The comments were made in an analysis of EFSA’s latest batch of article 13.1 opinions, sent yesterday to the European Commission by the European Responsible Nutrition Alliance (ERNA), the European Health Products Manufacturers (EHPM) and the European Botanical Forum (EBF).
The groups said the way in which EFSA assesses health claims “is disproportionate and not adapted to food research”, and that it “clearly fails to qualify the level of evidence underlying a health effect by an assessment of the totality of the evidence and weighing it.” They called on the Commission not to proceed with the adoption of any decisions until an assessment of EFSA’s approach is conducted.
Disease risk reduction
“The regulation foresees three different procedures, reflecting the different nature of the claims. We see that all claims are now considered in the same way and that only claims that show improvements of disease related end points have a chance of being considered positively. This was not the intention of the law and there is an urgent need to reconsider this before any decisions are taken,” said ERNA Vice-chair Keith Legge.
EFSA has so far only issued positive 13.1 opinions on essential nutrients or on compounds that relate to the reduction of a disease risk, state the comments sent to the EC’s Basil Mathioudakis. Other well recognised food components have received negative opinions, including glucosamine, chondroitine, alpha-lipoic acid, lutein and beta-carotene.
“EFSA addresses all claims by the same principles that are adopted for the extreme end of the claims spectrum: reduction of disease risk claims with an exclusive focus on the reduction of validated end points or biomarkers, that serve as risk factors to human diseases (cholesterol, bone loss, oral pH, etc),” write the groups.
This approach applied to foods is therefore similar to the one applied to pharmaceutical products, they said. “It leads to an unwanted medicalisation of food and a narrowing of the borderline between foods and medicinal products.”
“Food supplements are concentrated forms of substances intended to supplement the diet. It is imperative that the role of these substances and the contribution they can have for health can be communicated to the consumer, without them being turned into medicinal products. The adopted approach by the EFSA scientists makes such communication impossible,” write the groups.
EHPM, ERNA and EBF plan to raise these comments at the stakeholders meeting on health claims, due to be held on June 1.