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result(s) for
"Enterococcus lactis"
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Assessment of a feed additive containing Enterococcus lactis NCIMB 11181 (Lactiferm®) for weaned piglets, calves for fattening and calves for rearing for the renewal of its authorisation (Chr. Hansen A/S)
by
Pechová, Alena
,
Tarrés‐Call, Jordi
,
Mayo, Baltasar
in
Additives
,
Antimicrobial agents
,
calves
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive for weaned piglets, calves for fattening and calves for rearing. The product under assessment is based on a strain originally identified as Enterococcus faecium. During the current assessment, the active agent has been reclassified as Enterococcus lactis. The additive currently authorised is marketed in two formulations: Lactiferm Basic 50 (a solid formulation to be used in feed), and Lactiferm WS200 (a solid ‘water‐soluble’ formulation to be used in water for drinking). The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concludes that the use of Lactiferm® under the authorised conditions of use remains safe for the target species (calves up to 6 months and weaned piglets up to 35 kg), consumers and the environment. The Lactiferm WS200 formulation of the additive is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It is not possible to conclude on the irritating potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both forms of the additive to cause skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Journal Article
Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 (Provita LE) for calves for rearing for the renewal of its authorisation (Lactosan GmbH & Co.KG)
by
Pechová, Alena
,
Tarrés‐Call, Jordi
,
Mayo, Baltasar
in
Additives
,
Animal nutrition
,
Antibiotics
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of the additive Provita LE for calves for rearing, consisting of Enterococcus lactis DSM 7134 (formerly identified as Enterococcus faecium) and Lacticaseibacillus rhamnosus DSM 7133 (formerly identified as Lactobacillus rhamnosus) as a zootechnical feed additive. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The FEEDAP Panel concluded that the use of the feed additive in animal nutrition remains safe for calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. It was not possible to draw conclusions on the skin sensitisation potential of the additive under assessment. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Journal Article
Assessment of the feed additive consisting of Enterococcus lactis NCIMB 10415 (Cylactin®) for cats and dogs for the renewal of its authorisation (DSM Nutritional Products Ltd.)
2024
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Cylactin® as a zootechnical feed additive for cats and dogs. The active agent of the additive is Enterococcus lactis NCIMB 10415 and the micro‐encapsulated formulation, Cylactin® LBC ME5 PET, was assessed. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for cats and dogs. Regarding user safety, the additive was not shown to be skin and eye irritant, but it should be considered a respiratory sensitiser. No conclusions can be drawn on the skin sensitisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Journal Article
Assessment of the feed additive consisting of Enterococcus lactis DSM 10663 NCIMB 10415 (Oralin®) for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs for the renewal of its authorisation (Chevita Tierarzneimittel GmbH)
2026
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the additive Oralin®, a preparation containing viable cells of Enterococcus lactis DSM 10663 (formerly identified as Enterococcus faecium), as a zootechnical feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for the target animals, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive in all forms should be considered as a skin and respiratory sensitiser. Exposure by dermal and respiratory routes is considered a risk. The additive is not irritant to eyes in the powder (Oralin® 350 P), granulated (Oralin® 350 G) and liquid (Oralin® 100 S) preparations. The FEEDAP Panel is not in the position to conclude on the irritancy potential for eyes of the coated form (Oralin® 200 C). There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
Journal Article
Safety and efficacy of a feed additive consisting of Enterococcus lactis NCIMB 10415 for all animal species (Agri‐King, Inc.)
2025
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Enterococcus lactis NCIMB 10415 when used as a technological additive to improve ensiling of all types of fresh plant material for all animal species at a proposed minimum level of 1 × 108 colony forming units (CFU)/kg fresh plant material. The strain NCIMB 10415 was unambiguously identified as Enterococcus lactis, found not to belong to the hospital‐associated clade of Enterococcus faecium and acquired antimicrobial resistance genes were not detected. Consequently, the FEEDAP Panel concluded that E. lactis NCIMB 10415 is safe for all animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding the safety for the user, the additive is considered irritant to eyes and a skin and respiratory sensitiser. Therefore, any exposure is considered a risk. The FEEDAP Panel concluded that the addition of E. lactis NCIMB 10415 at a minimum level of 1 × 108 CFU/kg to fresh plant material has the potential to improve the production and fermentation quality of silage made from all types of plant materials.
