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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Abstract Cylactin® is the trade name for a feed additive based on dehydrated cells of Enterococcus faecium. It is marketed in three forms: Cylactin® LBC ME10 and Cylactin® LBC ME20 Plus – which contain the microencapsulated bacterium in concentrations of 1 × 1010 CFU/g and 2 × 1010 CFU/g, respectively – and Cylactin® LBC G35, a granulated form with a guaranteed content of 3.5 × 1010 CFU/g. In 2012, EFSA was requested by the European Commission to re‐evaluate the product when used as a zootechnical additive in feed for weaned piglets, sows and pigs for fattening. In the opinion delivered in 2015, the safety of the additive for consumers, users, the environment and target animals and its efficacy for piglets and sows were established. However, since only two efficacy studies with pigs for fattening could be considered and showed positive results, the Panel could not conclude on the efficacy for this target species due to insufficient data. The applicant has produced three additional feeding trials in pigs for fattening receiving the additive at the proposed inclusion level of 3.5 × 108 CFU/kg feedingstuffs, which are the subject of this assessment. None of these studies showed a significant effect on the performance of pigs for fattening. The data on average daily gain and feed to gain ratio of the three new studies and of the two from the previous opinion were pooled. Based on the results of this pooled analysis of five studies, but not supported by four out of the five individual studies, the EFSA Panel on Additives and Products or Substances used in Animal Feed concludes that Cylactin® has some potential to improve performance of pigs for fattening at 3.5 × 108 CFU/kg feed.

Cylactin® is the trade name for a feed additive based on dehydrated cells of Enterococcus faecium. It is marketed in three forms: Cylactin®LBC ME10 and Cylactin®LBC ME20 Plus – which contain the microencapsulated bacterium in concentrations of 1 × 1010 CFU/g and 2 × 1010 CFU/g, respectively – and Cylactin®LBC G35, a granulated form with a guaranteed content of 3.5 × 1010 CFU/g. In 2012, EFSA was requested by the European Commission to re‐evaluate the product when used as a zootechnical additive in feed for weaned piglets, sows and pigs for fattening. In the opinion delivered in 2015, the safety of the additive for consumers, users, the environment and target animals and its efficacy for piglets and sows were established. However, since only two efficacy studies with pigs for fattening could be considered and showed positive results, the Panel could not conclude on the efficacy for this target species due to insufficient data. The applicant has produced three additional feeding trials in pigs for fattening receiving the additive at the proposed inclusion level of 3.5 × 108 CFU/kg feedingstuffs, which are the subject of this assessment. None of these studies showed a significant effect on the performance of pigs for fattening. The data on average daily gain and feed to gain ratio of the three new studies and of the two from the previous opinion were pooled. Based on the results of this pooled analysis of five studies, but not supported by four out of the five individual studies, the EFSA Panel on Additives and Products or Substances used in Animal Feed concludes that Cylactin® has some potential to improve performance of pigs for fattening at 3.5 × 108 CFU/kg feed. [ABSTRACT FROM AUTHOR]

Abstract Cylactin® is the trade name for a preparation of Enterococcus faecium. It is currently authorised for use several animal species. The product is intended for use with sows at a minimum dose of 7 × 108 and a maximum dose of 1.25 × 109 colony‐forming unit (CFU)/kg feed and with weaned and suckling piglets and pigs for fattening at a minimum dose of 3.5 × 108 and a maximum dose of 1.0 × 109 CFU/kg feed. The characterisation of the additive was fully described and its safety for consumers, users and the environment was assessed in previous opinions and it was found not to give rise to any concerns. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is unaware of any new data which would lead it to revise its conclusions. Therefore, the focus of the present opinion is on the safety and efficacy of Cylactin® when used with the target animals. Results on the safety and efficacy apply to all forms of the additive when delivering the same dose. When used at 100 times the maximum recommended dose, Cylactin® did not show any adverse effect on the performance or mortality of piglets and sows. Therefore, the additive is considered safe for suckling and weaned piglets, pigs for fattening and sows at the maximum proposed dose. Cylactin® has the potential to be efficacious in sows and suckling piglets when supplemented to both sows and suckling piglets at 7.0 × 108 and 1 × 109 CFU/kg feed, respectively. Cylactin® also has the potential to be efficacious in weaned piglets when supplemented at the minimum recommended dose of 3.5 × 108 CFU/kg feed. Insufficient data were provided to support the efficacy of Cylactin® when used in pigs for fattening.

Abstract Cylactin® is a product consisting of viable cells of Enterococcus faecium NCIMB 10415. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed a tolerance study conducted with chickens for fattening, in which Cylactin® was included in diets at concentrations up to 100 times the recommended dose of 3 × 108 CFU/kg complete feed. No adverse effects were seen in this study and so the FEEDAP Panel concluded that the additive is safe when used at the recommended dose. This conclusion is extended to chickens reared for laying and extrapolated to minor poultry species for fattening and minor poultry species reared for laying. The potential of Cylactin® to be efficacious was previously demonstrated in chickens for fattening at 3 × 108 CFU/kg complete feed. This conclusion is extended to chickens reared for laying. Because it can be reasonably assumed that the mode of action in chickens for fattening would be the same in minor poultry species, the conclusion regarding chickens for fattening can be extrapolated to minor poultry species for fattening and minor poultry species reared for laying when the additive is used at the same dose. Cylactin® is compatible with lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin and salinomycin.

