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Objective: The purpose of this study was to investigate the incidence of benign paroxysmal positional vertigo (BPPV) specifically among patients with dizziness in the rehabilitation phase of concussion recovery and to provide evidence regarding the importance of BPPV assessment in physical therapy concussion evaluations., Setting: Outpatient neurologic rehabilitation center at a suburban comprehensive rehabilitation hospital., Participants: Fifty patients diagnosed with concussion and referred to vestibular physical therapy with complaints of dizziness were tested for BPPV within their first 3 visits., Design: In this prospective cohort study, a positive Dix-Hallpike test or Horizontal Roll test indicated the presence of BPPV., Main Measures: The primary outcome measure was the presence of BPPV. Additional demographic and injury-specific variables were also considered. Among secondary outcomes, patient characteristics and Dizziness Handicap Inventory scores were compared on the basis of presence or absence of BPPV., Results: Eleven participants, 22%, tested positive for BPPV. Only fall, as the mechanism of injury, was statistically significant ( P < .05), with 72.7% of those who tested positive for BPPV reporting having been injured in a fall compared with 30.8% in the negative group. Nearly half, 45%, of the participants who were positive for BPPV had resolution of their BPPV within 1 visit., Conclusion: This study is unique in its focus on mild traumatic brain injury in the rehabilitation phase of recovery. The results provide evidence regarding the importance of BPPV assessment in physical therapy concussion evaluations., Competing Interests: The authors declare no conflicts of interests., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

One of the flagship actions of the Pharmaceutical Strategy for Europe is to address environmental challenges associated with pharmaceutical use. This includes strengthening the Environmental Risk Assessment (ERA) at marketing authorisation (MA) of pharmaceuticals, and revision of the pharmaceutical legislation where needed. The overall aim of an ERA should be to enable comprehensive and effective identification and management of environmental risks of pharmaceuticals without affecting the availability of pharmaceuticals to patients. As experts in the evaluation of ERAs of human medicinal products submitted by pharmaceutical industries (Applicants), we have summarized the current status of the ERA and suggest legislative changes to improve environmental protection without affecting availability. Six regulatory goals were defined and discussed, including possible ways forward: 1) mandatory ERAs in accordance to the EMA guideline at the time of the MA, 2) enforcement of risk mitigation measures including re-evaluation of the ERA, 3) facilitated exchange of environmental data between pharmaceutical and environmental legislations, 4) substance-based assessments, 5) transparency of data, and 6) a catching-up procedure for active pharmaceutical ingredients that lack an ERA. These legislative proposals can be considered as prerequisites for a harmonised assessment and effective management of environmental risks and hazards of human pharmaceuticals., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Lucie Bielska reports a relationship with RECETOX Research Infrastructure (No LM2018121) that includes: funding grants., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Despite the well-documented need for nurse-focused efforts on health and wellness, too few healthcare organizations have made a meaningful impact on this issue. Nurse health should be integrated into the strategic and operational workings of the organization. Environments of health and wellness require attention, accountability, action, and accessibility. Although individual choice is the starting point, true success will be achieved when nurse health is a nonnegotiable outcome consistent with quality, safety, finance, and patient experience., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: To investigate the correlation between the FA parameters and Ki-67 labeling index, and their diagnostic performance in grading supratentorial non-enhancing gliomas and neuronal-glial tumors (GNGT)., Methods: This institutional review board-approved, Health Insurance Portability and Accountability (HIPAA) compliant retrospective study enrolled 35 patients, including 19 with low grade GNGT and 16 with high grade GNGT. The mean FA, maximal FA and mean maximal FA values derived from diffusion tensor imaging were measured. The correlation between the FA parameters and the Ki-67 labeling index was assessed by Spearman rank test. The receiver operating characteristic curve analysis and multivariate logistic regression analysis were performed to detect the optimal imaging parameters in grading GNGT., Results: The three FA parameters of low grade GNGT were significantly lower than the high grade GNGT (p < 0.001). The mean FA, maximal FA and mean maximal FA had significant positive correlation with Ki-67 labeling index (p = 0.001, p < 0.001, p < 0.001 respectively). The maximal FA showed a higher sensitivity and specificity in grading of non-enhancing GNGT with specificity of 78.9%, sensitivity of 100.0%, respectively., Conclusions: The FA parameters correlated with Ki-67 labeling index, and were useful surrogates in preoperative grading supratentorial non-enhancing