Guidance on the assessment of the safety of feed additives for the target species

Additives, Efsa Panel on; Rychen, Guido; Aquilina, Gabriele; Azimonti, Giovanna; Bampidis, Vasileios; Bastos, Maria de Lourdes; Bories, Georges; Chesson, Andrew; Cocconcelli, Pier Sandro; Flachowsky, Gerhard; Gropp, Jürgen; Kolar, Boris; Kouba, Maryline; López‐Alonso, Marta; Puente, Secundino López; Mantovani, Alberto; Mayo, Baltasar; Ramos, Fernando; Saarela, Maria; Villa, Roberto Edoardo; Wallace, Robert John; Wester, Pieter; Anguita, Montserrat; Galobart, Jaume; Innocenti, Matteo Lorenzo; Martino, Laura

doi:10.2903/j.efsa.2017.5021

Cited by 421 publications

(490 citation statements)

References 5 publications

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“…The approach followed by the FEEDAP Panel to assess the safety and the efficacy of Levucell ® SB is in line with the principles laid down in Regulation (EC) No 429/2008 7 and the relevant guidance documents: Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017b), Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA FEEDAP Panel, 2018a), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017c) and Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018b).…”

Section: Methodologiessupporting

confidence: 60%

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

Additives¹,

Bampidis²,

Azimonti³

et al. 2019

EFS2

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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 turkeys for fattening. The additive is intended for use as a zootechnical additive (functional group: other additives) for the reduction of Salmonella contamination on carcasses through its decrease in faeces. 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 and the environment. Since no concerns are expected from other components of the additive, Levucell ® SB is also considered safe for the target species, consumers and the environment. The additive is not a skin or eye irritant or a skin sensitiser. Considering the data on the dusting potential, the user can be exposed to the additive by inhalation when handling it. The additive in non-encapsulated form should be considered as a respiratory sensitiser. The coated formulation is not considered to pose a risk by inhalation. The efficacy of Levucell ® SB for the same purpose was previously established in chickens for fattening. The FEEDAP Panel concluded that there was some evidence that the addition of Levucell ® SB at 2 9 10 10 CFU/kg feed has a potential to aid the reduction of carcass contamination with Salmonella spp. Since the mechanism of action of the additive can be reasonably assumed to be same, Levucell ® SB can be presumed efficacious in turkeys for fattening at a dose of 2 9 10 10 CFU/kg feed without the need for additional studies.

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Section: Methodologiessupporting

confidence: 60%

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

Additives¹,

Bampidis²,

Azimonti³

et al. 2019

EFS2

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“…From this NOAEL, the applicant calculated the maximum safe level for chickens for fattening in feed according to the guidance on the safety for the target species (EFSA FEEDAP Panel, 2017). The results of that study indicate a NOAEL of 119,228 U/kg bw in rats.…”

Section: Safety For the Target Speciesmentioning

confidence: 99%

“…OJ L 133, 22.5.2008, p. 1.Panel 2012d), Guidance on the assessment of the safety of feed additives for the target species(EFSA FEEDAP Panel, 2017) and Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use (EFSA GMO Panel, 2011). OJ L 268, 18.10.2003, p. 29.…”

mentioning

confidence: 99%

Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a feed additive for chickens for fattening, chickens reared for laying and minor growing poultry species

Additives¹,

Bampidis²,

Azimonti³

et al. 2019

EFS2

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APSA PHYTAFEED ® 20,000 GR/L is a preparation of 6-phytase which is presented in solid and liquid forms. This additive is intended to be used as a zootechnical additive in chickens for fattening or reared for laying/breeding and minor poultry species for fattening or reared for laying/breeding. The 6phytase present in the additive is produced by a genetically modified strain of Komagataella phaffii. The production strain and its recombinant DNA were not detected in intermediate products used to produce the additive. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding. The FEEDAP Panel concluded that the use of APSA PHYTAFEED ® 20,000 GR/L as a feed additive gives rise to no concern for consumers. The additive, in either form, is not toxic by inhalation or irritant for skin or eyes and it is not a dermal sensitizer, but it is considered a potential respiratory sensitizer. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel evaluated three efficacy trials in which the retention of the phosphorus was studied. The data showed that the additive has the potential to improve the retention of phosphorus in the diets in chickens for fattening at 250 U/kg feed. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding.

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“…The approach adopted by the FEEDAP Panel to estimate animal dietary exposure to feed additives from default values for body weight and daily feed intake is reported for the main categories of farmed and companion animals in the Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017). This guidance recommends these default values for the main animal species/categories at specific growth rates or level of productivity and physiological status which are representative of the most sensitive phases of the production cycles (Table 3).…”

Section: Feed Intake Data (Feedap Panel)mentioning

confidence: 99%

Animal dietary exposure: overview of current approaches used at EFSA

Ardizzone¹,

Binaglia²,

Cottrill³

et al. 2019

EFS2

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At EFSA, animal dietary exposure estimates are undertaken by several Panels/Units to assess the risk of feed contaminants, pesticide residues, genetically modified feed and feed additives. Guidance documents describing methodologies for animal dietary exposure assessment are available both at EFSA and international levels. Although appropriate within pertinent regulatory frameworks, the methodologies used to assess animal dietary exposure vary across risk assessment areas. There are different approaches ranging from quick worst-case estimations to more refined methods assessing actual exposure, resulting from the use of a heterogeneous selection of animal populations and default values to estimate feed intake. Furthermore, current feed classification systems in place at international and national levels contain a large and heterogeneous number of feed materials, which may benefit from further harmonisation efforts. This technical report presents an overview of the current approaches in place at EFSA to assess the exposure to chemicals in feed. The possibility for a greater harmonisation of feed classification and terminology is also addressed by comparing the structure of the EU catalogue of feed materials and the Harmonised OECD tables of feedstuffs derived from field crops with the EFSA FoodEx2 system.

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Guidance on the assessment of the safety of feed additives for the target species

Cited by 421 publications

References 5 publications

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

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

Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6‐phytase) as a feed additive for chickens for fattening, chickens reared for laying and minor growing poultry species

Animal dietary exposure: overview of current approaches used at EFSA

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