Article 13 health claim deadlines in jeopardy

By Shane Starling

- Last updated on GMT

Related tags Efsa European union European food safety authority

The European Union health and nutrition claims regulation deadline of January, 2010, is coming under increasing pressure as European risk assessors and risk managers lurch under the sheer weight of processing more than 4000 generic article 13 claims.

The European Food Safety Authority (EFSA) recently published the full list of its article 13 claims (available here​), an event that has alarmed companies, trade bodies and EU member states because of the number of questions EFSA has raised over submissions.

A European Commission spokesperson contacted by this morning said something like “50 per cent of the 4000 claims needed clarification” ​a fact that “would have an impact on the timing of the whole exercise”.

These 2000-or-so queried claims have been sent back to the various bodies, groups and companies within the member states that are now tasked with gathering additional data.

The Commission spokesperson added​that a meeting between EFSA, the European Commission and member states, was scheduled for Monday “to discuss the whole process”.

The UK Food Standards Agency is one of those bodies to which claims have been returned and it said in an email to today that it had been asked by EFSA to, “clarify some of the details supplied by UK companies. We are currently liaising with the European Commission on how best to manage this process to ensure that EFSA receives all of the information it has requested.”

This uncertainty is of increasing concern to industry, and many are beginning to question the feasibility of the January 2010 deadline, which can only be altered in a European Parliament vote.


Nigel Baldwin, the senior scientific and regulatory consultant at UK-based consultancy, Cantox Health Sciences International, said many claim dossiers were being sent back to their creators for clarification because of lack of guidance from the Commission and EFSA.

“That lack of guidance is what has caused this problem and we find ourselves in a position where industry is becoming increasingly worried,”​ he told “But this lack of guidance means that in many cases companies have cherry-picked scientific references that are now being queried by EFSA. Unless they reject the claims en masse I can’t see how they can meet the deadline in January.”

An EFSA spokesperson said the Parma-based assessor had been explicit about why dossiers had failed to meet its six claims screening criteria, and that it “was open to dialogue”​ if petitioners were in doubt about what kind of data or clarification was being sought.

In addition to the article 13 claims there are something like 300 article 14 children’s health and disease reduction claims. So far 49 claims have been processed although not all of them have as yet been published on the health claims section of the European Food Safety Authority (EFSA) website.

EFSA published its first claim opinions in August, 2008. To date it has issued positive opinions on only a handful of opinions and its “gold standard”​ scientific approach has been heavily criticised by industry.

EFSA’s claims screening criteria was published by its claims body, the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA), on October 7, last year. It can be viewed here.

Cantox is hosting a health claims workshop on March 24 in Geneva. For details click here.

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