GNGT., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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 an essential oil from the seeds of Elettaria cardamomum (L.) Maton when used as a sensory additive for all animal species. Characterisation of the essential oil identified 37 components accounting for > 99% of its composition, with terpineol acetate (> 35%) and 1,8-cineole (> 20%) being the most prevalent compounds. In the absence of toxicological data of the feed additive itself, a component-based approach was applied to assess the safety of the essential oil as a mixture. Based on structural and metabolic similarity, the components of cardamom oil were allocated to seven assessment groups. Assuming the absence of toxicologically relevant interactions among components, dose addition was applied within each assessment group by calculating the combined margin of exposure as a basis for risk characterisation. The FEEDAP Panel concluded that the additive under assessment is safe at the proposed use level of 5 mg/kg in feed for all animal species. A concentration of 5 mg/L water for drinking is considered safe for all animal species. The use of cardamom essential oil in animal feed is considered safe for the consumer. In the absence of studies, the Panel cannot conclude on the safety for the users when handling the additive. The use of the essential oil under assessment in animal production is not expected to pose a risk for the environment. Since the seeds of E. cardamomum and their preparations are recognised to flavour food and their function in feed would be essentially the same, no further demonstration of efficacy is considered necessary. The Panel made a recommendation to limit the content of methyleugenol in the oil., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives used in animal nutrition. It specifically covers the assessment of the safety for the environment. [Table: see text]., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 Robenz ® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz ® 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a margin of safety of approximately 2.5. This conclusion is extrapolated to turkeys for fattening. Robenidine HCl is active against Gram-positive but not against Gram-negative bacteria. It is not expected that the use of robenidine HCl as a feed additive would induce resistance or cross-resistance to antimicrobials used in human and animal therapy. The use of robenidine HCl from Robenz ® 66G at the highest proposed level of 36 mg/kg complete feed in chickens and turkeys for fattening is considered safe for the consumer. The existing maximum residues limits for both avian species are confirmed. Robenidine HCl is not a skin or eye irritant and not a skin sensitiser. The risk via inhalation is considered negligible. The use of robenidine HCl from Robenz ® in feed for chickens for fattening and turkeys for fattening up to 36 mg/kg complete feed does not pose a risk to either the terrestrial or the aquatic compartment. A risk for bioaccumulation cannot be excluded. The risk for secondary poisoning is not likely to occur. The FEEDAP Panel concludes that 36 mg robenidine HCl/kg complete feed from Robenz ® 66G has the potential to effectively control coccidiosis of chickens for fattening under field conditions but cannot conclude on the efficacy of robenidine HCl in turkeys for fattening. The existing 5-day withdrawal period to avoid off-flavours in edible tissues should be maintained., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Congenital cerebrovascular anomalies in the pediatric age group are myriad with diverse etiologies. The purpose of this paper is to provide an imaging overview of congenital vascular malformations and vascular tumors, as these conditions are varied and the characteristic vascular abnormality may even suggest the underlying systemic condition in helping to guide further management. For example, the identification of an arterial anomaly such as agenesis/hypoplasia/duplication may warrant further evaluation for an associated syndrome. Recognition of other pertinent findings, such as persistent carotid-vertebrobasilar anastomoses for instance, would be particularly important for the planning of potential embolization/coiling of associated vascular malformation and/or aneurysm. Awareness of congenital dural sinus anomalies, including hypoplasia, aplasia, and or duplication, prevents the incorrect or overdiagnosis of sinus thrombosis. Moreover, multiple developmental venous anomalies in a patient may require further investigation for its familial association. In a similar context, there may be familial association with multiple cavernous malformations and children with central nervous system vascular malformations may have an association with other vascular conditions, eg, hereditary hemorrhagic telangiectasia, etc. An accurate description of vascular lesions is critical for understanding the natural history of the disease process and ultimately for guiding treatment. An important example of this includes Sturge-Weber syndrome, which is often incorrectly viewed as an arteriovenous malformation, but actually a type of venous malformation. Another example which is important to recognize includes the differentiation between an infantile hemangioma and a vascular malformation, particularly as the course of the pathology and the treatment is so different between the two., (© 2018 by the American Society of Neuroimaging.)