Journal Article
Efficacy of a feed additive consisting of Enterococcus lactis NCIMB 11181 (Lactiferm®) for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying and ornamental birds (Chr. Hansen A/S)
2025
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Lactiferm®, a preparation containing viable cells of Enterococcus lactis NCIMB 11181, as a zootechnical feed additive (functional group: gut flora stabilisers). The additive is intended to be used in the feed (3 × 1010 CFU/kg complete feed) and water for drinking (1.5 × 1010 CFU/L) for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying and ornamental birds. In a previous assessment, the FEEDAP Panel concluded that the additive is safe for the target species, consumers and the environment but could not conclude on its efficacy because only two out of the six trials submitted showed significant and positive effects on the zootechnical performance of chickens for fattening. The applicant provided two published studies, one pooled analysis of the data from two previously assessed trials and two long‐term trials in chickens for fattening to address the data gaps in the efficacy assessment. Based on the results of the trials in the previous and current applications, the FEEDAP Panel concluded that Lactiferm® has the potential to be efficacious when supplemented either in the feed or water of chickens for fattening, and the conclusion was extended to chickens reared for laying and extrapolated to other poultry for fattening and reared for laying and ornamental birds.
Journal Article
Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)
2025
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Bonvital® as a zootechnical additive for sows. Bonvital® is currently authorised for use in weaned piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). The active agent of Bonvital® was originally identified as Enterococcus faecium. In a previous opinion the strain was reassigned to Enterococcus lactis. The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® in its powder form is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Bonvital® should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.
Journal Article
Safety and efficacy of a feed additive consisting of Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐10867 and Clostridium butyricum FERM BP‐10866 (BIO‐THREE®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, all avian species for rearing/fattening to slaughter and all avian species reared for laying or breeding to point of lay (TOA BIOPHARMA Co., Ltd.)
2022
Following 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 BIO‐THREE® when used as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, all avian species for rearing/fattening to slaughter and all avian species reared for laying or breeding to point of lay. The product under assessment is based on viable cells/spores of Bacillus subtilis FERM BP‐07462, Enterococcus lactis FERM BP‐10867 and Clostridium butyricum FERM BP‐10866. Based on the tolerance study provided, the Panel concluded that the additive is safe for the target species under the conditions of use. The additive is safe for the consumers of products derived from animals receiving the additive. The additive is not irritant to skin and eyes. The additive is a respiratory sensitiser. No conclusions could be drawn on its potential to be a skin sensitiser. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel was not in the position to conclude on the efficacy of BIO‐THREE® for the target species. BIO‐THREE® is compatible with diclazuril, decoquinate and halofuginone. No conclusions could be drawn on the compatibility of BIO‐THREE® with monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium.
Journal Article
Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for chickens reared for laying and minor poultry species other than those used for laying for the renewal of its authorisation (Lactosan GmbH & Co.KG)
by
Pechová, Alena
,
Mayo, Baltasar
,
Durjava, Mojca
in
Antimicrobial agents
,
Chickens
,
Drug resistance
2023
Bonvital® is the trade name for a feed additive currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). This opinion concerns the renewal of the authorisation of Bonvital® as a zootechnical additive for chickens reared for laying and minor poultry species other than those used for laying. The active agent of Bonvital® was originally identified as Enterococcus faecium. During the current assessment, the strain was reassigned to Enterococcus lactis. The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® was found to be non‐irritant to skin and eyes, but a potential respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.
Journal Article
Safety and efficacy of the feed additive consisting of Enterococcus lactis NCIMB 10415 (Cylactin®) for all poultry for fattening or reared for laying/breeding and ornamental birds, all Suidae, calves and other ruminant species for fattening or rearing (DSM Nutritional products Ltd)
by
Bories, George
,
Pechová, Alena
,
Innocenti, Matteo Lorenzo
in
Additives
,
Animal breeding
,
Birds
2023
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of Cylactin® as zootechnical additive. The active agent of the additive is Enterococcus lactis NCIMB 10415, and three additive formulations currently authorised: Cylactin® LBC G35, Cylactin® LBC ME10 and Cylactin® LBC ME20 plus. The additive is currently authorised in the EU for use in poultry (chickens and minor poultry species for fattening, chickens and minor species reared for laying), calves and kids for rearing and for fattening, sows, suckling and weaned piglets and pigs for fattening. The applicant is now seeking the renewal of its authorisation and the extension of use for chickens and minor poultry species reared for breeding, turkeys for fattening and reared for breeding, ornamental birds, lambs for rearing and for fattening, minor or other ruminants' species for rearing and fattening, minor suckling and weaned Suidae species, pigs and minor Suidae species for fattening, rearing or reproduction. In addition, the applicant is seeking authorisation for use in water for drinking for all above‐mentioned target species and categories. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The FEEDAP Panel concludes that the additive is safe for the target animals, consumers and the environment under the authorised/new proposed conditions of use. The Cylactin® LBC ME10 and LBC ME20 plus are not skin and eye irritants, but no conclusion could be drawn on the potential of Cylactin® LBC G35 to be skin and eye irritant. Moreover, no conclusions could be drawn on the additive skin sensitisation potential. The additive is considered a potential respiratory sensitiser. The efficacy for the new target species/categories as well its use in water was extrapolated from the previous efficacy studies.
Journal Article