Last week saw the European Food Safety Authority (EFSA) publish its reassessment of the additive, concluding that it poses a risk for the spread of resistance to two antibiotics used in human and veterinary medicine - tetracycline and chloramphenicol.
“We disagree with this new opinion. We have demonstrated with our own Expert Panel that EFSA is wrong in its statements.
We will continue to demonstrate the safety of our product to the global livestock industry and also to the whole scientific community,” said Dag Andersen, Rubinum’s general manager.
The feed additive is based on a strain originally defined as Bacillus cereus var. toyoi and now re-assigned to Bacillus toyonensis.
It was previously subject to re-evaluation in 2012, and a negative opinion by EFSA on Toyocerin in October of that year saw the EU Commission move to suspend existing authorizations for the product under Regulation No (EU) 288/2013.
However, the ruling allowed Rubinum the possibility of submitting additional supporting documentation to give EFSA’s FEEDAP Panel more scope to reconsider its assessment of the product.
Data based on latest methodologies
Andersen told us the company set about gathering scientific data from experts based “inside and outside of the EU” on Bacillus cereus, antibiotic resistance and toxicity in January 2013 in order to demonstrate the safety of Toyocerin to EFSA’s working group on microorganisms.
“We worked very hard to produce data based on the newest methodologies and finally delivered the supplementary information in December 2013,” said the Rubinum representative.
The Spanish company, in the supplementary data, had included reports from various “well recognized” scientists on the safety of the Toyocerin strain.
But the FEEDAP Panel, in its opinion last week, remained unconvinced: “These reports represent the authors’ individual opinions and, with the exception of one, do not provide any further new data.”
Engagement with EFSA
Andersen said, in a bid to shore up the new evidence it submitted on Toyocerin, the company met representatives of the EU Commission and EFSA in May this year where “it was agreed that some misunderstandings in regards to the data submitted could have arisen and, therefore, EFSA proposed to have a scientific meeting in June in order to clarify them.”
However, he said, that meeting did not allow room for any real debate or clarification of any point to enable the generation of a “common scientific conclusion” on the Toyocerin strain.
A spokesperson for EFSA told this publication: "Technical hearings are not an opportunity for the applicant to hear the views of the Panel or Working Group on their application during an ongoing risk assessment. EFSA is touch with Rubinum over this issue."
The Authority said it is currently reviewing the use of technical hearings with a view to "further improving the services" it offers to applicants.