Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product containing L-arginine produced by fermentation from Corynebacterium glutamicum (ATCC-13870) for all animal species

The European Food Safety Authority (EFSA) received a request from the European Commission to issue an opinion on the safety and the efficacy of a product containing Larginine produced by fermentation from Corynebacterium glutamicum (ATCC-13870) modified by conventional methods. It contains a minimum of 98 % L-arginine on dry matter basis (maximum 18% water). L-arginine is classified as a non-essential amino acid for adult humans and most mammalian species, but essential for mammalian neonates, strict carnivores, birds, fish and possibly reptiles. Apart from its role as a component of protein synthesis, arginine has many different functions in the metabolism. The product can be used as a substitute of arginine from dietary protein. Demonstration of efficacy of the product is not considered necessary by the FEEDAP Panel, because Larginine is a recognized nutrient. Taking into account published literature, the FEEDAP Panel considers L-arginine from the product as bioavailable. The FEEDAP Panel concludes that L-arginine gives no animal safety concern when used as a nutritional additive for all animal species. On the basis of the data available and considering the high degree of purity of the product containing L-arginine, the FEEDAP Panel does not expect any risk for the consumer. The product L-arginine was not mutagenic and showed no adverse effects up to 5% in the diet of rats for 90 days. Increased deposition of L-arginine in animal products from the use of the product is not expected. The product contains no particles of less than 10 μm, thus potential for inhalation is not considered of concern. No other data on user safety is provided but the manufacturer considers the product may possess irritant properties and therefore proposes the use of barrier protection methods. L-arginine from the product is not expected to pose a risk to the environment. The FEEDAP Panel does not see the need for additional requirements for a post-market monitoring plan. The FEEDAP Panel recommends refinements of the Register entry: (i) the additive should be described as L-arginine, (ii) the description of the additive should be supplemented by ‘Larginine produced by fermentation from Corynebacterium glutamicum ATCC 13870’, (iii) the minimum L-arginine content should be given on a dry matter basis (e.g. 98 % DM). The FEEDAP Panel also recommends the use of HPLC with post column derivatisation with ninhydrin and photometric detection at 570nm for the determination of L-arginine in feedingstuffs, and VDLUFA method 4.11.6 for the determination of the active substance in the feed additive.