Publications by authors named "Fernando Ramos"

588 Publications

Efficacy and landscape of Covid-19 vaccines: a review article.

Rev Assoc Med Bras (1992) 2021 Jan;67(3):474-478

Centro Universitário Cesmac - Maceió (AL), Brazil.

Introduction: The rapid advance of Coronavirus disease 2019 (Covid-19) has led to the incessant search for therapeutic and prophylactic measures to fight the pandemic. Because it is a viral infection, the safest long-term prophylactic form, in addition to social distance and hygiene, is the vaccine.

Objective: Thus, this study aimed at conducting a review of the efficacy and landscape of Covid-19 vaccines.

Methods: The following electronic databases were used MEDLINE via PubMed, SCIELO, LILACS, NEJM, and Clinical Trials. Our study includes the 7 vaccines (phase 3) that reported an efficacy rate for Covid-19, including characteristics inherent to each one of them.

Results: Preliminary studies have shown that, although an efficacy ≥70% is necessary to eliminate the infection, a prophylactic vaccine with efficacy <70% will still have an important impact and can contribute to the elimination of the virus, provided that appropriate measures of social distancing remain.

Conclusions: The effectiveness of the vaccines obtained in this study varied between 50.38 and 95%, data that may represent a reduction in serious cases, hospitalizations, sequels, and deaths caused by Covid-19, respecting the panorama presented in this article.
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http://dx.doi.org/10.1590/1806-9282.20210073DOI Listing
January 2021

Food Safety, Security, Sustainability and Nutrition as Priority Objectives of the Food Sector.

Int J Environ Res Public Health 2021 07 30;18(15). Epub 2021 Jul 30.

Department of Animal Pathology and Production, Bromatology and Food Technology, Faculty of Veterinary, Universidad de Las Palmas de Gran Canaria, Trasmontaña s/n, 35413 Arucas, Spain.

Food systems are at the center of global environmental, social, and economic challenges such as resource scarcity, ecosystem degradation, and climate change [...].
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http://dx.doi.org/10.3390/ijerph18158073DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8345497PMC
July 2021

The Role of Food Supplementation in Microcirculation-A Comprehensive Review.

Biology (Basel) 2021 Jul 2;10(7). Epub 2021 Jul 2.

Research Institute for Medicines (iMed.ULisboa), Faculdade de Farmácia, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-003 Lisbon, Portugal.

(1) Background: Cardiovascular disease (CVD) is a major public health concern worldwide and a key cause of morbidity and mortality in developed countries. Accumulating evidence shows that several CVD forms are characterized by significant microcirculatory dysfunction, which may both cause and be caused by macrovascular disease, often preceding clinical manifestations by several years. Therefore, interest in exploring food supplements to prevent and restore microcirculation has grown. Given the continuous need to expand the available therapeutic arsenal for CVD, the food supplements market has recently grown and is expected to continue growing. (2) Methods: We provide an authoritative up-to-date comprehensive review of the impact of food supplementation on microcirculation by analyzing the European and American legal food supplements framework and the importance of food safety/food quality in this industry. We review the main literature about food bioactive compounds with a focus on microcirculation and some main food supplements with proven benefits. (3) Results: Despite a lack of scientific evidence, diet and microcirculatory function are clearly connected. The main food supplement examples in the literature with potential beneficial effects on microcirculation are: L., L., L., Bunge, spp., Ginseng, L., L., L., and L. (4) Conclusions: Further clinical trials are necessary to better explore the effects of these food supplements.
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http://dx.doi.org/10.3390/biology10070616DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8301032PMC
July 2021

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

EFSA J 2021 Jul 29;19(7):e06715. Epub 2021 Jul 29.

