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 (R) 2000 as a feed additive according to Regulation (EC) No 1831/2003

Sel-Plex (R) consists of inactivated and dried selenized yeast produced by Saccharomyces cerevisiae and provides selenium (Se) in an organic form (mainly selenomethionine). Sel-Plex (R) is intended to be used in poultry, pigs and bovines as a nutritional additive, being a source of the essential trace element Se. The applicant also claims for its use as a zootechnical additive. While inorganic Se is permanently authorised as feed additive at Community level (Council Directive 70/524/EEC, as trace element, in the forms of sodium selenite and sodium selenate), authorisation does not yet exist for organic forms of dietary Se. Following an application submitted by the applicant, in accordance with Regulation (EC) No 1831/2003, the European Food Safety Authority (EFSA) has been requested to assess the efficacy and the safety of Sel-Plex (R) for the target animals (poultry, pigs and bovines), and the safety for users, consumers and the environment. Sel-Plex (R) has a shelf-life of at least 24 months and is stable in premixes (12 months) and complete feedingstuffs (6 months). Sel-Plex (R) mixes homogeneously into feed at different stages of the production process. Se from Sel-Plex (R) is absorbed and distributed in the body fluids and tissues. The efficacy studies demonstrate that Se from Sel-Plex (R) is bioavailable and therefore meets the criteria of a nutritional additive. The FEEDAP Panel considers the data claimed as evidence of zootechnical effects, as far as they were demonstrated, was a consequence of the specific nutritional property of selenomethionine and hence already covered by the claim of "nutritional efficacy". The FEEDAP Panel concludes that an excessive Se intake through Sel-Plex (R) at or above 10 times the authorised maximum Se content of feeds (0.5 mg Se kg(-1) DM) produces a reduction on performance parameters of poultry, pigs and bovines. Calculations using SCOOP consumption figures, the expected Se contents in milk, eggs and edible tissues from pigs (the species with the highest tissue level) induced by Sel-Plex (R) addition to the feeds up to the maximum permitted level, and the average background intake of Se in Europe (60 mu g d(-1)) resulted in total Se loads to the consumer between 99 mu g d(-1) (children 4-6 years) and 165 mu g d(-1) (adults). This is slightly above (children) and far below the respective ULs. However, it may be assumed that background Se intake in small children is significantly lower due to their comparably lower food consumption. Consequently, total Se load in small children may be expected to range well below the respective UL, too. In total, the FEEDAP Panel does not see any risk for the consumer from the higher Se content in food of animal origin due to the use of Sel-Plex (R) in animal nutrition. The FEEDAP Panel does not consider appropriate to set MRLs for widespread trace elements, such as Se, that are naturally present in environment, vegetable and animal tissues. The FEEDAP Panel concludes that the use of Sel-Plex (R) is unlikely to elicit a significant exposure to Se for the user. However, appropriate measures to minimize inhalation exposure to breathable Se and protein components should be taken. As Sel-Plex (R) will replace other Se sources, its use will not alter the concentration and distribution of Se in the environment.