Safety and efficacy of a feed additive consisting of Enterococcus lactis NCIMB 11181 (Lactiferm®) for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying, and ornamental birds (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of Enterococcus lactis NCIMB 11181 (Lactiferm®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening, chickens reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The additive is available in two formulations: Lactiferm WS200 and Lactiferm Basic 50. The FEEDAP Panel concluded that the use of the additive is safe for chickens for fattening or reared for laying, other poultry species for fattening or reared for laying, and ornamental birds. The Panel also concluded that the use of the feed additive is safe for consumers, and the environment. Lactiferm WS200 is not irritant to skin or eyes. Owing to the proteinaceous nature of the active agent, both formulations of the additive are considered respiratory sensitisers. It was not possible, however, to conclude on the irritancy potential for skin and eyes of the Lactiferm Basic 50 formulation or on the potential of both formulations of the additive to cause skin sensitisation. The efficacy studies submitted did not allow to draw a conclusion on the efficacy of the additive for the target species. Lactiferm® is considered compatible with the coccidiostats monensin sodium and decoquinate.

Safety and efficacy of a feed additive consisting of l-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 for all animal species (Eppen Europe SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a nutritional feed additive for use in feed and in water for drinking for all animal species. The production strain is non-genetically modified, qualifies for the QPS approach to safety assessment when used for production purposes, is susceptible to the relevant antibiotics and contains no antimicrobial resistance genes of concern. No viable cells of the production strain were detected in the final product. The additive does not give rise to any safety concern regarding the production strain. l-Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered safe for the target species, the consumer and the environment. Regarding the use in water, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reiterates its concerns over the safety for the target species of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the FEEDAP Panel is not in a position to conclude on the potential of l-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation is likely. l-Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered as an efficacious source of the essential amino acid l-isoleucine for non-ruminant animal species. For the supplemental l-isoleucine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

Assessment of the feed additive consisting of l-cystine for all animal species for the renewal of its authorisation (Bretagne Chimie Fine [BCF Life Sciences]).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of l-cystine as nutritional feed additive. The additive is authorised for use in all animal species (3c391). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, the consumers and the environment. As regards the safety for the user, l-cystine is not an irritant to skin or eyes and is not a skin sensitiser. Exposure by inhalation of persons handling the additive cannot be excluded. The present application for the renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for reassessing the efficacy.

Safety and efficacy of a feed additive consisting of l-threonine (produced with Escherichia coliCGMCC 7.455) for all animal species (Kempex Holland B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l-threonine produced by fermentation with Escherichia coli CGMCC 7.455 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain is genetically modified. None of the introduced genetic modifications raised a safety concern. Viable cells of the production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain. The use of l-threonine (≥ 98.5%) produced with E. coli CGMCC 7.455 to supplement feed is safe for the target species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns on the safety of the simultaneous oral administration of l-threonine via water for drinking and feed due to possible amino acid imbalances and hygienic reasons. The use of l-threonine produced with E. coli CGMCC 7.455 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity in the additive does not pose a risk for the user via inhalation. The additive l-threonine is regarded as an effective source of the amino acid l-threonine for all non-ruminant species. In order to be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.

Safety and efficacy of a feed additive consisting of l-tryptophan (produced with Escherichia coliCGMCC 7.460) for all animal species (Kempex Holland B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l-tryptophan produced by fermentation with Escherichia coli CGMCC 7.460 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. The use of l-tryptophan (≥ 98%) produced with E. coli CGMCC 7.460 to supplement feed is safe for non-ruminant species. There may be a risk for an increased production of toxic metabolites when unprotected tryptophan is used in ruminants. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has concerns on the safety of the simultaneous oral administration of l-tryptophan via water for drinking and feed due to possible amino acid imbalances and hygienic reasons. The use of l-tryptophan produced with E. coli CGMCC 7.460 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin or eyes, or on its potential to be a dermal sensitiser. The endotoxin activity of the additive in combination with the high dusting potential may represent a risk of exposure by inhalation to endotoxins for users. The additive l-tryptophan is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. To be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.

