Soy protein suppliers have reacted with disappointment to a decision by the European Food Safety Authority (EFSA) to reject a health claim application for soy and cholesterol reduction.
A group of industry trade bodies submitted an Article 14 disease reduction claim stating that soy “reduces blood cholesterol and may therefore reduce the risk of coronary heart disease”. However, EFSA – which is assessing all claims submitted under the EU’s Nutrition & Health Claims Regulation – rejected the dossier on the basis that the 40 studies submitted by the applicants “do not support an effect of the protein component of soy on LDL-cholesterol concentrations.”
The agency took issue with most of the studies on the basis that they either tested the benefits of soy protein isolate, rather than pure soy protein, or involved soyfoods that also contained other constituents. But the European Natural Soyfood Manufacturers Association and the European Vegetable Protein Federation, two of the bodies behind the dossier, said that the positive effect of soy protein on blood cholesterol had been “scientifically proven in several studies” and pointed out that the health claim submitted had already been approved in the past by several EU member states individually. They were, they added, “considering all legal possibilities provided for in the claims evaluation procedure to further clarify [the] claim to the EU regulator.”
Solae, one of the world’s largest soy suppliers, described EFSA’s negative opinion as “disconcerting”. Elaine Krul, science fellow & lead, molecular nutrition at Solae, said: “Based on a great body of scientific evidence related to soy protein and heart health and numerous approved soy protein and cholesterol reduction health claims in 12 countries, we are disappointed with EFSA’s opinion to not approve a similar claim in Europe. “Solae is preparing comments to submit during the thirty-day comment period. We will also work with our industry partners and organizations to continue to demonstrate the strong relationship of soy protein and the reduction of cholesterol based on the significant amount of published scientific evidence that continues to emerge.”