Use of balloon catheter dilation vs. traditional endoscopic sinus surgery in management of light and severe chronic rhinosinusitis of the frontal sinus: a multicenter prospective randomized study

OBJECTIVE: Chronic rhinosinusitis (CRS) of the frontal sinus is a complex pathological condition and many surgical techniques were described to treat this area endoscopically, like traditional endoscopic sinus surgery (ESS) and balloon catheter dilation (BCD). PATIENTS AND METHODS: We designed a multicenter prospective randomized study to assess the validity and safety of BCD vs. ESS in symptomatological chronic rhinosinusitis of the frontal sinus enrolling a population of 102 adult patients (64 men and 38 women; overall 148 frontal sinuses studied) with non-polypoid CRS. For a better evaluation of the disease, in our study we decided to analyze both radiological (Lund-McKay CT scoring modified by Zinreich) and symptomatological results (SNOT-20 questionnaire). We divided the population affected in two groups, one with light/mild frontal CRS and the other with moderate/severe frontal CRS, basing on radiological findings at Lund-MacKay modified by Zinreich score. Every group was divided in two subgroups, in one we used BCD and in the other we used traditional ESS. RESULTS: The current literature does not support the suggestion that indications for BCD and ESS are identical, and additional research is needed to determine the role for BCD in specific patient populations. The results showed a not statistically significative difference between BCD and conventional ESS of the frontal sinus in patients with light/mild CRS and in patients with moderate/severe CRS at Lund-Mackay modified by Zinreich score. The same not statistically significative difference was observed comparing the results of SNOT-20 questionnaire in the group of light/mild frontal chronic rhinosinusitis. However, we noticed a statistically significant better outcome of SNOT-20 score in patients with moderate/severe chronic rhinosinusitis that underwent BCD of frontal sinus compared to ESS. CONCLUSIONS: BCD and ESS are two alternative weapons in the baggage of every endoscopic surgeon, even because they present similar outcomes, safeness and effectiveness both in light/mild and moderate/severe chronic rhinosinusitis of the frontal sinus. An interesting result of our study was the statistically significant better outcome of SNOT-20 score in patients that underwent BCD of frontal sinus for a moderate/severe CRS, compared to those that underwent a traditional ESS

Safety of the feed additive consisting of manganese chelates of lysine and glutamic acid for all animal species (Zinpro Animal Nutrition)

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 for target animals of manganese chelates of lysine and glutamic acid (Manganese-LG) as a nutritional feed additive for all animal species. The European Commission request followed an opinion of the FEEDAP Panel published in 2020; in that opinion, the FEEDAP Panel could conclude on the safety of the additive for chickens for fattening, but not for the rest of the target animals. The applicant submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, comprising two tolerance studies (one with chickens for fattening and one with laying hens), were the subject of this opinion. The tolerance study in laying hens was not considered for the assessment since the housing conditions of the animals were not appropriate according to the relevant EU provisions. The results of the tolerance study in chickens for fattening showed that Manganese-LG at the highest level tested – 800 mg Mn/kg feed – is safe for these target animals. The FEEDAP Panel also considered a previous tolerance study in chickens for fattening. Taking all the evidence together the Panel concluded that Manganese-LG is safe for chickens for fattening at 150 mg Mn/kg feed, with a margin of safety of 5.5. This conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total manganese in feed are not exceeded

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2016; in that opinion, the FEEDAP Panel could not conclude on the efficacy of the additive. The applicant has submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, related to the efficacy of the additive, are the subject of this opinion. In the efficacy study provided, the use of the additive reduced the AfM1 in milk, although this effect seemed to be not consistent over time; this study presented some weaknesses and limitations (incomplete data analysis, reporting and lack of determination of the active substance of the additive in feed) which do not allow the FEEDAP Panel to draw any conclusion on the efficacy of the additive. Due to insufficient evidence, the FEEDAP Panel cannot conclude on the efficacy of the algae interspaced bentonite as a technological feed additive for all animal species

Safety and efficacy of TYFER\u2122 (Ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFERTM (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFERTM/kg complete feed; this conclusion can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. No concerns for consumer safety are expected from the use of the additive in poultry nutrition. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the additive poses a risk to users by inhalation, and should also be considered as an irritant to skin, eyes and mucous membranes. Due to the presence of nickel, ferric tyrosine chelate should also be considered as a dermal and respiratory sensitiser. The supplementation of feed with the additive is not expected to pose an environmental risk. TYFERTM used at the minimum recommended level (20 mg/kg feed) in chickens diets has the potential to improve zootechnical parameters of birds. The additive at 20 mg/kg feed has the potential to reduce the caecal load Campylobacter spp. by at least 1 log10-units in chickens for fattening, thus with a potential impact to reduce the risk of human campylobacteriosis; however, the Panel notes that the load of Campylobacter in the chickens caecum is one of the multiple factors that contribute to Campylobacter load in carcases-meat. The conclusions on the efficacy of the additive can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. The Panel recommends including a specification for maximum lithium content in a potential authorisation of the additive

