresh and frozen fruit, vegetables and herbs (ffFVHs) is a global concern. The most relevant microbial hazards associated with this water are: Listeria monocytogenes, Salmonella spp., human pathogenic Escherichia coli and enteric viruses, which have been linked to multiple outbreaks associated with ffFVHs in the European Union (EU). Contamination (i.e. the accumulation of microbiological hazards) of the process water during post‐harvest handling and processing operations is affected by several factors including: the type and contamination of the FVHs being processed, duration of the operation and transfer of microorganisms from the product to the water and vice versa, etc. For food business operators (FBOp), it is important to maintain the microbiological quality of the process water to assure the safety of ffFVHs. Good manufacturing practices (GMP) and good hygienic practices (GHP) related to a water management plan and the implementation of a water management system are critical to maintain the microbiological quality of the process water. Identified hygienic practices include technical maintenance of infrastructure, training of staff and cooling of post‐harvest process water. Intervention strategies (e.g. use of water disinfection treatments and water replenishment) have been suggested to maintain the microbiological quality of process water. Chlorine‐based disinfectants and peroxyacetic acid have been reported as common water disinfection treatments. However, given current practices in the EU, evidence of their efficacy under industrial conditions is only available for chlorine‐based disinfectants. The use of water disinfection treatments must be undertaken following an appropriate water management strategy including validation, operational monitoring and verification. During operational monitoring, real‐time information on process parameters related to the process and product, as well as the water and water disinfection treatment(s) are necessary. More specific guidance for FBOp on the validation, operational monitoring and verification is needed. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
43. Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus luchuensis strain FL108SC.
- Author
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Lambré, Claude, Barat Baviera, José Manuel, Bolognesi, Claudia, Cocconcelli, Pier Sandro, Crebelli, Riccardo, Gott, David Michael, Grob, Konrad, Lampi, Evgenia, Mengelers, Marcel, Mortensen, Alicja, Rivière, Gilles, Steffensen, Inger‐Lise, Tlustos, Christina, Van Loveren, Henk, Vernis, Laurence, Zorn, Holger, Herman, Lieve, Roos, Yrjö, Andryszkiewicz, Magdalena, and Gomes, Ana
- Subjects
LIPASES ,AMINO acid sequence ,ASPERGILLUS ,ENZYMES ,FOOD safety ,FATS & oils - Abstract
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified Aspergillus luchuensis strain FL108SC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in an immobilised form for the production of modified fats and oils by interesterification. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 774 mg TOS/kg body weight per day. As the food enzyme is used in an immobilised form and as any residual amounts of the food enzyme‐total organic solids (TOS) are removed during the food manufacturing process, dietary exposure was not calculated. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
44. Monitoring of chronic wasting disease (CWD) (IV)
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordoñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Skandamis, Panagiotis, Suffredini, Elisabetta, Miller, Michael W, Mysterud, Atle, Nöremark, Maria, Simmons, Marion, Tranulis, Michael A, Vaccari, Gabriele, Viljugrein, Hildegunn, Ortiz-Pelaez, Angel, Ru, Giuseppe, Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
663/664 - Abstract
The European Commission requested an analysis of the Chronic Wasting Disease (CWD) monitoring programme in Norway, Sweden, Finland, Iceland, Estonia, Latvia, Lithuania and Poland (9 January 2017–28 February 2022). Thirteen cases were detected in reindeer, 15 in moose and 3 in red deer. They showed two phenotypes, distinguished by the presence or absence of detectable disease-associated normal cellular prion protein (PrP) in lymphoreticular tissues. CWD was detected for the first time in Finland, Sweden and in other areas of Norway. In countries where the disease was not detected, the evidence was insufficient to rule out its presence altogether. Where cases were detected, the prevalence was below 1%. The data also suggest that the high-risk target groups for surveillance should be revised, and ‘road kill’ removed. Data show that, in addition to differences in age and sex, there are differences in the prion protein gene (PRNP) genotypes between positive and negative wild reindeer. A stepwise framework has been proposed with expanded minimum background surveillance to be implemented in European countries with relevant cervid species. Additional surveillance may include ad hoc surveys for four different objectives, specific to countries with/without cases, focusing on parallel