Planning, wording and relevant science are the keys to fibre health claim success in the EU, researchers have found after scrutinising the European Food Safety Authority (EFSA) approach to hydrocolloids.
The study published in the journal Bioactive Carbohydrates and Dietary Fibre by Glyndwr University and Phillips Hydrocolloids Research Ltd concluded that most dossiers failed due to presentational errors or as they lacked rigorous scientific support.
EFSA considered 13 categories of potential health claims for hydrocolloids under article 13.1 of the EU nutrition and health claims regulation (NHCR) such as “maintenance of normal bowel function” and “maintenance of normal blood cholesterol concentrations”. It issued positive opinions for three.
EFSA health claims
The successful submissions to EFSA were for beta-glucan, konjacmannan, HPMC, pectin, and guar gum, which managed to achieve at least one positive outcome in the 13 categories.
With beta-glucan and pectin there existed numerous human intervention studies over a prolonged time period using well designed trials with a high number of participants and trial periods of significant duration.
In the case of beta-glucan more than 50 relevant scientific studies were submitted to back up the claim.
The situation for pectin was similar with numerous relevant studies, summarised in a review publication and one meta-analysis, which overall demonstrated a significant effect.
Guar gum’s dossier included 18 relevant studies summarised in one meta-analysis, again with sufficient data to expect a positive outcome.
For konjacmannan (glucomannan) not all the relevant studies established a significant effect, and the number of relevant studies was less than 10. However the EFSA health claims (NDA) panel found enough evidence to issue a positive opinion.
The outcomes demonstrate the importance of clearly defining the wording of the submitted claim, note the researchers; making sure it is within a category that is considered a (potential) beneficial physiological effect.
The next step is to define the relevant accepted biomarkers to analyse the effect and the design of the human intervention trial to make sure it is of relevant scope and aimed at the correct demographic target population.
The hydrocolloid that stands out, in the number of relevant studies submitted to back up the claim, is HPMC, the authors noted.
The NDA panel only considered five studies to have relevance but one of these studies (Maki et al., 1999) was large enough that on its own convinced the panel that cause and effect had been demonstrated.
Wording of health claim
Wording of the health claim should as far as possible be checked with the relevant legislative authority for plausibility and usability.
That step is is also important from a marketing point of view because it gives an idea about the target market, demographic reach and thereby potential market volume and size.
From this starting point the relevant biomarkers to be measured have to be identified and the study or studies (human intervention studies) have to be designed. Data has to be obtained for the targeted demographic population.
The review concludes that obtaining a health claim can be a long and arduous process. However with the correct planning and understanding one or two studies should be enough to clearly demonstrate a cause and effect between the claimed physiological effect and the consumption of the food hydrocolloid, and thereby open up the potential for new profitable markets for these versatile food ingredients.
The 2009 Codex definition of a dietary fibre gave regulatory approval for the major commercial important hydrocolloids to be designated as dietary fibres.
Aside from their healthful properties, food hydrocolloids are used as thickeners, gelling agents, stabiliser, bulking agents, and emulsifiers in foods such as, beverages, confectionery, dairy based products and bakery.
Bioactive Carbohydrates and Dietary Fibre
‘Food Hydrocolloids and health claims’
Authors: Christer Viebke, Saphwan Al-Assaf, Glyn. O. Phillips