Efficacy of a feed additive consisting of endo-1,4-beta-xylanase produced by Trichoderma citrinoviride (IMI SD 135) (HOSTAZYM® X) for sows in order to have benefits in piglets (Huvepharma NV)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefits in piglets. This additive consists of endo-1,4-β-xylanase produced by a non-genetically modified strain of Trichoderma citroviride. The additive is to be used in sows at 1,500 EPU/kg feed. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. The applicant provided new efficacy data to complete the assessment of the efficacy of the additive. Based on the previously assessed data and the newly submitted one, the Panel could not conclude on the efficacy of the additive

Safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino-ethanol (DMAE)) in the additive at concentrations up to 0.09%. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the proposed modification would not substantially affect the previous assessment as related to the safety of the environment and the efficacy of the product. Since the safety of the active substance was established, the current assessment has dealt with the impurity DMAE. Considering the toxicological profile of DMAE, the estimated intake by the target animal and consumers, and making use of the Threshold of Toxicological Concern (TTC) approach, the Panel concluded that Taminizer D, manufactured by the DMAE route, is safe for both chickens for fattening and consumers, up to the maximum level of 1,000 mg/kg feed. The FEEDAP Panel extends its conclusions about Taminizer D produced by the original method to cover also Taminizer D produced by the new DMAE method. There is minimal risk to users from dust produced as a result of normal handling of the additive. Taminizer D is not irritant to skin but may be irritant to eyes; it is regarded as a potential skin sensitiser. The FEEDAP Panel recommended to set a specification for the DMAE content in the additive

Safety and efficacy of benzoic acid for pigs and poultry

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked by the European Commission to deliver a scientific opinion on the safety and efficacy of benzoic acid as feed flavouring for piglets (suckling, weaned), pigs for fattening, sows (for reproduction, in order to have benefit in piglets), minor porcine species, chickens (for fattening, reared for laying), hens (laying, breeding), turkeys (for fattening, for breeding purposes, reared for breeding) and minor poultry species. Benzoic acid is safe for weaned piglets at 2,500 mg/kg feed, and for laying hens, turkeys and chickens for fattening at 500 mg/kg feed; no conclusions could be drawn for suckling piglets and sows. The conclusions on weaned piglets can be extended to pigs for fattening and extrapolated to growing minor porcine species. The conclusions on chickens/turkeys for fattening can be extended to chickens reared for laying and turkeys reared for breeding and extrapolated to minor poultry species up to the point of lay. In the absence of safety margin in laying hens, no conclusions can be reached for minor poultry species for laying/breeding. The use of the additive is not expected to pose a risk to consumer, considering that the additive is rapidly metabolised with very low deposition, if any, in edible tissues of pigs and poultry and that foods of animal origin provide a very minor contribution, if any, to the overall dietary intake of benzoic acid. Owing to the unlikelihood of exposure, no risk to users upon inhalation of the additive is expected; the additive is not a skin sensitiser, but is a skin/ eye irritant. The proposed use of the additive does not pose environmental risks. Benzoic acid is authorised as food flavouring and its function in feed is essentially the same; no further demonstration of efficacy is necessary

Safety and efficacy of Biomin \uae DC-C as a zootechnical feed additive for weaned piglets

The additive (trade name Biomin \uae DC-C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were exposed to feed containing up to an intended 1,250 mg additive/kg complete feed showed that additive is safe for piglets at the maximum recommended level with at least a sixfold margin of safety. The active components of the additive are not genotoxic and from the available residue study, based on the detection of five marker compounds, no measurable exposure of the consumers is foreseen; consequently, the use of the additive is considered safe for consumers of animal products. The FEEDAP Panel considered that exposure to users by inhalation is unlikely; in the absence of data, the Panel cannot conclude on the effects of Biomin \uae DC-C on skin and eyes. The use of the additive in animal production is not expected to pose a risk for the terrestrial or aquatic environments. Based on the results of three efficacy studies in which positive benefits were seen, the additive has a potential to improve the growth performance of weaned piglets at a minimum application rate of 75 mg/kg complete feed

Safety and efficacy of Biomin ® DC-C as a zootechnical feed additive for weaned piglets

The additive (trade name Biomin \uae DC-C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l-menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were exposed to feed containing up to an intended 1,250 mg additive/kg complete feed showed that additive is safe for piglets at the maximum recommended level with at least a sixfold margin of safety. The active components of the additive are not genotoxic and from the available residue study, based on the detection of five marker compounds, no measurable exposure of the consumers is foreseen; consequently, the use of the additive is considered safe for consumers of animal products. The FEEDAP Panel considered that exposure to users by inhalation is unlikely; in the absence of data, the Panel cannot conclude on the effects of Biomin \uae DC-C on skin and eyes. The use of the additive in animal production is not expected to pose a risk for the terrestrial or aquatic environments. Based on the results of three efficacy studies in which positive benefits were seen, the additive has a potential to improve the growth performance of weaned piglets at a minimum application rate of 75 mg/kg complete feed

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by Bacillus subtilis LMG S-15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)

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 Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo-1,4-β-xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S-15136). In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panel retained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panel concludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters