# Assessment of the feed additive consisting of Enterococcus lactis DSM 10663 NCIMB 10415 (Oralin®) for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs for the renewal of its authorisation (Chevita Tierarzneimittel GmbH)

## TL;DR

This paper assesses the safety of a feed additive containing Enterococcus lactis for various animals and concludes it remains safe under current conditions.

## Contribution

The study provides updated safety evaluation of Oralin® for continued authorization as a feed additive.

## Key findings

- The additive is safe for target animals, consumers, and the environment under authorized conditions.
- The additive is a skin and respiratory sensitiser, posing risks via dermal and respiratory exposure.
- The coated form of the additive may have eye irritancy potential, but this could not be conclusively assessed.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the additive Oralin®, a preparation containing viable cells of Enterococcus lactis DSM 10663 (formerly identified as Enterococcus faecium), as a zootechnical feed additive for calves for rearing, piglets, chickens for fattening, turkeys for fattening, cats and dogs. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for the target animals, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive in all forms should be considered as a skin and respiratory sensitiser. Exposure by dermal and respiratory routes is considered a risk. The additive is not irritant to eyes in the powder (Oralin® 350 P), granulated (Oralin® 350 G) and liquid (Oralin® 100 S) preparations. The FEEDAP Panel is not in the position to conclude on the irritancy potential for eyes of the coated form (Oralin® 200 C). There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.