Risks associated with endotoxins in feed additives produced by fermentation

Acknowledgements We thank Jordi Tarrés Call, who recorded the discussions and offered advice about procedures, and Nicole Reisinger and Gerd Schatzmayr, who provided valuable information about endotoxins in animal feeds. The Rowett Institute of Nutrition and Health is funded by the Rural and Environment Science and Analytical Services Division (RESAS) of the Scottish Government.Peer reviewedPublisher PD

Guidance on the renewal of the authorisation of feed additives

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the renewal of the authorisation of additives for use in animal nutrition. It follows the structure and definitions of Regulation (EC) No 1831/2003and its implementing rules (Regulation (EC) No 429/2008)

Scientific Opinion on the safety and efficacy of concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride and L-lysine monohydrochloride produced by Escherichia coli (FERM BP-10941) for all animal species, based on three dossiers submitted by Ajinomoto Eurolysine SAS

Concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride (HCl) and L-lysine HCl technically pure are produced by fermentation with a genetically modified Escherichia coli (FERM BP-10941). Neither the production strain nor its recombinant DNA was detected in any of the final products. The final products do not raise any safety concern with regard to the genetic modifications. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are considered safe for target species when supplemented in appropriate amounts. Lysine produced by E. coli (FERM BP-10941) is not genotoxic and the results of subchronic studies do not indicate any specific concerns. As there are no lysine metabolites associated with safety concerns in the animal tissues and products, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) considers that the use of L-lysine and its hydrochloride salts in animal feed does not pose a risk for the consumer. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are not considered to have the potential to cause respiratory toxicity, skin or eye irritation or skin sensitisation, but respiratory sensitisation cannot be excluded. L-Lysine is a substance naturally occurring in bacteria, plants and animals. The use of L-lysine-containing feed additives does not represent a risk to the environment. Concentrated liquid L-lysine (base), concentrated liquid L-lysine HCl and L-lysine HCl technically pure are considered equivalent in terms of L-lysine availability to the target animals. The efficacy of supplementing L-lysine and its hydrochloride salts is extensively demonstrated in the literature for mammals (except ruminants), poultry and fish, including its use in a liquid or a powder form. Therefore it does not require any further demonstration. Response in ruminants requires some degree of protection of L-lysine from ruminal degradation

Safety and efficacy of l‐threonine produced by fermentation with Escherichia coli CGMCC 11473 for all animal species

Abstract The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 11473). It is intended to be used in feed and water for drinking for all animal species and categories. It was not possible to characterise the genetic modification with the information provided. Uncertainty remained on the possible presence of cells from the production strain and their recombinant DNA in the product. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product l‐threonine, produced by fermentation with Escherichia coli CGMCC 11473 for the target species, consumers and the environment. The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of threonine containing additives via water for drinking and feed. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be an irritant for skin and eyes or to be a skin sensitiser. There is a risk from the exposure by inhalation to endotoxins for persons handling the additive. The product under assessment is considered an efficacious source of the amino acid l‐threonine for all animal species. For l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli KCCM 80135 for all animal species

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation using Escherichia coli KCCM 80135 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain and its recombinant DNA were not detected in the additive. l‐Tryptophan produced by fermentation with E. coli KCCM 80135 does not raise any safety concern with regard to the genetic modification of the production strain. The use of l‐tryptophan produced using E. coli KCCM 80135 in supplementing feed to compensate for tryptophan deficiency in feedingstuffs is safe for non‐ruminant target species. Using unprotected forms of tryptophan in ruminants can be a risk. The use of l‐tryptophan produced by fermentation using E. coli KCCM 80135 in animal nutrition presents no safety concerns to consumers of animal products. l‐Tryptophan produced by E. coli KCCM 80135 is not toxic by inhalation. The additive is not an irritant to skin and eyes, and it is not a skin sensitiser. The additive under assessment is considered safe for the environment. It is regarded as an effective source of the amino acid l‐tryptophan for all non‐ruminant species. If the additive l‐tryptophan is intended for use in ruminants, it should be protected from ruminal degradation