Scientific Opinion on the safety and efficacy of vitamin D₃ (cholecalciferol) as a feed additive for all animal species or categories based on a dossier submitted by Lohmann Animal Health GmbH

The principal physiological role of vitamin D in all vertebrates is in calcium and phosphorus homeostasis. The classic clinical deficiency syndrome is rickets. The FEEDAP Panel notes that for turkeys for fattening, equines, bovines, ovines and pigs the maximum authorised content of vitamin D3 in feed does not provide any margin of safety, and that, except for pigs and fish, the maximum content is above the upper safe level, according to National Research Council data when animals were fed a supplemented diet for more than 60 days. The FEEDAP Panel is not in a position to draw final conclusions on the safety of vitamin D for target animals but considers the current maximum contents temporarily acceptable pending a review of the recent scientific literature. The two vitamin sources under application are considered safe for the target animals provided the current maximum contents in feed are respected. Any administration of vitamin D3 via water for drinking could exceed the safe amounts of vitamin D and therefore represents a safety concern. Current nutritional surveys in 14 European countries showed that vitamin D intake is below the upper safe limit. The FEEDAP Panel assumes that foodstuffs of animal origin were produced following current production practices, including vitamin D3 supplementation of feed, and concludes that the use of vitamin D in animal nutrition at the currently authorised maximum dietary content has not and will not cause the tolerable upper intake level to be exceeded. Vitamin D3 should be considered as irritant to skin and eyes, and as a dermal sensitiser. Inhaled vitamin D3 is highly toxic; exposure to dust is harmful. No environmental risk resulting from the use of vitamin D3 in animal nutrition is expected. The vitamin D3 under application is regarded as an effective dietary source of the vitamin in animal nutrition

Expert opinion as 'validation' of risk assessment applied to calf welfare

<p>Abstract</p> <p>Background</p> <p>Recently, a Risk Assessment methodology was applied to animal welfare issues in a report of the European Food Safety Authority (EFSA) on intensively housed calves.</p> <p>Methods</p> <p>Because this is a new and potentially influential approach to derive conclusions on animal welfare issues, a so-called semantic-modelling type 'validation' study was conducted by asking expert scientists, who had been involved or quoted in the report, to give welfare scores for housing systems and for welfare hazards.</p> <p>Results</p> <p>Kendall's coefficient of concordance among experts (n = 24) was highly significant (P < 0.001), but low (0.29 and 0.18 for housing systems and hazards respectively). Overall correlations with EFSA scores were significant only for experts with a veterinary or mixed (veterinary and applied ethological) background. Significant differences in welfare scores were found between housing systems, between hazards, and between experts with different backgrounds. For example, veterinarians gave higher overall welfare scores for housing systems than ethologists did, probably reflecting a difference in their perception of animal welfare.</p> <p>Systems with the lowest scores were veal calves kept individually in so-called "baby boxes" (veal crates) or in small groups, and feedlots. A suckler herd on pasture was rated as the best for calf welfare. The main hazards were related to underfeeding, inadequate colostrum intake, poor stockperson education, insufficient space, inadequate roughage, iron deficiency, inadequate ventilation, poor floor conditions and no bedding. Points for improvement of the Risk Assessment applied to animal welfare include linking information, reporting uncertainty and transparency about underlying values.</p> <p>Conclusion</p> <p>The study provides novel information on expert opinion in relation to calf welfare and shows that Risk Assessment applied to animal welfare can benefit from a semantic modelling approach.</p

Determining motivation to engage in safe food handling behaviour

Purpose: To apply the protection motivation theory to safe food handling in order to determine the efficacy of this model for four food handling behaviours: cooking food properly, reducing cross-contamination, keeping food at the correct temperature and avoiding unsafe foods. Design: A cross-sectional approach was taken where all protection motivation variables: perceived severity, perceived vulnerability, self-efficacy, response efficacy, and protection motivation, were measured at a single time point. Findings: Data from 206 participants revealed that the model accounted for between 40 and 48% of the variance in motivation to perform each of the four safe food handling behaviours. The relationship between self-efficacy and protection motivation was revealed to be the most consistent across the four behaviours. Implications: While a good predictor of motivation, it is suggested that protection motivation theory is not superior to other previously applied models, and perhaps a model that focuses on self-efficacy would offer the most parsimonious explanation of safe food handling behaviour, and indicate the most effective targets for behaviour change interventions. Originality: This is the first study to apply and determine the efficacy of protection motivation theory in the context of food safety

