EFSA Publishes Final Batch of Health Claims, Soy Isoflavones Take a Beating

The European Food Safety Authority (EFSA; Parma, Italy) published 35 Article 13 health claims opinions last week, its final batch excluding opinions for botanical ingredients. Of note, numerous health claims submitted for soy isoflavones were rejected.

Among other claims, EFSA concluded that a cause-and-effect relationship had not been established between soy isoflavones and the following conditions: protection of DNA, proteins, and lipids from oxidative damage; maintenance of normal blood LDL-cholesterol concentrations; and reduction of vasomotor symptoms associated with menopause. EFSA also turned down claims for “cardiovascular health,” stating that the condition was not sufficiently defined; and for prostate cancer, rejecting the disease nature of the claim.

EFSA also rejected bone-health claims: for carbonate and bicarbonate salts of sodium and potassium for maintaining normal bones, and for potassium or sodium salts of citric acid on normal bones.

Claims that fared better were those for creatine. A cause-and-effect relationship was found between creatine and an increase in physical performance during short-term, high-intensity, repeated exercise bouts. However, a relationship was deemed not established between creatine and an increase in endurance capacity or an increase in endurance performance.

Monocolin K from red yeast rice also received a positive nod for maintenance of normal blood LDL-cholesterol concentrations, at the level of 10 mg daily.

EFSA also ruled positively for the effects of slowly digestible starch, compared with rapidly digestible starch, in cereal products on reduced postprandial glycemic response. The application had been submitted by Kraft Foods Europe.

Looking back, the agency states that it reviewed 2,758 food-related general-function health claims, between July 2008 and March 2010, of a total 4,637 claims submitted. It says that 331 claims were withdrawn.

Notably, 1,548 botanical-related health claims have been placed on hold for evaluation.

In a statement announcing its “milestone” completion, EFSA added:

Professor Albert Flynn, Chair of EFSA’s NDA Panel, said: “This very challenging task was completed thanks to the dedication and commitment of the experts on the NDA Panel in collaboration with EFSA staff, who have had to cope with an unprecedented workload, coupled with very tight deadlines and often poor information. 

“Despite these challenges our experts have assessed the claims consistently and fairly to the highest possible scientific standards. All this was achieved within the deadline agreed with the Commission.

“EFSA’s independent evaluation concluded that a considerable number of claims made on foods are backed by sound science, including claims related to a wide range of health benefits.”

The outcomes of evaluations were favourable when there was sufficient evidence to support the claims. This was the case for about one in five claims reviewed, which related mainly to:

  • vitamins and minerals;
  • specific dietary fibres related to blood glucose control, blood cholesterol, or weight management;
  • live yoghurt cultures and lactose digestion;
  • antioxidant effects of polyphenols in olive oil;
  • walnuts and improved function of blood vessels;
  • meal replacement and weight control;
  • fatty acids and function of the heart;
  • the role of a range of sugar replacers (such as xylitol and sorbitol) in maintaining tooth mineralisation or lowering the increase of blood glucose levels after meals;
  • carbohydrate-electrolyte drinks/creatine and sports performance.

Experts issued unfavourable opinions in cases where the information provided did not allow a relationship between the food and the claimed effect to be established. Reasons included:

  • lack of information to identify the substance on which the claim is based (for example, claims on “probiotics”, or on “dietary fibre” without specifying the particular fibre);
  • lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (for example, food with “antioxidant properties” and claims on renal “water elimination”);
  • lack of precision regarding the health claim being made (for example, claims referring to terms such as “energy” and “vitality”, or claims on women’s health or mental energy);
  • lack of human studies with reliable measures of the claimed health benefit;
  • claims referring to food categories which were considered to be too broad, such as “fruits and vegetables” and “dairy products” to be linked to specific effects.