Assessment of the feed additive consisting of l-cystine for all animal species for the renewal of its authorisation (Bretagne Chimie Fine [BCF Life Sciences]).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of l-cystine as nutritional feed additive. The additive is authorised for use in all animal species (3c391). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, the consumers and the environment. As regards the safety for the user, l-cystine is not an irritant to skin or eyes and is not a skin sensitiser. Exposure by inhalation of persons handling the additive cannot be excluded. The present application for the renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for reassessing the efficacy.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the wood of Juniperus deppeana Steud. (cedarwood Texas oil) 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 an essential oil obtained from the wood of Juniperus deppeana Steud. (cedarwood Texas oil), when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for veal calves (milk replacer), cattle for fattening, sheep, goats, horses, dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 10 mg/kg for piglets, 12 mg/kg for pigs for fattening, 14 mg/kg for sows and dairy cows, 8.5 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 4 mg/kg complete feed. The use of cedarwood Texas oil in water for drinking was considered safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. Since the individual components of cedarwood Texas oil are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) for suckling and weaned piglets and other growing Suidae (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) as a zootechnical feed additive for suckling and weaned piglets and other growing Suidae. The additive is standardised to contain a concentration of the sum of the four alkaloids sanguinarine, chelerythrine, protopine and allocryptopine of 1.25%, with 0.5% sanguinarine. Owing to the presence of the DNA intercalators sanguinarine and chelerythrine, a concern for genotoxicity was identified. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns for the target species when the additive is used at the recommended level of 0.750 mg sanguinarine/kg complete feed for suckling and weaned piglets and other growing Suidae. Since in all consumer categories the exposure to sanguinarine and chelerythrine via the use of Sangrovit® Extra exceeds the threshold of toxicological concern of 0.0025 µg/kg bw per day for DNA reactive mutagens and/or carcinogens, the FEEDAP Panel could not conclude on the safety for the consumers. The additive was shown to be irritant to the eyes but not irritant to skin or a skin sensitiser. The FEEDAP Panel could not exclude the potential of the additive to be a respiratory sensitiser. When handling the additive, exposure of unprotected users to sanguinarine and chelerythrine may occur. Therefore, to reduce the risk, the exposure of users should be reduced. The use of Sangrovit® Extra as a feed additive under the proposed conditions of use was considered safe for the environment. The additive Sangrovit® Extra had the potential to be efficacious in improving performance of weaned piglets at 0.600 mg sanguinarine/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing Suidae.

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Cymbopogon nardus (L.) Rendle (citronella oil) 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 citronella oil obtained from the leaves of Cymbopogon nardus (L.) Rendle, when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that citronella oil from C. nardus is of low concern for long-living and reproductive animals at the use levels in complete feed of 3.5 mg/kg for laying hens and rabbits, 6 mg/kg for sows and dairy cows, 9.5 mg/kg for sheep/goats and horses, 2.0 mg/kg for cats and 10 mg/kg for dogs. For short-living animals (species for fattening), the additive was considered of no concern at concentrations of 18 mg/kg in chickens for fattening, 24 mg/kg in turkeys for fattening, 20 mg/kg for piglets, pigs for fattening, veal calves (milk replacer), cattle for fattening, sheep/goats for meat production, horses for meat production and rabbits for meat production, and 30 mg/kg for salmonids. The conclusions were extrapolated to physiologically related minor species. For any other species, the additive is considered of low concern at 2.0 mg/kg complete feed. The use of citronella oil in animal feed is expected to be of no concern for the consumers and for the environment. The essential oil under assessment should be considered as irritant to skin and eyes and as a dermal sensitiser. When handling the essential oil, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of C. nardus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of an essential oil derived from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L. (cajuput oil) for use in all animal species (FEFANA asbl).

