Publications by authors named "Henrik Christensen"

545 Publications

Complications and survival after total pelvic exenteration.

Eur J Surg Oncol 2022 Jan 1. Epub 2022 Jan 1.

Department of Surgery, Aarhus University Hospital, Denmark.

Background: Pelvic exenteration is a procedure with high morbidity despite careful patient selection. This study investigates potential associations between perioperative markers and major postoperative complications including survival.

Methods: Retrospectively collected data for 195 consecutive patients who underwent total pelvic exenteration (January 2015-February 2020) at a single tertiary university hospital were analyzed.

Results: The 30-day mortality was 0.5%, and the rate of major postoperative complications (≥3 Clavien-Dindo) was 34.5%. Low albumin level (p = 0.02) and blood transfusion (p = 0.02) were significantly correlated with a major postoperative complication in univariate analyses. This had no impact on survival. Positive margins (p = 0.003), liver metastasis (p = 0.001) were related to poor survival in multivariate analyses for colorectal patients. A Charlson Comorbidity Index >6 (p < 0.05) was associated with poor survival in all patients.

Conclusion: The occurrence of major postoperative complication does not negatively impact the overall survival. Pelvic exenteration is a potential life-prolonging operation when negative margins can be obtained, despite known risks for complications. Comorbidity is a predictor for inferior outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejso.2021.12.472DOI Listing
January 2022

Safety and efficacy of a feed additive consisting of l-lysine monohydrochloride and l-lysine sulfate produced by CGMCC 14498 for all animal species (Kempex Holland BV).

EFSA J 2021 Dec 17;19(12):e06980. Epub 2021 Dec 17.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-lysine monohydrochloride (l-lysine HCl) and l-lysine sulfate produced by () CGMCC 14498 as a nutritional feed additive for all animal species. The active substance is l-lysine and it is produced in two different forms (monohydrochloride or sulfate). The production strain CGMCC 14498 and its recombinant DNA were not detected in the final products. The products l-lysine HCl and l-lysine sulfate do not pose any safety concern associated with the production strain. l-Lysine HCl and l-lysine sulfate produced by CGMCC 14498 are considered safe for the target species. When using l-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. l-Lysine HCl and l-lysine sulfate produced by CGMCC 14498 are safe for the consumer and the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of l-lysine HCl produced by the strain CGMCC 14498 to be toxic by inhalation, and on the potential of l-lysine HCl and l-lysine sulfate produced by the above-mentioned strain to be irritant to skin or eyes, or on their potential to be dermal sensitisers. l-Lysine HCl and l-lysine sulfate produced by CGMCC 14498 are considered efficacious sources of the essential amino acid l-lysine for non-ruminant animal species. For the supplemental l-lysine to be as efficacious in ruminants as in non-ruminant species, this would require protection against degradation in the rumen.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6980DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8678793PMC
December 2021

Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga).

EFSA J 2021 Dec 17;19(12):e06987. Epub 2021 Dec 17.

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 Allura Red AC for small non-food-producing mammals and ornamental birds when used as an additive that add or restore colour in feedingstuffs. The use of Allura Red AC up to the proposed conditions of use of 500 mg/kg complete feed is considered safe for guinea pig, chinchilla, degu, hamster, gerbil and chipmunk. The following maximum safe levels (mg/kg complete feed) apply to the following species: ferrets 99, rabbits 123, canaries, budgerigars, mynah and toucans 45, lovebirds 51, cockatiels 79, cockatoos 115, amazons 145, parrots 147, yellow breast macaw 150, blue-throated macaw 173 and hyacinth macaw 214. The maximum safe level of Allura Red AC for other small non-food-producing mammal is 99 mg/kg feed and for other ornamental birds is 45 mg/kg feed. Inhalation exposure of Allura Red is regarded as hazardous. In the absence of data, the Panel cannot conclude on the potential of Allura Red to be a skin/eye irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the efficacy of the additive.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6987DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8678712PMC
December 2021

Safety and efficacy of a feed additive consisting of α-galactosidase (produced by ATCC SD6740) and endo-1,4-β-xylanase (produced by CBS 139997) (Capsozyme SB Plus) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying) (Industrial Técnica Pecuaria S.A.).

EFSA J 2021 Dec 13;19(12):e06981. Epub 2021 Dec 13.