testing of obex and lymph nodes from adult cervids in high-risk target groups, sustained over time, using sampling units and a data-driven design prevalence. Criteria for assessing the probability of CWD presence have been outlined, based on the definition of the geographical area, an annual assessment of risk of introduction, sustained minimum background surveillance, training and engagement of stakeholders and a surveillance programme based on data-driven parameters. All positive cases should be genotyped. Sample sizes for negative samples have been proposed to detect and estimate the frequency of PRNP polymorphisms. Double-strand sequencing of the entire PRNP open reading frame should be undertaken for all selected samples, with data collated in a centralised collection system at EU level. info:eu-repo/semantics/publishedVersion
- Published
- 2023
45. Evaluation of a multi-step catalytic co-processing hydrotreatment for the production of renewable fuels using Category 3 animal fat and used cooking oils
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Fernández Escámez, Pablo, Griffin, John, Ortiz-Pelaez, Angel, Alvarez-Ordoñez, Avelino, Indústries Alimentàries, Funcionalitat i Seguretat Alimentària, Koutsoumanis, Konstantino, Allende, Ana, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagioti, Suffredini, Elisabetta, Fernández Escámez, Pablo, Griffin, John, Ortiz-Pelaez, Angel, and Alvarez-Ordoñez, Avelino
- Subjects
renewable fuel ,663/664 ,Veterinary (miscellaneous) ,hydrotreatment ,Animal Science and Zoology ,Parasitology ,Plant Science ,cooking oil ,Microbiology ,Category 3 ,animal fat ,Food Science - Abstract
An alternative method for the production of renewable fuels from rendered animal fats (pretreated using methods 1–5 or method 7 as described in Annex IV of Commission Regulation (EC) No 2011/142) and used cooking oils, derived from Category 3 animal by-products, was assessed. The method is based on a catalytic co-processing hydrotreatment using a middle distillate followed by a stripping step. The materials must be submitted to a pressure of at least 60 bars and a temperature of at least 270°C for at least 4.7 min. The application focuses on the demonstration of the level of reduction of spores from non-pathogenic spore-forming indicator bacterial species (Bacillus subtilis and Desulfotomaculum kuznetsovii), based on a non-systematic review of published data and additional extrapolation analyses. The EFSA BIOHAZ Panel considers that the application and supporting literature contain sufficient evidence that the proposed alternative method can achieve a reduction of at least 5 log10 in the spores of B. subtilis and a 12 log10 reduction in the spores of C. botulinum. The alternative method under evaluation is considered at least equivalent to the processing methods currently approved in the Commission Regulation (EU) No 2011/142. info:eu-repo/semantics/publishedVersion
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- 2022
46. Search strategies for the maintenance and update of list of QPS-recommended biological agents
- Author
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EFSA BIOHAZ Panel, Koutsoumanis, Kostas, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Maradona, Miguel Prieto, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barrizzone, Fulvio, Correia, Sandra, Herman, Lieve, Munoz Guajardo, Irene, Da Costa, Irene, Aguillera‐Gomez, Margarita, Aguillera, Jaime, Gelbmann, Wolfgang, Brozzi, Rosella, Bote, Katrin, Heng, Leng, Istace, Frédérique, Richardson, Malcolm, Romero, Patricia, and Rossi, Annamaria
- Subjects
search strategy ,qualification ,QPS - Abstract
The aim of the Extensive Literature Search (ELS) carried out in response to the terms of reference set out in the EFSA mandate on the Qualified Presumption of safety (QPS), i.e. review of the recommendations for the QPS list and specific qualifications, was to identify any publicly available studies reporting on safety concerns for humans, animals or the environment caused by organisms that have QPS status, since the publication of the previous QPS review in 2016 (i.e. publications from June 2016 to June 2019). The details on the search strategy, search keys and approach are presented here. Notes to the versions: - 27 January 2022 and 25 July 2022: The search strategy has been updated to reflect additions to the QPS list and changes in taxonomy. - 25 January 2023 version is linked to QPS part 17, ON-7746. -10 July 2023 version is linked to QPS part 18, ON-8092, EU; PDF; biohaz@efsa.europa.eu
- Published
- 2023
- Full Text
- View/download PDF
47. Update of the list of qualified presumption of safety (QPS) recommended microbiological agents intentionally added to food or feed as notified to EFSA 17: suitability of taxonomic units notified to EFSA until September 2022
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luísa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Maradona, Miguel Prieto, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barizzone, Fulvio, Correia, Sandra, Herman, Lieve, Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