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 cajuput oil obtained from fresh leaves of Melaleuca cajuputi Maton & Sm. ex R. Powell and Melaleuca leucadendra (L.) L., when used as a sensory additive for all animal species. The FEEDAP Panel concluded that cajuput oil is safe up to the maximum proposed use levels in complete feed of 30 mg/kg for sows and dogs, 50 mg/kg for horses and ornamental fish, 40 mg/kg for salmon and 5 mg/kg for cats. For the other species, the calculated safe concentrations were 18 mg/kg for chickens for fattening, 26 mg/kg for laying hens, 23 mg/kg for turkeys for fattening, 37 mg/kg for pigs for fattening, 31 mg/kg for piglets, 78 mg/kg for veal calves (milk replacer), 69 mg/kg for cattle for fattening and sheep/goats, 45 mg/kg for dairy cows and 28 mg/kg for rabbits. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 5 mg/kg complete feed. The use of cajuput oil in water for drinking was considered safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. The essential oil under assessment should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. Since cajuput oil was recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Outcomes and effect of somatic mutations after erythropoiesis stimulating agents in patients with lower-risk myelodysplastic syndromes.

Background: Erythropoiesis stimulating agents (ESAs) are the first-line therapy in patients with lower-risk myelodysplastic syndromes (LR-MDS). Some predictive factors for ESAs response have been identified. Type and number of somatic mutations have been associated with prognosis and response to therapies in MDS patients. Objectives: The objective was to evaluate the outcomes after ESAs in patients with LR-MDS and to address the potential predictive value of somatic mutations in ESAs-treated patients. Design: Multi-center retrospective study of a cohort of 722 patients with LR-MDS included in the SPRESAS (Spanish Registry of Erythropoietic Stimulating Agents Study) study. Retrospective analysis of 65 patients with next generation sequencing (NGS) data from diagnosis. Methods: ESAs' efficacy and safety were evaluated in patients receiving ESAs and best supportive care (BSC). To assess the potential prognostic value of somatic mutations in erythroid response (ER) rate and outcome, NGS was performed in responders and non-responders. Results: ER rate for ESAs-treated patients was 65%. Serum erythropoietin (EPO) level <200 U/l was the only variable significantly associated with a higher ER rate (odds ratio, 2.45; p = 0.036). Median overall survival (OS) in patients treated with ESAs was 6.7 versus 3.1 years in patients receiving BSC (p < 0.001). From 65 patients with NGS data, 57 (87.7%) have at least one mutation. We observed a trend to a higher frequency of ER among patients with a lower number of mutated genes (40.4% in <3 mutated genes versus 22.2% in ⩾3; p = 0.170). The presence of ⩾3 mutated genes was also significantly associated with worse OS (hazard ratio, 2.8; p = 0.015), even in responders. A higher cumulative incidence of acute myeloid leukemia progression at 5 years was also observed in patients with ⩾3 mutated genes versus <3 (33.3% and 10.7%, respectively; p < 0.001). Conclusion: This large study confirms the beneficial effect of ESAs and the adverse effect of somatic mutations in patients with LR-MDS.

Microplastics in the stomach content of the commercial fish species Scomber colias in the Gulf of Cadiz, SW Europe.

Concerning microplastics (MPs) contamination is increasing due their negative impacts on marine food webs and their potential toxicity to wildlife and humans. In this study, we analyze the presence of MPs in the stomachs of the commercial fish species Scomber colias (Atlantic chub mackerel) in the Gulf of Cadiz (GoC). Out of the 104 analyzed stomachs, 90.4 % contained some type of MPs, with an average of 5.4 MPs per individual. Of the 1152 MPs analyzed, 91.1 % were fibers, and 8.9 % fragments type. Fourier Transformation Infrared Spectrometry analysis was performed on 152 items, revealing that 73.6 % were MPs. The most common synthetic polymers found were polyamide (64 %), polypropylene (15 %), polystyrene (12 %), polyvinyl chloride (5 %), and polyethylene (4 %). The consistent ingestion of synthetic polymers by the individuals of Atlantic chub mackerel across different zones might suggest an even distribution of MP contamination throughout the GoC.

Survival Outcomes and Health-Related Quality of Life in Older Adults Diagnosed with Acute Myeloid Leukemia Receiving Frontline Therapy in Daily Practice.