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 Capsozyme SB Plus as a zootechnical feed additive (digestibility enhancers) for chickens for fattening, chickens reared for laying and minor poultry species (for fattening and reared for laying). The additive contains two enzyme ingredients (α-galactosidase, produced by a non-genetically modified strain of ; and endo-1,4-β-xylanase, produced by a non-genetically modified strain of ) and is presented in solid form. In 2020, the FEEDAP Panel issued an opinion on this product. In that assessment, the Panel considered the additive safe for the target species and the environment. The Panel concluded that the additive does not raise concern for genotoxicity but could not conclude on consumer safety due to the limitations identified in the 90-day toxicity study. Owing to the lack of data, the Panel could not conclude on the potential of the additive as a skin or eye irritant nor as a skin sensitiser. Moreover, the Panel could not conclude on the efficacy of the additive for chickens for fattening due to the limited evidence provided. The applicant provided supplementary data to support the safety for consumers and the efficacy of the product in chickens for fattening. The FEEDAP Panel concluded that the data provided support the absence of toxicological risk for the consumer. Likewise, according to the new data submitted, the FEEDAP Panel concluded that the additive has the potential to be efficacious in chickens for fattening at the level of 14 GALU (α-galactosidase)/18 AXC (endo-1,4-β-xylanase) per kg feed, and this conclusion was extended to chickens reared for laying and extrapolated to minor poultry species for fattening/reared for laying.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6981DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8666944PMC
December 2021

Safety and efficacy of a feed additive consisting of sodium aluminosilicate, synthetic, for all animal species (European Zeolites Producers Association (EUZEPA) & Association of Synthetic Amorphous Silica Producers (ASASP)).

EFSA J 2021 Dec 15;19(12):e06976. Epub 2021 Dec 15.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of sodium aluminosilicate, synthetic, as a technological feed additive for all animal species. The additive sodium aluminosilicate, synthetic, is proposed to be manufactured in two different forms, amorphous and crystalline, characterised by different ratios among the main components, silica, aluminium and sodium. In the absence of adequate data, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was not in the position to conclude on the safety of the additive sodium aluminosilicate, synthetic, in both the amorphous and crystalline forms, for the target species, the consumer and the user. The use of sodium aluminosilicate, synthetic, as a feed additive was considered safe for the environment. In the absence of appropriate data, the FEEDAP Panel could not conclude on the efficacy of sodium aluminosilicate, synthetic, as a technological additive.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6976DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8672359PMC
December 2021

Safety and efficacy of a feed additive consisting of a tincture from the bark of J. Presl (cinnamon tincture) for use in all animal species (FEFANA asbl).

EFSA J 2021 Dec 9;19(12):e06986. Epub 2021 Dec 9.

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 tincture from the bark of J. Presl (cinnamon tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a water/ethanol ■■■■■ solution, with a dry matter content of approximately 0.9%. The product contains on average 0.344% polyphenols (of which 0.001% are flavonoids) and 0.001% cinnamaldehyde. Methyleugenol was present at the limit of detection in one out of the five batches examined. The FEEDAP Panel concluded that cinnamon tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for all animal species except horses. For horses, the maximum proposed use level of 60 mg/kg complete feed is considered safe. No safety concern would arise for the consumer from the use of cinnamon tincture up to the highest proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the cinnamon tincture as a flavour in animal feed is not expected to pose a risk for the environment. Since and cinnamon bark extracts are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the tincture under application.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6986DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655621PMC
December 2021

Safety and efficacy of a feed additive consisting of monosodium l-glutamate produced by fermentation with KCCM 80187 for all animal species (CJ Europe GmbH).

EFSA J 2021 Dec 9;19(12):e06982. Epub 2021 Dec 9.

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 monosodium l-glutamate monohydrate produced by fermentation using KCCM 80187 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The production strain is genetically modified and viable cells of the production strain, and its DNA were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. Monosodium l-glutamate monohydrate produced using KCCM 80187 is considered safe for the target species, for the consumer and for the environment. Moreover, it is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. The FEEDAP Panel expressed reservations on the use of the additive in water for drinking due to concerns on its impact on the hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6982DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655623PMC
December 2021

Safety and efficacy of the feed additive consisting of selenium-enriched yeast ( CNCM I-3060) for all animal species (Alltech Ireland).

EFSA J 2021 Dec 9;19(12):e06979. Epub 2021 Dec 9.

