The latest batch is the last that will be published before June 2011 – and the last for the foreseeable future to include any botanicals – as the Commission announced last month that the batch-wise approach is to be ditched amid concerns over market distortion when companies whose claims have been rejected have had to stop using them but those still waiting can carry on.
Article 13.1 claims for botanicals are troublesome because under the Traditional Herbal Medicinal Products Directive (THMPD) they could make claims with little proof other than traditional usage – while under the health claims regulation EFSA has been seeking randomised clinical trials.
It includes the first positive opinion on a weight loss claim, for konjac mannan (glucomannan), in the context of an energy-restricted diet. EFSA reiterated a previous positive on konjac and normal blood cholesterol concentrations, but turned down five others for it.
Nigel Baldwin of Cantox pointed out that this creates a curious situation, as konjac is a food additive rather than a food ingredient, raising questions as to whether it would need to go through novel foods approval to be used on the basis of its health benefits.
The same quandary holds for two other additives, HPMC and pectin, which both got the EFSA ok for reduction of post-prandial glycaemic responses and maintenance of normal blood cholesterol concentrations.
The omega-3 industry will be hailing the latest batch for DHA’s slew of good news, on normal brain function, normal vision, and maintaining normal (fasting) blood concentrations of triglycerides. For DHA and EPA there was new good news on normal cardiac function ; but EPA alone received five ‘nos’ on mood, calming, attention, increase in appetite after unintentional weight loss, and protecting blood lipids from oxidative damage.
“DHA is rocking and rolling,” Baldwin said. “It gets pretty much a full house”. He added that it puts an end to splitting hairs with article 14 claims over when an infant becomes an toddler because it has brain and eye health for the whole population.
Vitamins and minerals
Vitamins and minerals also received many positives, particularly for tiredness and fatigue. They seem to fall into three kinds of positive opinion however: a straight yes; a yes, but there doesn’t seem to be evidence of insufficiency in the diet; and in the case of niacin and blood flow, yes there is a relationship, but the amount needed would be so high that it would encourage excessive intakes.
Tea, prunes and pomegranates
There was bad news for green tea, (Camellia sinensis (L.) Kuntze), on body weight, reducing body fat mass, and long term maintenance of normal blood glucose concentrations.
A sad day too for punicalagin/ellagic acid in pomegranate/pomegranate juice, as EFSA deemed that six claims did not hold up, including for erectile dysfunction, anti-ageing, and maintaining normal cholesterol.
As for prunes and normal bowel function, Baldin said: “That must have been a hard one and they should have withdrawn.”
Other botanicals opinions are bundled into some of the opinions covering multiple foods proposed for similar effects.
The Commission is understood to have drawn up a list of which health claims it believes related to botanicals, which will dash hopes of anyone may have been harbouring of buying more time by claiming to be botanical.
EFSA spokesperson Lucia da Luca told NutraIngredients that a list of the outstanding 13.1 claims, for opinions next June, will be published on the EFSA website in due course - but not a list of botanicals. The opinions on botanicals included in this week’s batch were adopted before the Commission decided to set botanicals aside so EFSA was obliged to publish them.
NutraIngredients health claims 2010
These matters and more will be discussed at the second NutraIngredients Health Claims 2010 conference to be held in Brussels on December 1. The conference will deconstruct the latest article 13.1 claim opinions, hear first-hand experience from players like Kellogg’s, outline regulation-coping marketing strategies, and feature comparison with the US claims system from leading industry figure, Dr Andrew Shao.
For more details click here.