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1.
EFSA J ; 22(5): e8793, 2024 May.
Article in English | MEDLINE | ID: mdl-38774115

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) as a zootechnical feed additive for suckling and weaned piglets and other growing Suidae. The additive is standardised to contain a concentration of the sum of the four alkaloids sanguinarine, chelerythrine, protopine and allocryptopine of 1.25%, with 0.5% sanguinarine. Owing to the presence of the DNA intercalators sanguinarine and chelerythrine, a concern for genotoxicity was identified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns for the target species when the additive is used at the recommended level of 0.750 mg sanguinarine/kg complete feed for suckling and weaned piglets and other growing Suidae. Since in all consumer categories the exposure to sanguinarine and chelerythrine via the use of Sangrovit® Extra exceeds the threshold of toxicological concern of 0.0025 µg/kg bw per day for DNA reactive mutagens and/or carcinogens, the FEEDAP Panel could not conclude on the safety for the consumers. The additive was shown to be irritant to the eyes but not irritant to skin or a skin sensitiser. The FEEDAP Panel could not exclude the potential of the additive to be a respiratory sensitiser. When handling the additive, exposure of unprotected users to sanguinarine and chelerythrine may occur. Therefore, to reduce the risk, the exposure of users should be reduced. The use of Sangrovit® Extra as a feed additive under the proposed conditions of use was considered safe for the environment. The additive Sangrovit® Extra had the potential to be efficacious in improving performance of weaned piglets at 0.600 mg sanguinarine/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae.

2.
Animals (Basel) ; 14(9)2024 Apr 29.
Article in English | MEDLINE | ID: mdl-38731343

ABSTRACT

Black soldier fly larvae (BSFL) can utilize food by-products or residues for growth, benefiting farm animal's diets' production sustainability. The experiment aimed to assess the effect of different substrate compositions on larval growth, chemical composition, and substrate temperature. BSFL were allocated to one of the four diets (control, vegetable, carnivorous, and omnivorous) for the entire experiment (8 days). The temperature was measured twice daily using a thermal-imaging camera, and the accumulated degree hours (ADH) was calculated. The results showed that the larvae fed the vegetable diet exhibited a significantly reduced growth performance, with a biomass reduction of 26.3% compared to the control diet; furthermore, vegetable-fed larvae showed a lower dry matter content (-30% compared to the average of other diets) due to lower fat content (-65% compared to average of other diets). The nutritional composition of larvae fed an omnivorous diet was similar to larvae fed a high-quality substrate diet (control diet-chicken feed), indicating that the omnivorous diet could be an ideal solution for rearing BSFL larvae; however, the current European legislation prohibits the use of animal meal. The study also revealed that substrate temperatures did not have a discernible influence on larval growth, further emphasizing the importance of diet in BSFL rearing strategies.

3.
EFSA J ; 22(5): e8802, 2024 May.
Article in English | MEDLINE | ID: mdl-38751501

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DSM 34246 as a zootechnical feed additive for dogs and cats. The additive, with the trade name Canobios-BL, is intended for use in feed for cats and dogs at a proposed minimum inclusion level of 5 × 109 CFU/kg complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and the additive is composed by dried cells of the active agent and an emulsifier, that are not expected to introduce any risk, the additive is considered safe for the target species. Canobios-BL is not a skin or eye irritant but should be considered a skin and respiratory sensitiser. Canobios-BL is considered to be efficacious in feedingstuffs for dogs and cats at the use level 5 × 109 CFU/kg complete feed.

4.
EFSA J ; 22(5): e8795, 2024 May.
Article in English | MEDLINE | ID: mdl-38751505

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 efficacy of ROVABIO® ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 as a zootechnical feed additive for weaned piglets at the recommended use level of 1800 U xylanase and 1250 U glucanase per kg feed. In a previous assessment, three long-term trials in weaned piglets were submitted. Two of them were considered to support the efficacy of the additive while a third trial was not further considered due to the large number of veterinary treatments applied. A new trial was provided to support the efficacy of the additive, but it did not show a significant improvement of the performance parameters at the minimum recommended use level. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species.