Assessment of the feed additive consisting of Levilactobacillus brevis DSM 21982 for all animal species for the renewal of its authorisation (Marigot Ltd T/A Celtic Sea Minerals).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Levilactobacillus brevis DSM 21982 as a technological feed additive, silage additive, for all animal species. 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 all animal species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. No conclusions can be drawn on the eye irritancy potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Enterococcus lactis DSM 22502 for all animal species for the renewal of its authorisation (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Enterococcus lactis DSM 22502 as a technological feed additive for all animal species. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions regarding the safety and efficacy of the additive. The FEEDAP Panel concluded that E. lactis remains safe for all animal species, consumers and environment under the authorised conditions of use. Regarding the user safety, the Panel concluded that the additive is not irritating to the skin or eyes. No conclusions can be drawn on the potential of the additive to cause skin sensitisation, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of endo-1,4-ß-xylanase produced by Komagataella phaffii ATCC PTA-127053 (Xygest™ HT) for all Suidae (Kemin Europa N.V).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-ß-xylanase produced by Komagataella phaffii ATCC PTA-127053 (Xygest™ HT) as a zootechnical feed additive (functional group: digestibility enhancers) for all Suidae at a recommended minimum level of 90,000 U/kg complete feed for pigs in the growing period and 45,000 U/kg complete feed for sows. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that the additive is safe at the minimum recommended use level for all growing Suidae and all sows in the lactating phase. Xygest™ HT was considered safe for the consumers and for the environment when used in feed for all Suidae. The additive was considered not to be irritant to eyes and skin, but was considered as a dermal and respiratory sensitiser. In the absence of sufficient data, the FEEDAP Panel was not in the position to conclude on the efficacy of Xygest™ HT for all Suidae.

Safety and efficacy of a feed additive consisting of fumonisin esterase produced with Komagataella phaffii NCAIM (P) Y001485 for all pigs (piglets, pigs for fattening, sows and minor growing and reproductive porcine species) (Dr. Bata Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the additive based on fumonisin esterase (Free Yeast® F), produced with a genetically modified strain of Komagataella phaffii. The additive is categorised as a technological feed additive, for the reduction of the contamination of feed by mycotoxins and intended for use in all pigs species (piglets, pigs for fattening, sows and minor growing and reproductive porcine species). It was shown that the production strain and its recombinant genes are not present in the additive. The FEEDAP Panel concluded that the additive is safe for weaned and suckling piglets and pigs for fattening, and all minor growing porcine species up to 60 U/kg complete feed. No conclusions can be drawn on the safety of the additive in sows. The use of the additive in animal nutrition is of no concern for consumer safety. The additive is dust-free, and therefore, respiratory sensitisation/irritation is unlikely. The additive is non-irritant to the eyes and the skin. No conclusion could be made on skin sensitisation. The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive is efficacious as technological feed additive for the reduction of feed contamination by fumonisins, when used at the minimum recommended concentration of 60 U/kg. This conclusion can be extrapolated to all growing and reproductive pigs and other minor porcine species.

Safety and efficacy of a feed additive consisting of inactivated selenised yeast (Saccharomyces cerevisiae CCTCC M 2022402) for all animal species (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: 'granules' and 'micro') as a nutritional feed additive for all animal species. Based on a tolerance-efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust-free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium in feedingstuffs for all animal species.

Association of environmental traits with the geographic ranges of ticks (Acari: Ixodidae) of medical and veterinary importance in the western Palearctic. A digital data set.

We compiled information on the distribution of ticks in the western Palearctic (11°W, 45°E; 29°N, 71°N), published during 1970-2010. The literature search was filtered by the tick's species name and an unambiguous reference to the point of capture. Records from some curated collections were included. We focused on tick species of importance to human and animal health, in particular: Ixodes ricinus, Dermacentor marginatus, D. reticulatus, Haemaphysalis punctata, H. sulcata, Hyalomma marginatum, Hy. lusitanicum, Rhipicephalus annulatus, R. bursa, and the R. sanguineus group. A few records of other species (I. canisuga, I. hexagonus, Hy. impeltatum, Hy. anatolicum, Hy. excavatum, Hy. scupense) were also included. A total of 10,280 records was included in the data set. Almost 42 % of published references are not adequately referenced (and not included in the data set), host is reported for only 61 % of records and a reference to time of collection is missed for 84 % of published records. Ixodes ricinus accounted for 44.3 % of total records, with H. marginatum and D. marginatus accounting for 7.1 and 8.1 % of records, respectively. The lack of homogeneity of the references and potential pitfalls in the compilation were addressed to create a digital data set of the records of the ticks. We attached to every record a coherent set of quantitative descriptors for the site of reporting, namely gridded interpolated monthly climate and remotely sensed data on vegetation (NDVI). We also attached categorical descriptors of the habitat: a standard classification of land biomes and an ad hoc classification of the target territory from remotely sensed temperature and NDVI data. A descriptive analysis of the data revealed that a principal components reduction of the environmental (temperature and NDVI) variables described the distribution of the species in the target territory. However, categorical descriptors of the habitat were less effective. We stressed the importance of building reliable collections of ticks with specific references as to collection point, host and date of capture. The data set is freely downloadable.

