Health status: waiting for EFSA

1 September 2010

Karin E Nielsen, Bio2com, discusses the hopes and fears surrounding EFSA's Article 13 of Regulation (EC) No 1924/2006.

The weeks leading up to October 2010 have been quiet as everyone awaits the victories and defeats the health and nutrition industry will face with the third-batch release of Article 13 of Regulation (EC) No 1924/2006 regarding health claims.

"EFSA has issued negative opinions on more than 80% of Article 13.1's general function claims."

So far, the European Food Safety Authority (EFSA) has issued negative opinions on more than 80% of Article 13.1's general function claims (which are based on 'generally accepted science'). The fears are that few ingredients will be permitted to carry health claims in Europe, with the exception of minerals and vitamins.

This is an evolution for better health, carefully weighing consumer's safety and industry efforts on a very delicate scale. These issues are debated and discussed among large manufacturers. Examples include the soya industry with Danone and Gencor, who recently took part in heated debates with EFSA about the evidence and health significance of the studies they have been presenting in their applications; however, it's too early to tell what will be achieved in relation to improving population health, which should be the long-expected outcome.

Established health-claim products

While it is likely that only a few nutrients or ingredients will be able to carry healthy claims, it does not necessarily mean that there won't be healthy products with such claims: vitamins and minerals such as vitamin D, iron, magnesium and calcium may get the proper awareness in a society highly in need of a better balance. Also, the cholesterol-lowering effects of sterols and stanols (particularly LDL); alpha-linolenic acid and brain development; and the omega-3 fatty acid DHA and visual development in infants are significant claims that have been realised.

"Vitamins and minerals may get the proper awareness in a society highly in need of a better balance."

Another example is a statement about a magnesium-approved claim: "The Panel concludes that a cause-and-effect relationship has been established between the dietary intake of magnesium and electrolyte balance, normal energy-yielding metabolism, normal neurotransmission and muscle contraction including heart muscle, normal cell division, maintenance of normal bone, maintenance of normal teeth, and normal protein synthesis."

Data from middle-aged and older women suggest that magnesium intake is inversely associated with systemic inflammation and the prevalence of the metabolic syndrome. Or to quote the US National Institutes of Health: "Even though dietary surveys suggest that many Americans do not get recommended amounts of magnesium, symptoms of magnesium deficiency are rarely seen in the US.

"However, there is concern that many people may not have enough body stores of magnesium because dietary intake may not be high enough. Having enough body stores of magnesium may be protective against disorders such as cardiovascular disease and immune dysfunction."

"In Mintel's GNPD, 10,000 new energy beverages were launched within the last year (2010)."

In the EFSA's evaluations, it is stated: "Estimates of intake are usually calculated by using data from food questionnaires together with nutrition tables. However, with respect to magnesium, these data are probably 20-30% too high because the concentrations measured in food duplicates were considerably lower than values derived from nutritional tables. With these reservations in mind, the following estimates of intake are presented (in milligrams of magnesium per day)."

Thus, estimated magnesium intakes in Europe may also be too low as very few studies of actual intakes exist. Or as the UK Food Standards Agency inform in their evaluation: "Magnesium is ubiquitous in foods, but the content varies substantially. Leafy vegetables, as well as grains and nuts, generally have a higher magnesium content (60-2,700mg/kg) than meats and dairy products (less than 280mg/kg)."

Only a few beverage companies have grasped this chance. In Mintel's Global New Products Database, approximately 10,000 new energy beverages were launched within the last year. Among these, 559 included caffeine, 336 taurine, 222 with magnesium and 165 with glucuronolactone. Is magnesium just too simple and boring?

Barriers to healthy profiling

As this movement towards profiling healthy products vs others is a long-term process, it also becomes evident that many of the clinical studies invested by industry were not designed to substantiate long-term and sustainable benefits for healthy consumers, as these studies may take decades and cohorts before manifestations. That is a barrier for the industry, which should be achieving premium pricing for adding clinical documentation to their ingredients.

"The industry should be achieving premium pricing for adding clinical documentation to their ingredients."

Another hurdle is to understand at what level we have documentation, as academic institutions' public relation activities may lead consumers, as well industry, to believe that new findings and evidences are established and consolidated.

When academics relate to the health and industrial potentials, they typically think abstract and long term, but may not be interpreted that way by others.

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