Article 13.5 won’t resolve EFSA’s data gaps

By Shane Starling

- Last updated on GMT

Related tags: Nutrition, Platelet

Re-formatting and re-submitting rejected, article 13.1 health claim dossiers under article 13.5 will not miraculously turn red lights green as many are hoping, according to a leading European health claims expert.

Patrick Coppens, the secretary general of the Brussels-based trade group, European Responsible Nutrition Alliance (ERNA), said article 13.5 may provide better opportunities for dialogue between applicants and EFSA’s health claims panel, but results may be similar given the scientific criteria is similar.

“New submissions under article 13.5 may change the way the data is presented but not the data itself and so the end-result is likely to be the same,” ​Coppens told NutraIngredients this morning.

The European Food Safety Authority’s Panel on Dietetic Products, Nutrition and Allergies (NDA) has to date evaluated two batches of article 13.1 generic health claims comprising opinions on 937 dossiers. Almost all of the opinions other than for vitamins and minerals have been negative, prompting speculation that resubmission or reworked dossiers under article 13.5 may yield a more favourable interpretation from the NDA.

Leading lutein players such as Cognis, Kemin and OmniActive have begun this process, stating that subsequent criteria clarifications since the article 13.1 dossier was submitted more than two years ago – and the fact applicants can deal with the NDA one-on-one under article 13.5 will win their eye health claims a green light from the NDA.

But Coppens said the NDA failed to respond to points his group, the European Federation of Associations of Health Product Manufacturers (EHPM) and the European Botanical Forum (EBF) had raised in a recent 17-page joint letter, sent an ominous signal to industry.

Many queries raised at a recent stakeholder’s meeting at EFSA’s Parma, Italy, headquarters also remained unanswered, he said, although EFSA has committed to producing a briefing document that will address some of the 50-odd questions that came in at the meeting and other industry input it received in the lead-up to the event.

These concerns included:

  • the way proprietary data is being treated
  • dosage required to make health claims
  • scientific criteria not applied consistently
  • greater involvement in final claim wording
  • whether the regulation is meeting a remit to protect consumers
  • removing most remaining dossiers from the system

Article 13.1 is for generic health claims that have been submitted by member states, whereas article 13.5 is for emerging and proprietary science claims. The NDA has so far issued opinions on 22 article 13.5 claims, with only one, for a tomato extract that can benefit blood platelet aggregation, winning a positive opinion.

The next batch of article 13.1opinions is due to be published by the NDA in September and all 4500+ claims so far submitted under the EU's 2006 nutriton and health claims regulation are due to be processed by the end of 2011.

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