Acute myeloid leukemia has a poor prognosis in older adults, and its management is often unclear due to its underrepresentation in clinical trials. Both overall survival (OS) and health-related quality-of-life (HRQoL) are key outcomes in this population, and patient-reported outcomes may contribute to patient stratification and treatment assignment. This prospective study included 138 consecutive patients treated in daily practice with the currently available non-targeted therapies (intensive chemotherapy [IC], attenuated chemotherapy [AC], hypomethylating agents [HMA], or palliative care [PC]). We evaluated patients' condition at diagnosis (Life expectancy [Lee Index for Older Adults], Geriatric Assessment in Hematology [GAH scale], HRQoL [EQ-5D-5L questionnaire], and fatigue [fatigue items of the QLQ-C30 scale]), OS, early death (ED), treatment tolerability (TT) and change in HRQoL over 12 months follow-up. The median OS was 7.1 months (IC not reached, AC 5.9, HMA 8.8, and PC 1.0). Poor risk AML category and receiving just palliative care, as well as a higher Lee index score in the patients receiving active therapy, independently predicted a shorter OS. The Lee Index and GAH scale were not useful for predicting TT. The white blood cell count was a valid predictor for ED. Patients' HRQoL remained stable during follow-up.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the fruit of Coriandrum sativum L. (coriander oil) (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of Coriandrum sativum L. (coriander oil), when used as a sensory additive in feed for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of coriander oil is safe up to the maximum proposed use levels of 30 mg/kg complete feed for piglets, pigs for fattening, sows, veal calves (milk replacer), cattle for fattening, sheep, goats and horses, salmonids, dogs and ornamental fish. For the other species, the calculated safe concentrations in complete feed are: 14 mg/kg for chickens for fattening, 28 mg/kg for laying hens, 26 mg/kg for turkeys for fattening, 28 mg/kg for rabbits and 14 mg/kg for cats. These conclusions were extrapolated to physiologically related species. For any other species, the additive was considered safe at 14 mg/kg complete feed. The proposed conditions of use for veal calves (10 mg/kg) and ruminants, horses and dogs (5 mg/kg) were considered safe provided that the use in water for drinking alone or in combination with the use in feed should not exceed the daily amount that is considered safe when consumed via feed alone. No concerns for consumers and the environment were identified following the use of coriander oil up to the maximum proposed use level in feed. Coriander oil should be considered as irritant to skin and eyes and the respiratory tract and as a dermal and respiratory sensitiser. Since C. sativum and its preparations are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of feed additives consisting of essential oils from the fruit and stems of Foeniculum vulgare Mill. ssp. vulgare: Bitter fennel oil for use in all animal species and sweet fennel oil for use in 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 essential oils from fruit and stems of Foeniculum vulgare Mill. (bitter fennel oil and sweet fennel oil), when used as sensory additives (flavourings). For long-living and reproductive animals, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered of low concern the use of bitter fennel oil (with a content of estragole up to 6.1%) at the proposed use level in complete feed: 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.5 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 7.1 mg/kg for ornamental fish. For short-living animals (animals for fattening), the Panel had no safety concern when bitter fennel oil is used at the proposed use level in complete feed of 18.2 mg/kg for chickens for fattening, 24.3 mg/kg for turkeys for fattening and 25 mg/kg for piglets, pigs for fattening, veal calves, cattle for fattening, sheep/goats, horses, rabbits and salmon. These conclusions were extrapolated to other physiologically related species. The use of sweet fennel oil (with a content of estragole up to 5.0%) was considered of low concern at the proposed use level in complete feed of 2.3 mg/kg for dogs and 1.9 mg/kg cats. The use of bitter fennel oil in animal feed is expected to be of no concern for consumers and the environment. 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%), fennel oils are classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of F. vulgare Mill. ssp. vulgare and its preparations are recognised to flavour food, no further demonstration of efficacy was necessary.

