“It is disconcerting that the EFSA panel considers the studies cited and analysed in nine peer-reviewed meta-analyses (based collectively on the existing soy protein and cholesterol literature) to not be designed appropriately to assess the effects of soy protein on cholesterol lowering,” the company said.
Solae Europe managing director Reinhart Schmitt told NutraIngredients this morning that while the company was disappointed with the opinion of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), “it would not keep us from selling our product”.
Pure and formalistic approach
“EFSA have not said that soy cannot lower cholesterol rather they have said that there is insufficient evidence to prove that soy protein causes cholesterol reduction,” Schmitt said.
“They have taken a very narrow view of what a soy protein is so that soy isoflavones which they acknowledge can lower cholesterol, and soy protein isolates are not considered within their definition of soy protein. I am a chemist and I can understand their pure and formalistic approach but it is in defiance of the procedures of many other agencies around the world.”
The NDA opinion can be found here.
Defining soy protein
Two of the trade groups that participated in the submission – the European Vegetable Protein Federation (EUVEPRO) and the European Natural Soyfoods Manufacturers Association (ENSA) – issued statements highlighting the soy protein definition issue.
“EUVEPRO will contribute to clarifying scientific interpretations to the European Commission and EFSA NDA Panel in order to provide more clarity and precision on the definition of the term ‘soy protein’ as well as the mechanism by which the protein component of soy would exert the claimed effect,” EUVEPRO said.
The soy industry has noted how the NDA definition of soy protein differs from that of other agencies and the Codex Alimentarius which includes soy protein isolates, soy protein concentrates and soy protein flour in its official definition.
EUVEPRO and ENSA, along with Solae and others such as the UK-based Soy Protein Association, said they would submit comments to the Commission in the 30-day comment period.
Jean Christoph Kremer from EUVEPRO – which counts ADM, Cargill and Solae among its members – said the group was surprised by the opinion.
“We thought the dossier was strong enough,” he said, even after the NDA came back with additional questions regarding the data. “We were feeling comfortable. This is not good news but we will react firstly by submitting comments to Commission.”
Solae’s Schmitt said the company did not expect the NDA panel to change its opinion even after the comment period but that the Commission and member states may interpret the opinion more favourably due to them.
The comments may also have a bearing on two generic, article 13.1 soy-cholesterol lowering dossiers that are yet to be assessed by the NDA.
Soy-cholesterol lowering claims are approved in Japan, the US, the UK, South Africa, the Philippines, Brazil, Indonesia, Korea, Malaysia and Turkey.