EU market authorization suspension for feed probiotic upheld

16-Jul-2015 - Last updated on 17-Jul-2015 at 20:24 GMT

The EU Commission’s standing committee on plants, animals, food and feed (SCoPAFF), in a majority vote last week, upheld the authorization withdrawal decision on the controversial feed additive, Toyocerin.

Dag Andersen, general manager of Rubinum, the Spanish producer of that additive, told FeedNavigator he was not surprised at the ScoPAFF decision. “It [the vote] was just a formality following the negative EFSA opinion of July 2014,” he said.

However, the Commission this week, he said, has formally invited the Spanish company to submit an application for a new safety evaluation of Toyocerin.

“We see this as an opportunity but we remain convinced that there is a need to resolve the controversy around the principles applied in the scientific risk assessment prior to submission of a new application,” said Andersen.

He said the firm is again calling on the European Food Safety Authority (EFSA) to facilitate the exchange of scientists that is “badly needed” to clarify the scientific approach used in the evaluation of the gut flora stabilizer.

Risk assessment background

In October 2012, EFSA concluded Toyocerin 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 additive.

Rubinum complied but July last year saw EFSA found against Toyocerin, 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."

Drumming up support

Last month, the company met with Marco Valletta, a member of the cabinet of EU Commissioner for health and food safety, Vytenis Andriukaitis, and Marta Ponghellini, acting head of the animal nutrition at DG Sante, to drum up support for a new scientific meeting involving the FEEDAP panel and a Rubinum led scientific group to discuss the risk assessment of the probiotic.

Rubinum said such a forum would help it fully understand the “rational” behind the FEEDAP Panel’s conclusions and 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.”

Court case

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.