08 Jan 2016 — The EU Commission has authorized an Article 13.5 company specific health claim with proprietary use for BENEO’s chicory root fiber inulin promoting digestive health. The official wording for the claim is: “chicory inulin contributes to normal bowel function by increasing stool frequency.”
From January 1, 2016, this proprietary claim is available for use by BENEO’s customers. By incorporating the company’s inulin into any food and beverage applications in combination with the health claim, manufacturers can help consumers to understand and benefit from the positive effect chicory inulin has on bowel function.
In addition to the authorized 13.5 proprietary health claim, general health-related well-being claims under Article 10.3 of the EU’s Health Claims Regulation are also possible. Among others, these include “chicory inulin promotes digestive health” or “chicory root fiber supports a healthy and balanced digestive system.” Manufacturers that want to use the claim should consider that the beneficial effect is achieved with a daily intake of 12 gram chicory inulin and the consumer should be informed accordingly. The amount of 12 gram can be split up into several servings per day.
“This new claim is a real boost in digestive health and it can be achieved without any negative effects. Consumers want to have bowel regularity, but don’t want to be bothered by it either, and this is what the data shows,” Anke Sentko, VP Regulatory Affairs and Nutrition Communication at Beneo told FoodIngredientsFirst. “What we will see in the market is the development of these types of messages on products containing our ingredient that relate to supporting digestive health, which is a key area that our research shows that consumers are interested in,” she adds. In fact Beneo’s digestive health research (2015) found that nearly 3 out of 4 European consumers eat products supporting digestive health, because they feel it is good for their overall health.
Since the claim has only just become valid, Sentko remained coy in terms of the specific companies looking to adopt it in the short term, but she is confident that products will reach the shelf soon. “We knew that this claim was coming after the positive opinion from EFSA, so it is of course of interest, as is the topic of digestive health for the industry as a whole,” she adds.
The science behind this health claim has been positively evaluated by the European Food Safety Authority (EFSA) and included six human intervention studies that have consistently proven that the consumption of Orafti Inulin increases stool frequency and thus supports digestive health. Significant results were demonstrated with a proprietary study of BENEO for a total intake of 12 gram per day. While the recommended daily intake of dietary fiber is 25 gram per day and actual intake is significantly lower, the authorization shows that adding inulin to a formulation helps to improve stool frequency and at the same time to achieve the dietary goal of adequate fiber intake by the general population in an easy way.
The authorization confirms that BENEO’s prebiotic fiber inulin contributes to normal bowel function, by increasing stool frequency without triggering diarrhoea. This is possible because inulin resists digestion in the small intestine and is fully fermented in the large intestine.
Sentko notes that the approval is strictly in place for BENEO products and no consortium was involved in the process. The dossier submission featured proprietary science that served as the basis for the approval. “For this specific claim we conducted new research that follows the gold standards of the guidelines that EFSA developed. Those made the whole submission proprietary to us. It is not published yet, as this a prerequisite for it being proprietary and conducted specifically for that claim,” she noted.
BENEO will benefit from exclusivity on this claim for a period of 5 years, unless equivalent products are also substantiated under the same procedure. Therefore from January 1, 2021 this claim will be open to other companies offering equivalent products, who have not had a successful Article 13.5 claim in the meantime. “If someone else is investing in research, they can of course submit, if they receive a positive opinion then they can use a comparable claim, but they will need to go through this procedure and develop their own data,” she says.
This was a pending claim and Sentko notes that the company has already been successful on others under the generic Article 13.1 submission process i.e. isomaltulose [blood sugar and dental claims] and isomalt [blood sugar and dental]. “If you develop a new claim and invest in research it will take 5-10 years until you have a claim approved, so it is not something that comes every couple of months. But it shows our success and commitment in what we have achieved so far,” she stressed.
The industry has been pretty negative about the EFSA submission process for many years, particularly when over 2,500 Article 13.1 claims were initially rejected under the EU process for the harmonization of health claims. But Sentko agrees that the relationship between industry and the regulatory body is warming, now that there is greater clarity around health claim dossier submissions. “There has been a learning process on both sides and there are now guideline documents available too. There are opinions available which allow you to draw conclusions. This history was not there when the whole claims evaluation process started,” she explained.
Sentko noted that overall EFSA has been quite reliable in their 5 months period of evaluation, which in some cases can be even quicker. However, she stressed how the role of the Commission and Member States themselves in then allowing the claim to obtain final approval can be much less predictable. The often frustrating process is not chronological and is instead impacted on how long it takes within the working group involved and how much debate is required around the specific topic.
In the case of their digestive health claim, the process was fast, with submission to approval taking about 18 months [10 months at the Commission level]. “But there are other examples where we really think there is no need for this period of time. We have one claim application that got a positive opinion in January 2014 [‘lowering blood glucose response’] and is still not approved just due to procedural reasons of going from one postponement to the next. There is room for improvement in many cases, but for the example of BENEO’s fast proprietary claim of digestive health we are proud of,” she added.
Moving forward, the company will continue to look to substantiate data around the potential health benefits of chicory root fiber, although specific details on claims being pursued is not being communicated. “The next direction depends on the research and the results, but be sure that something is coming. There is ground research and specific research that we are doing that we cannot communicate with the public at this stage,” she notes.
Potential research areas for the ingredient are very broad however. “Groundwork and specific research starts with digestive health and more aspects that are related to that. It also relates to blood glucose and blood sugar management, because they are important regulators in obesity and diabetes. The immune system is also related to the gut and this is an exciting area,” she notes. “Addressing the microbiota and prebiotic effect is something that is very specific for chicory root fibers and addressing the question of what constitutes a normal gut flora and makes it supportive to health is another area to look at. Weight management is another interesting area to support nutrition and health. We will see what kind of claims come out of these fields in Europe and elsewhere,” she concludes.
A body of work behind functional ingredients is being built and we can expect to see many more claim submissions and success stories in the medium term.
by Robin Wyers
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