663/664 - Abstract
The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge and safety concerns. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this Statement, new information was found leading to the withdrawal of the qualification ‘absence of aminoglycoside production ability’ for Bacillus velezensis. The qualification for Bacillus paralicheniformis was changed to ‘absence of bacitracin production ability’. For the other TUs, no new information was found that would change the status of previously recommended QPS TUs. Of 52 microorganisms notified to EFSA between April and September 2022 (inclusive), 48 were not evaluated because: 7 were filamentous fungi, 3 were Enterococcus faecium, 2 were Escherichia coli, 1 was Streptomyces spp., and 35 were taxonomic units (TUs) that already have a QPS status. The other four TUs notified within this period, and one notified previously as a different species, which was recently reclassified, were evaluated for the first time for a possible QPS status: Xanthobacter spp. could not be assessed because it was not identified to the species level; Geobacillus thermodenitrificans is recommended for QPS status with the qualification ‘absence of toxigenic activity’. Streptoccus oralis is not recommended for QPS status. Ogataea polymorpha is proposed for QPS status with the qualification ‘for production purposes only’. Lactiplantibacillus argentoratensis (new species) is included in the QPS list. info:eu-repo/semantics/publishedVersion
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- 2023
48. Update of the list of qualified presumption of safety (QPS) recommended microorganisms intentionally added to food or feed as notified to EFSA
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Álvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, de Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luísa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Prieto Maradona, Miguel, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barizzone, Fulvio, Hempen, Michaela, Correia, Sandra, Herman, Lieve, Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
663/664 - Abstract
The qualified presumption of safety (QPS) provides a generic pre-assessment of the safety of microorganisms intended for use in the food or feed chains, to support the work of EFSA’s Scientific Panels. QPS assessment allows a fast track evaluation of strains belonging to QPS taxonomic units (TUs): species for bacteria, yeast, fungi, protists/microalgae and families for viruses. QPS TUs are assessed for their body of knowledge and safety. Safety concerns related to a QPS TU are reflected, when possible, as ‘qualifications’, which should be tested at strain and/or product level. Based on the possession of potentially harmful traits by some strains, filamentous fungi, bacteriophages, oomycetes, streptomycetes, Enterococcus faecium, Escherichia coli and Clostridium butyricum are excluded from the QPS assessment. Between October 2019 and September 2022, 323 notifications of TUs were received, 217 related to feed additives, 54 to food enzymes, food additives and flavourings, 14 to plant protection products and 38 to novel foods. The list of QPS-recommended TUs is reviewed every 6 months following an extensive literature search strategy. Only sporadic infections with a few QPS status TUs in immunosuppressed individuals were identified and the assessment did not change the QPS status of these TUs. The QPS list has been updated in relation to the most recent taxonomic insights and the qualifications were revised and streamlined. The qualification ‘absence of aminoglycoside production ability’ was withdrawn for Bacillus velezensis. Six new TUs received the QPS status: Bacillus paralicheniformis with the qualification ‘absence of toxigenic activity’ and ‘absence of bacitracin production ability’; Bacillus circulans with the qualifications for ‘production purposes only’ and ‘absence of cytotoxic activity’; Haematococcus lacustris (synonym Haematococcus pluvialis) and Ogataea polymorpha, both with the qualification ‘for production purposes only’; Lactiplantibacillus argentoratensis; Geobacillus thermodenitrificans with the qualification ‘absence of toxigenic activity’. info:eu-repo/semantics/publishedVersion
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- 2023
49. Microbiological safety of aged meat
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bover-Cid, Sara, Chemaly, Marianne, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Blagojevic, Bojan, Van Damme, Inge, Hempen, Michaela, Messens, Winy, Bolton, Declan, Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
663/664 ,Veterinary (miscellaneous) ,Animal Science and Zoology ,Parasitology ,Plant Science ,Microbiology ,Food Science - Abstract
