Effects of opium tincture on gastrointestinal function and motility in healthy volunteers: A magnetic resonance imaging study.

BACKGROUND: Opioids inhibit motility and secretion of the gut and have been used for antidiarrheal treatment for centuries. However, the underlying mechanisms of opium tincture are not evident. AIM: To investigate the effects of opium tincture on gastrointestinal motility, intestinal volumes, and water content of different gut segments assessed by magnetic resonance imaging (MRI). METHODS: Twenty healthy volunteers were included in a randomized, placebo-controlled, crossover study of 9 days of treatment with 30 drops of opium tincture per day. MRI was performed on day 1 (before treatment) and day 9 (during treatment). Measurements included assessments of gastric volume, gastric emptying, gastric motility, small bowel volume, small bowel water content, small bowel motility, colon volume, colon water content, and whole gut transit. KEY RESULTS: Opium tincture delayed gastric emptying by a mean difference of 5.6 min [95% CI: 1.8-9.4], p = 0.004, and increased postprandial gastric meal volume (17-21%, p = 0.02). Small bowel endpoints did not change. Opium tincture delayed whole gut transit time (p = 0.027) and increased ascending colon volume by 59 mL [95% CI: 15-103], p = 0.004, and transverse colon volume by 48 mL [95% CI: 4-92], p = 0.027. T1-relaxation time of the descending colon chyme was decreased during opium treatment, indicating dryer feces (difference: -173 ms [95% CI: -336 -11], p = 0.03). CONCLUSION AND INFERENCES: Opium tincture induced changes in the stomach and colon in healthy volunteers. An improved understanding of how opioids affect gut functions may lead to a better understanding and optimized management of diarrhea.

Opium tincture has anti-propulsive effects in patients with chronic diarrhea: a randomized, placebo-controlled, and cross-over trial.

OBJECTIVE: Chronic diarrhea affects approximately 5% of the population. Opioids inhibit gastrointestinal motility, and opium tincture has shown anti-propulsive effects in healthy, but no controlled studies of its clinical efficacy exist. We aimed to investigate the anti-propulsive and central nervous system (CNS) effects of opium tincture in patients with chronic diarrhea. MATERIALS AND METHODS: The study was a randomized, double-blinded, placebo-controlled, cross-over trial in subjects with chronic diarrhea refractory to standard treatment. Participants received opium tincture or placebo during two intervention periods, each lasting seven days. Bowel movements were recorded daily, and gastrointestinal transit time was investigated with the wireless motility capsule system. Gastrointestinal symptoms, health-related quality of life, and CNS effects (pupil size, reaction time, memory, and general cognition) were also investigated, along with signs of addiction. RESULTS: Eleven subjects (mean age: 45 ± 17 years, 46% males) with a median of 4.7 daily bowel movements were included. The number of daily bowel movements was reduced during opium tincture treatment to 2.3 (p = 0.045), but not placebo (3.0, p = 0.09). Opium tincture prolonged the colonic transit time compared to placebo (17 h vs. 12 h, p < 0.001). In both treatment arms, there were no changes in self-reported gastrointestinal symptoms, health-related quality of life, or CNS effects, and no indication of addiction was present. CONCLUSION: Opium tincture induced anti-propulsive effects in patients with chronic diarrhea refractory to standard treatment. This indicates that opium tincture is a relevant treatment strategy for selected patients with chronic diarrhea. Moreover, no evidence of opioid-induced sedation or addiction was found.Trial Registration Number: NCT05690321 (registered 2023-01-10).

Antonio Grossich, the doctor and the irredentist.

The routine use of iodine tincture in medicine represents a turning point in the history of surgical procedures. It was the Istrian doctor Antonio Grossich (1849-1926) who first defined and applied the best formula and demonstrated to the world its superiority over other antiseptics. Although his was a life guided by medicine and the steadfast translation of his political ideals into practice, Grossich's achievements were somewhat obscured by his active involvement in the Istrian irredentism of the first decades of the wentieth century.

Heterogeneity of transport and metabolism of Tormentillae rhizoma constituents across human intestinal epithelium cellular model.

