Anke Sentko, vice president regulatory affairs and nutrition communication told NutraIngredients.com that Beneo welcomed the idea of the health claim regulation: “Market harmonisation means trustful messages to consumer, that those companies investing in research for ingredients and products are winners in the game.”
However, she said that continued uncertainty over what constituted proprietary data under the regulation was blocking publication of new science in Europe, where firms felt ‘trapped’ and unable to publish cutting-edge data relating to functional foods.
Proprietary data trap
Speaking of proprietary science for Beneo’s palatinose/isomaltulose (functional carbohydrate) products, Sentko said:“We have a lot of science to publish – but since the health claim regulation came out there is no clarity at all over how the Commission views this proprietary data.”
“If you pay for research, the regulation applies five years protection to your data. But currently the legal services of the Commission – it is ludicrous – are saying that only unpublished studies can be regarded as proprietary.
Beneo corporate communications manager Claudia Meissner added: “It wouldn’t be too difficult to accredit findings to a specific company, university, small or big company, ingredient or food manufacturer.
"But currently there’s something of a vacuum in the EU. You need confidentiality agreements to proceed with product development projects."
Sentko said that Beneo had“limited our publications to the basic science or physiology to show that palatinose is completely but slowly hydrolised and absorbed, accordingly. “But we have not published more exciting science that will form part of our 13.5 dossiers [which include requests for proprietary data protection].”
Sentko said that Beneo had“limited our publications to the basic physiology /or science to show that palatinose is completely but slowly hydrolised and absorbed,” accordingly. “But we have not published more exciting science that will be part of 13.5 dossiers [which include requests for proprietary data protection].”
What is a health claim?
Sentko said further problems arose with definitions of what constitutes a claim, which she describes as “very broad – whatever is communicated on a product relating to health benefits would be covered.”
She said that EFSA’s implementation of the health claim regulation narrows the scope to bio-active ingredients added to food . Changing the physiological properties of a food by smart choice of ingredients, e.g. by using a sugar-replacer instead of sugar and thus lowering the GI, seems not be eligible for evaluation, said Sentko, although the definition of the claims is "broad enough".
EFSA’s role involves checking if science substantiates a given claim, where the regulation dictates that this be done based on an undefined notion of “generally accepted scientific evidence” for article 13 and article 14 (disease-risk reduction and children’s health) claims.
Sentko said this approach risked deterring “innovative claims”, if generally accepted scientific evidence is interpreted as existing textbook knowledge alone and called for “proportionality and a solution in this respect”.
“With respect to claims addressing normal growth and health in the US, for example, you can do it with substantiation provided by a good basis of studies, although what you are saying should still be credible.
“For structure function claims there is no pre-market approval process…and for so-called qualified health claims, you need to provide the FDA [Food and Drug Administration] with notification . So you still have a chance to communicate and develop your product further.”
'Biological effect' issue
Sentko said that in 2006 Beneo expected EFSA to reserve the “higher hanging fruits” for article 14 claims, with the requirements for article 13 claims less stringent; the subsequent decision to harmonise scientific criteria for both was surprising, and risked penalising submissions regarding holistic health benefits.
“What EFSA is doing is now is looking for physiological effect of bioactive ingredients…a specific measurable effect. One successful example is the blood agglomeration claim …you have a specific parameter (say cholesterol) that decreases as shown by a well-accepted marker.”
“But on a macro-nutrient level you are talking about holistic approach of nutrition, not dose effects. For example, if you replace a fermentable carbohydrate that can cause dental caries with a non-fermentable carbohydrate.
“EFSA is currently saying it cannot evaluate such claims – so for me this seems they are evaluating biological effect ingredients, because they accept all vitamins and minerals, on textbook knowledge alone, with no new assessment.”
Given that, in Sentko’s words, the functional food industry has “never been in such a complicated situation as it is today”, the Beneo Group launched its institute in November 2009 to market its nutritional science and regulatory expertise to industry.
Meissner said that despite its infancy, the institute was already involved in “an eye-level dialogue with the big companies”, while small to medium-sized food manufacturers were also customers, “even if it’s just to ask us to check out their labelling.”
“There is a level of trust in our consultancy – even if it’s simply getting a second opinion to avoid being attacked by the authority or competitors,” she said.
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 a key figure there.
For more details click here.