EFSA assessment process not fit for purpose, says Rubinum after it loses ECJ case

By Jane Byrne

- Last updated on GMT

EFSA assessment process not fit for purpose, says Rubinum after it loses ECJ case

Related tags Efsa European union

Spanish feed additive producer, Rubinum, says the European Food Safety Authority (EFSA) is ‘out of control’ and it is calling for a debate at EU parliamentary level on the future role of the EU risk assessor.

Dag Andersen, Rubinum’s general manager, told FeedNavigator this morning:

“The current EU food and feed product risk assessment system is not working and it is hampering industrial growth in the bloc.  

EFSA is going beyond the guidelines, so much so the feed additive re-evaluation process has been held-up – there is a serious lack of efficiency in how the risk assessor is carrying out its work.

We are calling on MEPs to urgently review the implications of the current set up. Essentially, there needs to be a scientific body led route of appeal within EFSA to allow companies a voice, but not influence. As it is, the applicant can do little to complain about an EFSA finding, on scientific grounds.

Art. 19 of the Reg. 1831/2003 only offers administrative review of EFSA’s findings not a scientific re-evaluation.

EFSA should initiate a communication and appeals process similar to that adopted by the European Medicines Agency (EMA). This would involve pre-submission meetings, scientific advice and opportunity for follow-up questions of clarification, an oral hearing during the assessment, an appeal process and an oral hearing during an appeal."

Andersen’s call to action echoes the demands made in a letter​by 11 European trade associations to EFSA in February last year.

EFSA told this publication recently that while it is not considering pre-submission meetings with individual applicants, in future, there might be the possibility of pre-submission meetings with groups of applicants, as part of the Open EFSA​initiative.

EU Court of Justice finds against Rubinum

The Rubinum general manager’s comments came after his company lost a EU Court of Justice (ECJ) case​it had brought against the EU Commission over a decision to withdraw authorization for its feed additive, Toyocerin, in Europe, based on an negative EFSA opinion.

The ECJ yesterday found for the EU regulator and ordered Rubinum to pay costs.

“The outcome is very disappointing. We had thought the ECJ would be the one EU institution that might give us a fair hearing,” ​said Andersen.

Rubinum is still awaiting a decision on how much it will have to shell out to cover the costs.

“We have already had an outlay to the tune of €500K to cover all the expenditure associated with the EFSA re-evaluation of Toyocerin. We were forced to restructure last year and undertake some cost cutting. The process has seriously undermined our business,”​ said the general manager.

A negative opinion from EFSA on the Spanish company’s feed ingredient, Toyocerin, 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 under Regulation No (EU) 288/2013.

The additive, which is based on the strain Bacillus toyonensis, ​had originally been authorized in the EU in 1994 for use in the diets of sows, piglets and pigs.

Rubinum, in an application originally filed in April 2013, asked the EU Court of Justice to suspend operation of Regulation No (EU) 288/2013.

‘EFSA’s doors are closed to industry’

It claimed the EFSA opinion and the Commission’s decision to not renew product authorization was “based only on assumptions”​ and that, in fact, neither the transfer of antibiotic resistance nor the production of toxins “could actually be established”.

“At the time of withdrawal of EU product approval, the EU market represented 70% of our sales for Toyocerin.

While we have developed other markets for the probiotic, the level of existing business is not enough to compensate for the loss of the European livestock segment.

We have as much interest as EFSA and the Commission in ensuring our products are safe but how can we ensure two-way communication on the science if EFSA’s doors are closed to industry,” ​said Andersen.

Regulation No (EU) 288/2013 did allow Rubinum the possibility of submitting additional supporting documentation to give EFSA’s FEEDAP Panel more scope to reconsider its assessment of the probiotic.

Unfair treatment

Andersen said it sent through all the supplementary data and a raft of peer reviewed expert studies but July 2014 saw EFSA issue a negative opinion again on Toyocerin.

The company believes it has been unfairly treated by EFSA in that it was only allowed one ‘clock stop’ whereas “other applicants have had four or five."

“Furthermore the clarification questions we were asked by the FEEDAP Panel were based on draft EFSA guidance on Bacillus cereus that had not yet been made public. This is not a transparent way to carry out risk assessments,” ​said the Rubinum representative, who also questioned the level of expertise within EFSA in relation to probiotic science.

The next session of the Standing Committee on Plants, Animals, Food and Feed (PAFF) – 3 June 2015 - is set to discuss the Commission’s denial of authorization for Toyocerin. “It is on the agenda, so there is always hope,”​ said Andersen. 

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