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 selenium-enriched yeast ( CNCM I-3060) 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 as selenomethionine produced by CNCM I-3060 as a nutritional additive (compound of trace elements) with a minimum selenium content of 2,000 mg/kg. The applicant proposed the inclusion of an additional formulation with a minimum content of selenium in the additive of 3,000 mg/kg. Considering (i) that the main changes in the manufacturing of the product compared to the former application involve the drying phase (spray-drying vs drum drying), which has led to slightly different values of the dusting potential and particle size, and (ii) the conditions of use already authorised, the FEEDAP Panel stated that the modification requested would only affect the safety for the target animals and the users, without impacting the safety for the consumers, safety for the environment or the efficacy of the additive. The FEEDAP Panel concluded that there are no concerns for the safety of the target animals based on its previous assessment and an additional study on homogeneity of the additive. The additive is hazardous by inhalation, is not irritant for the eyes, skin and is not a dermal sensitiser.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6979DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655508PMC
December 2021

Safety and efficacy of a feed additive consisting of l-isoleucine produced by KCCM 80185 for all animal species (CJ Europe GmbH).

EFSA J 2021 Dec 9;19(12):e06977. Epub 2021 Dec 9.

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 a feed additive consisting of l-isoleucine produced by KCCM 80185 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is genetically modified, does not carry acquired antimicrobial resistance genes and no viable cells of the production strain were detected in the final product. The FEEDAP Panel could not exclude the presence of recombinant DNA from the production strain in the product. However, since no sequences of concern remain in the final production strain, the potential presence of recombinant DNA in the final product does not raise any safety concerns. The Panel concluded that the additive is safe for the target species, for the consumer and for the environment under the proposed conditions of use. Regarding the use in water, the FEEDAP Panel reiterated its concerns over the safety of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. The FEEDAP Panel concluded that l-isoleucine produced by KCCM 80185 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. However, due to the high dusting potential, exposure to dust might be a hazard for the user. l-Isoleucine produced by KCCM 80185 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.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6977DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8655626PMC
December 2021

Assessment of a feed additive consisting of all-rac-alpha-tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (Jilin Beisha Pharmaceutical Co., Ltd).

EFSA J 2021 Dec 3;19(12):e06974. Epub 2021 Dec 3.

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 assessment of the application for renewal of authorisation of all-rac-alpha-tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all-rac-alpha-tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all-rac-alpha-tocopheryl acetate in the context of the renewal of the authorisation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6974DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8640925PMC
December 2021

Postoperative MRI Findings Following Conventional and Extralevator Abdominoperineal Excision in Low Rectal Cancer.

Front Surg 2021 16;8:771107. Epub 2021 Nov 16.

Department of Radiology, Aarhus University Hospital, Aarhus, Denmark.

The disparity in outcomes for low rectal cancer may reflect differences in operative approach and quality. The extralevator abdominoperineal excision (ELAPE) was developed to reduce margin involvement in low rectal cancers by widening the excision of the conventional abdominoperineal excision (c-APE) to include the posterior pelvic diaphragm. This study aimed to determine the prevalence and localization of inadvertent residual pelvic diaphragm on postoperative MRI after intended ELAPE and c-APE. A total of 147 patients treated with c-APE or ELAPE for rectal cancer were included. Postoperative MRI was performed on 51% of the cohort ( = 75) and evaluated with regard to the residual pelvic diaphragm by a radiologist trained in pelvic MRI. Patient records, histopathological reports, and standardized photographs were assessed. Pathology and MRI findings were evaluated independently in a blinded fashion. Additionally, preoperative MRIs were evaluated for possible risk factors for margin involvement. Magnetic resonance imaging-detected residual pelvic diaphragm was identified in 45 (75.4%) of 61 patients who underwent ELAPE and in 14 (100%) of 14 patients who underwent c-APE. An increased risk of margin involvement was observed in anteriorly oriented tumors with 16 (22%) of 73 anteriorly oriented tumors presenting with margin involvement vs. 7 (9%) of 74 non-anteriorly oriented tumors ( = 0.038). Residual pelvic diaphragm following abdominoperineal excision can be depicted by postoperative MRI. Inadvertent residual pelvic diaphragm (RPD) was commonly found in the series of patients treated with the ELAPE technique. Anterior tumor orientation was a risk factor for circumferential resection margin (CRM) involvement regardless of surgical approach.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3389/fsurg.2021.771107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8635027PMC
November 2021

Safety and efficacy of a feed additive consisting of strains CNCM I-4606, CNCM I-5043 and CNCM I-4607 and  CNCM I-4609 for all animal species (Nolivade).

EFSA J 2021 Nov 19;19(11):e06907. Epub 2021 Nov 19.

