(6)An authorisation of riboflavin with a purity of minimum 80 % produced by Bacillus subtilis KCCM 10445 was previously denied and existing stocks of that additive and feed containing it were to be withdrawn from the market as laid down by Commission Implementing Regulation (EU) 2018/1254note, due to the presence in the additive of viable cells and recombinant DNA from the genetically modified production strain Bacillus subtilis KCCM 10445, carrying antimicrobial resistance genes and posing a risk for the target species, consumers, users and the environment. The riboflavin for which authorisation was denied as well as the present riboflavin (98 %) produced by Bacillus subtilis KCCM 10445 and the preparation of riboflavin (80 %) produced by Bacillus subtilis KCCM 10445 are produced by the same production strain (Bacillus subtilis KCCM 10445). However, the purity of riboflavin has been improved, by increasing from 80 % in the authorisation that was denied to 98 % in this authorisation. In its above-mentioned opinions, the Authority stated that viable cells and recombinant DNA from Bacillus subtilis KCCM 10445 were not detected in the riboflavin and in the preparation of riboflavin subject to this application and that therefore, those additives do not pose any safety concern associated with the genetic modification of the production strain.
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