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The qualified presumption of safety (QPS) was developed to provide a generic safety evaluation for biological agents to support EFSA's Scientific Panels. It is based on an assessment of the taxonomic identity, the body of knowledge, safety concerns and antimicrobial resistance. Safety concerns identified for a taxonomic unit (TU) are where possible to be confirmed at strain or product level, reflected by 'qualifications'. No new information was found that would change the previously recommended QPS TUs of the 39 microorganisms notified to EFSA between October 2019 and March 2020, 33 were excluded, including five filamentous fungi, five Escherichia coli, two Enterococcus faecium, two Streptomyces spp. and 19 TUs already evaluated. Six TUs were evaluated. Akkermansia muciniphila was not recommended for QPS status due to safety concerns. Clostridium butyricum was not recommended because some strains contain pathogenicity factors. This TU was excluded for further QPS evaluation. Galdieria sulphuraria and Pseudomonas chlororaphis were also rejected due to a lack of body of knowledge. The QPS status of Corynebacterium ammoniagenes (with the qualification 'for production purposes only') and of Komagataella pastoris (with the qualification 'for enzyme production') was confirmed. In relation to the taxonomic revision of the Lactobacillus genus, previously designated Lactobacillus species will be reassigned to the new species and both the old and new names will be retained in the QPS list. [ABSTRACT FROM AUTHOR]

Abstract FUMzyme® is an enzyme‐based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for avian species. It is produced from a genetically modified strain of Komagataella pastoris. The additive is already authorised for use with pigs. During the course of this assessment, it was shown that the production strain and its recombinant genes are not present in the final product. Safety for the consumer, the user and the environment were also established. The extension of its use to all avian species is not expected to alter these conclusions. Chickens and turkeys for fattening and laying hens showed no adverse effect when given feed containing 100 times the maximum recommended dose. Consequently, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive is safe for poultry when used within the dose range proposed (15–300 U/kg feed) and extends this conclusion to all other avian species. Five short‐term feeding studies were made in which poultry were given feed contaminated with fumonisins with or without the additive. Each included a measure of the concentration of fumonisin B1 and its breakdown products and showed that the enzyme was able to significantly reduce the concentration of fumonisin in faeces and various points in the digestive tract and increase the concentration of the degradation products. In addition, ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis, was significantly reduced by the addition of FUMzyme® at the minimum proposed dose, when added to diets contaminated with fumonisins. FUMzyme® has the capacity to degrade fumonisins in feed, at concentrations below the Guidance limits operating in the EU in chickens and turkeys for fattening and laying hens at the minimum recommended dose of 15 U/kg complete feed. This conclusion can be extrapolated to all avian species.

FUMzyme® is an enzyme-based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for avian species. It is produced from a genetically modified strain of Komagataella pastoris. The additive is already authorised for use with pigs. During the course of this assessment, it was shown that the production strain and its recombinant genes are not present in the final product. Safety for the consumer, the user and the environment were also established. The extension of its use to all avian species is not expected to alter these conclusions. Chickens and turkeys for fattening and laying hens showed no adverse effect when given feed containing 100 times the maximum recommended dose. Consequently, the EFSA Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP) concludes that the additive is safe for poultry when used within the dose range proposed (15-300 U/kg feed) and extends this conclusion to all other avian species. Five short-term feeding studies were made in which poultry were given feed contaminated with fumonisins with or without the additive. Each included a measure of the concentration of fumonisin B1 and its breakdown products and showed that the enzyme was able to significantly reduce the concentration of fumonisin in faeces and various points in the digestive tract and increase the concentration of the degradation products. In addition, ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis, was significantly reduced by the addition of FUMzyme® at the minimum proposed dose, when added to diets contaminated with fumonisins. FUMzyme® has the capacity to degrade fumonisins in feed, at concentrations below the Guidance limits operating in the EU in chickens and turkeys for fattening and laying hens at the minimum recommended dose of 15 U/kg complete feed. This conclusion can be extrapolated to all avian species. [ABSTRACT FROM AUTHOR]

FUMzyme® is an enzyme-based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for growing pigs. It is produced from a genetically modified strain of Komagataella pastoris. The viable production strain and its recombinant genes are not present in the final product. Piglets showed no adverse effect when given feed containing 15-times the maximum recommended dose. Consequently the FEEDAP Panel concludes that the additive is safe for pigs when used within the dose range proposed (15 – 300 units/kg feed). In studies with the additive, no evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity found in a subchronic oral toxicity study. Metabolites of fumonisin B1 produced by the action of the active agent have a lower toxicity than the parent compound. Consequently use of the additive in feed for pigs is considered safe for consumers of pork products. The additive is non-irritant and is not a skin sensitiser but presents a hazard for respiratory sensitisation. The active substance of FUMzyme® is a protein and as such is largely degraded/inactivated during passage through the digestive tract of animals. In addition, any hydrolysis of fumonisins in the digestive tract would anticipate that which would occur naturally in soils. Therefore, no risks for the environment are expected. A number of short and long-term feeding studies were made in which pigs were given feed contaminated with fumonisins with or without the additive. Each included a measure of the ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis. This ratio was significantly reduced in piglets by the addition of FUMzyme® at the minimum proposed dose when added to diets contaminated with fuminosins above and below the guidance limits operating in the EU. Sphinganine/sphingosine values generally returned to those seen in animals fed corresponding diets free from fumonisins.

FUMzyme® is an enzyme-based feed additive intended to degrade fumonisin mycotoxins found as contaminants in feeds for growing pigs. It is produced from a genetically modified strain of Komagataella pastoris. The viable production strain and its recombinant genes are not present in the final product. Piglets showed no adverse effect when given feed containing 15-times the maximum recommended dose. Consequently the FEEDAP Panel concludes that the additive is safe for pigs when used within the dose range proposed (15 - 300 units/kg feed). In studies with the additive, no evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity found in a subchronic oral toxicity study. Metabolites of fumonisin B1 produced by the action of the active agent have a lower toxicity than the parent compound. Consequently use of the additive in feed for pigs is considered safe for consumers of pork products. The additive is non-irritant and is not a skin sensitiser but presents a hazard for respiratory sensitisation. The active substance of FUMzyme® is a protein and as such is largely degraded/inactivated during passage through the digestive tract of animals. In addition, any hydrolysis of fumonisins in the digestive tract would anticipate that which would occur naturally in soils. Therefore, no risks for the environment are expected. A number of short and long-term feeding studies were made in which pigs were given feed contaminated with fumonisins with or without the additive. Each included a measure of the ratio of sphinganine/sphingosine, considered the most sensitive endpoint for fumonisin toxicosis. This ratio was significantly reduced in piglets by the addition of FUMzyme® at the minimum proposed dose when added to diets contaminated with fuminosins above and below the guidance limits operating in the EU. Sphinganine/sphingosine values generally returned to those seen in animals fed corresponding diets free from fumonisins. [ABSTRACT FROM AUTHOR]