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 preparation of CNCM I-4606, CNCM I-5043, CNCM I-4607 and CNCM I-4609 when used as a technological additive (hygiene condition enhancer) for all animal species. The product is intended for use in compound feeds and feed materials for all animal species at a minimum inclusion level of 1 × 10 CFU and 1 × 10 CFU per kg or litre. The two bacterial species are considered by EFSA to be eligible for the qualified presumption of safety (QPS) approach. As the identity of the strains has been clearly established and they did not show acquired resistance to antibiotics of human and veterinary importance, the use of these strains in animal nutrition is considered safe for the target species, consumers and the environment. The additive is not irritant to skin and eyes or a skin sensitiser. Given the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of the additive to significantly reduce the growth of either Typhimurium or in feed.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6907DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8603003PMC
November 2021

Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd).

EFSA J 2021 Nov 19;19(11):e06905. Epub 2021 Nov 19.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bovaer 10 as a zootechnical additive for ruminants for milk production and reproduction. Systemic exposure or site of contact toxicity for the active substance 3-nitrooxypropanol (3-NOP), for which genotoxicity has not been fully clarified, in the target species, is unlikely based on ADME data available. Consequently, the FEEDAP Panel concluded that Bovaer 10 was safe for dairy cows at the maximum recommended level. However, as a margin of safety could not be established, the FEEDAP Panel could not conclude on the safety of the additive for other animal species/categories. The FEEDAP Panel considered that the consumer was exposed to 3-nitrooxypropionic acid (NOPA), which is one of the 3-NOP metabolites. NOPA was not genotoxic based on the studies provided. The FEEDAP Panel concluded that the use of Bovaer 10 in animal nutrition under the conditions of use proposed was of no concern for consumer safety and for the environment. The FEEDAP Panel concluded that the active substance 3-NOP may be harmful if inhaled. It is irritant (but not corrosive) to skin, irritant to the eyes but it is not a skin sensitiser. As the genotoxicity of 3-NOP is not completely elucidated, the exposure through inhalation of the additive may represent an additional risk for the user. The Panel concluded that the additive has a potential to be efficacious in dairy cows to reduce enteric methane production under the proposed conditions of use. This conclusion was extrapolated to all other ruminants for milk production and reproduction.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8603004PMC
November 2021

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).

EFSA J 2021 Nov 19;19(11):e06891. Epub 2021 Nov 19.

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. However, in target species fed citrus by-products as part of daily feed, the use of the expressed orange oil and its fractions was not expected to increase the exposure to perillaldehyde to a relevant extent (< 10%). For dogs, cats, ornamental fish and ornamental birds not normally exposed to citrus by-products, no conclusion can be drawn. For the other species, the FEEDAP Panel concluded that the additives under assessment are safe at the maximum proposed use levels in complete feed. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additives up to the maximum proposed use level in feed. The additives under assessment should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. The use of the additives under the proposed conditions of use in animal feed was not expected to pose a risk for the environment. Expressed orange oil and its fractions were recognised to flavour food. Since their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6891DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8603005PMC
November 2021

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).

EFSA J 2021 Nov 8;19(11):e06906. Epub 2021 Nov 8.

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). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6906DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573526PMC
November 2021

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.).

EFSA J 2021 Nov 8;19(11):e06903. Epub 2021 Nov 8.

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. The FEEDAP Panel concluded that the active agent of Calsporin should be taxonomically designated as DSM 15544. The Panel also concluded that Calsporin is presumed safe for the target species, consumers and the environment. Calsporin is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Calsporin when supplemented at 3 × 10 CFU/kg complete feed has the potential to be efficacious in all avian species for rearing, fattening, laying and breeding purposes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6903DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573525PMC
November 2021

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

EFSA J 2021 Nov 8;19(11):e06902. Epub 2021 Nov 8.

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. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety DSM 16245 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6902DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573527PMC
November 2021

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).

EFSA J 2021 Nov 8;19(11):e06901. Epub 2021 Nov 8.

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. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered a skin and respiratory sensitiser. No conclusions could be drawn on the eye and skin irritancy potential of the additive. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573531PMC
November 2021

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).

EFSA J 2021 Nov 8;19(11):e06900. Epub 2021 Nov 8.

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. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, DSM 12835 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6900DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573530PMC
November 2021

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).

EFSA J 2021 Nov 8;19(11):e06899. Epub 2021 Nov 8.