Scientific Opinion on the evaluation of the substances currently on the list in the annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils – Part III of III

Shipping of edible fats and oils into Europe is permitted in bulk tanks, in which substances, included in a positive list, had been previously transported. The European Commission requested EFSA to evaluate the list of substances in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils, taking into account its review of the Scientific Committee on Food criteria for acceptable previous cargoes and criteria proposed by the Codex Committee for Fats and Oils. This is the third and last scientific opinion of the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) on this topic, in which sixteen of these substances or groups of substances have been evaluated. The CONTAM Panel concluded that sodium silicate (water glass) solution, iso-octanol, iso-nonanol, iso-decanol, 1,3-propanediol, isobutyl acetate, sec-butyl acetate, tert-butyl acetate, n-butyl acetate, propylene tetramer, paraffin wax, candelilla wax, white mineral oils and glycerol would not be of health concern as previous cargoes. The CONTAM Panel concluded that carnauba wax was not acceptable as a previous cargo because of its insolubility in water and high melting point, which raise concerns regarding the efficiency of tank cleaning. There was insufficient information available on the composition of montan wax for the CONTAM Panel to conclude that it would be of no health concern when used as previous cargo and hence it does not meet the criteria for acceptability as previous cargo. The CONTAM Panel made several recommendations regarding the way in which the substances are described in the Annex to Commission Directive 96/3/EC, to correct inaccuracies and to better reflect current transport practices

The path of least resistance: Paying for antibiotics in non-human uses

Antibiotic resistance is a critical threat to human and animal health. Despite the importance of antibiotics, regulators continue to allow antibiotics to be used in low-value applications - subtherapeutic dosing in animals, and spraying tobacco plants for blue mold, for example - where the benefits are unlikely to outweigh the costs in terms of increased resistance. We explore the application of a user fee in non-human uses of antibiotics. Such a fee would efficiently deter low value uses while also providing funding to support the development of the urgently needed new antibiotics

Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all species: Ferrous sulphate monohydrate based on a dossier submitted by Kronos International, Inc.

Ferrous sulphate monohydrate is safe when supplied up to a maximum iron content per kilogram complete feedingstuff of 450 mg for bovines and poultry, 500 mg for ovines, 600 mg for pets, and 750 mg for other species/categories, except horses and fish; for piglets up to one week before weaning a maximum of 250 mg Fe/day is considered safe. Because of insufficient data on horses and fish, as a provisional measure, the current value (750 mg Fe/kg) could be maintained. The values for total dietary iron for pigs, ovines, horses, fish and other species/categories (except poultry, bovines and pets) are in line with those currently authorised. Iron from ferrous sulphate monohydrate is unlikely to modify the iron concentration in edible tissues and products of animal origin. Consumer exposure in the EU is not associated with a risk of excess iron intake to the general population. Therefore, the FEEDAP Panel does not foresee any concern for consumer safety resulting from the use of ferrous sulphate monohydrate in animal nutrition, provided that the maximum iron content in complete feedingstuffs is respected. Ferrous sulphate monohydrate is irritant and corrosive to the skin, eyes and respiratory tract. The additive contains up to 109 mg Ni/kg. Nickel is a dermal and respiratory sensitiser, and inhalation may cause lung cancer. Thus, handling the additive poses a risk to the user/worker. Considering the high concentration of iron and sulphur in soil and water, the supplementation of feed with the additive is not expected to pose an environmental risk. Ferrous sulphate monohydrate is an effective iron source for all animal species and categories. The FEEDAP Panel recommends that the currently authorised maximum iron content in complete feed be reduced for bovines and poultry from 750 to 450 mg Fe/kg, and for pets from 1250 to 600 mg Fe/kg