Apocalypse now for article 13.1 health claims as batch 3 is published

By Elaine Watson

- Last updated on GMT

Related tags Health claims Nutrition

EPA and DHA claims: Mixed picture, but mostly good news
EPA and DHA claims: Mixed picture, but mostly good news
Armageddon appears to be fast approaching for vast swathes of the functional ingredients trade following the publication of the third batch of ‘article 13.1’ health claims opinions from the European Food Safety Authority (EFSA).

EFSA scientists yesterday issued negative opinions​ for the majority of claims in its third batch of opinions on article 13.1 health claims, which are based on 'generally accepted science' and cover the role of nutrients in the body (eg. 'calcium contributes to the maintenance of normal bone structure').

It now seems increasingly likely that only a handful of ingredients will in future be permitted to carry health claims in Europe with the exception of minerals and vitamins.

There was however, some good news for the long-chain omega-3 fatty acids EPA and DHA, with EFSA agreeing that consuming DHA did help maintain normal vision, brain function and blood triglyceride levels. EPA and DHA together were also deemed to contribute to normal cardiac function and blood triglyceride levels.

EPA alone fared badly, however, with EFSA giving short shrift to claims about mood, calming, attention, increase in appetite after unintentional weight loss, and protecting blood lipids from oxidative damage.

There was also good news for pectins, which were deemed to help reduce glycaemic response after a meal and maintain normal blood cholesterol concentrations; lactulose, which EFSA agreed helped to reduce intestinal transit times, and plant sterols and stanols, which EFSA agreed helped to maintain normal blood cholesterol.

Thumbs down: Wholegrains, PS, soy protein, CLA, whey protein

However, claims about wholegrain were not possible to assess because wholegrains were not sufficiently characterised, said EFSA.

The so-called 'memory molecule' phosphatidylserine (PS), which can be derived from plants such as soy as well as animal sources, was also deemed to be insufficiently characterised, while EFSA also controversially concluded that it had not been presented with sufficient evidence to prove that cocoa flavanols protected lipids from oxidative damage or helped maintain normal blood pressure.

Soy protein, which was the subject of a recent highly controversial article 14 negative health claim opinion,​ also failed to impress EFSA, which concluded that it had not been presented with compelling evidence that it helped people manage their weight, maintain normal blood cholesterol concentrations or protect DNA, proteins or lipids from oxidative damage.

Claims about the ability of CLA (conjugated linoleic acid​) promoted by firms including Cognis and Lipid Nutrition to help people manage their weight and increase lean muscle mass also lacked evidence, according to EFSA, although Cognis said there was more to the opinion than met the eye.

"While the EFSA panel rejected some health claims relating to CLA, it did not give any specific opinion about the relationship between CLA and body fat reduction. Cognis’ Tonalin CLA is marketed not as a weight loss ingredient, but rather as an ingredient for body fat reduction, a benefit that has been proven in numerous human studies. This is why we will review the opinion in detail and raise our concerns with the European Commission to clarify whether our claims will be evaluated in a later batch."

Jaap Kluifhooft, regulatory affairs boss at rival Lipid Nutrition, said the firm would now apply to make​ claims about CLA and body-fat reduction under article 13.5 of the health claims Regulation. "We have learned from the process and are very confident to receive a positive opinion via article 13.5.”


Meanwhile, claims about whey protein and satiety, weight maintenance, body-shaping and muscle tissue repair post exercise were also given short shrift, although generic claims about 'protein' and the growth or maintenance of muscle mass and bones were given the thumbs up.

This was despite the fact that EFSA said that generic claims about 'dietary fibre' for example were not possible to assess as there was so many types, Nigel Baldwin at consultant Cantox Health Sciences International told FoodManufacture.co.uk. "It does seem to be a bit inconsistent."

The latest batch of opinions covers 808 claims, taking EFSA up to 1,745 article 13.1 claims out of the 4,637 it has agreed to assess under the EU health claims Regulation.

Lack of precision

In many cases, unfavourable opinions were issued as ingredients were not sufficiently characterised or applicants had not cited compelling human studies to substantiate claims, said EFSA.

Some applications also suffered owing to a “lack of precision”,​ with references to phrases such as 'energy' and 'vitality' without clear definitions of these terms or how to measure them.

The opinions have been sent to the European Commission and Member States, which ultimately decide whether to approve them or not. Successful 13.1 claims will be added to an EU-wide register of approved claims and will be available for all food manufacturers to use provided that they meet the conditions of use for the ingredients in question.

EFSA will finalise the evaluations of all article 13.1 general function health claims (other than botanicals) by the end of June 2011.

Article 13.5 claims

Meanwhile, health claims based on new science and/or proprietary data (article 13.5) have fared little better.

So far, just one article 13.5 claim - about Provexis' heart-healthy tomato extract Fruitflow - has passed muster from a pool of more than 20 applications.

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