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the environment of the coccidiostat Coxar (nicarbazin) when used in feed for turkeys for fattening. In previous assessments, the FEEDAP Panel could not conclude on the safety of Coxar for the environment due to concerns on 4,40-dinitrocarbanilide (DNC, one of the moieties of nicarbazin). On the basis of the new data provided, the FEEDAP Panel updates its previous conclusions on the safety of Coxar for the environment as follows: The use of nicarbazin from Coxar in complete feed for turkeys does not pose a risk for the terrestrial and aquatic compartment and in sediment. No concern for groundwater is expected. The bioaccumulation potential of nicarbazin in the environment is low.
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http://dx.doi.org/10.2903/j.efsa.2021.6715DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8319813PMC
July 2021

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

EFSA J 2021 Jul 30;19(7):e06710. Epub 2021 Jul 30.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on xanthan gum as a feed additive for all animal species. Xanthan gum is manufactured using different production strains belonging to the species. The identity of the strains producing xanthan gum was not unambiguously established, data on antimicrobial susceptibility were incomplete, and it was not possible to exclude the presence in the additive of viable cells/DNA of the production strains. Consequently, no conclusions could be drawn on the safety of the strains ■■■■■. Considering the above and in the absence of adequate information on the additive under assessment, the FEEDAP Panel cannot conclude on the safety of xanthan gum produced by the strains ■■■■■ for the target species, the consumer, the user and the environment. Xanthan gum is considered as an efficacious stabiliser and thickener in feedingstuffs for all animal species at the proposed conditions of use.
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http://dx.doi.org/10.2903/j.efsa.2021.6710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323031PMC
July 2021

Halophytes as source of bioactive phenolic compounds and their potential applications.

Crit Rev Food Sci Nutr 2021 Aug 2:1-24. Epub 2021 Aug 2.

Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.

Halophytes are salt-tolerant plants that inhabit environments in which they are exposed to extreme stress, wherefore they exhibit conserved and divergent metabolic responses different from those of conventional plants. Thus, the synthesis and accumulation of metabolites, especially of those oxidative stress-related such as phenolic compounds, should be investigated. The potential of halophytes as a source of phenolics and their prospective industrial applications are evaluated based on a comprehensive review of the scientific literature on the phenolic compounds of more than forty halophytes and their biological activities. Additionally, an overview of the analytical methodologies adopted for phenolics determination in halophytes is provided. Finally, the prospective uses and beneficial effects of the phenolic preparations from these plants are discussed. Halophytes are complex matrices, exhibiting a wide variety of phenolics in their composition, wherefore the results can be greatly affected depending on the organ plant under analysis and the extraction methodology, especially the extraction solvent used. High-performance liquid chromatography, coupled with diode array detection (HPLC-DAD) or mass spectrometry (HPLC-MS), are the most used technique. Halophytes biosynthesize phenolics in concentrations that justify the remarkable antioxidant and antimicrobial activities shown, making them ideal sources of bioactive molecules to be employed in a multitude of sectors.
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http://dx.doi.org/10.1080/10408398.2021.1959295DOI Listing
August 2021

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

EFSA J 2021 Jul 28;19(7):e06711. Epub 2021 Jul 28.

The tincture derived from L. (great mullein tincture) is intended to be used as a sensory additive in feed for all animal species. The product is a water/ethanol solution, with a dry matter content of ˜ 2.8% and contains on average 0.216% polyphenols including 0.093% flavonoids. According to a previous assessment, the additive was not characterised in full and about 82% of the dry matter fraction remained uncharacterised (representing 2.26% of the tincture). There was also uncertainty on the potential presence of iridoid glycosides in the tincture. Therefore, 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 50 g/kg complete feed for all animal species or for the consumer. The applicant has provided new data which show that the unidentified fraction consists of crude fibre, other carbohydrates, and protein. The tincture also contains aucubin (0.004%). Considering the genotoxic potential of aucubin and other related iridoids, no conclusions can be drawn for long-living animals (pets and other non-food producing animals, horses and animals for reproduction). For short-living animals (animals for fattening), the FEEDAP Panel concludes that the tincture is safe at the maximum proposed use level of 50 mg/kg complete feed and 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 safety concerns would arise for the consumer from the use of the tincture up to the highest safe level in animal nutrition. In the absence of data, no conclusions can be drawn on the potential of the tincture to be a dermal/eye irritant or a skin sensitiser.
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http://dx.doi.org/10.2903/j.efsa.2021.6711DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317052PMC
July 2021