Safety and efficacy of a feed additive consisting of l-valine produced by Corynebacterium glutamicum CGMCC 18932 for all animal species (Xinjiang Fufeng Biotechnologies Co., Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-valine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (CGMCC 18932). l-Valine is intended to be used in feed and water for drinking as a nutritional additive, functional group amino acids, their salts and analogues, for all animal species and categories. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concluded that l-valine produced by C. glutamicum CGMCC 18932 is considered safe for the target species when supplemented to the diet in appropriate amounts according to the nutritional needs of the target species. The use of l-valine produced using C. glutamicum CGMCC 18932 in animal nutrition is considered safe for the consumer and for the environment. No conclusion could be drawn on the potential of l-valine produced using C. glutamicum CGMCC 18932 to be irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The FEEDAP Panel concluded that the l-valine produced by fermentation using C. glutamicum CGMCC 18932 is an efficacious source of the essential amino acid l-valine for non-ruminant nutrition. To be as efficacious in ruminants as in non-ruminants, supplemental l-valine requires protection against ruminal degradation. The FEEDAP Panel expressed concerns on the use of amino acids in water for drinking for hygienic reasons.

Scientific opinion on the presence of viable cells in a feed additive consisting of lactic acid produced by Weizmannia coagulansDSM 32789 (Jungbunzlauer SA).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on lactic acid produced by fermentation using a strain of Weizmannia coagulans (DSM 32789). The additive is intended to be used as a technological additive, functional group preservatives, in complete feed and water for drinking for all animal species except for fish. In a previous opinion, the FEEDAP Panel concluded that the production strain qualified for the qualified presumption of safety (QPS) approach for safety assessment. Uncertainty remained concerning the possible presence of viable cells and/or spores of the production strain in the final product, however, the presence of viable cells of a QPS strain would not raise safety concerns for the target species, humans, and the environment. The applicant has provided additional information in the form of a scientific report to support the absence of viable cells and/or spores in the final product. Based on the data provided, the FEEDAP Panel concluded that the final product contains no viable cells and/or spores of the production microorganism.

Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 and Lacticaseibacillus rhamnosus DSM 7133 (Provita LE) for calves for rearing 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 the authorisation of the additive Provita LE for calves for rearing, consisting of Enterococcus lactis DSM 7134 (formerly identified as Enterococcus faecium) and Lacticaseibacillus rhamnosus DSM 7133 (formerly identified as Lactobacillus rhamnosus) as a zootechnical feed additive. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The FEEDAP Panel concluded that the use of the feed additive in animal nutrition remains safe for calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. It was not possible to draw conclusions on the skin sensitisation potential of the additive under assessment. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Scientific opinion on the presence of DNA in the feed additives consisting of concentrated liquid l-lysine, l-lysine monohydrochloride and concentrated liquid l-lysine monohydrochloride produced by Escherichia coliNITE BP-02917 for all animal species (METEX NOOVISTAGO).

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 concentrated liquid l-lysine, l-lysine monohydrochloride and concentrated liquid l-lysine monohydrochloride produced by a genetically modified strain of Escherichia coli (NITE BP-02917) as nutritional and as sensory (flavouring compound) feed additives for all animal species. In 2022, the FEEDAP Panel issued an opinion on the safety and efficacy of these products. In that assessment, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the genetically modified production organism in the products. The applicant provided supplementary data to exclude the presence of recombinant DNA derived from the production organism in the final products. Based on the new data provided, the FEEDAP Panel concluded that no DNA of the production strain E. coli NITE BP-02917 was detected in concentrated liquid l-lysine, l-lysine monohydrochloride and concentrated liquid l-lysine monohydrochloride.

Safety and efficacy of a feed additive consisting of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 for all animal species (Kempex Holland B.V.).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B2 (riboflavin) produced by Bacillus subtilis CGMCC 13326 as a nutritional feed additive for all animal species. The additive is produced by a genetically modified production strain. Although the production strain harbours some genes coding for resistance to antimicrobials, viable cells and DNA of the production strain were not detected in the final product. Therefore, the use of B. subtilis CGMCC 13326 to produce vitamin B2 does not raise safety concerns. The use of riboflavin 80% produced by B. subtilis CGMCC 13326 in animal nutrition does not represent a safety concern for the target species, consumers and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential skin and eye irritation or potential toxicity by inhalation of the additive under assessment. Riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The additive under assessment is effective in covering the animals' requirements of vitamin B2 when administered via feed.

