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EFSA health claim opinions

EFSA rejects caffeine (alertness) and sterol (cholesterol) claims

By Shane Starling+

Last updated on 26-Feb-2014 at 16:57 GMT2014-02-26T16:57:12Z

EFSA rejects caffeine (alertness) and sterol (cholesterol) claims

Less than 75mg of caffeine per serving does not increase alertness, and the cholesterol-lowering ability of plant sterols cannot be communicated in food supplements, the European Food Safety Authority (EFSA) has found in two new opinions.


For the caffeine claim submitted by SmithKline Beecham Limited in the UK, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) noted it had already handed in an article 13.1, general function positive opinion for caffeine and alertness when 75 mg of caffeine were consumed with each serving.

That claim, along with four other approvals, has not yet passed into the EU law books as member states have raised over-consumption concerns, but despite that, the NDA rejected SmithKline Beecham’s proposition because it proposed a lower dosage of 40 mg and the evidence didn’t support the effect at that level.

The rebuttal came despite the article 13.5 proprietary and emerging science application submitted under the EU nutrition and health claims regulation (NHCR) containing 18 human intervention studies, 15 human studies on bioavailability or mechanistic studies, one pooled analysis and 12 non-human studies.

“In weighing the evidence, the Panel took into account the fact that most studies found no effect of caffeine at doses < 75 mg on reaction time in various cognitive tasks (simple reaction time, choice reaction time and reaction time on other vigilance tasks),” it wrote.

“At the particular dose range between 40 and < 75 mg, no effect of caffeine was found on the majority of outcome measures of reaction time. The Panel notes that the majority of studies with caffeine doses of 75 mg or higher showed a significant reduction in measures of reaction time, irrespective of the type of tasks which were assessed.”

“On the basis of the evidence provided, the Panel reiterates its previous conclusion that, in order to bear the claim, a product should contain at least 75 mg caffeine per serving.”

The opinion can be found here.

Plant sterol food supplements-cholesterol

The NDA rejected a submission from Sanofi-Aventis France to broaden the already approved sterols-stanols cholesterol lowering claim to powdered supplements diluted in water at 2 g per day. It said this could lower blood LDL-cholesterol concentrations by 5.4-8.1% after six weeks of daily consumption.

It submitted one piece of unpublished, proprietary science under article 13.5 for its plant sterol supplement which was a multi-centre, double-blind, placebo-controlled study involving 253 subjects.

The NDA acknowledged that the study showed significant results for LDL cholesterol reduction but noted three supporting human intervention studies, “did not comply with the specifications provided by the applicant for the extension of the conditions of use.”

It therefore said the one study was not enough to back the claim as it needed to be replicated in other research.

It wrote: “The Panel reiterates its previous conclusion that, while plant sterols added to foods such as margarine-type spreads, mayonnaise, salad dressings, and dairy products such as milk, yoghurts, including low-fat yoghurts, and cheese have been shown consistently to lower blood LDL-c concentrations in a large number of studies, the effective dose of plant sterols (as powder diluted in water) needed to achieve a given magnitude of effect in a given timeframe, cannot be established with the data provided.”

The opinion can be found here .

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