Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update)

Publication, Efsa

doi:10.2903/j.efsa.2013.3449

Cited by 161 publications

(122 citation statements)

References 142 publications

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“…The species S. cerevisiae is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment (EFSA, 2007;EFSA BIOHAZ Panel, 2013). This approach requires the identity of the strain to be conclusively established and evidence that the strain does not show resistance to antibiotics of human and veterinary importance.…”

Section: Assessmentmentioning

confidence: 99%

“…In the view of the FEEDAP Panel, the identity of the strain having being established (see Section 3.1.2), S. cerevisiae CNCM I-3060 is considered by EFSA to be suitable for the QPS approach to safety assessment (EFSA, 2007;EFSA BIOHAZ Panel, 2013), and consequently, is presumed safe for the target species, consumers of products from animals fed the additive and the environment.…”

Section: Safetymentioning

confidence: 99%

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Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I‐3060 (selenised yeast inactivated) for all animal species

Additives¹,

Bampidis²,

Azimonti³

et al. 2018

EFS2

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The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 (selenised yeast inactivated) (Sel-Plex ® ) for all animal species. In 2006, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive; subsequently it was authorised in the EU. The evidence provided indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. In particular, the Panel confirms that the use of Sel-Plex ® in animal nutrition does not pose a risk to consumers provided that the maximum selenium supplementation of 0.2 mg/kg feed from Sel-Plex ® is not exceeded, yet respecting the maximum total selenium in feed of 0.5 mg/kg. In the context of the current application, the Panel reviewed toxicological studies; based on two repeated-dose studies on rats and dogs, it is concluded that the toxic potential of Sel-Plex ® is only related to its selenium content. New data on characterisation of the additive and studies on effects on skin and eyes led the Panel reconsider the safety for the user. The Panel concluded that the additive is hazardous upon inhalation and a likely respiratory sensitiser; owing to the high dusting potential, persons handling the additive are at risk by inhalation. It is considered not irritant to the eyes and skin. A recommendation regarding the denomination of the additive under assessment was proposed by the Panel.

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Section: Assessmentmentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I‐3060 (selenised yeast inactivated) for all animal species

Additives¹,

Bampidis²,

Azimonti³

et al. 2018

EFS2

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“…The species B. subtilis is considered by EFSA to be suitable for the QPS approach to safety assessment (EFSA, 2007;EFSA BIOHAZ Panel, 2013). In the view of the FEEDAP Panel, the identity of the production strain is established as B. subtilis.…”

Section: Bacillus Subtilis Kccm 10673pmentioning

confidence: 99%

“…The bacterial species B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment (EFSA, 2007;EFSA BIOHAZ Panel, 2013). This approach requires the identity of the strain to be conclusively established and requires evidence that the strain lacks toxigenic potential and does not show resistance to antibiotics of human and veterinary importance.…”

Section: Introductionmentioning

confidence: 99%

Scientific Opinion on the safety and efficacy of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP as feed additives for all animal species

2015

EFS2

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PepSoyGen-C is described as pure cultures of Aspergillus oryzae and Bacillus subtilis added simultaneously to feed materials to reduce antinutritional factors. The applicant is seeking its authorisation as a technological additive, under a newly proposed, currently non-existent functional group, "substances for the reduction of antinutritional factors". The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the two microbial cultures should be regarded as two independent feed additives that are the subject of the evaluation. The additives are poorly characterised. The inclusion level is likely to be 2 % by weight of the total substrate. The ratio of the two cultures is described as 50/50 on a weight basis. A dose expressed in colony-forming units per kilogram of feed is not proposed. No evidence of toxigenic potential or resistance to antibiotics of human and veterinary importance was found, according to the current guidance documents. Therefore, the B. subtilis additive is presumed safe for target animals, consumers of products fed the additive and the environment. The B. subtilis additive should be considered as having the potential to be a skin and eye irritant and a skin sensitiser and be treated accordingly. In the absence of data on production of toxic secondary metabolites in A. oryzae, the FEEDAP Panel cannot draw conclusions on its safety for the target species and consumers of products fed the additive. The A. oryzae additive should be considered as having the potential to be a skin and eye irritant and a skin and respiratory sensitiser and be treated accordingly. The use of the additive as a technological feed additive is not expected to pose a risk to the environment. The FEEDAP Panel cannot draw conclusions on the efficacy of the additives in reducing antinutritional factors in soybean and other feed materials. SUMMARYFollowing a request from the European Commission, the 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 the product PepSoyGen-C as a feed additive for all animal species. The additive is said to be composed of a mixture of pure cultures of Aspergillus oryzae and of Bacillus subtilis. PepSoyGen-C is intended to treat feed materials such as soybean meal for use in all animal species in order to reduce antinutritional factors. For this purpose the applicant is seeking an authorisation for PepSoyGen-C as a technological additive under a newly proposed, currently non-existent functional group, "substances for the reduction of antinutritional factors". The FEEDAP Panel considers that the two microbial cultures should be regarded as two independent feed additives that are the subject of the evaluation.The additives are poorly characterised. They are said to be combined only at the point of application to the target feed. The applicant indicates that the inclusion level is likely to be 2 % by weight of the total substrate (20 g/kg feed material). Th...

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“…The original strain from which the production organism was derived belongs to K. pastoris, which is considered by EFSA to be suitable for the QPS approach to safety assessment when used for enzyme production (EFSA BIOHAZ Panel, 2013). The production strain harbours one copy of the appA-m gene, which codes for a 6-phytase, and a gene enabling growth in the absence of histidine.…”

Section: Safety Of the Genetic Modificationmentioning

confidence: 99%

Scientific Opinion on the safety and efficacy of ENZY PHOSTAR® (6‐phytase) as a feed additive for avian and porcine species

2015

EFS2

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ENZY PHOSTAR ® is a preparation of 6-phytase produced by a genetically modified strain of Komagataella pastoris to be used as a zootechnical additive in avian and porcine species. Neither the production strain nor its recombinant DNA was detected in the final products. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in the tolerance studies performed, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe at the minimum recommended dose for the species/categories studied. The conclusion was extended to chickens reared for laying and turkeys reared for breeding and it was extrapolated to other avian species and minor porcine species at the corresponding dose. The recipient strain is considered to qualify for the Qualified Presumption of Safety approach to safety assessment and the genetic modification to which it was subject to does not give rise to concern; consequently, it was concluded that the use of ENZY PHOSTAR ® as a feed additive gives rise to no concern for consumers. The additive is hazardous by inhalation. The solid formulation of the additive is not a dermal or eye irritant, but it is a skin sensitiser, and the liquid formulation should be considered a potential irritant and a potential skin sensitiser. No risks to the environment are expected. It was concluded that the additive has the potential to be efficacious at the dose of 125 U/kg in laying hens, 250 U/kg in chickens for fattening and all pig categories and at 500 U/kg in turkeys for fattening. The conclusions were extended to chickens reared for laying and turkeys reared for breeding and extrapolated to all minor poultry species, other avian species and minor porcine species.

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Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update)

Cited by 161 publications

References 142 publications

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I‐3060 (selenised yeast inactivated) for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae CNCM I‐3060 (selenised yeast inactivated) for all animal species

Scientific Opinion on the safety and efficacy of Bacillus subtilis KCCM 10673P and Aspergillus oryzae KCTC 10258BP as feed additives for all animal species

Scientific Opinion on the safety and efficacy of ENZY PHOSTAR® (6‐phytase) as a feed additive for avian and porcine species

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