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Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product Selenium enriched yeast (Saccharomyces cerevisiae NCYC R397) as a feed additive for all species in accordance with Regulation (EC) No 1831/2003

The product (Alkosel®) consists of inactivated selenized Saccharomyces cerevisiae yeast strain (NCYC R397) used as a source of selenium (Se) in an organically-bound form (mainly selenomethionine, SeMet). It is intended to be used in all farm animal species as a nutritional additive, being a source of the essential trace element Se. The European Food Safety Authority (EFSA) has been requested by the European Commission to assess the efficacy and the safety of this product for all species, as well as the safety for the user, consumer and the environment. The product has a shelf-life of at least 12 months and a stability of at least four months in premixes and three months in complete feed when stored under normal conditions. It shows an adequate homogeneity of distribution in premixes and feedingstuffs. Several studies in dairy cows indicated that Alkosel® supplementation increased the levels of Se in whole blood, plasma and blood GSH-Px activity, demonstrating the bioavailability of Se from Se-enriched yeast in lactating cows. Based on the extensive knowledge of Se metabolism, the FEEDAP Panel considers these studies as a reasonable demonstration of bioavailability for all animal species. Studies on target animal safety were performed on chickens for fattening, piglets and dairy cows. Se from the Se-enriched yeast at the maximum permitted level (0.5 mg Se kg-1 complete feed) is considered safe for all animal species as no significant adverse effects were observed in the tested species exposed to overdose (seven- to ten-fold) of the product. The variation in supplementation ranging from the recommended dose of 0.3 mg Se kg-1 to levels considerably above the maximum permitted concentration in feedingstuff allowed in the EU, introduces considerable uncertainties in assessing maximum tissue deposition and therefore human exposure. Data were provided to assess Se deposition in muscle (chicken), liver (chicken and pig), eggs and milk. Based on this limited tissue deposition data and using literature values for kidney, the worst case scenario suggests that the consumer exposure would exceed the Upper tolerable Level (UL) of Se for adults (0.3 mg day-1). Refining this calculation using SCOOP data and making allowance for Se intake from other dietary sources resulted in a consumption of 52% of the adult UL of Se. Despite the lack of product-specific kidney data and the potential species variation in tissue Se concentrations, all further calculations do not give any reason for concern regardless of the consumer age group. A series of in vitro and in vivo assays did not indicate any genotoxic risk of the product for consumers. In a 90-day study on rats, liver toxicity was observed at the top dose corresponding to 0.2 mg Se kg-1 bw. The FEEDAP Panel concludes that the use of Alkosel® is unlikely to elicit a significant exposure to Se for the user. However, appropriate measures to minimize skin contact and inhalation exposure to Se-enriched yeast should be taken. The use of Alkosel® at recommended levels is unlikely to alter the concentration and distribution of Se in the environment, as Se-enriched yeast will replace other Se additives and does not present therefore an additional load to the environment. The FEEDAP Panel does not see a need for specific requirements of post market monitoring, in addition to the need for traceability and recall procedures established by Regulation (EC) No 183/2005. The FEEDAP Panel makes a number of recommendations, principally that a specification for maximum Se content in the product be given.

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