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

EFSA J 2021 Jul 27;19(7):e06709. Epub 2021 Jul 27.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a dried flavonoid-rich extract of  ×  L. fruit (bitter orange extract), when used as a sensory additive for all animal species. The use of the additive in feed was not expected to increase the exposure to furocoumarins of those target species that are already fed citrus by-products to a relevant extent (< 5%). For dog, cat and ornamental fish, not normally exposed to citrus by-products, no conclusion could be drawn. The FEEDAP Panel concluded that the additive under assessment is safe up to the maximum proposed use level of 400 mg/kg for veal calf (milk replacer), sheep, goat, horse and salmon. For the other species, the calculated maximum safe concentration in complete feed is 102 mg/kg for chicken for fattening, 151 mg/kg for laying hen, 136 mg/kg for turkey for fattening, 182 mg/kg for piglet, 217 mg/kg for pig for fattening, 268 mg/kg for sow, 259 mg/kg for dairy cow and 161 mg/kg for rabbit. 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, except dog, cat and ornamental fish. No concerns for consumer safety were identified following the use of the additive up to highest safe level in feed for the target animals. The extract under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. Since the additive contains 5-methoxypsoralen, it may cause phototoxicity. The use of the extract in animal feed under the proposed conditions was not expected to pose a risk for the environment. Bitter orange 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.
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http://dx.doi.org/10.2903/j.efsa.2021.6709DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314171PMC
July 2021

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

EFSA J 2021 Jul 27;19(7):e06704. Epub 2021 Jul 27.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of (formerly ) IMI 507027 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no 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. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 10 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.
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http://dx.doi.org/10.2903/j.efsa.2021.6704DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314169PMC
July 2021

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

EFSA J 2021 Jul 23;19(7):e06706. Epub 2021 Jul 23.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-lysine sulfate produced by KCCM 80227 as a nutritional feed additive for all animal species. The FEEDAP Panel concluded that the production strain KCCM 80227 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and is not detected in the final product. l-Lysine sulfate produced using KCCM 80227 does not pose any safety concern associated with the production strain. The additive under assessment is 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 sulfate produced by KCCM 80227 is safe for the consumers, users and for the environment. The additive l-lysine sulfate is considered as an efficacious source 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, it would require protection against degradation in the rumen.
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http://dx.doi.org/10.2903/j.efsa.2021.6706DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299270PMC
July 2021

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

EFSA J 2021 Jul 22;19(7):e06705. Epub 2021 Jul 22.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of (formerly ) IMI 507028 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no 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. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 10 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.
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http://dx.doi.org/10.2903/j.efsa.2021.6705DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295889PMC
July 2021

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

EFSA J 2021 Jul 22;19(7):e06702. Epub 2021 Jul 22.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of IMI 507025 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by the European Food Safety Authority to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no 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. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 10 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.
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http://dx.doi.org/10.2903/j.efsa.2021.6702DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295885PMC
July 2021

Safety and efficacy of a feed additive consisting of IMI 507024 for all animal species (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland]).

EFSA J 2021 Jul 22;19(7):e06701. Epub 2021 Jul 22.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of IMI 507024 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no 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. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 10 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.
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http://dx.doi.org/10.2903/j.efsa.2021.6701DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295888PMC
July 2021

Safety and efficacy of a feed additive consisting of (formerly ) IMI 507023 for all animal species (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland]).

EFSA J 2021 Jul 23;19(7):e06700. Epub 2021 Jul 23.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of (formerly ) IMI 507023 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony-forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been 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. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 10 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.
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http://dx.doi.org/10.2903/j.efsa.2021.6700DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299352PMC
July 2021

Safety and efficacy of a feed additive consisting of MUCL 39885 (Biosprint) for cats and dogs (Prosol S.p.A.).