Safety and efficacy of a feed additive consisting of iron(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

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 safety and efficacy of iron(II)-betaine complex as a nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chickens the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of iron in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum iron levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the iron(II)-betaine complex in animal nutrition at the maximum iron levels authorised for the animal species poses no concern to the safety of consumers. The additive is not a skin irritant, but it is an irritant to the eyes. Due to the traces of nickel, the additive is considered to be a respiratory and skin sensitiser. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals, land-based and sea cages aquaculture is considered safe under the proposed conditions of use. Based on the deposition of iron in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable iron, comparable to the standard inorganic iron source, and therefore, the additive is efficacious in meeting the birds iron requirements. This conclusion can be extrapolated to all animal species and categories.

Machine Learning Improves Risk Stratification in Myelodysplastic Neoplasms: An Analysis of the Spanish Group of Myelodysplastic Syndromes.

Myelodysplastic neoplasms (MDS) are a heterogeneous group of hematological stem cell disorders characterized by dysplasia, cytopenias, and increased risk of acute leukemia. As prognosis differs widely between patients, and treatment options vary from observation to allogeneic stem cell transplantation, accurate and precise disease risk prognostication is critical for decision making. With this aim, we retrieved registry data from MDS patients from 90 Spanish institutions. A total of 7202 patients were included, which were divided into a training (80%) and a test (20%) set. A machine learning technique (random survival forests) was used to model overall survival (OS) and leukemia-free survival (LFS). The optimal model was based on 8 variables (age, gender, hemoglobin, leukocyte count, platelet count, neutrophil percentage, bone marrow blast, and cytogenetic risk group). This model achieved high accuracy in predicting OS (c-indexes; 0.759 and 0.776) and LFS (c-indexes; 0.812 and 0.845). Importantly, the model was superior to the revised International Prognostic Scoring System (IPSS-R) and the age-adjusted IPSS-R. This difference persisted in different age ranges and in all evaluated disease subgroups. Finally, we validated our results in an external cohort, confirming the superiority of the Artificial Intelligence Prognostic Scoring System for MDS (AIPSS-MDS) over the IPSS-R, and achieving a similar performance as the molecular IPSS. In conclusion, the AIPSS-MDS score is a new prognostic model based exclusively on traditional clinical, hematological, and cytogenetic variables. AIPSS-MDS has a high prognostic accuracy in predicting survival in MDS patients, outperforming other well-established risk-scoring systems.

Safety and efficacy of a feed additive consisting of a fraction of the essential oil from the fruit and leaves of Illicium verum Hook.f. (star anise terpenes) 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 fraction of the essential oil from the fruit and leaves of Illicium verum Hook.f. (star anise terpenes), when used as a feed additive for all animal species. The additive contains up to 25% estragole by specification and is obtained by a manufacturing process which results in the enrichment of this genotoxic carcinogen. This is not in line with the principles outlined in the general approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic when used as feed additives. Therefore, the FEEDAP Panel considered it was inappropriate to perform an assessment of the safety and efficacy of star anise terpenes for its use as a feed additive.

Safety and efficacy of a feed additive consisting of an essential oil derived from the fruit of Illicium verum Hook.f. (star anise oil) 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 star anise oil from the fruit (without or with the presence of plant leaves) of Illicium verum Hook.f., when used as a sensory additive in feed and water for drinking for all animal species. For long-living and reproductive animals, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered of low concern the use of the additive in complete feed at 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.6 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 6.5 mg/kg for ornamental fish. For short-living animals, the Panel had no safety concern when the additive is used at 83.3 mg/kg for veal calves, 73.3 mg/kg for sheep/goats, cattle for fattening and horses for meat production, 83.8 mg/kg for salmonids, 24.8 mg/kg for turkeys for fattening, 18.5 mg/kg chickens for fattening, 33.3 mg/kg for piglets, 40 mg/kg for pigs for fattening and 29.3 mg/kg for rabbits for meat production. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered of low concern at 0.6 mg/kg. The use of star anise oil in animal feed is expected to be of no concern for consumers and for the environment. The additive under assessment should be considered as an irritant to skin and eyes, and as a dermal and respiratory sensitiser. Due to the high concentration of estragole (≥ 1%), the additive is classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of I. verum and its preparations are recognised to flavour food and their function in feed would be the same, no further demonstration of efficacy was necessary.

