# Safety and efficacy of a feed additive consisting of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 as an acidity regulator for all animal species (Lactosan GmbH & Co.KG)

## TL;DR

This paper evaluates the safety and effectiveness of a bacterial feed additive for regulating acidity in animal feed, finding it safe for animals and the environment but potentially harmful to users.

## Contribution

The study provides a safety and efficacy assessment of a bacterial feed additive for all animal species, including its impact on pH reduction.

## Key findings

- The additive is safe for target species, consumers, and the environment.
- The additive is a skin and respiratory sensitiser, posing risks to users.
- The additive can reduce the pH of plant-origin feed materials effectively.

## Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive (acidity regulator) in feed for all animal species. The additive is intended to be incorporated into feed materials of plant origin with high moisture content (dry matter range between 25% and 40%). The bacterial species B. subtilis and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identification of both strains has been clearly established; they did not show acquired resistance to antibiotics of human and veterinary importance, and B. subtilis DSM 33862 lacks toxigenic potential. The FEEDAP Panel concluded that the preparation of B. subtilis DSM 33862 and L. buchneri DSM 12856 is safe for the target species, consumers and the environment. Regarding user safety, the additive should be considered as a skin and respiratory sensitiser. Exposure of users via dermal and respiratory routes is considered a risk. The FEEDAP Panel concluded that incorporation of B. subtilis DSM 33862 and L. buchneri DSM 12856 at a minimum concentration of 1.0 × 108 CFU/kg feed material has the potential to reduce the pH of feed materials of plant origin at the proposed conditions of use.