Tormentilla erecta (L.) Raeusch is a widespread plant in Europe and Western Asia. Its rhizomes (Tormentilae rhizoma) are the main ingredient of herbal alcoholic beverages and can be used as a natural preservative in beer production. Apart from its unique taste qualities, therapeutic properties in gastrointestinal tract ailments are attributed to the tincture obtained from Tormentillae rhizoma. The presented research aimed to determine the mutual relationship between the components of Tormentillae tincture, present in popular alcoholic beverages, and intestinal epithelium (Caco-2 cell monolayers). A comprehensive qualitative and quantitative analysis of the tincture was performed, including the determination of condensed and hydrolyzable tannins as well as triterpenoids (UHPLC-DAD-MS/MS). Incubation of the tincture with Caco-2 monolayers has shown that only triterpenes pass through the monolayer, while condensed tannins are mainly bound to the monolayer surface. Ellagic acid derivatives were the only components of the Tormentillae tinctura being metabolized by cell monolayers to the compounds not previously described in the literature, which may be crucial in the treatment of intestinal diseases with inflammatory background.

Raha syrup attenuates the morphine withdrawal-induced locomotor sensitisation by increasing the cerebrospinal fluid serotonin in rats receiving the opium tincture maintenance treatment.

Morphine withdrawal increases locomotor sensitisation, relapse and impair regulation of serotonin system. We evaluated the effectiveness of Raha syrup on the cerebrospinal fluid (CSF) serotonin levels following locomotor sensitisation in morphine-withdrawn rats receiving the opium tincture (OT). Morphine withdrawal rats gavaged daily with OT and Raha syrup (for 30 days) and then challenged with morphine and evaluated for locomotor activity and CSF serotonin levels before morphine challenge and 2 weeks after cessation of treatment. Raha syrup attenuated locomotor activity, increased the CSF serotonin after morphine challenge, and continued 2 weeks after cessation of treatment in rats receiving OT. Whereas, rats receiving OT alone after morphine challenge exhibited a relative decrease in locomotor activity, without changing CSF serotonin. Raha syrup attenuated locomotor sensitisation in morphine-withdrawn rats receiving OT probably by increasing serotonin. Therefore, administration of Raha syrup along with OT may benefit to treatment relapse in addicts receiving OT maintenance treatment.

Safety and efficacy of a feed additive consisting of a tincture derived from the flowers of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove tincture) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried flower bud of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■) solution, with a dry matter content of ~ 1.66%. The product contains on average 0.511% phenolic acids (of which 0.0344% were flavonoids), 0.039% eugenol, 0.00019% methyleugenol and 0.00008% estragole. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove tincture is very unlikely to be of safety concern for the target species up to the maximum proposed use level of 50 mg clove tincture/kg complete feed for all animal species, except for horses, for which the proposed use level is 200 mg/kg complete feed. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered very unlikely to be of safety concern when consumed via feed alone. No safety concern would arise for the consumer and the environment from the use of clove tincture up to the maximum proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the flower buds of S. aromaticum and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of a tincture derived from the leaves of Eucalyptus globulus Labill. (eucalyptus tincture) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the leaves of Eucalyptus globulus Labill. (eucalyptus tincture) when used as a sensory additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of ~ 1.86%, which contains on average 0.454% phenolic acids and flavonoids (of which 0.280% was gallic acid), 0.0030% 1,8-cineole and 0.00012% methyleugenol. In the absence of analytical data on the occurrence of mono- or diformylated adducts of acylphloroglucinols with terpenes in the tincture and in the absence of toxicity data, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the use of eucalyptus tincture for long-living and reproductive animals. For short-living animals (species for fattening), the additive was considered of no concern at 4 mg/kg complete feed for chickens for fattening, 5 mg/kg for turkeys for fattening, 6 mg/kg for piglets and rabbits for meat production, 7 mg/kg for pigs for fattening, 16 mg/kg for veal calves (milk replacer), 14 mg/kg for cattle for fattening, sheep/goats and horses for fattening, and 15 mg/kg for salmonids. These levels were extrapolated to physiologically related minor species. No safety concern would arise for the consumer from the use of eucalyptus tincture up to the levels in feed considered of no concern. Eucalyptus tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of eucalyptus tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the leaves of E. globulus and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Safety and efficacy of feed additives consisting of ginkgo tinctures obtained from the leaves of Ginkgo biloba L. for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tinctures obtained from the dried leaves of Ginkgo biloba L. (ginkgo tinctures) when used as sensory additives. The tinctures are water/ethanol solutions with a dry matter content of 5.7% (tincture A) and 3.0% (tincture B). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additives under assessment are safe for the target species at the following concentrations in complete feed: (i) ginkgo tincture A at 240 mg/kg for horses and 750 mg/kg for dogs; (ii) ginkgo tincture B at 600 mg/kg for horses and 50 mg/kg for all other animal species. No safety concern would arise for the consumer from the use of ginkgo tinctures up to the maximum proposed use level in feed for the target species. The tinctures should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of ginkgo tinctures at the proposed use levels in feed for the target species is not considered to be a risk to the environment. While the available data indicate that Ginkgo preparations have a distinctive flavour profile, there is no evidence that ginkgo tinctures would impart flavour to a food or feed matrix. Therefore, the FEEDAP Panel cannot conclude on the efficacy of the additives.

