Abstract
The additive Selemax consists of selenium‐containing inactivated yeast (Saccharomyces cerevisiae NCYC R646), enriched during the fermentation process with organic selenocompounds, and is intended to be used as a nutritional additive, providing a source of the essential trace element selenium for all animal species. Based on data from a tolerance study in chickens for fattening, the use of Selemax as a selenium source is considered to be safe for all animal species. The FEEDAP Panel reiterates its former conclusion that the use of any selenised yeast would result in similar selenium deposition in tissues and products. To ensure consumer safety from consumption of tissues and products of animals treated with Selemax, the FEEDAP Panel concludes that dietary selenium supplementation from Selemax, as for other selenised yeasts, should not exceed a maximum of 0.2 mg Se/kg complete feed. In the absence of specific data, the product is considered as a potential irritant to skin and eyes and sensitiser to skin. Owing to its proteinaceous nature, the additive is considered a potential respiratory sensitiser. The FEEDAP Panel considers that the use of Selemax in feed does not pose an additional risk to the environment, compared to other sources of selenium for which it will substitute, as long as the maximum authorised content in feedingstuffs is not exceeded. Based on the response of liver glutathione peroxidase activity and the liver/plasma concentration of selenium, the FEEDAP Panel considers Selemax an effective source of selenium for all species. Selemax does not modify the quality of meat as measured by physical parameters.
Keywords: Nutritional additive, compound of trace elements, selenium enriched yeast, selenium, Selemax 1000/2000, selenomethionine, safety, efficacy
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) ; Scientific Opinion on safety and efficacy of selenium in the form of organic compounds produced by the selenium‐enriched yeast Saccharomyces cerevisiae NCYC R646 (Selemax 1000/2000) as feed additive for all species. EFSA Journal 2012;10(7):2778. [17 pp.] doi: 10.2903/j.efsa.2012.2778.
Panel members: Gabriele Aquilina, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Christer Hogstrand, the late Reinhard Kroker, Lubomir Leng, Secundino López Puente, Anne‐Katrine Lundebye Haldorsen, Alberto Mantovani, Giovanna Martelli, Miklós Mézes, Derek Renshaw, Maria Saarela, Kristen Sejrsen and Johannes Westendorf.
Correspondence: feedap@efsa.europa.eu
Acknowledgement: The Panel wishes to thank the members of the Working Group on Trace Elements for the preparatory work on this scientific opinion.
Adoption date: 15 June 2012
Published date: 25 July 2012
Question number: EFSA‐Q‐2010‐01029
On request from: European Commission
References
- AAFCO (Association of American Feed Control Officials) , 2010. Selenium Yeast. Page 374 in Feed Terms and Ingredient Definitions. 57. Mineral Products. Tentative T57.163. Official publication. Association of American Feed Control Officials Inc., Olympia, WA. [Google Scholar]
- EC (European Commission) , 2000, online. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Selenium. Available from ec.europa.eu/food/fs/sc/scf/out80g_en.pdf
- EC (European Commission) , 2004, online. Reports on Tasks for Scientific Cooperation (SCOOP). Task 3.2.11. Assessment of the dietary exposures to arsenic, cadmium, lead and mercury of the population of the EU Member States Directorate General Health and Consumer Protection. Available from ec.europa.eu/food/food/chemicalsafety/contaminants/scoop_3‐2‐11_heavy_metals_report_en.pdf
- EFSA (European Food Safety Authority) , 2006a. Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product Sel‐Plex;®2000 as a feed additive according to Regulation (EC) No 1831/2003. The EFSA Journal, 348, 1–40. [Google Scholar]
- EFSA (European Food Safety Authority) , 2006b. 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 EFSA Journal 430, 1–23. [Google Scholar]
- EFSA (European Food Safety Authority) , 2007. Introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. Opinion of the Scientific Committee. The EFSA Journal, 587, 1–16. [Google Scholar]
- EFSA (European Food Safety Authority) , 2008. Selenium‐enriched yeast as source for selenium added for nutritional purposes in foods for particular nutritional uses and foods (including food supplements) for the general population. The EFSA Journal, 766, 1–42. [DOI] [PMC free article] [PubMed] [Google Scholar]
- EFSA (European Food Safety Authority) , 2009. Safety and efficacy of SELSAF (Selenium enriched yeast from Saccharomyces cerevisiae CNCM I‐3399) as feed additive for all species. The EFSA Journal 992, 1–24. [Google Scholar]
- EFSA (European Food Safety Authority) , 2010. Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2010 update). EFSA Journal, 8(12): 1944. [Google Scholar]
- EFSA (European Food Safety Authority) , 2011a. Scientific Opinion on the safety and efficacy of selenium in the form of organic compounds produced by the selenium‐enriched yeast Saccharomyces cerevisiae NCYC R645 (SelenoSource AF 2000) for all species. EFSA Journal 9(6):2279. [Google Scholar]
- EFSA (European Food Safety Authority) , 2011b. Scientific Opinion on Safety and efficacy of Sel‐Plex;® (organic form of selenium produced by Saccharomyces cerevisiae CNCM I‐3060) for all species. EFSA Journal 9(4):2110. [Google Scholar]
- EFSA (European Food Safety Authority) , 2011c, online. The EFSA Comprehensive European Food Consumption Database. Available from: www.efsa.europa.eu/en/datex/datexfooddb.htm
- IDC (Ingredient Definition Committee) , 2010, online. Minutes of meeting August 1, 2010. Portland, Oregon. Available from www.aafco.org/Portals/0/minutes/idc_aug_2010.pdf [Google Scholar]
- Jansen HD, 1992. Mischtechnik im Futtermittelbetrieb. Anforderungen an Mischenlage, Arbeits‐ und Mischgenauigkeit. Die Mühle+ Mischfuttertechnik 129, 265–270. [Google Scholar]
- Ruiz Encinar J, Sliwka‐Kaszynska; M, PolSatajko A, Vacchina V and Szpunar J, 2003. Methodological advances for selenium speciation analysis in yeast. Analytica Chimica Acta 500, 171–183. [Google Scholar]
