Guidance on the assessment of the efficacy of feed additives

et al. 2019

EFS2

Self Cite

Following a request from the European Commission, the EFSA 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 ZM16 10 for all pigs. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens intended for use in feed at the proposed dose of 5 9 10 8 CFU/kg complete feedingstuffs and in water for drinking at 1.7 9 10 8 CFU/L. The additive exists in two forms, ZM16 and ZM16 10, and has been previously characterised by the FEEDAP Panel. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements and consequently, the additive was presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. The data made available by the applicant allowed the Panel to conclude that the additive, in either form, has a potential to be efficacious as a zootechnical additive when added to feed for piglets (suckling and weaned), pigs for fattening and sows at 5 9 10 8 CFU/kg (corresponding to 1.7 9 10 8 CFU/L). The conclusions on the efficacy were extrapolated to all Suidae species.

Section: Data and Methodologiesmentioning

confidence: 89%

Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for sows in order to have benefits in piglets, sows for reproduction, piglets (suckling and weaned), pigs for fattening and minor porcine species

Additives¹,

Bampidis²,

et al. 2019

EFS2

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“…The approach followed by the FEEDAP Panel to assess the safety and the efficacy of RONOZYME ® WX CT/L (endo‐1,4‐β‐xylanase) is in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents: Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, ) and Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, ).…”

Section: Data and Methodologiesmentioning

confidence: 99%

Safety and efficacy of RONOZYME® WX CT/L (endo‐1,4‐β‐xylanase) as a feed additive for sows for reproduction

Additives¹,

Bampidis²,

et al. 2019

EFS2

Self Cite

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 RONOZYME® WX CT/L as a feed additive for sows for reproduction. This additive contains endo‐1,4‐β‐xylanase produced by a genetically modified strain of Aspergillus oryzae and it is authorised in the EU as a feed additive for poultry for fattening, weaned piglets and pigs for fattening. The applicant requests the extension of use of the additive to sows for reproduction at 200 FXU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of RONOZYME® WX in sows. The FEEDAP Panel concluded that the additive is not a skin or eye irritant, but it should be considered a respiratory sensitiser, but could not conclude on the skin sensitisation potential of the additive. A tolerance trial in lactating sows and two toxicological studies were made available to support the safety of the target species. Based on the data available, the FEEDAP Panel concluded that the additive is safe for sows for reproduction at the recommended level with a wide margin of safety. Three efficacy studies in lactating sows were evaluated. Sows that received RONOZYME® WX showed improvements on the apparent faecal digestibility of the energy in the three trials. The enzyme activity in feed that showed efficacy ranged from 124 to 287 FXU/kg feed, and the FEEDAP Panel concluded that the additive has the potential to be efficacious as a zootechnical additive in lactating sows at a level of approximately 250 FXU/kg feed. No data has been provided in gestating sows, and consequently, the Panel could not conclude on this physiological stage of the productive cycle.

“…The approach followed by the FEEDAP Panel to assess the safety and the efficacy of Levucell ® SB ( Saccharomyces cerevisiae CNCM I‐1079) is in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, ).…”

Section: Data and Methodologiesmentioning

confidence: 99%

Safety and efficacy of Levucell® SB (Saccharomyces cerevisiae CNCM I‐1079) as a feed additive for all pigs

Additives¹,

Bampidis²,

et al. 2019

EFS2

Self Cite

Following a request from the European Commission, the EFSA 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 Levucell® SB when used in feed for suckling piglets, pigs for fattening and minor porcine species. Levucell® SB is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae currently authorised as a zootechnical additive for weaned piglets, sows, chickens for fattening and minor poultry species for fattening. The applicant is now seeking authorisation as a zootechnical additive for use with all pigs. In the context of a previous opinion, the identity of the strain was confirmed, and according to the Qualified Presumption of Safety (QPS) approach to safety assessment, it was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, Levucell® SB is also considered safe for the target species, including all pigs, consumers and the environment. Levucell® is not a skin or eye irritant or a skin sensitiser. Inhalation exposure is unlikely. Encapsulation used in the existing coated forms is not expected to introduce hazards for users. In previous opinions, Levucell® SB was found to have the potential to be efficacious in sows and weaned piglets at the dose of 1 × 109 colony forming units (CFU)/kg complete feedingstuffs. Since the dose proposed for use with all pigs is the same as that demonstrated to be effective in weaned piglets and sows, and it can be reasonably assumed that the mode of action is the same, the conclusion on efficacy for weaned piglets and sows can be extrapolated to all pigs. Therefore, the FEEDAP Panel concludes that Levucell® SB has the potential to be efficacious in all pigs at 1 × 109 CFU/kg feedingstuffs.