Safety and efficacy of a feed additive consisting of a tincture derived from the roots of Panax ginseng C.A.Mey. (ginseng tincture) for horses, dogs and cats (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Panax ginseng C.A.Mey. (ginseng tincture), when used as a sensory additive in feed for horses, dogs and cats. The product is a water/ethanol (40:60 v/v) solution, with a dry matter content of no more than 6% and a content of 0.01%-0.5% (w/w) for the sum of the two triterpene saponins ginsenoside Rb1 and ginsenoside Rg1. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the tincture is safe for horses, dogs and cats at the maximum proposed use level of 48.6, 228.7 and 162 mg/kg complete feed, respectively. The Panel also concluded that the additive is considered safe for consumers when used at the proposed conditions of use in feed for horses. Ginseng tincture should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of the ginseng tincture as a flavour in feed for horses was not expected to pose a risk for the environment. Since the roots of P. ginseng and its preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of a tincture derived from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture) for poultry, horses, dogs and cats (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture), when used as a sensory additive in feed for horses, cats, dogs, and in feed and in water for drinking for poultry. The product is a water/ethanol (55:45 v/v) solution, with a dry matter content of not more than 4% (w/w) and a content of 0.01%-0.15% (w/w) for the sum of schisandrin and deoxyschisandrin. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that omicha tincture is safe at the following concentrations in complete feed: 16 mg/kg for turkeys for fattening, 12 mg/kg for chickens for fattening and other poultry for fattening or reared for laying/reproduction, 18 mg/kg for laying hens and other laying/reproductive birds, 56 mg/kg for dogs and 47 mg/kg for horses and cats. The additive is considered safe for consumers when used up to the highest safe level in feed for poultry species and horses. Omicha tincture should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of omicha tincture as a flavour in feed for poultry species and horses was not considered to be a risk to the environment. Since it was recognised that the fruit of S. chinensis can influence sensory properties of feedingstuffs, no further demonstration of efficacy was considered necessary for the tincture under assessment.

Miao medicine Gu Yan Xiao tincture inhibits mTOR to stimulate chondrocyte autophagy in a rabbit model of osteoarthritis.

ETHNOPHARMACOLOGICAL RELEVANCE: The Gu Yan Xiao tincture, a blend of traditional Chinese herbs, is traditionally used for osteoarthritis and related pain. This study investigated its mechanism of action in order to rationalize and validate its therapeutic use. AIM OF THE STUDY: This study analyzed, in a rabbit model of knee osteoarthritis, whether and how Gu Yan Xiao tincture exerts therapeutic benefits by modulating chondrocyte autophagy. MATERIALS AND METHODS: The active constituents within the GYX tincture were identified using liquid chromatography-mass spectrometry. The rabbit model was established by injecting animals with type II collagenase intra-articularly, and the effects of topically applied tincture were examined on osteoarthritis lesions of the knee using histopathology, micro-computed tomography and x-ray imaging. Effects of the tincture were also evaluated on levels of inflammatory cytokines, matrix metalloproteases, and autophagy in chondrocytes. As a positive control, animals were treated with sodium diclofenac. RESULTS: The tincture mitigated the reduction in joint space, hyperplasia of the synovium and matrix metalloproteases in serum that occurred after injection of type II collagenase in rabbits. These therapeutic effects were associated with inhibition of mTOR and activation of autophagy in articular chondrocytes. Inhibiting mTOR with rapamycin potentiated the therapeutic effects of the tincture, while inhibiting autophagy with 3-methyladenine antagonized them. CONCLUSIONS: Gu Yan Xiao tincture mitigates tissue injury in a rabbit model of osteoarthritis, at least in part by inhibiting mTOR and thereby promoting autophagy in chondrocytes. These results rationalize the use of the tincture not only against osteoarthritis but also potentially other diseases involving inhibition of autophagy in bones and joints.

