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1.
EFSA J ; 21(10): e08347, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37908446

ABSTRACT

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.

2.
EFSA J ; 20(8): e07424, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35978622

ABSTRACT

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 Pediococcus acidilactici CNCM I-4622 when used as a technological additive (acidity regulator and hygiene condition enhancers) for all animal species. The product is intended for use in mash compound feeds and/or solid feed materials used for the preparation of liquid feeds at a minimum inclusion level of 1 × 109 CFU kg feed. The bacterial species is considered by EFSA to be eligible for the qualified presumption of safety (QPS) approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of this strain in animal nutrition is considered safe for the target species, consumers and the environment. The additive is considered to be a respiratory sensitiser but is not irritant to eyes/skin or a skin sensitiser. Pediococcus acidilactici CNCM I-4622 at 1 × 109 CFU/kg complete feed showed the potential to reduce the pH and the growth of coliforms in liquid feeds. Pediococcus acidilactici CNCM I-4622 is compatible with halofuginone, diclazuril, decoquinate and nicarbazin at the highest authorised levels for chickens for fattening.

3.
EFSA J ; 18(6): e06141, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32874322

ABSTRACT

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 OptiPhos PLUS ® to be used as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening, minor poultry species reared for laying, minor poultry species reared for breeding and ornamental birds. The active substance is 6-phytase produced by a genetically modified strain of Komagataella phaffii. The FEEDAP Panel concludes that the genetic modification of the production strain does not give rise to safety concerns. Based on the tolerance studies provided, the Panel concludes that the additive is safe for the target species under the conditions of use with a wide margin of safety. The additive is not a skin irritant. It is found to be a dermal sensitiser. The FEEDAP Panel cannot conclude on the eye irritation potential of the additive. Owing to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The FEEDAP Panel concludes that the additive has the potential to be efficacious in increasing the phosphorus utilisation in chickens for fattening at the level of 250 FTU/kg feed. These conclusions can be extended to turkeys for fattening and chickens and turkeys reared for laying/breeding and extrapolated to all minor poultry species and other avian species up to the point of lay.

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