Safety and efficacy of feed additives consisting of expressed sweet orange peel oil and its fractions from (L.) Osbeck for use in all animal species (FEFANA asbl).

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 expressed sweet orange oil and its fractions obtained from the fruit peels of (L.) Osbeck, when used as sensory additives (flavourings) in feed and water for drinking for all animal species. The presence of perillaldehyde was identified as a source of potential concern.

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by LMG S-27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-β-xylanase (Beltherm MP/ML), produced by a genetically-modified strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel).

Safety and efficacy of a feed additive consisting of DSM 15544 (Calsporin) for piglets (suckling and weaned), pigs for fattening, sows in order to have benefit in piglets, ornamental fish, dogs and all avian species (Asahi Biocycle Co.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of DSM 15544 (Calsporin) when used as a feed additive for piglets (suckling and weaned), pigs for fattening, sows in order to have benefit in piglets, ornamental fish, dogs and all avian species. The additive is authorised for use in sows, suckling and weaned piglets, pigs for fattening, chickens for fattening, laying hens, ornamental fish and dogs. With this application the company requested a new authorisation for all avian species and the modification of the current authorisations as regards the strain taxonomy from DSM 15544 to DSM 15544.

Assessment of the feed additive consisting of (formerly DSM 16245 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

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 assessment of the application for renewal of authorisation of (formerly ) DSM 16245 as a technological additive for all animal species. The additive aims to improve the production of silage and is currently authorised at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation.

Safety and efficacy of a feed additive consisting of (formerly ) NCIMB 30121 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co. KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of (formerly ) NCIMB 30121 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised without a minimum inclusion level. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation.

Assessment of the feed additive consisting of (formerly ) DSM 12835 EU for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

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 assessment of the application for renewal of authorisation of (formerly ) DSM 12835 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised without a minimum inclusion level. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation.

Assessment of the feed additive consisting of sodium benzoate (Protural) for weaned piglets for the renewal of its authorisation and the extension of use to other growing Suidae (Taminco Finland Oy).

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 Protural (sodium benzoate) when used as a zootechnical additive in feed for weaned piglets and other growing Suidae at 4,000 mg/kg feedingstuff. Protural consists of sodium benzoate without any carrier materials and is currently authorised for use in weaned piglets. This opinion concerns the renewal of the authorisation of Protural for weaned piglets and the evaluation of the new use in other growing Suidae.

Safety and efficacy of a feed additive consisting of iron (II) chelate of amino acids hydrate for all animal species.

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 iron (II) chelate of amino acids hydrate for all animal species, brand name Availa Fe, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 9% iron. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to include a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (iron), with an inclusion level of 9-10%.

Safety and efficacy of a feed additive consisting of an aqueous extract of (L.) Osbeck (lemon extract) for use in all animal species (Nor-Feed SAS).

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 an aqueous extract of (L.) Osbeck (lemon extract) when used as a sensory additive in feed for all animal species. The FEEDAP Panel concluded that the additive under assessment is safe for all animal species up to the maximum proposed use levels of 1,000 mg/kg complete feed and 250 mg/kg water for drinking.

Safety of a feed additive consisting of a dried aqueous ethanol extract from the leaves of L. for all animal species (Nor-Feed SAS).

The additive under assessment is a dried aqueous ethanol extract of L. leaves, intended to be used as a sensory additive (flavouring compound) in feed for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid.

Safety and efficacy of a feed additive consisting of (formerly ) DSM 26571 for all animal species (Chr. Hansen A/S).

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 (formerly ) DSM 26571 when used as a technological additive intended to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.

Safety and efficacy of a feed additive consisting of zinc chelate of amino acids hydrate for all animal species (Zinpro Animal Nutrition (Europe) Inc.).

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 zinc chelate of amino acids hydrate, brand name Availa Zn, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein with a minimum content of 10% zinc. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 17%; (iii) to introduce a tighter specification of the zinc content of 10-11%.

Safety and efficacy of a feed additive consisting of copper (II) chelate of amino acids hydrate for all animal species (Zinpro Animal Nutrition (Europe) Inc.).