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 a feed additive consisting of an essential oil derived from the aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson (lemongrass oil) for use in all animal species (FEFANA asbl).

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 lemongrass oil obtained from the aerial parts of Cymbopogon flexuosus (Nees ex Steud.) Will. Watson when used as a sensory additive for all animal species. The FEEDAP Panel concluded that lemongrass oil is safe up to the maximum proposed use levels in complete feed of 125 mg/kg for salmonids; 100 mg/kg for sows and horses; 75 mg/kg for veal calves (milk replacer), cattle for fattening, dairy cows, sheep and goats; and 50 mg/kg for dogs and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 41 mg/kg for chickens for fattening, 61 mg/kg for laying hens, 55 mg/kg for turkeys for fattening, 74 mg/kg for piglets, 88 mg/kg for pigs for fattening, 65 mg/kg for rabbits and 33 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 33 mg/kg complete feed. The use of lemongrass oil in water for drinking for poultry, pigs, calves and rabbit is safe provided that the total daily intake does not exceed the daily amount considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the highest safe use level in feed. The essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the aerial parts of C. flexuosus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of feed additives consisting of essential oils derived from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove bud oil and clove leaf oils) 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 essential oils from the flower buds or the leaves of Syzygium aromaticum (L.) Merr. & L.M. Perry: clove bud oil, clove leaf oil and a ß-caryophyllene-rich fraction of clove leaf oil (CCL oil), when used as sensory additives in feed and water for drinking for all animal species. Clove oils contain methyleugenol (up to 0.13%). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove oils was of low concern for long-living and reproductive animals and of no concern for target species for fattening at the following concentrations in complete feed: 25-50 mg/kg for clove bud oil, 28-100 mg/kg for clove leaf oil and 20 mg/kg for CCL oil. The FEEDAP Panel considered that the use in water for drinking alone or in conjunction with use in feed should not exceed the daily amount that is considered of low or no concern when consumed via feed alone. No concerns for consumers were identified following the use of clove oils up to the highest safe level in feed. The additives under assessment should be considered as irritant to skin and eyes and the respiratory tract and as skin sensitisers. When handling the essential oils, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. The use of clove oils at the proposed use level in feed was not expected to pose a risk for the environment. Since clove bud oil and clove leaf oil are 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 an essential oil derived from Eucalyptus globulus Labill. (eucalyptus oil) 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 an essential oil from the leaves and twigs of Eucalyptus globulus Labill. (eucalyptus oil) when used as a sensory additive in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the use of eucalyptus oil is safe at the following concentrations in complete feed: 12 mg/kg for chickens for fattening, 18 mg/kg for laying hens, 16 mg/kg for turkeys for fattening, 22 mg/kg for piglets, 26 mg/kg for pigs for fattening, 32 mg/kg for sows, 55 mg/kg for veal calves (milk replacer), 48 mg/kg for cattle for fattening, sheep, goats and horses, 31 mg/kg for dairy cows, 19 mg/kg for rabbits, 55 mg/kg for salmonids, 58 mg/kg for dogs, 10 mg/kg for cats and 75 mg/kg for ornamental fish. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 10 mg/kg complete feed. No concerns for consumers were identified following the use of eucalyptus oil up to the highest safe level in feed. The additive under assessment should be considered as irritant to skin and eyes and the respiratory tract and as a skin sensitiser. The use of eucalyptus oil at the proposed use level in feed was not expected to pose a risk for the environment. Since E. globulus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of an essential oil from the herbaceous parts of Pelargonium graveolens L'Hér. (geranium rose oil) 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 an essential oil obtained from the herbaceous parts of Pelargonium graveolens L'Hér. (geranium rose oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of geranium rose oil is safe up to the maximum proposed use levels of 5 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of geranium rose oil up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of geranium rose oil at the proposed use level in feed was not expected to pose a risk to the environment. Since P. graveolens and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.