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EFSA gut/immune health meeting

Danone tells EFSA: Health claims “learning experience” is too costly

1 commentBy Shane Starling , 07-Dec-2010
Last updated on 20-Dec-2010 at 19:31 GMT2010-12-20T19:31:31Z

Danone says there is not enough claims clarity to make a submission for Actimel and other products
Danone says there is not enough claims clarity to make a submission for Actimel and other products
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The European Food Safety Authority (EFSA) has repeatedly emphasised that the 2006 EU nutrition and health claims regulation is a learning experience for everyone involved – from its health claims assessment panel to industry stakeholders, to the member states and the European Commission.

That may be so, but it is a highly expensive learning process, with the greatest burden of cost being borne by industry players like Danone, the company’s vice president of research and development in its dairy division, Frederic René, said after EFSA’s gut/immune function meeting in Amsterdam last week.

With Danone having twice submitted and then withdrawn dossiers for its probiotic yoghurts Actimel and Activia, citing a lack of clarity from EFSA at the time of both withdrawals, René said EFSA needed to be more communicative with applicants.

He said it was not acceptable that EFSA undertook its learning process by analysing dossiers and publishing opinions on them.

“It’s a trial and error process and I don’t think it is the right way to make a learning process.”

Like several others at the meeting, he proposed pre-screening of dossiers by EFSA’s Dietetic Products, Nutrition and Allergies (NDA) panel, a proposal NDA chief, Professor Albert Flynn, said was unlikely due to a lack of resources.

Lack of depth and precision

René said he was disappointed by the lack of specific guidance forthcoming at the meeting, save for some advice on clinical outcomes.

“In fact there is nothing really new,” he said. “We need to be more precise and maybe go in depth as proposed by many of the people attending the meeting.”

He said the situation remained unclear as to when health claim submissions for Activia and Actimel may be formally submitted to the process for a third time.

1 comment (Comments are now closed)

Confusion reigns

As a GP, I can report that this situation has caused confusion amongst doctors and their patients. People comment that they have heard that: "Probiotics don't work". This is obviously untrue. The balance of evidence is that they do work but the EFSA want more clear cut evidence on therapeutic efficacy. In the meantime, doctors should act on the evidence available when advising individual patients - but will they do this?

Report abuse

Posted by John Nichols FRCGP
08 December 2010 | 17h202010-12-08T17:20:07Z

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