In an opinion similar to that of 2012, the Parma based watchdog found new evidence submitted by the manufacturer did not demonstrate the safety of the gut flora stabilizer, which is based on the strain Bacillus toyonensis.
“On the basis of the data provided by the applicant, including the latest submissions, the FEEDAP Panel concludes that B. toyonensis has the capacity to elaborate functional toxins and thus, to pose a risk to humans exposed to the organism,” said EFSA’s report.
EU market withdrawal
A negative opinion by EFSA on Toyocerin in October 2012 subsequently saw the EU Commission suspend existing authorisations for the feed additive under Regulation No (EU) 288/2013.
However, the ruling allowed the company the possibility to submit supplementary data to potentially allow EFSA reconsider its assessment of the product.
In 2014, the Spanish feed additive company submitted further data and arguments relating to the identity of the active agent, its resistance to antibiotics and its ability to elaborate and export functional toxins.
Rubinum also provided further studies to back up the efficacy claims for use with certain species, as previous such data had been deemed inconclusive by EFSA in its earlier opinion.
Efficacy in weaned piglets backed
The FEEDAP Panel previously concluded that the addition of Toyocerin to feed has the potential to “improve at least one aspect of production in chickens for fattening, pigs for fattening, sows, calves for rearing, cattle for fattening and rabbits for fattening.”
But EFSA said it had been unable to conclude on its efficacy when used in diets for weaned piglets because of insufficient data.
In the latest opinion, the EU feed safety assessor said the results of three trials of the additive with weaned piglets, demonstrated “a consistent improvement in daily weight gain, final body weight and feed to gain ratio."
It thus backed Toyocerin in terms of its potential to improve performance of weaned piglets at the minimum recommended dose.
The Spanish firm had also submitted reports from various scientists on the safety of the Toyocerin strain.
But the FEEDAP Panel remained unconvinced: “These reports represent the authors’ individual opinions and, with the exception of one, do not provide any further new data.”
The opinion can be read here.