# Safety and efficacy of feed additives consisting of vitamin B2 (98%) and vitamin B2 (80%) produced with Bacillus subtilis CGMCC 7.449 for all animal species (Chifeng Pharmaceutical Co., Ltd.)

## TL;DR

This study evaluates the safety and effectiveness of vitamin B2 produced using a genetically modified Bacillus subtilis strain for use in animal feed.

## Contribution

The study confirms the safety and efficacy of vitamin B2 produced via a genetically modified Bacillus subtilis strain for all animal species.

## Key findings

- The final products do not contain viable cells or DNA of the production strain, posing no safety concerns.
- The additives are effective in meeting animals' vitamin B2 requirements when administered via feed.
- The additives are dermal and respiratory sensitisers, with inhalation and dermal exposure considered a risk.

## Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B2 98% and vitamin B2 80% in the form of riboflavin produced by fermentation with a genetically modified strain of Bacillus subtilis (CGMCC 7.449) as nutritional feed additives for all animal species. Viable cells and DNA of the production strain were not detected in the final products and therefore, the use of B. subtilis CGMCC 7.449 to produce vitamin B2 does not raise safety concerns. The use of vitamin 98% and 80% produced with B. subtilis CGMCC 7.449 in animal nutrition does not represent a safety concern for the target species, consumers and for the environment. The additives are not dermal nor eye irritants but are dermal and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. The additives under assessment are effective in covering the animals' requirements of vitamin B2 when administered via feed.