Long-term detoxification of opioid use disorder with opium tincture assisted treatment.

Introduction: Retention in treatment, craving, and relapse rate are important indicators of the success rate in addiction maintenance therapy as they evaluate the effectiveness of the therapy and make necessary adjustments to the treatment plan. However, the rate of continuation in the treatment process and the rate of craving in patients with opioid use disorder undergoing maintenance treatment with opium tincture have not been studied. The present study aimed to investigate the rate of relapse, craving, and psychiatric disorders in patients with opioid use disorder undergoing treatment of gradual detoxification with opium tincture. Methods: Ninety patients with opioid use disorder who underwent treatment with the gradual detoxification method using opium tincture in the form of Congress 60 for 11 months were enrolled in the study. The level of craving based on the Desire for Drug Questionnaire (DDQ) and patients' self-report of drug use, the level of anxiety, depression, and sleep quality of patients were evaluated using the Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI), respectively. Also, suicidal thoughts were assessed by Beck Scale for Suicidal Ideation and quality of life by the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). Results: The study found that the treatment resulted in a relapse rate of 16.7% for relapse. We also found that all sub-scales of the desire for drug questionnaire (DDQ), depression, and anxiety were significantly lower at the end of the study compared to its beginning. Additionally, quality of life and sleep significantly increased at the end of the study. All areas of craving, anxiety, and depression significantly decreased in all follow-up sessions that took place 1, 5, and 11 months after the start of treatment. Moreover, sleep disorders were improved considerably at the end of the treatment. Conclusion: The current study presented a low relapse rate of Iranian patients with opioid use disorder under structured treatment of gradual detoxification with opium tincture in a one-year follow-up period. Opium tincture under the Congress 60 protocol may help to control carving, decrease psychological disorders, improve quality of life, and consequently, lower relapse rate.

Cannabidiol Oil Ingested as Sublingual Drops or Within Gelatin Capsules Shows Similar Pharmacokinetic Profiles in Healthy Males.

Introduction: Cannabidiol (CBD) is a nonintoxicating phytocannabinoid used in clinical treatments and sold widely in consumer products. CBD products may be designed for sublingual or oral delivery, but it is unclear whether either is advantageous for CBD absorption. This study compared CBD pharmacokinetics after providing CBD oil as sublingual drops and within orally ingested gelatin capsules, at a dose relevant to consumer products. Materials and Methods: Eight males completed three conditions in a participant-blinded, randomized crossover design. Participants received the following combinations of placebo and CBD-containing (69 mg/mL) hemp oil in capsules and as sublingual drops: placebo capsules/placebo drops (Placebo), CBD capsules/placebo drops (CBD-Caps), and placebo capsules/CBD drops (CBD-Drops). Blood samples, blood pressure, and subjective scales were obtained/completed hourly for 6 h and at 24 h. Discussion: Plasma CBD concentrations were not different between CBD-Caps and CBD-Drops (interaction effect p=0.76). Peak CBD concentration (28.0±15.6 vs. 24.0±22.2 ng/mL), time of peak CBD concentration (4±1 vs. 4±2 h), and area under the concentration curve (45.3±20.3 vs. 41.8±23.3 ng/mL·6 h) were not different between conditions (p≥0.25). Cardiometabolic outcomes (plasma glucose/triacylglycerol, heart rate, blood pressure), liver function (plasma alanine aminotransferase/aspartate aminotransferase), kidney function (plasma creatinine), and subjective feelings/symptoms were not different between conditions (p≥0.07). Conclusions: Plasma CBD profiles were comparable between CBD-Caps and CBD-Drops, suggesting that there were not meaningful differences in routes of CBD absorption between conditions. This implies that CBD oil delivered sublingually is swallowed before oral mucosal CBD absorption occurs, which may have implications for research design, CBD product design, and consumer product choice.