Deccox ® , containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20-40 mg/kg complete feed. Decoquinate from Deccox ® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial action. Decoquinate is not genotoxic and not carcinogenic. Deccox ® is safe for the consumer under the proposed conditions of use. No withdrawal period is required to ensure consumer safety. No maximum residue limits are considered necessary. The inhalation risk for users is considered negligible since inhalation toxicity and exposure are very low. Deccox ® is not an irritant to skin and eyes and has no sensitisation potential. The ratios predicted environmental concentration/predicted no effect concentration (PEC/PNEC) for terrestrial, aquatic compartment and sediment are below 1, indicating that decoquinate used in chickens for fattening up to the highest proposed dose, does not pose a risk for these compartments; as well, no risk is expected neither for secondary poisoning nor for groundwater contamination. Due to insufficient evidence, the potential of decoquinate to prevent coccidiosis in chickens for fattening cannot be established., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 Monteban ® G100 for ducks. Monteban ® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60-70 mg/kg of complete feed. Narasin from Monteban ® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed with a margin of safety of about 4. The FEEDAP Panel assumes that the residues in duck tissues would be of the same magnitude as those measured in the physiologically similar major species, chickens for fattening. The use of Monteban ® G100 at a maximum concentration of 70 mg/kg complete feed for ducks for fattening is safe for the consumer without applying a withdrawal period, provided the maximum residue limit (MRL) of 50 μg narasin/kg for all wet tissues would not be exceeded. Monteban ® G100 is irritant to the eyes but not to the skin. It has the potential to induce skin sensitisation. The acute systemic toxicity following dermal application is low. Inhalation exposure would pose a risk to persons handling the additive. Narasin, when used as feed additive for ducks for fattening at 70 mg/kg feed, is not expected to pose a risk to the environment. The risk for sediment compartment cannot be assessed. Narasin is not considered to have a bioaccumulation potential. Insufficient data were provided to allow a conclusion on the efficacy of Monteban ® G100 in ducks., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The feed additive Monteban ® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60-70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens . The FEEDAP Panel cannot conclude on the absence of genetic determinants for antimicrobial resistance in Streptomyces spp. under assessment. Based on the available data set, the FEEDAP Panel cannot conclude on the safety of Monteban ® G100 for chickens for fattening. The simultaneous use of Monteban ® G100 and certain antibiotic drugs (e.g. tiamulin) is contraindicated. Narasin is not genotoxic. No indication of carcinogenicity or developmental toxicity was found at the doses tested in the mouse, rat and rabbit. The lowest no observed effect level (NOEL) identified in the oral toxicity studies was 0.5 mg/kg body weight (bw) per day for the neuropathy seen in a one-year dog study. The acceptable daily intake (ADI) derived from this NOEL is 0.005 mg narasin/kg bw applying a uncertainty factor of 100. Monteban ® G100 is safe for the consumer. Maximum residue limits (MRLs) of 50 μg narasin/kg for all wet tissues ensure consumer safety. Monteban ® G100 is irritatant to the eyes but not to the skin. It has the potential to induce skin sensitisation. Inhalation exposure would pose a risk to persons handling the additive. Narasin, when used as a feed additive for chickens for fattening at 70 mg/kg feed, is not expected to pose a risk to the environment. The risk for sediment compartment cannot be assessed. The FEEDAP Panel cannot conclude on the efficacy of Monteban ® at the minimum applied dose of 60 mg narasin/kg complete feed for chickens for fattening., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The coccidiostat Monimax ® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC) and 2-hydroxy-4,6-dimethylpyrimidine (HDP) which behave independently. Monimax ® does not represent a genotoxic risk. No safety concerns would arise from the nicarbazin impurities p -nitroaniline and methyl(4-nitrophenyl) carbamate. The lowest no observed effect level (NOEL) identified for monensin sodium in a developmental study in rabbits is 0.3 mg monensin sodium/kg body weight (bw) per day for maternal toxicity in rabbits. The lowest no observed adverse effect level (NOAEL) identified in a 52-week study in rat using DNC + HDP was 20 mg DNC + 8 mg HDP/kg bw per day based on the absence of microcrystals in urine and related microscopic renal observations. No significant interaction between monensin sodium and nicarbazin is expected from toxicological studies. The use of Monimax ® at the highest proposed dose will not pose a risk to persons consuming animal products from treated chickens for fattening. This conclusion is extended to chickens reared for laying. No withdrawal time is required for Monimax ® in chickens for fattening. Residue data comply with the established maximum residue limits (MRLs) for monensin and DNC. