The European Food Safety Authority (EFSA) has come in for renewed criticism from both MEPs and industry over its treatment of health claims.
Last month EFSA released the fourth batch of article 13 ‘general function’ claims under the 2006 Nutrition and Health Claims Regulation (NHCR). Once again, the majority of claims submitted were rejected by the Authority.
EFSA has now assessed 2,150 general function claims, 80% of the claims submitted (excluding claims for ‘botanicals’, which are now being treated separately). To date, under 20% of claims have been approved — ie received ‘positive opinions’
The latest batch of claims assessed (442 in total) relate to health areas such areas oxidative damage to body cells, cognitive and bowel function, and maintenance of normal blood cholesterol levels. ‘Winners’ (claims receiving positive opinions from EFSA) include several sugar replacers — judged to “decrease tooth mineralisation”; caffeine — “increases alertness and attention; meat and fish “can improve iron absorption”; and walnuts — “can help improve function of blood vessels”.
‘Losers’ include claims for several probiotic strains, and for many ingredients and actives used in popular food supplements. For example, L-tryptophan was judged “not to help maintain normal sleep, cognitive function or body weight; Lycopene “does not protect DNA from oxidative damage; ALA does “not maintain normal cardiac function; Charcoal “does not reduce bloating”; EPA/DHA “does not enhance mood; and L-arginine “does not help grow muscle mass”.
EFSA says that where negative opinions were given, the problem typically was with the quality of scientific dossiers. In a statement, the Authority said: “Information gaps included, for instance: the inability to identify the specific substance on which the claim is based; the lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions; or the lack of precision regarding the health claim being made.” In addition, it said, some claims were “outside the scope of the current legal framework.”
“How is it that over 95% of cases of health claims filed for natural or herbal substances received a negative opinion?”
However some MEPs have sharply criticized EFSA’s handling of Article 13 claims, particularly in relation to supplements and botanicals. One MEP, Michele Rivasi, Greens/European Political Alliance (EPA), told nutraingredients.com: “How is it that over 95% of cases of health claims filed for natural or herbal substances received a negative opinion?”
Rivasi went on to reiterate the claim made by many in the food and food supplements industry that the methodologies employed by EFSA are “fundamentally flawed”. He added: “EFSA’s approach is too stringent and based on procedures derived from the drug industry. It takes into account very little scientific evidence and dismisses claims that have been approved in several European countries.
The campaign group, the Alliance for Natural Health (ANH), meanwhile has accused EFSA or “carrying on regardless” and of threatening to create a European marketplace “almost derelict of important health claims information that helps consumers differentiate healthy from less-healthy foods”.
ANH adds that the 80% failure of claims submissions represents “a spectacular failure rate when viewed in the context that these claims will be lost once the NHCR positive list is implemented next year.”
“This is the big one. We could see literally thousands of health claims lost to the health food trade”
At last month’s Natural & Organic Products Europe, HFMA executive director, Graham Keen, warned that the NHCR currently represented the biggest single threat to the health food trade. He told delegates at a special legislation seminar: “This is the big one. We could see literally thousands of health claims lost to the health food trade. It’s the most damaging thing that could happen to our industry. Think about it, if we can’t say anything about our products, there’s a gradual erosion of our whole market.”
• Nutraingredients.com has posted a full list of Batch 4 ‘winners’ and ‘losers’ here.