The impact of dry-ageing of beef and wet-ageing of beef, pork and lamb on microbiological hazards and spoilage bacteria was examined and current practices are described. As ‘standard fresh’ and wet-aged meat use similar processes these were differentiated based on duration. In addition to a description of the different stages, data were collated on key parameters (time, temperature, pH and aw) using a literature survey and questionnaires. The microbiological hazards that may be present in all aged meats included Shiga toxin-producing Escherichia coli (STEC), Salmonella spp., Staphylococcus aureus, Listeria monocytogenes, enterotoxigenic Yersinia spp., Campylobacter spp. and Clostridium spp. Moulds, such as Aspergillus spp. and Penicillium spp., may produce mycotoxins when conditions are favourable but may be prevented by ensuring a meat surface temperature of −0.5 to 3.0°C, with a relative humidity (RH) of 75–85% and an airflow of 0.2–0.5 m/s for up to 35 days. The main meat spoilage bacteria include Pseudomonas spp., Lactobacillus spp. Enterococcus spp., Weissella spp., Brochothrix spp., Leuconostoc spp., Lactobacillus spp., Shewanella spp. and Clostridium spp. Under current practices, the ageing of meat may have an impact on the load of microbiological hazards and spoilage bacteria as compared to standard fresh meat preparation. Ageing under defined and controlled conditions can achieve the same or lower loads of microbiological hazards and spoilage bacteria than the variable log10 increases predicted during standard fresh meat preparation. An approach was used to establish the conditions of time and temperature that would achieve similar or lower levels of L. monocytogenes and Yersinia enterocolitica (pork only) and lactic acid bacteria (representing spoilage bacteria) as compared to standard fresh meat. Finally, additional control activities were identified that would further assure the microbial safety of dry-aged beef, based on recommended best practice and the outputs of the equivalence assessment. info:eu-repo/semantics/publishedVersion
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- 2023
50. Update of the list of QPS-recommended microbiological agents intentionally added to food or feed as notified to EFSA 16: suitability of taxonomic units notified to EFSA until March 2022
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Kostas, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Prieto Maradona, Miguel, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barizzone, Fulvio, Hempen, Michaela, Correia, Sandra, Herman, Lieve, Indústries Alimentàries, Funcionalitat i Seguretat Alimentària, Koutsoumanis, Kosta, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Peixe, Luisa, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagioti, Suffredini, Elisabetta, Cocconcelli, Pier Sandro, Fernández Escámez, Pablo Salvador, Maradona, Miguel Prieto, Querol, Amparo, Sijtsma, Lolke, Suarez, Juan Evaristo, Sundh, Ingvar, Vlak, Just, Barizzone, Fulvio, Hempen, Michaela, Correia, Sandra, and Herman, Lieve
- Subjects
663/664 ,Veterinary (miscellaneous) ,Companilactobacillus formosensi ,Pseudomonas fluorescen ,Plant Science ,Papiliotrema terrestri ,Microbiology ,Streptococcus salivarius ,QPS ,Ensifer adhaeren ,Pseudonocardia autotrophica ,Microbacterium foliorum ,Animal Science and Zoology ,Parasitology ,Food Science - Abstract
The qualified presumption of safety (QPS) approach was developed to provide a regularly updated generic pre-evaluation of the safety of microorganisms, intended for use in the food or feed chains, to support the work of EFSA's Scientific Panels. The QPS approach is based on an assessment of published data for each agent, with respect to its taxonomic identity, the body of relevant knowledge, safety concerns and occurrence of antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are, where possible, confirmed at the species/strain or product level and reflected by ‘qualifications’. In the period covered by this statement, no new information was found that would change the status of previously recommended QPS TUs. Of the 50 microorganisms notified to EFSA in October 2021 to March 2022 (inclusive), 41 were not evaluated: 10 filamentous fungi, 1 Enterococcus faecium, 1 Clostridium butyricum, 3 Escherichia coli and 1 Streptomyces spp. because are excluded from QPS evaluation, and 25 TUs that have already a QPS status. Nine notifications, corresponding to seven TUs were evaluated: four of these, Streptococcus salivarius, Companilactobacillus formosensis, Pseudonocardia autotrophica and Papiliotrema terrestris, being evaluated for the first time. The other three, Microbacterium foliorum, Pseudomonas fluorescens and Ensifer adhaerens were re-assessed. None of these TUs were recommended for QPS status: Ensifer adhaerens, Microbacterium foliorum, Companilactobacillus formosensis and Papiliotrema terrestris due to a limited body of knowledge, Streptococcus salivarius due to its ability to cause bacteraemia and systemic infection that results in a variety of morbidities, Pseudonocardia autotrophica due to lack of body of knowledge and uncertainty on the safety of biologically active compounds which can be produced, and Pseudomonas fluorescens due to possible safety concerns. info:eu-repo/semantics/publishedVersion
- Published
- 2022
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