5.
EFSA J ; 22(3): e8643, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38450084

ABSTRACT

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 Huvezym® neXo 100 G/L, a product containing endo-1,4-ß-xylanase, endo-1,4-ß-glucanase and xyloglucan-specific-endo-ß-1,4-glucanase activities produced by a non-genetically modified strain of Trichoderma citrinoviride (DSM 33578), as a zootechnical additive for all Suidae. The applicant provided information confirming the taxonomic identification of the production strain. The batches used for the characterisation of the final formulations showed compliance with the minimum specifications of the additive in terms of enzyme activities (> 15,000 EPU, > 1000 CU, > 1000 XGU per g) but not for the ratio of the enzymes, which is lower (ca. 7:1:1) than the ones specified (15:1:1). The Panel could not conclude on the representativeness of the test item used in the toxicological and tolerance studies with respect to the final formulations. Therefore, the conclusions are limited to the product with a minimum enzyme activity of 15,000 EPU, 1000 CU, 1000 XGU per g and a xylanase:glucanase:xyloglucanase ratio of 15:1:1. The Panel concluded that the additive is safe for the target species, consumers and the environment. Huvezym® neXo 100 G is not an irritant to the skin and eyes but should be considered a skin sensitiser. Huvezym® neXo 100 L is neither an irritant to the skin and eyes nor a skin sensitiser. Due to the proteinaceous nature of the active substances, the additive is considered a respiratory sensitiser. The additive has the potential to be efficacious in all reproductive Suidae at the minimum proposed use level. Owing to the lack of sufficient data, the Panel could not conclude on the efficacy of the additive for Suidae for fattening or reared for reproduction.

6.
EFSA J ; 22(3): e8614, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38464413

ABSTRACT

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.

7.
EFSA J ; 22(3): e8639, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38440251

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 efficacy of a feed additive consisting of carvacrol (Nimicoat®) as a zootechnical feed additive for weaned piglets at the recommended use level of 250 mg/kg complete feed. In a previous assessment, three efficacy trials and one tolerance-efficacy trial were assessed. Only one of the efficacy trials was considered to support the efficacy at the recommended use level. The applicant provided amendments to two previously submitted studies and a new trial. The amendments to the previously submitted studies did not change the conclusions from the previous assessment. The new efficacy study showed a significant improvement of the zootechnical parameters. Two studies showed positive and significant effects on the performance of the weaned piglets when the additive was administered at 250 mg/kg feed. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species.

8.
EFSA J ; 22(3): e8663, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38469362

ABSTRACT

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 6-phytase produced by the genetically modified strain Aspergillus oryzae DSM 33737 (HiPhorius™ 10, 40, 20L and 50L) as a zootechnical feed additive for all poultry, all Suidae and all fin fish. The FEEDAP Panel concluded that the genetic modification of the production strain does not give rise to safety concerns. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry, all Suidae and all fin fish at the proposed conditions of use. The Panel also concluded that the use of the product as a feed additive is of no concern for the consumers and the environment. The liquid formulations of the additive are not skin or eye irritants. The two solid ones are not skin irritants but are eye irritants. Owing to the lack of data, the Panel cannot conclude on the skin sensitisation of the final formulations of the additive. Due to the proteinaceous nature of the active substance (6-phytase), the additive is considered a respiratory sensitiser. The Panel concludes that the additive is efficacious when included in the diet of poultry for fattening or reared for laying/breeding, reproductive Suidae, and all fin fish. Due to the lack of sufficient data, the Panel could not conclude on the efficacy for laying and reproductive poultry and growing Suidae.