Quality control and evaluation of Xiaozhong Zhitong tincture by multi-wavelength fingerprint combined with electrochemical fingerprint.

Xiaozhong Zhitong tincture (XZZTT), a prominent Traditional Chinese Medicine (TCM) formulation comprising 21 intricate herbal components, poses a challenge in terms of quality control due to its complex composition and the interplay of diverse chemical constituents. To address this issue, a comprehensive assessment strategy was devised by integrating chromatographic and electrochemical techniques to construct a multidimensional fingerprint for XZZTT samples. This study encompassed the evaluation of 42 XZZTT samples through a systematic quantitative fingerprinting method (SQFM), while also quantifying the concentrations of four specific compounds-Geniposide, Palmatine hydrochloride, Paeonol, and Chlorogenic acid. The experimental approach encompassed the establishment of fingerprints using High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and GC-HPLC tandem fingerprints methods. Furthermore, electrochemical fingerprints (ECFP) were established using the B-Z oscillation system, and eight characteristic parameters in the oscillation system were recorded and compared among samples. Hierarchical Clustering Analysis (HCA) was subsequently employed to classify the distinct fingerprints and compare outcomes from one-dimensional spectroscopy, GC-HPLC tandem chromatography, and the fusion fingerprints. Finally, Grey Relation Analysis (GRA) was harnessed to unravel the relationship between ECFP outcomes and peak areas in fusion fingerprints, facilitating predictions regarding the substances' reducing potency. In conclusion, the rational combination of multidimensional fingerprinting and multidimensional analysis provides a reliable and comprehensive method for the evaluation of XZZTT and its related products.

Quality of life of patients treated with opium tincture or methadone: A randomized controlled trial.

OBJECTIVE: Quality of life (QoL) is an increasingly recognized patient-centered treatment outcome in individuals with opioid use disorder. There is a gap in literature on the impact of opium tincture (OT) on patients' QoL compared to standard treatment options such as methadone. This study aimed to compare the QoL of participants with opioid use disorder receiving OAT using OT or methadone and identify the factors associated with their QoL during treatment. METHODS: The opium trial was a multicenter non-inferiority randomized clinical trial in four private OAT outpatient clinics in Iran. The study assigned patients to either OT (10 mg/ml) or methadone sirup (5 mg/ml) for a follow-up of 85 days. QoL was assessed using the brief version of the World Health Organization Quality of Life instrument (WHOQOL- BREF). RESULTS: A total of 83 participants, 35 (42.2%) in the OT arm and 48 (57.8%) in the methadone arm, completed the WHOQOL-BREF in full and were included in the primary analysis. The mean score of patients' QoL showed improvement compared to baseline, but differences were not statistically significant between OT and methadone arms (p = 0.786). Improvements were mainly observed within the first 30 days of receiving treatment. Being married and lower psychological distress were associated with an improved QoL. Within the social relationships domain, male gender showed significantly higher QoL compared to females. CONCLUSION: OT shows promise as an OAT medication, comparable to methadone in improving patients' QoL. There is a need to incorporate psychosocial interventions to further sustain and improve the QoL in this population. Identifying other social determinants of health which affect QoL and the cultural adaptation of assessments for individuals from various ethnocultural backgrounds are critical areas of inquiry.

Safety and efficacy of a feed additive consisting of a tincture derived from the buds of Pinus sylvestris L. (pine tincture) for use in all animal species (FEFANA abl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the buds of Pinus sylvestris L. (pine tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product under assessment is a ■■■■■ solution, with a dry matter content of ~ 2.2%. The product contains on average 0.0882% polyphenols, of which 0.0222% are phenolic acids. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that pine tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for all animal species. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered safe when consumed via feed alone. No safety concern would arise for the consumer from the use of pine tincture up to the maximum proposed use level in feed. Pine tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. The use of pine tincture in animal feed was not expected to pose a risk for the environment. Since twigs of P. sylvestris, which are considered similar in composition to the source material for the production of pine tincture, are described to flavour food, no further demonstration of efficacy is deemed necessary.

