Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of L-lysine sulphate (Vitalys®Liquid and Dry) for all animal species

Abstract

SUMMARYThe European Food Safety Authority (EFSA) received a request from the European Commission for an opinion on the safety and efficacy of Vitalys ® , an additive that consists of L-lysine sulphate and by products produced by fermentation by a specific strain of Corynebacterium glutamicum. The product is formulated as a liquid (minimum 25 % L-lysine) and a solid (minimum 44 % L-lysine).All the studies submitted have been made with Vitalys products which were not demonstrated to be identical to the product that is proposed to be placed on the market.The FEEDAP Panel concludes that Vitalys in both application forms (dry or liquid) contains bioavailable lysine. Vitalys is therefore considered a lysine source for all animal species.The applicant has provided two in vitro studies with Vitalys which may be considered to give sufficient reassurance that the product possesses no genotoxic potential in vitro. However, a 90-day study in rats has identified, in high dose treated animals, proliferative lesions in the urogenital tract which are not satisfactorily explained. In the absence of such an explanation the carcinogenic potential of the product cannot be excluded. Therefore the FEEDAP Panel is not in a position to conclude on the safety of Vitalys for the consumer.Although nothing in the data provided on the use of Vitalys in pigs and poultry suggested that Vitalys would pose a risk when used to satisfy lysine requirements, the data from the 90-day rat study does raise concerns for target animal safety. Safety and efficacy of L-lysine sulphate for all animal speciesThe EFSA Journal (2007) 522, Both dry and liquid Vitalys are presumed to be potential respiratory sensitizers. The evidence of dermal sensitisation by dry Vitalys confirms the potential for user risk. Both the dry and the liquid Vitalys are required to be labelled as an irritant and marked "Xi". Both products show no evidence of short term toxicity by inhalation. Without further data on the effects seen in rats after 90-days exposure, the potential for carcinogenicity cannot be excluded and the product should be handled accordingly.The FEEDAP Panel concludes that the use of Vitalys as feed additive is not expected to present a risk to the environment. The FEEDAP Panel recommends: i) that the Register entry should contain, under description, the exact strain (DSM 14764) of the Corynebacterium glutamicum used for fermentation; ii) that since the specification of the product tested in the 90-day study is within that of the product already authorised, the safety of that product should be reconsidered.

Safety and efficacy of the feed additives concentrated liquid l‐lysine (base) and l‐lysine monohydrochloride produced by Corynebacterium glutamicum KCCM 80183 for all animal species (CJ Europe GmbH)

“…25 Pesticides (358 species) were analysed in three batches of concentrated liquid L-lysine (base) and found below the LOD. 26 Microbiological contaminants as total plate counts, yeasts and filamentous fungi were below the LOD; Salmonella spp. was absent in 25-mL samples; and Escherichia coli and coliforms were not detected.…”

Safety and efficacy of concentrated liquid l‐lysine (base) and l‐lysine monohydrochloride produced by fermentation with Corynebacterium casei KCCM 80190 as feed additives for all animal species

“…), reported as negative (Escherichia coli, coliforms), below the specification (< 1 9 10 3 CFU/g for total plate count and < 50 CFU/g for yeast and moulds) or below the LOD (Enterobacteriaceae). 25 Mycotoxins (aflatoxins B1, B2, G1, G2; ochratoxin A, zearalenone, deoxynivalenol (DON) and fumonisins B1, B2) were found below the respective limits of detection. 26 Pesticides (358 species) were analysed in three batches of concentrated liquid L-lysine (base) and found below the LOD of the analytical method.…”

“…24 From the analysis submitted, LOD (in µg/kg) were (depending on the laboratory making the analyses): 1 and 0.015 for lead, 1 and 0.01 cadmium, 1 and 0.04 for arsenic and 5 and 0.01 for mercury (Technical Dossier/Section II/Annex II.1.9 and Technical dossier/Supplementary information April 2020/Annex SIN_05). 25 Technical dossier/Supplementary information April 2020/Document/03 Sin L-lys 80190 20200423. LOD in CFU/g was 100 for total plate count, 10 for yeasts and molds, and 1 for E. coli and coliform bacteria.…”

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strains NRRL‐B‐67439 or NRRL B‐67535 for all animal species

“…Safety of L-lysine HCl and concentrated liquid L-lysine (base) produced by C. glutamicum strains NRRL B-67439 or NRRL B-67535 3.4.1. Safety of the production strains For both strains, the recipient organism belongs to a species, C. glutamicum, that is considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment when used for production purposes (EFSA, 2007;EFSA BIOHAZ Panel, 2019).…”

“…The Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has published several opinions on the safety and efficacy of L-lysine: some of them on L-lysine sulphate produced by fermentation using different strains of C. glutamicum for all animal species (EFSA FEEDAP Panel, 2007, 2015a,b, 2016b or using a strain of Escherichia coli (EFSA FEEDAP Panel, 2017a); and others on the safety and efficacy of concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride and/or L-lysine monohydrochloride for all animal species (EFSA FEEDAP Panel, 2013, 2015c, 2016a, produced by fermentation using different strains of E. coli or C. glutamicum (EFSA FEEDAP Panel, 2016b, 2019b The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) issued an opinion on L-lysine and its monohydrochloride salt when used as a flavouring compound (EFSA, 2008;EFSA AFC Panel, 2010). The Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) issued three opinions on the substantiation of health claims related to L-lysine (EFSA NDA Panel, 2011a,b, 2014.…”