9.
EFSA J ; 21(12): e8454, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38075628

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of benzoic acid (Kalama®) as a zootechnical feed additive for weaned piglets at a level of 5000 mg/kg complete feed and for pigs for fattening at a minimum content of 5000 mg/kg and a maximum content of 10,000 mg/kg complete feed. The FEEDAP Panel concluded that benzoic acid is safe for weaned piglets at 5000 mg/kg complete feed and for pigs for fattening at 10,000 mg/kg complete feed. The Panel considered the use of benzoic acid under the proposed conditions of use to be of no concern for consumer safety and the environment. Benzoic acid poses a risk by inhalation, it is irritant to skin and corrosive to eyes, but no conclusions can be drawn on dermal sensitisation. The additive, benzoic acid, is efficacious as a zootechnical feed additive for weaned piglets and for pigs for fattening at the proposed conditions of use.

10.
EFSA J ; 21(12): e8468, 2023 Dec.
Article in English | MEDLINE | ID: mdl-38099055

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Pediococcus acidilactici CNCM I-4622 as a zootechnical additive (functional group: physiological condition stabilisers) for all insects. The active agent used in the additive is already authorised for use in all animal species as a technological additive, and as a zootechnical additive in all Suidae species for fattening and for breeding, other than sows, all avian species, all fish species and all crustaceans. The active agent has been identified as a strain of P. acidilactici and consequently meets the qualifications required by the qualified presumption of safety (QPS) approach. The use of the additive is considered safe for all insect species, consumers and the environment. The additive is considered non-irritant to skin and eyes but a respiratory sensitiser. No conclusions can be drawn regarding its skin sensitisation potential. In the absence of adequate data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive as a physiological condition stabiliser for honeybees nor for all insect species.

11.
EFSA J ; 21(10): e08340, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37886609

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read-across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed.

12.
Vet Sci ; 10(9)2023 Sep 03.
Article in English | MEDLINE | ID: mdl-37756076

ABSTRACT

The aim of this study was to evaluate the effects of a complete hay-based total mixed ration (TMR) for calves, focusing on their feed intake, animal growth performance, and fecal output, and to develop a preliminary estimation equation for solid feed intake and body weight in Holstein heifer calves. Twenty female Italian Holstein calves (37.14 ± 2.72 kg) born between February and July were studied from the day of birth until 77 days of age. From the fourth day of life, they were fed 3 L/day of pasteurized milk twice daily and supplemented with the same hay-based TMR. The data on feed intake, fecal characteristics, and growth performances were collected and showed that these calves had adequate parameters. Moreover, the data collected was used to create equations to predict body weight and solid feed intake using a mixed model. The goodness of fit of the developed equations was evaluated by coefficients of determinations (R2). The equation obtained shows high R2 (0.98 for solid feed intake and 0.99 for calf weight), indicating the satisfactory precision and accuracy needed to predict female calves' body weight and solid feed intake.

13.
Animals (Basel) ; 13(18)2023 Sep 20.
Article in English | MEDLINE | ID: mdl-37760366

ABSTRACT

We assessed the effects of inhalation administration of lavender essential oil (LEO) either once (L1) or twice (L2) a day on animal welfare indicators, carcass and meat quality of Italian heavy pigs. Pigs (n = 108) were allotted to three experimental groups (control -C-, L1 and L2) and lavender was administered, via a vaporizer device, to the treated groups during the entire fattening-finishing period (79-160 kg BW). Tail lesion severity was reduced in L1 at the end of the trial compared to the other groups (p < 0.05). Body lesion counts, however, were higher in L2 than in C (p < 0.05), resulting in a more severe overall damage classification (p < 0.01). At slaughter, no differences were observed in carcass traits or blood stress indicators, only minor differences were observed in meat quality, and no LEO residual was found in fat or lean tissues, highlighting the preserved suitability of thighs for the dry curing process. While it was not possible to conclude on the ability to improve animal welfare of vaporized LEO in this production phase, the absence of adverse effects on meat quality and the discrepancies observed regarding the body lesions in L1 and L2 make further studies on behavioral aspects and the method of administration (route, frequency) of the product desirable.

14.
EFSA J ; 21(8): e08150, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37539080

ABSTRACT

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.

15.
EFSA J ; 21(6): e07862, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37396874

ABSTRACT

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.