Safety and efficacy of feed additives consisting of an essential oil and tincture from the berries of Juniperus communis L. (juniper oil and juniper tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of juniper oil and juniper tincture obtained from the berries of Juniperus communis L., when used as sensory additives for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that juniper oil is safe up to the maximum proposed use levels in complete feed of 5 mg/kg for laying hens, 15 mg/kg for veal calves (milk replacer) and cattle for fattening and 20 mg/kg for ornamental fish. For the other species, the calculated safe concentrations in complete feed were 4 mg/kg for chickens for fattening, 5 mg/kg for turkeys for fattening, 7 mg/kg for piglets, 8 mg/kg for pigs for fattening, 10 mg/kg for sows, dairy cows, 16 mg/kg for sheep, goats and horses, 6 mg/kg for rabbits, 17 mg/kg for salmonids, 18 mg/kg for dogs and 3 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 3 mg/kg complete feed. The FEEDAP Panel concluded that juniper tincture is safe up to the maximum proposed use level in feed of 45 mg/kg complete feed or water for drinking for all animal species. No concerns for consumers and the environment were identified following the use of the additives to the highest safe level in feed. The additives under assessment should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. Since the berries of J. communis and their preparations are recognised to flavour food and their function in feed would be the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of feed additives obtained from the fruit of Pimpinella anisum L.: anise oil for use in poultry and horses and anise tincture for use in poultry, dogs, cats and horses (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of anise oil and anise tincture obtained from the fruit of Pimpinella anisum L., when used as sensory additives. The use of the anise oil at the proposed use level in complete feed of 1.9 mg/kg for laying hens and 5 mg/kg for horses was considered of low concern. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concern when anise oil is used at the proposed use levels of 1.5 mg/kg for chickens for fattening and at 1.7 mg/kg for turkeys for fattening. The use of anise tincture at the proposed conditions of use was considered of low concern in dogs, cats, horses and laying hens, and of no concern in chickens for fattening. The use of the additives up to the highest level in feed which was considered of low or no concern for target animals was also expected to be of no concern for consumers. The additives under assessment should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. Due to the high concentration of estragole (≥ 1%), anise oil is classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. When handling anise tincture, exposure of unprotected users to estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of these additives in animal feed was not expected to pose a risk to the environment. Since the fruit of P. anisum and its preparations are recognised to flavour food and their function in feed would be the same, no further demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Pimpinella anisum L. (anise tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the fruit of Pimpinella anisum L. (anise tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 1.6%. The product contained on average 0.0414% polyphenols (of which 0.0144% were flavonoids), 0.0009% anisaldehyde, 0.0003% anethole. Estragole (≤ 1.2 mg/kg) was detected in the additive. The estimated maximum content of furocoumarins was 8.2 mg/kg. The use of the anise tincture 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 (< 10%). For dogs, cats and ornamental fish not normally exposed to citrus by-products, no conclusion could be drawn. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the anise tincture was safe at the maximum proposed use levels in complete feed of 200 mg/kg for horses and 50 mg/kg for poultry, pigs, ruminants, rabbits and salmonids and other fin fish. Anise tincture should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since anise tincture may contain furocoumarins, they may cause phototoxicity. When handling the additive, exposure of unprotected users to estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of the anise tincture as a flavour in animal feed was not expected to pose a risk for the environment. Since the fruit of P. anisum and its preparations were recognised to flavour food and their function in feed would be the same, no demonstration of efficacy was necessary.

Safety and efficacy of a feed additive consisting of a tincture derived from the roots of Eleutherococcus senticosus (Rupr. & Maxim.) Maxim. (taiga root tincture) for use in dogs, cats and horses (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the roots of Eleutherococcus senticosus (Rupr. & Maxim.) Maxim. (taiga root tincture) when used as a sensory additive in feed for dogs, cats and horses. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for dogs, cats and horses at the maximum proposed use level of 460.7, 489.5 and 140.7 mg/kg complete feed, respectively. The additive was considered safe for consumers when used at the proposed conditions of use in horses for meat production. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the taiga root tincture as a flavour in feed for horses was not expected to pose a risk for the environment. Since the root of E. senticosus has flavouring properties and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the tincture under assessment.