Speaking to FoodManufacture.co.uk after EFSA published an opinion stating that the applicants had failed to establish that eating soy protein helped reduce LDL (’bad’) cholesterol, HarlandHall Associates boss Janice Harland said a “number of options” were being explored in order to achieve an acceptable claim.
The sticking point of the application, which was lodged under article 14 of the EU health claims Regulation, related to EFSA’s definition of soy protein, which excluded soy protein isolates and isoflavones.
This was not consistent with definitions accepted by standards body Codex, the US Food and Drug Administration or the now-defunct UK Joint Health Claims Initiative, said Harland.
“What’s been really disappointing is EFSA’s incredibly narrow interpretation of soy protein. On EFSA’s request, we did send over a lot of additional information and analysis about studies on soy protein isolates and isoflavones, so we were a little surprised at the end of the process that they hadn’t taken on board that particular set of data.”
Cutting the cloth in a different way
However, by “cutting the cloth in a different way” – either by broadening or narrowing the definition of the active ingredient in question – there was still a good chance of being able to support some kind of claim under one of the articles (13.1, 13.5 or 14) of the Regulation, given the large number of high-quality studies looking at every component of soy, said Harland.
But she also accepted that the soy protein definition issue that had scuppered the article 14 application could potentially thwart an article 13.1 application that EFSA has yet to assess, which refers to soy protein and cholesterol control.
The applicants - the Soya Protein Association, the European Vegetable Protein Federation and the European Natural Soyfood Manufacturers Association - have 30 days to provide comment to the European Commission, which ultimately decides whether to approve claims assessed by EFSA.
For a more detailed analysis of the opinion and reaction from the applicants from our sister publication NutraIngredients.com click here.