16.
EFSA J ; 21(6): e08050, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37304346

ABSTRACT

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 25-hydroxycholecalciferol (produced by Pseudonocardia autotrophica DSM 32858) for all pigs, all poultry for fattening and ornamental birds and other poultry species. The production strain P. autotrophica DSM 32858 is not genetically modified however, uncertainties remain on the possible presence of its viable cells in the final product. Due to the lack of adequate safety data and uncertainty on the presence of nano particles, the FEEDAP Panel cannot conclude on the safety of the additive for the target species and the consumer. The additive was shown not to be irritant to skin or eyes and it is not a skin sensitiser. Considering the low dusting potential of the additive, the FEEDAP Panel concluded that the exposure through inhalation is unlikely. However, the FEEDAP Panel considered that uncertainties remain on genotoxicity and on the possible presence of viable cells of P. autotrophica DSM 32858 in the final product which might have an impact on the safety for the users. The use of the feed additive is considered safe for the environment. The Panel concluded that the additive has a potential to be efficacious under the proposed conditions of use.

17.
EFSA J ; 21(6): e08045, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37304355

ABSTRACT

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 product containing ß-mannanase produced by a non-genetically modified strain of Aspergillus niger (CBS 120604). The commercial name is Nutrixtend Optim and it is intended to be used as a zootechnical feed additive for all poultry for fattening. Based on a tolerance trial in chickens for fattening and the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the additive was considered safe for all poultry for fattening. The Panel concluded that the use of the product as a feed additive does not give rise to concerns for consumers and the environment. The additive is considered an irritant to skin and eyes and a dermal sensitiser. Due to the proteinaceous nature of the active substance, it is also considered a respiratory sensitiser. The Panel concludes that the additive has the potential to be efficacious as a zootechnical additive at the level of inclusion in feed of chickens for fattening of 30 U ß-mannanase/kg complete feed. This conclusion was extrapolated to all poultry for fattening.

18.
EFSA J ; 21(4): e07964, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37064055

ABSTRACT

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 a dry grape extract (Nor-Grape® α) as a zootechnical feed additive, functional group physiological condition stabilisers - increase antioxidant defences, for all avian species. The additive is already authorised for use as a feed flavouring for all animal species, except dogs. The FEEDAP Panel concluded that the additive is safe for all avian species. The use of the additive in animal nutrition is of no concern for consumer safety. Based on the data submitted, the FEEDAP Panel could not conclude on the potential of the additive to be a skin or eye irritant or a dermal or respiratory sensitiser. However, the Panel considered that exposure through inhalation is likely. The use of the feed additive is considered safe for the environment. The Panel was unable to conclude on the potential of the additive to be efficacious under the proposed conditions of use.

19.
EFSA J ; 21(3): e07879, 2023 Mar.
Article in English | MEDLINE | ID: mdl-37009446

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a pancreatic extract (Pan-zoot) as a zootechnical additive for dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of Pan-Zoot as a feed additive for dogs under the proposed conditions of use. The FEEDAP Panel could not conclude on the skin/eye irritancy potential of the additive or on the dermal sensitisation potential. Owing to its proteinaceous nature, the additive is considered a respiratory sensitiser. The additive may induce allergic reactions to the exposed users. The Panel concluded that there is no need for an environmental risk assessment. The FEEDAP Panel could not conclude on the efficacy of the product as a feed additive at the recommended conditions of use.

20.
EFSA J ; 21(1): e07713, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36698489

ABSTRACT

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 27 compounds to provide a milky-vanilla flavour belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fifteen of the 27 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. No adverse effects were observed in the tolerance studies at 10-fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 15 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 12 compounds, read-across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 12 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer from the use of the 27 compounds up to the highest levels considered safe for target animals. No new data were submitted on the safety for the user that would allow the FEEDAP Panel to change its previous conclusion for 5-methylhept-2-en-4-one [07.139], 5-methylfurfural [13.001] and 4-phenylbut-3-en-2-one [07.024]. The concentrations considered safe for the target species are unlikely to have detrimental effects on the environment for all the compounds.

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