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Pomegranate Best Positioned for EFSA Antioxidant ClaimPomegranate Best Positioned for EFSA Antioxidant Claim

May 13, 2013

7 Min Read
Pomegranate Best Positioned for EFSA Antioxidant Claim

Effective marketing campaigns mean berries enjoy superstar status with consumers. However, they have been less than convincing when it comes to the stringent health claims process in Europe. To date, no berry has been successful in achieving a coveted EFSA health claim, but this doesn't mean berries can't be successful in the future. Valeriya Krasovskaya, researcher at Jessevandervelde.com, is presenting at the Vitafoods Europe Conference this month and shared with INSIDER her thoughts on what the future might hold for berries and health claims relating to antioxidant capacity.

Valeriya Krasovskaya, researcher at Jessevandervelde.com

INSIDER: What are the primary obstacles most companies face when seeking an antioxidant health claim?

Valeriya Krasovskaya: I'd like to reverse this question and instead of the obstacles, focus on the openings for those seeking to have their antioxidant claim/s authorized.

Since the appearance of the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health, which was published in the EFSA Journal in December 2011, things have become much clearer for applicants. It summarizes what EFSA considers pertinent scientific substantiation for the proposed claims and is therefore a useful tool.

In the document, the Panel stated with the exception of well-established risk factors (e.g., low-density lipoprotein (LDL) cholesterol concentration and blood pressure), the benefit of the reduction of a risk factor in the context of a suggested health claim should be considered on a case-by-case basis. Further, it reminded, pursuant to Regulation 1924/2006, reference to general, nonspecific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim.

In considering whether the studies provided are pertinent, the NDA Panel addresses the following criteria:

  • Whether the studies have been carried out with the food/constituent for which the claim is made;

  • Whether the design and quality of the studies allow conclusions to be drawn for the scientific substantiation of the claim;

  • Whether the studies have been carried out in a study group representative of the population group for which the claim is intended; and

  • Whether the studies used (an) appropriate outcome measure(s) of the claimed effect.

  • In paragraphs three and four of the Guidance the Panel described the biomarkers and types of studies it considers un/reliable.

With regard to claims on antioxidant status and antioxidant defense, as far as EFSA is concerned, studies that measure the overall antioxidant capacity of plasma are not a reliable indication of any health benefits for humans. ORAC, TEAC, TRAP, FRAP and FOX evaluations that assess changes in the antioxidant capacity of plasma are often used for research purposes; these are explicitly mentioned in the Guidance with the remark that, It is not established that changes in the overall antioxidant capacity of plasma exert a beneficial physiological effect in humans as required by Regulation (EC) No 1924/2006." Further, those changes, do not predict a role of the food/constituent in the protection of body cells and molecules such as DNA, proteins and lipids from oxidative damage in vivo, and therefore are not suitable outcome measures for the scientific substantiation of the claimed effect." Therefore, claims supported by this type of data are assessed by the EFSA with an unfavorable outcome.

In my presentation during the Vitafoods Europe Conference I will present Nine steps to have your antioxidant claims authorized," which summarizes EFSAs criteria and is an easy model to follow.

INSIDER: Why are berries uniquely positioned to ultimately receive an antioxidant health claim?

Krasovskaya: Approximately 40 of the 2,758 claims selected by EFSA for the final authorization procedure were related to berries, half of which were related to antioxidant effects. However, none of them have been authorized by EFSA.

Berries have been consumed in fresh, dried and preserved (jams and condiments) form for centuries and have been used as nutraceuticals to prevent and treat numerous diseases. Since the beginning of the 21st century, some berries, traditionally used in certain parts of the world, have found fame elsewhere with the superfoods" tag. Examples include goji berries, pomegranate juice and freeze-dried açaí berry. Efficient marketing strategies have led them to reach broad audiences thanks to communication of the berries outstanding qualities and high appraisal in the media. These products are sold as health food items and marketers are willingly making use of selected research, mostly in vitro experiments, to stress the antioxidant effects of berries.