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Monimax ® for the environment. Monimax ® has the potential to control coccidiosis in chickens for fattening at a minimum concentration of 40 mg monensin and 40 mg nicarbazin/kg complete feed., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The feed additive Aviax 5%, containing the active substance semduramicin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 20-25 mg/kg complete feed. Semduramicin sodium is present in Aviax 5% in its mycelial form and is produced by fermentation of Actinomadura spp. (ATCC 53664). Semduramicin sodium is active against certain Gram-positive bacteria, while Gram-negative bacteria are resistant; its use as a feed additive is unlikely to increase shedding of Salmonella , Escherichia coli and Campylobacter and to induce resistance and cross-resistance to antimicrobials used of human and animal relevance. In the absence of a tolerance study in chickens for fattening performed according to the current EU standards, the FEEDAP Panel cannot conclude on the safety of Aviax 5%, containing semduramicin mycelium. Semduramicin sodium in the feed is not compatible with the concurrent use of tiamulin. Mycelial semduramicin sodium is not genotoxic. There is no evidence that the mycelial semduramicin is more toxic than the crystalline by oral administration. The acceptable daily intake (ADI) of 0.00125 mg/kg set for the crystalline semduramicin is applicable to mycelial semduramicin. The use of semduramicin sodium is safe for the consumer provided a withdrawal time of 24 h is respected. No conclusions can be made on the irritancy of Aviax 5% to skin and eye and on the potential for dermal and respiratory sensitisation. Model calculations on inhalation exposure of persons handling the additive indicate a serious risk. Aviax 5% used in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for the terrestrial compartment. A risk for the aquatic compartment and for groundwater pollution cannot be excluded. Aviax 5% at a minimum dose of 20 mg/kg feed has the potential to effectively control coccidiosis in chickens for fattening., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Calsporin ® is the trade name for a feed additive based on Bacillus subtilis DSM 15544. It is currently authorised for use in chickens for fattening, weaned piglets, chickens reared for laying, turkeys, minor avian species and other ornamental and game birds, and ornamental fish. This opinion concerns the renewal of the authorisation of Calsporin ® as a zootechnical additive for chickens for fattening. In 2006 and 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted two opinions on the safety and efficacy of Calsporin ® when used in chickens for fattening, and the active agent was further characterised in an opinion from 2015. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. Furthermore, according to the information provided in the technical dossier, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions on the safety of the additive. The FEEDAP Panel confirms its previous conclusion that Calsporin ® is safe for the target species, consumers of products from animals fed the additive, users and the environment., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Cyanocobalamin is a synthetic form of vitamin B 12 used in pharmaceuticals, supplements and as a food additive. It is intended to be used in feed for all animal species and categories. The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of cyanocobalamin produced by fermentation with Ensifer adhaerens strains SCM 2034 or CICC 11008s or Ensifer fredii strain CMCC (B) 70000. Since relevant data were not provided by the applicant that would allow a proper identification and characterisation of the production strains, the Additives and Products or Substances used in Animal Feed (FEEDAP) Panel cannot conclude on the safety of the use of vitamin B 12 produced using E. adhaerens CICC 11008s and E. fredii CMCC (B) 70000 in animal nutrition for the target animals, the consumer, the user and the environment. Due to significant uncertainties on the identity and safety of the production strain E. adhaerens SCM 2034, including the presence of antibiotic resistance genes, the absence of viable cells of the production strain or their DNA in the product, the FEEDAP Panel cannot conclude on the safety of the use of vitamin B 12 , produced by E. adhaerens SCM 2034 in animal nutrition for the target species, consumers and the environment. Due to high endotoxin content, potential inhalation exposure when handling premixtures and reported irritancy for skin and eyes, vitamin B 12 produced by E. adhaerens SCM2034 is considered to pose a risk to user safety. Vitamin B 12 additives produced by Ensifer spp. are regarded as effective in meeting animals' requirements., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a riboflavin-based additive (minimum 80%) produced by a genetically modified strain of Ashbya gossypii (■■■■■). It is intended to be used in feed for all animal species and categories. The additive under assessment does not give rise to safety concerns on the genetic modification of the production strain. The additive contains 80% of riboflavin (vitamin B 2 ) and 20% of spent growth medium. The additive is safe for target animals with a wide margin of safety. The use of riboflavin 80% produced by A. gossypii ■■■■■ in animal nutrition does not represent a safety concern for consumers. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot draw a final conclusion on the risk posed for the user by inhalation of riboflavin produced by A. gossypii ■■■■■ and on the potential to be irritant to skin or eyes. The product under assessment is not a skin sensitiser; however, riboflavin is a known photosensitiser. The use of riboflavin produced by A. gossypii ■■■■■ in animal nutrition does not pose a risk to the environment. The additive is regarded as an effective source of riboflavin in covering the animal's requirement when administered via feed. The FEEDAP Panel made recommendations on the description of the additive., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 betaine anhydrous produced ■■■■■ as a nutritional additive to be used in feed for all food-producing animal species except rabbits. Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous tissues of vertebrates as an osmolyte ensuring osmoprotection. Betaine anhydrous (97%, 96% or 91%) is considered safe for the target species at a maximum supplementation rate of 2,000 mg betaine/kg complete feed. The use of betaine anhydrous (97%, 96% and 91%) as a feed additive up to a supplementation of 2,000 mg/kg complete feed does not pose concerns to consumer safety. The betaine liquid product contains a high proportion of unknown material (about 30% on dry matter basis). The FEEDAP Panel therefore cannot conclude on the safety of the liquid form of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety for the user. The supplementation of feed with betaine anhydrous does not pose a risk to the environment. Betaine has a potential to become efficacious in food-producing animal species and categories when administered via feed, especially when methyl groups from methionine or choline are limiting. The FEEDAP Panel made a recommendation on the use of the additive in premixtures without choline chloride., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The coccidiostat amprolium hydrochloride from COXAM ® is considered safe for chickens for fattening at 125 mg/kg complete feed. The margin of safety is at least 5. This conclusion is extended to chickens reared for laying. Amprolium hydrochloride does not possess any significant antibacterial activity. The applicant provided no information on the absorption, distribution, metabolism and excretion (ADME) and on the toxicology of the additive or active substance. Reference was made to the Committee for Medicinal Products for Veterinary Use (CVMP) summary reports from 1999 and 2001 citing studies used for the establishment of maximum residue limits (MRLs) for amprolium. However, the original data used in these assessments were not provided and the literature review covering the subsequent period was not made. Thus, the FEEDAP Panel cannot independently evaluate all data relevant to the current application and is therefore unable to conclude on the safety for the consumer of amprolium when used as a feed additive in chickens for fattening and chickens reared for laying. COXAM ® is considered to be a skin and respiratory sensitiser. Inhalation exposure to dust from COXAM ® may present a risk for the user. The use of amprolium hydrochloride from COXAM ® in feed for chickens for fattening up to 125 mg/kg complete feed does not pose a risk for the environment. This conclusion can be extended to chickens reared for laying because of the lower predicted concentration in soil. COXAM ® was effective as a coccidiostat in three floor pen studies and in two anticoccidial sensitivity tests. Since three anticoccidial sensitivity tests showing positive effects of the treatment are required, the FEEDAP Panel is not in the position to conclude on the efficacy of COXAM ® for chickens for fattening under EU farming conditions. Consequently, a conclusion on the efficacy for chickens reared for laying is also not possible., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 renewal of the authorisation of Actisaf Sc47 as a zootechnical additive for lambs for fattening, minor dairy ruminants, horses and pigs for fattening. In 2006, 2007 and 2008, the FEEDAP Panel adopted opinions on the safety and efficacy of Actisaf Sc47 when used in lambs for fattening, minor dairy ruminants, horses and pigs for fattening. Actisaf Sc47 is the trade name for a feed additive based on viable cells of Saccharomyces cerevisiae CNCM I-4407 with no carrier. It is currently authorised for use in sows, piglets, pigs for fattening, cattle for fattening, calves for rearing, dairy cows, dairy buffaloes, lambs for fattening, dairy sheep, dairy goats, horses, rabbits for fattening and non-food producing rabbits. Actisaf Sc47 is marketed in three forms: standard, powder and HR. All of them are authorised with a declared minimal concentration of viable yeast cells in the additive of 5 × 10 9  CFU/g. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. In previous opinions, Actisaf Sc47 was presumed safe for the target species, consumers of products from animals fed the additive and the environment. Additionally, it was not found to be a skin or eye irritant. No new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions on the safety of Actisaf Sc47. Therefore, the Panel considers that the additive Actisaf SC47 remains safe under the approved conditions for lambs for fattening, minor dairy ruminants, horses and pigs for fattening, the consumer, user and the environment., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The additive under assessment is a muramidase from Trichoderma reesei DSM 32338 which is to be used as a zootehcnical additive in feed for chickens for fattening and minor poultry species. The production strain is a genetically modified microorganism. The introduced genetic sequences do not give rise to safety concerns and no viable cells and no DNA of the production strain were detected in the additive. The results of a tolerance trial in chickens for fattening showed that the birds tolerated well 10-fold the highest recommended level of 45,000 LSU(F)/kg feed. Therefore, the Panel concluded that the additive is safe for chickens for fattening and extrapolated the conclusion to minor poultry species for fattening. The enzyme filtrate used to formulate the additive was tested in genotoxicity studies and in a subchronic oral toxicity study. The results of these tests did not indicate any reason for concern for consumer safety arising from the use of the product as a feed additive. Therefore, the Panel concluded that the additive is safe for the consumers. The Panel could not conclude on the potential of the additive for skin/eye irritancy or for its skin sensitisation potential. Owing to the proteinaceous nature of the active substance, the additive is considered to have potential for respiratory sensitisation. The FEEDAP Panel concluded that the use of this product as a feed additive poses no risks to the environment. The additive is to be used as a zootechnical additive, functional group other additives. To support the efficacy, the applicant submitted three efficacy studies with comparable design. The results showed significant and positive improvements on the feed to gain ratio of the birds receiving the additive at the lowest recommended level (25,000 LSU(F)/kg feed). This conclusion was extrapolated to minor poultry species for fattening., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

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 modification of the terms of authorisation of lecithins as a feed additive for all animal species. Lecithins are currently authorised for use in feed for all animal species (Commission Implementing Regulation (EU) 2017/2325). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion of the additive lecithins in 2016. The Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as emulsifier. The requested modification refers to the alignment of the specifications of the feed additive to the specifications set for lecithins when used as food additives, and the inclusion in the authorisation of rapeseed among the botanical sources of hydrolysed and de-oiled lecithins and of de-oiled hydrolysed soybean lecithins as an additional form of the additive. Based on the data available, all the lecithins of different botanical origin and their forms under application meet the specifications set for the use of lecithins as a food additive. The Panel therefore recommended applying the specifications set for food additive to the lecithins under application. In its previous opinion, the Panel concluded that lecithins are safe for the target species, the consumer, the user and the environment, and that they are efficacious as an emulsifier. The Panel is not aware of any information related to the use of rapeseed as an additional source of hydrolysed liquid lecithins and de-oiled lecithin powder that would modify the previous conclusions., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

l-Arginine is considered to be a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The product subject of this assessment is l-arginine produced by fermentation using a non-genetically modified strain of Corynebacterium glutamicum (KCCM 10741P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations at or below thresholds specified by EFSA; thus, C. glutamicum KCCM 10741P may be considered safe by the qualified presumption of safety (QPS) approach. No viable cells of C. glutamicum were detected in the final product. The amount of identified material exceeded 99.8%, and no impurities of concern were detected. The use of l-arginine produced by C. glutamicum KCCM 10741P is safe for target species when supplemented to diets in appropriate amounts, for the consumer and the environment. l-Arginine produced by C. glutamicum KCCM 10741P is considered corrosive to skin and eyes and therefore poses a risk by inhalation. The additive is an effective source of arginine for all species. For the supplemental l-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against microbial degradation in the rumen., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