Cylactin® is the trade name for a preparation of Enterococcus faecium. It is currently authorised for use several animal species. The product is intended for use with sows at a minimum dose of 7 × 108 and a maximum dose of 1.25 × 109 colony-forming unit (CFU)/kg feed and with weaned and suckling piglets and pigs for fattening at a minimum dose of 3.5 × 108 and a maximum dose of 1.0 × 109 CFU/kg feed. The characterisation of the additive was fully described and its safety for consumers, users and the environment was assessed in previous opinions and it was found not to give rise to any concerns. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) is unaware of any new data which would lead it to revise its conclusions. Therefore, the focus of the present opinion is on the safety and efficacy of Cylactin® when used with the target animals. Results on the safety and efficacy apply to all forms of the additive when delivering the same dose. When used at 100 times the maximum recommended dose, Cylactin® did not show any adverse effect on the performance or mortality of piglets and sows. Therefore, the additive is considered safe for suckling and weaned piglets, pigs for fattening and sows at the maximum proposed dose. Cylactin® has the potential to be efficacious in sows and suckling piglets when supplemented to both sows and suckling piglets at 7.0 × 108 and 1 × 109 CFU/kg feed, respectively. Cylactin® also has the potential to be efficacious in weaned piglets when supplemented at the minimum recommended dose of 3.5 × 108 CFU/kg feed. Insufficient data were provided to support the efficacy of Cylactin® when used in pigs for fattening. [ABSTRACT FROM AUTHOR]

Cylactin® is the trade name for a preparation of Enterococcus faecium. It is currently authorised for use in chickens for fattening, pigs for fattening, piglets, sows, calves, turkeys for fattening, cats and dogs in various formulation. The product is intended for use with dogs at a minimum dose of 4.5 x 106 and a maximum dose of 2.0 x 109 CFU/kg feed and with cats at a minimum dose of 5.0 x 106 and a maximum dose of 8.0 x 109 CFU/kg feed. The Cylactin® strain does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and is susceptible to clinically relevant antibiotics, except for kanamycin, which is considered of no concern. Cylactin® is safe for dogs and cats at the recommended dose range. The additive is not a skin/mucosal irritant or a skin sensitiser. As this formulation has a large particle size and the dusting potential is low, the potential for exposure via the respiratory route is considered minimal. Three studies carried out in dogs demonstrated that the additive has the potential to produce a beneficial effect in dogs, when added to feedstuffs at a dose of 2.5 x 109 CFU kg, by increasing the intestinal or serum concentration of IgA. Cylactin® showed inconsistent effects on faecal quality in three studies in which cats were fed the additive at the dose of 7 x 109 CFU/kg of feed.

Cylactin® consists of dehydrated cells of a strain of Enterococcus faecium. It is authorised for use in feeds for chickens, turkeys and pigs for fattening, piglets, sows, calves and cats and dogs. The applicant is now seeking re-evaluation when used with calves and a new authorisation for use in feed for goat kids and lambs for rearing and for fattening at 1.0 x 109 - 6.6 x 109 CFU/kg feed. The strain does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and is susceptible to clinically relevant antibiotics, except for kanamycin which is considered of no concern. There were no adverse effects seen in calves when Cylactin® was administered at a 100-fold overdose. Consequently, Cylactin® is considered safe for calves for fattening and for rearing at the recommended dose. This conclusion was extended to kids for fattening and rearing. However, lambs for fattening are not considered a minor species and require a separate demonstration of safety which was not provided. No additional concerns would arise for consumers, users and the environment from the proposed extension of use. Seven trials made with calves for fattening or rearing were considered. Use of the additive with calves for fattening significantly increased final body weight and/or daily gain in four of five trials when used at a dose of 1 x 109 CFU/kg complete feed. An additional study with calves for rearing confirmed these results at the same dose. As the mechanism of action of the additive can be reasonably assumed to be same, the positive results seen in calves for fattening and rearing can be extrapolated to kids for rearing and fattening. Conclusions on the efficacy of the product for sheep would derive from results with lambs for fattening which were not made available.

Cylactin® is a product consisting of viable cells of Enterococcus faecium NCIMB 10415. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed a tolerance study conducted with chickens for fattening, in which Cylactin® was included in diets at concentrations up to 100 times the recommended dose of 3 × 108 CFU/kg complete feed. No adverse effects were seen in this study and so the FEEDAP Panel concluded that the additive is safe when used at the recommended dose. This conclusion is extended to chickens reared for laying and extrapolated to minor poultry species for fattening and minor poultry species reared for laying. The potential of Cylactin® to be efficacious was previously demonstrated in chickens for fattening at 3 × 108 CFU/kg complete feed. This conclusion is extended to chickens reared for laying. Because it can be reasonably assumed that the mode of action in chickens for fattening would be the same in minor poultry species, the conclusion regarding chickens for fattening can be extrapolated to minor poultry species for fattening and minor poultry species reared for laying when the additive is used at the same dose. Cylactin® is compatible with lasalocid A sodium, maduramycin ammonium, narasin, narasin/nicarbazin and salinomycin. [ABSTRACT FROM AUTHOR]