Toyocerin story: Rubinum leans on DG Sante in bid to set up 'scientific discussion' with EFSA

By Jane Byrne

- Last updated on GMT

Toyocerin story: Rubinum leans on DG Sante in bid to set up 'scientific discussion' with EFSA

Related tags European union

EU Commission representatives have told feed company, Rubinum, to submit a new dossier to EFSA in its bid to get a positive opinion for its probiotic, Toyocerin.

Last month, the Spanish firm met with Marco Valletta, a member of the cabinet of EU Commissioner for health and food safety, Vytenis Andriukaitis, to drum up support for a new scientific meeting involving the FEEDAP panel of the European Food Safety Authority (EFSA) and a Rubinum led scientific group to discuss the assessment of Toyocerin.

Marta Ponghellini, acting head of the animal nutrition at DG Sante and Robert Vanhoorde, another DG Sante representative, were also present at the 11 June meeting.

“They recommended we prepare a new dossier and present it to EFSA. But we have already provided additional submissions on our additive to the FEEDAP panel in accordance with EFSA guidance, supported by independent expert reports.

Our scientists now are at a loss as to know what else would be needed. It is our belief that only a meeting between us and the FEEDAP panel will help us to understand their doubts and to prepare a new dossier in order to demonstrate the safety of Toyocerin," ​Lau Andersen, president of Rubinum, told FeedNavigator.

A negative opinion from EFSA on the feed ingredient, published in October 2012, concluded it posed a risk for the spread of resistance to two antibiotics used in human and veterinary medicine, and the Commission subsequently moved to suspend existing authorizations for the product, originally approved in 1994, under Regulation No (EU) 288/2013.

That ruling did allow the Spanish firm the possibility of submitting additional supporting data to give EFSA’s FEEDAP panel more scope to reconsider its assessment of the gut flora stabilizer.

Rubinum complied but July last year saw EFSA issuing another negative opinion, saying: “On the basis of the data provided by the applicant  ... the panel concludes that B. toyonensis has the capacity to elaborate functional toxins and thus, to pose a risk to humans exposed to the organism."

Email request 

In follow-up communication to the DG health and food safety cabinet on 19 June, Rubinum again requested its assistance in organizing a meeting with EFSA and the Spanish firm’s scientific experts to understand the “rational”​ behind the FEEDAP Panel’s conclusions and to analyze “the divergence of interpretation of the supplementary dossier we submitted in December 2013 that led to the most recent EFSA opinion on our additive – that of July 1 2014.”

Rubinum wants DG Sante to guarantee that such a meeting will be organized in a way to allow all parties provide their understanding of the data submitted by it "in the frame of the assessment of the safety of Toyocerin as a feed additive." 

Andersen said the firm is still awaiting a response to that email.

SCoPAFF spotlight

The Commission’s standing committee on plants, animals, food and feed (SCoPAFF) is also putting the safety assessment of Toyocerin under the spotlight this week.

But Andersen is not hopeful anything positive will come from that Brussels debate. “We expect that Committee to uphold the authorization suspension imposed under Regulation No (EU) 288/201,”​ he said.

In May, Rubinum lost an EU Court of Justice (ECJ) case​it had brought against the EU Commission over the decision to withdraw authorization for Toyocerin.

The ECJ found for the EU regulator and ordered the Spanish firm to pay costs.

Market foothold

Toyocerin is currently used in feed in several Latin American and Asian markets.

Meanwhile, Rubinum said it is working to provide the US Food and Drug Administration (FDA) with the necessary data to get a Generally Recognized as Safe (GRAS) letter of no objection for Toyocerin to be authorized for use in animal food in the US.

The March 2012 notice from the FDA can be read here​.​ 

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