l-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. l-Arginine produced by fermentation with Escherichia coli NITE BP-02186, genetically modified to enhance the production of l-arginine, is intended to be used in feed and water for drinking for all animal species and categories. The product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. Its use as a nutritional additive is safe for target species when supplemented to diets in appropriate amounts. The use of l-arginine as a feed flavouring agent is unlikely to pose any concern. No risks are expected for the consumer from the use of the product under assessment as a feed additive. It is not irritant to skin or eyes, nor a skin sensitiser. Although the presence of endotoxin activity is of no concern, the available exposure and toxicological data indicate that the additive may pose a risk to users by inhalation. The use of this additive in animal nutrition does not pose a risk to the environment. The additive is an effective source of arginine for all species. l-Arginine is considered efficacious when used as a flavouring compound in animal nutrition., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

l-Glutamic acid, N , N -diacetic acid, tetrasodium salt (GLDA-Na 4 ) (Kelforce ® ) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce ® is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA-Na 4 , respectively. Kelforce ® is safe for chickens for fattening at the maximum level of 1,000 mg GLDA-Na 4 /kg complete feed. Based on the toxicological profile of GLDA-Na 4 and the consumer exposure to GLDA-Na 4 and to nitrilotriacetic acid trisodium salt (NTA-Na 3 ; an impurity of the additive), the use of Kelforce ® at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA-Na 4 is unlikely to pose a risk by inhalation. However, owing to the high-dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce ® is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Hemicell ® HT/HT-L is an additive that presents endo-1,4-β-mannanase produced by a genetically modified strain of Paenibacillus lentus . This additive is aimed to be used as a feed additive for chickens for fattening/reared for laying, turkeys for fattening/reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species. In a previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the safety of the additive regarding the production strain, target species, consumer and user. However, limitations on the data regarding the absence of the production strain and its DNA did not permit to conclude on the safety of the additive for the environment. In that assessment, the Panel considered that the additive has a potential to be efficacious in the target species with the exception of pigs for fattening and in minor porcine species. The applicant provided new data to address the limitations identified. New data provided allowed the FEEDAP Panel to conclude that production strain and its recombinant DNA are not detected in the intermediate product used to formulate the additive. Therefore, the Panel concluded that the additive does not pose any environmental safety concern. Regarding the efficacy in pigs for fattening, the applicant provided a new analysis of the trials previously assessed which allowed the Panel to conclude that the additive has a potential to improve the feed to gain ratio at 32,000 U/kg feed. No data was provided regarding the efficacy in minor porcine species. However, considering the data available in major porcine species and that the mode of action of enzymes is well-known and can be reasonably be considered to be similar among porcine species the Panel extrapolated the conclusion drawn in pigs for fattening to minor porcine species for fattening., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Fumonisin esterase produced from a genetically modified strain of Komagataella phaffi is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300 U/kg feed to represent a likely upper limit. This concentration showed to be safe for piglets, chickens and turkeys for fattening and laying hens; the additive is thus safe for those categories. This conclusion is extended to all pigs, chickens reared for laying and turkeys reared for breeding and extrapolated to all other poultry species for growing and laying and to minor porcine species. No evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity from a repeated-dose oral toxicity study; the residue assessment did not identify any concern. The use of the additive is, thus, considered safe for consumers. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non-irritant to skin and eyes and is not considered a dermal sensitiser. No risks for the environment are expected following the use of the additive in feeds under the proposed condition of use. The additive has the capacity to degrade fumonisin contaminants in feed of marketable quality when used at the minimum recommended dose of 10 U/kg complete feed, as shown in studies with chickens for fattening, laying hens and weaned piglets. Since the mode of action of the additive can be reasonably assumed to be the same in animal species for which the application is made, the Panel on Additives and Products or Substances used in Animal Feed ( FEEDAP) considers the additive efficacious for all poultry and all pigs., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)