Assessment of eight feed additives consisting of Lactiplantibacillus plantarumCNCM I-3235, L. plantarumCNCM I-3736/DSM 11672, Pediococcus acidilacticiCNCM I-3237, P. acidilacticiCNCM I-4622/DSM 11673, Pediococcus pentosaceusNCIMB 12455, Acidipropionibacterium acidipropioniciCNCM I-4661, Lentilactobacillus buchneriNCIMB 40788/CNCM I-4323 and L. buchneriNCIMB 40788/CNCM I-4323 plus Lentilactobacillus hilgardiiCNCM I-4785 for all animal species for the renewal of their authorisation (Danstar Ferment AG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of eight technological additives, including two Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) [CNCM I-3235 and CNCM I-3736/ DSM 11672], two Pediococcus acidilactici [CNCM I-3237 and CNCM I-4622/DSM 11673], one Pediococcus pentosaceus [NCIMB 12455], one Acidipropionibacterium acidipropionici (formerly Propionibacterium acidipropionici) [CNCM I-4661], one Lentilactobacillus buchneri (formerly Lactobacillus buchneri) [NCIMB 40788/ CNCM I-4323], and the additive composed by the two active agents L. buchneri NCIMB 40788/ CNCM I-4323 and Lentilactobacillus hilgardii (formerly Lactobacillus hilgardii) CNCM I-4785, as silage additives for use in forage for all animal species. The applicant has provided evidence that the additives currently on the market comply with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additives remain safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additives should be considered as respiratory sensitisers. In the absence of data, no conclusions could be drawn on the skin sensitisation, and skin and eye irritancy potential of the additives, with the exception for Pediococcus acidilactici CNCM I-4622/DSM 11673 (for which the Panel concluded that is non-irritant to skin and eyes). There is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation.

Efficacy of the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) CECT 8350 and Limosilactobacillus reuteri (formerly Lactobacillus reuteri) CECT 8700 (AQ02) for suckling piglets (Aquilon Cyl S.L.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) CECT 8350 and Limosilactobacillus reuteri (formerly Lactobacillus reuteri) CECT 8700 (AQ02) as a zootechnical feed additive for suckling piglets. In a previous opinion the FEEDAP Panel concluded that the additive is considered safe for the target species, the consumer, and the environment. The Panel concluded that the additive should be considered a respiratory sensitiser but could not conclude on the skin/eye irritation potential or on its skin sensitisation potential. The Panel previously could not conclude on the efficacy of AQ02. The applicant has provided supplementary information to support the efficacy of the additive in suckling piglets. Based on the data provided, the FEEDAP Panel could not conclude on the efficacy of the additive.

Safety and efficacy of a feed additive consisting of endo-ß-1,4-xylanase produced by Komagataella phaffiiCGMCC 7.371 (VTR-xylanase) for all avian species, piglets (suckling and weaned) and minor growing porcine species (Victory Enzymes GmbH).

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 endo-ß-1,4-xylanase (VTR-xylanase) as a zootechnical feed additive for all avian species, piglets (suckling and weaned) and minor growing porcine species. VTR-xylanase is available in a powder and a liquid form and is produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.371). The genetic modification of the production strain does not give rise to safety concerns. Viable cells of the production strain and its DNA were not detected in the final products. The additive does not pose any safety concern regarding the production strain. VTR xylanase (powder/liquid) produced by Komagataella phaffii CGMCC 7.371 is safe for all avian species, piglets and minor growing porcine species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid and powder formulations of VTR-xylanase are non-irritant to eyes but should be considered skin sensitisers. No conclusions can be drawn on the potential of the final formulations of the additive to be irritant to skin. Due to the proteinaceous nature of the active substance, the additive is a respiratory sensitiser. The additive has the potential to be efficacious in all laying birds and piglets (suckling and weaned) from all Suidae at 2,000 U/kg and in all other avian species/categories at 1,000 U/kg feed.

Safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol monohydrate produced with Saccharomyces cerevisiaeCBS 146008 for all ruminants (DSM Nutritional Products Sp. z.o.o.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 25-hydroxycholecalciferol monohydrate produced with Saccharomyces cerevisiae CBS 146008 as a nutritional feed additive for all ruminants. The additive is already authorised for use with chickens for fattening, turkeys for fattening, other poultry and pigs. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not give raise to any safety concern regarding the production strain. The additive is safe for cattle for fattening and dairy cows at the maximum recommended use level of 0.1 mg 25-OH-D3/kg complete feed. This conclusion can be extended to other cattle categories and extrapolated to all ruminant species. The use of 25-OH-D3 in all ruminants under the proposed conditions of use is considered safe for the consumer. The additive is not irritant to the skin or eyes. No conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. The use of the additive under assessment at the recommended conditions of use is considered safe for the environment. 25-OH-D3 is an efficient source of vitamin D3 for all ruminants when used according to the proposed conditions of use.