EFSA J 2021 Jul 22;19(7):e06699. Epub 2021 Jul 22.

The additive Biosprint contains viable cells of MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to cats and dogs at a minimum inclusion level of 7 × 10 CFU/kg of complete feed. is considered by EFSA to have qualified presumption of safety status and consequently is considered safe for the target species. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. Based on the results on efficacy studies provided, the FEEDAP Panel concludes that Biosprint is efficacious when used in feeds for dogs. However, the FEEDAP Panel considered that the biological relevance of the magnitude of the effect detected is questionable. Based on the trial available, the FEEDAP Panel was unable to conclude on the efficacy of the additive when administered to cats.
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http://dx.doi.org/10.2903/j.efsa.2021.6699DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295886PMC
July 2021

Safety and efficacy of a feed additive consisting of MUCL 39885 (Biosprint) for all pigs (other than sows and weaned piglets) and other minor porcine species (Prosol S.p.A.).

EFSA J 2021 Jul 21;19(7):e06698. Epub 2021 Jul 21.

The additive Biosprint contains viable cells of MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to all pigs (other than sows and weaned piglets) and other minor porcine species at a minimum inclusion level of 3 × 10 CFU/kg feed. is considered by EFSA to have qualified presumption of safety (QPS) status and consequently is considered safe for the target species, the consumers and the environment. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. In previous evaluations, the FEEDAP Panel concluded that the additive is efficacious in sows and weaned piglets. In the current application, these conclusions are extrapolated to all pigs (other than sows and weaned piglets) and to other minor porcine species.
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http://dx.doi.org/10.2903/j.efsa.2021.6698DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8295240PMC
July 2021

Safety and efficacy of a feed additive consisting of butylated hydroxyanisole (BHA) for use in cats (FEDIAF).

EFSA J 2021 Jul 20;19(7):e06714. Epub 2021 Jul 20.

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 butylated hydroxy anisole (BHA) when used as a technological additive (antioxidant) in feed for cats. BHA is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3--butyl-4-hydroxyanisole and 2--butyl-4-hydroxyanisole and is currently authorised for use in all animal species except in cats. In support of the safety of the additive for the target species, the applicant has submitted a tolerance study which demonstrated that BHA is tolerated by cats at a concentration up to 150 mg/kg complete feed. The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation was considered unlikely; therefore, a risk is not expected. BHA is authorised as an antioxidant for food use at comparable use levels; therefore, no studies were required to demonstrate the efficacy of BHA as an antioxidant in complete feed for cats.
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http://dx.doi.org/10.2903/j.efsa.2021.6714DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8290245PMC
July 2021

Assessment of the feed additive consisting of  DSM 12834 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

EFSA J 2021 Jul 19;19(7):e06713. Epub 2021 Jul 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 assessment of the application for renewal of the authorisation of  DSM 12834 as a technological additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety  DSM 12834 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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http://dx.doi.org/10.2903/j.efsa.2021.6713DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287481PMC
July 2021

Safety and efficacy of a feed additive consisting of (formerly ) IMI 507026 for all animal species (ALL-TECHNOLOGY (IRELAND) LIMITED [Alltech Ireland]).

EFSA J 2021 Jul 19;19(7):e06703. Epub 2021 Jul 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 safety and efficacy of (formerly ) IMI 507026 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 10 colony forming units (CFU)/kg fresh material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach. As the identity of the strain has been established and no 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. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or a skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The additive at the proposed application rate of 1 × 10 CFU/kg fresh material has the potential to improve the fermentation of the silages from easy to moderately difficult to ensile forages.
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http://dx.doi.org/10.2903/j.efsa.2021.6703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287479PMC
July 2021

Assessment of the feed additive consisting of  DSM 16243 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co.KG).