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. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Protural is safe under the current conditions of authorisation for the target species, consumers of products from animals fed the additive and the environment. Protural was not considered as irritant to skin and eyes but a skin sensitiser. Based on dusting potential data, the FEEDAP Panel considered that the powder formulation of the additive represented a risk by inhalation. There was no need for assessing the efficacy of Protural in the context of the renewal of the authorisation for weaned piglets. The efficacy data previously evaluated allowed the FEEDAP Panel to conclude that the additive has the potential to be efficacious at the level of 4,000 mg/kg feedingstuff in other growing Suidae. A conclusion cannot be reached for the efficacy in pigs for fattening.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6899DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573538PMC
November 2021

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

EFSA J 2021 Nov 5;19(11):e06894. Epub 2021 Nov 5.

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%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/2330. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust, it is not possible to make the assessment of the exposure by inhalation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6894DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8569693PMC
November 2021

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).

EFSA J 2021 Nov 8;19(11):e06893. Epub 2021 Nov 8.

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. No concerns for consumers were identified following the use of lemon extract up to the highest safe level in feed. The additive should be considered a skin and eye irritant, and a potential corrosive. The use of the extract in animal feed under the proposed conditions was not expected to pose a risk for the environment. Lemon extract was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8573541PMC
November 2021

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

EFSA J 2021 Oct 29;19(10):e06904. Epub 2021 Oct 29.

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. In a previous assessment, considering the contradictory data from the Ames tests and uncertainty about the qualitative and quantitative presence of flavonoids and other compounds in the extract from L. leaves, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the additive at the proposed use levels of up to 100 mg/kg complete feed for the target species, the consumer and the user. The new data submitted identified luteolin 3'-glucuronide as the only flavonoid present in the additive, improved the characterisation of the hydroxycinnamates present and demonstrated that the additive is not genotoxic. The FEEDAP Panel concludes that the additive under assessment is safe up to the maximum proposed use level of 100 mg/kg complete feed for all animal species. The use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No safety concern would arise for the consumer from the use of the additive up to the highest safe level in animal nutrition. The exposure of users to dusts from the additive is not of concern. No data are provided on irritant properties for eyes or skin, thus no conclusion can be drawn on these aspects. Due to the nature of the additive, it may be assumed to be potentially both a skin and respiratory sensitiser.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6904DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8554654PMC
October 2021

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

EFSA J 2021 Oct 28;19(10):e06898. Epub 2021 Oct 28.

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. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers and for the environment. The additive is not irritant to skin or eyes and is not a skin sensitiser but should be considered a potential respiratory sensitiser. The FEEDAP Panel concluded that the addition of DSM 26571 at a minimum concentration of 1 × 10 CFU/kg may improve the production of silage from easy, moderately difficult and difficult to ensile forage material.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6898DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8552088PMC
October 2021

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

EFSA J 2021 Oct 29;19(10):e06897. Epub 2021 Oct 29.

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%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2016/1095. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6897DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8554653PMC
October 2021

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.).

EFSA J 2021 Oct 29;19(10):e06896. Epub 2021 Oct 29.

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%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2018/1039. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6896DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8554661PMC
October 2021

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

EFSA J 2021 Oct 29;19(10):e06895. Epub 2021 Oct 29.

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%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/1490. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6895DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8554659PMC
October 2021

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

EFSA J 2021 Oct 29;19(10):e06892. Epub 2021 Oct 29.

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. The additive is considered skin and eye irritant and a skin sensitiser. Exposure via inhalation is unlikely. The additive is an effective antioxidant in feedingstuffs and feed material for all animal species at the proposed conditions of use.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2903/j.efsa.2021.6892DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8555381PMC
October 2021

Prediction of Mannheimia haemolytica serotypes based on whole genomic sequences.

Vet Microbiol 2021 Nov 6;262:109232. Epub 2021 Sep 6.

Department of Veterinary and Animal Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Fredriksberg C, Denmark.

The aim of the investigation was to predict the serotypes of M. haemolytica based on whole genomic sequences with the capsular gene region as target. A total of 22 strains selected to have been serotyped and to represent all serotypes were investigated by whole genomic sequencing. The BIGSdb (Bacterial Isolate Genome Sequence Database) was downloaded and installed on a Linux server. Here the sequence database was setup with unique loci at serotype level. The server allows serotypes of M. haemolytica to be predicted from whole genomic sequences and the service is available to the public for free from https://ivsmlst.sund.root.ku.dk.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.vetmic.2021.109232DOI Listing
November 2021
-->