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Health claims update: Article 13.1 ‘on track’

By Lorraine Heller , 26-Jul-2010

The European Food Safety Authority (EFSA) says it is on track to release its next batch of Article 13.1 health claim opinions in September this year, but there is still no indication as to how many dossiers will be evaluated in the third group.

So far, EFSA has published 1,080 Article 13.1 health claim opinions, released in two batches – the first in October 2009 and the second in February 2010.

Overall, 4,637 claims were submitted under Article 13.1 of the European nutrition and health claims regulation, which covers general health claims, including those linking vitamin, mineral and herbal extract consumption with health maintenance. EFSA now has another 3,259 claims to evaluate, following the withdrawal of 297 claims.

Evaluation challenges

The risk assessor has repeatedly said that these will be released “progressively”, but has highlighted “challenges” along the way, resulting from a higher number of dossiers than expected as well as the poor quality of information included in many of the claims.

This has caused some industry observers to question the risk assessor’s ability to stick to its planned publication deadlines, however EFSA this morning confirmed that it is currently on track to release its third batch of opinions by the end of September this year.

EFSA was unable to confirm how many opinions will be included in the third batch, but re-iterated that it expects all opinions to be published by December 2011.

Rejections to date

The majority of Article 13.1 opinions issued so far have been negative, including submissions linking health benefits to vitamin D, probiotics, green tea, black tea, lutein, beta glucans, meso-zeaxanthin, alpha-lipoic acid, melatonin, peptides, xanthan gum, sugar-free gum, guar gum, gamma-linolenic acid (GLA), fermented whey, linoleic acid (LA) and a range of botanical substances.

EFSA says the negative opinions were due to:

  • Lack of information to identify the substance on which the claim is based, e.g. “probiotics”;
  • Lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g. food with “antioxidant properties”);
  • Lack of human studies with reliable measures of the claimed health benefit.