EFSA J 2021 Jul 19;19(7):e06697. Epub 2021 Jul 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 assessment of the application for renewal of authorisation of  DSM 16243 as a technological additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety  DSM 16243 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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http://dx.doi.org/10.2903/j.efsa.2021.6697DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287480PMC
July 2021

Assessment of the feed additive consisting of (formerly ) DSM 16774 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co.KG).

EFSA J 2021 Jul 9;19(7):e06696. Epub 2021 Jul 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 assessment of the application for renewal of authorisation of (formerly ) DSM 16774 as a technological additive to improve ensiling of forage for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety DSM 16774 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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http://dx.doi.org/10.2903/j.efsa.2021.6696DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8267826PMC
July 2021

Plasmid-Encoded AmpC and Extended-Spectrum Beta-Lactamases in Multidrug-Resistant Isolated from Piglets in Portugal.

Microb Drug Resist 2021 Jun 29. Epub 2021 Jun 29.

Univ Coimbra, CIMAGO, Coimbra, Portugal.

Considering the concept of "One Health," the aim of this study was to determine susceptibility profiles of in piglets' intestinal microbiota from different farms in Portugal. Beyond antimicrobial susceptibility, the occurrence of multiple antibiotic resistance and detection of phenotypic/genotypic extended-spectrum beta-lactamases (ESBLs) and plasmid mediated AmpC beta-lactamases (pAmpC) were done. From 10 different pig farms, 340 isolates were obtained from 75 feces samples. Susceptibility to amoxicillin-clavulanic acid (AMC), piperacillin (PIP), cefoxitin (FOX), ceftazidime (CAZ), cefepime (FEP), aztreonam (AZT), imipenem (IP), amikacin (AK), ciprofloxacin (CIP), and trimethoprim-sulfamethoxazole (SXT) was determined. Five-gene panel for amplification of genes was used for ESBL (TEM, SHV, CTX-M) and pAmpC (CMY-2, ACC). Among isolates, 209 were distributed in three resistance profiles: 57.7% MDR, 3.5% extensively drug-resistance (XDR) (resistant to CIP, SXT, and beta-lactams, except IP, with variability to AK) and 0.3% pandrug-resistance (PDR) (resistant to all antibiotics used). pAmpC and/or ESBLs genes were presented in 65% of the isolates. Presence of different associations of genes in the same isolate was the most observed (31%), and the most common were an ESBL (TEM) and a pAmpC (CMY-2). Presence of three or four genes in various associations were detected. These isolates were very resistant, especially those with four genes, which were resistant to beta-lactams (except IP), CIP, and SXT. This study showed a surprisingly high rate of MDR isolated in Portuguese piglets, with enzymes that impair activity of the most used antibiotics in human therapeutic.
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http://dx.doi.org/10.1089/mdr.2020.0387DOI Listing
June 2021

Safety and efficacy of a feed additive consisting of titanium dioxide for all animal species (Titanium Dioxide Manufacturers Association).

EFSA J 2021 Jun 16;19(6):e06630. Epub 2021 Jun 16.

Following a request from the European Commission, the EFSA was asked to deliver a scientific opinion on the safety and efficacy of titanium dioxide (TiO) for all animal species. TiO is applied to be used as a sensory additive (functional group: colourants; i) substances that add or restore colour in feedingstuffs). The specification for TiO used as feed additive meets the specifications of TiO used as food additive. The EFSA Panel on Food Additive and Flavourings (FAF) concluded that TiO (E171) can no longer be considered as safe when used as a food additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) endorses this conclusion and considers that it also applies to TiO as a feed additive for all animal species. TiO is absorbed to a low extent; however, particles of TiO can accumulate in the body due to their long half-life. The genotoxicity of TiO particles cannot be ruled out raising potential concerns on the safety of the additive for the target species (especially for long-living animals and reproductive animals), consumers and user. Considering this fact and the absence of specific data related to its use as a feed additive, the Panel cannot conclude on the safety of TiO for the target species, consumers and environment. In the absence of studies with the additive under assessment, the Panel cannot conclude on the assessment of the effects of the additive on eyes and skin. TiO is potentially carcinogenic to workers if inhaled. The concern for genotoxicity of TiO particles cannot be ruled out, this should be considered as an additional potential concern to users handling the additive. TiO is efficacious in colouring the food for cats and dogs at a minimum content of 1%.
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http://dx.doi.org/10.2903/j.efsa.2021.6630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207357PMC
June 2021

