RESUMEN

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the selenised yeast (inactivated) Saccharomyces cerevisiae CCTCC M 2022402 (Plexomin® Se 3000, available in two forms: 'granules' and 'micro') as a nutritional feed additive for all animal species. Based on a tolerance-efficacy trial, the FEEDAP Panel concluded that the additive is safe for chickens for fattening at proposed conditions of use and this conclusion can be extrapolated to all animal species. In the absence of deposition data in all animal species and products, the FEEDAP Panel cannot conclude on the safety for the consumer. Plexomin® Se 3000 (granules) is dust-free; therefore, the exposure through inhalation is unlikely. Plexomin® Se 3000 (micro) presents a risk by inhalation. Both forms of the additive (granules and micro) are considered as respiratory sensitisers. Due to the lack of data, no conclusions can be drawn on the dermal and eye irritation potential of Plexomin® Se 3000 (granules). Plexomin® Se 3000 (micro) is not irritant to the skin and the eyes. No conclusions can be drawn on the potential of both forms of the additive to be dermal sensitisers. The use of the additive in animal nutrition is considered safe for the environment. The additive is an efficacious source of selenium in feedingstuffs for all animal species.

RESUMEN

Purpose: Of the several selenized yeasts authorised for use as feed additives in the EU, Saccharomyces cerevisiae CNCM I-3060 inactivated' (Sel-Plex®), was the first to be approved for use, in 2006. The additive has a concentration of selenium between 2000 and 2400 mg/kg and a selenomethionine content greater than 63%. Previous toxicological and safety studies have shown Sel-Plex® to be safe for use for target animal species, consumers, users and the environment. A new formulation of Sel-Plex® was recently developed however, with a minimum selenium content of 3000 mg/kg. The increase in selenium in this product, Sel-Plex® 3000, presented the need to assess the risk for workers and users and to establish if there would be any eye and/or skin irritancy and skin sensitisation effects associated with the product. The purpose of this paper is to present the methodology and results of the user safety skin and eye studies performed on Sel-Plex® 3000.Materials & Methods: In vitro skin and eye models were used to assess skin and eye irritancy, while skin sensitisation was examined using an in vivo method. The acute eye irritation was evaluated using a Reconstructed human Cornea-like Epithelium (RhCE) model, which followed the OECD guideline 492. The skin irritation was assessed based on its ability to induce cell death in a commercial reconstructed human epidermis (RhE) model (EPISKIN™) according to the OECD Guideline No. 439. The skin sensitising potential was evaluated in the Guinea pig in line with OECD Guideline 406, and measured the extent and degree of skin reaction to a challenge exposure following previous topical exposure of a substance on the skin.Results: The skin and eye irritation test results showed that Sel-Plex® 3000 was a non-irritant in both cases. The skin sensitisation study showed that the additive did not generate a sensitisation response in the guinea pig and should not be considered a skin sensitiser.Conclusion: These results indicate that Sel-Plex® 3000 is safe to use for workers in an industrial setting when handling the product and the studies may be further used to support regulatory compliance in respective markets.

Asunto(s)

RESUMEN

Selenium-enriched yeast produced by Saccharomyces cerevisiae CNCM I-3399 (selenised yeast inactivated) (SELSAF) is characterised as organic selenium mainly containing selenomethionine (Se-Met, ≥ 63%). The applicant requested for the renewal of the authorisation for selenium-enriched yeast produced by S. cerevisiae CNCM I-3399 when used as a feed additive for all animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of selenium-enriched yeast produced by S. cerevisiae CNCM I-3399 under the current authorised conditions of use is safe for the target species, the consumers and the environment. The additive is non-irritant to skin and eyes but should be considered a respiratory sensitiser. No conclusion can be reached on its dermal sensitising properties. The additive is hazardous by inhalation. Exposure of users by inhalation is very likely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

RESUMEN

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was initially authorised in 2007 with a content of 2,000-2,400 mg Se/kg (97-99 % of organic selenium) and in 2017 the authorisation was further amended to introduce a selenium range of 2,000-3,500 mg Se/kg. Additionally, in 2013, the initial authorising Regulation was modified to introduce a maximum supplementation selenium from this additive in feed (0.2 mg Se from Alkosel®/kg feed). The evidence provided indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. In particular, the Panel confirms that the use of Alkosel® in animal nutrition does not pose a risk to consumers provided that the maximum selenium supplementation of 0.2 mg/kg feed from Alkosel® is not exceeded, yet respecting the maximum total selenium in feed of 0.5 mg/kg. Data on the characterisation of the additive and studies on skin/eyes effects led the Panel reconsider the safety for the user, concluding that Alkosel® is (i) hazardous upon inhalation, (ii) non-irritant to skin and considered irritant for the eyes and mucosae, and (iii) a dermal sensitiser and likely a respiratory sensitiser. A recommendation regarding the denomination of the additive under assessment was proposed by the Panel.

RESUMEN

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae CNCM I-3060 (selenised yeast inactivated) (Sel-Plex®) for all animal species. In 2006, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive; subsequently it was authorised in the EU. The evidence provided indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions in the safety for target species, consumers and environment. In particular, the Panel confirms that the use of Sel-Plex® in animal nutrition does not pose a risk to consumers provided that the maximum selenium supplementation of 0.2 mg/kg feed from Sel-Plex® is not exceeded, yet respecting the maximum total selenium in feed of 0.5 mg/kg. In the context of the current application, the Panel reviewed toxicological studies; based on two repeated-dose studies on rats and dogs, it is concluded that the toxic potential of Sel-Plex® is only related to its selenium content. New data on characterisation of the additive and studies on effects on skin and eyes led the Panel reconsider the safety for the user. The Panel concluded that the additive is hazardous upon inhalation and a likely respiratory sensitiser; owing to the high dusting potential, persons handling the additive are at risk by inhalation. It is considered not irritant to the eyes and skin. A recommendation regarding the denomination of the additive under assessment was proposed by the Panel.