Meanwhile, berries that are more common to the U.S. and European audiences, such as blueberries and cherries, are also being intensively promoted by institutions such as the U.S. Highbush Blueberry Council and Cherry Marketing Institute, respectively. These institutions stimulate and collect research on the health benefits of the berries and make it available to the public.

Berries in general are known to be nutrient-dense foods: they contain large amounts of water-soluble vitamins, minerals (potassium, manganese, zinc) and fiber. Scientists hypothesize, though, that berry polyphenols are the major health-giving component in them. Most of the studies obtainable through academic databases are in vitro experiments focusing on quantification of polyphenols, their metabolic pathways and the effect on different biomarkers. Numerous animal studies are also available. However, there is still a lack of reliable human data.

Berry polyphenols are generally considered to be nontoxic and beneficial for health, although the precise mechanisms of their metabolism and action remains largely unclear. What needs to be noted is that research teams worldwide have no consensus on how best to assess the metabolism of (berry) flavonoids and their impact on health. Furthermore, (human) research is needed in order to design a reliable model to assess the use of berry active compounds by humans and their alleged benefits.

Since berries are safe, tasty and nutrient-dense, their consumption should be encouraged. The coming years will certainly shed more light on their benefits for human health.

INSIDER: What is the most promising berry in the antioxidant area?

Krasovskaya: One of the most promising berries, perhaps truly the most promising berry, is pomegranate. Centuries-long observations have made the establishment of a connection between the ingestion of certain berries and (the improvement of) certain conditions possible: a connection has been observed between the regular consumption of pomegranate as part of the Mediterranean diet and a lower incidence of cardiovascular disease (CVD) in the region.

The antioxidant properties of pomegranate are attributed to its polyphenolic complexwhich includes fatty acids, punicalagins (pomegranate ellagitannins), hydrolysed tannins and ellagicand anthocyanins of which delphinidin, cyanidin, and pelargonidin are predominant.

Ellagitannins are the major polyphenols in pomegranate fruit and it juice (juice-pressed whole fruit, arils, and seeds) and account for more than 90 percent of the antioxidant activity of the juice. Commercial pomegranate juices have shown an antioxidant activity three times higher (18-20 TEAC) than that of red wine and green tea (6-8 TEAC).

The protective qualities of pomegranate juice against atherogenesis have been extensively studied over the last decade by Michael Aviram and co-workers at the Rappaport Institute of Haifa, Israel. Research from other parts of the world is also available. At the time of writing, at least 10 randomized control trials have studied the effect of pomegranate constituents on human health and yielded significantly positive results. Some of the findings include: an increase in the antioxidant capacity of plasma, an inverse correlation between the consumption of pomegranate constituents and total plasma cholesterol concentration, a reduction of plasma LDL and an increase in plasma high-density lipoprotein (HDL) concentrations, a reduction in systolic blood pressure, an increase in PON 1 (Paraoxonase) activity and an increase in the (carotid) lesion GSH content.

As far as pomegranate and EFSA, 12 applications relating to pomegranate have been made but none authorized. The EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on the pomegranate related health claims, which it issued in 2010. The NDA Panel considered that the provided scientific trials were too small and uncontrolled, therefore concluding that a cause and effect relationship was not established between the consumption of pomegranate constituents and health benefits.

Since the NDA issued its opinion, new research has been conducted. Although the choice of markers (which, if used alone, cannot be used for substantiation of health effects) will not allow the study to be qualified as a reliable scientific substantiation by the EFSA, these new studies can probably be used as strong supporting evidence alongside research focusing on other biomarkers. Research on pomegranate activity is currently underway (for instance at the Rappaport Institute Haifa, Israel) and over the years to come it is likely that enough evidence can be compiled to substantiate a claim relating to the antioxidant properties of pomegranate.

For further details about Vitafoods Europe and Finished Products Europe, or to register, visit vitafoods.eu.com or finishedproductseurope.com.

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