Assessment of the feed additive consisting of (formerly ) DSM 12836 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

EFSA J 2021 Jun 14;19(6):e06626. Epub 2021 Jun 14.

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 12836, as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but is considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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http://dx.doi.org/10.2903/j.efsa.2021.6626DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8201172PMC
June 2021

Safety and efficacy of the feed additive consisting of  CECT 5940 (Ecobiol) for turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (Evonik Operations GmbH).

EFSA J 2021 Jun 16;19(6):e06620. Epub 2021 Jun 16.

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 extension of use of the feed additive consisting of  CECT 5940 (tradename: Ecobiol) to turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (except for reproduction). The product under assessment is based on viable spores of a strain originally identified as . During the course of the current assessment, the active agent has been reclassified as  CECT 5940. The bacterial species is considered suitable for the qualified presumption of safety (QPS) approach. The identity of the active agent was established and the compliance with the other qualifications confirmed. Therefore,  CECT 5940 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, the additive Ecobiol is also considered safe for the target species, consumers and the environment. The additive is not irritant to skin/eye or a skin sensitiser, but should be considered a respiratory sensitiser. The efficacy data previously evaluated allowed the Panel to conclude that the additive has the potential to be efficacious at the level of 1 × 10 CFU/kg feed in turkeys for fattening, turkeys reared for breeding, minor poultry species for fattening and reared for laying and ornamental birds (except for reproduction).
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http://dx.doi.org/10.2903/j.efsa.2021.6620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207430PMC
June 2021

Safety and efficacy of an additive consisting of phyllite, natural mixture of minerals of metamorphic origin, as a feed additive for all animal species (Marmorkalkwerk Troesch GmbH & Co. KG).

EFSA J 2021 Jun 9;19(6):e06616. Epub 2021 Jun 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 phyllite, a natural mixture of minerals of metamorphic origin, as a feed additive for all animal species. The additive, specified to contain at least 40% of mica, muscovite, illite, chlorite and talc as the main components, and maximum 60% of quartz, potassium-feldspar, sodium-feldspar and calcite, is intended for use as a technological additive (functional groups: (i) anticaking agents) in premixtures and feedingstuffs for all animal species at a maximum inclusion level of 25,000 mg/kg. The additive is safe for chickens for fattening and chickens reared for laying/breeding at the maximum inclusion level of 25,000 mg/kg feed, with no margin of safety determined. Owing the absence of data in pigs and ruminants and in the absence of data on the potential genotoxicity of the additive, the Panel is not in the position to conclude on the safety of the additive for any other animal species/categories. The additive is considered safe for the consumers and the environment at the proposed conditions of use. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant and skin sensitiser. Exposure via inhalation is considered a risk. The FEEDAP Panel is not in the position to conclude on the efficacy of the additive as an anticaking agent.
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http://dx.doi.org/10.2903/j.efsa.2021.6616DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188398PMC
June 2021

Safety and efficacy of a feed additive consisting of acetic acid for all animal species.

EFSA J 2021 Jun 7;19(6):e06615. Epub 2021 Jun 7.