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 copper (II) chelate of amino acids hydrate, brand name AvailaCu, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 10% copper. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (copper), with an inclusion level of 10-11%.

Safety and efficacy of a feed additive consisting of manganese chelate of amino acids hydrate for all animal species (Zinpro Animal Nutrition (Europe) Inc.).

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 manganese chelate of amino acids hydrate, brand name AvailaMn, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 8% manganese. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 17%; and (iii) to introduce a tighter specification on the mineral content (manganese), with an inclusion level of 8-9%.

Safety and efficacy of a feed additive consisting of cashew nutshell liquid for all animal species (Oligobasic Europe).

Following a request from 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 the additive cashew nutshell liquid as a technological additive (antioxidant) in feedingstuffs for all animal species. The additive cashew nutshell liquid consists of an artificial mixture of two components, the oil extracted from the cashew nutshell, called CNSL and castor oil. In the absence of adequate data, the FEEDAP Panel is not in the position to conclude on the characterisation of the additive nor to conclude on the safety of cashew nutshell liquid for the target species, the consumer and the environment.

Manipulation of the gut microbiome in gluten-intolerance.

Purpose Of Review: Gluten is a complex mixture of highly immunogenic glutamine- and proline-rich proteins found in some cereals. In celiac disease (CeD), gluten triggers an autoimmune response due to its interaction with the human leukocyte antigen heterodimers that confer the genetic risk. The involvement of gluten in other disorders has also been investigated, but its role beyond CeD is still unclear.

Safety for the environment of a feed additive consisting of nicarbazin (Coxar) for use in turkeys for fattening (Huvepharma N.V.).

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the environment of the coccidiostat Coxar (nicarbazin) when used in feed for turkeys for fattening. In previous assessments, the FEEDAP Panel could not conclude on the safety of Coxar for the environment due to concerns on 4,40-dinitrocarbanilide (DNC, one of the moieties of nicarbazin). On the basis of the new data provided, the FEEDAP Panel updates its previous conclusions on the safety of Coxar for the environment as follows: The use of nicarbazin from Coxar in complete feed for turkeys does not pose a risk for the terrestrial and aquatic compartment and in sediment.

Safety and efficacy of an additive consisting of xanthan gum produced by strains ■■■■■, ■■■■■ for all animal species (Biopolymer International).

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 xanthan gum as a feed additive for all animal species. Xanthan gum is manufactured using different production strains belonging to the species. The identity of the strains producing xanthan gum was not unambiguously established, data on antimicrobial susceptibility were incomplete, and it was not possible to exclude the presence in the additive of viable cells/DNA of the production strains.

Safety of a feed additive consisting of a tincture derived from L. (great mullein tincture) for use in all animal species (MANGHEBATI SAS).

The tincture derived from L. (great mullein tincture) is intended to be used as a sensory additive in feed for all animal species. The product is a water/ethanol solution, with a dry matter content of ˜ 2.

Safety and efficacy of a feed additive consisting of a flavonoid-rich dried extract of × L. fruit (bitter orange extract) for use in all animal species (FEFANA asbl).

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 a dried flavonoid-rich extract of  ×  L. fruit (bitter orange extract), when used as a sensory additive for all animal species. The use of the additive in feed was not expected to increase the exposure to furocoumarins of those target species that are already fed citrus by-products to a relevant extent (< 5%).

Safety and efficacy of a feed additive consisting of (formerly ) IMI 507027 for all animal species (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland]).

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 (formerly ) IMI 507027 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach.

Safety and efficacy of a feed additive consisting of l-lysine sulfate produced by KCCM 80227 for all animal species (Daesang Europe BV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-lysine sulfate produced by KCCM 80227 as a nutritional feed additive for all animal species. The FEEDAP Panel concluded that the production strain KCCM 80227 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and is not detected in the final product. l-Lysine sulfate produced using KCCM 80227 does not pose any safety concern associated with the production strain.

Safety and efficacy of a feed additive consisting of (formerly ) IMI 507028 for all animal species (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland]).

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 (formerly ) IMI 507028 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach.

Safety and efficacy of a feed additive consisting of IMI 507025 for all animal species (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland]).

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 IMI 507025 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety approach.