Lack of information stalls EFSA opinion on two additives

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety for the target animals, consumer, user and for the environment and on the efficacy of a product based on a single strain of Lactobacillus pentosus (DSM 14025), when used as a technological additive intended to improve the ensiling process at a proposed dose of 1.0 x 10⁸ CFU/kg fresh material.

 

L. pentosus DSM 14025 is resistant to the antibiotics tetracycline, ampicillin and clindamycin, all antibiotics of human and veterinary importance.

 

Although the applicant on the basis of a bioinformatic analysis could exclude the presence of many known resistance genes, the reason for the resistance shown to tetracycline, ampicillin and clindamycin was not established.

 

“In the absence of information on the genetic basis of these resistances, the extent of the risk of horizontal gene transfer to other bacteria in the food chain and in the environment cannot be established,” FEEDAP concluded.

 

The substance is on the positive list of authorised feed additives and was subject to re-evaluation in the framework of the EU Regulation No 1831/2003.

FEEDAP was also asked to deliver a scientific opinion on the safety and efficacy of Biosprint (Saccharomyces cerevisiae from Scotmin Nutrition) as a feed additive for cattle for fattening.

 

The additive is a microbiological feed additive containing cells of the yeast Saccharomyces cerevisiae.

 

Re-evaluation of the product was requested when used as a zootechnical additive (functional group: gut flora stabilisers) in diets for cattle for fattening at a minimum dose of 4 x 10⁹ and a maximum dose of 9 x 10⁹ CFU/kg feedingstuffs.

 

As the last assessment of the safety of Biosprint was performed in 2010, the FEEDAP Panel did not consider a re-assessment of the safety necessary.

 

Only two of the six efficacy studies with cattle for fattening could be considered due to significant weaknesses in the experimental design in the other four.

 

In only one study there was evidence of a significant benefit in weight gain. Therefore, the FEEDAP Panel was unable to conclude on the efficacy of Biosprint when used in feed for cattle for fattening.

 

The European Commission will now decide on how to proceed and whether they will ask the applicants for further information, those needed to finalise the evaluation.