In 2012, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of acetic acid when used as a technological additive (preservative) for all animal species. The characterisation and condition of use of the additive are the same as those already assessed by the FEEDAP Panel in the previous opinion on acetic acid. Acetic acid produced with the new manufacturing process complies with the specifications set by Commission Regulation (EU) No 231/2012. The FEEDAP Panel considers that the conclusions reached in the previous assessment apply to the acetic acid produced by the new manufacturing process. The FEEDAP Panel concluded that the additive is considered safe for poultry, pigs and pet animals at a maximum concentration of 2.5 g acetic acid/kg complete feed (or 1 g/L water for drinking). The known high endogenous production of acetic acid in the ruminants shows that the tolerance of these target animals is considerably higher. No data is available for salmonids. The use of the additive in animal nutrition is of no concern for consumer safety. The risks for users handling the additive depend on the concentration and include skin, eyes, and respiratory tract irritation (10-25% solution) and corrosion (> 25% solution). The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive has a potential to be efficacious as preservative in feedingstuffs and water for drinking. The FEEDAP Panel has some reservations about the effectiveness of acetic acid as preservative in dry feedingstuffs with a typical moisture content of ≤ 12%.
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http://dx.doi.org/10.2903/j.efsa.2021.6615DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8182647PMC
June 2021

Assessment of the feed additive consisting of (formerly ) DSM 12837 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

EFSA J 2021 Jun 14;19(6):e06614. Epub 2021 Jun 14.

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 12837 as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but is considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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http://dx.doi.org/10.2903/j.efsa.2021.6614DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8201176PMC
June 2021

Assessment of a feed additive consisting of vitamin B (pyridoxine hydrochloride) for all animal species for the renewal of its authorisation (Kaesler Nutrition GmbH).

EFSA J 2021 Jun 9;19(6):e06612. Epub 2021 Jun 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 assessment of the application for renewal of authorisation of vitamin B (pyridoxine hydrochloride) produced by chemical synthesis as a feed additive for all animal species. The applicant has provided data demonstrating that the additive in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of pyridoxine hydrochloride under the current authorised conditions of use is safe for the target species, the consumers and the environment. Pyridoxine hydrochloride is non-irritant to skin and eyes. In the absence of data, no conclusion can be drawn on skin sensitisation potential. Pyridoxine hydrochloride may cause photosensitisation. Despite the lack of data on inhalation toxicity, the additive is not dusty and exposure through inhalation is unlikely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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http://dx.doi.org/10.2903/j.efsa.2021.6612DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188396PMC
June 2021

Safety and efficacy of a feed additive consisting of ferric (III) ammonium hexacyanoferrate (II) for ruminants (domestic and wild), calves prior the start of rumination, lambs prior the start of rumination, kids prior the start of rumination and pigs (domestic and wild) (Honeywell Specialty Chemicals Seelze GmbH).

EFSA J 2021 Jun 11;19(6):e06628. Epub 2021 Jun 11.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ferric (III) ammonium hexacyanoferrate (II) as technological feed additive for ruminants (domestic and wild), calves prior the start of rumination, lambs prior the start of rumination, kids prior the start of rumination and pigs (domestic and wild). The additive is already authorised for use in ruminants (domestic and wild), calves prior the start of rumination, lambs prior the start of rumination, kids prior the start of rumination and pigs (domestic and wild). The additive is effective at the minimum recommended concentration of 50 mg/kg complete feedingstuffs (corresponding to about 10 mg/10 kg bw) in reducing the contamination of food derived from ruminants (domestic and wild), calves, lambs and kids prior to the start of rumination, and pigs (domestic and wild) by caesium. Considering the scarce information available, the Panel is not in the position to conclude on the safety of the additive for the target species. The use of ferric (III) ammonium hexacyanoferrate (II) in feed for ruminants, calves, lambs, kids and pigs at the maximum recommended concentration of 500 mg/kg feed (corresponding to about 150 mg ferric (III) ammonium hexacyanoferrate (II)/10 kg bw) is safe for the consumer. In the absence of data, the Panel is not in the position to conclude on the safety of the additive for the user. The use of ferric (III) ammonium hexacyanoferrate (II) as a feed additive is considered safe for the environment.
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http://dx.doi.org/10.2903/j.efsa.2021.6628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8193505PMC
June 2021
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